Everyone knows that medical information flows out of medical centers and schools, research institutions and the NIH, pharmaceutical companies, journals and medical societies. But one important information source — medical communication companies (MCCs)– “are among the most significant but least analyzed health care stakeholders,” according to Sheila Rothman and colleagues. In a new report in JAMA they set out to explore…
Behind The Curtain: Study Reveals Big Role of Medical Communication Companies
December 17, 2013 by Leave a Comment
FDA Removes Restrictions On Avandia
November 25, 2013 by Leave a Comment
In a remarkable climax to a long-running drama, the FDA today lifted major restrictions on rosiglitazone (Avandia, GlaxoSmithKline). The drug has been the subject of intense criticism and controversy since the 2007 publication of the famous Nissen meta-analsysis that first raised the possibility that the blockbuster diabetes drug might increase the risk of heart attack and cardiovascular death. The FDA said…
Promising GSK Heart Drug Misses Primary Endpoint In 15,000 Patient Trial
November 12, 2013 by Leave a Comment
GlaxoSmithKline announced today that the first of two large pivotal phase 3 trials with a new drug, darapladib, had failed to meet its primary endpoint. Full results of the trial will be presented at a scientific meeting. The STABILITY trial (STabilisation of Atherosclerotic plaque By Initiation of darapLadIb TherapY) tested the effect of darapladib, an investigational Lp-PLA2 inhibitor,…
FDA Advisory Panel Backs Looser Restrictions On Avandia
June 6, 2013 by Leave a Comment
After two days of deliberation an FDA advisory panel today recommended that the severe restrictions (REMS) placed on rosiglitazone (Avandia, GlaxoSmithKline) be modified. The vote constitutes a modest revival in fortune for the embattled drug and its maker after many years of controversy and bad news. Only 5 panel members voted to continue the current severe restrictions….
With One Big Exception FDA Reviewers Back More Benign View Of Avandia Trial
June 3, 2013 by Leave a Comment
The FDA today released a 538-page briefing document for an advisory panel meeting on Wednesday and Thursday that will reassess a key clinical trial and reconsider the fate of the now-tarnished former blockbuster diabetes drug rosiglitazone (Avandia, GlaxoSmithKline). (Click here for the FDA documents.) As reported last week, the re-adjudication of the RECORD safety trial performed…
Independent Re-Adjudication Of RECORD Confirms Safety Of Rosiglitazone
May 29, 2013 by Leave a Comment
An independent re-adjudication of the RECORD trial has confirmed the original findings of the trial, that rosiglitazone d0es 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 two-day FDA advisory committee meeting next…
Spinning RECORD: Battle Over Rosiglitazone Heats Up Two Weeks Before Crucial FDA Meeting
May 24, 2013 by 1 Comment
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). 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…
FDA Schedules Another 2 Day Avandia Advisory Panel
April 12, 2013 by Leave a Comment
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 Monday, 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…
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