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

Description

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. Dedication Contents Preface and Acknowledgments Note to the Reader Introduction: The Odyssey of Depo- Provera 1. The Grady Hospital Study: The Corruption of Contraceptive Research 2. The Twenty-Five-Year FDA Approval Controversy: Cancer and the Politics of Acceptable Risk 3. Contraceptive Chaos: Unapproved Use and Upjohn v. MacMurdo 4. Marketing Approval and Litigation: Osteoporosis and the Realities of Medical Risk 5. Chemical Castration: The Johns Hopkins Clinic and People v. Gauntlett Conclusion: Contraceptive Drug Risk Failure, Human Dignity, and a Duty to Act Glossary of Legal and Medical Terms Notes Index About the Author