Question of the Week: August 25th, 2015

How do you feel about the FDA’s recent approval of Flibanserin/Addyi?

If you haven’t been following the issue, here’s an article on NPR about it, and Rotten Zucchinis clears up some misconceptions.

When there was a campaign to encourage the FDA to disapprove of the drug, I had mixed feelings about it, but the recent approval introduces moral clarity.  Now I’m geared up to start critiquing some Addyi advertisements.

About Siggy

Siggy is a physics grad student in the U.S. He is gay gray-A, and makes amateur attempts at asexual activism. His interests include godlessness, scientific skepticism, and math. While not working or blogging, he plays video and board games with his boyfriend, and folds colored squares.
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8 Responses to Question of the Week: August 25th, 2015

  1. There are such huge problems with Addyi’s effectiveness (or, rather, lack thereof) and side effects that those alone would be sufficient grounds to oppose and be concerned about its approval.

    My understanding of how Addyi is supposed to work is based on the model of sexuality presented in Emily Nagoski’s Come As You Are. As a drug that started life as an anti-depressant, Addyi would be most effective for cis women who are experiencing inhibited sexual desire due to emotional or psychological issues (Nagoski’s model talks about how the brain’s excitation and inhibition systems affect sexual desire). An anti-depressant certainly can and should be part of the range of treatment options that any person is entitled to seek out for such issues. I also suspect that rather than taking this pill alone, it would be more effective to additionally work with a therapist and to explore non-medical solutions (apparently mindfulness meditation has shown to be effective in some studies). There might also be drugs that are more effective as anti-depressants, with fewer side effects, than Addyi.

    In any case, since that isn’t at all why I don’t experience sexual desire, I assume that Addyi would not be effective for me even if it did work effectively for the target population.

    But even if there was a drug that would somehow do this, I wouldn’t want to take it. My asexuality has deeply shaped the way I relate to people and that I think about myself my entire adult life (I’m 42) and if you changed that, you would change ME. I don’t want to be changed in that way. I just want to be free to live authentically as myself without pressure.

  2. luvtheheaven says:

    What do you mean by “the recent approval introduces moral clarity”?

    I would say I’m uneasy about the approval and worried for what it’ll mean exactly and feel fairly convinced that it shouldn’t have been approved because it’s too risky and also doesn’t even work well enough but was only approved due to political/social pressure, which is not how the FDA is supposed to work.

    • Siggy says:

      I was pretty ambivalent about whether it should be approved. For example, I read about the risks and they sound bad, but for all I know, bad-sounding risks are typical for many FDA-approved drugs. I don’t know how you would ever know that the FDA made their choice only due to political/social pressure. Also consider that we were applying political/social pressure in the other direction, so we’re not exactly taking a principled stand against it.

      • Sara K. says:

        The FDA has a mandate to only approve drugs which are safe and effective. Granted, the FDA does approve a lot of drugs with a similar level of side effects, though I think there is a big difference between approving those drugs with those kind of side effects for treating a life-threatening disease, and approving a drug with these kinds of side effects for a drug which is primarily intended to increase sexual desire. However, I think the real scandal is that it is approving a drug which, in spite of all of the tricks which pharmaceutical companies use to game the clinical trials (a simple trick is to shut down any study with undesirable results early, and wait until a trial has desirable results by chance) the difference with the placebo is only 0.5 to 1 more sexually satisfying event per month (which might be the super-placebo effect: people noticing that they have side effects, then figuring out that they didn’t get the placebo – this is why placebos should also have side effects). I elaborate more on this in my most recent blog post.

        As far as the concept of a libido pill (independent of effectiveness/safety) … well, it’s not a new idea. My opinion is that, if informed adults want to use it, that’s their business, but it belongs in the same category as elective cosmetic surgery, and should not be used as a treatment for a mental disorder.

      • luvtheheaven says:

        You make good points. I truly don’t *know* how or why they made their choice, but that “The Dirty Normal” article/blog post that Sara K. just linked to made for some very interesting reading…

  3. elenaolenska says:

    I’m strongly against the approval of flibanserin, mostly for medical reasons. As doctors have written, the drug isn’t safe, was tested primarily in men despite being a drug only for women and women who take it can’t drink alcohol ever. (Link here, since I can’t figure out how to embed it: https://drjengunter.wordpress.com/2015/08/23/want-to-take-flibanserin-addyi-for-low-sex-drive-you-cant-drink-alcohol-ever/). Considering this drug to fall under “safe” and “effective” is stretching the definition of those words too far.

    That said, I’m more ambiguous on the question of whether a hypothetical, fully safe and fully effective flibanserin should be approved because of issues of competing values. I do think that it encourages bad norms and can lead to people being pressured, and other issues. But plastic surgery, for example, probably reinforces less-than-ideal beauty norms and the importance of physical appearance to begin with, and most people who find that distasteful probably wouldn’t want to “ban” plastic surgery, because bodily autonomy is important. There needs to be give and take here, but I’d need to think more before deciding which side I fall on.

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