Today at morning report we discussed the recent increase in retractions of clinical trial reports. Dr. Johnson referenced an interesting case/control study recently published in BMJ which evaluated the frequency of objective discrepancies in retracted vs. un-retracted trials. The same issue of BMJ has a scathing editorial by BMJ associate editor Peter Doshi calling for the retraction of the now infamous Study 329. This study was sponsored by SmithKline Beecham (now GlaxoSmithKline) and published in 2001 in the Journal of the American Academy of Child and Adolescent Psychiatry. A recent re-analysis of the unpublished data from this trial contradicts the original conclusions of the study that paroxetine is safe and effective for treatment of depression in adolescents. This re-analysis was published under the restoring invisible and abandoned trials (RIAT) initiative which includes the concept of data above and below the waterline, depicted below. Read more about the STudy 329 re-analysis at Medscape.
As physicians, we must remember that published clinical trials are not sacred and it is our obligation to question everything!
Citations: BMJ 2015;351:h4708, BMJ 2013;346:f2865, BMJ 2015;351:h4320, Retract Antidepressant Drug Trial, Experts Say. Medscape. Sep 17, 2015