Wednesday, June 2, 2010

More on the petition about Flibanserin

Yesterday, I made a post encouraging people to sign a petition urging the FDA not to approve the drug Flibanserin, developed by Boehringer Ingelheim. I made this post after reading about the petition on Shades of Gray and reading up on it (I had already read a number of things on the matter and posted parts of a few of them here with specifically mentioning this drug.)

Feeling that this is a very important matter--and a matter that is very much relavant to the asexual community--I made a post on AVEN and another version on Apositive. I also copied a version of my blog onto the Asexuality community on LJ.

The responses have been very mixed, and I wanted to respond to a lot of the negative responses and (what I see as) the misunderstandings behind them.

I'll summarize the main arguments against my position:

1) Even though asexuals aren't distressed about not being interested in sex, many people are distressed about it. It's not our place to prevent them from getting help.

2) If the drug works, the FDA should approve it. If it doesn't, they shouldn't. Why should potentially bad consequences (especially bad consequences for a small minority like asexuals) play any role?

3) No one is going to force us to take it, so why should we care?

4) Even if this is a bad idea, why would the FDA even care about this petition?

I'll address these in reverse order.

Even if this is a bad idea, why would the FDA even care about this petition?

On the New View Campaign Website they explain the purpose of the petition:
Please go to Change.org and look for the Low Sexual Desire petition and sign it and circulate it to others. ASAP, please. We will take these petitions to the June 18 Flibanserin hearing.

It seems that the purpose of the petition is to bolster support for their position, giving them more credibility in making their arguments. I don't know how much this petition will help, but I doubt it will hurt.

No one is going to force us to take it, so why should we care?
This objection can take either one of two flavors, and, for those making it, I'm not sure which was intended. One version is a "live and let live" approach. If it's not hurting me and it helps others, great. Why should I prevent that? This version essentially boils down to (1) above (addressed below.) The other flavor this can take is, "It's not my problem, so why should I care?" If that's your position, I probably can't do much to change it.

If it works, the FDA should approve it. If it doesn't, they shouldn't. Why should potentially bad consequences (especially bad consequences for a small minority like asexuals) play any role?

I think that the social effects are a legitimate concern. Essentially, the question should be "Will approving this do more good than harm?" For the possible harm of approving it, cost, side-effects, and social consequences are all legitimate areas of concern.

Neuroskeptic copies a chart about side effects, summarizing it as follows:
100 mg flibanserin nightly caused 14% of patients to drop out due to side effects, vs 7% in the placebo group - so an extra 7% decided it wasn't worth it. It caused dizziness, nausea, fatigue, somnolence - and bizarrely, also insomnia. Notably, 50mg daily was much worse than 100 mg nightly, which suggests that taking this at night, rather than in the morning, is a good idea. But given what it is meant to treat, you'd want to do that anyway, right?


Further troubling facts about this drug have to do with how it's marketed. If you look at the site Sex, Brain, Body (with hard to read text at the bottom saying, "This content was developed with the support of a sponsorship from Boehringer Ingelheim Pharmaceuticals, Inc."), it's clear that they're painting a picture of this "disorder" that fits with what the drug supposedly does. As Dr. Petra explains:
In the past five years we’ve seen some interesting (and worrying) developments in the area of drug development for HSDD. For several years the general view was women’s lack of desire was linked to hormonal deficits (specifically Testosterone) with hormonal patches designed to ‘treat’ the problem. These performed poorly at trial and were not approved by the FDA (although did get approval for use in Europe). A systematic review of all trial data indicated the Intrinsa patch was not effective at dealing with low desire in women.

The focus has now shifted to seeing women’s lack of desire as a neurological problem, with Flibanserin working in a similar way to an antidepressant (indeed it was developed as an antidepressant but was not fit for purpose). The naming of the promotional site as ‘Sex. Brain. Body’ particularly shifts attention towards female desire problems as being psychological, complex and emotional.

Intrinsa was only designed for women who had low desire following surgical menopause, whereas Flibanserin can be taken by any woman diagnosed with low sexual desire. Already we have seen practitioners associated with Boehringer Ingelheim working on Flibanserin also suggesting the contraceptive pill reduces desire which is one market which may benefit from having a pill to boost arousal.


Furthermore, the troubling social consequences of this would not be limited to the asexual community (not remotely). It is largely sex-therapists troubled by the medicaliaztion of sexuality--setting up a universal sexual norm, and ignoring relational, social, and political factors--who are leading the work against this. For an interesting perspective on a related issue, I would suggest an article by Allen Frances: Should Practical Consequences Influence DSM5 Decisions? Yes, Of Course.

Even though asexuals aren't distressed about not being interested in sex, many people are distressed about it. It's not our place to prevent them from getting help.
I am most certainly not opposed to people distressed about lack of interested in sex from getting help. In my history of Hypoactive Sexual Desire Disorder and the Asexual Community (which provides useful historical background for those interested) I explained the position members of the AVEN DSM Taskforce (as we called ourselves) found ourselves in:
[One] big difficulty is that a lot of people to see therapists complaining of low sexual desire. In the US, being diagnosed with something is an important part of getting insurance reimbursement, so simply advocating that the diagnosis be deleted did not seem a viable option. We knew we wanted a more asexual-friendly way of diagnosing low sexual desire, but we weren’t even sure what that would be.

The objection to this drug is largely that it barely does anything positive, but the negatives are considerable.

As before, I feel that this is something that we, in the asexual community, should be very concerned about, which is why I strongly encourage people to sign the petition. I would also encourage other bloggers to read up on it and blog about it.

2 comments:

Anonymous said...

I took part in the clinical study and Flibanserin fixed all of my sexual issues. My desire is back to what is was 5 years ago, and sex is no longer painful, like it has been for the past 5 years. For the past 5 years, until I joined the study, I couldn't enjoy sex and lost all interest in it. I was very distressed about the lack of interest and tried countless things to fix my problems. Nothing worked until Flibanserin. I had none of the side effects, and the side effects listed are not exactly that serious. I can't believe that there are people out there who don't care about not having a sex drive but find the need to try and stop people who DO care from getting something that helps. Shame on you and anyone who signs you petition for your reasons.

ACH said...

Since it's been a while since you made this comment, I don't know if you'll read this, but I'm kind of wondering if you actually read my posts before you tried to shame me for it or if you just sort of already had you mind made up and just skimmed one of them.

You also don't seem to grasp why anecdotal evidence is unreliable to understand the effect of drugs and why large scale clinical trials are necessary.