- Historic Sites
The Story Of The Pill
How a Crash Program Developed an Efficient Oral Contraceptive in Less Than a Decade
August/September 1978 | Volume 29, Issue 5
She and her colleagues also stress, however, that their occasional nightmare visions of possible catastrophe were, from the moment of their arrival in Puerto Rico, overwhelmed by their daylight vision of actual human tragedy—the poverty and disease and ugly death directly consequent upon the continuing population explosion. There was certainly no reluctance on the part of Puerto Rican women to take such personal chances as the experiment would involve. As soon as word of the impending trial was spread abroad, they flocked to birth control clinics to volunteer for it. Each woman was then informed of the distinct possibility of highly unpleasant side effects and of the further possibility, real if remote, that a side effect would be permanently damaging, even fatal. Seldom was a woman’s eagerness to take part reduced in the slightest by such warning: her greatest fear in almost every case was that, upon physical examination, she would be judged unfit for the test and therefore condemned to the agony and potentially fatal danger of further pregnancy and childbirth. “The gratitude of those selected was pitiful,” says Anne Merrill, echoed by Mary Ellen Johnson of the Worcester Foundation, who was also on the team. Even worse than conditions in San Juan were those in Haiti. There the cruelty of circumstances was augmented by the brutal political tyranny, itself partly caused by the miseries of overpopulation.
Moreover, as the field tests proceeded, the worst fears were one by one allayed. There were unhappy side effects: nausea, dizziness, headaches, edema, tender breasts, and menstrual irregularities. These suggested that the amount of progesterone and estrogen should be reduced, if this could be done without reduction of contraceptive effectiveness. (It was done in later pills.) But there were no unexpected side effects, as Enovid-10 proved to be 100 per cent effective in preventing ovulation when taken as prescribed by more than 15,000 Puerto Rican and Haitian volunteers, many of whom were “on the Pill” for a half-dozen years or more. The women who went off the Pill to become pregnant had normal pregnancies; they produced boy and girl babies in the normal proportion. Most reassuring of all were the negative results of tests and statistical studies to determine whether the tiny amounts of estrogen in the tablets had any carcinogenic effect. A couple of the cancer studies on the islands seemed to indicate that Enovid-10 might actually have some anti carcinogenic effect. A major test for possibly precancerous cells in women is the Papanicolaou vaginal smear; this test was made of women who had been on the Pill for two years or more, the results being compared with those of the same test on a control group. It was found that possibly precancerous conditions occurred in 3.6 per cent of 3,000 women not using the Pill as compared with only 1.6 per cent of 6,000 women who were using it. Similarly with breast cancer. In Puerto Rico the incidence of breast cancer for women in the 25-39 age group was twenty per thousand; there was no breast cancer among the 6,000 women on the Pill.
In June, 1960, Enovid-10® (its complete name) was formally approved by the U.S. Pood and Drug Administration for use as an oral contraceptive. There were safeguards. Enovid was to be available by medical prescription only, its use closely monitored by a physician; warnings of possible unpleasant side effects were to go to physicians and pharmacists, along with a strong recommendation (later relaxed) that use be continuous for no more than two years.
All the same, the decision was bold by any standard; it was dismayingly reckless in the view of some; and one can only hope that the prospect of great monetary profit for pharmacists and pharmaceutical firms was not, consciously or unconsciously, directly or indirectly, a factor in it. For though massive testing over half a decade had uncovered no evidence of immediate adverse irreversible effects, there could be no certainty in 1960 that the Pill (it was at once thus capitalized in the public mind) would not prove harmful and perhaps disastrous in the long run. Would the twenty-day cyclic dosage of estrogen, tiny though it was per day, have cumulative carcinogenic effect if continued for eight years, or ten, or more? Would women who went off the Pill after so prolonged a period of use still be fertile? And if they were, would the babies born to them be healthy? Such questions could not but remain open—they must continue to be answered solely in terms of probabilities—for many years to come.