GlaxoSmithKline Statement - BBC Panorama

GlaxoSmithKline Statement - BBC Panorama LONDON, Jan. 29, 2007 - This statement has been issued in anticipation of the BBC Panorama programme, ‘Secrets of The Drugs Trials’ which is to be aired on Monday 29th January. GlaxoSmithKline (GSK) has provided a written response to the allegations it understands are to be made in the above programme. GSK has not seen the programme but strongly denies suggestions that it has acted in any way improperly. The company has no confidence that its responses will be accurately, or appropriately, represented in the programme, or in the BBC’s publicity materials. GSK therefore wishes to make the following points that include a summary of the information provided to the programme: · We are extremely concerned that Panorama, will again, through misleading and deliberately provocative commentary, alarm patients about using their anti-depressant medication, with potentially serious consequences. · Patients concerned by issues raised in the programme should seek advice from their doctor. · Depression is a severe and disabling condition. 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. · In developing Seroxat, GSK has always been strongly conscious of the duty it owes to the millions of patients, including those under the age of 18, who suffer from depression and we refute any allegation that we have failed in this duty. 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. · GSK utterly rejects any suggestion that it has improperly withheld drug trial information. 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 are available on GSK’s website. · 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. 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. · GSK does not promote its medicines for indications for which they are not approved.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 (“Key Opinion Leaders”) or any other route. · Seroxat has never been approved by EU or US 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 EU or the US, is made by a doctor on the basis of his/her clinical judgement and the interests of their patient. · GSK, in 2004, further demonstrated its commitment to data transparency by creating an unsurpassed on-line database, called the Clinical Trial Register (CTR). This is a record of detailed summaries of more than 2,800 clinical trials conducted in 50 countries to study 52 GSK prescription medicines and vaccines which is available to the public at http://ctr.gsk.co.uk

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