Testosterone for sex

Friend Indeed, A, Jan/Feb 2005

Are we courting another hormone disaster?

It's no secret that drug companies such as BioSanté Pharmaceutical Inc. and Nastech Pharmaceutical are scrambling to find the equivalent of Viagra for women's alleged sexual dysfunction so that they can cash in on the market of menopausal women, among others, who are supposedly looking to boost their sex lives. However, to date, no drugs have been specifically approved in Canada or the United States for women's sexual dysfunction. In fact, last month, an advisory committee to the U.S. Food and Drug Administration recommended against Procter & Gamble's new drug, Intrinsa, a testosterone patch for women, largely on the basis of safety issues. P&G provided only six months of data in a total of 1,095 menopausal women who had had their ovaries removed. The women had to wear the patch every day, changing it twice a week. One vocal opponent of the testosterone patch was Leonore Tiefer, Ph.D., a clinical associate professor of psychiatry at the New York University School of Medicine and a sex therapist in private practice.

Q: What were your objections to the Intrinsa Patch?

A: As a psychologist with more than 30 years of teaching, research, awards and publications in sexuality, I believe that the FDA hearing for the Intrinsa Patch represented a perilous moment in the history of women's sexuality. Intrinsa was the first women's sexuality drug that the FDA has ever reviewed. Basically, the Intrinsa trials were inadequate to assess the long-term risks. I hope we don't have to go through another hormone scandal to learn this again. Intrinsa is not like Viagra - it's not a Saturday night drug to enhance experience. This is a steroid hormone women must take continuously for weeks before getting an effect. Yet Procter & Gamble's promotional materials encourage the belief that millions of women are walking around under-androgenized in danger of imminent sexual withering away. Its a revival of menopause as a deficiency disease - only this time it's testosterone, not estrogen that rides to the rescue.

Q: What are the health concerns about the Intrinsa patch and other testosterone drugs for women?

A: In the past, women who have used testosterone products approved for use by men (with acknowledged higher doses than women need) have experienced hoarseness or deepening of the voice, unnatural hair growth or loss, acne or oily skin, decreased breast size, increase in the size of the clitoris and irregular menstrual cycles. Moreover, some users of testosterone products - men and women - have experienced liver cancer. The other compounding factor is that women in the Intrinsa clinical trials were also taking estrogen. What additional risks - from heart disease to breast cancer - do women assume by taking estrogen with testosterone?

Q: You suggest that the use of testosterone in women requires more study.

A: Very modest desirable effects along with unwanted side effects were observed by researchers in women who received testosterone for between 14 to 24 weeks. But this period is much too short for hormone side effects to appear. Were drugs to be marketed with only this amount of testing, women users would be guinea pigs, as women were in the 1960s with the early birth control pill. After many years on the market, we learned of the elevated risk of malignancies (cancers) of various tissues in women who were on hormone replacement therapy. Can we assume, without evidence, that testosterone will be benign?

Q: Women's ovaries make small amounts of testosterone. So when women have full hysterectomies, they have been known to report a decline in their libido. Does testosterone help these women?

A: Some women with full hysterectomies report this decline. Others do not. That may be why P&G had trouble finding women to participate in their trials - after all, they tried recruiting women in 52 centres and managed to get only 1,095 participants in their trials. What's more, according to the Intrinsa trials, the placebo patch helped many of these women and the testosterone patch provided only limited additional help.

Q: So what you're saying is that sexual response is an individual matter.

A: I think it should be, but we are seeing an increasing homogenizing of expectations - women are all supposed to respond in the same way, and at the same high levels, for decades. This is not realistic and it will make many women insecure. In the revised 1980 version of the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, a brand new list of individual disorders of desire, excitement (arousal), orgasm and pain appeared, including "inhibited sexual desire" (changed in 1987 to "hypoactive sexual desire disorder"). The basis for this particular list was arbitrary, based on laboratory measures of volunteers' sexual activity combined with clinical experience with people's sexual complaints. But sexual complaints relating to romance, intimacy, cooperation, sensuality, body acceptance and pleasure, just to name a few, while known, didn't make it to the level of official "diagnoses." The psychiatrists chose to stick to the basic reproductive sexual script and proclaimed that regular performance was "sexually normal" and anything else was a problem. As a consequence, the list of sexual disorders used today overemphasizes genital responses and the performance of sexual intercourse, and shortchanges the more humanistic and emotional aspects of lovemaking.