Drug giant 'covered up safety fear on Seroxat'

A drugs firm covered up vital evidence about the

safety of an anti-depressant linked to a string of suicides, it was claimed last night.

Seroxat was taken by an estimated 50,000 British youngsters before being banned for patients

under 18 in 2003.

But scrutiny of thousands of documents and e-mails from manufacturer GlaxoSmithKline revealed it had fears about the drug's safety

years earlier.

But GSK, which makes £1billion a year from Seroxat, continued to promote it for youngsters, documents obtained by BBC's Panorama reveal.

Since it was first prescribed in Britain in 1990, it has been linked to at least 50 suicides of adults and children in the UK.

British experts said the continued prescription of

Seroxat led to young people’s deaths.

Charles Medawar, of pharmaceutical watchdog Social Audit, said more transparency by GSK would have "no doubt saved a number of lives".

The investigation revealed three key documents among thousands released for a U.S. court case

brought by bereaved families.

One from GSK’s marketing department in 1999 refers to side-effects, adding: "It seems incongruous that we state [the drug] is safe yet report so many serious adverse effects."

In 2001, the firm still claimed it was

safe, telling sales staff it showed

"remarkable safety and efficacy in the

treatment of adolescent depression".

And an e-mail from a PR executive admits research showed it did not work on teenage depression. It says: "Essentially, the study did not really show it was effective in treating adolescent

depression, which is not something we want to publicise."

Sophie Corlett, of mental health charity Mind, said: "GSK appears to have been playing Russian roulette with the lives of young people."

And Barbara Herts, of children's

mental health charity Young Minds, said: "The allegations suggest companies are putting profit ahead of the safety of young people."

Pam Armstrong, of the Council for Information on Tranquillisers and Anti-Depressants, said: "I cannot understand that so many people in

one company could feel it was okay to do nothing. When you are looking at the possibility of children being affected it is reprehensible."

Seroxat – also known as paroxetine – alters levels of mood-regulating

chemicals in the brain.

It was given to children as young as six by doctors who called it a "wonder drug".

But young patients began to commit suicide as their parents told how the children had mood swings, nightmares and personality changes.

It was not until 2004 that GSK published full details of studies from as early as 1993 showing children on Seroxat were twice as likely to feel

suicidal as those on a dummy pill.

Karen Barth Menzies, a lawyer in the U.S. case, said: "Even when they have negative studies that show Seroxat is going to harm some kids,

they still spin that study as remarkably

effective and safe for children."

Last year, GSK warned the drug could also cause adults to feel suicidal.

dal.

But it is still being used by hundreds of thousands of British adults.

GSK, which is being investigated by the Medicines and Healthcare Products Regulatory Authority and

sued by British patients, said there

were no child suicides in trials.

Only when data from nine studies was collated

did a suicide link emerge.

It said: "GSK has always been strongly conscious of the duty it owes the millions of patients who

suffer from depression and refutes

any allegation it has failed in its duty."