Before approving “female Viagra” in 2015, the FDA asked for a study to see if it was safe when taken with alcohol. The drug’s sponsor conducted a test of 25 people — 23 of whom were men.
That’s right. Almost all of the subjects in this study of a pill to boost women’s libido — officially known as Addyi — were dudes.
What’s worse, this wasn’t some fluke or a deliberate scientific quirk. When it comes to medical research, this has often been the norm.
According to a 2009 analysis, women make up just 37 percent of research subjects, even though they comprise more than half the US population. Historically, this discrepancy sprang from concerns about harming pregnant women — but researchers also claimed it’s easier to study men, who don’t have hormonal cycles that can affect results. In 1993, Congress passed a law requiring clinical studies funded by the National Institutes of Health to include women. But women are often under-represented even today.
Medical studies in the past — including some major well-known ones — have gone so far as to enroll only men, such as:
- A 1986 pilot study from New York City’s Rockefeller University exploring how obesity impacts breast and uterine cancer, of all things. No women were studied.
- The Physicians’ Health Study from 1982 analyzing the effect of a daily aspirin on heart disease, which tested 22,071 men and zero women.
- The 1982 Multiple Risk Factor Intervention Trial looking at whether dietary change and exercise could help prevent heart disease had 13,000 male subjects and no female ones.
- The Baltimore Longitudinal Study researching “normal human aging” didn’t include any women for 20 years. The researchers’ explanation? There wasn’t a women’s bathroom at the test site.Researchers even prefer studying male animals over female ones. According to a 2007 report, 80 percent of drug studies using rodents tested only male subjects.Researchers offer various excuses, including those pesky hormonal cycles — and even the complaint that female mice have smellier urine.Male animals are the norm even when it comes to researching illnesses that disproportionately impact women, such as pain disorders, which are 150 percent more likely to affect the female sex. But it wasn’t until 2014 that the NIH finally insisted that animal studies use both male and female subjects.
Meanwhile, research increasingly shows that men and women are often medically different. For example:
- Women suffering a heart attack are more likely to have “atypical” symptoms — like indigestion, jaw pain, upper-back pain, nausea and fatigue — and sometimes don’t report chest pain at all.
- Women with lung cancer are more likely than men to have never smoked.
- Women metabolize many drugs differently. After studies revealed that women take longer to clear the sleeping pill Ambien from their bodies, the FDA cut the recommended female dosage in half.
The result of all this? We have a dearth of knowledge about women’s symptoms, diseases and responses to treatments — and women often receive subpar medical care because of it. In fact, eight out of 10 FDA-approved drugs pulled from the market between 1997 and 2001 were due to “unacceptable health risks” that were more harmful to women than to men.
“We literally know less about every aspect of female biology compared to male biology,” Dr. Janine Austin Clayton, associate director for women’s health research at the NIH, told The New York Times in 2014.
Four years later, doctors still aren’t equipped with the knowledge they need about women’s health. And women are still exposed to inappropriate — even dangerous — treatments as medicine too slowly plays catch-up.
Maya Dusenbery is the author of “Doing Harm: The Truth About How Bad Medicine and Lazy Science Leave Women Dismissed, Misdiagnosed, and Sick” (HarperOne), out now.
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