Is lack of sexual desire a medical condition? If so, can it be treated with a pill?
That is the debate that has been sparked by the drug flibanserin – future brand name Addyi – a product of Sprout Pharmaceuticals.
An expert panel of the U.S. Food and Drug Administration recommended Friday, in a 0-18-6 vote, that the drug be approved. The zero is important: It means none of the panelists believe flibanserin should be sold with label warnings alone (like most drugs), but 18 think it could be okayed with conditions and six voted for outright rejection. The drug has been denied approval twice previously, in 2010 and 2013. The final decision will be made by the FDA proper by Aug. 18. Health Canada approval could follow at some later date.
Critics believe flibanserin is a lousy drug but proved third-time lucky because of the clever media campaign Even the Score, which accused the FDA of being sexist because it has approved dozens of drugs to treat sexual dysfunction in men but none for women.
Flibanserin is often referred to as "pink Viagra." It's a catchy name, but a poor comparison. Viagra (or sildenafil) works by increasing blood flow to the penis, facilitating an erection. Viagra can also increase blood flow and lubrication of the vagina, but it failed in tests on women because it didn't increase their desire to have sex.
This re-affirms the message that social science – rather than biology – has delivered for decades: For women, the brain is the important sexual organ.
Flibanserin works on the brain, by altering levels of serotonin and dopamine, much like antidepressants. Yet, it still does a poor job of flicking the desire switch.
According to Sprout, 7 per cent of women suffer from hypoactive sexual desire dysfunction (HSDD), an "illness" invented by those lusting to market a sex pill to women.
Clinical trials conducted on pre-menopausal women with HSDD in heterosexual, monogamous relationships showed that they had, on average, three to four "satisfying sexual events" monthly. Those treated with flibanserin had an additional 1.7 "events" per month. Those treated with a placebo (a sugar pill) had one more satisfying event monthly.
In other words, taking the little pink pill resulted in 0.7 more "sexually satisfying events" per month, a result the FDA panel deemed to be "numerically small but statistically significant."
(Insert "size matters" joke here.)
Sexual desire, which is a subjective feeling, was measured on a scale of 1.2 to 6 and women taking flibanserin increased that score by a modest 0.3 points; again, that's about the same of those taking a placebo.
Half-an-orgasm a month and a smidgen of elusive desire is a pretty paltry benefit for a highly-touted drug.
Flibanserin also has a lot of undesirable side effects: Low blood pressure, nausea, dizziness and fainting. About 1 in 5 women suffer those side effects and they are particularly severe in those who consume alcohol or take birth control pills, which is why the FDA panel said the drug should only be prescribed with strict conditions.
Consider too that, unlike Viagra, which is taken "when needed," flibanserin is taken nightly, and we don't know the long-term effects. We also don't know the price, but it won't be cheap.
The most intriguing aspect of the flibanserin debate is how it has divided women, and feminists in particular. The Even the Score campaign has aggressively pushed the view that the FDA is gender-biased for denying access to "pink Viagra," and some feel they were guilted into giving approval.
But the sexism argument is dubious. There are dozens of birth control pills for women, but none for men. This is not gender bias, it's a failure of science to find an effective male birth control pill.
There are many reasons for low sexual desire: Lack of sleep, poor self-image, depression, hormonal fluctuations, a partner who is not attractive and so on.
Women deserve to have sexual fulfilment, and to have their sexual dysfunctions treated seriously. Right now, the best treatments we have are loving relationships and psychotherapy.
A magic pill may some day come, but its name is not flibanserin. For women in search of desire, a mediocre drug with a poor safety profile is not a solution, it's another problem.