PRESS RELEASE
March 13, 2012, 6:00 a.m. EDT
According to AHF, the FDA spied on its own scientists and doctors, shows little or no transparency and granted fast track review to Gilead Sciences for its application for use of its blockbuster AIDS treatment, Truvada, as a form of 'Pre-exposure Prophylaxis' (PrEP) for use as an HIV prevention pill in uninfected individuals despite dubious studies supporting the application
WASHINGTON, Mar 13, 2012 (BUSINESS WIRE) -- --In response, AHF expands advocacy campaign targeting the FDA and Gilead with a new online banner ad asking, "What's Rotten at FDA?" on the Politico.com website and Mike Allen's Politico Playbook; public is invited to send e-letters to HHS Secretary Kathleen Sebelius asking her to ensure that Truvada for HIV prevention and other unsafe drugs and medical devices are not hastily approved by FDA
As part of its ongoing effort to ensure that the Food and Drug Administration (FDA) does not hastily approve Gilead Sciences' controversial application for expanded use of its blockbuster AIDS treatment, Truvada, as a form of HIV prevention in uninfected individuals, AIDS Healthcare Foundation (AHF) this week expanded its media and advocacy campaign targeting the two parties with a series of pointed online text and banner ads on Mike Allen's Politico Playbook on Politico.com asking, "What's rotten at FDA?" The banner ad runs in the online version of Politico Playbook March 12 through March 16. In addition, text ads embedded into Allen's editorial content will run each of those days. The 'What's rotten...' banner ad directs people to a website where the public may send e-letters to H.H.S. Secretary Kathleen Sebelius asking her to ensure that Truvada for HIV prevention and other unsafe drugs and medical devices are not hastily approved by FDA.
"In January, the FDA was sued for spying on its own scientists and doctors. In February, it announced it was fast tracking consideration of expanded use of Gilead's AIDS treatment, Truvada, as a possible HIV prevention pill drug despite numerous failed clinical trials for that purpose. Overall, it has shown little or no transparency in its dealing with the public--this, in a presidential administration that has vowed to be the most transparent in history," said Michael Weinstein, President of AIDS Healthcare Foundation. "Something is certainly rotten at the FDA and through these ads and this campaign, we hope to shine a bright light on it."
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. On February 13, 2012, Gilead announced that FDA had granted its fast track application for consideration of Truvada as a form of 'Pre-exposure Prophylaxis' (PrEP) for use as an HIV prevention pill in uninfected individuals despite dubious studies supporting the application.
AHF's What's rotten at FDA? Advocacy advertisements on Mike Allen's Politico Playbook, March 12-16
Text of Ad #1 What's Rotten at FDA? ** A message from AIDS Healthcare Foundation: What's rotten at FDA? The U.S. Food & Drug Administration refuses to release documents regarding contact with drug company Gilead Sciences about the drug Truvada for HIV prevention. The FDA is now hastily considering approving this drug despite several failed clinical trials. More info at www.nomagicpills.org . **
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** A message from AIDS Healthcare Foundation: Something is rotten at the FDA when the agency is hastily considering approving an HIV prevention drug despite serious concerns about safety and effectiveness. Current studies show that patients failed to take the drug (Gilead Sciences' Truvada) daily, a precondition for effectiveness. There is also a significant risk that the people who take it haphazardly will mistakenly believe they are protected from HIV and other STDs and behave recklessly, increasing the number of new infections. The agency has refused to release documents regarding its contact with Gilead. What do they have to hide?
The mismanagement at FDA reaches beyond HIV. The Washington Post reported that the agency's own scientists are suing because the FDA secretly monitored the personal e-mail of a group of internal "whistle-blowers." Clearly, the FDA can no longer fulfill its mission to protect the public health.
What is rotten at FDA? More info at www.nomagicpills.org . **
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Text of Ad #2 What's Rotten at FDA?--No Transparency ** A message from AIDS Healthcare Foundation: AIDS advocates and doctors warn that FDA's hasty review of Gilead's Truvada for HIV prevention threatens the safety of the American public. The FDA is ignoring this warning, claiming that its drug review process "is not a participatory process," and the "premise that FDA's review of a pending drug application should be transparent is also wrong." More info at www.nomagicpills.org .
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** A message from AIDS Healthcare Foundation: Something is rotten at the FDA when the agency is hastily considering approving an HIV prevention drug despite serious concerns about its safety and effectiveness. AIDS advocates and the medical community have loudly warned that this drug (Gilead Sciences' Truvada) has failed to prevent HIV in multiple clinical trials, and carries an increased risk of kidney damage for people who take it.
In response to these concerns and calls for greater transparency at FDA, the agency says that its drug review process "is not a participatory process," and that the "premise that FDA's review of a pending drug application should be transparent is also wrong." FDA has also refused to release documents regarding its close contact with Gilead. What do they have to hide?
More info at www.nomagicpills.org .
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Text of Ad #3 What's Rotten at FDA?--Spying ** A message from AIDS Healthcare Foundation: What's rotten at FDA? Spying. The 'Washington Post' reported the FDA secretly monitored personal e-mail accounts of some 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. More info at www.nomagicpills.org .
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** A message from AIDS Healthcare Foundation: The Post said the surveillance, unearthed by six of the scientists and doctors, who then filed a federal lawsuit against the FDA, took place over two years as the group accessed their personal G-mail accounts from government computers. This behavior took place at the highest levels of the FDA during the Obama administration--which vowed to be the 'most transparent' in history. Now, FDA is considering fast track approval an HIV prevention drug despite serious concerns about its safety and effectiveness, which might actually result in MORE HIV infections. Why? People may think they are fully protected when they are not, and may not use condoms, a proven HIV prevention method 95% effective when used correctly and consistently. Something is rotten at FDA--jeopardizing the health and safety of the American people--the very people FDA is charged with protecting. More info at www.nomagicpills.org .
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Background on Gilead and the FDA
Gilead is seeking FDA approval to market the AIDS drug, Truvada, 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.
The alleged 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.
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 135,000 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
SOURCE: AIDS Healthcare Foundation
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