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Women excluded from heart studies
Who was left out
Researchers doubted women could give consent properly, and they assumed women's health was entirely a matter of reproductive health. Men show up with heart disease about 10 years earlier than women on average, so older women were not who anyone was looking for. Women who did have heart attacks or heart failure sometimes presented differently, which meant they did not fit the male model being built in the 1950s, 60s, and 70s.
The picture of a heart patient
Culture filled in the picture: a cartoon man in a suit, holding a briefcase, with a cigarette and a pastrami sandwich, clutching his chest. A cardiologist who finished medical school the year more women began dying of heart disease than men was still taught it was a man's disease. A woman who came in with back pain, belching, or a little jaw discomfort was unimaginable as a heart patient, so doctors dismissed her.
The gap in numbers
The gap shows in the numbers. Women are 38 percent of participants in cardiovascular clinical trials, and for heart attacks, heart failure, and rhythm problems, the share is even lower. With no studies on how women do with diagnostic testing, treatment, or prevention, women and doctors alike underestimated the disease. Women who put their families first also arrive late and play down their symptoms.
Why did early trials leave women out?
In 1977 the US Food and Drug Administration recommended excluding women of childbearing potential from early-phase drug trials. The guidance followed the thalidomide tragedy of the early 1960s and the discovery that diethylstilbestrol caused cancers in the daughters of women who took it. Researchers also found that women's hormone cycles added variation to results. That policy stayed in place until the 1990s.
How did a 1993 law change the picture?
The NIH Revitalization Act of 1993 required that women and minorities be included in clinical research funded by the National Institutes of Health. It also required that trials be designed to allow analysis of differences between sexes where relevant. The FDA reversed its 1977 guideline the same year. Women's participation in trials has risen since, though it still lags in many heart conditions.
Why do women get heart disease later than men?
The American Heart Association reports that women develop heart disease roughly seven to ten years later than men on average. Estrogen's effects on cholesterol and blood vessels appear to protect women until menopause. After menopause, the gap closes over the following decades. Since 1984, more women than men in the United States have died of cardiovascular disease each year.
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