Posts Tagged ‘RECORD’

May 29th, 2013

Report on the RECORD Trial Released

An independent re-adjudication of the RECORD trial has confirmed the trial’s original finding that rosiglitazone does not increase cardiovascular risk. But critics of the trial and the drug are unlikely to be appeased by the new result. The re-adjudication of RECORD will be the subject of an extraordinary 2-day FDA advisory committee meeting next week on […]

May 24th, 2013

Spinning RECORD: Battle Over Rosiglitazone Heats up Two Weeks Before Crucial FDA Meeting

Battle lines are being drawn two weeks before a highly unusual two-day FDA advisory committee meeting to discuss the contentious diabetes drug rosiglitazone (Avandia, GlaxoSmithKline [GSK]). This will be the second time an FDA panel has wrestled with the fate of the drug and expectations have been that the discussion will once again be heated. But at […]

April 13th, 2013

FDA Schedules Another 2-Day Avandia Advisory Panel

Once again the controversial diabetes drug rosiglitazone (Avandia, GlaxoSmithKline) will be the subject of a 2-day FDA hearing. According to a meeting announcement scheduled to be published in the Federal Register on April 15, the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will meet on June 5 and June 6 to  “discuss the results […]

July 2nd, 2012

Selections from Richard Lehman’s Literature Review: July 2nd

This week’s topics include pay for performance, Don Berwick’s Harvard commencement address, tPA for ischemic stroke in warfarin-treated patients, surgery for infective endocarditis, the American health care system, and the record number of RECORD studies.

July 26th, 2010

Questions for Sanjay Kaul about TIDE and Avandia


CardioExchange’s editor-in-chief Harlan Krumholz discussed the TIDE trial on email with Sanjay Kaul, who was a member of the FDA’s advisory panel last week on Avandia. Here is a lightly edited version of their exchange. Krumholz: What is your response to the FDA announcement that it has placed TIDE on a “partial clinical hold”? Do you […]

July 22nd, 2010

Lessons Learned from 2 Avandia Panels

In a perspective published online in the New England Journal of Medicine, Clifford Rosen, who was the chair of the 2007 FDA Advisory Panel that allowed rosiglitazone (Avandia) to remain on the market and also a member of the panel that met last week, writes about “lessons learned” from the extraordinary series of events involving […]