GSK statement on MHRA investigation

GSK statement on MHRA investigation

Issued – Thursday 6 March 2008, London

GlaxoSmithKline (GSK) notes the conclusions announced today by the Medicines and Healthcare products Regulatory Agency (MHRA) regarding its investigation into disclosure of paediatric trial data for the anti-depressant medicine Seroxat (paroxetine).

“The safe use of our medicines is paramount to everyone who works for GSK and the company is committed to ensuring that all appropriate information is made available to regulators, doctors and patients. We firmly believe we acted properly and responsibly in first carrying out this important clinical trials programme and then informing the regulatory agencies when we identified a potential increased risk of suicidal thinking and behaviour in patients under 18,” said Dr Alastair Benbow, Medical Director for GSK Europe.

“Whilst there are substantive and rigorous requirements in place regarding disclosure of clinical trial data, it is clear that there is a need and benefit to strengthen the confidence of decision-makers and the general public that all pharmaceutical industry clinical trial data are disclosed promptly and transparently. GSK is committed to working with the Government, appropriate regulatory authorities and other pharmaceutical companies to take whatever action is necessary to improve legislation and policy in this area,” he added.

Paediatric clinical trials programme

GSK conducted nine studies, over eight years, to examine the use of Seroxat in treating patients under the age of 18 with depression and other psychiatric disorders, as treatment options for these vulnerable patients are extremely limited.

No suicides were reported in any of the nine paediatric trials conducted by GSK. 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.  As has been confirmed by the MHRA in their conclusions, it was only when all the data became available, at the end of the research programme, and were analysed together was an increased rate of suicidal thinking or attempted suicide revealed in those paediatric patients taking Seroxat. GSK brought this analysis to the attention of the regulatory authorities, including in the UK.

The company rejects any suggestion that it withheld drug trial information as results from its paediatrics studies were documented and submitted to regulators in accordance with regulatory requirements. Results were also presented publicly, published in scientific journals and have been made available on GSK's website.

Seroxat promotion

Seroxat has never been approved by UK or European regulators as a medicine for those under 18 years of age. GSK's UK product labelling has been entirely consistent with that position, and at the time of the events in question, this label stated: “the use of Seroxat in children is not recommended, as safety and efficacy have not been established in this population.” Any decision to prescribe a medicine outside its authorised indications, in the UK, is made by a doctor on the basis of his/her clinical judgement and the interests of their patient. GSK does not promote its medicines for indications for which they are not approved and maintains that Seroxat was not promoted to UK doctors for use outside the terms of the UK marketing authorisation.

Clinical trial data disclosure

GSK has been at the forefront of industry efforts to publish clinical trial findings and is committed to maintaining best practice disclosure of clinical data. GSK rigorously meets all requirements to provide data to regulators and makes extensive efforts to publish its clinical trial findings in peer review journals and at scientific meetings. GSK also discloses all trial information, irrespective of outcome, on its Clinical Trial Register.This is a record of detailed summaries of more than 2,800 clinical trials conducted to study its prescription medicines and vaccines and is available to the public at http://ctr.gsk.co.uk [1]. GSK also provides relevant unpublished clinical trial data to agencies such as the National Institute for Clinical Excellence (NICE) in accordance with their current processes.

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.