GSK utterly rejects any suggestion that it has improperly withheld drug trial information.

Depression is a severe and disabling condition and a well-recognised tragic outcome of the disease, particularly among young people, is suicide.

Careful monitoring of all patients is essential, regardless of whether they are taking medication or not.

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

Results from these studies were documented and submitted to regulators in accordance with regulatory requirements.

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.

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.

Seroxat has never been approved by EU or US regulators as a medicine for those under 18 years of age and GSK's UK product labelling has been entirely consistent with that position stating: "The use of Seroxat in children is not recommended, as safety and efficacy have not been established in this population."

Disclosure of paediatric clinical trial results

From 1994 to 2002, nine paediatric trials were conducted in depression, obsessive compulsive disorder, and social anxiety disorder, involving over 1,000 patients treated with Seroxat.

The study results from the individual trials were provided to regulatory agencies worldwide in accordance with regulatory requirements. Upon completion of the individual studies, safety and efficacy data were also communicated publicly in a variety of formats such as peer-reviewed journals, and poster presentations at scientific meetings, as is common practice in the disclosure of data.

Analysis of data from paediatric clinical trial results

No suicides were reported in any of the nine paediatric trials conducted by GSK and none of these trials when reviewed individually by GSK or independent investigator showed a clinically meaningful increase in the rate of suicidal thinking or attempted suicide.

Only when all the data became available at the end of the research programme and were analysed together was an increased rate revealed in those paediatric patients taking Seroxat. GSK brought this analysis to the attention of the regulatory authorities, including in the UK.

Your reference to "the possibility of obtaining a safety statement was considered but rejected" needs clarification. This showed that GSK had an honest belief that these preliminary data on safety were reassuring as the company was considering whether to submit new (more positive) safety wording for inclusion in the product's label to regulators for approval. However, it was recognised that any submission could only be made in the context of efficacy as well as safety. Given the failure of Study 377 to demonstrate efficacy, it was rightly concluded that a submission for new wording on safety should not be made.

Promotion of Seroxat for treatment of paediatric depression

Seroxat has never been approved by EU or US regulators as a medicine for those under 18 years of age. Any decision to prescribe a medicine outside its authorised indications, in the EU or the US, 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 the company strongly refutes any suggestion that Seroxat was promoted to UK doctors for use outside the terms of the UK marketing authorisation, whether through clinical experts (KOLs) or any other route.

Internal documents prepared by GSK's US subsidiary were specific to that subsidiary and were not distributed to the company's UK subsidiary or market.