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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 Copyright © National Academy of Sciences. All rights reserved. Contraceptive Research and Development: Looking to the Future http://www.nap.edu/catalog/5156.html 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 Sci- ences, 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. Copyright © National Academy of Sciences. All rights reserved. Contraceptive Research and Development: Looking to the Future http://www.nap.edu/catalog/5156.html COMMITTEE ON CONTRACEPTIVE RESEARCH AND DEVELOPMENT Allan Rosenfield,* Chair, Dean, School of Public Health, Columbia University Hedia Belhadj-El 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. iii Copyright © National Academy of Sciences. All rights reserved. Contraceptive Research and Development: Looking to the Future http://www.nap.edu/catalog/5156.html Copyright © National Academy of Sciences. All rights reserved. Contraceptive Research and Development: Looking to the Future http://www.nap.edu/catalog/5156.html 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 objec- tives 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 devel- opment, held at the Academy in May 1995. This activity consisted of panel discussions and presentations by representatives from the legal, policy, regula- tory communities, and large and small pharmaceutical industry, and our thanks *Please see Appendix E for list of participants and their affiliations. v Copyright © National Academy of Sciences. All rights reserved. Contraceptive Research and Development: Looking to the Future http://www.nap.edu/catalog/5156.html vi ACKNOWLEDGMENTS 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