Wednesday, March 05, 2008

How about an Avandia Vytorin combo?


Maybe not!

The government's watchdog agency is investigating whether the Food and Drug Administration's drug-review process cleared two blockbuster medications without sufficient proof of their safety or effectiveness.

Sen. Charles Grassley said Tuesday the Government Accountability Office has agreed to study a much-debated method for approving drugs used to clear GlaxoSmithKline PLC's diabetes pill Avandia and Merck & Co. Inc. and Schering-Plough's cholesterol drug Vytorin.

The Iowa Republican requested the investigation after recent studies suggested the drugs may not lower the risk of heart attack and artery-clogging plaque, as assumed by millions of patients and doctors.

"There's enough of a pattern of problematic drugs to ask for an independent review of how the FDA follows up on the effects of medicines that it's approved," said Grassley, in a statement.

More at BusinessWeek

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