Libido drug for women poses debate
Government science advisers are expected to decide today whether to recommend approval of the first ''female Viagra," a hormone patch that supporters say will reignite the sex lives of millions of women. But critics worry it will be overused and expose women to unforeseen long-term side effects.
Intrinsa, a testosterone patch made by
Supporters of Intrinsa say sexual dysfunction, like many other women's health problems, was long neglected by medicine and that the drug will draw much-needed attention to a problem most women did not realize was treatable.
''This is the nuclear bomb of women's sexual health -- it doesn't get any bigger than this," Dr. Irwin Goldstein, director of the Institute for Sexual Medicine at Boston University, said of Intrinsa. He said the drug could transform female sexual dysfunction into a curable disorder in much the same way antibiotics changed the treatment of infectious diseases. Goldstein has been a consultant to a number of companies, including Procter and Gamble, but said he was not involved with any of the Intrinsa trials.
However, some doctors and sex therapists contend that arousal is more complicated in women than men, involving a mix of psychology, evolutionary biology, hormone balance, and age. They believe that women's sexual problems are less likely to be treatable with a drug alone.
Moreover, they say that Intrinsa is the latest example of drug companies trying to expand their markets by manufacturing a disorder and a cure. As it has done with other lifestyle drugs, such as the hair-loss treatment Propecia, the industry is seeking to ''medicalize" middle age, these critics say.
''A shift in how we view normality . . . will be subtly imposed on the public through advertisement," said Leonore Tiefer, a clinical psychologist from New York University. ''There are people who are suffering, but there are far more people who are just curious."
The scientific advisory panel's recommendation will go to top administrators in the US Food and Drug Administration, whose decision will be closely watched because of recent concerns about the adequacy of the agency's monitoring of the safety of drugs after they are approved.
Critics worry that the testosterone patch, which is worn on the abdomen, could have negative long-term side effects, like the increased risk for breast cancer that was discovered years after replacement therapy for another hormone, estrogen, became a popular treatment for side effects of menopause.
''Women have been subjected to horrible hormone experiments by the pharmaceutical companies. I hope we don't have amnesia about this," Tiefer said.
Female sexual dysfunction, defined as decreased interest in sex and an absence of sexual fantasies, was estimated to affect 43 percent of adult women in the United States in a much-cited study published in 1999, but the data's credibility has been challenged because of the methods used and the fact that one author was a consultant for six drug companies and another helped advise
Procter and Gamble is initially seeking approval of Intrinsa for only a small percentage of these women: those who have had their ovaries removed and are taking estrogen. The ovaries produce testosterone, which is thought to have a role in sexual desire.
In studies of women who had undergone ovary removal surgery or were menopausal, women taking Intrinsa for six months reported that they experienced an average of one additional episode of intercourse, masturbation, or oral sex every four weeks compared with women given an inactive patch. The women on Intrinsa also reported greater sexual desire, with less feelings of distress. Side effects like acne, hair growth, or deepened voices occurred in women taking the drug, but were rare. The studies were reported at medical conferences.
Dr. Alice Mark, an obstetrician and gynecologist at Brigham and Women's Hospital in Boston who was not involved in Intrinsa studies, said they were ''well done," but she noted an interesting effect: ''Even women using a placebo patch also had an increase in sexual functioning, and probably what that indicates is that anyone who is willing to go out and do something for sexual function will have some results."
If the FDA approves Intrinsa for women without ovaries, doctors would be allowed by law to prescribe the drug ''off label" to any patient. Critics fear that the drug would be widely advertised to consumers, and that the ads, by playing on women's insecurities about sex, would spur millions to seek prescriptions.
Before prescribing the patch to women with functioning ovaries, a group that was not included in the Intrinsa studies, doctors would probably use blood tests of hormone levels and questionnaires about sexual satisfaction to determine who might benefit from the drug.
But Mark said it is difficult to tell whether women have normal or low levels of testosterone because tests are inexact and no norms have been established. Without an accurate testosterone level, she said, it would be hard to say whether a woman was a good candidate for the patch.
Goldstein already treats some women for sexual dysfunction with an ''off-label" testosterone patch intended for men. One of those patients, a 58-year-old Andover woman, is eager for Intrinsa to be approved.
After her daughter was born 29 years ago, sex dropped off the radar screen for the woman. ''Desire was gone, arousal was gone, everything just disappeared."
Two and a half years ago, she went to Goldstein and began getting testosterone therapy, and six weeks later something strange began to happen, she said. ''I was walking down the canned-food aisle in the supermarket and I started to think about sex."
Carolyn Johnson can be reached at cjohnson@globe.com.
