The US consumer advocacy group Public Citizen has piled yet more criticism on the US Food and Drug Administration (FDA), for mismanaging the regulation of Avandia (rosiglitazone), GlaxoSmithKline’s diabetes drug. A meta-analysis published this week in the in the New England Journal of Medicine concluded that the drug significantly increased the risk of heart attack and death. But the group claims that the FDA was aware of the risks nearly five years ago.
This will come as a blow to the FDA, which has endeavoured to reassure consumers that this time it remains in control of drug regulation. Public confidence in the agency was rocked after the now infamous and ongoing Vioxx case. It released a statement in response to the NEJM article saying that it was in the process of analysing all of the safety data and would convene an advisory committee as soon as possible.
The author of the study, Steven Nissen from the Cleveland Clinic in Ohio, is no stranger to controversial meta-analyses. He was part of the group of authors that raised initial concerns about Vioxx in a JAMA and he went on the record with his concerns about the risks associated with Avandia in September 2006, according to a Wall Street Journal report.
Nissen’s past warnings have proven accurate. GSK has refuted the conclusions of his analysis on this occasion but will no doubt be holding its breath.