Contraceptive Risk: The FDA, Depo-Provera, and the Politics of Experimental Medicine

by William Green

Overview

The story of Depo-Provera joins the national struggle over the drug's FDA approval to the state legal issues raised by its contraceptive and criminal justice uses.

Depo-Provera is known as an injectable hormonal birth control method, but few are familiar with its dark and complicated history. Depo-Provera was tested on women since the mid-1960s without their informed consent until it was FDA-approved in 1992, but never FDA-approved as chemical castration for male sex offenders.

Contraceptive Risk is William Green's landmark study of Depo-Provera. Based on a fascinating combination of archival materials and interviews, the book is framed as three interconnected stories told by Judith Weisz, who chaired the FDA's Public Board of Inquiry on Depo-Provera, a scientific court; by Anne MacMurdo who brought a products liability suit against Upjohn, the drug's manufacturer, for the deleterious side effects she suffered from the drug's use; and by Roger Gauntlett, an Upjohn heir who, when he was convicted of sexual assault, refused to take a dose of his family's own medicine as a probation condition. Together these three stories of Depo-Provera's convoluted fifty year odyssey call for a paradigm shift in pharmaceutical drug development.
Contraceptive Risk is a thoroughly researched and engrossing approach to the scientific, political and institutional forces involved in health law and policy, as well as the multifaceted politics of measuring risk.

Product Details

ISBN-13:	9781479836987
Publisher:	New York University Press
Publication date:	05/02/2017
Series:	Biopolitics , #12
Pages:	336
Product dimensions:	5.90(w) x 9.00(h) x 1.00(d)

About the Author

William Green is Professor of Government at Morehead State Universityin Kentucky, where he teaches constitutional law and comparative politics. His research and publications explore constitutional and civil liberties issues and the political and legal dimensions of economic development, labor relations, language rights, and pharmaceutical drug policies.

Table of Contents

Preface and Acknowledgments ix

Note to the Reader xiii

Introduction: The Odyssey of Depo-Provera 1

1 The Grady Hospital Study: The Corruption of Contraceptive Research 15

2 The Twenty-Five-Year FDA Approval Controversy: Cancer and the Politics of Acceptable Risk 45

3 Contraceptive Chaos: Unapproved Use and Upjohn v. MacMurdo 83

4 Marketing Approval and Litigation: Osteoporosis and the Realities of Medical Risk 129

5 Chemical Castration: The Johns Hopkins Clinic and People v. Gauntlett 169

Conclusion: Contraceptive Drug Risk Failure, Human Dignity, and a Duty to Act 213

Glossary of Legal and Medical Terms 229

Notes 239

Index 305

About the Author 322

Editorial Reviews

"William Greens fascinating tale of the use and misuse of Depo-Provera highlights the complex and faulty world of & risk management, the competing powerful interests at stake in drug approval and use, and the misuse of contraceptive drugs in controlling reproduction and sexual deviance."

Karen L. Baird

"Seldom has a study connected the micro with the macro, the personal with the legal, the individual with the structural in the manner and depth present in Contraceptive Risk. Using three concurrent and overlapping stories, Green explores in dizzying fashion, the politics of contraceptive risk management."

New Genetics and Society

William Green’s fascinating tale of the use and misuse of Depo-Provera highlights the complex and faulty world of ‘risk management,’ the competing powerful interests at stake in drug approval and use,
and the misuse of contraceptive drugs in controlling reproduction and sexual deviance.”
-Karen L. Baird,co-author of Beyond Reproduction: Women's Health, Activism, and Public Policy

"By far the most thorough account of the Depo-Provera story to date. Though we may never get clear answers about whether Depo-Provera has done more harm than good over the past few decades, this well-researched history will be of great interest to those in the public health and women and gender studies fields, as well as many women contemplating the use of Depo-Provera themselves."-Judy Norsigian,co-author and co-founder of Our Bodies Ourselves and the Boston Women’s Health Book Collective

From the Publisher

"By far the most thorough account of the Depo-Provera story to date. Though we may never get clear answers about whether Depo-Provera has done more harm than good over the past few decades, this well-researched history will be of great interest to those in the public health and women and gender studies fields, as well as many women contemplating the use of Depo-Provera themselves."

Judy Norsigian