Over the weekend, GlaxoSmithKline issued a strongly wordedrejection of the US Senate Finance Committee report alleging the drugmaker downplayed and hid knowledge of various safety issues concerning its Avandia diabetes drug. Glaxo complained the report ( see here) drew inconsistent conclusions, cherry picked information from documents and mischaracterized "efforts to research Avandia and communicate those findings to regulators, physicians and patients."
The statement went on to say that Glaxo "has consistently shared...data with regulators around the world, and worked with them to ensure that the Avandia product labeling is updated to add cardiovascular and other safety information as new data become available so that physicians can make the best treatment choices for their patients."
Well....sort of... There was this March 25, 2008, letter from the FDA to former Glaxo ceo JP Garnier, chastising the drugmaker because it "failed to report multiple postmarketing studies involving Avandia in mandatory Periodic and/or NDA Annual Reports." The letter followed an inspection of Glaxo's North Carolina office.
Specifically, Glaxo's didn't convey "a status report for all postmarketing studies being performed by, or on behalf of, GlaxoSmithKline as required...." and not all of the periodic reports "contained a history of actions taken because of adverse drug experiences since the last adverse drug experience report, as required." One report failed to include info about initiating a 5,000-patient study called RECORD trial that Glaxo hoped would prove Avandia was safe.
There are oversights in this world, and then there are oversights.