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I
EXECUTIVE OFFICE OF THE PRESIDENT
16-Oct-1996 08:57am
TO:
Jennifer L. Klein
TO:
Nicole R. Rabner
FROM:
Pauline M. Abernathy
National Economic Council
SUBJECT:
FYI latest HHS breast cancer funding numbers
FYI.
HHS funding for breast cancer in FY97 is $531 million, up from $476 million in
FY96. The FY97 level is $16 milion above our request, but we were still
requesting a significant increase, so I think we can now say we have "doubled"
funding since FY93 ($271 m).
THU 17:30 FAX 2026905673
DHHS/ASPA
002
HHS FACT SHEET
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
October 18, 1996
Contact: HHS Press Office
(202) 690-6343
Office on Women's Health
(202) 690-7650
BREAST CANCER: NEW EFFORTS UNDERWAY
Overview: Breast cancer is the most commonly diagnosed
cancer and the second leading cause of cancer deaths
among American women. There is no proven way to prevent
breast cancer, so early detection, through mammography
and clinical breast exams, and treatment are essential.
For women age 50-69, having regular mammograms can reduce
the chance of death from breast cancer by one third or
more. Despite these numbers, nearly half of women age 50
and older have not had a mammogram in the past two years,
while only 37 percent of women age 65 and older have a
mammogram every two years.
The Clinton Administration has responded to the
significant threat posed by breast cancer with increased
efforts in research, prevention and treatment. HHS
Secretary Donna E. Shalala convened a conference in
December 1993 to establish a National Action Plan on
Breast Cancer. The national plan, which is being carried
out today by the public, private and volunteer sectors,
is a key element of the Administration's commitment to
addressing breast cancer as a high priority concern.
At the same time, federal spending on breast cancer has
been significantly increased since 1993.
And last year, First Lady Hillary Rodham Clinton launched
a campaign urging older women to obtain mammograms, and,
in particular, to promote use of Medicare coverage for
mammography. Both the President and the First Lady have
appeared in TV public service announcements encouraging
older women to get mammography screening.
10/24/96 THU 17:31 FAX 2026905673
DHHS/ASPA
003
-2-
Background: More Women Can Survive Breast Cancer
The lifetime risk of developing breast cancer today is one
in every eight women, up from one in every 20 women just two
decades ago. Although death rates from breast cancer have
been declining in recent years, breast cancer accounts for
31 percent of all cancers among women.
In 1995 alone, approximately 182,000 new cases of breast
cancer were diagnosed in women and 46,000 died from the
disease. Epidemiologic studies estimate that breast cancer
will be diagnosed in 1.5 million American women in this
decade and that breast cancer will claim nearly half a
million lives.
Death rates from the disease are highest among older, black,
and low-income women. During the last 20 years, death rates
from breast cancer for women over 65 increased by 35 percent
for black women and 11 percent for white women. Mortality
rates vary widely among racial and ethnic groups in the
United States. Hispanic, Chinese, Filipino and Japanese
women have annual rates at or below 15 per 100,000 women,
while black, white and Native Hawaiian women have rates
above 25 per 100,000 women.
with proper screening and treatment, however, the chances of
surviving breast cancer are improving. Breast cancer
mortality trends among both black and white women have
improved markedly in the United States since the 1980s.
During the most recent 5-year period of available data (1989
to 1993), the age-adjusted breast cancer mortality rates
fell approximately 6 percent among white women and rose
about 1 percent among black women. By comparison, from 1980
to 1989, rates increased 3 percent among white women and 16
percent among black women.
During the most recent 5-year period, death rates among
white women declined for all decades of age from 30 to
79 years. Among black women, rates were down for all
decades of age from 30 to 69 years. Among both groups,
the greatest improvements in mortality were seen in the
younger age groups. For women aged 30 to 39 years,
rates dropped about 13 percent among whites and 5
percent among blacks. For women aged 40 to 49 years,
rates dropped 9 percent among whites and 2 percent
among blacks.
HHS Spending On Breast Cancer
HHS funding for breast cancer research, prevention and treatment
has increased from approximately $273 million in FY 1993 to an
estimated $531 million in FY 1997. As the Centers for Disease
- More -
10/24/96 THU 17:31 FAX 2026905673
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- 3 -
Control and Prevention (CDC) are working to increase access for
all women to mammography screening and follow up services, the
resources devoted to breast cancer services have increased from
$42 million in FY 1993, to $81 million in FY 1997. Cancer
research is vital to our understanding of how to prevent, detect
and treat breast cancer. The Clinton Administration has invested
in breast cancer research at the National Institutes of Health by
increasing funding from $229 million in FY 1993, to $420 million
in FY 1997. HHS also helps provide treatment for breast cancer
through the Medicare and Medicaid programs and through the Indian
Health Service.
HHS Action To Combat Breast Cancer
Under President Clinton, a wide array of activities are underway
and new initiatives have been launched:
National Action Plan on Breast Cancer
HHS' Office on Women's Health is coordinating the National Action
Plan on Breast Cancer. This first-ever national plan was
developed in 1993 under Secretary Shalala's leadership. The Plan
has awarded over $9 million in grants for 99 innovative research
and outreach projects, with a special emphasis on the development
of public-private partnerships targeted in the six priority
areas:
The Information Action Council Working Group is working to
improve access to information about breast cancer for
consumers, scientists, and practitioners via the Internet
and other information technologies.
The Etiology Working Group is focusing on efforts to expand
the scope and breadth of biomedical, epidemiological and
behavioral research on breast cancer. The group has
identified four priority areas: chemicals and hormones,
viruses, radiation and electromagnetic fields, and lifestyle
factors.
The National Biological Resources Banks Working Group
(NAPBC) has focused on the development of a national
mechanism and standard for obtaining and storing tissue for
multiple areas of breast cancer research. The NAPBC has
awarded funds to establish a national biological resources
bank and is now conducting a survey of tissue banks
throughout the country to identify and determine the
accessibility of all available biological resources.
- More -
005
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- 4 -
The Working Group to Ensure Consumer Involvement has defined
several specific activities to help ensure consumer
involvement at all levels in the development of national
research, education, and service delivery programs related
to breast cancer.
The Clinical Trial Accessibility Working Group has
identified a series of initiatives to address four types of
barriers to participation in clinical trials, including
barriers associated with the informed consent process,
patient and physician misperceptions about clinical trials,
lack of information about the availability of trials, and
cost.
The Working Group on Heredity Susceptibility is evaluating
the ethical, legal and policy issues of individuals carrying
breast cancer susceptibility genes.
Discovery of BRCA1 and BRCA2 Genes for Breast Cancer
Breast cancer research has been expanded at the National
Institutes of Health. Promising news came late in 1994 when a
team of investigators at the University of Utah, Myriad Genetics,
and the National Institute of Environmental Health Sciences
(NIEHS) identified a breast cancer susceptibility gene (BRCA1)
that may account for 5-10 percent of the breast cancers diagnosed
each year. The discovery of a second, entirely different breast
cancer susceptibility gene, BRCA2, has helped us understand even
more about the genetics of breast cancer. Most recently
researchers discovered a particular variant of the BRCA1
susceptibility gene in Jewish women of eastern European descent
(Ashkenazi Jews). While only 5-10 percent of all breast cancers
are the result of an inherited anomaly, these findings hold
promise for the development of new prevention and treatment
strategies.
Other breast cancer research includes psychosocial research,
which looks at how to enhance the quality of life in women with
breast cancer, and the Breast Cancer Prevention Trial, which is
studying ways in which to prevent breast cancer.
National Breast and Cervical Cancer Early Detection Program
The CDC's National Breast and Cervical Cancer Early Detection
Program offers free or low-cost mammography screening to
uninsured, low-income, elderly, minority, and Native American
women nation-wide. The program, which has been operating in an
increasing number of states over the past six years, has
provided screening tests to almost one million medically
underserved women. In October, 1996, the program went
nationwide, with funding for all 50 states.
- More -
006
10/24/96 THU 17:32 FAX 2026905673
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- 5 -
Breast Cancer Among the Elderly
The Agency for Health Care Policy and Research (AHCPR) is
currently funding a five-year Patient Outcomes Research Team
study on the care, costs, and outcomes of early stage breast
cancer. The study
will examine three alternative treatments for early stage breast
cancer in the elderly: modified radical mastectomy, breast-
conserving surgery with radiotherapy, and breast-conserving
surgery without radiotherapy. The project will look at quality
and cost-effectiveness in these projects and will develop clear
recommendations for treating early stage breast cancer in the
elderly.
New Frontiers In Breast Cancer Early Detection
The Department of Health and Human Services has been working with
the Department of Defense, the CIA, NASA, and other public and
private entities to explore ways in which imaging technologies
from other fields may be applied to the early detection of breast
cancer. In particular, the computer technologies that have been
used to improve spy satellites may help improve breast cancer
detection as well. In October, 1996, HHS awarded $1.98 million
to the University of Pennsylvania to conduct a series of clinical
trials of imaging technology from the intelligence community --
originally used for missile guidance and target recognition -- to
improve the early detection of breast cancer.
Centers of Excellence
on October 1, 1996, the Department of Health and Human Services
established six National Centers of Excellence in Women's Health
to serve as national models for improving the health care of
American women. The new Centers of Excellence program, with
facilities located at academic institutions in different areas of
the country, will integrate health care services, research
programs, public education and health care professional training.
Mammography Clinical Practice Guidelines
Recognizing the importance of the quality of screening mammograms
in the early detection of breast cancer, the AHCPR in October
1994, developed a Clinical Practice Guideline--Quality
Determinants of Mammography--with separate versions for
mammography providers, health care professionals, and consumers.
The guidelines define the areas of responsibility for each member
of the health care team delivering mammograms, including women
themselves.
- More -
007
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- 6 -
Mammography Standards
New regulations were put in place in 1992 to ensure that all
women have access to high quality mammography services. The
roughly 10,000 mammography facilities nationwide accredited by
the FDA must meet quality standards for equipment and personnel,
and are inspected annually.
These regulations spell out the details for requiring facilities
to hire capable technicians, use quality equipment that produces
clear images, and employ skilled radiologists to interpret the
results. The rules also require that doctors and patients be
fully and quickly informed of results so that any follow-up
testing or treatment can begin immediately. The names and
locations of FDA certified mammography facilities are available
by calling the Cancer Information Service at 1-800-4-CANCER.
Environmental Factors and Breast Cancer
HHS' Office on Women's Health has established a Federal
Interagency Coordinating Committee on the Environment and Women's
Health that focuses on how home, work, atmospheric pollutants,
exogenous hormones, drugs, and other environmental factors may
contribute to the risk of breast cancer and other disorders.
###
09/30/96
18:44
USPHS OWH -> 94569412
NO. 088
001
Attn: Jennifer Klein
Here's the information about the clinical trials on breast cancer imaging.
Jacci Duncan, 202/401-9545
Clinical Trials
The U.S. Public Health Service's Office on Women's Health, in a unique collaboration
with the CIA, has awarded $1.98 million to the University of Pennsylvania to conduct a series of
clinical trials of imaging technology from the intelligence community -- originally used for
missile guidance and target recognition -- to improve the early detection of breast cancer.
Over the last two years, the Public Health Service's Office on Women's Health, within
the Department of Health and Human Services, has been exploring how our national
investments in defense, space and intelligence technologies can be used to improve breast cancer
detection techniques. Research results from this initiative indicated there was a strong potential
for adapting the high-tech imaging capabilities of the CIA and the Department of Defense --
estimated to be some 10 years ahead of medical imaging, to improve the early detection and
diagnosis of breast cancer.
Clinical trials mark a turning point in the progress of transfering imaging technologies
from other fields to improve breast cancer detection. The trials mean we can now start applying
what we've learned at the research bench to the clinical setting, with the hope of finding breast
cancer at an earlier stage when there is the greatest hope for eeffective treatment and better
survival.
Contact:
Susan Blumenthal, M.D., M.P.A., Deputy Assistant Secretary for Women's Health
U.S. Public Health Service's Office on Women's Health
09/30/96
18:44
USPHS OWH -> 94569412
NO. 088
002
THE U.S. PUBLIC HEALTH SERVICE'S OFFICE ON WOMEN'S HEALTH
LAUNCHES "CENTERS OF EXCELLENCE IN WOMEN'S HEALTH"
The U.S. Public Health Service's Office on Women's Health, within the Department of
Health and Human Services, has announced the establishmentof six National Centers of Excellence
in Women's Health to serve as national models for improving the health care of American women.
The National Centers of Excellence in Women's Health, located at academic institutions in
different areas of the country, will serve as demonstrations and models which can be evaluated and
duplicated throughout the nation. The Centers will integrate health care services, research programs,
public education and health care professional training, as well as forge links with health care services
in the community.
"The National Centers of Excellence in Women's Health will be innovative models of one-
stop shopping for women's health care, and at the same time they will provide an integrated research
agenda, and community and professional leadership for women's health," said Susan J. Blumenthal,
M.D., M.P.A., Deputy Assistant Secretary for Women's Health and Assistant Surgeon General.
The Centers represent a public-private partnership between HHS and the academic
institutions. The U.S. Public Health Service's Office on Women's Health is providing $1 million to
support the centers.
Women served by the National Centers of Excellence in Women's Health will have all of
their health care needs met in one place by having access to comprehensive services and resources.
In addition, the centers will develop a multidisciplinary research agenda across medical specialties;
focus medical education on gender differences in the causes, treatment and prevention of disease;
and use new information technologies to bring cutting edge women's health information to the public
09/30/96
18:44
USPHS
OWH
94569412
NO. 088
003
and health care providers. The Centers will also develop leadership strategies to foster recruitment,
retention and promotion of women in academic medicine.
"Until six years ago, women's health was seriously neglected in research, health care service
delivery, and public and health care professional education," Dr. Blumenthal said. "Since 1990, a
new national focus on women's health, reflected in numerous initiatives in the public and private
sectors, is brightening the prospects for a healthier future for American women. The purpose of the
National Centers of Excellence is to facilitate this progress through increased knowledge, improved
treatment and prevention of discases in women. "The Centers of Excellence will provide the
following women's health resources and services:
An integrated one-stop shopping center for the delivery of clinical health care services to
women.
Emphasis on preventive care.
Emphasis on psychosocial issues in health.
A research agenda on women's health issues.
Strategies to promote women's participation in clinical research trials.
Coordination and linkage between clinical services in academic centers and surrounding
communities.
Educational programs and materials for the general public and health care professionals on
women's health, using new cutting edge information technologies and telemedicine
approaches.
The integration of a women's health curriculum into medical school education.
A leadership plan to foster the recruitment, retention and promotion of women in academic
medical careers.
Networking within the community to form alliances with business groups, consumer groups,
scientific organizations and public policy leaders.
09/30/96
18:44
USPHS OWH -> 94569412
NO. 088
004
The U.S. Public Health Service's Office on Women's Health is the focal point for women's
health within the Department of Health and Human Services, providing national leadership in
advancing women's health in public policy, research, service delivery and education. The Office acts
as a catalyst for developing new national and regional initiatives to improve women's health in the
United States and internationally.
September 24, 1996
MEMORANDUM TO MELANNE VERVEER
JENNIFER KLEIN
NANCY ANN MIN
LYNN HOGAN
FROM:
BARBARA WOOLLEY
RE:
NATIONAL BREAST CANCER COALITION POLICY PLATFORM
Thought you might be interested in the National Breast Cancer Coalition Breast Cancer Policy
Platform.
TO: 94566682
SEP-24 96 10:44 FROM:
/ he National Breast Cancer Coalition believes that the following policies must be implemented in order 10 continue 10 make
program against breast cancer and ultimately, 111 eradicate the disease.
ON
The United States Congress must appropriate $2.6 billion for high quality, peer-reviewed breast cancer
research. by the year 2000.
Two
The United States Congress and the President of the United States must continue support for the
Department of Defense peer-rcviewed breast cancer research program. under the strategies recommended
by the Institure of Medicine.
THREE The United States Congress and the President of the United States must commit to continued. increasing
appropriations for biomedical research through the National Institutes of Health and the National Cancer
Institute and implement or expand programs in fund quality. pect-reviewed breast cancer research through
all appropriate agencies and departments. such as the Environmental Proteccion Agency and the Veterans
Administration.
FOUR
The President of rhe United Scares and the United States Congress must expand the federal commitment
to eradicating breast cancer through increased outreach and education programs and the regulation and
provision of creatment and other services, in all agencies and departments. including the Environmental
Protection Agency. che Cencer for Disease Control, the Health Care Financing Administration, the Department
of Education, the Department of Defense and the Veterans Administration.
FIVE
The President of the United States should concinue support for a national action plan on breast cancer
char is a public/private partnership. under the leadership of the National Breast Cancer Coalition.
Six
The laws. regulations and policies of the United States must mandate universal access to high quality
health care.
SEVEN All women of appropriate age should have access to high quality. screening mammography at
appropriate intervals.
EIGHT Discrimination in the provision of health insurance or employment based (in pre-existing condicions or
predisposition to disease must be eliminated.
NINE Third party payment of all coses. including all medically necessary care, incurred by participation in
approved clinical trials and investigational studies must be mandated
THN
The laws of the United Scares and regulations of all federal and state agencies and departments chai
impact breast cancer, musc mandate the inclusion of representative consumers in all decision making.
January. 1996
National Breast Cancer Coalition Breast Cancer Policy Platform Statement of Endorsement
I,
Jn endorse and
,
(position/candidare for)
pledge my support for the National Breast Cancer Coalition's Breast Cancer Policy Platform.
Signature
Date
Representing
07/29/96 15:25
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FAX COVER
Health and Personnel Division
Executive Office of the President
Office of Management and Budget
OEOB, Room 262
Washington, D.C. 20503
THE
DATE:
TO:
Jennifer Klein
AGENCY:
FAX NO:
6- 4-2878 2878
FROM:
Nancy-Ann Min
Associate Director for Health and Personnel
Phone Number (202) 395-5178
Fax number (202) 395-9119
Number of pages (including cover) 2
COMMENTS:
can if you have questions or need
additional information
- Sarah B.
07/29/96
15:26
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President Clinton's Commitment to Breast Cancer Research
*Since the President took office, National Institutes of Health funding for breast cancer research
has increased from $229 million to $410 million, a 79% increase over four years.
*Department of Defense breast cancer research funding moved from $206 million in Fiscal Year
1993 to $0 in the Fiscal Year 1997 budget.
*Total Federal breast cancer research rose from $436 million in 1993 to $478 million in 1996, an
increase of $42 million.
*Total Federal breast cancer research moved from $436 million in FY 1993 to $410 million in FY
1997, a decline of $26 million.
Federal Breast Cancer Research Funding
YEAR
National Institutes
Department of
Total Federal
of Health
Defense
Spending
FY 1993
$229 million
$207 million
$436 million
FY 1996
$403 million
$ 75 million
$478 million
FY 1997
$410 million
$ 0
$410 million
002
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NIH BREAST CANCER RESEARCH FUNDING
Millions
$500
2403 $409
$400
$504
$306
$300
$229
$200
$155
$101
$100
$80
$88
$76
$0
1988 1989 1990 1991 1992 1993 1884 1885 1655 1897
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PE . 118
NATIONAL INSTITUTES OF HEALTH
Breast Cancer Spending/Action Plan
QUESTION:
What is included in the 1997 NIH request for breast cancer
research? What is the status of the National Action Plan on
Breast Cancer (NAPBC)
ANSWER:
BUDGET: NIH will devote $409 M to breast cancer research and
education in 1997, a $6.3 M (+1.6%) increase over 1996. and a
$181 M (+79%) increase over 1993. This includes maintaining
the $20 M within the NCI budget to support the Secretary's
National Breast Cancer Action Plan. [See note next page on
spending changes.]
"ACTION PLAN" ACTIVITIES:
In the 18 months since the Secretary's Conference to
Establish a National Action Plan on Breast Cancer (NAPBC),
a public/private partnership has been created to meet the
objectives outlined by this Conference.
Six priority areas were identified and Working Groups for
each have been formed to implement the Plan's goals:
- Hereditary susceptibility.
- National biological resources banks.
- Etiology.
- Clinical trials accessibility.
- Ensuring consumer involvement.
- Information action council.
Efforts to implement the NAPBC have been focused primarily
around a combination of grants for innovative breast
cancer research and outreach projects, and workshops.
Recent major activities include:
Awarded $9.2 M for innovative projects to 55 grantees in
September 1995, out of 610 applications reviewed.
- Convened a workshop on Genetic Information and Health
Insurance and produced a list OI recormendations for
publication in Science magazine.
Convened a workshop on Hormones, Hormon. metabolism, and
Breast Cancer, which identified potential new areas for
research.
- Awarded a contract to conduct a survey on biological
resources accessibility and to establish à national
database of tissue sources.
- Compiled an inventory of breast cancer-related
information on the Internet.
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ADDITIONAL INFORMATION:
NOTE: SPENDING CHANGE: Following its review in 1995 of breast
cancer research proposals, NIH is now projecting Lower spending
levels in breast cancer research. According to NIH, fewer righ
quality research grant proposals were received than expected,
and as a result, 1995 spending totaled $364 M compared to the
planned $377 M. NIH now projects breast cancer spending in
1996 to be $403 M, instead of the $426 7. plan cz 10 year ago.
Incidence: Breast cancer affects one of every eight women in
the U.S., and represents 32% of all cancers in wamen.
Progress: Much progress is being made in our battle against
breast cancer:
Three genes linked to hereditary breast cancer have been
discovered in the last two years.
Breast cancer screening rates are the highest in history;
Breast cancer mortality has begun to decline down 5% since
1989, the largest short-term decline in &0 yealo thanks to
advances in chemotherapy, hormonal treatments, and access to
and use of screening mammography.
Clinical trials using tamoxifen have decreased breast cancer
recurrence by as much 28 50%.
Breast Cancer Awareness Campaign: The National Cancer
Institute and the U. S. Postal Service are joining forces to
spread the word about breast cancer. The Postal Service will
issue 100 million Breast Cancer Awareness stamps this year as
the centerpiece of a nationwide awareness campaign from ite
post offices across the country. NCI's Cancer Information
Service toll-free number (1-800-4-CANCER) will appear on the
border of each sheet of stamps as the source tor information on
breast cancer.
CDC Breast/Cervical Cancer Prevention: For 1997, CDC expects
to spend $125 M for breast and cervical cancer prevention, the
same level as in 1996, and & 75% increase over 1993. Beginning
in 1996, the CDC Breast and Cervical Cancer Early Detection
Program will be implemented in all 5C States and $ Indian
tribes or tribal organizations.
National Action Plan on Breast Cancer:
In October 1993, President Clinton was presented with a
petition signed by 2.6 million people calling for the
establishment of a strategy to end the breast cancer
epidemic.
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on December 14-15, 1993, 300 individuals attended the
Secretary's Conference to Establish a National Action Plan
on Breast Cancer- (NAPBC), including many of the country's
leading experts in breast cancer research, education and
health policy.
"The Proceedings of the Secretary's Conference to Establish
a National Action Plan on Breast Cancer" provided a
framework and plan for activities.
This is not a Federal plan, but a national operational
strategy, promoting partnerships among public, private and
profit sectors to solve problems and coordinate actions
related to breast cancer.
Many of the activities called for 1= the NAPSC will be
carried out directly by or through partnerships with
private industry; Federal, State, and community health
organizations; consumer groups: researchers; health
professionals; the media; advocacy groups; and voluntary
organizations.
Dr. Susan J. Blumenthal, Deputy Assistant Secretary for
Women's Health; and Frances Visco, President of the
National Breast Cancer Coalition, are NAPBO co.chairs.
PKS's Office of Women's Health will coordinate the Plan's
implementation.
NIN Breast Cancer Spending
(Dollars in millions)
1995
1956
1997
Change
& Che
NCI
$308.7
$336.8
$361.0
-54.2
+1.3%
NHLBI
1.3
1.3
1.4
+0.1
45.08
NIDDK
17.9
18.6
18.6
-0.2
+1.1%
NIGMS
10.9
14.7
14.9
+0.2
+1.2%
NICHD
5.4
5.7
5.8
+0.1
-2.8%
NEI
0.7
0.7
0.5
+0.1
+1.6%
NIEHS
5.0
8.5
9.6
+1.1
-13.5%
NIA
1.7
2.6
2.€
-2.0
+1.6%
NIMH
1.0
1.3
1.2
-0.1
-2.9%
NIAAA
0.8
0.9
0.9
..
NINR
2.5
2.6
2.7
+0.1
+1.5t
NCRR
1.1
1.2
1.2
NCHGR
6.8
8.2
8.5
+0.3
+3.25
FIC
0.1
0.1
01
Total, NIH
$363.9*
$403.2*
$403.5
+$6.3
+1.6%
"
Last year's spending plan was $399.1 M in 1995 - 5.26.2 F. in 1996.
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NATIONAL ACTION PLAN ON BREAST CANCER
QUESTION: Senator Specter wrote to you on May 24 regarding Senate report
language directing that NCI designate $14.5 million for implementation of the
National Action Plan on Breast Cancer. What is the status of this funding?
ANSWER: I am committed to continuing to expand our effors in breast cancer
research and to fully implementing the National Action Plan. Thus far, we have
spent $5.0 million in FY 1996 for continuation funding of research grants and related
management costs.
We are currently programming the remaining $9.5 million to be used for rien
research grants and further planning and related activities. The Director of the
National Cancer Institute has advised me that there are sufficient quality research
proposals which address the priorities in the Plan and will result in us spending at
least $14.5 million this year.
04/12/96 13:47
703 695 8691
DASG-RDZ/SARD-TM
4.
001/002
1
DEPARTMENT OF THE ARMY
OFFICE OF THE ASSISTANT
SURGEON GENERAL
(RESEARCH AND DEVELOPMENT)
ROOM 3E368, PENTAGON
(703) 695-5615
Fax: (703) 695-8691
FAX TRANSMISSION COVER SHEET
Date: April 12, 1996
To:
JENNIFER KLEIN
Fax:
202-456-2878
Re:
Breast Cancer Research Funding
Sender: LTC TERRY RAUCH
YOU SHOULD RECEIVE 2 PAGE(S), INCLUDING THIS COVER SHEET. IF
YOU DO NOT RECEIVE ALL THE PAGES, PLEASE CALL (703) 695-5615.
1
BREAST CANCER FUNDING PROFILE
($M)
REQUEST APPROPRIATION CONGRESSIONAL
13:47 04/12/96
ADD
FY 92
0
25.0
25.0
FY 93
0
210.0
210.0
FY 94
0
30.0
30.0
FY 95
0
150.0
150.0
3703 8691 895
DASG-RDZ/SARD-TM
002/002
PEHB/OLCA,NCI
ID:3014021225
APR 22'96 18:06 No. 009 P.01
NATIONAL CANCER INSTITUTE
PLANNING, EVALUATION, AND ANALYSIS BRANCH
OFFICE OF PROGRAM OPERATIONS AND PLANNING
DATE: 4-22-96
TO:
Jennifer Klein
FAX NO. 707-456-7878
FROM: Anne Middleswarth
Building 31, Room 11.A21
National Cancer Institute, Bethesda, MD 20892
FAX NO. 301-402-1225 TELEPHONE NO. 301-496-5515
Cover Sheet + 7 Page(s) Transmitted
ADDITIONAL COMMENTS:
Here's breast cancer information as requested
PEAB/OLCA.NCI
ID:3014021225
APR 22'96
18:06 No.009 P.02
April 22, 1996
NOTE TO JENNIFER KLEIN RE NCI BREAST CANCER INFORMATION
In response to your request to Ed Sondik, here is information about selected research and other
activities related to breast cancer that are supported by the National Cancer Institute. Feel free to
contact me if you have questions about the material or would like more information.
There are numerous NCI Fact Sheets on breast cancer topics that are accessible through
Worldwide Web. You can type the address http://www.nih.gov/ to get to the NIH Home Page.
Then click on Health Information, then click on NIH Gopher Cancernet Menu. Fact Sheets are
one of the choices on the Cancernet Menu. (We can send you fact sheets, too, if the computer
route doesn't work for you.)
Hope this is helpful.
Anne Middleswarth
Anne Middleswarth
Planning, Evaluation and Analysis Branch
Office of the Director, NCI
(301) 496-5515
PEAB/OLCA.NCI
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APR 22'96
18:07 No 009 P.03
NATIONAL CANCER INSTITUTE BREAST CANCER RESEARCH
Breast cancer is the second leading cause of cancer death in women, and comprises about 30
percent of all female cancer cases with 184,300 new cases and 44,300 deaths estimated for 1996.
NCI-supported breast cancer research activities include basic research and investigations to
improve prevention, early detection and diagnostic technology, treatment, rehabilitation, and
community outreach. Selected NCI breast cancer data and research activities follow.
Incidence Data: White women have the highest incidence rates of all racial/ethnic groups at
112.8 per 100,000 women. Hawaiian women are next with a rate of 105.6, followed by black
women with a rate of 97.3 per 100,000. Since 1973, there has been a 24% increase in incidence
(all races), but it appears that the increase leveled off after 1987. The increase is largely due to
increased incidence in women age 50 and over.
Mortality Data: Breast cancer mortality in all American women declined from 27.5 per
100,000 to 25.9 per 100,000 between 1988 and 1993; the decrease was most prominent among
younger women. Racial differences in the rates exist. For all ages combined, mortality rates for
black women are higher than those for white women (31.3 compared to 26.6 per 100,000). In the
period from 1989 to 1993, breast cancer mortality decreased about 6% for white women, but did
not decline for black women. Research is underway to understand these and other ethnic
differences and to determine how risk factors, access to screening and early detection, treatment
and medical follow-up, and supportive care influence cancer rates.
Hereditary Breast Cancer: Researchers, supported in part by NCI, cloned and sequenced
BRCA1, a breast and ovarian cancer susceptibility gene on chromosome 17. In high-risk
families, women who carry mutations in BRCA1 have an 80-90 percent lifetime risk of breast
cancer, and a 40-50 percent risk of ovarian cancer. Another breast cancer susceptibility genc,
BRCA2, has been mapped to chromosome 13; mutations in this gene do not appear to increase
risk of ovarian cancer.
NCI-supported scientists, in collaboration with researchers from the National Center for Human
Genome Research (NCHGR) and the extramural community, have identified a specific BRCAI
mutation (185delAG) in nearly 1 percent of blood samples collected from women of Ashkenazi
(Eastern European) Jewish descent. This is the first evidence that an alteration in the BRCA1
gene is present not only in families at high risk for breast cancer, but in a subgroup of the general
population. This mutation may account for as much as 16 percent of breast and 39 percent of
ovarian cancers in Ashkenazi Jewish women age 50 and under.
NCI is funding a new "snapshot" study in the Washington, D.C. metropolitan area to estimate the
risk of breast and ovarian cancer associated with the 185delAG deletion in Ashkenazi Jews,
outside of high risk families, by collecting blood samples and information on the personal and
family medical histories of study participants.
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To facilitate research on genetic predisposition to cancer and to address information and
education needs of the public and health care providers regarding gene mutations and cancer,
NCI is forming a Cancer Genetics Network. This national infrastructure will allow wide access
to genetic testing for cancer predisposition and supply information to individuals who seek and
receive testing, health care providers, and researchers. As envisioned, this network will be wide-
ranging yet highly interconnected to facilitate access to genetic testing, aid research efforts, and
make educational materials and other information relevant to cancer genetics readily available.
In conjunction with the NCHGR, the National Institute for Nursing Research, and the National
Institute of Mental Health, NCI is funding a Cancer Genetics Studies Consortium to conduct
multidisciplinary research to examine the psychosocial and clinical impact of using testing for
genetic alterations in families with heritable breast, ovarian, and colon cancer. Objectives of this
research effort include:
identifying individuals who are most likely to benefit from genetic counseling for
heritable cancer risks; and
determining the best ways to educate people who are considering genetic tests for
cancer risk assessment and how to counsel those who are tested.
NCI supports a network of organizations that comprise a Cooperative Family Registry for
Breast Cancer (CFRBC). The purpose of the registry is to collect pedigree information,
epidemiologic and clinical data, and biological specimens (such as blood and tissue samples)
from patients with a family history of breast cancer in order to provide resources for
epidemiologic and interdisciplinary studies. The registry also will help identify women at high
risk for brest cancer who might benefit from new preventive and therapeutic strategies.
Screening Mammography Rates: Data from the 1992 National Health Interview Survey show
that 36 percent of women in the United States had screening mammography in the year
preceding the survey. 68 percent of women reported yes when asked had they ever been
screened with mammography. These rates show an increase from 1989 when only 17 percent of
women had a mammogram within the previous year and 38 percent had ever had a mammogram.
Research on Screening: Research shows that regular screening mammography significantly
reduces the death rate from breast cancer in women over the age of 50. Trials performed over the
past 30 years to determine whether regular screening mammography can save lives do not
answer definitively the question of the value of screening mammography in younger women.
There is no question that mammography is often able to detect breast cancer in women under the
age of 50, but the extent to which finding those cancers will translate into saved lives is
uncertain.
NCI has provided partial support for a study in the United Kingdom which is looking at the
efficacy of screening in women 40-49. At a meeting in March 1996, researchers re-cxamined the
data from Swedish studies regarding the mortality benefit of screening mammography in women
ages 40-49. NCI hopes that further analysis of these promising data, some of which have not
2
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been published, along with NCI's own meta-analysis of past studies will determine the benefit of
screening mammography in these women.
Although regular screening with mammography is known to reduce breast cancer deaths among
women aged 50 and over, many in this age group do not get mammograms on a regular schedule.
Researchers are testing ways to reach this population through behavioral strategies such as
telephone counseling, tailored print communications, and programs through community
organizations. These efforts focus especially on lower income, older, and minority women.
NCI continues to support research to develop imaging technologies with greater sensitivity and
specificity than conventional mammography such as digital mammography, computer-aided
diagnosis, magnetic resonance imaging, nuclear medicine, digital ultrasound, PET imaging, and
optical imaging.
The Mammography Quality Standards Act, which became effective October 1, 1994, and the
quality mammography guidelines published by the Agency for Health Care Policy and
Research help ensure that mammography in the U.S. is of high quality. The Mammography
Quality Standards Act (enforced by the Food and Drug Administration) requires facilities that
offer mammography to meet certain requirements for equipment, staff expertise, and quality
control procedures and to be certified. The guidelines tell women what to look for in the facility
where they get a mammogram, including examination, interpretation, and reporting procedures.
All FDA-certified facilities are listed in NCI's Physcian Data Query (PDQ) system and are
available through the Cancer Information Service, reached at 1-800-4-CANCER.
Breast Cancer Prevention Trial (BCPT): The BCPT is studying the ability of tamoxifen to
prevent breast cancer in women at high risk, and includes women with ductal carcinoma in situ
(DCIS) and lobular carcinoma in situ (LCIS), conditions that may precede development of
invasive breast cancer. About 280 centers are participating in this study which will accrue
16,000 women to a randomized trial. Participants take either tamoxifen or a placebo daily for
five years. Neither the participants nor their physicians know which pills they are assigned. As
of the end of January 1996, 11,837 women have been randomized to the trial. The informed
consent includes all known information about tamoxifen-associated risks, and has been updated
to include new information.
Adverse Effects of Tamoxifen Use: Since clinical trials have shown that tamoxifen can
increase the risk of endometrial cancer, NCI advises women to report any unusual vaginal
bleeding while taking tamoxifen, and recommends an annual examination by a gynecologist. A
board of scientists convened by the International Agency for Research on Cancer (IARC)
reviewed published reports on the potential cancer risk of tamoxifen and determined that "there
is conclusive evidence that tamoxifen reduces the risk of contralateral breast cancers" in women
with breast cancer, and that there is evidence for an increased risk of endometrial cancer in
women receiving tamoxifen. They also report that there is a lack of evidence in humans that
tamoxifen increases the risk for other cancers.
3
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Treatment: Validating promising breast cancer therapies in clinical trials is a high priority for
NCI. When a trend becomes apparent in these trials, NCI advises investigators and physicians to
modify or stop their trials or treatment regimens. In November 1995, NCI distributed a clinical
announcement to 22,000 oncologists nationwide recommending that physicians limit tamoxifen
use in the treatment of early breast cancer to 5 years. This followed a decision by the
National Surgical Adjuvant Breast and Bowel Project (NSABP) to stop a clinical trial in which
investigators found no additional benefit for women being treated for breast cancer who took
tamoxifen for more than five years. A Scottish trial found that women who stopped taking
tamoxifen after 5 years had a lower rate of breast cancer recurrence than the group receiving
treatment for more than 5 years. NCI stresses that, for women with early stage breast cancer,
treatment with tamoxifen confers a proven survival benefit when given as an adjuvant
(additional) therapy for up to five years following breast cancer surgery.
Research is underway to define the predictive value of newly identified markers such as genes
or gene products. We are finding that the absence or presence of certain proteins can indicate
that a tumor is more likely to recur or to be more aggressive. Learning to read these molecular
signs will enable us to tailor treatments to individuals. For example, women whose breast
cancers express high levels of the oncogene c-erbB-2 appear to experience more aggressive
tumor development, and higher treatment intensity may be more effective than low intensity
treatment.
Studies suggest that the chance of cure for women with advanced breast cancer or with adverse
prognostic indicators may be increased by a higher dose of chemotherapy, but this may be toxic
to the patient's bone marrow, thereby increasing the likelihood of infections. Autologous bone
marrow transplantation (ABMT) can reduce this complication. NCI is sponsoring randomized
clinical trials to determine if high-dose cheotherapy with ABMT increases survival in women
with advanced or poor prognosis breast cancer.
Expanded Access to Clinical Trials: NCI and the Department of Defense (DoD) recently
signed an interagency agreement that allows patients who are beneficiaries of TRICARE/
CHAMPUS, the DoD's health program, to participate in NCI-sponsored treatment clinical trials.
The DoD provides health services to about 8.3 million beneficiaries (most are members of the
armed forces and their families). The new agreement gives these individuals access to NCI-
sponsored clinical trials that test promising treatments for cancer in medical centers around the
country. It builds on a DoD demonstration project that provided CHAMPUS reimbursement for
eligible beneficiaries to receive high dose chemotherapy with stem cell rescue for breast cancer
under NCI-approved trials.
NCI and DoD will evaluate the success of the new program, looking specifically at patient
enrollment and cost of care. Patients will enjoy the benefits of receiving protocol-level care, and
research will benefit with the increased enrollment of patients to clinical trials. This project may
serve as a model for future partnerships with groups such as the Health Care Financing
Administration, manage care companies, and self-insured corporations.
4
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Research on Causes of Breast Cancer: NCI supports basic and population-based research to
identify environmental and genetic factors contributing to breast cancer incidence and mortality.
For example, in collaboration with the National Institute of Environmental Health Sciences, NCI
is conducting the Long Island Breast Cancer Study Project (LIBCSP) to evaluate the
contribution of various environmental and occupational factors to the etiology of breast cancer,
and to develop a geographic system to evaluate current and past exposures. Current projects
funded at New York area universities and cancer centers are studying a variety of compounds
including organochlorines, polycyclic aromatic hydrocarbons, estrogen metabolites, genetic
factors, and electromagnetic field (EMF) exposures, and are collecting tissue samples and data
about family history to elucidate connections between environmental factors and breast cancer.
Research in other parts of the United States may help clarify the genetic, hormonal, and/or
environmental influences on breast cancer. The Northeast/Mid-Atlantic Study is examining
the role of various environmental exposures along with other possible risk factors to better
understand the causes of breast cancer in the northeastern United States, an area of high
incidence and mortality.
A recently published study of geographic patterns of breast cancer reported that mortality
rates were much more uniform throughout the United States when regional differences in the
percentage of women with known breast cancer risk factors due to personal and family history
were taken into account, and the Northeast no longer had a particularly high breast cancer
mortality rate. However, not all of the geographic variation in breast cancer mortality could be
explained.
In 1995, NCI began a study of the risk of breast cancer associated with DDT exposure in
African Americans from Triana, Alabama, where the population was heavily exposed to
pesticides found in fish caught in contaminated waterways. In 1996, a small feasibility study
will investigate the association between breast cancer risk and DDT exposure in India where this
agent continues to be used in agriculture.
Research Programs Dedicated to Breast Cancer: NCI supports six Specialized Programs of
Research Excellence (SPOREs) for breast cancer. A key focus of the SPOREs is to move
research results from the laboratory to the clinic and other human settings and to send clinical
observations to the laboratory to help understand the biology of human disease. The SPOREs
also maintain tissue resources that are available to researchers and offer career development and
training for cancer scientists. Interdisciplinary research at SPOREs is expected to lead to
reductions in cancer incidence and mortality. One SPORE is combining molecular,
epidemiologic, and public health research approaches to reduce breast cancer incidence and
mortality in rural African American populations.
Outreach and Information Dissemination: NCI's Cancer Information Service (CIS) provides
accurate, up-to-date cancer information to patients and their families, the public, and health care
professionals in all 50 states through 19 offices located at NCI-funded Cancer Centers and other
5
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health care institutions. By dialing 1-800-4-CANCER, callers are automatically connected, free
of charge, to the office serving their region. The CIS answers more inquiries about breast cancer
than any other cancer site. It supports state and local breast cancer education efforts and is a
partner to organizations that want to sponsor media campaigns, screening programs, and other
related community actions.
The Centers for Disease Control and Prevention (CDC) is supporting outreach coordinators at
four CIS offices to bring more women into low-cost breast and cervical cancer screening
programs (also supported by CDC) in four states. Linking the CIS offices and the CDC
screening programs should benefit both parties and the communities they serve.
The United States Postal Service will issue a Breast Cancer Awareness Stamp on June 15.
NCI's CIS toll-free number will appear on the border of each sheet of stamps as the source for
breast cancer information. In addition, educational materials will be available at post offices
across the country, and a video on breast cancer produced by LIFETIME television will be
shown in more than 2,000 post office Jobbies. NCI helped develop resources and media products
for the information campaign. ENCORE a program of the YWCA of the U.S.A., the
American Cancer Society, and several breast cancer groups will join with the Postal Service to
provide brcast health information forums and mammography screenings at selected post offices
and other community locations.
DHHS Secretary's National Action Plan on Breast Cancer (NAPBC): NCI is a key partner
in the NAPBC, a transgovernment and private sector collaboration to reduce the burden of breast
cancer. The DHHS Office on Women's Health coordinates implementation of the Action Plan.
NCI Breast Cancer Funding
FY 1995
FY 1996
Actual
Estimate
$309 Million
$337 Million
4/22/96
6
JAN-19-96 FRI 08:43 PM NARAL
FAX NO. 202 973 3030
P.01
NARAL Promoting Reproductive Choices
FAX COVER SHEET
DATE:
1/19/96
TO:
Jen Klein
456-1715
OFFICE:
FROM:
Karen Guss PHONE: 973 3013
THIS IS PAGE ONE OF 3 TOTAL PAGES
COMMENTS:
JK-
I predict that HRC will get some
mail on this subject so I Thought D'd
pass on these clips to you.
Sorry I haven't been able to call-
all hell is I haven't stopped
working since back. (Truey I had
time I can't
complain a life.
anyway, one of these days fill ged
before our big AlimAiley date!
Molly Can wext you have week? lunch hope w/we I and getto (engaged.) see you
National Abortion and Reproductive Rights Action League. 1158 15th Street. N.V. Suite 700, Washington, D.C. 20005
Phone Number: (202) 973-3000
Fax Numbers: (202) 973-3096, 3097, 3098, 3099
JAN-19-96 FRI 08:43 PM NARAL
FAX NO. 202 973 3030
P.02
Breast-Ca1 cer Gei e Study Adva ces;
Official Wants to Restrict Use of Test
By MICHAEL WALDHOLZ
interpret complicated results of the test
staff Reporter of THE WALL STREET JOURNAL
For example. doctors aren't certain how
The head of the U.S. human genome
best to treat a woman who has the gene. He
project said a new genetic test detecting a
also is concerned that women without the
gene that causes breast cancer should be
gene will be given a false sense of security
restricted to certain medical-research cen-
because they still have the same 1-in-12
ters at this time.
risk of getting breast cancer.
Francis Collins, director of the National
In the Massachusetts General study,
Center for Human Genome Research. said
the researchers tested young Jewish
he expects that new research to be re-
women who had breast cancer before age
leased today will spur many women to
40. Late last year, scientists found that one
seek the test. But he said he is against the
specific type of flaw in the gene accounted
widespread screening for the gene outside
for about 1% of all breast cancers among
of selective research institutions. Two
women with an Eastern European Jewish
gene-testing companies are hoping to sell
heritage. In the new study, the Massachu-
the breast-cancer-gene test to the public
setts General researchers led by Dr. Haber
outside of research centers.
found that eight of 39 young Jewish women
"Right now, the many risks associated
with breast cancer carried the gene muta-
with the test exceed its benefits," he said.
tion. None of the women previously sus-
"Many questions need to be answered by
pected they had a family history of the
researchers before it makes sense to rec-
disease.
ommend the test for most women."
In a separate report from the Fred
In late 1994, following an intense world-
Hutchinson Cancer Research Center in
wide scientific race, scientists found that a
Seattle. scientists said they found gene
defect to a gene called BRCAI causes
defects in six of 80 women under age 35
an inherited form of breast cancer that
with breast cancer who also had no family
accounts for about 5% or so of all breast-
history of the disease. Taken together. the
cancer cases. Immediately. several TP:-
studies suggest there are many women at
search teams began random testing of
risk of carrying the gene who are unaware
women with breast cancer to determine if
they have a family risk of developing
their disease was caused by the inherited
breast cancer.
gene defect.
This week, OncorMed Inc., a genetics-
In studies released by two of those
testing company in Gaithersburg. Md.,
research groups that are being published
announced that it is making available
in today's New England Journal of Medi-
to doctors its own BRCAI test. The com-
cine. researchers found that breast cancer
pany has provided the test to research
among a good portion of women under age
centers since the middle of last year but
40 is likely to be caused by inheriting the
will now provide it to independent doctors
defective gene. In two separate reports.
and their patients who agree to meet
the researchers said that between 10% and
certain guidelines. Another company,
20% of breast cancer among young women
Myriad Genetics Inc. of Salt Lake City,
is due to inheriting the flawed gene.
hopes to also offer the test later this year.
The finding is striking because none of
these women had known of a family history
of breast cancer.
"We definitely need to move ahead
cautiously [with testing young women|."
said Dr. Daniel Haber. a researcher at
Massachusetts General Hospital who di-
rected one of the studies. "But we need to
figure out how to test many women who are
unknowingly at risk."
Dr. Haber said young women with
breast cancer found to carry the gene
defect should be closely monitored because
they are at high risk for developing an-
other bout of breast cancer or ovarian
cancer. which is also caused by the gene.
Moreover. the test can help alert the
women's close female relatives who may
also be at risk of developing the cancers.
But in a commentary accompanying re-
lease of the two studies. Dr. Collins said
the gene test is still highly experimental.
He urged that women get screened only at
WSJ
a handful of medical centers where scien-
tists and genetic counselors are studying
1.18.96
how best to use the test information.
Dr. Collins said he and others are
B/O
worried that women and doctors will mis-
P.03
Gene Linked to Early Breast Cancer
Thursday's issue of the New England
Journal of Medicine.
Francis Collins, head of the Nation-
FAX NO. 202 973 3030
al Center for Human Genome Re-
Associated Press
tional Cancer Institute. "It takes ge-
tified, genetics experts are recom-
search, wrote in an editorial in the
netic susceptibility the next step-
mending that, for now, testing for mu-
journal that the reports suggest that
BOSTON, Jan. 17-A single bad
from individuals who are members of
tations in the gene should be done on-
in women under 30, the genetic defect
gene appears to cause a significant
preselected families with a history of
ly as part of research.
is responsible for 38 percent of breast
share of breast cancer in young wom-
cancer-and now looks at all young
When it works properly, the
cancer among Jews and 8 percent
en, especially Jews, in whom it may
women."
BRCA1 gene helps prevent cancer.
among non-Jews. Under age 40, it
trigger more than a quarter of all cas-
The younger women are when they
Last September, researchers re-
causes 27 percent of cases among
es under age 40.
get breast cancer, the more likely it is
ported that 1 percent of American
Jews and 5 percent among non-Jews.
A whirlwind of research over the
that the disease is caused by a muta-
Ashkenazi Jews, whose families came
The American Cancer Society esti-
past two years has pinpointed a gene
tion in the recently discovered gene,
from Central and Eastern Europe,
mates breast cancer will kill 44,300
that is often to blame when breast
called BRCA1.
carry one particular defect in their
U.S. women this year, more than any
cancer clearly runs in families.
The discovery of the importance of
BRCA1 gene. The new work suggests
other form of cancer except lung can-
Now, two new studies show for the
BRCA1 does nothing to steer doctors
this mutation accounts for a signifi-
cer. However, the disease is rare
first time that this same gene is fre-
toward better treatments, although
cant fraction of breast cancer cases in
among the young. Before age 30,
quently the cause whenever the dis-
that may someday happen. It raises
young Jewish women.
breast cancer strikes 17 in every 1
ease strikes women in their twenties
the possibility of getting a jump on the
Two studies on BRCA1 in a total of
million women.
and thirties, even if there is no strong
disease by testing women for the
498 young breast cancer patients
The National Cancer Institute is co-
pattern of breast cancer among the
faulty gene, if researchers are able to
were conducted at Massachusetts
ordinating a study of Ashkenani Jews
victim's close relatives.
develop effective methods of prevent-
General Hospital in Boston and the
in the Washington area to determine
"This is an important finding," said
ing breast cancer. However, since
Fred Hutchinson Cancer Research
the prevalence of the mutation and its
Richard Klausner, director of the Na-
such methods have not yet been iden-
Center in Seattle. Both studies are in
relation to breast and ovary cancer.
JAN-19-96 FRI 08:44 PM NARAL
A5
1.18.96
WT
14:33
301 402 0338
001/002
Fax Transmittal
Office of the Director
National Cancer Institute
Date:
3-16-95
To:
Jennifer Klein
Fax No.
202-456-2878
From:
Dr. Sondeh
Bldg. 31;Room 11A48
National Cancer Institute, Bethesda, Maryland 20892
Fax No. 301-402-0338 Telephone No. 496-5615
or
Fax No. 301 496 6005
Cover Sheet Plus / Pages Transmitted
Additional Comments:
NATIONAL
ANCER
INSTITUTE
03/16/95
14:33
301 402 0338
4.
002/002
It is critical that we safeguard the welfare of the thousands of patients
and participants in NSABP and other clinical studies and do everything
possible to ensure the proper execution and oversight of the studies in
progress. The NCI has worked closely with the University of
Pittsburgh and the NSABP to resolve the problems that were uncovered
last spring and to restore seriously eroded confidence in clinical trials.
As a result, new leadership is in place, and the NSABP has been
restructured in a manner that separates its headquarters and operating
center from its statistical center, emphasizing the importance of quality
Enrollment Enro in
control and auditing procedures. Accrual to NSABP studies has
reopened, and there is every reason to expect that this work will go
forward with the precision and integrity that the public, the scientific
community, and the Government expect and deserve.
The NCI intends to continue it support of the critically important
NSABP research agenda. As the work moves forward, it is essential to
build on the successes of the past as well as learn from the failures.
Every action will be taken to maintain support for clinical trials, a vital
component of the National Cancer Program.
Thank you for your interest and your expression of concern.
111 2.878
03/09/95 13:13
DR BLUMENTHAL
001
CREAT HEALTH LTH SERVICE
Susan J. Blumenthal, M.D., M.P.A.
Deputy Assistant Secretary for Health
(Women's Health)
ST
Assistant Surgeon General
*
1798
Office on Women's Health
U.S. Public Health Service
Hubert Humphrey Bldg, Rm. 730-B
200 Independence Avenue, SW
Washington, DC 20201
Date: 3/9/95
To: tenniger Klein
Organization/Office:
Fax: 456-2878
Telephone:
Subject:
From: Susan J. Blumenthal
Telephone: (202) 690-7650
Fax:
(202) 401-4005
Speek will mr letter K abntumo signaturn M A There's lawsuit the a
pending betwom Putstang + NCI!
No. of Pages (including cover):
PLEASE NOTE:
Hert's a suggested reply letter
Let me know of you nord anything else-
funds Bramenthal
03/09/95 13:13
DR BLUMENTHAL
002
1
002/004
03/08/95 18:37
301 402 0338
Dear
:
Thank you for your letter to
, regarding the National
Surgical Adjuvant Breast and Bowel Project (NSABP). We understand
your concerns, and we want to assure you that the pioneering
contributions made by the NSABP and Dr. Bernard Fisher to breast
cancer research are recognized and appreciated.
You are probably aware of the finding of scientific fraud at St. Luc
Hospital in Montreal, the subsequent investigation by the Office of
Research Integrity (ORI), and widespread concern about NSABP's
delay in notifying journals, the press, and the public about this incident.
You also may be aware that, in addition, NSABP did not promptly
provide to the National Cancer Institute (NCI) information in their
possession regarding an episode of possible misconduct and data
manipulation at yet another hospital (St. Mary's) in Montreal, even in
the face of the report from ORI on the St. Luc case. In addition,
serious management problems occurred at NSABP, including failure to
properly oversee audit and quality control activities, as well as issues
related to proper informed consent procedures.
03/09/95
13:14
DR BLUMENTHAL
003
003/004
03/08/95
18:37
301 402 0338
It is critical that we safeguard the welfare of the thousands of patients
and participants in NSABP and other clinical studies and do everything
possible to ensure the proper execution and oversight of the studies in
progress. The National Cancer Institute (NCI) has worked closely with
both the University of Pittsburgh and the NSABP to resolve the
problems that were uncovered last spring and to restore seriously
eroded public confidence in clinical trials. As a result, new leadership
is in place, and the NSABP has been restructured to strengthen internal
data quality control. Accrual to NSABP studies has reopened, and
there is every reason to expect that this organization's important work
will go forward with the precision and integrity that the scientific
community, and the American public expect and deserve.
The NCI fully intends to continue supporting the critically important
NSABP research agenda. As the work moves forward, it is essential to
build on the successes of the past as well as learn from the failures.
Every action will be taken to maintain support for clinical trials, a vital
component of the National Cancer Program.
Thank you for your interest and your expression of concern.
03/16/95
12:10
301 402 0338
001/011
Fax Transmittal
Office of the Director
National Cancer Institute
Date:
3-16-95
To:
Jennifer Klein
Fax No.
202-456-2878
From:
Dr. Sondeh
Bldg. 31;Room 11A48
National Cancer Institute, Bethesda, Maryland 20892
Fax No. 301-402-0338 Telephone No. 496-5615
or
Fax No. 301-496-6005
Cover Sheet Plus 10 Pages Transmitted
Additional Comments:
NATIONAL
CANCER
INSTITUTE
Edward J. Sondik, Ph.D.
Acting Director
National Cancer Institute
NSABP
March 13, 1995
03/16/95
12:10
301 402 0338
003/011
2
0
Thank you. I appreciate the opportunity to
speak with you. As of March 1st I began
to serve as Acting Director of the NCI.
As many of you know, for the last year I
served as NCI's Acting Deputy Director,
and prior to that I served for several years
as the Deputy Director of the Division of
Cancer Prevention and Control and the
Associate Director of the Surveillance
Program.
For us at NCI the next several months will
be a challenge with our changes in leader-
ship, with the intramural program and
streamlining reviews underway, and,
perhaps most important, with the focus on
reducing the budget deficit, but it is a
challenge I look forward to. Today,
however, I am here to talk about NSABP.
0
Let me begin with a brief report from the
NCI Surveillance, Epidemiology and End
Results (SEER) Program that relates to
NSABP.
03/16/95
12:10
301 402 0338
004/011
3
o
Our mortality statistics tell us that deaths
from breast cancer declined by over 5
percent from 1989 to 1992. This is the
largest sustained decrease since 1950. The
changes are due, we believe, to a combina-
tion of advances in therapy and screening
programs--and I emphasize therapy--as
well as a possible change in risk factors.
Clearly the NSABP research contribution
deserves great credit.
o
We see declines in mortality in all age
groups, but most dramatically in the age
group 30 and 39 years of age. Indeed, for
these young women the decline amounts to
about nine percent since 1989 and almost
18 percent since 1987. It is especially
important to note that not only have lives
been saved, but they have been saved with
improvements in surgery that offer a better
quality of life.
o
I must hasten to add, however, this decline
was only seen among whites while African
American women experienced a 2 percent
increase in death rate. In fact, African-
Americans have higher incidence and death
rates for cancer overall. We need to find
the causes of these differentials, and
increase minority accrual to clinical trials
to ensure that all Americans benefit from
research.
03/16/95
12:11
301 402 0338
005/011
4
0
It is impossible to study such improve-
ments and not see the value and impor-
tance of clinical trials and specifically the
value and importance of the NSABP.
o
All of us have been through a devastating
year.
o
The NSABP is central to NCI's commit-
ment to reduce death and suffering from
cancer. If I leave any doubt when I fly
out of San Diego that NSABP is of funda-
mental importance to the NCI, then I have
failed. Breast cancer is the second leading
cause of death in American women.
Colorectal cancer is the second leading
cause of cancer death. NCI has a deep
commitment to this research and to clinical
trials. I would venture to say that seldom
has a nation had such agreement on a
problem to be solved. The public wants
progress, the Congress wants progress and
the scientists and clinicians want progress,
particularly about breast cancer.
03/18/95
12:11
301 402 0338
006/011
5
o
The recent gene discoveries pose, in turn,
major challenges for future research and
development, for progress in screening and
treatment, for stratification in clinical trials
and for counseling. On the other hand,
never has science and the day-to-day
process of science had such visibility. We
must be sure we without shelter and with-
out shadow, and translate the results of
research to the public as expeditiously as
possible.
But now we are emerging from this awful
year for the clinical trials community in
general and for NSABP specifically.
0
With the publication of papers on the
audit process and on the reanalysis we will
have set the scientific record straight so
that the public and the profession can be
fully informed about the comparable
efficacy of lumpectomy and mastectomy.
0
I am optimistic that we are now in a strong
position to once again focus on clinical
research. Let me be as emphatic and clear
as I can be: I am here to reaffirm NCI's
continuing commitment to the NSABP and
to its history and achievements. We are
here to look to the future of NSABP and
breast and colorectal cancer treatment and
prevention clinical trials.
03/16/95
12:11
301 402 0338
007/011
6
0
That we are all here today is due to the
hard work of many people. I want to
thank, even more strongly, I want to
commend Ronald Herberman and Norman
Wolmark. Ron Herberman deserves
thanks from all of us for his role as Inter-
im Chairman of the NSABP during a
period of unprecedented public and scien-
tific scrutiny. His work helped to maintain
the continuity of NSABP clinical trials. I
believe we share relief and optimism as
accrual to NSABP studies continues.
03/16/95
12:11
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008/011
7
0
And we at NCI wish Dr. Wolmark well as
he assumes the Chairmanship of this
Group and we will stand by to assist him
and we congratulate him on his appoint-
ment.
0
We want to acknowledge the exceptional
cooperation of this Cooperative Group in
carrying out the B-06 audit. In addition to
reaffirming the results of B-06 clinical
trials, it demonstrated the quality of the
clinical research that had been conducted
by the NSABP over many years.
0
And, I want to thank and commend the
NSABP staff for their commitment and
dedication over this most difficult of
periods. I had the chance to meet just
some of them last year and was most
impressed then--and since--with their
achievements.
0
In addition, on behalf of the NCI and the
NIH, I am pleased that Dr. Wolmark has
proposed Dr. Fisher as Scientific Director
of the NSABP. Dr. Fisher has made
seminal contributions to breast cancer
research and galvanized breast cancer
research both in the United States and
internationally. His research, together
with his colleague Carol Redmond, accu-
mulating the evidence that breast cancer is
a systemic disease was a profound achieve-
ment. We recognize Dr. Fisher's pioneer-
03/16/95
12:12
301 402 0338
009/011
8
ing contributions, his decades of devotion
to breast cancer research and his place in
the hearts of many American women.
o
We, NSABP and NCI, both have organiza-
tional issues before us. You have huge
challenges as a group. The administrative
restructuring, both accomplished and
proposed by NSABP will bring improved
and intensified quality control and auditing
procedures. Accrual needs to be accelerat-
ed and additional clinical trials must be
developed.
o
At NCI we also face challenges. Our
intramural program is undergoing a rigor-
ous review under the leadership of Drs.
Bishop and Calabresi; there are stringent
targets for streamlining, and all of us are
involved in taking a hard look at what we
do and finding better ways to do it. With
Dr. Broder and Dr. Adamson's retirements
we have had losses in valuable leadership.
03/16/95
12:12
301 402 0338
010/011
9
0
Dr. Bruce Chabner's impending departure
is a great loss to us. I am totally confident
that the clinical trials will be in good hands
when Dr. Robert Wittes succeeds Bruce as
Acting Director of the Division of Cancer
Treatment. Bob knows CTEP inside and
out and he has a long-standing relationship
with the NSABP. The staff you have
worked so closely with--Mike Friedman,
Rick Ungerleider, Jeff Abrams, Leslie
Ford, and Leo Buscher--and all the others
as well, are in place and committed to
assisting the NSABP and committed to the
importance of this effort.
0
Later this week Dr. Varmus, on behalf of
NIH and Dr. Chabner and I will be testify-
ing before Congress on the President's
budget request for next fiscal year. As the
Administration and the Congress move to
reduce the deficit all aspects of funding are
under scrutiny.
03/16/95
12:12
301 402 0338
011/011
10
0
The Secretary has made it clear that bio-
medical research is a high priority and that
the budget projections for HHS need not
necessarily apply across the board, but if
they do NIH will experience a budget
reduction by the turn of the century of
about 10 percent which, accounting for
modest inflation, amounts to about a 25
percent cut. When a panel of Nobel
laureates testified before the House Sub-
committee recently they were asked about
the effect of a 30 percent reduction.
Please be aware of the economic realities,
and that tough choices for all of us lie
ahead. We will all be put to the test, and
we at NCI will ask for and expect your
help in making the difficult choices.
All of this change for you and us sends
shock waves, but it also offers the oppor-
tunity to improve and to strengthen.
Again, we all share a deep commitment to
the women of America. We have made
progress but there is a great deal that
needs to be done. Thank you for your
attention.
OCT-04-1994 13:57 FROM PHS BUDGET OFFICE
TO
92024566244
P.02
PHS - 47
WOMEN'S HEALTH- - PHS
Breast Cancer
QUESTION:
What does you FY 1995 budget include for Breast Cancer?
ANSWER:
For NIH Breast Cancer Research, the budget includes $387
million, an $87 million, or 29 percent increase over 1994.
The request also amounts to an 69% increase for NIH breast
cancer research funding since 1993.
The NIH request includes $10 million for implementation of
the Breast Cancer Action Plan, which calls for a wide range
of immediate actions to make progress against this discase.
The request also includes $20 million for FDA to continue
implementation of the Mammography Quality Standards Act of
1992 (MQSA). FDA will conduct safety and quality
inspections of mammography facilities for the first time in
FY 1995.
For CDC, the budget includes $46.9 million for CDC's State
Breast Cancer Screening and Education program. (This is the
same level as FY 1994.)
Finally, the HHS budget includes $320 million for Medicare
coverage of mammograms, an increase of +$30 M (+10%) over
1993.
Taken together, these activities underscore the
Administration's commitment to prevention and early
treatment LO improve health outcomes. Breast cancer has a
high cure rate if detected early.
HHS Funding for Breast Cancer Research/Prevention
(Program Level in Millions)
+/- FY 1994
1993
1994
1995
$
&
NIH
$229
$300
$387
+$87
+29%
CDC
43
47
47
FDA
3
13
20
+7
+54%
IHS/AHCPR
1
1
1
Subtotal, PHS
$276
$361
$455
+$94
+26%
Medicare
$260
$290
$320
+S30
+10%
Total, HHS
$515
$650
$771
+S121
+19%
Prepared by the Office of Budget/ASME
March 10, 1994