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FDA to consider patch seen as female Viagra, or a fraud

Published Aug. 29, 2005

In recent months, Procter & Gamble Pharmaceuticals has stirred quite a buzz about its experimental testosterone patch, with some media describing it as a "female Viagra" that helped postmenopausal women have "four times more" sex than usual.

Thursday, a less breathless picture will emerge when a U.S. Food and Drug Administration advisory panel considers whether the patch should be approved.

While a pair of company-funded studies found the patch increased women's self-reported "satisfying sexual activity" _ meaning anything from cuddling to coitus _ so did a placebo.

With or without a testosterone kick, the 1,100 women weren't exactly insatiable. In P&G's first study, patch-users had one more satisfying episode per month than women on placebo; in a second study, the patch made even less difference.

Robin Kroll, a Seattle obstetrician-gynecologist paid to help conduct the research, said even one episode can be like a flood for a woman in a drought: "If you're having only one or two or three episodes a month and you increase it by one, that's a big deal."

P&G's Intrinsa _ the first of a wave of new products intended to boost women's sex drive with male hormones _ is raising concerns about dangerous side effects, corporate-sponsored research and misleading media coverage.

"In their search for sexy stories, some media outlets are exaggerating the benefits of the patch, inflating the potential pool of patients, playing down well established harms and ignoring important conflicts of interest," journalist Ray Moynihan concluded in this week's British Medical Journal.

The market for a female version of Viagra is vast, at least if you believe latest research _ which critics do not, since drug companies are behind much of it. For example, while developing Intrinsa, P&G-sponsored researchers developed a questionnaire for women to assess their sex drives and sex lives. That questionnaire was used in the Instrina studies, as well as in a P&G-funded study that found one in three naturally menopausal women don't have much sex _ although only one in 10 were distressed about it.

"It's completely bogus. Lots of women have lots of periods in their life when they're not that interested in sex. That's normal," said Lenore Tiefer, a New York University psychologist and sex therapist who will offer a dim view of the patch at Thursday's hearing. "People are anxious and gullible and the companies will exploit that."

After Vioxx, Celebrex sales up

WASHINGTON _ Pfizer's Celebrex gained a majority of sales for new-generation painkillers in the month after Merck & Co. yanked Vioxx due to safety concerns, according to IMS Health, a pharmaceutical information company.

Merck faces a flood of lawsuits after Vioxx was linked to increased risk of heart attack and stroke and the company withdrew it from the market Sept. 30. Analysts estimate the company's legal liabilities could reach $18-billion.

In October, the first full month of data after the Vioxx withdrawal, sales of Celebrex topped $260-million, or 63.5 percent of the market for cox-2 inhibitors. In September, Celebrex accounted for 48.7 percent of the market for new-generation painkillers.