July 13, 2010 - Glaxo Hid Avandia Risk Data

Bloomberg News (7/10, Feeley, Cortez) reported that Dr. Rosemary Johann-Liang, "a former US Food and Drug Administration official” alleged in a deposition that the manufacturer “withheld from regulators a study showing its Avandia diabetes drug may cause heart attacks” The New York Times (7/13, A1, Harris) provided additional front page coverage of the story, reporting that recently obtained documents indicate that SmithKline Beecham, the precursor to GlaxoSmithKline, spent 11 years trying to cover up a study that found Avandia (rosiglitazone) was "no better than Actos [pioglitazone]," and also "that it was riskier to the heart." Dr. Martin I. Freed, a SmithKline executive, "wrote in an email message dated March 29, 2001, about the study results that [were] obtained by The Times, 'Per Sr. Mgmt request, these data should not see the light of day to anyone outside of GSK.'" Meanwhile, Dr. John Jenkins, director of the FDA's office of new drugs, "has argued internally that Avandia should remain on the market," and "briefed the company extensively on the agency's internal debate." The Wall Street Journal (7/13, Mundy) reported that Dr. Rosemary Johann-Liang, a former FDA official who quit the agency after being unable to convince her superiors about the need for stronger warnings on Avandia, said there were early reports written by company researchers that noted scientists' concerns about the heart risks with the drug.