Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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A Young Woman's View of Flibanserin ("Pink Viagra"), FSD, and Pharma

A Young Woman's View of Flibanserin ("Pink Viagra"), FSD, and Pharma | Pharmaguy's Insights Into Drug Industry News | Scoop.it
The push for flibanserin and its treatment of hypoactive sexual dysfunction disorder in women not only makes a mockery of the drug approval process. It marks a dangerous emboldening of the trend towards medicalizing women’s sexuality and a step away from women’s equality in the bedroom.


FSD [Female Sexual Dysfunction] is a textbook example of pharmaceutical company disease-mongering. By creating FSD and promoting a medicalized view of women’s sexuality, pharmaceutical companies successfully established a market for drugs to treat low desire in women. The greatest offense, however, is the lack of scientific data and research backing FSD, a condition whose legitimacy is shaky at best. In fact, there is still very little that is known about the biological processes governing women’s sexuality.


Let’s not let Big Pharma fundamentally change how we view our bodies and sex lives. Let’s refuse to settle for a pill that denies us the emancipatory process of engaging in a much needed conversation and reconceptualizing of sexual desire in all genders.


The worst side effect of all is the drug’s association of loss of desire with a female dysfunction. Not only does this fault women for unfulfilling sexual unions, it treats sexual desire as an individual phenomenon that is gifted to someone else rather than something to be cocreated through partnership. Even the model of consent that is frequently taught continues to view sexual desire as something that is requested and then given, often a woman’s acceptance to a man’s invitation.

Pharma Guy's insight:


CLARA JANE HENDRICKSON - the author of this piece - is a rising College senior from San Francisco studying political science at UPenn.

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Is the FDA Sexist? Regulators Pressed to OK Drugs for Female Sex Problems

Is the FDA Sexist? Regulators Pressed to OK Drugs for Female Sex Problems | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Is the FDA guilty of gender bias? A coalition of consumer advocacy groups and drug makers recently launched an online campaign – complete with a petition – to pressure the FDA to approve more drugs to treat female sexual dysfunction. Called Even The Score, the crusade claims that there are more than two dozen drugs available to help men combat sexual problems, but none for women.


A key backer is Sprout Pharmaceuticals, a privately held drug maker that has been haggling with the FDA over approval of its flibanserin treatment. The drug was once owned by Boehringer Ingelheim, but later sold to Sprout after an FDA rejection. Last fall, the agency rejected the pill again and Sprout responded in December by taking the rare step of filing an appeal, even though such efforts often go nowhere.

Pharma Guy's insight:


Boehringer gave up on flibanserin -- so-called "Female Viagra" -- after the FDA refused to approve it for female sexual arousal disorder, also known as hypoactive sexual desire disorder (HSDD), which is a relatively new diagnosis.

Recall that I blasted the trial data Boehringer submitted to the FDA before the FDA decision (see here). The data from that trial showed that women taking flibanserin experienced 0.8 more "satisfying sex acts" per month than did women taking a placebo. By the way, a "satisfying sex act" can include ... wait for it ... masturbation!


Now, Sprout Pharmaceuticals is trying to get this drug approved. Sprout claims that a NEW trial of 1,000 patients (Study 511.147) published in the Journal of Sexual Medicine, resulted in "statistically significant improvements in the number of satisfying sexual events (SSEs), as well as increase in sexual desire when compared with placebo."

I don't have access to the data, but the description (here) of endpoints sounds very suspicious of data manipulation.


Read more about that here: Lack Sexual Desire? Try, Try Again!

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