The Food and Drug Administration will decide the fate of a drug to treat low libido in women by Tuesday.
Depending on your point of view, the "little pink pill," flibanserin — popularly but incorrectly dubbed the "female Viagra" — is either the answer to a woman's prayers or a risky drug that turns a normal condition into a medical problem that only pharmaceuticals can solve.
It will be FDA's third consideration of flibanserin in five years. The agency has rejected the drug twice since 2010.
This time around, the drug is benefiting from a major public relations push from an advocacy group, Even the Score, which is supported by flibanserin's manufacturer, Sprout Pharmaceuticals of Raleigh, N.C. High-profile supporters include the National Organization for Women and 11 members of Congress who wrote to the FDA on flibanserin's behalf.
Dozens of women filled FDA hearing rooms at meetings over the past year, testifying about the anguish and marital turmoil caused by their loss of sex drive. Sprout's CEO, Cindy Whitehead, has acknowledged that her company paid for many of the women's travel expenses.
"It's important to put the patient voice at the center of the discussion," Whitehead said in an interview.
In June, an FDA advisory panel voted to recommend approval of flibanserin, provided that Sprout take certain steps to limit the pill's risks.
But critics say Sprout is using its publicity campaign to make up for weaknesses in the drug, arguing that the science behind flibanserin hasn't changed since the last time the FDA rejected it.
About 200 health professionals signed open letters to the FDA in July, arguing that flibanserin is little better than a placebo when it comes to improving libido, and its side effects could endanger women's health.
"Approving flibanserin will not only unleash an unsafe drug onto the U.S. market, but will send a message to industry that pressuring the FDA through public relations campaigns can get a drug approved," said one of the letters, whose lead author was Adriane Fugh-Berman, an associate professor at Georgetown University Medical Center in Washington and director of its PharmedOut program, which critiques pharmaceutical industry marketing.
Fugh-Berman questioned whether the women in the flibanserin studies were experiencing a real medical problem or simply the fluctuations of libido that commonly occur as women age and cope with the fatigue caused by work, motherhood and other demands. Some of the women's distress could be caused not by the women's lack of sex drive, but from a mismatch between their libido and that of a partner interested in having a lot more sex, Fugh-Berman said.
In clinical trials of flibanserin, women experienced two to three "satisfying sexual events" per month before joining the study. Compared to women given a placebo, those taking flibanserin had an average of 0.5 to 1.0 additional satisfying sexual events per month, according to an FDA analysis.
Sprout's marketing of flibanserin "is medicalizing a normal condition," Fugh-Berman said. "Do we really need to have a corporately determined level of libido?"
Advocates for flibanserin note that one in 10 women suffer from low libido, a problem that the FDA lists as an area of "unmet need" in medicine.
On its website, Even the Score takes the FDA to task for approving Viagra and other drugs that improve men's sex lives, without approving drugs to help women.
In a letter to the FDA, Rep. Jackie Speer, D-Calif., and 10 other members of Congress wrote, "We firmly believe that access to health care should be a fundamental right, regardless of whether you are a man or a woman."
FDA officials have defended their record, however, noting that flibanserin is not, as some have claimed, a female equivalent of Viagra.
Viagra treats erectile dysfunction, not low libido. At a June hearing, the FDA's Hylton Joffe said there are no approved drugs for low libido in either women or men.
Flibanserin's manufacturer agrees that its medication works very differently than drugs that help men achieve erections.
For women, "it's not about blood flow," Whitehead said. "Desire is happening in the brain."
Unlike Viagra, which men take before sex, women would take flibanserin every day for the rest of their sex lives. Sprout has asked the FDA to approve flibanserin for premenopausal women whose lack of sex drive is not caused by a medical or mental health condition or by a medication, such as antidepressants. Flibanserin isn't designed to treat vaginal dryness that can make intercourse painful.
Amanda Parrish, 51, said flibanserin helped restore her sex life.
Although she had a healthy sexy drive when she met her husband, her libido faded three or four years into their relationship, when she was about 46. Although she still enjoyed sex, she was no longer interested in initiating it. Their encounters fell from about six a month to two. Two weeks after she began taking flibanserin as part of a clinical trial, however, she found herself calling her husband to meet for a lunch-time rendezvous. While Parrish acknowledges that her experience is not the typical response to flibanserin, she says women should have the right to try it.
"I just got friskier again," said Parrish, from Brentwood, Tenn. "I even sent him a pantygram."
Parrish said flibanserin "is not a cure-all and not an aphrodisiac." At the same time, "most of us resist aging as much as we can," said Parrish, who has reached menopause. "Look at the market for eye creams. I'm going to fight aging every way I can."
Parrish notes that her husband, 58, began taking testosterone supplements to combat fatigue.
Critics of flibanserin reject the notion that the FDA needs to "even the score" on sexual health.
Supporters of flibanserin "have created this whole fiction about the FDA being sexist for not approving the drug," Fugh-Berman said in an interview. "It's not feminist to want a lower standard of safety for women."
Fugh-Berman noted that flibanserin can cause serious side effects: increased risk of fainting, low blood pressure, dizziness and sleepiness. Fainting can be especially dangerous if women lose consciousness while driving, she said. Taking flibanserin is as sedating as four alcoholic drinks, she said in her letter.
These risks are magnified if women drink alcohol or take common medications, such as antifungal, migraine medications and a long list of others, Fugh-Berman said.
The notion of telling women taking flibanserin to give up alcohol for the rest of their lives would be "both preposterous and doomed," said psychiatrist Leonore Tiefer, of the New York University School of Medicine, in a letter to the FDA co-signed with about 100 other health professionals. In her letter, she said therapy and education help many women with low libido.
Parrish said she's lucky that she has a husband willing to talk openly.
"There are a lot of women out there who are in bad relationships," Parrish said. A pill is "not going to make them want to have sex with a husband they aren't interested in."