Healthy Skepticism Library item: 18858

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Godlee F, Loder E
Missing clinical trial data: setting the record straight
BMJ 2010 Oct 12; 341:
http://www.bmj.com/content/341/bmj.c5641

Abstract:

Like us, you have probably grown accustomed to the steady stream of revelations about incomplete or suppressed information from clinical trials of drugs and medical devices.1 If so, this issue of the BMJ features a pair of papers that will dismay but not surprise you. Researchers for an official German drug assessment body charged with synthesising evidence on the antidepressant reboxetine encountered serious obstacles when they tried to get unpublished clinical trial information from the drug company that held the data, an experience from which they draw several lessons (doi:10.1136/bmj.c4942).2

Once they were able to integrate the astounding 74% of patient data that had previously been unpublished, their conclusion was damning: reboxetine is “overall an ineffective and potentially harmful antidepressant” (doi:10.1136/bmj.c4737).3 This conclusion starkly contradicts the findings of other recent systematic reviews and meta-analyses published by reputable journals.4 5 6 7 8 These studies presumably met prevailing standards for the conduct of meta-analyses. Yet we now know that they did not provide …