GSK rebuffs claim of ‘distorted’ Seroxat trial results

GlaxoSmithKline (GSK) has rejected claims to be made in a forthcoming television programme that the firm distorted the results of clinical trials investigating Seroxat, an antidepressant.

Panorama, to be broadcast this evening on BBC One, will claim that GSK attempted to suppress the inefficacy of the compound in treating depression in adolescents, while using employees to influence supposedly independent academics.

The BBC website reports that Seroxtat was banned for use in patients aged under 18, after the Medicine and Healthcare Products Regulatory Authority reported that studies from GSK showed the compound could increase the risk of suicidal behaviour in young people.

As a result of a lawsuit brought by a number of families in the US, GSK has been forced to give access to its internal archive of confidential material.

In response to these claims, GSK states: “We are extremely concerned that Panorama will again, through misleading and deliberately provocative commentary, alarm patients about using their anti-depressant medication, with potentially serious consequences.”

The company adds that Seroxat is not and has never been recommended in the EU or US for use by patients under the age of 18, with the product labelling noting that its safety and efficacy had not been established for this section of the population.

It reports that administration of the drug in these patients would occur as a result of decisions by physicians made as a basis of their own clinical judgement.

Scotsman.com reports that Panorama will claim GSK internal documents from 1999 reveal concerns from within the company regarding the safety of Seroxtat.