FDA Doctor Calls GSK Avandia Trial Biased

Law360, New York (July 9, 2010, 1:40 PM EDT) -- A U.S. Food and Drug Administration doctor has blasted a GlaxoSmithKline PLC trial for its diabetes drug Avandia, which the company has held up as proof that the controversial blockbuster does not cause heart attacks and strokes.

The report by Dr. Thomas Marciniak, a medical team leader in the agency's cardiovascular and renal products division, described GSK's RECORD trial as deeply flawed, “inappropriate and biased.”

Marciniak's study, posted on the FDA's website Friday, is just one of dozens of reports that a joint panel of the...
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