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Last Updated: Monday, 29 January 2007, 06:15 GMT
Seroxat: Statement from GlaxoSmithKline
GlaxoSmithKline logo
In developing Seroxat, GSK has always been strongly conscious of the duty it owes to the millions of patients who suffer from depression and refutes any allegation that it has failed in this duty.

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.

  • Study 329 was complete in late 1998 and was first submitted for journal publication in mid 1999. Full results of the trial were published in The Journal of the American Academy of Child and Adolescent Psychiatry in 2001. The study was also presented at several scientific meetings between 1998 to 2000.
  • Study 377 was also completed in late 1998. It was presented at the American Academy of Child and Adolescent Psychiatry meeting in 1999 and was referenced in a number of psychiatry journals from 2000. However, opportunities to publish these data in a scientific journal were limited as the study failed to establish efficacy for Seroxat.
  • Study 701 was completed in 2001. The data were presented as part of a combine publication at the scientific meeting NCDEU (New Clinical Drug Evaluation Unit) in 2002 and referenced in The Psychopharmacology Bulletin in 2003.
  • 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.

  • In the case of study 329 although a numerical difference in adverse events was observed by the company and the study's investigators, for patients taking Seroxat compared to placebo, these findings were not, by themselves, considered clinically meaningful due to the limited number of patients involved and the fact that suicidal thinking and behaviour is a recognised symptom of the underlying disease.
  • Of the adverse events reported in this blinded study (where the patient, investigator and company do not know whether the patient received Seroxat or a dummy pill) only one - headache - was attributed by the independent investors to Seroxat. This opinion was published in the Journal of American Academy of Child and Adolescent Psychiatry in July 2001.
  • The subsequent paediatric studies - 377 and 710 - also were not considered to show any increased 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.

  • A memo sent to the company's US sales force was produced to inform the sales force of the publication of study 329 in the Journal of American Academy of Child and Adolescent Psychiatry. As is clearly stated in the memo, this information was not to be used with, or distributed to, physicians, consistent with GSK's global policy prohibiting off-label promotion. This memo was never issued or used by sales representatives outside of the United States, and would not have been seen in the UK.
  • The company did periodically receive direct unsolicited requests from doctors for medical information about use of Seroxat to treat children and adolescents with depression. As is standard practice, a 'medical information letter', was sent to the individual doctor. This letter identified published literature and clearly stated that Seroxat was not authorised for use in depression in patients under 18 years of age.



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