Research For Men Only

By ANDREW PURVIS

The huge research project included 22,071 volunteer subjects. And the main conclusion, published in 1988, was headline material: taking small doses of aspirin can reduce the risk of a heart attack. But women who read the fine print discovered that the study had little apparent relevance to them. Reason: not one of the 22,071 subjects was a woman. Admittedly, the overall risk of heart disease is greater in men, but after women reach menopause that difference in susceptibility largely disappears. Many older women would have been interested to know whether taking aspirin would improve their chances of avoiding a heart attack.

The for-men-only bias of the aspirin study was not unusual. As an article in last week's Journal of the American Medical Association points out, medical research often appears to ignore women. In studies of everything from the link between smoking and cataracts to the benefits of eating fish after having heart attacks, the subjects have all been men. That concerns some medical experts and political leaders.

In December the Congressional Caucus for Women's Issues asked for a review of National Institutes of Health grants in the past two years to see whether the studies fairly represented women. The report is due in April. Says Representative Pat Schroeder, a Colorado Democrat: "At this point, doctors just aren't getting the kind of guidance they need when they try to prescribe to women."

In most cases, if a drug is proved effective in men, it will do the same job in women. But not always. The information gap becomes important when the sexes respond differently to a given treatment. For example, the menstrual cycle is known to alter the effect of some antidepressant drugs.

For many drugs and treatments, doctors simply cannot be sure how well they will work in women. Because of the predominance of male-only studies, physicians do not have clear scientific proof that women can lower their cholesterol with drugs and low-fat diets. For similar reasons, little is known about the specific effects of AIDS drugs on women.

Why are women so often excluded from medical studies? Cost is usually the reason. In a well-designed trial, the subjects must be as similar as possible so that the treatment is the only variable. A study that includes both men and women must generally be larger -- and more expensive -- than a males-only trial to have the same degree of statistical validity. Though the costs may be steep, an increase in testing of women is called for. As for pharmaceuticals that are already available, some researchers feel that the Government should make a greater effort to monitor their effects on women.

The one-sided nature of medical testing reflects a broader neglect of female health issues, some experts say. For example, the NIH reportedly spends just 13% of its budget studying women's health. The research shortfall, observes Dr. Florence Haseltine, director of the NIH's Center for Population Research, has left uncertainties on many vital questions, including the causes of infertility and the effect of diet on breast cancer.

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CREDIT: TIME Chart by Joe Lertola.

CAPTION: THE FORGOTTEN FEMALE