A Drug for Arousal
It's not just men who want some help with sexual performance
The ink had barely dried on the Food and Drug Administration's approval of Viagra when women began asking, "What about us?" Nearly seven years after the drug hit the market, Cialis and Levitra have also been OK'd for men, but there is still nothing for women. The wait appeared to be over late last year when an FDA advisory committee studied Intrinsa, a testosterone patch backed by promising studies. But the committee recommended against approval.
Those who voted down Intrinsa worried about the drug's possible long-term side effects, an understandable concern following news of ill effects from female hormones and Vioxx. But the ongoing Intrinsa story raises other questions, too: What, really, is female sexual dysfunction? Are drugs a good way to treat it? Was Intrinsa held to a different standard because the drug is intended for women?
Intrinsa is not a female Viagra. Indeed, there will probably never be the equivalent of that drug for women. Sexual dysfunction in men is mostly the inability to get and maintain an erection throughout intercourse. By contrast, there is no precise definition for female sexual dysfunction. It includes disorders of desire and arousal, difficulties in achieving orgasm, pain tied to intercourse, and disgust at the thought of sex. In fact, many argue that a woman's sexual dysfunction (FSD in the jargon) can't be analyzed as simply a medical issue--that beliefs from her upbringing and the quality of her relationships are just as influential as biology.
Rekindling romance. Whatever the definition of FSD, the most common sexual complaint doctors hear from women is one of low libido, or, as it's called in medicalese, hypoactive sexual desire disorder. Though many things, from not enough sleep to screaming kids, can dampen desire, one hormonal suspect is a lack of testosterone. Though it's thought of as a male hormone, testosterone is found in women, too, albeit at much lower levels; the ovaries and adrenal glands split the task of making it. Testosterone influences desire in both sexes, so it is used to rekindle a low libido.
Kathy Kelley runs Hystersisters.com, a support website for women who have undergone hysterectomies and removal of the ovaries. While some women actually report increased libido after surgery, others feel a slow and distressing decline. For these women, the usual advice to "spice things up" isn't adequate, Kelley says. "The doctor pats you on the head and says, 'Run down to Victoria's Secret,' " she adds. Many women have already discovered testosterone, in off-label use of products intended for men and in Estratest (a combination of estrogen and testosterone intended to relieve menopausal symptoms) or formulations compounded at pharmacies.
In the Intrinsa trials, women whose ovaries were removed and who took the drug reported a higher number of satisfactory sexual events (a placebo worked well, too, but not as well as the drug). A majority of the advisory panel members agreed there was a benefit, but they worried about long-term safety, especially when Intrinsa is taken in combination with estrogen replacement therapy. The risks they were concerned about--breast cancer and heart disease--would probably not show up for years, indicating that those who review clinical trials have become much more conservative in the post-hormone-replacement-therapy, post-Vioxx era. "It appears that the rules are changing," says Stephen Simes, president and CEO of BioSante, who expects to begin human trials of the testosterone gel Libigel this year. "Traditionally, we've always thought of 12 months as [the period for] safety studies," he says. The FDA "may make it 18 months, but if it's beyond three or four years, that's not practical." For its part, Procter & Gamble, the developer of Intrinsa, is talking with the FDA about what data it must provide to satisfy the agency's safety concerns.
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