Friday, November 14, 2014

The sham drug idea of the year: 'pink Viagra'

Snippet from from an Op-Ed featured in the LA Times by Ellen Laan and Leonore Tiefer

Ellen Laan is an associate professor of sexology at the University of Amsterdam, the Netherlands, and a Kinsey Institute research fellow. Leonore Tiefer is a clinical associate professor of psychiatry at NYU School of Medicine and founder of the New View Campaign

Many women report losing their desire for sex, some temporarily, some permanently. Is this a relationship problem, a normal aspect of life changes or, as the pharmaceutical industry maintains, an “unmet medical need”? That was the question under consideration for two days of meetings in late October, during which the Food and Drug Administration heard from sexual medicine experts and women with sexual complaints.

It was a rowdy meeting by sedate, scientific standards, and months of public relations campaigning had preceded it. The International Society for the Study of Women's Sexual Health, which is largely funded by the pharmaceutical industry, had joined with Sprout Pharmaceuticals and other companies with skin in the game to develop two slick campaigns, “eventhescore.org” and “womendeserve.org,” which argued that the FDA's failure to approve a drug to treat women's sexual problems was “sexist.” After all, men have Viagra and its various relatives.

The patients told stories of their frustrations and distress, but they appeared to have been coached to demand drug solutions. They acknowledged that their travel expenses to the meeting had been paid. Wearing matching green scarves and buttons proclaiming “#WomenDeserve,” the women described the mixed results and side effects of their various off-label treatments, including implanted testosterone pellets, testosterone gels and antidepressants. They insisted they had no nonmedical problems. Their desire had simply “turned off like a light switch,” as one woman said, sometimes as much as 30 years earlier, and they wanted it back, routine and predictable.

As professional sexologists and advocates of women's sexual rights, we were horrified by the campaigns' use and abuse of the language of equality to pressure the FDA to approve a potential billion-dollar blockbuster “pink Viagra.”

The only two drugs for women's sexual dysfunctions that have come to the FDA in the 16 years since Viagra was approved were rejected. One was Sprout's drug, flibanserin, then owned by a German company. The drugs for women didn't work and were unsafe. Not approving them isn't sexism, it's proper regulation.

The campaigns to “even the score” are deceptive for several reasons.

[...]

There is absolutely no evidence for womendeserve.org's claim that “a biological lack of desire to have sex negatively impacts 1 in 10 American women.”

No diagnostic test has identified any biological cause — brain, hormone, genital blood flow — for most women's sexual problems. On the contrary, abundant evidence shows that low sexual desire in women typically reflects a difference in desire between two partners. It is unethical and unscientific to attribute a couple's discrepancy in desire to the woman's biological deficit. In study after study, women's response to both test medications and placebo drugs is high. These repeated findings do not support the “unmet medical need” theory.
Emphasis added by this blogger.

Be sure to read the full Op-ED at this link

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