Healthy Skepticism Library item: 13244

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

Coombes R.
UK government tightens rules on drug trial results
BMJ 2008 Mar 15; 336:(7644):576
http://www.bmj.com/cgi/content/extract/336/7644/576-b

Abstract:

The UK government is to increase drug companies’ responsibility to pass on information about clinical trials.

The move comes after the regulators announced last week that it could not prosecute GlaxoSmithKline (GSK) for non-disclosure of trial data that showed it was unsafe for children younger than 18 to take the antidepressant paroxetine (Seroxat).

The Medicines and Healthcare Products Regulatory Agency (MHRA) issued the final report of its four year investigation into GlaxoSmithKline, during which investigators sifted through one million pages of evidence. It concluded that the drug company hadn’t broken the law but criticised it for not reporting the information earlier. GlaxoSmithKline denied it had broken any regulations.

Fears about the safety of paroxetine for children younger than 18 first surfaced in 2003 after a comprehensive review of selective serotonin reuptake inhibitors (SSRIs) by the Committee on Safety of Medicines. The review uncovered clinical trial data that show an increased . . .