Warning on Viagra’s Role in STDs Is Requested
Public health officials here are making an unusual appeal to federal regulators to warn consumers that use of the sexual impotence drug Viagra is linked to gonorrhea transmission.
“The data’s clear, the evidence is strong,” said Dr. Jeffrey Klausner, director of sexually transmitted disease control for the city, who has conducted a study on the issue. “There’s really at this point no excuse for inaction by the FDA or the manufacturer.”
But Food and Drug Administration spokeswoman Laura Bradbard said Thursday that her agency wants to wait for more studies before deciding if changes to Viagra’s warning label are necessary.
Klausner is not suggesting that Viagra causes gonorrhea. Rather, he contends that Viagra leads to risky sexual behavior, which is associated with higher rates of STD transmission. Gonorrhea presents the greatest risk because it is more common than other STDs among gay and bisexual men, and it is far more infectious.
“It is one of the most infectious organisms we know,” Klausner said.
He said young gay and bisexual men often use Viagra recreationally, along with ecstasy and other illegal drugs, lessening their resolve to use condoms. In fact, Viagra’s manufacturer, Pfizer Inc., has warned doctors about the danger of mixing amyl nitrate (a street drug known as “poppers”) with Viagra, which can cause a sharp drop in blood pressure.
Pfizer spokesman Geoff Cook noted, however, that “any pharmaceutical product can be abused, and that’s beyond our control.”
Cook said the company is satisfied that Viagra’s consumer label adequately addresses the issue of STD transmission. It reads: “Viagra does not protect you or your partner from getting sexually transmitted diseases, including HIV--the virus that causes AIDS.”
“Nobody should think that by taking Viagra they can be protected,” Cook said. “Clearly they need to engage in safe sex.”
Klausner said the label doesn’t address his concerns. His team’s study of 844 men conducted at San Francisco’s STD clinic found that gay and bisexual men were more than four times more likely to use Viagra than heterosexual men in the prior year. Of the 108 gay Viagra users, 43% mixed it with ecstasy and 28% took it with methamphetamines. In addition, more men received the drug from a friend than from a health-care provider.
Nearly a third of gay and bisexual Viagra users had some STD at the time of the study, compared with 23% of non-Viagra users. Even more telling, Viagra users had an average of 5.4 sexual partners in the last two months compared with 3.5 partners for nonusers.
The findings have been accepted for publication in an upcoming issue of the journal AIDS.
Klausner is known for his bold efforts at STD prevention. Last year, he successfully appealed to federal regulators to force drug companies to tone down ads touting HIV drugs. Those ads--featuring muscular, healthy-looking men--downplayed the drugs’ side effects and the consequences of HIV, he argued. The FDA agreed.
Klausner said he sought the FDA’s help on Viagra because he was ignored or rebuffed in his efforts to work with Pfizer.
Klausner’s counterpart in Los Angeles County agreed that a warning label is necessary. Dr. Peter Kerndt, director of STD control for the county, said he too has noted recreational Viagra use in the gay community.
“That’s where the real risk of STDs is,” he said, “when it’s used recreationally and combined with other drugs like methamphetamine or ecstasy.”
But the idea of a warning label on Viagra was met with skepticism in San Francisco’s Castro district, a largely gay area.
“We live in a culture where we blame everything but the person for their actions,” said James Salaiz, a 29-year-old waiter. “It’s not really the drug but the person involved.”
Kevin Hunt, a 29-year-old financial analyst, said that he and his partner were given prescriptions for Viagra even though the physician knew that it was for recreational use and that they were using crystal methamphetamine.
More Studies Are Needed
Hunt reasoned, “If we were responsible enough to ask him for a prescription for Viagra to sustain our own sex life, then we were less likely to go out and find other partners,” he said. “That couldn’t be further from the truth.”
Crystal meth inhibits erections, Hunt said, so Viagra helps to counteract that. “I know from experience,” he said.
“Let’s place blame where it lies. It’s not fair to target a pharmaceutical company because people find a legal method to cope with an illegal problem.”
Medical experts said that other studies must be conducted to determine if Klausner’s findings can be replicated.
“What he’s attempting to do is definitely laudable,” said Dr. Vince Silenzio, an assistant professor at Columbia University’s medical school. “But on the other hand, we don’t know what’s going on yet, so it’s a little premature to issue the specific warning about what’s causing it.”
Silenzio, a board member of the Gay and Lesbian Medical Assn., said he doubts that Pfizer would want a warning label because that could hurt its sales.
“Every penny that they can make on this drug, they’re going to make,” he said. “I don’t think it’s necessarily going to be in their best interest to react to one study and to issue the warning.”
