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COMMITTEE TO REVIEW THE DEPARTMENT OF DEFENSE'S BREAST CANCER RESEARCH PROGRAM
UTA FRANCKE (Chair),* Professor,
Department of Genetics, and Investigator, Howard Hughes Medical Institute, Stanford University School of Medicine
JUDITH AREEN, Executive Vice President for Law Affairs and Dean of the Law Center,
Georgetown University
JAY C. BISGARD, Director,
Health Services, Delta Air Lines, Inc., Atlanta
CARLO M. CROCE,† Director,
Kimmel Cancer Center, Jefferson Medical College, Thomas Jefferson University
KAY DICKERSIN, Associate Professor,
Department of Epidemiology and Preventive Medicine, University of Maryland School of Medicine, Baltimore
RHETAUGH GRAVES DUMAS,* Vice Provost for Health Affairs,
University of Michigan, Ann Arbor
WILLIAM H. HINDLE, Professor,
Department of Clinical Obstetrics and Gynecology, University of Southern California, and
Director,
Breast Diagnostic Center, Women's and Children's Hospital, Los Angeles
DEBRA J. LERNER, Scientist,
The Health Institute, New England Medical Center, Boston
BERYL MCCORMICK,
Radiation Oncology, Memorial Sloan Kettering Cancer Center Hospital, New York City, and
Associate Professor of Medicine,
Cornell University Medical College
ROBERT S. MCDONOUGH, Medical Director and Senior Technology Consultant,
Aetna U.S. Healthcare, Hartford, Connecticut
BETH A. OVERMOYER, Director,
Breast Cancer Program, Hematology and Medical Oncology, The Cleveland Clinic Foundation, Cleveland, Ohio
DAVID B. THOMAS, Professor and Head,
Program in Epidemiology, Fred Hutchinson Cancer Research Center, Seattle
SAMUEL ALONZO WELLS,* Bixby Professor and Chairman,
Department of Surgery, Washington University School of Medicine, St. Louis
Staff
CAROL WEST SUITOR, Acting Director (beginning April 1997)
ALLISON A. YATES, Director (through March 1997)
MARY I. POOS, Study Director
GEORGE N. DAVATELIS, Program Officer (through April 1997)
Preface
According to current statistical data, one in eight women will be diagnosed with breast cancer some time during her life. Although the five-year survival rates have improved due to earlier detection, the overall mortality rates have changed little. A massive grassroots and lobbying effort, coordinated by the National Breast Cancer Coalition, resulted in a $210 million appropriation for breast cancer research in the 1993 Department of Defense budget.
An Institute of Medicine (IOM) committee was convened to advise the U.S. Army Medical Research and Development Command on strategies for managing a Breast Cancer Research Program. Assuming this would be a one-time allocation, the IOM committee provided detailed recommendations on the programmatic investment strategy and on procedures for a two-tiered peer review, recommendations that were followed closely by the Army.
With ongoing lobbying efforts by dedicated groups of breast cancer survivors, Congress has continued to appropriate funds for the Breast Cancer Research Program (BCRP) on an annual basis. To date, the total approaches $500 million; it appears to be here to stay. Thus, the Army Command has asked the IOM for an independent evaluation of program management and program achievement, and for identification of important, but underfunded, areas in breast cancer research that might be targeted by the program in the future.
The IOM organized a 13-member interdisciplinary group, excluding scientists funded by the Army's program. This committee represented a wide range of expertise and views on basic and clinical cancer research, cancer treatment, health care outcomes, and psychosocial issues related to breast cancer diagnosis and survival. It met five times between July 1996 and January 1997, reviewing the breast cancer research programs funded by other agencies and the status of the field in 1996. The Army provided the committee with oral presentations and written documentation regarding the management of the program and the investment portfolio of funded projects. The committee heard
testimony and interviewed representatives of the peer review contractors, executive secretaries of study sections, and past and current presidents and members of the advisory council (called the Integration Panel). The committee also received approximately 100 letters from grantees in response to a "Dear Colleague" letter asking for comments on various aspects of the program.
This IOM report documents the process used by the Army to solicit and select research proposals for funding. It analyzes the portfolio of funded projects for their responsiveness to the recommendations and fundamental questions in breast cancer research that were articulated in the original 1993 IOM report. The data for the two funding cycles (1993/1994 and 1995) that were available for review did not suggest that the program supported research that is fundamentally different from that supported by other funding agencies. It is too early to evaluate the outcome of the Army's BCRP in terms of breakthrough results and new insights produced by the funded projects or investigators. Therefore, this report cannot provide definitive judgment of the program's success. Its purpose is to give the Army command the report card they requested and some guidance for program management and targets for future research.
The unique aspects of the Army program include the involvement of consumer advocates at both levels of review—scientific merit review and programmatic review leading to funding recommendations—and the ability to quickly change direction and goals ("turn on a dime") on a year-by-year basis. This report documents the changes that were made recently in investment strategy and programmatic goals. The direction the program has taken in the 1996 funding cycle, that is, to focus on funding innovative ideas in the absence of preliminary supporting data and on supporting multidisciplinary research with "translational potential," represents a clear departure from the more balanced funding portfolio recommended in the 1993 IOM report, although both directions were included in the report's recommendations.
The committee was generally enthusiastic about the program as implemented by the Army and was intrigued with the potential for experimentation with the peer review process and the potential to focus on innovation, in ways that go beyond what traditional institutions like the National Institutes of Health (NIH) are able to do. Nevertheless, concerns about the lack of an oversight structure were raised. Because the Army does not have in-house expertise in breast cancer research and all the decisions are based on recommendations by a group of outside experts who serve as contractors or subcontractors, the committee felt that a mechanism for long-term independent oversight should be established if this program were to become a more permanent part of DOD-supported biomedical research programs. The levels of concern about this recommendation varied greatly among committee members, resulting in long discussions before a consensus could be reached. Other controversial issues included early recommendations that parts of the program
be turned over to the National Cancer Institute (NCI). The committee eventually reached consensus that the Army's BCRP is a unique and valuable entity.
Cancer research at the molecular level is in its "golden age." Since 1993, significant progress has been made in the identification of genes that predispose to hereditary breast and ovarian cancer as well as genes that are changed during the process of turning a normal breast cell into a cancer cell. The research opportunities have never been greater to arrive at a detailed understanding of the step-wise process of carcinogenesis with a potential for prevention and cure. Research on the contributions of environmental factors, the utilization of mammography, the efficacy of current treatment modalities, and means to improve the quality of life for affected women in times of rapid changes in the health care system is considered just as important. Given its many unique characteristics, the research program as implemented by the Army has great potential for major contributions in all these areas. The committee felt the impact of breast cancer on women's lives with painful immediacy when, during the course of this study, two of the women intimately involved with it were newly diagnosed.
The chair and the entire committee would like to express their gratitude for the staff assistance and support provided by the IOM. We are indebted to Kenneth I. Shine, Institute of Medicine president; Karen Hein, executive officer; Allison A. Yates, division director; Mary I. Poos, study director; George Davatelis, program officer; Alice Kulik, research assistant; Gerri Kennedo, project assistant; Andrea Posner, editor; and Carlos Gabriel, financial associate. The work of the committee was only made possible by the contributions of these individuals. The committee also thanks the many individuals who provided testimony and/or written materials and who are listed in the Appendixes.
Uta Francke, Chair
Committee on Breast Cancer Research
List of Tables, Boxes, and Figures
TABLES
1 |
Dedicated Breast Cancer Research Funding in the United States |
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2-1 |
Age-Specific Incidence of Breast Cancer and Mortality Rates of Women by Race in the United States, 1988–1992 |
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2-2 |
Racial/Ethnic Patterns of Invasive Breast Cancer in the United States, 1988–1992 |
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3-1 |
Search Results for Reports of Breast Cancer Research for 1994 and 1995 |
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3-2 |
National Institutes of Health Funding for Research on the Four Most Common Types of Cancer by Site, 1995–1996 |
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3-3 |
National Cancer Institute Funding for Breast Cancer Research by Category |
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3-4 |
Other National Institutes of Health Institutes Supporting Breast Cancer Research |
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3-5 |
American Cancer Society Support of Breast Cancer Research in 1996 |
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4-1 |
1993 Institute of Medicine Recommendations for Breast Cancer Research Programmatic Investment Strategies |
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5-1 |
Distribution of Research Proposals by Subject Area or Discipline, Fiscal Year 1993/1994 |
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5-2 |
Distribution of Research and Recruitment/Training Proposals by Subject Area or Discipline, Fiscal Year 1995 |
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5-3 |
Funding for Infrastructure Enhancement and Distribution of Proposals and Awards, Fiscal Year 1993/1994 |
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5-4 |
Funding for Training and Recruitment, Fiscal Year 1993/1994 |
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5-5 |
Distribution of Proposals and Recommended Awards for Training and Recruitment, Fiscal Year 1993/1994 |
5-6 |
Distribution of Training and Recruitment Awards Among Subject Areas/Disciplines, Fiscal Year 1993/1994 |
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5-7 |
Distribution of Training and Recruitment Proposals by Funding Mechanisms, Fiscal Year 1995 |
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5-8 |
Numbers of HBCU/MI and SDB Proposals by Category of Award, Fiscal Year 1993/1994 |
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5-9 |
Designation of Minority Status and Gender for Research Awards, Fiscal Year 1993/1994 |
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5-10 |
Designation of Minority Status and Gender, All Awards, Fiscal Year 1995 |
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5-11 |
Fundamental Areas of Breast Cancer Research |
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5-12a |
Number of Funded Grants, U.S. Army Breast Cancer Research Program, Fiscal Year 1993/1994 |
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5-12b |
Amounts of Funded Grants, U.S. Army Breast Cancer Research Program, Fiscal Year 1993/1994 |
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5-13a |
Number of Funded Grants, U.S. Army Breast Cancer Research Program, Fiscal Year 1995 |
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5-13b |
Amounts of Funded Grants, U.S. Army Breast Cancer Research Program, Fiscal Year 1995 |
BOXES
1 |
Other Recommendations |
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1-1 |
Groups Providing Input to the 1997 Institute of Medicine Breast Cancer Research Committee |
FIGURES
1 |
Appropriation history of the BCRP |
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2 |
USAMRMC BCRP FY 1993/1994 award totals |
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3 |
USAMRMC BCRP FY 1995 award totals |
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2-1 |
Female breast |
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2-2a |
Ductal carcinoma in situ |
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2-2b |
Lobular carcinoma in situ |
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2-3 |
Four stages of transformation |
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4-1 |
USAMRMC Breast Cancer Research Program organizational chart |
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4-2 |
Peer review scoring system |
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5-1 |
Research projects by funding mechanism |
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5-2 |
Number of research proposals by funding mechanism, FY 1993/1994 |
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5-3 |
Number of research proposals by funding mechanism, FY 1995 |