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Contraceptive RiskThe FDA, Depo-Provera, and the Politics of Experimental Medicine$
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William Green

Print publication date: 2017

Print ISBN-13: 9781479876990

Published to NYU Press Scholarship Online: January 2018

DOI: 10.18574/nyu/9781479876990.001.0001

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PRINTED FROM NYU Press SCHOLARSHIP ONLINE (www.nyu.universitypressscholarship.com). (c) Copyright University of NYU Press Press, 2019. All Rights Reserved. An individual user may print out a PDF of a single chapter of a monograph in NYSO for personal use.date: 13 October 2019

The Grady Hospital Study

The Grady Hospital Study

The Corruption of Contraceptive Research

Chapter:
(p.15) 1 The Grady Hospital Study
Source:
Contraceptive Risk
Author(s):

William Green

Publisher:
NYU Press
DOI:10.18574/nyu/9781479876990.003.0002

Judith Weisz's story of the politics of drug risk management begins with the FDA’s limited control of Depo-Provera's contraceptive research. After the agency authorized Upjohn to conduct human clinical trials, drug testing was the responsibility of the company and its researchers. Her story begins at the Grady Memorial Hospital Family Planning Clinic, which conducted Depo-Provera's major domestic clinical trial by administering the drug to 11,400 women, principally poor African American women, from 1967 to 1978. When the FDA audited the Grady Clinic's study, it found serious deficiencies in the design and conduct of the clinic's testing protocol, including inaccurate screening, defective informed consent procedures, and no follow-up of the women. The FDA audit team concluded that the clinic had sacrificed scientific assessment of the drug’s health risks to its acceptability in promoting family planning goals. The agency terminated the clinic's program, but its risk management flaws were not publically exposed and its research was not discredited until the FDA's Public Board of Inquiry, chaired by Judith Weisz, held hearings in 1983. Yet the women whose health had been harmed by their participation in the Grady Clinic's study went without a legal remedy.

Keywords:   clinical testing protocol, clinical trial, contraceptive research, family planning, health risks, informed consent

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