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Contraceptive Research, Introduction, and Use Lessons from Norplant Polly F. Harrison and Allan Rosenfield, Editors Subcommittee for Workshop on Implant Contraceptives: An Illuminating Case Study in Current Dilemmas and Possibilities Committee on Contraceptive Research and Development Division of Health Sciences Policy INSTITUTE OF MEDICINE NATIONAL ACADEMY PRESS Washington, D.C. 1998
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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 study was supported by a grant from the Henry J. Kaiser Family Foundation, Menlo Park, California. The views presented in this report are those of the Committee on Contraceptive Research and Development and are not necessarily those of the funding organization. International Standard Book No. 0-309-05985-2 Additional copies of Contraceptive Research, Introduction, and Use: Lessons from Norplant, are available for sale from the National Academy Press, Box 285, 2101 Constitution Avenue, N.W., Washington, DC 20055; Call (800) 624-6242 or (202) 3343313 (in the Washington metropolitan area), or visit the NAP's on-line bookstore at http://www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at http://www.nas.edu/iom. Copyright 1998 by the National Academy of Sciences. All rights reserved. Printed in the United States of America
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SUBCOMMITTEE FOR WORKSHOP ON IMPLANT CONTRACEPTIVES Allan Rosenfield* (Chair), Dean, School of Public Health, Columbia University Hedia Belhadj-El Ghouayel, Deputy to the Director, Division for Arab States and Europe, United Nations Population Fund, New York Nancy L. Buc, Partner, Buc & Beardsley, Washington, D.C. Rebecca J. Cook, Professor, Faculty of Law, University of Toronto Richard H. Douglas, Vice President, Corporate Development, Genzyme Corporation, Boston 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, Co-director, Boston Women's Health Book Collective Study Staff Polly F. Harrison, Senior Study Director Gretchen Ganzle Kidder, Research Assistant Christina Thacker, Project Assistant Division Staff Valerie P. Setlow, Director Linda DePugh, Administrative Assistant Jamaine Tinker, Financial Associate * Institute of Medicine member.
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COMMITTEE ON CONTRACEPTIVE RESEARCH AND DEVELOPMENT Allan Rosenfield* (Chair), Dean, School of Public Health, Columbia University Hedia Belhadj El Ghouayel, Deputy to the Director, Division for Arab States and Europe, United Nations Population Fund, New York Donald D. Brown,† Director, Department of Embryology, Carnegie Institute of Washington, Baltimore, Maryland Nancy L. Buc, Partner, Buc & Beardsley, Washington, D.C. Peter F. Carpenter, Founder/Director, Mission and Values Institute, Visiting Scholar, Center for Biomedical Ethics, Stanford University Willard Cates, Jr., Corporate Director of Medical Affairs, Family Health International, Research Triangle Park, North Carolina Rebecca J. Cook, Professor, Faculty of Law, University of Toronto Horacio B. Croxatto, Professor, Instituto Chilena de Medicina Reproductiva, Santiago, Chile Richard H. Douglas, Vice President, Corporate Development, Genzyme Corporation, Boston Michael J. K. Harper, Professor, Department 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, Co-director, Boston Women's Health Book Collective Sandra Panem, Managing Partner, Vector Fund Management, Vector Securities International, Deerfield, Illinois Bennett M. Shapiro, Executive Vice President, 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 * Institute of Medicine member. † National Academy of Sciences member.
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Acknowledgments This document reports the proceedings of a workshop that depended for any useful outcome not just on the knowledge and experience of its participants but on their willingness to engage in flexible and open dialogue. Much appreciation is owed to: presenters James Anderson, David Archer, Marie Bass, Paul Blumenthal, Ward Cates, Jacqueline Darroch, Angela Davey, Andrew Davidson, Lynne Gaffikin, Michael Green, Debra Kalmuss, Helen Koo, Preston Marx, Olav Meirik, Noel Rose, Ruth Simmons, Irving Sivin, Felicia Stewart, and Paul Van Look; panelists Martha Katz, Ruth Macklin, Ellen Moskowitz, Cynthia Pearson, Julia Scott, and Marian Secundy, and all participants, whose expertise and commitment contributed so constructively to advancing understanding of a persistently difficult subject. As small as this document is, much work went into its preparation. For that we thank our project staff Christina Thacker and Gretchen Kidder, who handled the workshop logistics, drafted the presentation summaries, and prepared this document for the press; Claudia Carl, who shepherded the report through review; Michael Edington, who helped with its editing and publication; and Valerie Setlow, who was unfailingly helpful in many ways. We also offer our thanks to the subcommittee for its willingness to continue membership on the Committee on Contraceptive Research and Development in order to encompass this activity. Finally, we thank the Henry J. Kaiser Family Foundation for its support, patience, and unflagging conviction that this is a very important topic. To all, our gratitude is very great and most sincere. Allan Rosenfield, Chair Polly F. Harrison, Senior Study Director
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Contents 1 INTRODUCTION 1 2 WORKSHOP REPORT 3 Efficacy and Safety, 3 Efficacy, 3 Safety, 4 Who Uses Norplant and How, 9 User Populations, 9 Method Continuation and Discontinuation, 11 Side Effects as Factors, 12 User Satisfaction, 13 Barriers to Discontinuation, 18 Insertion and Removal: Experience and Implications, 23 Technical Aspects, 23 Case Experiences, 23 Rates of Complicated Removals, 25 Implications, 25 Consumer Perspectives, 27 Communication and Quality of Care, 27 Informed Decision-Making, 28 Consumer Involvement, 31 New Approaches, 31 Reproductive Health Technologies Project's "Boom and Bust Initiative," 32 The WHO Strategic Approach to Contraceptive Introduction, 32 A "Government Standards Defense," 34
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3 WORKSHOP SUMMARY AND ANALYSIS 37 Data Review 38 Efficacy 38 Safety 38 User Profiles 39 Side Effects 39 Continuation and Discontinuation 39 User Satisfaction 40 Postmarketing Surveillance 40 Cost-Effectiveness 41 Lessons Learned 41 Next Steps: Areas for Consideration and Action 44 Areas for Strengthening or Expansion 44 Areas for New Initiative 47 Final Comment 49 APPENDIXES A Presentation Summaries 59 B Norplant: Historical Background 107 C Workshop Agenda 115