Issue:  Vol. 47 / No. 41 / 12 October 2017
 

Pfizer sued over Viagra ads

NEWS


AHF is suing Pfizer over Viagra
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The Los Angeles-based AIDS Healthcare Foundation 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 Monday, January 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," Weinstein asserted. "Viagra was not approved for performance anxiety."

Company officials denied the allegations.

"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, Ph.D., 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 during a telephone conference call Monday 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 spokeswoman Shreya Prudlo said that AHF recently approached the Pfizer marketing team "with a multimillion-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, an independent group within the company.

"To date, our grants committee has not received a grant proposal from Mr. Weinstein regarding this initiative," Prudlo said.

Prudlo told the Bay Area Reporter that Viagra ads and package materials warn that the drug does not protect against sexually transmitted diseases, including HIV.

"Our package insert says, 'Viagra does not protect you or your partner from getting sexually transmitted diseases, including HIV – the virus that causes AIDS,'" Prudlo said in an e-mail.

Similar wording is included in every print ad, she added. Television ads contain what's called a "super" that states: "Viagra does not protect against sexually transmitted diseases including HIV."

Klausner conundrum

Also participating in the news conference was Dr. 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 as a representative of any city agency.

Health department spokeswoman Eileen Shields said in an e-mail to the B.A.R. that Health Director Dr. Mitch Katz was on vacation this week and unavailable to comment on the department's position regarding the AHF lawsuit. She said that no one else at the department was in a position to comment.

Klausner said that 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 Food and Drug Administration 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 Klausner's position. Stall also attended that conference. He said, "The jury is still out" on evidence to back up Klausner's claims.

The multi-disciplinary panel of researchers and scientists, known as the Bolger conference, found no "convincing evidence ... to support the conclusion that PDE-5 inhibitor use is a risk factor for HIV infection," a summary of the conference stated. Erectile dysfunction medications are known as Phosphodiesterase type 5 inhibitors.

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 has long been a critic of Viagra, and at one time filed a citizens complaint with the FDA to have erectile dysfunction drugs classified as a controlled substance.

Former San Francisco AIDS policy adviser Jeff Sheehy was highly critical of Klausner when that happened; this week, he questioned AHF's decision to file the lawsuit against Pfizer.

"The idea that people on speed are having wild sex with Viagra because they saw a halftime commercial during the Super Bowl is ridiculous," Sheehy told the B.A.R. "I don't like direct to consumer TV ads, but the rest [of the suit] is just extortion."

FDA

Klausner said that he 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 have 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 funding.

The lawsuit claims unfair business practices of "false and misleading advertising," said AHF general counsel Tom Myers. AHF is 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 court. 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," he said.

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 [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."

Asked to respond to the activists' charges, Weinstein sent an e-mail statement that read, "AHF's mission is: Cutting edge medicine and advocacy regardless of ability to pay. AHF drug company advocacy has resulted in lowering of prices worldwide that has allowed hundreds of thousands of people to access life-saving medications."

He added, "Ninety-six cents of every dollar AHF collects goes directly to the care of the 53,000 patients of AHF around the world. AHF clinics in San Francisco, Oakland and Los Angeles run large deficits. One hundred percent of all proceeds AHF has derived or will derive from the settlement of any legal action will go to treat more patients. Our drug advocacy victories are among our proudest achievements."






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