Avandia Update

FDA may be considering stopping Avandia study.
On the front of its Marketplace section, the Wall Street Journal (4/19, B1, Mundy, Dooren) reports that the Food and Drug Administration is now considering whether to stop a trial involving thousands of people that explores the safety of Avandia (rosiglitazone), a diabetes drug manufactured by GlaxoSmithKline PLC. Research reported since 2007 has associated use of the drug with a higher risk for heart attacks. But, the trial's lead investigator, Hertzel Gerstein, called the current safety study "ethical and appropriate." He said that the American College of Cardiology, among other groups, has requested additional data on both Avandia and the drug Actos (pioglitazone).
Reuters (4/19, Erman) reprises the Wall Street Journal's coverage of the story, quoting the FDA's Principal Deputy Commissioner Joshua Sharfstein, who said that the decision to let the safety trial go on "cannot be de-linked from the agency's view of Avandia," and may even factor into its consideration of allowing the drug to remain on the US market. To date, however, the agency has made no decision on the trial, Sharfstein indicated.
JAMA editorial calls for independent analysis of industry-sponsored drug trial data. In a related story, American Medical News (4/19, O'Reilly) reports, "Medical journal editors should require independent analysis of industry-sponsored trial data by an academic statistician before publishing results, according to an editorial published in the March 24/31 Journal of the American Medical Association." The editorial "comes in response to internal GlaxoSmithKline documents revealed as part of a February Senate Finance Committee report investigating the company's handling of data related to its diabetes drug Avandia (rosiglitazone)." In fact, "it is in these kinds of cases that journals requiring an independent academic statistician to review the data analysis could help ensure that physicians and patients are not misled about industry-sponsored trial results, said Catherine D. DeAngelis, MD, MPH, editor-in-chief of JAMA."