For years now, Viagra-fueled couples have frolicked across the television promising near-immediate relief from male erectile dysfunction. Many women have no doubt wondered, Where is the blissfully happy pill for us? After all, it’s been more than a decade since Viagra burst onto the market. Turns out that drug companies have been racing to create something similar for the opposite gender. What they’ve stumbled upon validates something a lot of people already know: When it comes to sex, women are more complicated.
Tricky biology hasn’t stopped a Lincolnwood-based pharmaceutical company, BioSante, from trying to devise its own version of the little blue pill. LibiGel, its product, is a topical testosterone gel aimed at boosting the libido of post-menopausal women; research indicates that testosterone has a modest, but positive, effect on a female’s sexual desire. The drug is in the final stage of testing, and if all goes well, the company expects to submit its application to the Food and Drug Administration in 2010. They hope to launch LibiGel about a year later, despite some experts’ concerns that such a product may be unnecessary—or unsafe.
Still, BioSante has high hopes that LibiGel will outsell Viagra, which did a whopping $1.8 billion in sales in 2007. “We think the market for women is even bigger,” says the company president and CEO, Stephen Simes. Such optimism may sound over-the-top for a tiny enterprise with revenues of half a million dollars in 2007. (Its primary product is Elestrin, for menopausal symptoms.) But consider that in the same year, doctors wrote two million “off-label” testosterone prescriptions for women, aiming to boost their natural testosterone levels with medications that the FDA has approved for men.
BioSante is racing at least one much larger company, Procter & Gamble, to be the first to offer such a drug, but the road to approval has been rocky. For one thing, the FDA requires testosterone drugs for women to meet a standard of effectiveness different from those for men. A decade ago, all the manufacturers had to show was that a pill could give men an erection; basically, if a man looked turned on, he was. In contrast, women can show physiological signs of arousal, such as lubrication, but that doesn’t mean they are actually in the mood. To meet the FDA’s standard, a testosterone product for women must lead to more sex—and test subjects must rate the sex as “satisfying.” Pfizer gave up trying to meet the standard with Viagra; meanwhile, Simes touts BioSante research that found that LibiGel subjects went from happily doing it 2.5 times a month to 7.5 times.
Proving the safety of the product has been the other major hurdle, particularly in the wake of the 2004 debacle with Vioxx, the arthritis drug yanked from the market because long-term use led to heart attacks and strokes. “The whole [safety] paradigm changed,” Simes says, though exactly how has been a murky issue. A year ago, the company finally came to an agreement with the FDA over what would constitute adequate safety trials: Currently, BioSante is tracking cardiovascular health and breast cancer incidence in 3,000 postmenopausal women who are taking LibiGel (or a placebo) for 12 months. (Simes says the company will apply for FDA approval after a year but will continue to follow the women for another 48 months.)
Cheryl Newman, 54, an Oak Park resident, is one of the women in the trial. She says that, after menopause, she quit making overtures to her husband. “I would respond to him,” Newman says, “but not with the enthusiasm that I had before. It was distressing to me and distressing to him.” While LibiGel hasn’t made her feel the way she did in her 20s, she says, it most definitely has renewed her libido and made her, and her husband, very happy. “The sooner we can get this product out and known to women, the better everyone will be.”
Not everyone agrees. That LibiGel may make it onto the market trailing a single year’s worth of safety data troubles Leslie Schover, a sex therapist and researcher at the University of Texas M. D. Anderson Cancer Center. Schover wrote a recent Fertility and Sterility review of the published studies on testosterone and women’s health, because, she says, “I thought the people prescribing testosterone were really ignorant of the risks.” The studies indicated that breast cancer risk was significantly higher for women with high levels of naturally occurring testosterone as well as for women taking hormone replacement regimens that included testosterone.
Last fall, The New England Journal of Medicine published a study on Procter & Gamble’s product Intrinsa, which has been approved for use in Europe; the company is in talks with the FDA to enter the market here. In the group of 313 women receiving testosterone, four developed breast cancer, while none of the women in the placebo group did. (The treatment group reported two times as many “sexually satisfying events” as the placebo group.) Simes maintains that the four cases were not statistically significant, and the two that were diagnosed after such a short period were unlikely to have been caused by the testosterone. Schover, however, cautions that a full five years’ worth of data is needed to accurately determine risks. “I believe [women] are risking their lives to gain a very modest increase in sexual desire.”
Are testosterone products for women simply a solution in search of a problem? The New View Campaign, a national coalition of feminist social scientists and health-care practitioners, contends that pharmaceutical companies like BioSante are medicalizing women’s sexuality, making them think they have a problem where none exists. Domeena Renshaw, a psychiatrist and director of Loyola University’s Sex Therapy Clinic in Maywood, says the reasons for low libido have little to do with testosterone levels: “I tell my residents, ‘If you scratch a desire disorder, there’s often [another] symptom underneath.’” Poor communication with her partner, too much stress, even lack of education about how her body works can all negatively affect a woman’s desire for sex.
Simes says he actually agrees with these critics—up to a point. “If you have an issue in your relationship, counseling is a wonderful thing,” he says. “And if a woman doesn’t care [about low libido], she shouldn’t be treated. But if she cares, if she has distress, then she should have options. Help and choices are coming.”