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.
Wed 23 May 2007 at 2:35 pm
The European Medicines Agency has pitched in as well.
http://www.emea.europa.eu/pdfs/general/direct/pr/23005707en.pdf
Interesting that the rules for the drug’s use – specifically, contraindicated in patients with a history of cardiac failure – are different than in the US
Wed 23 May 2007 at 3:58 pm
And another one:
The Lancet has published an editorial calling for calm and reason. It refers to an as yet unpublished phase III clinical trial called RECORD, which is design to specifically assess the cardiovascular events associated with rosiglitazone. The article says that until the results from that trial are in it would be premature to overinterpret the meta-analysis.
Fri 25 May 2007 at 9:10 am
Another Vioxx?
The Avandia saga continues to unravel as a doctor in the US now claims to have alerted the FDA about his concerns about the drug as early as March 2000. John Buse, president-elect of the American Diabetes Association sent a letter to the FDA citing “a worrisome trend in cardiovascular deaths and severe adverse events” according to a Reuters report. GSK’s shares have continued to slide as litigation looms. It’s starting to look like history repeating itself.