Launching this week in five markets, AIDS Healthcare Foundation print ad publicly thanks 618 doctors & advocates for urging the FDA and Gilead Sciences’ CEO John Martin to halt pursuit of FDA approval for use of Gilead’s blockbuster AIDS treatment Truvada as a pre-exposure prophylaxis
Doctors & advocates cite effectiveness concerns, risk of decrease in condom use & lack of information showing proper use in “real world” situations; Say more study needed to ensure patient safety & the public’s health
LOS ANGELES--(BUSINESS WIRE)-- AIDS Healthcare Foundation (AHF) unveiled a new print ad today which publicly thanks the 618 doctors and advocates who sent or signed letters to the U.S. Food and Drug Administration (FDA) and to drug-maker Gilead Sciences urging a halt to pursuit of FDA approval for use of Gilead’s blockbuster AIDS treatment drug Truvada as a pre-exposure prophylaxis (PrEP) or HIV prevention pill. The heading of the ad: “There is no magic pill.”
The “No Magic Pill” ads are scheduled to run beginning this week in eight publications aimed at an LGBT (Lesbian, Gay, Bisexual and Transgender) audience: Bay Area Reporter in San Francisco, California; Frontiers Magazine in Los Angeles, California; GA Voice in Atlanta, Georgia: Gay City News in New York, New York; Out Front in Denver, Colorado; South Florida Gay News in Miami/Ft. Lauderdale, Florida; Washington Blade in Washington, D.C.; and Windy City Times in Chicago, Illinois.
Included among the 618 signers are 55 physicians, who recently sent a letter to the U.S. Food & Drug Administration (FDA) urging the agency not to approve the use of Gilead’s HIV/AIDS treatment drug Truvada for use as an HIV prevention pill – also known as “pre-exposure prophylaxis” (PrEP). In addition, 563 individuals sent e-letters to Gilead CEO John Martin through www.nomagicpills.org expressing concern over the company’s rush to obtain premature FDA approval of Truvada as a pre-exposure prophylaxis.
“With this ad, we hope to raise public awareness of the issues surrounding the use of Gilead’s drug Truvada as PrEP and the possible public health implications of premature approval of its use as an HIV prevention pill,” said Michael Weinstein, President of AIDS Healthcare Foundation. “With this action, we—along with the 618 doctors and advocates who have signed or sent letters—also intend to send a strong message to Gilead that the groundswell against premature approval for Truvada as PrEP is growing and will continue to grow until the company halts pursuit of FDA approval.”
Added Weinstein: “Currently, any physician can prescribe Truvada as PrEP to an HIV negative patient on an off-label basis. An individual medical provider who, in his or her best judgment, believes that a patient will not practice safer sex can prescribe this medication. AHF supports an individual provider’s right to do so. However, if the FDA approves a specific indication for the use of Truvada, then the drug manufacturers will be free to advertise this use and promote it to providers. We do not believe that this is in the best interest of patients or the public health.”
In the letter sent to the FDA, spearheaded by AIDS Healthcare Foundation, physicians detail a number of concerns raised by first-in humans efficacy data emerging from the iPrEX study of Truvada to prevent HIV transmission. (In the letter, Truvada is referred to by the drug formulation names: tenofovir disoproxil fumarate and emtricitabine or TDF/FTC.) Ultimately, the doctors are concerned that widespread use of PrEP, based on the available data, will unwittingly lead to more risky behavior, and more HIV infections.
The iPrEX study of 2,499 high-risk men who have sex with men (MSM) found that the once-daily pill could decrease the likelihood of HIV infection by 44%. However, the physicians conclude that this very low result is insufficient to support approval as a prevention tool at this time. The group urges the FDA to not consider approval of the drug as an HIV prevention pill until the final results of all studies are available – still a number of years away.
The letter concludes: “As medical care providers, we strongly support continued research on the prevention of HIV, but oppose approval of a pre-exposure prophylaxis that runs the risk of contributing to the spread of HIV and drug-resistant viruses. Our first obligation is to do no harm to individuals and to the public health.”
Background on Gilead’s Truvada
Truvada, a drug compound that consists of Gilead’s drugs Viread (tenofovir DF) and Emtriva (emtricitabine), is currently FDA-approved for use as part of antiretroviral therapy combinations for individuals already living with HIV or AIDS. FDA-approval for pre-exposure use as a possible form of HIV prevention for those NOT infected with the virus would be a first for the FDA, and a move that AHF and many other AIDS advocates believe would set a dangerous precedent.
In 2010, Truvada was Gilead’s second-best selling product generating over $2.6 billion in revenue. One analyst told Bloomberg that FDA-approval to prescribe the drug for pre-exposure prophylaxis may add $1 billion to Gilead’s sales of Truvada.
To view the ad, please click here or go to: http://www.aidshealth.org/assets/pdf/nmpspread_final.pdf
AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and services to more than 163,000 individuals in 26 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific region and Eastern Europe. www.aidshealth.org.
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AIDS Healthcare Foundation
Lori Yeghiayan, AHF Associate Director of Communications
Telephone: 323-308-1834 Mobile: 323-377-4312
E-Mail: [email protected]
Ged Kenslea, AHF Communications Director
Telephone: 323-308-1833 Mobile: 323-791-5526
E-Mail: [email protected]
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