Firm attacked over drug trial data

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The Medicines and Healthcare Products Regulatory Agency (MHRA) said it remains concerned that GSK failed to raise the alarm earlier over the side-effects of Seroxat.

Government prosecutors have ruled there is no realistic prospect of getting a conviction over the issue. But new legislation ensuring drugs companies pass on results of clinical trials promptly is to be introduced, public health minister Dawn Primarolo told Parliament.

Seroxat is the most frequently-prescribed anti-depressant in the UK, but there have been complaints that it triggers suicidal feelings in some patients.

The MHRA launched an investigation into GSK in May 2003 over allegations that it knew of the drug's dangers for several years but failed to pass the information on.

Data from an earlier clinical trial showed Seroxat was not effective in treating under-18s and had in some cases triggered a higher risk of suicidal behaviour. Once the results were made known, the watchdog immediately warned doctors of the side effects.

Announcing the results of the subsequent investigation into GSK, professor Kent Woods, chief executive of the MHRA, said: "I remain concerned that GSK could and should have reported this information earlier than they did. All companies have a responsibility to patients, and should report any adverse data signals to us as soon as they discover them."

In a letter to GSK, Prof Woods states that a tightening up of the law will now be introduced as a result of the firm's failure to declare information promptly.

In a written statement to parliament, Ms Primarolo announced that "immediate steps" would be taken to strengthen the law, making it clear that drugs firms must disclose any information they had which could have a bearing on the protection of health.

Seroxat was designed to restore the taker's confidence and general happiness. But some patients claim their lives have been blighted by addiction as a result of taking the drug, suffering serious withdrawal symptoms when trying to get off it. Others claim it has resulted in self harm or made them feel suicidal.