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| Antidepressant drug firm slammed | Antidepressant drug firm slammed |
| (20 minutes later) | |
| Regulators have ruled drug firm GlaxoSmithKline did not raise the alarm about the risk of suicide associated with Seroxat in under 18s soon enough. | Regulators have ruled drug firm GlaxoSmithKline did not raise the alarm about the risk of suicide associated with Seroxat in under 18s soon enough. |
| The regulator banned the antidepressant in under 18s in June 2003 but an investigation found GSK should have passed on data earlier. | |
| Criminal charges cannot be brought because the laws on disclosure were not strong enough at the time. | Criminal charges cannot be brought because the laws on disclosure were not strong enough at the time. |
| GSK has rejected claims it improperly withheld drug trial information. | GSK has rejected claims it improperly withheld drug trial information. |
| We will take immediate steps to ensure the law is strengthened further, so that there can be no doubt as to companies' obligations to report safety issues Professor Kent Woods, MHRA | |
| The Medicines and Healthcare products Regulatory Agency (MHRA) received data from clinical trials in May 2003 showing that patients under 18 had a higher risk of suicidal behaviour if they were treated with Seroxat than if they received a placebo. | |
| Data also showed that Seroxat was not effective for treating depression in children and adolescents. | |
| The drug was subsequently banned for use in under 18s. | |
| 'Responsibilities' | |
| A BBC Panorama investigation claimed in January last year that secret e-mails revealed that the company distorted trial results of an antidepressant, covering up a link with suicide in teenagers. | |
| Although the MHRA investigation showed the drug company could have disclosed trial data earlier, the regulator ruled there was no realistic prospect of a conviction. | |
| Legislation in place at the time was not sufficiently strong or comprehensive as to require companies to inform the regulator of safety information when the drug was being used for, or tested outside its licensed indications | |
| The four-year investigation looking at over one million pages of evidence was the largest of its kind in the UK. | |
| Professor Kent Woods, MHRA chief executive, 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. | |
| "This investigation has revealed important weaknesses in the drug safety legislation in force at the time. | |
| "Subsequent legislation has partially addressed the problem, but we will take immediate steps to ensure the law is strengthened further, so that there can be no doubt as to companies' obligations to report safety issues." |