The efficacy was not sufficiently robust to justify the risks," said Dr. Julia Johnson, the panel's chairwoman and head of obstetrics and gynecology at the University of Massachusetts Medical School. (link)
In a recent editorial in the Psychiatric Times, Ronald Pies, the editor of that publication uses this opportunity to raise a fundamental question: FDA Lacks Desire for Flibanserin—But Does Hypoactive Sexual Desire Disorder Even Exist?
He gives a much-deserved rebuttal to an argument for regarding this as a disorder and why we should be so concerned about it
Dr Sue Goldstein, who oversees clinical trials at the San Diego Sexual Medicine Center, writes that:“We are the forgotten gender,” she said. “We’ve been told to accept this dysfunction. Do we accept cancer or heart disease?” she said. “Do we or do we not have the right to choose whether we want treatment?”
Comparing reduced sexual desire to heart disease or cancer seems quite a stretch to me.
Then citing a different expert saying that a sexual problem is only a disorder if it causes the person distress, he comments:
what if the woman’s “distress” is related solely or primarily to the expectations of her sexual partner, as in the case of Mrs M? If Mrs M were suddenly marooned on a desert island, without her demanding husband (now there’s a fantasy!), would she experience any sexually-related “distress”? I have argued in several contexts that true disease generally ought to meet 2 criteria: the presence of intrinsic suffering and substantial incapacity. I have used the “desert island test” to distinguish between conditions, such as major depression and schizophrenia; and, for example, antisocial personality disorder (APD).
The first 2 usually meet the desert island test, whereas the third (APD) usually does not (although there are undoubtedly exceptions). For example, the person with severe, melancholic major depressive disorder is likely to experience both intrinsic suffering and incapacity, even on a desert island—despite the absence of interpersonal contact and responsibilities. He or she is still likely to feel guilty, worthless, suicidal, and have difficulty concentrating (for example, on building a raft), difficulty eating, sleeping, etc. All other things being equal, the stranded person with APD is likely to feel just fine, thanks--except perhaps for missing those exhilarating Ponzi schemes. (I acknowledge that these hypotheses require confirmation through actual research, which I suspect would not pass muster with most institutional review boards). By these lights, APD is not usually an instantiation of disease (dis-ease), though I am aware that some “sociopaths” are subjectively distressed and certainly provoke distress in others.
He fully supports providing help for people distressed about sexual problems--clinicians often provide help for people without any disorder, and the DSM has a section in the back called V-Codes which is for conditions that are not disorders but may be the object of clinical attention. (A number of relationship problems are involved.)
His argument raises a fundamental question about what is a disorder. Generally, people feel that it must involve something having gone wrong in the individual (this is necessary to exclude "normal pain") and that the condition causes distress or disability. With distress, there is the fact that all sorts of things can cause distress. (People can be distressed about being too tall or too short, having a nose that is too big or too large, about wanting to be an artist while their parents want them to be a lawyer, etc.) Many feel that something must be inherently distressing for the distress requirement to count. (Migraines and panic attacks, for instance, are generally considered to be inherently distressing.)
What is interesting is that he never even considers the possibility that HSDD could be a disorder because it is inherently impairing. Why this is interesting is that such (rather far fetched) logic was the justification for first including it in the DSM in the first place--it was an impairment in ability to experience the "normative" full human sexual response cycle that was then in vogue. If we reject that lack of interest in sex is a disability and that only inherent distress counts, there is no logical basis for including HSDD in the DSM.