Tuesday, July 6, 2010

Flibanserin rejected and HSDD questioned

As many readers likely already know, the FDA did not approve Flibanserin.
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.


missmarymax said...

Great post. I was so thrilled when Flibanserin was rejected. The history of the drug's development is seriously appalling, and dysfunctional and functional folk alike are better off that it's not on the market.

I read a few good posts on the topic, but I think this one makes some particularly good "supplemental" points about HSDD: http://tinyurl.com/25mvpqd Thanks for the post!

ACH said...

Dr. Petra has a number of good posts on her blog about the subject, and I have also found the marketing strategy of the drug company involved to be rather appalling. In some countries, it is not even legal to advertise prescription medications to the general public, and I'm inclined to think this is a good idea.

Anonymous said...

First of all if certain drugs weren't advertised to consumers, many people wouldn't think to even ask their doctors about conditions and treatments that could really improve their quality of life. And Doctors don't have the time to sit with each patient to let them know what'sout there.

Furthermore, I think it was an insult to women that Flibanserin and the "distress" caused by HSDD wasn't taken seriously.

Take one look at the blogs and you will find an outpooring of frustration about "why my libido hasn't returned after having kids"--there are a lot of frustrated women out there and all they get in return is cosmopolitan magazine, sex tips, and assumptions that they're in a bad relationship with an overly demanding partner.

If Flibanserin could have helped some one and is determined to be safe enough-- let them have it. If it's not safe, there's nothing you can do, but it just doesn't seem like they're taking the benefit of this drug seriously--I just hope there were some women on this FDA panel.

Just wanted to give you another perspective before you continue CELEBRATING the rejection of this drug that was intended to help people desperate for a legitimate solution to this problem.

Who knew a lack of sexual desire would be so taboo for women?!I'm just glad there are drug companies out there that aren't scared to recognize a useful therapy for women when they see one.

ACH said...

Anonymous, I am aware of the argument about how drug advertising encourages people to talk with their doctors about things that they otherwise wouldn't, and I do think that there is something to it, though my own gut feeling is that in many cases, it does more harm than good.

You tell me to look at "the blogs" but don't refer to any. I also am unsure why you think calling this a mental disorder is supposed to reduce stigma, given the enormous stigma attached to mental disorders. I also wonder if there would be as much distress if there weren't so much associated stigma.

The fact that there are people who are distressed about being gay doesn't mean that we should try to "cure" people of being gay; likewise, the fact that a minority of women not interested in sex are distressed about it doesn't convince me that we should be trying to "cure" lack of interest in sex. Furthermore, the results of the trials for Flibanserin hardly inspired confidence that this was much of a cure. If some medication was out there that actually work, I wouldn't have been celebrating its rejection. This one was a no-brainer. There really was no case for its acceptance other than that it would have made money for the company making the drug. (Other than arguments that actually ignore the facts of the situation, as your does.)

As for the argument that if there were some women that it would help, we should allow it is utterly nonsensical. Any intelligent on something as public-policy oriented as this MUST consider the pros and the cons at the social level. Sure there could be some women helped by this, but I am quite certain that there would be a lot more harm than good that would have resulted from this being approved.

Funny how you neglected to mention just how tiny the effect size was. Proponents of having this don't seem to like to mention that in their arguments.

Anonymous said...

I am curious to know if anybody has been on Flibanserin (as a part of the research Study) and what your personal findings and feelings were while being on it?)

ACH said...

I think that qualitative data of that sort would be interested (my impression is that most pharmacological studies don't deal with issues like this or questions like "what effect did it have on their relationship?") However, it is also important to keep in mind that the placebo effect is very real, and so it is quite possible that some people who felt that the drug had a positive effect on them may have been on the placebo--and that certainly wouldn't justify approving a drug. Because of this, anecdotal evidence is quite unreliable, as is simply how individuals felt. Looking at differences between the treatment and control groups is necessary.