Attraction. Desire. Sex. Orgasm. All words you are more likely to hear steaming up the back lot of a Hollywood studio than stirring the corridors of the staid Food and Drug Administration.
Yet these are the very words taking center stage in Washington, D.C. this week, as experts from the FDA sit poised and ready to hear pros and cons about a new drug that promises to help some women improve their sex lives.
That new drug is Intrinsa (search), a testosterone hormone skin patch developed by Proctor & Gamble for use in women who experience a loss of libido (search). If approved, it would be the first drug for treatment of women with female sexual dysfunction.
“We have very convincing evidence of the safety and efficacy of a drug that, in some women, could make a significant difference in the quality of their intimate life,” says Glenn D. Braunstein, MD, chairman, department of medicine at Cedars Sinai Medical Center in Los Angeles. Braunstein is a prominent researcher on testosterone therapy in women and one of several doctors who helped test Intrinsa.
Proctor & Gamble is seeking approval of the testosterone patch specifically for women with hypoactive sexual desire (search).
“This is a condition in which women lose their desire for sexual intimacy and are greatly distressed by that, and I underscore the distress aspect, because part of the criteria for treatment is that a woman is upset by her inability to enjoy sex,” says NYU professor Steve Goldstein, MD, who was not involved in the testing of Intrinsa but does serve on Proctor & Gamble's advisory board on female sexual dysfunction disorder (search).
Though testosterone is primarily thought of as a male hormone, it is also made by the ovaries in tiny amounts. Researchers say it is also responsible for some aspects of sexual function in women, particularly arousal.
When testosterone levels drop — as they do naturally with age or when the ovaries are surgically removed — the result can be a dramatic shift in intimate desires.
For more than a decade, doctors — and women — dealt with the problem quietly by using tiny amounts of male testosterone.
In other instances, pharmacies that make drugs using raw ingredients offered natural testosterone supplementation that also helped some women cope.
For the most part, however, most women, say experts, suffered in silence with no treatment at all.
Now the hope is for Intrinsa to make treatment not only easier and more accessible, but possibly safer via tiny metered doses of what Proctor & Gamble describes as “natural, bioidentical" testosterone delivered via a skin patch applied to the pelvic area twice weekly.
According to Proctor & Gamble spokeswoman Mary Johnson, Intrinsa would also be "the first testosterone product, and there will be others to follow, designed specifically for use in women and to have been studied extensively in well-controlled trials."
For Natan Bar-Chama, MD, Intrinsa is nothing short of a miracle.
“It is the single most important advance in the treatment of female sexual dysfunction we have ever seen,” says Bar-Chama, director of the Sexual Health Program at the Mt. Sinai Medical Center in New York.
Once therapy begins, results are said to be seen in about a month, with full effects in about 90 days. If treatment is stopped, however, even for just a few days, testosterone levels and desire will fall rapidly.
Miracles in Question
While some doctors are singing the praises of Intrinsa, others are warning women that help may not be on the way, at least not yet.
At the heart of their concerns: whether Proctor & Gamble’s bid for FDA approval of Intrinsa is premature and, moreover, a rush to market that some say precedes adequate proof of the drug's safety and effectiveness.
”I’m concerned about the lack of safety data, I’m concerned about the fact that this drug has only been tested for six months and only tested in women who were also taking estrogen therapy, and I’m outraged that the studies on Intrinsa thus far have all been sponsored by the manufacturer and that not one of those studies was ever submitted for publication to a peer review medical journal,” says NYU endocrinologist Loren Wissner Greene, MD.
However, Johnson points out that that while the peer review process may have been skipped, six months of clinical trials with follow-ups of up to 18 months have shown neither safety nor effectiveness to be an issue.
The most common side effects, she says, were facial hair and acne, which in most cases were not problematic enough to make the women want to quit the study.
Goldstein says he believes Intrinsa is safe and that the lack of long-term data should not dissuade doctors from prescribing this drug or women from taking it.
Further, Goldstein is confidant the FDA will scrutinize the research with more gusto than any peer review journal, and if the safety and effectiveness data are not there, he says, “the drug simply won’t be approved.”
In terms of women’s health, perhaps the biggest explosion in drug safety came when the Women's Health Initiative study detonated the bomb labeled HRT (hormone replacement therapy) in the summer of 2002. That’s when reports first surfaced about the dangers of estrogen-progesterone treatment, including increased risk of breast cancer, stroke, and heart disease among some women using HRT. It’s also a treatment, Greene points out, that women were encouraged to take before there were adequate data to prove it worked, or even that it was safe.
Now, she fears we are in danger of repeating this same mistake with testosterone.
“It might very well turn out to be an important and helpful treatment for some women, but I don’t think that, based on what we know thus far, we can say that, and I don’t think it’s fair to women to make them believe that we know more than we do about a drug that may have the potential to harm them,” says Greene.
Gambling With Women's Health?
Still another bone of contention is whether the Intrinsa studies being presented this week accurately portray the drug’s potential to help even a select group of women. According to figures released by Proctor & Gamble, 74 promise of women who tried the Intrinsa patch reported a more satisfying love life.
But as an editorial in the current issue of the British Medical Journal points out, when you translate these statistics into real-life numbers, results are far less impressive. Visiting British Medical Journal Editor Ray Moynihan writes, "Several abstracts seem to show that wearing the testosterone patch for six months increases satisfying sexual activity for women by just one episode or less a month, compared with placebo."
Greene says, "It's just not enough of a benefit to gamble with women’s health."
Perhaps the biggest concern surrounding the approval of Intrinsa is one shared by both critics and supporters alike: namely, that once approved the drug may be misused — demanded by women and offered by doctors in scenarios that are not only inappropriate, but possibly even dangerous.
Indeed, as a result of a sometimes-questionable, sometimes-helpful medical practice known as “off-label prescribing” doctors are, in fact, legally allowed to prescribe any drug that has been FDA approved for any purpose, even if that purpose was neither studied or even considered when approval was given.
In the case of Intrinsa, Proctor & Gamble has created a very narrow channel through which their approval boat can sail. But some critics believe that's just a ruse to get the drug to market quickly, grabbing a sizeable portion of what some estimate will eventually be a billion dollar-plus market.
Indeed, even some who support Intrinsa's approval fear it may be positioned as the new "female Viagra" and marketed inappropriately by those seeking to profit, including Internet portals who will likely offer it in much the same way they now offer Viagra, without adequate medical guidance.
"This is not a Saturday night drug. It's not going to make painful sex more comfortable, it's not going to affect vaginal lubrication, it's not going to make it physically more comfortable for a woman to have sex, and we have to be careful that the expectations for this treatment don't exceed its documented use and what it can deliver," says Bar-Chama.
Proctor & Gamble says it has extensive education programs for doctors and women ready to launch to help keep this problem from happening.
If Intrinsa is supported by the FDA's recommendation committee, we still won’t know right away if the drug will be approved, or if it is, when it will become available. However, many believe it could become a treatment option as early as spring 2005.
What's more, approval may open the door a little wider for other drugs to enter a woman's erotic medicine chest a lot quicker, including drugs such as Vivus, a spray product that promises delivery of testosterone in metered amounts absorbed directly through the skin.
By Colette Bouchez, reviewed by Brunilda Nazario, MD
SOURCES: Glenn Braunstein, MD, chairman, department of medicine, Cedars Sinai Medical Center, Los Angeles. Steven Goldstein, MD, professor of obstetrics and gynecology, NYU Medical Center, New York; advisory physician to Proctor & Gamble's committee on Female Sexual Dysfunction Disorder. Mary Johnson, spokeswoman, Proctor & Gamble. Natan Bar-Chama, MD, director, Sexual Health Program, Mt. Sinai Medical Center, New York. Loren Wissner Greene, MD, associate professor of endocrinology, NYU Medical Center, New York City. Women's Health Initiative Study, July 9, 2002. The Journal of the American Medical Association. British Medical Journal, Nov. 27, 2004; vol 329.
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