Recalling a Pill

Until last month, no serious side effects had been reported. Chlormadinone, the "one-every-day" birth control pill, was on general-prescription sale in Britain, France and Mexico and was being widely tested in the U.S. Then a few beagle bitches being dosed with abnormally large quantities of chlormadinone developed nodules near their nipples. In the resulting fuss, further distribution of the contraceptive was halted in the U.S. Now the feeling is growing among many researchers that the recall of chlormadinone pills--like the banning of cyclamates--was a hasty and precipitous action that was based on insufficient and possibly misleading evidence.

Chlormadinone differs from conventional forms of the Pill in two vital respects: 1) it consists simply of a synthetic analogue of the hormone progesterone and contains none of the estrogen that has been implicated in clotting disorders among Pill users (TIME, Jan. 26); 2) it is taken every day of the year, and not on the 21-days-on, seven-days-off schedule of other forms of the Pill. Like the other versions--and, in fact, like all other potent medications--chlormadinone has its drawbacks. The failure rate, judged by unwanted pregnancies, is slightly higher than with other pills, and some women complain of irregular menstrual bleeding.

Did the beagle reaction justify the Food and Drug Administration recommendation that testing of chlormadinone be suspended, and the dutiful decision by Syntex to recall the contraceptive? Researchers engaged in chlormadinone test programs point out that no one knows whether beagle bitches are more likely than other animals to develop abnormal and possibly precancerous nodules under heavy stimulation by hormones. (It is known, on the other hand, that monkeys given similar doses did not develop the lumps.) Furthermore, even the three pathologists who examined the "breast tissue" from these beagles could not agree completely about which samples were benign and which might be precancerous.

The strongest reaction came from U.S.-born Dr. Edris Rice-Wray, who began Pill research in Puerto Rico in 1957 and has continued it intensively in Mexico City. Some 130,000 Mexican women are using the Pill, she insisted, and there is no evidence that it has caused cancer in women. "There's a lot of funny business behind all this," she said, referring to the recent Senate hearings on the Pill. "People are making a lot of charges without evidence. All this is only going to misinform women." The result? Dr. Rice-Wray pessimistically predicts that "many women are going to stop taking the Pill, and get abortions and die. Or they will have a lot of unwanted children."

This file is automatically generated by a robot program, so reader's discretion is required.