LONDON, Jan. 29, 2007-Documents revealed tonight on BBC One's Panorama programme suggest that Britain's largest drugs company deliberately misled doctors about the safety and effectiveness of its antidepressant and promoted it as a treatment for children.
Panorama (8.30pm, Monday 29 January 2007, BBC One) has had exclusive access to thousands of internal memos which GlaxoSmithKline (GSK) released to lawyers involved in United States legal action against the company.
The documents show that as far back as the late Nineties there was an acknowledgement within GSK that tests had failed to prove that Seroxat was a safe or beneficial treatment for depressed children.
Seroxat was banned for under-18s in 2003 after the medicines regulator, the MHRA, revealed that GSK's own studies showed the drug actually trebles the risk of suicidal thoughts and behaviour in depressed children.
Panorama has obtained documents which show how GSK tried to spin the results of the clinical trials, which had failed to show that Seroxat was safe or that it worked for depressed children.
In 2001 the company told its US sales representatives that Seroxat: "…demonstrates REMARKABLE efficacy and safety in the treatment of adolescent depression."
Yet, months earlier, the company's marketing people were saying something significantly different: "Essentially the study did not really show [it] was effective in treating adolescent depression, which is not something we want to publicize."
Even graver concerns were expressed within GSK in 1999 about the drug's side-effects: "It seems incongruous that we state that [the drug] is safe yet report so many Serious Adverse Events."
GlaxoSmithKline rejects 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.
But the documents are likely to be of interest to the the MHRA which has been investigating GSK's Seroxat studies on children for three years. As yet no action has been taken.
Karen Barth Menzies, a lawyer leading a US class action against GSK on behalf of bereaved families, tells the programme: "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."
Asked by reporter Shelley Jofre - What does that amount to, in your view? Menzies responds: "It's a lie." "That's fraud."
Source: Panorama on BBC One (via Fierce Biotech)