The Safe and Effective Pills

No previous medical phenomenon has ever quite matched the headlong U.S. rush to use the oral contraceptives now universally known as "the pills." An estimated 5,000,000 American women now take them; and, as a special advisory committee of the U.S. Food and Drug Administration said: "Never have so many people taken such potent drugs voluntarily over such a protracted period for an objective other than the control of disease."

The committee was appointed almost a year ago to study the efficacy and safety of the pills. Its report, published this week, makes two main points: 1) the pills are more than 99% effective, far more so than any other contraceptive, if taken regularly on the prescribed schedule; 2) they are safe and have no major deleterious side effects, as far as anyone can tell. In fact, the committee noted tentative evidence that the pills may have welcome benefits in protection against disease, but emphasized that it is still too early to draw firm conclusions.

Clots & Cancer. On the key issue of whether the pills are really safe, the formal report took refuge behind a double negative: "The committee finds no adequate scientific data, at this time, proving these compounds unsafe for human use." A committee spokesman translated: "We wanted to put a word of caution, to put a yellow light, not a green light, on the matter."

The pills have been suspected as possible factors in some women's deaths, but the report found no clear evidence of the pills' guilt. The committee's difficulty was that there are few reliable bases for comparison--no one knows the incidence of various disorders and diseases among women generally, including those who have never taken the pills.

This is especially true of thromboembolic (traveling bloodclot) disorders. According to the Government's admittedly incomplete data on annual death causes, roughly 17 out of every 1,000,000 women die of such disorders. The researchers had no better base to go on; they also could only assume that pill-taking women have at least the same thromboembolic disease incidence as the general population. As a result, they multiplied 17 by 5 and came to the conclusion that approximately 85 of the 5,000,000 pill-taking women should have died in 1965 from the effects of traveling clots, with no other apparent cause. In fact, a study of all available death certificates showed only 13 such deaths.

The committee offered two possible explanations: either many doctors failed to report that the women who died of the thromboembolism had been taking the pills--or else the pills are actually protective against such disease. Cautiously, the committee chose underreporting as an explanation. But it could not rule out the alternative.

Much more is known about the general incidence of breast cancer; and on statistical evidence, among the thousands of cases, there should have been hundreds among pill-taking women. Yet FDA files showed only one such case. Again, the experts concluded that doctors had simply failed to say whether their breast-cancer victims had been on the pills.

Unenforceable Rule. The committee paid no heed to minor side effects such as acne and weight gain. Even on the major effects, the pills cannot be certified as completely safe until after years of detailed study on tens of thousands of patients. But the committee felt confident enough to recommend that the FDA stop forbidding doctors to prescribe the pills for more than four consecutive years. To this the FDA agreed. The rule is unenforceable and penalizes poor patients getting the pills at clinics. Apparently, the committee concluded, the pills cause no major harmful effects within four years.

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