Word: fda
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Dates: during 1980-1989
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...FDA considers approving a controversial contraceptive...
...Depo-Provera is not approved as a contraceptive in the U.S. Reason: the Food and Drug Administration fears that not enough is known about the drug's long-term side effects. Last week, at the behest of the Upjohn Co., which developed and markets the drug, a special FDA-appointed panel conducted a five-day hearing to see if Depo-Provera should finally be made available to American women...
...from a ten-year study using 52 rhesus monkeys were equally alarming: two of the animals developed cancer of the endometrium (the lining of the uterus). Upjohn's own scientists concluded in 1978 that the cancer was "likely related to treatment with Depo-Provera." Later that year the FDA refused to allow Upjohn to market the drug as a contraceptive, though it is approved for treating certain diseases...
Opponents of Depo-Provera are unconvinced. Questions raised about the animal studies are "highly conjectural," says Dr. Robert Temple, acting director of the FDA's Office of New Drug Evaluation. "The FDA does not approve animal carcinogens for prolonged use in young, healthy people." Temple also points out that it may take 20 years for cancer to show up in women taking the drug. He is joined in his concerns by a number of other government scientists and by such organizations as Consumer Advocate Ralph Nader's Health Research Group and the National Women's Health Network...
After the panel of inquiry makes its recommendations, FDA Commissioner Arthur Hayes will face a difficult choice: deciding whether the known benefits of Depo-Provera are worth risking its possible unknown dangers...