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Wednesday, March 14, 2007

Seroxat also linked to suicide in adults

July 2006

GlaxoSmithKline (GSK), the manufacturer of the controversial antidepressant drug Seroxat, has admitted that the medication can result in adults becoming suicidal.


Now read what the 'experts' said

Dr ALASTAIR BENBOW Head of European Psychiatry , GlaxoSmithKline
The evidence, however, is clear, these medicines are not linked with suicide, these medicines are not linked with an increased rate of self harm

Dr ALISTAIR BENBOW Head of European Clinical Psychiatry GlaxoSmithKline
We have been asked by the regulatory authorities to provide all our information related to suicides and I can tell you the data that we provide to them clearly shows no link between Seroxat and an increased risk of suicide – no link.

In an email to anti Seroxat campaigner, Robert Fiddaman, Prof. Kent Woods, CEO of the MHRA, stands by Report of the Committee on Safety of Medicines Expert Working Group on the Safety of Selective Serotonin Reuptake Inhibitor Antidepressants, stating that “I have already given you a full account of the Agency’s position in this matter and there is nothing to add to it.”This, despite recent new evidence suggesting that the Expert Working Group did not have access to all the clinical trial data as recently published in Dr Peter Breggin’s report

There is very good clinical trial evidence that these drugs do not cause suicide, they do not cause suicidal thoughts in adults. There is a very large database.

Stuart Dollow, medical director of GlaxoSmithKline UK, said his company published the results of all its studies on all drugs "whether negative or positive".

The primary role of the MHRA is to protect the public health. It also has got a responsibility to ensure that only drugs which are effective and safe come to the market and remain on the market.

GlaxoSmithKline, which earned £100 million last year from UK sales of Seroxat, has always denied there was "compelling evidence" linking SSRIs with suicide.

Dr ALASTAIR BENBOW Head of European Clinical Psychiatry GlaxoSmithKline
Whilst self-harm and suicidal thoughts are clearly a feature of depression, they have not been shown in carefully done studies to be a feature of treatment with these medicines.

In the adult population the drugs are effective.

It’s very important that since safety is an issue which is built up as more experience is gained with the drug, that safety is kept under review and this is why we insist on post marketing surveillance of a drug, which means that its safety is kept under review during its lifetime.

It is a matter of regulatory and practical judgement as to when information should be transmitted. When it is in the public’s interest that information should be transmitted rapidly, we will do it

Dr ALISTAIR BENBOW Head of European Clinical Psychiatry GlaxoSmithKline
Now not everybody who tragically takes their own life will say to people: "I'm feeling suicidal, I'm going to kill myself." In fact many people who have decided that they're going to do that, deliberately withhold that information from their friends and family.

There is no other agency which has kept these.. these drugs under such constant and careful review since 1990 as we have done and we will continue to do so in the interests of the public health.

People can’t get hooked on Seroxat as they did on the older drugs such as Librium and Valium, claims GSK. For over a decade, the company line has been swallowed, along with the pills. But a court case in Wyoming, USA, has changed all that. The jury decided Seroxat - Paxil in the USA - was to blame for Donald Schell killing his wife, daughter, baby granddaughter and then himself. Enter Ian Hudson, witness for the defence and at the time of his deposition earlier in 2001, worldwide safety director for GSK. That’s Ian Hudson, now director of licensing at the Medicines Control Agency (Now MHRA) in the UK. What did he have to say to the evidence of Mr Schell’s closest remaining family and three psychiatrists who all believed the tablets of Paxil/Seroxat Mr Schell took for just two days precipitated him into an unnatural and totally uncharacteristic murderous and suicidal frenzy? His position is that an individual case cannot tell you one way or the other - only randomised controlled trials will do.

Alan Metz, GSK North American medical director told the Wall Street Journal: “Each time it hs been looked at, there is no suggestion of an association with suicidal tendencies in adults

March 11 2003:
A coroner calls for an inquiry into the widely-prescribed anti-depressant drug Seroxat. Powys coroner Geraint Williams has written to the UK Health Secretary to ask for an urgent inquiry and for the drug to be withdrawn from use.It follows the death of a man from Brecon who killed himself two weeks after being prescribed the drug for anxiety - the coroner recorded an open verdict on Tuesday.

May 11 2003:
The makers of the popular anti-depressant Seroxat have denied claims that their product is addictive and causes suicidal feelings. Speaking on BBC One’s Panorama programme, Dr Alastair Benbow, head of European clinical psychiatry at GlaxoSmithKline, admitted that people could have misunderstood the information on patient leaflets which said the drug was not addictive.

June 9 2003:
Experts are set to update the safety advice provided with the controversial antidepressant Seroxat. The drug has been at the centre of a storm amid claims that it is addictive and could increase the risk of violent behaviour in some patients. Its maker, GlaxoSmithKline, insists that it is a safe drug - prescribed to thousands of patients in the UK.

June 2 2004:
UK drugs group Glaxosmithkline (GSK) has been sued in the US for allegedly lying about the effectiveness and safety of its antidepressant Seroxat.

December 2004:
In the USA, ABC News uncovers internal documents that suggest GlaxoSmithKline, maker of the popular antidepressant Paxil, was aware that the drug had little or no effect in treating depression in children and adolescents, and that it may cause suicide-related behaviours in young patients. In spite of this information, GlaxoSmithKline distributed a memo to its sales force in 2001 touting the drug’s “remarkable efficacy and safety in the treatment of adolescent depression.”

March 22 2005:
The Health Select Committee publishes The Report of the Fourth Session 2004-05 entitled The Influence of the Pharmaceutical Industry. From the MHRA, Professor Alaisdair Breckenridge (Chairman), Kent Woods (CEO) and June Raine (Director of Vigilence and Risk Management) are asked to attend a hearing for questioning in January 2005. Also from the MHRA, Ian Hudson is asked to attend but does not. Prior to joining the MHRA, Hudson was Worldwide Director of Safety at GlaxoSmithKline, with a significant involvement in Seroxat. During the hearing, angry MPs are unable to ask specific questions regarding the safety and trials of Seroxat due to Hudson’s non apperance. Among its recommendations, the Report calls for more control over the way Pharmaceutical companies market their drugs, as well as calling for a complete review of the MHRA itself. The MHRA appoints a Director of Communications (Marketing and PR).

February 27 2006:
A previously sealed product liability report against Glaxo SmithKline (GSK) is published. The medical expert report documents how the company systematically hid and manipulated data concerning Seroxat (Paxil) induced suicidality in depressed adults.

May 2006:
GlaxoSmithKline (GSK) submits documents to the FDA in the USA and other regulatory agencies worldwide, contradicting its decade long denial that its antidepressant drug, paroxetine (Paxil/Seroxat) increased the risk of suicidal behaviour in the company’s controlled clinical trials. GSK insists the timing of the warning, made so soon after Dr. Peter Breggin’s previously sealed product liability report against Glaxo SmithKline was made public, has nothing to do with that document.

Dr Ian Hudson
December 20th, 2006
While I’m thinking about the MHRA, here’s something else I want to share with you. The MHRA is not funded by the taxpayers of the UK - rather, it is entirely funded by the Pharmaceutical industry - it takes fees from those it regulates. However, unlike many regulators, it competes with other European agencies for fee income.

The links between industry and the MHRA are very, very close. Dr Ian Hudson is the MHRA’s Director of Licensing - but the job he had before he joined the agency was at GlaxoSmithKline - he was their Worldwide Director of Safety, and we know that one of the drugs he had “significant involvement with” was, in fact, Seroxat. (Also, the Chairman of the MHRA, Professor Alasdair Breckenridge, sat on Glaxo’s scientific advisory committee for many years.

The strange thing is that on the day the House of Commons Health Select Committee wanted to hear evidence from the MHRA specifically about Seroxat trial data and safety, Professor Alaisdair Breckenridge (MHRA Chairman), Professor Kent Woods (MHRA CEO) and June Raine (MHRA Director of Vigilence and Risk Management) all managed to attend the hearing. MPs had expected to be able to question Ian Hudson as well… unfortunately Dr Hudson could not attend as he had a prior engagement.
Roger Cleghorn, UK Seroxat Campaigner

Professor Kent Woods Chief Executive MHRA
In relation to the use of SSRIs in young adults the Expert Working Group concluded that there is no clear evidence of an increased risk of self-harm and suicidal thoughts in young adults of 18 years or over. However, given that individuals mature at different rates and that young adults are at a higher background risk of suicidal behaviour than older adults, as a precautionary measure young adults treated with SSRIs should be closely monitored. The Group also recommended that in further research on the safety and efficacy of SSRIs, young adults should be assessed separately.