A new drug designed to boost sexual desire in women is controversial for some and eagerly awaited by others, but it's hit a potentially serious snag. The drug didn't boost women's desire any more than a placebo in two clinical trials. The Food and Drug Administration posted the clinical trial results on its website today in advance of a committee meeting on Friday, when a panel of experts will vote whether or not to recommend approval of the drug called flibanserin. (The FDA usually follows the recommendations of its expert panels.) Although there was a slight increase in the number of sexually satisfying events flibanserin users had each month, the FDA staff who reviewed the results said the so-called response rate isn't "particularly compelling."
In a statement posted on the FDA website, manufacturer Boehringer Ingelheim maintains that flibanserin really works, while acknowledging it's better at increasing a woman's "global desire" than "the intensity of [her] acute episodes of desire." That phrasing suggests the drug's effects are, well, rather subtle.
Trouble is, flibanserin has side effects that may outweigh its tepid benefits. About 15 percent of flibanserin users in the experimental trial stopped taking the drug because of bad reactions like dizziness, nausea, anxiety and insomnia, compared to 7 percent of the placebo users. Side effects were heightened in those who used the drug at the same time they were taking other medications, such as anti-fungal treatments, hormonal contraceptives, and antidepressants. Flibanserin itself was originally designed to be an antidepressant, but past clinical trials found that it didn't alleviate depression.
While flibanserin's fate rests in the hands of the FDA, Boehringer Ingelheim has kicked off a widespread education campaign to make us aware that having a low sex drive is a real medical condition that affects "approximately 1 in 10 women"—a statistic disputed as overinflated by some sexual health experts. The company has hired actress Lisa Rinna to be the poster girl for low libido and funded the "Sex, Brain, Body" website that has an "educational toolkit" that urges women to please talk to their doctors if they think they have a problem.
[Not in the Mood? You Could Have Hypoactive Sexual Desire Disorder]
Interestingly, the Discovery Channel has also hopped on the bandwagon to educate their viewers about low sexual desire disorder. This documentary aired on its stations last month and was funded by, yes, Boehringer Ingelheim. John Whyte, a physician who oversees Discovery's continuing medical education (CME) and patient education programs, told U.S. News that Discovery maintained full editorial control of the film, which has the feel of an infomerical but doesn't mention flibanserin. Whyte said that the drug manufacturer was allowed to review the film before it aired "as a courtesy" and that "they could suggest experts for us to interview." One of the experts featured prominently is Sheryl Kingsberg, a clinical psychologist at Case Western Reserve University School of Medicine who is a paid consultant for Boehringer Ingelheim and is participating in their clinical trials of flibanserin. Another person interviewed is Phyllis Greenberger, head of the Society for Women's Health Research, which received funding from the drug manufacturer to produce the "Sex, Brain, Body" website.
If the Discovery program had mentioned flibanserin by name, Boehringer Ingelheim could have ended up in hot water with the FDA, which restricts marketing of drugs it hasn't approved. While the Discovery program doesn't identify the unapproved drug, it does show women who were somehow helped by their doctors—it doesn't say specifically how. One woman proclaimed, "I felt vital again. I felt energetic again. I had that drive." When asked if any of the women featured in the film were participants in the flibanserin clinical trials, Elizabeth Hillman, senior vice president of communications at Discovery responded, "we really don't know." She did admit, though, that this film made by Discovery's CME department isn't "a traditional Discovery Channel documentary" in terms of its journalistic rigor.
