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.
About the Author
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
About the Author 322