GSK hits back at Avandia safety probe
pharmafile | February 25, 2010 | News story | Sales and Marketing | Avandia, diabetes
GlaxoSmithKline has hit back at allegations from US Senators that its diabetes drug Avandia raises the risk of heart attacks, and denies concealing damning safety data.
Headed by Senators Max Baucus and Chuck Grassley, the US Senate Committee on Finance have published a report concluding that GSK knew of the possible cardiac risks associated with Avandia “years before such evidence became public” and that it had not warned the FDA.
The Senators allege that GSK executives “intimidated independent physicians, focused on strategies to minimise findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that the rival drug Actos (pioglitazone) might reduce cardiovascular risk”.
The committee’s report was issued on 20 February, and now GSK has followed up its initial response with an in-depth rebuttal of the report, claiming it fails to present an “accurate, balanced, or complete view” of the currently available information on Avandia.
The company also rejects allegations of inappropriate behaviour or concealing safety information.
GSK says it respectfully disagrees with the committee’s conclusions, and says its report contains many errors of fact, omissions, and incorrect inferences.
The company says that “among its most glaring omissions” is the report’s failure to include final results from a series of large scale trials, the ADOPT, DREAM, or RECORD studies.
Data from these studies and other sources were evaluated by an independent FDA advisory board in 2007 after safety concerns were first raised, with the FDA then voting 22-1 in favour of keeping Avandia on the market.
Despite these and numerous other points raised by GSK, Avandia is likely to see its use fall even further. Sales of the drug exceeded $3 billion in 2006, but following the 2007 scare, have continued to fall, and last year stood at $1.2 billion.
The FDA says it will ask an expert panel to review the evidence once again, with a public meeting scheduled for July to present its findings and decide if further restrictions or complete withdrawal of the drug is necessary.
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