Pharmaceutical Business review

GSK accused of drug trial cover-up

Documents obtained by the program show that tests had failed to prove that Seroxat was a safe or beneficial treatment for depressed children, according to the BBC. Seroxat was banned for under-18s in 2003 after the UK medicines regulator, the MHRA, revealed that GSK’s own studies showed the drug actually trebles the risk of suicidal thoughts and behavior in depressed children.

However, the documentary alleges that GSK knew of the risks as far back as the late 1990s, yet was still promoting the drug in the treatment of adolescent depression.

GlaxoSmithKline has rejected any suggestion that it has improperly withheld drug trial information and points out that no suicides were reported in any of its studies involving children.

Karen Barth Menzies, a lawyer leading a US class action against GSK on behalf of bereaved families, told the BBC: “They didn’t tell the regulators or the physicians or parents about these risks or the lack of efficacy; instead they went out and promoted this specific study as remarkably effective and safe for kids.”