The Pharmaceutical Industry

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Senate report links diabetes drug Avandia to heart attacks

The diabetes drug Avandia is linked with tens of thousands of heart attacks, and drugmaker GlaxoSmithKline knew of the risks for years but worked to keep them from the public, according to a Senate committee report released Saturday.

The 334-page report by the Senate Finance Committee also criticized the Food and Drug Administration, saying that the federal agency that regulates food, tobacco and medications overlooked or overrode safety concerns found by its staff.

The Senate report was developed over the past two years by committee investigators who reviewed more than 250,000 pages of documents provided by GlaxoSmithKline, the FDA and several research institutes. Committee investigators also conducted numerous interviews and phone calls with GlaxoSmithKline, the FDA and anonymous whistleblowers.


According to the Senate report:
• FDA scientists estimated in July 2007 that Avandia was associated with approximately 83,000 heart attacks since the drug came to market.
"Had GSK considered Avandia's potential increased cardiovascular risk more seriously when the issue was first raised in 1999 ... some of these heart attacks may have been avoided," the report states.
• GlaxoSmithKline undertook attempts to undermine information critical of Avandia.