Drug Companies, FDA, Health Officials to Discuss How Use of Erectile Dysfunction Drugs, HIV Cases Might Be Associated

Officials from drug companies, FDA and other government agencies are meeting on Monday and Tuesday to discuss how the use of erectile dysfunction drugs such as Cialis, Levitra and Viagra might be associated with the spread of HIV and other sexually transmitted diseases, the Boston Globe reports. Men who have sex with men are more likely to engage in risky sexual behaviors with multiple partners when they combine crystal methamphetamine, an illegal drug that reduces inhibitions, with erectile dysfunction drugs, public health officials say. More than 20 million men in the U.S. use the prescription drugs. Jeffrey Klausner, director of sexually transmitted disease prevention and control at the San Francisco Department of Public Health, said his research has linked erectile dysfunction drugs with risky sexual behavior and an increase in the number of sexually transmitted disease cases in Chicago, Los Angeles and New York (Henderson, Boston Globe, 9/26). One study that Klausner co-wrote found that 31% of a group of MSM reported using Viagra without medical supervision and that use of the drug was associated with higher rates of STDs and risky sexual behavior. Another study presented in July 2004 at the XV International AIDS Conference in Bangkok, Thailand, found that recreational Viagra users were twice as likely as nonusers to be HIV-positive. Although the drug itself might not be directly linked to an increased risk of HIV infection, it might be contributing to higher rates of other STDs that increase vulnerability to HIV. For example, the longer duration of sexual activity that the drug enables might increase the possibility of ruptured tissue, which then becomes a portal for infections to cross into the bloodstream. Klausner on Aug. 4 filed a citizen's petition with FDA to make Viagra a controlled substance because of such studies (Kaiser Daily HIV/AIDS Report, 8/24/04).

Stronger Regulation
Klausner is urging drug companies to stop distributing free samples and limit refills of erectile dysfunction drugs. He also wants federal regulators to increase efforts to curb illegal distribution of the drugs, possibly by labeling them controlled substances. "The FDA, actually, can do a lot," Klausner said, adding, "They can require the manufacturers to do more education at the population level. They can require the manufacturers to educate the doctors and the prescribers. They can encourage the manufacturers to modify their advertising and marketing efforts." However, Dan Shames, director of FDA's division of reproductive and urologic drugs, said, "We're sympathetic but not sure what our particular agency can do," adding, "As far as FDA and labeling is concerned, a lot of this is really, really off-label." FDA has the authority to require stronger warnings on labels, but such warnings pertain only to the drug's prescribed purpose and not for any off-label use, such as when the drug is combined with other substances like crystal meth. Michal Fishman -- a spokesperson for Pfizer, which manufactures Viagra -- said the company supports "efforts to prevent the spread of STDs and HIV through education of safe-sex practices, including the use of condoms" (Boston Globe, 9/26).

Back to other news for September 27, 2005