Contraceptive Research and Development

Looking to the Future

Polly F. Harrison and Allan Rosenfield, Editors

Committee on Contraceptive Research and Development

Division of Health Sciences Policy

Institute of Medicine

NATIONAL ACADEMY PRESS
Washington, D.C.
1996



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--> Contraceptive Research and Development Looking to the Future Polly F. Harrison and Allan Rosenfield, Editors Committee on Contraceptive Research and Development Division of Health Sciences Policy Institute of Medicine NATIONAL ACADEMY PRESS Washington, D.C. 1996

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--> National Academy Press 2101 Constitution Avenue, N.W. Washington, D.C. 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. This project was funded by the Contraceptive Research and Development (CONRAD) Program, the Andrew W. Mellon Foundation, the National Institute of Child Health and Human Development of the National Institutes of Health, the Rockefeller Foundation, and the United States Agency for International Development. USAID does not take responsibility for statements or views expressed in this report. Library of Congress Cataloging-in-Publication Data Contraceptive research and development : looking to the future / Polly F. Harrison and Allan Rosenfield, editors ; Committee on Contraceptive Research and Development, Division of Health Sciences Policy, Institute of Medicine p. cm. Based on two workshops held in 1994-1995. Includes bibliographical references and index. ISBN 0-309-05442-7 1. Contraception—Research—Congresses. 2. Contraception—Forecasting—Congresses. I. Harrison, Polly F. II. Rosenfield, A. (Allan) III. Institute of Medicine. Committee on Contraceptive Research and Development. [DNLM: 1. Contraception—methods—congresses. 2. Contraceptive Devices—congresses. WP 630 C753 1996] RG133.C66 1996 613.9′4—dc20 DNLM/DLC for Library of Congress 96-26149 CIP Cover: Ceramic plate. Robert Sperry, artist. This and other works by Mr. Sperry were shown at the National Academy of Sciences through Arts in the Academy, a public service program of the National Academy of Sciences. Copyright 1996 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 serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatlichemuseen in Berlin.

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--> Committee On Contraceptive Research And Development Allan Rosenfield,* Chair, Dean, School of Public Health, Columbia University Hedia Belhadj-EI Ghouayel, Technical Officer for Reproductive Health, United Nations Population Fund, New York Donald D. Brown,** Director, Department of Embryology, Carnegie Institute of Washington, Baltimore, Maryland Nancy L. Buc, Partner, Buc and Beardsley, Washington, D.C. Peter F. Carpenter, Public Policy/Public Service Fellow, Mission and Values Institute, Atherton, California Willard Cates, Jr., Director, Division of Training, Centers for Disease Control, Atlanta Rebecca J. Cook, Professor, Faculty of Law, University of Toronto Horacio B. Croxatto, Director, Chilean Institute of Reproductive Medicine, Santiago Richard H. Douglas, Vice President for Corporate Development, Genzyme Corporation, Cambridge, Massachusetts Michael J. K. Harper, Professor of Obstetrics and Gynecology, Eastern Virginia Medical School Donald Patrick McDonnell, Associate Professor of Pharmacology, Duke University Medical Center David C. Mowery, Professor of Business and Public Policy, Walter A. Haas School of Business, University of California at Berkeley Judy Norsigian, Codirector, Boston Women's Health Book Collective, Somerville, Massachusetts Sandra Panem, President, Vector Fund Management, Deerfield, Illinois Bennett M. Shapiro, Executive Vice President for Worldwide Basic Research, Merck Research Laboratories, Rahway, New Jersey Wylie Vale,** Professor, The Clayton Foundation Laboratories for Peptide Biology, The Salk Institute, La Jolla, California Bai-ge Zhao, Director, Shanghai Institute of Planned Parenthood Research, Shanghai, China Study Staff Polly F. Harrison, Senior Study Director Timothy Kanaley, Research Assistant Sharon Scott-Brown, Administrative Assistant Valerie A. Setlow, Director, Division of Health Sciences Policy *   Institute of Medicine member. **   National Academy of Sciences member.

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--> Acknowledgments There are many to thank. A study of this sort is a process and, as it goes forward and initial assumptions crumble and seemingly straightforward objectives ramify, the complexity of the process requires an ever-larger network of helpers. This study was organized around two major activities.* The first was a workshop on the prospects of the science underlying the development of new contraceptives, held at the National Academy of Sciences in December 1994. We were honored to have as invited presenters at that workshop: Nancy Alexander, Deborah Anderson, Mina Bissell, William Bremner, Egon Diczfalusy, Mahmoud Fathalla, Susan Fisher, Judah Folkman, Frank French, Henry Gabelnick, David Garbers, Walter Gilbert, David Hamilton, Jeffrey Harris, John Herr, Bertil Hille, Aaron Hsueh, William Lennarz, Bruce Lessey, Jiri Mestecky, Walter Moos, Andrés Negro-Vilar, Bert O'Malley, David Page, Paul Primakoff, JoAnne Richards, Patricia Saling, Neena Schwartz, Roy Smith, Allan Spradling, Robert Stein, Jerome Strauss, Paul Van Look, Geoffrey Waites, Debra Wolgemuth, and Lourens Zaneveld. The second major activity was a workshop on the opportunities, challenges, and strategies for private sector participation in contraceptive research and development, held at the Academy in May 1995. This activity consisted of panel discussions and presentations by representatives from the legal, policy, regulatory communities, and large and small pharmaceutical industry, and our thanks *   Please see Appendix E for list of participants and their affiliations.

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--> are especially due to Philip Corfman, Robert Essner, Ellen Flannery, Jacqueline Forrest, David Garbers, Michael Kafrissen, William Sheldon, and Hans Vemer. We thank as well the many other representatives of the pharmaceutical industry who joined us to participate in what was intended to be the beginning of a dialogue across sectors. We most particularly thank two individuals who were instrumental in this component of the study: Alan Goldhammer of the Biotechnology Industry Organization (BIO) who executed a survey of BIO members to help identify potential interest in that community in contraceptive research and development; and Laura Tangley, the science writer who so effectively summarized the proceedings of our first workshop as grist for the second and who did much of the later work on Chapters 3 and 4. We are also eager to thank others who contributed written material for this report. Deborah Anderson, David Hamilton, John Herr, Alison Quayle, Patricia Saling, Kevin Whaley, and Lourens Zaneveld who, together with the scientists on the study committee—Horacio Croxatto, Michael Harper, Donald McDonnell, and Wylie Vale—authored the scientific papers that constitute the appendixes summarized in Chapter 4. We also want to thank Andrés Negro-Vilar, who provided much material for Chapter 3, and Ellen Flannery, our legal bulwark for Chapter 7. There were others who gave us all manner of guidance and information along the way: Sarah Brown and Leon Eisenberg, whose work on the 1995 Institute of Medicine study, The Best Intentions: Unintended Pregnancy and the Well-Being of Children and Families, was so illuminating for this study; James Cavanaugh, who helped us begin a journey through unfamiliar waters; Steven Canafy and his tour of the current legislative environment; Lisa Kaeser's excellent analysis of contraception in the context of managed care; Olivia Judson, our link to current thinking in the United Kingdom about contraceptive technology; Luigi Mastroianni, Jr., chair of the 1990 National Research Council and Institute of Medicine study, Developing New Contraceptives: Obstacles and Opportunities , the wisest of historians; Bert Peterson, who helped us understand some of the implications of sterilization; James Trussell, a fount of information and clarification; as well as a number of staff members from the Alan Guttmacher Institute; the Population Council; the Program for Appropriate Technology in Health; and WHO's Special Programme for Research, Development, and Research Training in Human Reproduction. We thank Decision Resources, The Wilkerson Group, and Frost and Sullivan for permission to use information on the contraceptives market that would not otherwise have been available to us. All were extremely generous and prompt with whatever information we needed at whatever moment. We also express gratitude for the help of the Board on Health Sciences Policy in identifying study committee members, and to Institute of Medicine staff, Timothy Kanaley, research assistant; Sharon Scott-Brown, project assistant; and Linda DePugh, administrative assistant. We thank May Tang, who

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--> spent her Washington semester internship from Pomona College with us and developed the Glossary, constructed tables, and assisted greatly with preparation of the manuscript for review and publication; without her, completion of this project would have been far more difficult. We thank Valerie Setlow, director of the Division of Health Sciences Policy, for her support and administrative creativity; Nancy Diener, for her patience with the financial realities of executing a large and complex study; Claudia Carl, for her combination of compassion and rigor in shepherding the report through the review process; and Mike Edington, for getting this report to the press in rapid and good condition and for finding Andrea Posner as our copy editor. Finally—but far from last in importance—there are the sponsors: the Rockefeller Foundation, the Andrew W. Mellon Foundation, the Contraceptive Research and Development Program, the National Institute of Child Health and Human Development, and the United States Agency for International Development. The consensus around funding this study was formed in a climate of fiscal austerity, a climate in which tradeoffs among possible investments are typically difficult, especially around a topic that remains sensitive, controversial, and even somewhat unfashionable. The Institute of Medicine is, therefore, particularly earnest in its expression of appreciation for the confidence of the study sponsors, their patience, and their unfailing encouragement. POLLY F. HARRISON, SENIOR STUDY DIRECTOR ALLAN ROSENFIELD, CHAIR

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--> Contents     Summary   1     The Existence of Need and Some Fundamental Concepts,   1     The Prospects of the Science,   9     Translating Unmet Need into Market Demand,   15     Toward a More Temperate Climate,   20     Closing Comment,   26 1   Introduction   29     The First Contraceptive Revolution,   29     The Changing Structure of Contraceptive Needs,   30     New Concepts: Reproductive Health and the "Woman-centered Agenda,"   31     Contraception and Sexually Transmitted Disease,   33     The Need for a Second Contraceptive Revolution,   34     The Environment for Contraceptive Research and Development and the Objectives of This Study,   35     Study Methodology,   37     Report Organization,   41 2   The Need And Demand For New Contraceptive Methods   47     Issues of Terminology,   47     Market Demand,   48     Calculating the Unmet Need for Contraceptives,   49

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-->     Reproductive Preferences,   50     Third-party and Public Health Perspectives,   51     A Life Span Perspective,   55     Preferences and Intentions,   58     The Consequences of Unintended Pregnancy,   71     Involvement of Males in Contraception,   81     Concluding Comment,   83 3   Contraceptive Technology And The State Of The Science: Current And Near-Future Methods   94     Introduction,   94     Current Options,   95     Contraceptive Options for the Next Decade, 1995-2005,   110     Concluding Comment,   120 4   Contraceptive Technology And The State Of The Science: New Horizons   125     A Strategy for Basic Research on Contraception,   125     Approaches to New Contraceptives for Females,   130     Approaches for New Contraceptives for Males,   142     Approaches to Immunocontraception for Males and Females,   149     Concluding Comment,   157 5   The Market For New Contraceptives: Translating Unmet Need Into Market Demand   166     Current Contraceptive Use,   167     Specific Needs and Market Opportunities: The Limitations of Available Contraceptives,   171     Consumer Perspectives,   195     The Dimensions of the Market for Contraceptives,   200     The Cost-Effectiveness of Contraception,   213     Concluding Comment,   228 6   The Translators: Sectoral Roles In Contraceptive Research And Development   236     The Role of Industry in Contraceptive Research and Development,   236     Roles of the Public and Nonprofit Sectors in Contraceptive Research and Development,   273     Concluding Comment,   290

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--> 7   Issues Of Law, Regulation, Information, And The Environment For Contraceptive Research And Development   294     Regulatory Influences on Contraceptive Research and Development,   296     Legal Influences on Contraceptive Research and Development,   303     The Role of Information,   324     The Environment,   329     Concluding Comment,   333 8   Recommendations   341     The Prospects of the Science,   342     Advancing the Science and Translating Unmet Need into Market Demand,   343     Closing Comment,   347     Appendixes         A Female Methods Horacio Croxatto, Michael J.K. Harper, Donald McDonnell, and Wylie Vale   351     B Male Methods David W. Hamilton And Patricia M. Saling   381     C Immunocontraceptive Approaches John Christian Herr   401     D Barrier Methods and Mucosal Immunologic Approaches   430     Part 1: Lourens J. D. Zaneveld, Deborah J. Anderson, and Kevin J. Whaley         Part 2: Deborah J. Anderson And Alison J. Quayle         E Agendas and Participants in Committee Workshops   474     F Committee Biographies   490     Glossary   495     Index   505

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