Many of you have heard the criticisms raised about the FDA not approving a “breakthrough” medication for sexual dysfunction in women. The argument centers around the failed (actually, thrice failed) drug flibanserin.
Now, as a practicing internist I would prescribe a pill for female sexual issues if there were one, but flibanserin isn’t worth fighting for. Here are 10 things you need to know:
- Currently there are no FDA approved pharmacologic therapies for female sexual dysfunction. Studies on Viagra and the testosterone patch have not proven successful in treating sexual dysfunction in women. This is not for a lack of trying.
- Female sexual dysfunction (FSD) became a legitimate billable medical diagnosis in 2009. FSD takes many forms: lack of sexual desire, impaired arousal, inability to achieve orgasm, or pain with sexual activity.
- The timing of defining FSD as a medical syndrome and the search for the female Viagra is curious and compelling. For a drug to receive FDA approval it has to be linked to a medical diagnosis. This is not to say women don’t experience the above issues, but is this a “medical condition” that requires treatment? That’s the debate.
- Women aged 45 – 60 are particularly vulnerable to sexual issues: decreased libido, vaginal dryness, pain during intercourse, difficulty achieving orgasm. Primary care doctors are terrible at asking folks about their sexual history. Terrible. You may have to bring it up.
- The principal predictors of sexual satisfaction in women are physical and mental health and there is no “one pill fits all” for that.
- Now, what’s this flibanserin? Many of you heard about the failed attempts in 2010 to obtain FDA approval for flibanserin. It’s an antidepressant pill that was rejected for the third time in 2013 by the FDA (when another drug company bought it), for limited effectiveness and worrisome side effects. Flibanserin is a multifocal serotonin agonist and antagonist also known as MSAA.
- Does flibanserin work? You should base your decision on the drug-company-funded studies in 2010: at best, compared with placebo, the drug offered less than one extra “satisfying sexual event” per month. The FDA analysis found that neither of the two studies “met the agreed-upon criteria for success in establishing the efficacy of flibanserin.” More recent 2013 studies, also sponsored by the drug company, show similar results. In addition, over a third of women experienced some form of side effects, which included sleepiness, dizziness, nausea, fatigue, and upper respiratory tract infection.
- What are the side effects of flibanserin? This is the problem with this drug. The side effects include nausea, dizziness, fatigue, sleepiness, and sedation—causing almost 15% of women taking flibanserin to drop out of clinical trials. The trials also showed an increased frequency of rare but serious adverse events, including depression, unintentional injury, and fainting.
- What is EvenTheScore.org? A website that emerged attacking the FDA with the claim, “Men outscore women 26 to 0 when it comes to FDA approved treatments marketed for sexual dysfunction.” The argument is that men have Viagra and other drugs, but women have none. They argue for the FDA to approve the first-ever drug to treat the most common form of women’s sexual dysfunction. The drug company Sprout is a key sponsor of the campaign and Sprout is run by pharmaceutical and investment specialists who reportedly bought flibanserin in 2011.
- Is flibanserin worth fighting for? I love taking care of women as a primary care doctor and would love to prescribe a magic pill. But is this anger, recently profiled in the NY Times, a slick pharmaceutical campaign masquerading as a feminist movement? You decide.