Sci was toddling around the internet recently (as is her wont), when she came across the work of Dr. Petra. If you’re in to learning about sex, sex education, and everything else from a scientific point of view, Sci highly recommends Dr. Petra. This is a blogger who tells it like it is.
(Sci also just found out that Seed has a current article on humans as some very sexy beasts. Sci is suitably amused, and you should be too).
And it was an article from the awesome Dr. Petra which notified Sci of the current stuff going on with this drug called flibanserin, which has to be one of the WORST drug names. Sci keeps wanting to call it fibansin, or fibanserin, or flibansin. FLIBANSERIN?! Two syllables too many.
As you may know by now, the FDA rejected flibanserin for use in treatment of Hypoactive Sexual Desire Disorder (HSDD). Sci thinks this was extremely justified, as the results of the studies on flibanserin, first off, haven’t been PUBLISHED. This means they haven’t been peer reviewed. And there might be some good reasons. Neuroskeptic gave some great coverage of this. So far it looks like:
1) The trials did not show a statistically significant difference for the co-primary endpoint, the eDiary sexual desire score.
2) The Applicant’s request to use the FSFI [a questionnaire] desire items as the alternative instrument to evaluate the co-primary endpoint of sexual desire is not statistically justified and, in fact, was not supported by exploratory data from Study 511.77, which also failed to demonstrate a statistically significant treatment benefit on desire using the FSFI desire items.
3) The responder rates on the important efficacy endpoints for the flibanserin-treated subjects, intended to demonstrate the clinical meaningfulness, are only 3-15{9f43b4361d9a125bc126dd2a2d1949be02545ec69880430bc4fed2272fd72da3} greater than those in the placebo arm.
4) There were many significant medical and medication exclusion criteria for the efficacy trials, so it is not clear whether the safety and efficacy data from these trials are generalizable to the target population for the drug.
Um. Owie. So the whole thing was by questionnaire, which isn’t necessarily bad, except the questionnaire wasn’t itself proven to be any good. So then the results may not be any good. And the results they GOT suggest that even if the results WERE in fact an accurate representation, flibanserin doesn’t work any better than placebo. And even if it DID, there were so many exclusion criteria that we have no idea if the women used in the questionnaire even represented the regular target population. Excellent smackdown, FDA.
But there’s another deal here that Sci wishes to address, and that would be the issue of HSDD. Hold on to your hats.
As Neuroskeptic again so accurately points out, the disorder of HSDD is…remarkably undefined. I don’t necessarily agree with Neuroskeptic on things like Generalized Anxiety Disorder (GAD), but I think they have HSDD pretty well down. Here’s the thing. With issues like GAD, we have some ideas of what problems might be occurring in the brain to make the symptoms occur. We have drugs that can sometimes help with it. And while it may just be a case of being “generally anxious”, it also prevents a patient from functioning normally. When it prevents a patient from doing normal activities like their grocery shopping and going to work, and prevents successful social interaction and makes the person miserable, we’ve got a problem.
But what IS HSDD exactly? Simple, you might say, it’s the same as male erectile dysfunction! Nope. Not at all. Most masculine erectile dysfunction (ED) has a physical basis. Erections work by having blood flow go into the penis via vasodilation and stay there in the corpus canvernosa, causing rigidity. This is maintained by vasoconstriction of the vessels going OUT, so the blood stays in. Many cases of ED are caused when you can no longer vasoconstrict your outgoing veins from the penis effectively, and blood therefore doesn’t stay in the penis and flows out. Viagra, that champion of ED, works by increasing the vasodilation of the blood vessels going IN, allowing more blood to get in and the erection to be easier to maintain. For more on this, Sci has a post or two on it.
SO that’s male ED. But female HSDD? Well, blood flow to the clitoris doesn’t appear to be a problem. It’s not a problem of not getting the job done. It’s a problem of not having enough sexual desire.
But to this, Sci has a question: How much sexual desire is “enough”? Do women really need a sex pill?
And before you all say “well I have low libido and yes I do”, well…do you? Who exactly determines what is normal? What IS normal libido for a woman? Well, Cosmo will tell you that if you don’t want it at LEAST 7 times a week and tying up your hair with an extra thong for your many sexy times, you’re clearly a horrible person who is entirely failing your partner or you have deep psychological issues. But Sci wanted some real information and so she turned to Pubmed.
And she found a lot of stuff on “sexual arousability” and stuff on the “sexual health of couples” and changes in “arousability” throughout the menstrual cycle. But that’s not the same as DESIRE. Your ability to get it on and have a good time isn’t necessarily consistent with how horny you are at the time. And the studies on “sexual activity” don’t tell you anything about whether the women had high or low sexual DESIRE. The closest I got was this, which talks about sex in older couples, but asking a women whether she’s having ENOUGH sex isn’t the same as asking her how often she DESIRES to have sex.
So what is normal? WELL DANGIT I DON”T KNOW. And you don’t know. And Cosmo doesn’t know. And it looks like Pubmed doesn’t know either.
So I say, before you go about diagnosing women with HSDD and telling them they have a problem (which could arise from many sources), can we first answer the question of what exactly is a normal sex drive in a woman? The answer might surprise us all. Because here’s the thing. Until we know for real what an average woman’s sexual desire looks like (how many times per week does she desire sex, how many times per week does she THINK she should desire sex, and how this is affected by things like age and self-perception), if you diagnose yourself with HSDD…you’re never wrong. Because we don’t know what’s right.
So before we say we need a pill, let’s find out what the condition is.
