A Review of the Department of Defense's Program for Breast Cancer Research

Committee to Review the Department of Defense's Breast Cancer Research Program

INSTITUTE OF MEDICINE

NATIONAL ACADEMY PRESS
Washington, D.C.
1997



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A Review of the Department of Defense's Program for Breast Cancer Research A Review of the Department of Defense's Program for Breast Cancer Research Committee to Review the Department of Defense's Breast Cancer Research Program INSTITUTE OF MEDICINE NATIONAL ACADEMY PRESS Washington, D.C. 1997

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A Review of the Department of Defense's Program for Breast Cancer Research NATIONAL ACADEMY PRESS 2101 Constitution Avenue, N.W. Washington, DC 20418 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. This report has been reviewed by a group other than the authors according to procedures approved by a Report Review Committee consisting of members of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The Institute of Medicine was chartered in 1970 by the National Academy of Sciences to enlist distinguished members of the appropriate professions in the examination of policy matters pertaining to the health of the public. In this, the Institute acts under both the Academy’s 1863 congressional charter responsibility to be an adviser to the federal government and its own initiative in identifying issues of medical care, research, and education. Dr. Kenneth I. Shine is president of the Institute of Medicine. Support for this project was provided by the Department of the Army, Cooperative Agreement No. DAMD17-96-2-6002. The opinions or conclusions expressed herein do not, however, necessarily reflect those of the Department of the Army. Library of Congress Catalog Card No. 97-67577 International Standard Book Number 0-309-05780-9 This report is available for sale from the National Academy Press, 2101 Constitution Avenue, N.W., Box 285, Washington, D.C. 20055. Call (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area), or visit the NAP’s on-line bookstore at http://www.nap.edu. This report is also available from HQ USAMRMC, ATTN: MCMR-PLF (IOM Report), 524 Palacky Street, Fort Detrick, MD 21702-5024 For more information about the Institute of Medicine, visit the IOM home page at http://www2.nas.edu/iom. Copyright 1997 by the National Academy of Sciences. All rights reserved. Printed in the United States of America The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The image adopted as a logotype by the Institute of Medicine is based on a relief carving from ancient Greece, now held by the Staatlichemuseen in Berlin.

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A Review of the Department of Defense's Program for Breast Cancer Research 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) *   Member, Institute of Medicine. †   Member, National Academy of Sciences.

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A Review of the Department of Defense's Program for Breast Cancer Research ALICE L. KULIK, Research Assistant GERALDINE KENNEDO, Senior Project Assistant CARLOS M. GABRIEL, Financial Associate

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A Review of the Department of Defense's Program for Breast Cancer Research 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

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A Review of the Department of Defense's Program for Breast Cancer Research 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

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A Review of the Department of Defense's Program for Breast Cancer Research 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

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A Review of the Department of Defense's Program for Breast Cancer Research Contents     EXECUTIVE SUMMARY   1 1   INTRODUCTION   17     The Army Breast Cancer Research Program   17     Charge to the 1997 IOM Committee   18     Resources and Methods Used for This Report   19 2   BREAST CANCER: BIOLOGY AND MEDICINE   22     Incidence and Mortality   22     Stages of Breast Cancer Development   24     Breast Cancer Genetics   27     Other Risk Factors   28     Breast Imaging, Treatment, and Prevention   29     Social and Psychological Aspects   31 3   NON-BCRP SUPPORT FOR BREAST CANCER RESEARCH   33     Published Literature   33     Funding from the Federal Government   35     The California Breast Cancer Research Program   40     Private Foundations   41     National Professional Organizations and Societies   43     Pharmaceutical Industry   44 4   U.S. ARMY BREAST CANCER RESEARCH PROGRAM   45     Historical Overview   45     IOM Programmatic Vision (1993)   46     BCRP Implementation, 1993–1996   51     The Review Process   57

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A Review of the Department of Defense's Program for Breast Cancer Research 5   THE FUNDED PORTFOLIO OF THE 1993/1994 AND 1995 BCRP AWARD CYCLES   65     Research Projects   65     Infrastructure Enhancement   69     Training and Recruitment   69     Funding for Program Administration   77     Distribution of Awards Among Research Areas   78 6   CRITIQUE   86     Organizational Structure and Program Oversight   86     Application Process   89     Scientific Peer Review   89     Programmatic Review   90     Award Negotiation and Processing   93     Monitoring and Evaluation of Progress   94     Consumer Participation   94     Funded Portfolio   94 7   CONCLUSIONS AND RECOMMENDATIONS   97     Conclusions   97     Recommendations Related to Program Achievement and Management   99     Recommendations for Future Research Directions   102     REFERENCES   107     APPENDIXES     A   Individuals Who Provided Testimony to the Committee   113 B   Individuals Who Provided Written Response to Committee Questions   116 C   "Dear Colleague" Letter   117 D   Responses to "Dear Colleague" Letter   119 E   Tissue Bank Letter and Questionnaire   121     GLOSSARY AND ACRONYMS   125     BIOGRAPHICAL SKETCHES   131

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A Review of the Department of Defense's Program for Breast Cancer Research List of Tables, Boxes, and Figures TABLES 1   Dedicated Breast Cancer Research Funding in the United States   9 2-1   Age-Specific Incidence of Breast Cancer and Mortality Rates of Women by Race in the United States, 1988–1992   23 2-2   Racial/Ethnic Patterns of Invasive Breast Cancer in the United States, 1988–1992   24 3-1   Search Results for Reports of Breast Cancer Research for 1994 and 1995   34 3-2   National Institutes of Health Funding for Research on the Four Most Common Types of Cancer by Site, 1995–1996   38 3-3   National Cancer Institute Funding for Breast Cancer Research by Category   38 3-4   Other National Institutes of Health Institutes Supporting Breast Cancer Research   39 3-5   American Cancer Society Support of Breast Cancer Research in 1996   41 4-1   1993 Institute of Medicine Recommendations for Breast Cancer Research Programmatic Investment Strategies   49 5-1   Distribution of Research Proposals by Subject Area or Discipline, Fiscal Year 1993/1994   70 5-2   Distribution of Research and Recruitment/Training Proposals by Subject Area or Discipline, Fiscal Year 1995   70 5-3   Funding for Infrastructure Enhancement and Distribution of Proposals and Awards, Fiscal Year 1993/1994   71 5-4   Funding for Training and Recruitment, Fiscal Year 1993/1994   73 5-5   Distribution of Proposals and Recommended Awards for Training and Recruitment, Fiscal Year 1993/1994   74

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A Review of the Department of Defense's Program for Breast Cancer Research 5-6   Distribution of Training and Recruitment Awards Among Subject Areas/Disciplines, Fiscal Year 1993/1994   75 5-7   Distribution of Training and Recruitment Proposals by Funding Mechanisms, Fiscal Year 1995   75 5-8   Numbers of HBCU/MI and SDB Proposals by Category of Award, Fiscal Year 1993/1994   77 5-9   Designation of Minority Status and Gender for Research Awards, Fiscal Year 1993/1994   78 5-10   Designation of Minority Status and Gender, All Awards, Fiscal Year 1995   78 5-11   Fundamental Areas of Breast Cancer Research   81 5-12a   Number of Funded Grants, U.S. Army Breast Cancer Research Program, Fiscal Year 1993/1994   83 5-12b   Amounts of Funded Grants, U.S. Army Breast Cancer Research Program, Fiscal Year 1993/1994   84 5-13a   Number of Funded Grants, U.S. Army Breast Cancer Research Program, Fiscal Year 1995   85 5-13b   Amounts of Funded Grants, U.S. Army Breast Cancer Research Program, Fiscal Year 1995   85 BOXES 1   Other Recommendations   13 1-1   Groups Providing Input to the 1997 Institute of Medicine Breast Cancer Research Committee   20 FIGURES 1   Appropriation history of the BCRP   3 2   USAMRMC BCRP FY 1993/1994 award totals   6 3   USAMRMC BCRP FY 1995 award totals   7 2-1   Female breast   25 2-2a   Ductal carcinoma in situ   26 2-2b   Lobular carcinoma in situ   26 2-3   Four stages of transformation   27 4-1   USAMRMC Breast Cancer Research Program organizational chart   52 4-2   Peer review scoring system   61 5-1   Research projects by funding mechanism   66 5-2   Number of research proposals by funding mechanism, FY 1993/1994   67 5-3   Number of research proposals by funding mechanism, FY 1995   68

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A Review of the Department of Defense's Program for Breast Cancer Research A Review of the Department of Defense's Program for Breast Cancer Research

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