Big Pharma lobbies FDA to approve twice rejected women's libido pill

(NaturalNews) With its "female sexual dysfunction" drug twice rejected by the FDA as risky and ineffective, Sprout Pharmaceuticals has turned to political lobbying to secure the drug's approval.

Following the blockbuster success of the erectile dysfunction drug Viagra, drug makers began searching for an equivalent drug for women. Yet female sexuality has been unresponsive to drugs seeking to target blood flow, hormones or other simple, single-variable biological processes.

Flibanserin, the drug once again up for FDA approval, acts instead on chemicals in the brain that have been linked with mood and appetite. If approved, it would be indicated for "hypoactive sexual desire disorder" (low sex drive leading to emotional distress) in premenopausal women.

Risky, ineffective drug? Call in the lobbyists!

The FDA first rejected flibanserin in 2010, following a unanimous vote by an expert panel which found that the risks of the drug -- including side effects such as dizziness, fatigue and nausea -- outweighed the benefits. There was not sufficient evidence, the panel concluded, that the drug even worked as promised.

The drug's then-developer, Boehringer Ingelheim, sold the rights to the drug to pharmaceutical startup Sprout in 2011. Sprout tried to secure approval for the drug again, providing further data on safety and effectiveness. In October 2013, the FDA once again concluded that the risks of flibanserin outweighed the benefits. Sprout filed a formal appeal of this decision, prompting the FDA to agree to reconsider the decision if the company provided more information. Among the information requested is how flibanserin interacts with other drugs, and how it affects driving ability (based on studies finding that it caused sleepiness in nearly 10 percent of study participants).

As the FDA considers the data, Sprout has launched a major lobbying effort, enlisting everyone from female senators to women's nonprofits, framing the issue as one of women's rights.

"Women deserve equal treatment when it comes to sex," read an online petition to the FDA, which collected nearly 25,000 signatures. The petition was organized by Even the Score, which receives funding from companies including include Sprout Pharmaceuticals, Palatin Technologies and Trimel Pharmaceuticals, which are all working on female sexual dysfunction drugs.

When questioned by the press, a public relations spokesperson for Even the Score refused to reveal what proportion of the group's budget is provided by drug companies.

Other lobbying efforts include a letter to the FDA on behalf of Sprout's drug, signed by four female senators, and a meeting with the FDA by a coalition of seven women's and consumer health groups, including the National Organization for Women.

Preying on women

Regardless of drug company talking points, many women's health experts remain skeptical of the concept of a generic "female sexual dysfunction," let alone that such a condition could be treated by a single drug. In contrast to the physiology of the male erection, they note, female sexual desire is highly complex.

If drugs for "female sexual dysfunction" hit the market, warned female sexual desire researcher Leonore Tiefer of New York University in 2010, "the much larger group of women without any medical reason for their sexual distress will inevitably be misinformed and misled into thinking that there is a pill that can get them the sex life they read about, the one they think everyone else is having."

Critics also allege that studies finding high rates of "female sexual dysfunction" in the population have been funded by drug companies.

"This is really a classic case of disease branding," said drug marketing researcher Adriane Fugh-Berman of Georgetown University in 2010, commenting on Boehringer Ingelheim's initial marketing campaign to popularize the idea of female sexual dysfunction.

"The messages are aimed at medicalizing normal conditions, and also preying on the insecurity of both the clinician and the patient," Fugh-Berman said.

Sources:

http://www.utsandiego.com

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