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Gilead’s Phony Consensus on PrEP

The Lancet, American Public Health Association, British HIV Association join AIDS Healthcare Foundation and other health advocates in concern over health impact of Gilead’s unproven HIV prevention pill

WASHINGTON D.C. (August 9, 2012) ⎯ AIDS Healthcare Foundation (AHF), the nation’s largest HIV/AIDS nonprofit medical provider, today reaffirmed its opposition to the Food and Drug Administration’s (FDA) approval of Gilead Sciences’ Truvada for use as Pre-Exposure Prophylaxis (PrEP) to prevent transmission of HIV. AHF’s concern over the potential safety and health risks of PrEP is shared by a host of leading public health experts, including: The Lancet; American Public Health Association; British HIV Association and British Association for Sexual Health; Dr. Alain Lafeuillade, Chief of the Department of Infectious Diseases at Toulon General Hospital (France) and Chairman of the International Symposium on HIV & Emerging Infectious Diseases; and several members of the FDA Antiviral Drug Advisory Committee.

“Gilead Sciences and the FDA have created a phony consensus on PrEP. They want the public to believe that the health community stands behind its reckless decision to rush this drug to market when, in fact, leading public health experts don’t support it,” said Michael Weinstein, AHF’s President. “The public health community has stated its opposition loud and clear: PrEP is an unacceptable health and safety risk.”

In an editorial published in its September 2011 issues, The Lancet urges restraint regarding PrEP, saying “Expanding the use of antiretrovirals to include pre-exposure prophylaxis will increase the risk of resistance, which is already a serious problem. HIV is a rapidly evolving virus and development of resistance creates the need for ever changing regimens of drugs in various classes.”

“The public health community has stated its opposition loud and clear: PrEP is an unacceptable health and safety risk.”

Concerns over the potential decrease in safer sex is also addressed: “Furthermore, although some of the trial results have been very impressive, the protection with pre-exposure prophylaxis is unlikely to be 100%, and making drugs available as prophylaxis could encourage high-risk sexual behaviour among those who believe themselves to be protected.”

The Lancet is joined by the American Journal of Public Health (a publication of the American Public Health Association), which published an article this past April that raised similar concerns regarding PrEP. The article, A U.S Policy Perspective on PrEP, discusses the possibly harmful public health consequences of widespread use of Truvada by HIV-negative individuals.

In a March 2012 position statement, the British HIV Association (BHIVA) and the British Association for Sexual Health and HIV (BASHH) concluded that as yet the data on the efficacy of pre-exposure prophylaxis (PrEP) is not compelling enough for it to be offered to patients on demand, and that it should only be prescribed in the context of a clinical research study until more data on its efficacy is gathered.

During the May 10 FDA Antiviral Advisory Committee Meeting on PrEP, the Committee raised concerns about approving PrEP without important safeguards to protect patients. In the meeting, the committee chair, Dr. Judith Feinberg commented that, “the potential harm here [of approving PrEP without safeguards] is stupendous.”

Following the Advisory Committee’s contentious ruling to recommend approval of PrEP, Dr. Alain Lafeuillade, Chief of the Department of Infectious Diseases at Toulon General Hospital (France) and Chairman of the International Symposium on HIV & Emerging Infectious Diseases, commented that the FDA’s decision “is irresponsible and against Global Public Health Interests.” Dr. Lafeuillade also said that, "The vote [the panel’s decision to recommend PrEP] can only be explained by the lack of independence of the agency from financial and other powers because this is an absurd way to face the HIV pandemic."