The FDA, The Avandia Diabetes Pill And Meta-Analyses

Following years of high-stakes drama, the FDA has loosened restrictions on the Avandia diabetes pill, which has been under the equivalent of regulatory lock and key after a protracted and heated debate over the extent to which the GlaxoSmithKline drug may cause cardiovascular risks. The action caps a long-running episode that shined a harsh spotlight on agency decision-making and the practices of the pharmaceutical industry. The Avandia debate not only laid bare the political and scientific rifts that sometimes take place among FDA officials, but also became a prime example of how drugmakers do not always disclose unflattering clinical trial data. The FDA decision comes after an extraordinary advisory committee meeting was held last June in which the panelists were asked to reassess a Glaxo trial called RECORD that was, in part, the heated focus of a contentious FDA panel meeting three years ago. That earlier meeting was convened to review the Avandia safety record after a 2007 meta-analysis asserted the risks were higher than previously known. Following the 2010 meeting, the FDA restricted Avandia use to only Type 2 diabetics who are unable to benefit from other diabetes medications. The agency also announced a Risk Evaluation & Mitigation Strategy, or REMS, in which patients had to enroll in an access program and the pill was only be available by mail from certified, participating pharmacies (see this). However, in a move that reflected internal agency disagreement, the...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs