Healthy Skepticism Library item: 18861

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Publication type: Journal Article

Steinbrook R, Kassirer JP
Data availability for industry sponsored trials: what should medical journals require?
BMJ 2010 Oct 12; 341:
http://www.bmj.com/content/341/bmj.c5391.extract

Abstract:

Concerns about the reliability of the data in the Rosiglitazone Evaluated for Cardiovascular Outcomes in Oral Agent Combination Therapy for Type 2 Diabetes (RECORD) trial1 2 have once again raised an uncomfortable question-what criteria should medical journals use when they consider reports of industry sponsored clinical trials for publication? As published, the open label RECORD trial, which was sponsored by GlaxoSmithKline, showed that the addition of rosiglitazone (Avandia) to metformin or sulfonylurea was not inferior to treatment with a combination of these drugs for a composite endpoint of cardiovascular events and death, and was inconclusive about any possible effect on myocardial infarction.2 However, during the course of the review of the study by the United States Food and Drug Administration (FDA), a reviewer who audited the raw data found that potential bias and omissions in the adjudication of cardiovascular endpoints had downplayed the risk of myocardial infarction associated with taking rosiglitazone.3 4 Another FDA official said of the reviewer’s report, “ I think you could sum [the review] up in one word, and the word is truth. Can we trust the sponsor with the results of RECORD?”5 In September 2010, regulatory agencies announced that medicines containing rosiglitazone would be taken off the …