GSK accused of drug trial cover-up

29-01-2007

GSK accused of drug trial cover-up
GlaxoSmithKline (GSK), the UK's largest drugs company, has been accused of covering up evidence that its anti-depressant Seroxat had performed badly in clinical trials.

Internal company emails seen by the BBC's Panorama programme suggest that the pharmaceutical giant was aware that the drug might not help teenagers suffering from depression.

GSK is currently being sued in the US by bereaved parents who blame Seroxat for their children's suicide.

"Even when they have negative studies that show that this drug Seroxat is going to harm some kids they still spin that study as remarkably effective and safe for children," Karen Barth Menzies, a lawyer involved in the class action lawsuit, told the programme.

GSK has strongly denied any wrongdoing and said it conducted nine studies over eight years into the effects of Seroxat on patients under the age of 18.

"GSK utterly rejects any suggestion that it has improperly withheld drug trial information," it said in a statement.

The company added: "No suicides were reported in any of the nine paediatric trials conducted by GSK and when reviewed individually none of these trials were considered by GSK or independent investigators to show a clinically meaningful increase in the rate of suicidal thinking or attempted suicide."

The programme, which will be broadcast this evening, is likely to put the pharmaceutical industry in general under even greater scrutiny.

According to Joe Collier, a consultant in clinical pharmacology at St George's Hospital Medical School in London, trials conducted by drug-makers are often more positive than independent studies.

"Whenever anybody looks at trials that are done by drug companies versus, let's say, trials that have been done by independent bodies like the Medical Research Council, generally speaking the ones done by the drug companies, favour their products," he told the BBC's Five Live.

The Medicines and Healthcare Products Regulatory Agency (MHRA) banned the use of Seroxat for under-18s in June 2003 after studies showed evidence of an "increase in the rate of self harm and potentially suicidal behaviour in this age group, when
Seroxat is used for depressive illness".



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