If you're new here, I should say first that I am not a doctor or a scientist. I'm just a journalist with a passionate interest in health and science, and relevant to this post in particular, I'm a woman and a feminist. Hopefully that gives me enough credentials to critique the way much of the media has covered the new "female Viagra" known as Addyi just approved by the FDA.
My first reaction when I read about this in my Wall Street Journal iPhone app on the subway was to do a little fist pump. The idea that women's sexual health was finally getting the same attention as men's in the pharmaceutical industry was exciting. After further reading I got even more excited because the company that created the new drug, Sprout, is based in Raleigh, North Carolina, where a big part of my heart resides. (I know we are talking about science but I get emotional about Raleigh, deal with it.) But then I read about the side effects, which include drowsiness and nausea and get worse with alcohol, and a red flag popped up, not just because drowsiness and nausea are bad but because they are especially bad if they impair the user's faculties during a sexual situation. The FDA, despite its approval, is apparently very worried about the side effects too: it is requiring a special label and special handling of the drug.
And here's the other thing, which wasn't clear in a lot of the initial reporting about Addyi: it isn't like Viagra at all. Addyi actually started out as an antidepressant, and it allegedly improves users' libido by affecting dopamine and serotonin, some of the brain's "happy chemicals." In order for it to actually do that, though, you have to take it every day, much like other antidepressants. Viagra, as you probably know, is only taken as needed, and is meant to fix a distinctly physical problem.
Another piece of the puzzle that got lost in the excitable headlines (and I am not calling out the WSJ here, that story was pretty good in my opinion): no one is really sure what Addyi is treating, or if it's actually effective. Elizabeth Yuko, a bioethicist, addressed this on the Huffington Post today, noting:
In reality, there is no singular norm for sexual desire -- in males or females -- and this pathologization of women's sexuality is detrimental to anyone not exhibiting what society deems to be a "normal" libido...
While it is undoubtedly beneficial to have an ongoing dialogue about varying levels of sexual desire, and for women to be able to speak openly about sexual dissatisfaction, it is unfortunate that it had to take place in this context.
It's important here to take a look at who is behind all this. Many stories about Addyi painted it as a feminist triumph against Big Bad Patriarchal Pharma. The creator of the drug, Sprout, (which is, incidentally, now the subject of a $1 billion buyout bid from pharma company Valeant) put some serious money behind a lobbying group called Even the Score, which says it is aimed at achieving equality for men's and women's sexual health. But given the fact that many experts disagree as to the non-physical causes of low libido in women (is it a need for brain chemical adjustment or a different partner or less stressful life?), the concerning side effects, and the fact that Sprout's husband and wife founders have broken FDA rules about misleading statements before... it's not clear that this is really a win for anyone but Sprout, and now Valeant and its investors.
I've heard the other side of the argument, too: that if this helps even a few women feel better about sex in a world that tells them they should be willing to do it but never like it too much, it should be praised. People on both sides seem to have the same concern: that women still aren't on equal footing with men when it comes to sexual health. As researchers often like to say when presenting their conclusions... I think more study is needed.
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Meanwhile, this whole story is also really interesting to me from a business standpoint. The Sprout/Addyi saga reminds me a lot of that of Axovant and RVT-101, an up-and-coming Alzheimer's drug that almost didn't happen because pharma giant GlaxoSmithKline ditched it after disappointing studies. Addyi, too, almost didn't happen: Boehringer Ingleheim started working on it in 2006, but the FDA rejected it because it didn't appear to have a significant effect on libido over placebos. Regardless of either drug's efficacy, it's interesting to see two blockbuster drugs (Axovant recently had a massive IPO, though it doesn't yet have FDA approval) making headlines only after start-ups got hold of them. Maybe pharma is the next big industry to attract "disruptors"... and that opens up a whole box of other questions about how the interaction of science, money and lobbying impacts our health. And that's for another post!