Health

What Big Pharma Doesn’t Want You To Know About ‘Female Viagra’

The Food and Drug Administration (FDA) may soon green light a drug to increase women’s sexual desire. The therapy, clinically known as Flibanserin but popularly referred to as the “female viagra,” would be approved for premenopausal women who suffer from Hypoactive Sexual Desire Disorder (HSDD) — a condition characterized by impairments in sexual function as well as sexual desire that isn’t caused by mental illness, medications, or another medical condition.

Fifteen years after fast-tracking Viagra’s approval, the FDA has yet to rubber stamp a treatment for women. And now, women’s groups and prominent female members of Congress have joined a public relations campaign partially funded by the drug’s manufacturer, Sprout Pharmaceuticals, to call on the FDA to finally even the playing field. On June 4, a scientific committee advising the FDA recommended the drug’s approval.

But an investigation by ThinkProgress reveals that the drug’s public relations campaign, called Even The Score, is highly misleading and the drug’s effectiveness is moderate at best. As Cindy Pearson, Executive Director of the National Women’s Health Network, told us, “Even The Score is full of lies, knowing willful lies.”

1. For instance, the campaign claims that the FDA has approved 26 drugs for male sexual dysfunction and zero for women. But that’s just not true. There are multiple brand name drugs approved for sexual problems for men and multiple brand name drugs approved for sexual problems for women:

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2. Similarly, Even The Score implies that the drug is similar to Viagra. But Flibanserin, is totally different from Viagra in almost every conceivable way. While Viagra rushes blood to the penis, Flibanserin tries to convince the brain to desire sex.

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3. The FDA rejected Flibanserin twice before and this third time around, the company didn’t present any new effectiveness data. Instead, it conduced an alcohol interaction study with 23 men and just two women.

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4. Sprout bused in patients to testify before the advisory committee, many of whom echoed the false gender inequity claims advanced by Even The Score. One such patient was a 63-year-old woman who is postmenopausal and a two-time breast cancer survivor. During our interview, Dr. James A. Simon — who participated in the clinical trials for the drug — admitted that she would not qualify for it. Hear her testimony (abridged for clarity):

Moreover, the drug’s effectiveness was so small, we had trouble quantifying it.

As Caleb Alexander, one of the doctors who voted against the drug told us, “the FDA’s best estimate is that about 8 to 13 percent of individuals” experienced “up to a moderate improvement” in sexual desire. Most women didn’t feel the desired impacts, though Simon did assure us that some did say that they saw a meaningful improvement in their sex lives.

Still, most of the experts we spoke to worried that the drug’s benefits don’t measure up to its potential side effects: dizziness, lightheadedness, fainting, drop in blood pressure and sedation. “If you faint while you drive a car, you may kill yourself or someone else,” Alexander said. “So I think the worst case scenario is that we see a large number of adverse events associated with the use of this product” as it’s used by a more general population. The drug is also incompatible with alcohol, birth control pills and other hormonal contraceptives and hasn’t been studied on women in same-sex relationships or those who were on fertility treatments or seeking to become pregnant.

As a result, most of the 18 members who recommended that the FDA approve Flibanserin expressed deep concern about the therapy:

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Pearson summed up this concern best: “I believe that Sprout Pharmaceuticals is going to do everything it can to ensure the drug is widely used,” she said. “If women’s health and safety depends on the integrity of Sprout Pharmaceuticals, we’re in big trouble.” Simon, however, insisted that every drug is studied on a narrow spectrum of the population before it’s released to the wider public and comes with its own portfolio of adverse effects. [Flibanserin] “is not perfect. The drug is not perfect,” he said. “The FDA is not perfect, neither is anybody in this room. And so we accept certain imperfections to move progress.”

The FDA usually follows the recommendations of its advisory panel and is expected to green light Flibanserin before the end of the month.