Earlier this week, the FDA approved Addyi, a drug by Sprout Pharmaceuticals that the media is calling "the female Viagra" or the "little pink pill." It's the world's first drug to boost female libido. As a feminist and pharma industry professional, I am very upset about this decision, for many reasons:
It's not practical.
Addyi is approved to treat women with hypoactive sexual desire disorder (HSDD) - a loss of libido that can't be attributed to relationship problems, mental health issues, medication, or illness. Addyi is a daily pill that the woman needs to take for the rest of her life (or however long she wants to remain sexually active). Side effects include fainting and low blood pressure - which wouldn't be that big of a deal in and of themselves (every drug has side effects, after all), but apparently these are exacerbated by birth control and alcohol.
How many women in the real world have mysteriously lost their libido completely out of the blue, don't enjoy alcohol, and aren't interested in controlling their fertility? If I had to hazard a guess, I'd say literally zero.
It doesn't work.
In clinical trials, women on Addyi reported 0.5 more "sexually satisfying" events per month than those on a placebo.
First of all, "satisfying" is a completely subjective term. Second, the FDA analysis concluded that only 8-13% of women who take the drug will experience any effect. So we're going to ask women to take a pill every day, go off birth control, and abstain from alcohol...all so that less than 15% of them can have LESS THAN ONE additional "satisfying" sexual event a month!
The clinical trials were poorly conducted.
One study only had 25 participants, 23 of whom were male.
The company I work for sometimes runs clinical trials with fewer than 10 participants. However, that's because we develop drugs for extremely rare diseases that affect less than 120 Americans (I'm not sure about the rest of the world). Sprout, on the other hand, claims that "1 in 10" women suffer from HSDD. If that's the case, it would've been easier to recruit trial participants. The tiny sample size and inclusion of men confound the results.
It makes feminists look bad.
The drug was rejected by the FDA twice due to its poor safety profile and questionable efficacy. The FDA caved this time around due to the advocacy efforts of a group funded by Sprout called "Even the Score." They claimed that we have dozens of drugs to fix erectile dysfunction, but none for female sexual health.
First of all, this isn't even true. My company, for example, manufactures a hormone-replacement therapy to treat uncomfortable vaginal changes during menopause.
Second, the score is already even - there aren't any drugs out there to improve male libido, either. Viagra doesn't make men horny, it just enables them to get an erection once they're already in the mood.
Third, the FDA's prior refusal to approve any of the dozens of experimental HSDD meds out there isn't because the agency is full of misogynists who don't want women to have great sex lives (they've approved birth control, right?). It's because the agency is full of scientists who know how to read clinical trial data and conclude that the risks associated with a treatment outweigh it's benefits.
Second, the score is already even - there aren't any drugs out there to improve male libido, either. Viagra doesn't make men horny, it just enables them to get an erection once they're already in the mood.
Third, the FDA's prior refusal to approve any of the dozens of experimental HSDD meds out there isn't because the agency is full of misogynists who don't want women to have great sex lives (they've approved birth control, right?). It's because the agency is full of scientists who know how to read clinical trial data and conclude that the risks associated with a treatment outweigh it's benefits.
And most importantly...It pathologizes women.
There is nothing medically wrong with women who have low desire. Maybe we as a society need to be more accepting of women who are asexual instead of trying to "fix" them. Maybe we need to move beyond the abstinence-only fear campaigns that associate sex with pregnancy and disease but not with intimacy and pleasure. Maybe we need to stop photo-shopping the already-skinny models on magazine covers and billboards. Maybe partners need to do more laundry and pick up the kids from school so women can get out of 'mommy' mode and into a 'sexy minx' mindset.
Maybe we should treat the cause, instead of looking for quick fixes to address the symptoms.
I've been reading the testimonials of women who swear this drug is a godsend, and don't want to discredit the sincerity of their enthusiasm. But I fear that for every one woman genuinely helped by Addyi, dozens more will be physically harmed or emotionally left feeling "broken." Sprout currently doesn't have clearance to market Addyi directly to consumers. But once you start seeing their ads on TV or magazines, I hope you take their claims with a grain of salt.
No comments:
Post a Comment