A Drug for Arousal
It's not just men who want some help with sexual performance
Some breast-cancer experts echo the committee's concerns. Others agree with the decision but not for the FDA's reasons. Leonore Tiefer, a psychologist at NYU School of Medicine, worries about off-label use. She fears that female sexual dysfunction might be overdiagnosed and that drugs would become a quick fix, especially given P&G's marketing muscle.
Those disappointed by the decision make two points. They say the legitimate questions about direct-to-consumer marketing by drug companies and overmedicalization are larger issues and ones to which Intrinsa's fate should not be hitched. If it works, women who need it deserve the choice now. "Women are smart enough to know if this is applicable to them," says Elaine Plummer, a P&G spokesperson.
Sex bomb. They also question the consistency of the FDA's approval process. Viagra was approved after trials of six months, despite the fact that the FDA knew beforehand that it is dangerous for patients taking nitroglycerin. Testosterone products for men were approved after reviews of similar length, even though there have been no long-term studies of their effects and even though they may promote prostate cancer. Is a sex drug aimed at benefiting women perceived as less valuable than one aimed at men?
The questions are not going away. Unless the FDA, in the post-Vioxx era, is prepared to impose vastly more stringent trial requirements on drug makers, some testosterone product aimed specifically at women with low libido will eventually be approved. Other companies with their own versions of testosterone products are on P&G's heels, and until these drugs reach the market, off-label use will continue. Drugs for arousal disorder are also in the pipeline (Viagra itself was once studied for this). "In a certain way, the train has already left the station," says Tiefer. Or, as Sheryl Kingsberg, a clinical psychologist at the Case Western Reserve University School of Medicine who is involved in the drug's trials, puts it: "Intrinsa was the first hope but not the only hope."
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