By Bob Roehr
The AIDS Healthcare Foundation (AHF) has charged the pharmaceutical company Pfizer with "promoting Viagra as a party drug…leading to more infections with sexually transmitted diseases such as HIV," according to its president Michael Weinstein.
AHF filed suit in a Los Angeles court on Jan. 22 to force the company to end those ads, begin an education campaign on the responsible use of Viagra, and pay an unspecified sum to the organization to help care for people infected with HIV.
"Pfizer is advertising Viagra for mild erectile dysfunction or to improve your sex life, not for its approved use by the Food and Drug Administration (FDA)," Weinstein asserted. "Viagra was not approved for performance anxiety."
"Pfizer does not promote Viagra for recreational use," the company said in a written statement, "Which is why we encourage men with erectile dysfunction to see their doctor for a proper diagnosis and to discuss symptoms, treatment options, and safe sexual practices."
Weinstein said, "We estimate that a majority of new infections in this country are related to the use of crystal meth, and the majority of crystal meth users are also using Viagra." He called AHF "a victim of Pfizer's irresponsibility."
Ronald Stall questioned that estimate. The expert in HIV epidemiology at the University of Pittsburgh said, "I'm not even sure you could make that claim for gay men," and more than half of new infections are believed to be through heterosexual transmission.
When pressed to back up his assertion with data, Weinstein mentioned recently speaking with a group of black youth who said crystal meth "use is rampant" within their community.
Pfizer spokesperson Shreya Prudlo said that AHF recently approached the Pfizer marketing team "with a multi-million dollar funding request for a crystal meth educational program."
Those employees did not comment on the merits of the proposal but asked that AHF follow standard protocol and submit it through the grants committee, and independent group within the company. Prudlo said, "To date, our grants committee has not received a grant proposal from Mr. Weinstein regarding this initiative."
Klausner conundrum
Also participating in the news conference was Jeffrey D. Klausner, who was introduced as director of STD prevention and control services for the city of San Francisco. However, when asked, Klausner said that while his superiors knew of his participation, he was speaking only as an individual and not any city agency.
He has seen an association, though not necessarily a causation, between use of crystal meth, Viagra, and increased rates of sexually transmitted diseases in San Francisco. He has tried unsuccessfully to get the FDA to rein in advertising for the product.
However, a conference on erectile dysfunction drugs, supported by the National Institutes of Health, found little evidence to back up Klaussner's position. Stall also attended that conference. He said, "The jury is still out" on evidence to back up Klausner's claims.
The conference report was published last November in the Journal of Sexual Health. Editor Irwin Goldstein wrote, "Health care providers should be reminded that individuals infected with HIV frequently have erectile dysfunction from their disease or from pharmacologic agents commonly used in its treatment."
Klausner is "deeply troubled by what I consider to be the continued misleading and potentially off-label direct to consumer marketing practices of Viagra."
He has tried to work with the FDA in restricting advertising for HIV medicines and for Viagra. "Why the FDA has not acted on this issue…is not clear to me." He said the agency "takes a very narrow view and [believes they have] limited authority. I think that is driven by a variety of political appointees and leadership at FDA."
"Impotency only happens once in a while. The promotion of Viagra for what some of called recreational use must be stopped. Litigation is sometimes the only means available to the public to reverse unfair practices," Klausner said.
"We have gotten what we consider very lame responses from the FDA," said Weinstein. "The FDA under this administration comes close to being a wholly owned subsidiary of the pharmaceutical industry." The agency has acknowledged that it has insufficient resources for enforcement and has asked Congress for more.
The lawsuit claims unfair business practices of "false and misleading advertising," said AHF general counsel Tom Myers. They are seeking to prevent Pfizer from running these types of ads, to compel it to create a public education campaign, and for unspecified restitution to AHF for having to care for people infected with HIV while using Viagra.
Weinstein said they are "picking on Pfizer" because Viagra has the largest share of the market for erectile dysfunction drugs. They are filing in the California rather than in federal. That decision raises legal questions of jurisdiction and standing, and, should AHF eventually prove successful, the decision would apply only within California.
San Francisco AIDS activist Michael Petrelis thought he sensed another motive behind the AHF lawsuit.
"Considering that Pfizer is already responsibly including the message that Viagra does not stop HIV or other STDs in their bus shelter ads and on the package insert, which also stresses the need for safer sex, I suspect that the AIDS Healthcare Foundation is campaigning against the company in order to squeeze an educational grant out of them."
Was it just a coincidence that the AHF news conference was scheduled just three hours before Pfizer began a scheduled briefing of industry analysts? Few people think that was the case.
"I should have known that the petty, small-minded MW [Weinstein] wouldn't give up on this" lawsuit, said New York and LA AIDS activist Michael Barr in an e-mail. "And all because Pfizer said 'no' when he approached them for funding."
Petrelis said "AHF's unnecessary jihad on Pfizer contributes significantly to demonizing and stigmatizing gay men living with AIDS." It also puts the organization in the company of those on the right wing who are critical of recreational sex, such as supporters of abstinence only HIV programs.
