Do what you’re gonna do: Roll your eyes, groan, gnash your teeth, bang your head on the desk, throw your hands and declare, “I could have guessed that!”
If you happen to be a woman interested in taking Addyi, the first FDA-approved drug intended to treat low libido in women, your doctor will first tell you this: You absolutely cannot drink — at all — as long as you’re taking the drug, because alcohol has been shown to exacerbate its side effects, including fainting, dizziness, and low blood pressure. When the drug hits the market in mid-October, it will come with a black box underlining the importance of abstaining from alcohol while taking the medication.
But here’s the thing. Nobody actually even knows what would happen if a woman taking Addyi were to cheat and have, say, a glass of wine with dinner — because the research on the effects of drinking while on the medication was done almost entirely on men. The alcohol-safety study included 23 men, and a grand total of two women.
Okay, so: The good news is that there is a reason this happens, and it is perfectly understandable. The bad news is that this doesn’t actually help anything, and thus doesn’t count as good news.
Despite the stupidity, it’s not all about stupidity. This individual episode―
Cindy Whitehead, the CEO for Sprout Pharmaceutical, told Science of Us that participants were instructed to take two to four shots of grain alcohol within ten minutes in the morning, and then take a dose of flibanserin (the drug’s nonbrand name), adding that the study was designed according to FDA guidelines for these sorts of safety tests. (Valeant Pharmaceuticals recently acquired Sprout for $1 billion, but Whitehead remains CEO of Sprout.)
The gender disparity, Whitehead explained, occurred because the experimenters found many more men than women who wanted to consume that much alcohol that quickly. (Which — really, they couldn’t find more than two women willing to knock back a few shots in the name of sex science?) The experiment itself is what’s known as a “challenge study,” which purposefully does not mimic real-life conditions, but instead is designed to demonstrate what could happen under extreme circumstances. In this case, what happened was this: Many of the study volunteers experienced fainting and dangerously low blood pressure; in some cases medical intervention was needed. Hence, the alcohol restriction.
―only gets more complicated, both in the particular and general; we would not wonder if nobody is surprised to learn that women are significantly underrepresented in such research and testing. It is one thing to note that menstrual cycles affect the biochemistry of the test subject, except, well, right. The obvious and ironic just keep piling on.
And I’m sorry; the thing is that this really is none of my business, as I’m not a woman. However, I can’t shake this weird feeling that it still sounds like a bunch of dudes. It doesn’t really work; part of the reason it doesn’t work is because the “idea behind Addyi” “essentially overlooks” “how the libido works” for a significant enough number of women that “the market for Addyi will be even smaller than once thought”; it hasn’t been properly tested on women … let’s give it FDA approval! After all, it’s supposed to increase a woman’s libido.
Not that it has to mean anything; not that it is somehow a significant point. Just sayin’. Something about this bugs me, like we’re moving too quickly because, hey, it’s supposed to increase a woman’s libido!
Thus I should reiterate that it really is none of my business. And, in truth, I can so very easily be wrong.
Dahl, Melissa. “Addyi’s Alcohol Safety Was Tested Mostly on Men”. Science of Us. 25 August 2015.