FDA, flibanserin & female sexual dysfunction

This week the FDA will vote on flibanserin, the much-talked-about drug for women with the condition called hypoactive sexual desire disorder or – because everything in sexual health needs an acronym like ED or PE – HSDD.

On the eve of the FDA vote, CBS last week ran still another story about flibanserin. This drug has received so much news coverage, you’d think it cures cancer.

LjxBYPVogRemVyN-250.jpg And CBS did little more than promote the hype even more, saying FDA approval “could translate into a $2 billion market in this country alone” and then failing to challenge the disease-mongering estimate of “10 percent to 30 percent of women” with this condition. It all just goes along with the drug company’s efforts to build a demand before the drug is even approved.

In fairness, the story did call it “a rather vague diagnosis” and did say that some “critics say creating a pharmaceutical solution is driven by greed. ”

But then it flip flopped by offering only a single patient anecdote, a woman who didn’t want to be identified, who was “desperate” after “losing her sex drive completely” and who now says she is “definitely improved” after being in a trial of the drug.

Meantime, this weekend I got an e-mail from a group calling itself “The New View Campaign” which opposes FDA approval of the drug. They’ve posted an online petition.

This group says the drug:

1. offers only TRIVIAL benefits to women’s sexual lives, as shown in the company’s clinical trials.
2. might have serious ADVERSE EFFECTS when marketed to a large population.
3. comes with an AGGRESSIVE MARKETING campaign to convince women that sexuality is located in the brain, and that low sexual desire suggests chemical imbalances in the brain.
4. contributes to UNDERMINING and CONCEALING social and cultural issues that lead to women’s problems with sexual desire.
5. tends to pathologize normal sexual diversity and therefore NARROWS the ‘cultural ideal’ around female sexuality.
6. represents a classic case of the pursuit of PROFIT rather than women’s sexual pleasure and scientific knowledge.

A few issues that CBS didn’t touch on.

A few weeks ago, Medscape quoted Gail E. Wyatt, PhD, a sex therapist, psychologist, and professor in the Department of Psychiatry and Biobehavioral Sciences at the University of California, Los Angeles:

“There are sometimes good reasons why women have no sexual desire. They may be in a relationship that’s unhealthy or where there’s physical or sexual violence. …This drug is not going to be a panacea for sexual problems, because often sexual problems are complex and happen for a good reason. My concern is that by prescribing patients a drug like flibanserin, we are medicalizing sexual function, rather than understanding the problem.”

Finally, blogger Merrill Goozner writes:

“I have a much more prosaic concern. Because I write often about prescription drugs, I get inundated with email spam from robots selling male sexual dysfunction drugs (I don’t want to use their names because it only adds to the volume). Approval of flibanserin will double that volume. So in the name of God, I beg the FDA committee: Stop spam! Vote no on flibanserin.”


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Comments (12)

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June 14, 2010 at 9:54 am

Hmm, it sounds like the aggressive antipsychotic Abilify ads telling people “chemical imbalances” and bipolar/depression, along with women being the target of the campaign.
It’s quite common for pharma to target women in product sales. In the case of Abilify it is now being touted as an antidepressant, to further use of this drug, again, aimed at women in their DTC.
This is the main point of DTC, to gain sales, and have the product name in a person’s mind when they arrive at the doctor and ask for the product, which then a doc most likely will have a sample from a pharma rep all ready to go.
Chemical imbalance of the brain, used again, how creative!
Why the general public falls for that, one will never know. America loves quick fixes, and their pills that’s for sure.
Low T, meets the G spot in this campaign! lol


June 14, 2010 at 10:09 am

Really, now. Do you (sorry, Dr. Wyatt, who it appears you agree with) really advocate disapproval of this product just because there are **some** who have a good reason for no sexual desire or because they have a bad relationship? No? Oh, then…because someone gets spam, we shouldn’t approve this drug. Yeah, that’s the ticket….
What about the people who have real reasons for this problem, who actually consider it to be a problem, and who have a legitimate need for this drug? Why do so many want this to be taken away as a choice?
Men certainly have no shortage of remedies for this problem, if they need it. Why cannot women have the same choice, if their doctor and they decide it is a prudent route to take? No, it’s not a panacea. Do we now only approve drugs that are a panacea?


June 14, 2010 at 10:53 am

I kind of have the feeling that this drug maybe rejected. Not because it wouldn’t help some out but I just don’t think it will pass. That is just my opinion and it is obvious that there is much room for debate on it. After a huge placebo effect of 30% in there last trials it seems like flibanserin only worked for 18% of women. I am not totally sure what to think… I suppose it would help some but would be an invitation to abuse (yet so many prescription drugs are abused regardless) I guess time will tell.


June 15, 2010 at 10:53 pm

Totally agree with you! Men have so many options whereas we don’t! I will never sign that petition!

Louise Mayor

July 23, 2010 at 10:56 am

I strongly disagree with the idea of disapproving those pills. Gary, if you get impotence problems tomorrow, you’ll go to your doctor or to some internet page and order Viagra or something similar – there are plenty of options. So what’s wrong with the idea of me or any other women being able to do the same, hm? Women deserve the same chances to fight their libido problems as you men do. Plus there are plenty of positive responses to those pills. here for example http://femaledysfunction.com/ , or most of all – here: http://www.youtube.com/ ! Many women actually fell better. What’s wrong with that?

Gary Schwitzer

July 23, 2010 at 12:35 pm

You can let the FDA know about your disagreement with their actions.
But they’ll tell you that the evidence just didn’t stack up.
Vested interests that stand to profit from promoting unproven products can make any claims they want – up to a point. But to get FDA approval, you need evidence, not just anecdotes, commercial websites and YouTube videos.