Anti-impotence drugs such as Viagra and Levitra should not be marketed without clear warnings about an increased risk of HIV and sexually transmitted infections, the San Francisco Department of Public Health said yesterday in a complaint to the US Food and Drug Administration.
The Department is urging doctors, sexual health specialists and HIV prevention researchers to submit testimony to the FDA after it revealed that it filed a Citizen Petition earlier this month that forces the FDA to look at the issue. Interested parties now have 180 days to submit comments.
Concerns about Viagra and similar drugs have been rising over the past five years as it became evident that their use was facilitating high levels of sexual activity among gay and bisexual men who use methamphetamine. `Crystal meth` is associated with increased desire for sex that may last for over 24 hours, but paradoxically the drug also makes most men impotent. Viagra and other anti-impotence drugs are widely used to fix this problem, with the result that men can perform sexually for many hours with many partners, increasing the risk of exposure to sexually transmitted infections.
Sexually transmitted infection rates have been rising among gay men for the past seven years in North America and Europe, and Viagra use has been associated with a higher risk of unprotected anal intercourse with a partner of unknown or discordant HIV status in London (March 5 2001). In San Francisco gay men with HIV drug resistance were significantly more likely to report unprotected anal sex with HIV-negative partners if they also reported using Viagra. (Feb 12 2004).
The largest survey of Viagra use, in San Francisco, found that Viagra use was strongly associated with unprotected sex with a partner of unknown HIV status – Viagra users were twice as likely to report this activity.
Dr Jeffery Klausner wants manufacturers to specifically address the issue of recreational Viagra use, use of Viagra with other drugs such as methamphetamine and widespread abuse among younger men and men who have sex with men, both by product labelling and also by promoting discussion of safer sex to doctors who prescribe Viagra.
“It is mind boggling that a patient could request Viagra, a doctor prescribe it and there be silence about sexual activity or sexual risk behaviour. This is irresponsible and must change,” Klausner observed.
However, attempts to get doctors to talk about risk reduction with Viagra users at high risk of HIV may have a marginal effect. One study found that 44% of San Francisco gay male respondents did not obtain the drug from their doctor. Ironically, a report on the San Francisco complaint published at the www.gay.com website was accompanied on the day of publication by either a banner advert or pop-up ad for online purchase of Viagra, indicating just how easily the drug can be obtained.
Pfizer claims that it has engaged in a longstanding public education campaign to draw attention to the sexually transmitted infection risks involved in Viagra use. However, a campaign website called sexualsmarts.org accessed today bore the message `Coming soon` and provided no educational content. Similarly a `sexual health` quiz on the official Viagra product website makes no mention of sexually transmitted infections despite the fact that `sexual health` is commonly understood by professionals to refer to STIs rather than impotence.