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Lawmakers say GSK hid Avandia data

Leaders of the US Senate Finance Committee are accusing GlaxoSmithKline of suppressing safety data on the diabetes drug Avandia

Leaders of the powerful US Senate Finance Committee are accusing GlaxoSmithKline (GSK) of suppressing potentially damaging safety data on the diabetes drug Avandia (rosiglitazone) and of ghostwriting studies on the product that appeared in medical journals.

Senate Finance Committee chairman Max Baucus, the Democrat from Montana, and ranking member Chuck Grassley, the Iowa Republican, have turned over documents to the US Food and Drug Administration (FDA) that they say suggest GSK "failed to publish studies that found serious health risks associated with Avandia in a timely manner and actively promoted the drug despite the known safety concerns."

The documents, including internal company emails, were provided to plaintiffs' counsel in product liability litigation over Avandia, and were  unearthed as part of the Senate Committee's ongoing investigation of the drug's safety. They have been handed over to the FDA as the regulatory agency prepares for an advisory committee meeting this week to discuss whether Avandia raises the risk of cardiovascular events to unacceptable levels.
 
The documents "show that GlaxoSmithKline attempted to downplay scientific findings about the safety of Avandia as far back as 2000," according to the lawmakers. "Additionally, the Senate committee found Avandia was part of the drug manufacturer's ghostwriting campaign."

Grassley said in a statement that the Avandia issue highlights the need for more active postmarketing monitoring of drugs by the FDA. "I'll continue my effort to achieve this reform," he pledged.

GSK responded to the accusations by pointing out that the documents released by the committee are only a fraction of the information provided to the plaintiffs during the litigation and were taken out of context by the lawmakers. "Cherry-picking a handful of documents from more than 14m pages of documents distorts the record and is misleading," the company asserted.

"GSK has been diligent in providing its safety data on Avandia to the FDA and in publishing its clinical trial data in peer-reviewed journals or on its clinical trial website," the company said.

14th July 2010

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