Ace Flibanserin Task Force

Right now, the FDA is considering whether to approve the drug flibanserin– a psychoactive drug with sedating effects that women would need to take every day and which is supposed to increase sexual desire. The drug company is trying to get it approved for premenopausal (cis) women formally diagnosed with HSDD. HSDD is a diagnosis from the previous version of the DSM (i.e., the DSM-IV; APA) that’s defined by low sexual desire accompanied by “distress or interpersonal difficulties” and when the low sexual desire cannot be explained by a side-effect of medication.(1) 

The doctors at PharmedOut put together a FactSheet on flibanserin which is a good basic introduction. (The clinical trials show that flibanserin really doesn’t work much better than a placebo, and it has a whole bunch of nasty side-effects. Also it was only tested on cis women in heterosexual monogamous relationships who were *not* taking any medications from a very long list, and the interactions between flibanserin and alcohol were largely tested on men.) You can read up on the clinical trials themselves from the FDA report to the scientific advisory committee.

There’s also a huge pro-flibanserin narrative exploiting the language of “gender equality” or “choice”(2) with pro-flibanserin people claiming that the FDA has approved a bunch of drugs to treat men’s sexual problems but not women’s  even though there are no drugs approved to treat *anyone’s* low sexual desire. None. Despite what the pro-flibanserin narrative would have people believe. In fact shortly before co-founding Sprout Pharmaceuticals, Robert Whitehead– one of Sprout’s current Vice Chair and past Chief Executive Officer– has already been warned by the FDA to withdraw its misleading marketing and incorrect medical information around another drug (including falsely promoting it as a treatment for low sexual desire in men).

The FDA has already rejected the drug twice previously, but this time the pro-flibanserin tactic is to focus on a narrative about how terrible, shameful and un-liveable life is for women who don’t want to have sex (with their husbands)… because (apparently) wanting to have sex is a necessary part of any full and happy life and/or marriage and part of what a “wife should do”. These themes were central in the FDA's Open Public Hearings voiced by supporters of flibanserin (many of whom had received money from Sprout Pharmaceuticals, e.g., for travel, accommodations, expenses).

This time, the FDA’s Scientific Advisory Committee recommended for the FDA to approve the drug with additional steps beyond labeling to help mitigate the risks.  However, doctors on the FDA advisory committee have publicly acknowledged  that their decision to recommend that the drug be approved was based on factors *other* than scientific evidence about the drug's (very limited) effectiveness or its (questionable) safety. 

They were also clear that they would not have recommended that the FDA approve flibanserin if they had been making their decision solely on the basis of clinical evidence of the drug’s effectiveness or safety as they might have been if there were already other similar drugs approved. (i.e., Instead of using the usual FDA standards of safety and effectiveness in their risk/benefit assessment, the FDA’s scientific advisory committee lowered their standards for these things based on misleading pro-flibanserin narrative-- a narrative of how inherently terrible or shameful it is for anyone to not want to have sex with anyone that it is better to have something even if that something is minimally effective and comes with considerable risks).

The FDA is expected to make its final decision on August 18, 2015.

Many scientists oppose the approval of flibanserin already on the basis of its lack of safety and effectiveness. And scientists and clinicians have already submitted 2 mass-signed open letters urging the FDA to reject flibanserin on the basis of the drug’s poor performance in clinical trials.  And there is a petition started by Leonore Tiefer (the psychologist who founded the New View Campaign) urging the FDA to disregard the (misleading) pro-flibanserin marketing and instead to use the same high standards of safety and effectiveness the FDA requires for other drugs..

But so far, there has been nothing to challenge the damaging and influential pro-flibanserin narrative that not wanting to have sex is inherently horrible.

That is where the Ace Flibanserin Taskforce petition comes in: urging the FDA not to approve flibanserin and explicitly challenging the dangerous idea which seems to be influencing the FDA's considerations (namely the incorrect assumption that it is inherently horrible to not want to have sex). 

You can find the ace-related petition here. You do not need to be either American or live in the USA for your signature to count.

Notes:

(1)  In the DSM-5 (APA, 2013), the diagnosis was changed around and while women can be diagnosed with HSDD because their partners are upset about their low sexual desire, they cannot be diagnosed with FSIAD for that reason. But flibanserin is being proposed to treat pre-menopausal women diagnosed with HSDD and not FSIAD.

Even if flibanserin is approved, any other usage of the drug would be “off-label” (as in, not what the drug would have been approved for-- and not what the FDA would have decided is “worth the risk”). So even if the FDA does approve flibanserin, it would *not* be approved to treat women who experience low sexual desire as a side effect of some medication, or to treat post-menopausal women with low sexual desire, or for that matter to “treat” asexual women who don’t want to have sex who are dating non-asexual partners who do... But many drugs are prescribed “off-label” and there’s a good chance that if the FDA approves flibanserin that it would be prescribed “off-label” even though it has *not* been shown to be safe.

(2)  People, especially in the open public hearings were making a lot of arguments about how women should be given options (even if they’re not safe and don’t work very well) and then trusted to make their own informed choices with their doctors. But they neglected to mention how the available clinical trial research does not provide the information that women (and doctors) would need to make these decisions.

For example, the research tools measuring sexual desire are suspect and there isn’t enough info about interactions between flibanserin and alcohol or almost any prescription drugs the additional safety trials about the interaction between flibanserin and alcohol were conducted mostly with men and because of how the other clinical trials were done, there’s no information about how flibanserin interacts with most other drugs. (On the other hand, the outcomes of the clinical trials do suggest that flibanserin doesn’t work the way the researchers thought it did). The in-depth summary of the trial results are public, but they’re in medical-researcher-speak.

Furthermore, apparently in all the pro-flibanerin statements to the FDA emphasising giving women choices, pro-flibanserin advocates managed to miss the part where women should be given the choice *not* to be shamed for not wanting to have sex. They also managed to conceal the therapeutic options that do currently exist to for women to increase their sexual desire-- specific therapies mentioned in the petition which are already the recommended best practice by the International Consultation on Sexual Medicine, e.g., Basson, Wierman, van Lankveld & Brotto, 2010).