editorial comment well, if it's a disease.....

A Food and Drug Administration advisory board may have set back the 10 pharmaceutical companies working on drugs for female sexual dysfunction when it recommended last week that Procter & Gamble's Intrinsa testoterone patch undergo more testing before it can be sold on the open market.

But the search for the "female Viagra" is far from over. Brick by brick, we are witnessing the construction of a sexually dysfunctional populace and the heralding of sexual medicine as the solution.

For six years we have heard about erectile dysfunction and various blood-circulation tablets designed to enable erections. And we have watched as the public face of erectile dysfunction shifted dramatically from Bob Dole to much younger men, spurring expanding markets, growing pharmaceutical profits and (not often discussed) increasing male performance anxiety.

With more than a handful of female sexual dysfunction drugs awaiting FDA approval - in the form of nasal sprays, creams, gels, pills and the patch - attention is increasingly focused on the other half of the sexually dysfunctional couple.

As with Viagra, though these drugs initially are being targeted for particular populations such as women who have had ovaries surgically removed, inevitably the drugs will be used by women representing a broad spectrum of backgrounds and ages.

Sexual pharmacology is here to stay, backed by a whole new world of sexual medicine experts, clinics and conferences. Before long, you and your loved ones will be deemed sexually dysfunctional. My advice: Arm yourself now in preparation for the onslaught.

The focus on women's sexual bodies is not new, of course. For centuries Western medicine has been used to shape women into the right type of sexual being to fit the norms of the time. In the Victorian era, women were diagnosed with hysteria or nymphomania if they did not fit the asexual expectations of the time. In the 1950s, if women were not responsive to their husbands, they were considered "frigid."

Viagra solidified new expectations for men to conform to the norms of an increasingly sexualized, quick-fix society. And now if a woman does not fit within those norms, in other words, to have regular and "healthy" levels of sexual desire, arousal and orgasmic functioning, she is said to have "female sexual dysfunction."

In 1998, in anticipation of Viagra's debut, Pfizer's public relations teams, with the help of eager journalists, smoothed the way with new statistics, medical jargon and expert and personal testimonies. Cloaked in scientific legitimacy, Viagra became a blockbuster in sales.

Six years later, the PR game around women's sexual problems looks all too familiar, particularly in anticipation of the FDA's eventual approval of a testosterone patch or other form of treatment.

Journalists regularly cite a 43 percent statistic associated with female sexual dysfunction, use new medical jargon such as the very term "female sexual dysfunction" and "hypoactive sexual desire disorder," introduce happy trial subjects attesting to heightened sexual activity and profile sexual medicine experts testifying on the drug's behalf.

As you prepare yourself for phase two of the Viagra phenomenon, remember what we learned the first time. Scientific legitimacy can go a long way to sell the product, but healthy skepticism about the numbers, medical labels and expert testimonies is advised.

For example, those seemingly neutral docs who appear in the news, on the Internet or in a "medical education" meeting promoting a drug - they are likely to be affiliated with drug companies. The commonly cited statistic - that 43 percent of women have sexual dysfunction - is culled from a 1999 study conducted by sociologists who asked about dissatisfaction around a wide range of sexual concerns, not sexual dysfunction.



While a good percentage of women may complain of sexual dissatisfaction, the source of this dissatisfaction is unknown, and relational, psychological, cultural and social factors likely play into it.

Simplistic models of dysfunctional bodies obscure the social layers of an individual's life. Might the pressures associated with family, work and relationships affect one's levels of sexual desire? Sure, but in the pharmaceutical era, the prevailing wisdom is, if sexual medicine experts can locate the problem in the body, they can fix it - and make money in the process.

We rarely hear about the placebo effect. In one under-publicized clinical trial for Viagra, men taking sugar pills experienced heightened sexual arousal 40 percent of the time. Some clinical trials for women on Intrinsa show an even higher placebo effect. At Thursday's hearing one advisory board member commented on the small difference in outcomes between the placebo and Intrinsa test groups, suggesting, "maybe you could market the placebo."

Of even more concern is something called the "nocebo" effect - the idea that exposure to treatments actually can exacerbate the problems it seeks to treat, such as sexual performance anxiety. I have come across many men in my research who report enhanced performance anxiety in the Viagra era, in contrast to what Viagra, Cialis and Levitra offer - enhanced erectile performance.

As the public learns about sexual desire disorders for women, we can bet that millions of women will begin to see themselves as dysfunctional. But what is normal? If 43 percent of women are sexually dissatisfied, isn't that a high enough percentage to redefine normal?

Finally, we have come to expect information about side-effects associated with drugs, but what about long-term effects? Procter & Gamble brought its application to the FDA, despite serious concerns that testosterone use may correlate with cancer and cardiovascular disease. Fortunately, last Thursday it was clear that the FDA advisory board was not willing to take another risk so soon after the recall of Vioxx and hormone replacement therapy drugs.

After a full day of testimony from Proctor & Gamble, FDA representatives and the public, the FDA advisory board voted unanimously not to endorse the drug, largely due to safety concerns. Immediately after the decision, Procter & Gamble released a statement saying that it would continue to pursue FDA approval for Intrinsa in the near future.

It looks like sexual medicine is here to stay. Treatments for erectile dysfunction reflect a market in the billions. And the market for a "female Viagra" is projected to be even larger.

As sexual medicine gains a foothold in our culture, sex will continue to be conflated with health. For example, a recent Pfizer Pharmaceuticals mailing to doctors and patients reports that sex equals health, youth and life itself. As a result, there is increasingly no excuse for men and women to not be sexual in America.

One happy Intrinsa trial subject profiled this month in Forbes Magazine reports that she now has sex every day. Is this our new normal? Not after Thursday's advisory board meeting, thank gosh.



New questions about what constitutes "normal" in the realms of sexuality, medicine, aging and gender will continue to arise. If we allow corporations to dictate what is normal, expected and ideal for Americans, that means entering into an unending cycle of doubt and insecurity, which can only lead to financial and interpersonal bankruptcy. Instead, let us define reality for ourselves.

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