Gynecology: When the Law Worked

Another scare about a new birthcontrol pill set U.S. doctors' telephones jangling last week as women called to ask whether their particular pills were safe. The answer was the same as it has been since the pills first went on the market in 1960: "Yes, as far as anyone knows."

The facts in the current case were simple and clear. Merck Sharp & Dohme was testing a pill containing two synthetic hormones. One is an estrogen, familiar and long in use; the second is a new progestin, closely related to those in pills already available but differing in detailed chemical structure. Although 340 women have taken the still-experimental pill for several months with no apparent ill effects, the manufacturer tried giving exceptionally large doses—20 to 40 times the human dose—to dogs. Two of the dogs in the experiment developed cancer.

As required by 1962 law, Merck promptly notified the Food and Drug Administration and simultaneously asked physicians to stop testing the pills. Commented an FDA spokesman: "It seems clear that this is a case where the law worked the way it was supposed to."