Improving safety reporting in randomised controlled trials (isabelle pitrou, 16 June 2011)

I have read the editorial of Goldbeck et al. with a great interest (1). It is true that reporting is of high importance in the case of randomised controlled trials (RCTs). This has been highlighted recently with several sanitary crises, particularly when the pain medication rofecoxib (Vioxx) was taken off the market in 2004 after being linked to an increased risk of cardiovascular events among long-term users. The drug¿s safety profile had been questioned since 2000 when findings from the Vioxx Gastrointestinal Outcomes Research (VIGOR) trial showed a 5-fold higher incidence of myocardial infarction in patients taking rofecoxib compared with those taking naproxen, an effect somewhat attributed to a cardioprotective effect of naproxen (2). Despite this report, the drug was not withdrawn till... read full comment

Comment on: Goldbeck et al. Child and Adolescent Psychiatry and Mental Health, 5:4