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AHF Asks 'What's rotten at FDA?' in New Politico Ad

February 16, 2012
Business Wire - February 16, 2012

AHF expands advocacy campaign targeting the FDA and Gilead Sciences with new online banner ads asking, "What's Rotten at FDA?" on the online versions of Politico, Real Clear Politics and Roll Call; public invited to send e-letters to U.S. Congressman Darrell Issa, Chairman of the Committee on Oversight and Government Reform, asking him to convene an investigation of the FDA and to ensure that Truvada for HIV prevention and other unsafe drugs and medical devices are not hastily approved by FDA In September, AHF sued the FDA over its denial of AHF's Freedom in Information Act request seeking correspondence between the FDA and Gilead regarding its potential application for use of Truvada as a form of 'Pre-exposure Prophylaxis' (PrEP) for use as an HIV prevention pill in uninfected individuals WASHINGTON - As part of its ongoing effort to get information regarding any interactions and correspondence between the Food and Drug Administration (FDA) and Gilead Sciences about potential FDA approval of Gilead's blockbuster AIDS drug Truvada for use as a form of HIV prevention in uninfected individuals, AIDS Healthcare Foundation (AHF) is expanding its media and advocacy campaign targeting the two parties with a new online banner ad asking, asking, "What's rotten at FDA?"[https://secure2.convio.net/ahf/site/Advocacy?cmd=display&pa ge=UserAction&id=191] The banner ad runs in the online versions of Politico, Real Clear Politics and Roll Call from February 16 through February 22 in the greater Washington, D.C. area. Through the banner ads, viewers are directed to a website where the public is invited to send e-letters to U.S. Congressman Darrell Issa, Chairman of the Committee on Oversight and Government Reform, asking him to convene an investigation of the FDA and to ensure that Truvada for HIV prevention and other unsafe drugs and medical devices are not hastily approved by FDA.

"The FDA recently indicated that it will fast track consideration for approval of expanded use of this Gilead drug despite numerous failed clinical trials, a move which AHF and many AIDS care providers and advocates oppose and believe is unwarranted based on the clinical trial studies," said Michael Weinstein, President of AIDS Healthcare Foundation. "We have been told that Gilead has been encouraged by government officials to apply for this expanded use. The potential approval of Truvada for HIV prevention carries serious health risks for people who will take it expecting to be fully protected. If the FDA ignores these risks in favor of Gilead's greed, it will cost lives." Gilead is seeking FDA approval to market the drug as a means of Pre-Exposure Prophylaxis, or PrEP. The idea behind PrEP is that people who do not have HIV may protect themselves against HIV infection by taking Truvada, which is already approved as a daily treatment for people infected with HIV or living with AIDS. While early studies saw some initial potential, more recent studies have been halted because the drug has shown little or no preventative effect. In addition, a study released this month found that people who take Truvada are at higher risk for kidney disease[]and long-term kidney damage that persists even after they stop taking the drug.

AHF strongly opposes Gilead's application because the science does not yet demonstrate that Truvada for HIV prevention is safe or effective. While some studies claim to show a limited preventive effect (only 44%), other studies have been halted because PrEP was not shown to be any more effective than a placebo. A primary reason for these poor results is the failure of study participants to take the drug daily, a precondition for PrEP to have any preventive effect. When this occurs in a "real world" setting, people will not only be at higher risk for developing drug resistance, but we will see an increase in HIV infections.

According to AHF, the mismanagement at FDA reaches beyond HIV. In January, the Washington Post reported that the agency's own scientists are suing the agency because "the [FDA] secretly monitored the personal e-mail of a group of its own scientists and doctors after they warned Congress that the agency was approving medical devices that they believed posed unacceptable risks to patients." Clearly, the FDA can no longer fulfill its mission to protect the public health by ensuring that our food, drugs and medical equipment are safe and do not cause harm to the public.

Background on AHF's Freedom of Information Requests to the FDA regarding Gilead In September 2011, AHF filed a legal action in the United States District Court, Central District of California, against the FDA over its denial of AHF's Freedom in Information Act requests that asked for correspondence between the FDA and Gilead Sciences regarding its potential application for use of Truvada as a form of 'Pre-exposure Prophylaxis' (PrEP) in HIV-negative populations.

The advocates believed Gilead had filed for FDA-approval for expanding the use of its best-selling $35 per day AIDS drug to include its use as a form of HIV prevention last summer following a widely-reported study released earlier that year. The study, of 2,500 high-risk gay men using Truvada as prevention, showed a 44% efficacy rate in preventing HIV transmission. AHF believes such modest trial results are insufficient to support FDA approval of Truvada as an HIV prevention tool--and a move that AHF and other AIDS advocates believe would set a dangerous precedent.

In response to AHF's legal action, FDA officials filed a partial 'motion to dismiss' some elements of AHF's FOIA request, and have requested specific information from AHF on the date or dates of Gilead's application--some of the very information AHF was seeking in its initial FOIA requests.

On December 15, 2011, Gilead issued a press release formally announcing that it had filed an FDA application to expand use of Truvada as a form of HIV prevention, however, no date of the application was included in Gilead's statement.

For more information, please visit www.nomagicpills.org AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and/or services to more than 125,000 individuals in 26 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Eastern Europe. To learn more about AHF, please visit our website: www.aidshealth.org, find us on Facebook: www.facebook.com/aidshealth and follow us on Twitter: @aidshealthcare.

Contacts WASHINGTON AIDS Healthcare Foundation Tom Myers General Counsel 323-860-5259 (office/cell) Tom.myers@aidshealth.org or LOS ANGELES AIDS Healthcare Foundation Ged Kenslea Communications Director Los Angeles, CA, USA +1-323-308-1833 [work] +1-323-791-5526 [cell] gedk@aidshealth.org

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