AVANDIA READER POLL: Is FDA Correct To Hold This Meeting?

As the controversial FDA advisory committee meeting gets under way this morning (watch here), a key question remains – would easing restrictions on the troubled Avandia diabetes pill really matter? The GlaxoSmithKline drug, which was linked to heart attacks and strokes, is effectively under lock and key, thanks to a REMS program put in place in 2010 following a contentious FDA meeting that same year. The meeting is being held to review a Glaxo clinical trial called RECORD, which purported to refute a 2007 meta-analysis that found much greater cardiovascular risks than were previously known. That prompted a US Senate probe into Glaxo trial data disclosure and contributed to a $3 billion fine the drugmaker paid last year for various acts of bad behavior.   But while the RECORD trial was skewered by an FDA reviewer, some agency officials disagreed with this view and subsequently ordered a re-adjudication. The Duke Clinical Research Institute was tapped to sift through the data and found the pill was not associated with a significantly increased cardiovascular risk, although FDA reviewers say the trial design was weak. And FDA reviewer Tom Marciniak argues the re-adjudication process was not truly independent (read more here, here and here). The FDA convened the meeting to fully air the findings and revisit earlier decisions, which some may argue is a commendable effort at transparency. The agency, however, has been very publicly criticized by Cleveland Clinic cardiologist Ste...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs