Tuesday, 31 July 2007

GlaxoSmithKline statement - BBC Panorama - 29 January 2007

This statement has been issued following the BBC Panorama programme, ‘Secrets of The Drugs Trials’ which was aired on Monday 29th January.

GlaxoSmithKline (GSK) strongly denies the allegations made by Panorama in their programme that it has acted in any way improperly and wishes to make the following points:

· We are extremely concerned that as a result of the programme patients will be anxious about using their anti-depressant medication.

· 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.

· The JAACAP (Keller) publication in July 2001 was authored by Dr. Keller and the other named authors. GSK acted appropriately in engaging a professional medical writer to provide assistance with the manuscript, under the direction of the authors, and the medical writer’s contribution was clearly disclosed on the front of the article. The authors had full responsibility and editorial control for the article. The article clearly presented, in full, the primary and secondary outcomes and adverse events reported in the study.

· 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 (published and unpublished) conducted in 50 countries to study 52 GSK prescription medicines and vaccines which is available to the public at http://ctr.gsk.co.uk.

Updated January 29, 2007
© 2001-2006 GlaxoSmithKline - All rights reserved

I accept that the press release was issued pursuant, I suspect, to a damage limitation exercize, following Secrets of the Drugs Trials. Similarly I accept that GSK would be very keen to deny the allegations made, and that it would be concerned that patients should stop taking their medication - although why it should be concerned escapes me, just for the moment. As such, the instruction to consult with doctors is unsurprising.

"Depression" to the extent that we have any understanding of the "disease" does not cause death. The suggestion that suicide victims would have killed themselves, anyway, and that the drug had no influence on the matter is the most repulsive piece of blame-shifting I've ever seen. GSK acknowledges that an increased suicide risk exists with the drug, and the argument that nobody killed themselves during clinical trials is grotesque, in my view: before somebody kills him/herself they have to have thought about it, first. And suicidal ideations (and, indeed, other forms of suicidality), most definitely did feature in the trials.

In any event, GSK acknowledges that once it had completed its trials programme, it was able to analyse all the data, at which point the incidence of increased suicidality became apparent. Now, excuse the shit out of me, but I rather thought that GSK had not "improperly withheld" trials data from the regulator. Now, let's just assume for the minute that that means that they submitted all trials data to the MHRA, in the UK (it doesn't, because the industry traditionally regards trials data as proprietary information, which companies may withhold, as they see fit). However, assuming that the MHRA received everything, then it would have been constantly monitoring the situation, because this is what it tells us it does, repeatedly. Did it not occur to anybody, before the results were in from the ninth trial, that there was a pattern emerging? What the fuck are you cunts doing? Not regulating, and that's for sure. So, eight years down the line, somebody does a meta analysis, and it suddenly dawns that there's an issue with respect to increased suicide, whereupon a marketing authorization for treatment of adolescent depression is applied for. Doesn't quite fucking scan, does it?

There are suggestions circulating that "off label" prescribing is promoted to quacks. I have nothing else to say on that.

THE NAMED AUTHORS DID NOT WRITE THAT ARTICLE. Keller co-wrote a letter to Dr Mina Dulcan, at JAACAP, with Dr Neal Ryan and "WHOEVER [sic] WANTS TO OR SHOULD CO-AUTHOR THIS." I suggest you scroll down and read "The Life and Times of Martin Keller, MD - Part V..." for fuller details of what actually happened. The article had already been submitted, published and criticized, by the time that draft was written. And people were still adding their names to it. You fucking charlatans.

Whoopee-doo to your online databases. The Yellow Card system is supposed to be a world leader, but it's apparently so poorly administered that healthcare professionals have no faith in it, and no longer submit reports, because they know that there's only an even money chance that they'll be followed up.


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