US experts weigh guidelines for impotence drug use
Doctors, drugmakers and health officials should take steps to curb abuse of Erectile Dysfunction drugs while research continues on whether use of the medicines increase the rate of HIV infections, especially among gay men, experts said in draft guidelines on Tuesday.
Research may suggest a role, but more studies are needed on how the drugs affect transmission of the virus and whether they encourage risky sexual behavior, a group of physicians, drug company representatives and patient advocates said at a government-sponsored conference near Washington.
"The evidence was not consistent among all studies and ultimately inconclusive,” said conference co-chairman Raymond Rosen of the Robert Wood Johnson Medical School in Piscataway, New Jersey.
But, he added, “We concluded that there is evidence of (impotence drugs) being used in conjunction with other recreational drugs” such as methamphetamines.
Impotence drugs - known as phosphodiesterase type 5, or PDE5, inhibitors - are approved to treat men who have trouble sustaining an erection. In addition to Pfizer Inc.’s Viagra, they include Cialis, made by Eli Lilly & Co. and Icos Corp., and Levitra, co-promoted by GlaxoSmithKline and Bayer AG.
Rosen, a psychiatrist, said increasing reports of drug abuse among gay men as part of “high risk sex situations,” such as unprotected sex, triggered the meeting. Experts are also concerned about the impact on the rate of HIV infection. The virus targets the immune system and can cause full-blown AIDS, but can be controlled for years with antiretroviral drugs.
The conference, sponsored by the Food and Drug Administration, the Centers for Disease Control and Prevention, the National Institute on Drug Abuse and the National Institute of Mental Health, aimed to give officials specific recommendations on how to help curb rising infection rates and educate men on safe use of the drugs.
Government agencies should partner with drugmakers and community groups to educate men about possible risks, the experts said. Some also called for the agencies to create divisions focused on men.
“I think this shows there’s simply no place in government to go for men’s health,” said Jimmy Boyd, head of the nonprofit group Men’s Health Network.
Doctors also need to become more involved and could hand out condoms along with impotence drug prescriptions, the experts recommended.
While drugmakers have already pledged to improve their advertisements as part of voluntary guidelines, some experts called for companies to partner with community groups to circulate information about using the drugs responsibly.
Several drug company representatives said fake versions of their drugs obtained illegally were a major problem.
Without more research, taking action is difficult, said Ron Stall, a University of Pittsburgh health professor who used to work for the CDC. “The role of PDE5 on HIV is still controversial. There is no causal data,” he said.
The final guidelines are expected in about six weeks.
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