The evidence on false conclusions from drug trials, and their publications, is mounting. I am forced to the conclusion that, most likely,
1) This has been going on for a long time; the big change is that it’s occasionally getting noticed now, and
2) The results of this over many years must be that doctors are prescribing based on incorrect evidence. Specifically, lots of drugs are getting prescribed when they shouldn’t be.
According to the article by Nissen,1 the report of the Senate investigation,2 and published media accounts,8-9 the manufacturer of rosiglitazone exerted inappropriate influence during the conduct of a pivotal safety study of this drug, the RECORD Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes clinical trial,10-11 which included undertaking nonprespecified unblinding of study data; attempting to undermine the authority and responsibilities of the study steering committee; expediting publication of an unscheduled interim analysis,10 specifically to counter2 the publication of a meta-analysis by Nissen and Wolski12 that suggested increased cardiovascular risk associated with rosiglitazone; having employees extensively involved in statistical analysis,11 and preparation of the manuscript10 reporting the results of the trial; and reportedly2 failing to fully acknowledge the significant cardiovascular risk associated with this drug.