Glaxo's Memo on Avandia.
Posted By Power & Brown, LLC
The New York Times (8/20, B3, Harris) reports that Food and Drug Administration "regulators ordered GlaxoSmithKline to send a letter to crucial doctors describing a hearing in July where an expert advisory panel discussed the risks of Avandia [rosiglitazone], the company's controversial diabetes medicine." Now, "a federal official and some members of the panel...say the company's letter is misleading and could endanger patients." Recipients of the July 28 letter from GSK are "investigators in a study called the Tide trial, which was intended to compare the heart risks of Avandia with those of Actos [pioglitazone], a similar drug made by Takeda Pharmaceuticals." For his part, Dr. David Graham, of the FDA, called GSK's summary "biased, misleading, and not truthful."