By AIDS Healthcare Foundation
FDA has put the interests of drug companies ahead of the health and safety of the American public, says AHF President Michael Weinstein. AHF also cites FDA’s ‘shocking lack of transparency’ and the agency’s stated position that its “drug review process is not a participatory process”
AIDS Healthcare Foundation (AHF), the nation’s largest HIV/AIDS organization, today called on Food and Drug Administration (FDA) Commissioner Margaret Hamburg to step down in response to the agency’s gross mismanagement of new product reviews and a lack of transparency. Hamburg’s tenure as FDA Commissioner has been marred by questionable product reviews that have ignored scientific evidence, and often FDA’s own scientists. These issues have recently spilled over into the agency’s questionable review of a new HIV prevention pill.
On March 22, the New York Times reported that FDA leadership previously approved a new dosage of an Alzheimer’s drug “against the advice of reviewers” at the agency. Approving the new dosage allowed the drug company that makes the drug to extend the patent, but according to scientists interviewed by the NY Times, “it doesn’t really have much benefit, but does substantially more harm.” This controversy followed a Washington Post report that 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.”
“Under the leadership of Commissioner Hamburg, the FDA has proven that it cannot be trusted with protecting the American public from unsafe and ineffective drugs,” said Michael Weinstein, President of AIDS Healthcare Foundation. “Commissioner Hamburg was not appointed by President Obama to serve as the chief lobbyist for pharma.”
AHF’s call for Hamburg to step down is also in response to FDAs complete stonewalling of requests for information about its cozy relationship with drug companies. In a response to an AHF lawsuit on FDA’s refusal to disclose documents under the Freedom Of Information Act, FDA claimed that the “premise that FDA’s review of a pending drug application should be transparent is also wrong,” and that “FDA’s drug review process is not a participatory process.” The agency also asserted that “[t]he value of public participation in FDA’s scientific review of a new drug application is particularly ambiguous …”
“President Obama pledged that his administration would be the most transparent in history, yet FDA claims that it does not have to be transparent, and that the American public has no voice on how FDA conducts their business” said Tom Myers, AHF General Counsel and Chief of Public Affairs. “One can only assume that FDA’s shocking lack of transparency is because Commissioner Hamburg has something to hide.”
“We cannot afford to wait for the health and safety of the American public to be put at further risk before taking action. Hamburg must go,” said AHF’s Weinstein.
FDA’s failure to protect the American public from unsafe and ineffective drugs has now extended into HIV. In February, FDA granted Gilead Sciences an expedited review of its application for Truvada as HIV Prevention (so-called “Pre-Exposure Prophylaxis” – or “PrEP”) despite the fact that the drug failed to meet the agency’s own guidelines for approving an expedited review.
“It’s clearly time for a change in leadership at FDA when a drug like PrEP, which has failed several clinical trials and could potentially lead to an increase in HIV infections, is being rushed to market,” said Weinstein.
Background on FDA’s review of PrEP:
Under the FDA Manual of Policies and Procedures, an expedited review is granted only if a drug meets certain criteria; it must have the potential to be a “[s]afe and effective therapy where no satisfactory alternative therapy exists,” or “[a] significant improvement compared to marketed products, including nondrug products or therapies…” Truvada as PrEP does not meet this criteria. There are other safe and effective options available to HIV-negative (uninfected) individuals, such as condoms. In addition, condoms and treating positives, both of which reduce transmission by over 95%, are more effective than any study has demonstrated for PrEP.
Questions about PrEP’s safety and effectiveness extend beyond its qualifications for expedited review. 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 at preventing HIV. Due to the likely scenario that the people who take PrEP will not be protected, it could lead to an increase in HIV infections and other sexually transmitted disease. In addition, the people who take PrEP are at an increased risk of developing a drug resistant strain of the HIV virus and kidney disease, even after they stop taking the drug.
FDA committed staff and resources to examining the potential use of PrEP months before Gilead submitted its application. In August 2011, the Forum for Collaborative HIV Research (a group funded by Gilead) was “tasked by [its] collaborators in the public health community, including the US Food and Drug Administration” to convene a meeting on the implementation of PrEP. Several officials from FDA participated in the forum, including Dr. Debra Birnkrant, the Director of the Division of Antiviral Products.
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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.