Healthy Skepticism Library item: 13243

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Publication type: Journal Article

Godlee F.
A legal framework for drug safety
BMJ 2008 Mar 15; 336:(7644):0
http://www.bmj.com/cgi/content/full/336/7644/0

Abstract:

It’s welcome news that the UK government will close the legal loop hole that allowed GlaxoSmithKline to escape prosecution last week for not disclosing evidence of increased suicide risk in children taking seroxat (doi: 10.1136/bmj.39517.500961.DB). But this piece of legislation alone is not enough. It should be seen as just one further step on the legislative road to full mandatory disclosure of data from clinical trials.

There’s no mistaking the UK regulator’s frustration at having to drop its attempts to prosecute GSK. Staff at the Medicines and Healthcare products Regulatory Agency reviewed thousands of documents dragged out of GSK over four years. But in the end the existing EU legislation let them down: at the time it didn’t require companies to disclose adverse events from trials in groups of patients for whom the medicine was not licensed. On the basis of the same data but in a different legal framework, New York state successfully prosecuted GSK in 2004 for persistent fraud (BMJ 2004;329:590; doi: 10.1136/bmj.329.7466.590-d)…

Notes:

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