The Grady Hospital Study
The Grady Hospital Study
The Corruption of Contraceptive Research
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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