A San Francisco public health official has petitioned FDA to make Pfizer's anti-impotence drug Viagra a controlled substance because of studies showing an association between use of the medication and higher rates of HIV and other sexually transmitted diseases, the San Francisco Chronicle reports. Dr. Jeffrey Klausner, director of STD prevention and control for the San Francisco Department of Public Health, has requested that Viagra and similar drugs be listed as Schedule III controlled substances -- a category of legal drugs that are often used for non-prescription uses, such as steroids. Schedule III drugs are easier to track and harder to prescribe because they require more detailed reporting from doctors. The petition, which was filed Aug. 4 and made public Monday, also requests that labels for Viagra and similar drugs include a warning that the drug is linked to an increased risk of STDs. Klausner has been in talks with FDA for two years but said he decided this month to address the issue formally by filing the citizen's petition with the approval of the public health department. "While the FDA was not actively opposed to a label change, they were not making any effort to do anything about it," Klausner said. Pfizer opposes the petition, according to the Chronicle.
Several studies have shown an association between recreational use of Viagra and higher rates of risky sexual behavior that can increase the likelihood of contracting STDs, including HIV, Klausner said. One study that Klausner co-wrote found that 31% of a group of men who have sex with men reported using Viagra without medical supervision and that use of the drug was associated with higher rates of STDs and risky sexual behavior, according to the Chronicle. Another study presented in July at the XV International AIDS Conference found that recreational Viagra users were twice as likely as non-users to be HIV-positive. Although the drug itself may not be directly linked to an increased risk of HIV infection, it may be contributing to higher rates of other STDs that increase vulnerability to HIV, Klausner said, the Chronicle reports. For example, the longer duration of sexual activity that the drug enables may increase the possibility of ruptured tissue, which then becomes a portal for infections to cross into the bloodstream (Russell, San Francisco Chronicle, 8/24). "The predominant problem that we see in San Francisco is ... widespread use among gay men with multiple partners," Klausner said, adding that the drug "increases their ability to have more sex partners, particularly in multiple-partner environments, and reverses the chemical impotence associated with methamphetamine and crystal use" (Tanner, Reuters/New York Post, 8/24).
"This is a serious enough issue that we needed to bring it to the attention of the FDA directly," according to Robin Summers, spokesperson of the National Coalition of Sexually Transmitted Disease Directors, which sent a letter in support of the petition (San Francisco Chronicle, 8/24). However, Pfizer says it already has a public education campaign about the drug, including a Web site called sexualsmarts.org. "We can only give so much education material. Ultimately, people have to decide the kind of behavior they are going to engage in that will minimize the risk," Pfizer spokesperson Daniel Watts said, adding, "It also comes down to taking personal responsibility for your own behavior" (Tanner, Reuters, 8/23). Watts added, "There is a population of people who won't read labels. They are getting Viagra from other sources than pharmacies and are taking it with drugs that are illicit." FDA has 180 days to take public comment and rule on the petition, according to the Chronicle (San Francisco Chronicle, 8/24).
Back to other news for August 24, 2004
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