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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.
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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.
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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
Valeric P.Setlow, Director
Linda DePugh, Administrative Assistant
Jamaine Tinker, Financial Associate
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
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:
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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;
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panelists Martha Katz, Ruth Macklin, Ellen Moskowitz, Cynthia Pearson, Julia Scott, and Marian Secundy, and
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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
Contents
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The contents of the full report, from which this Workshop Summary and Analysis has been extracted, follow.
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 |
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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 |
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 |
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A |
Presentation Summaries, 59 |
B |
Norplant: Historical Background, 107 |
C |
Workshop Agenda, 115 |