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A Drug for Women, Tested on Men

January 14, 2016
by Rick Harrison

Outside of the presidential primary campaigns, perhaps the most discussed news concerning women’s health this summer involved the federal approval of Addyi, the first-ever drug to treat female sexual dysfunction.

Critics derided the drug’s limited pool of legitimate patients (which will certainly expand through popular usage beyond the prescribed indications), low level of effectiveness, significant side effects, and misleading feminist-themed marketing campaign.

But perhaps lost amidst the media blitz was the design of a study that the FDA required the drug company to complete to determine the degree of danger in mixing Addyi with alcohol, in which the researchers concluded that women should not drink any alcohol while taking this daily drug. That study enrolled 23 men and only two women. That’s a population of 92 percent men for a drug intended only for women.

Once again, the pharmaceutical industry’s testing — accepted by the U.S. Food and Drug Administration — has overlooked the female 51percent of the population. And this time, it’s supposedly in the name of a drug touted as a trailblazing strike for equality in a world stocked with men’s erectile dysfunction drugs.

For decades, biomedical researchers excluded women from clinical trials, assuming that women and men experience conditions and treatments identically. And for decades, we’ve known that isn’t true. Women differ from men in the prevalence, symptoms and response to treatments for many health problems.

From 1997-2000, eight of the 10 drugs taken off the market posed a more serious risk to women than men. In 2013, the FDA cut the recommended dosage of the sleep aid Ambien in half for women — 21 years after it was approved — because women absorb the drug differently than men and wake up the next day at greater risk for accidents.

Now there’s Addyi, designed for women and tested for severe interactions with alcohol in mostly men. Even though women absorb more alcohol in their blood when drinking the same amount as men, leaving them more inebriated and vulnerable to accident-induced trauma and liver and brain damage.

If this is a victory for women, perhaps I’m confused by the rules of the game.


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For questions, please contact Rick Harrison, Communications Officer, at 203-764-6610 or rick.harrison@yale.edu.

Submitted by Carissa R Violante on January 14, 2016