CAMPAIGNER WRITES TO MP

Below is a letter from fellow campaigner, Derek Scott, penned to Stewart Hosie MP for Dundee East. Derek pretty much sums up the way a lot of us are feeling about this issue.






Dear Mr Stewart Hosie MP for Dundee East,

I write further to my last letter dated 19th November 2006, which incidentally has as yet gone unanswered by your constituency office (see attached). As you are aware I have continually campaigned for the banning of Seroxat. If there was any doubt that this should occur one need only look to the excellent BBC Panorama documentary ‘Secret of the Drug Trials’ aired on Monday 29th January 2007 (please find enclosed CD containing the documentary). This is now the fourth in the series of BBC Panorama documentaries focusing on the defective antidepressant Seroxat. The question has to be asked as to when the Government is going to intervene to prevent further death and suffering of mentally ill citizens of the United Kingdom? The focal point of the latest BBC Panorama documentary was on pediatric clinical trial 329 (that I previously provided to you!) which illustrated that the antidepressant drug Seroxat failed in comparison to placebo in terms of efficacy, indeed the placebo was more effective. Worse Seroxat was shown to actually exacerbate depression and anxiety increasing the risk of suicide! When the FDA asked GlaxoSmithKline to reanalyse Paroxetine raw clinical trial data in 2006, this reanalysis established that the risk of suicidality was actually six times greater for children (three times greater for adults).

GlaxoSmithKline knew in 1998 (see attached clinical trial 329 in its entirety) that study 329 suggested that children and adolescents were at an increased risk of suicide in comparison to a non drug (placebo) but who concealed that information from Dr’s to the detriment of the lives of patients prescribed the defective antidepressant Seroxat. The purposeful concealment of study 329 by GlaxoSmithKline unquestionably means that innumerable innocent and vulnerable children have been murdered by Britain’s largest pharmaceutical company GSK, but let us not forget that adults too suffer exactly the same adverse drug and withdrawal reactions to Seroxat as their younger counterparts, something BBC Panorama ‘Seroxat Taken on Trust’ and previous documentaries on the subject have reiterated time and again since 2002.

The more the story unfolds the scarier things seem to become. If manufacturers of pharmaceutical drugs are routinely concealing clinical trial data that are commercially unfavourable this means that we, the consumers of medicinal products are at ever greater risk of suffering from severe adverse drug reactions. Clinical trials of TGN1412 that went spectacularly wrong in 2006 and which could in the future cost four young adults their lives, their immune systems having been forever altered by a defective compound means that those clinical trial participants (human guinea pigs) could develop life threatening illnesses such as cancer at a later date. The Government drug regulatory agency the MHRA authorized the trial of TGN1412 and should be held accountable, but not just over that novel compound, but also over the defective antidepressant Seroxat which it licensed in 1991.

The warning signs have been glaring the Committee on Safety of Medicines (CSM) in the face in 6 failed safety reviews of SSRI antidepressants, yet Seroxat was deemed to be safe and effective in adults following the Committee on Safety of Medicines Expert Working Group Safety Review of SSRI Antidepressants when the report was finally published in December 2004. The reanalysis of SSRI antidepressants by the FDA in 2006 which suggested a 6 fold increase in the risk of suicidal thoughts and acts in children and a 3 fold increase in the risk of such serious adverse drug reactions in adults should herald a complete ban of Seroxat and a reanalysis of other medicines of the SSRI class by an independent agency out-with the CSM or MHRA. The MHRA cannot be trusted to be impartial since both the chairman and director of licensing are previous employees of GSK, Sir Professor Alasdair Breckenridge and Dr Ian Hudson respectively.

Clearly the Government and its drug regulator the MHRA are in collusion with the pharmaceutical industry? Paul Flynn MP for Newport West authored Early Day Motion 767 and which suggests that Members of Parliament had been written to by GlaxoSmithKline urging them to oppose Early Day Motions critical of their conduct in the concealment of pediatric Paroxetine clinical trial 329, I quote below

EDM 767 “CONDUCT OF GLAXOSMITHKLINE 30.01.2007 Flynn, Paul

That this House questions the propriety and courtesy of the action of GlaxoSmithKline (GSK) in writing to hon. Members with constituency interests in GSK urging them to oppose Motions for Early Day (EDMs) critical of their conduct, then denying originators of the EDMs details of the content of their messages when requested.”

If the Government and its drug regulatory agency cannot be trusted, who can consumers trust? It is self evident that there is a despicable collusion between Government, the drug regulator MHRA and the pharmaceutical industry. Clinical trial 329 that you have before you advises that and I quote a segment directly from that study”

TARGET: "To effectively manage the dissemination of these data in order to minimise any potential negative commercial impact."

The target of GlaxoSmithKline in 1998 was to effectively manage the dissemination of the clinical trial data contained within clinical trial 329 in order to minimize any potential negative commercial impact on their billion dollar adult marketing of the antidepressant Seroxat. To discover that there is UK Government and drug regulator collusion via Paul Flynn MP for Newport West’s Early Day Motion 767 is beyond comprehension unless you hypothesise that the Labour party has been funded by GlaxoSmithKline and most likely other pharmaceutical companies and hence why GlaxoSmithKline wrote to Members of Parliament urging them to oppose EDM’s critical of their conduct exposed by BBC Panorama ‘Secrets of the Drug Trials’ in the concealment of Pediatric Paroxetine clinical trial 329.

Shelly Jofre the BBC Panorama investigative reporter in all four Seroxat documentaries asked US lawyer Karen Barth Menzies what she made of the claim: “Remarkable safety and efficacy”. She replied to the question that, “it was a lie, and fraud”.

The evidence is clear, Seroxat is a deadly antidepressant medicine and that the manufacturer knew this fact, and worse that drug regulators and governments (UK and US) were in collusion with the manufacturer GlaxoSmithKline. Shelly Jofre, Professor David Healy and various lawyers who have pursued the issues for years have to be commended for their perseverance.

What must now occur, and I concur with Charles Medawar of Social Audit Ltd., on this are three fold:

1.) The GMC (General Medical Council) should investigate and rule over the conduct (or rather misconduct) of Dr Alastair Benbow the Head of European Clinical Psychiatry at the pharmaceutical company GlaxoSmithKline.
2.) GlaxoSmithKline should be prosecuted by the Department of Health Enforcement Officers, it has been 3 years now since Lord Warner declared that and I quote from a 2004 letter addressed to me by Ian Luke former MP for Dundee East, “GSK were being investigated by the enforcement officers of the Health Department over the withholding of testing results at the final stage of the development of Seroxat. If any criminal intent is found then legal action will ensue.”
3.) An urgent and proper enquiry is required over the effectiveness of the MHRA something the Parliamentary Health Select Committee Report of the Influence of the Pharmaceutical Industry advised in 2005.

The latest BBC Panorama documentary ‘Secrets of The Drug Trials’ makes clear the importance of the main criticism of the MHRA made by the Health Select Committee in its final report of ‘The Influence of the Pharmaceutical Industry 2005’:

During this long inquiry we became aware of serious weaknesses in the MHRA. Worryingly, in both its written and oral evidence the Agency seemed oblivious to the critical views of outsiders and unable to accept that it had any obvious shortcomings, except those that could be remedied by more transparency. The Agency’s attitude to its public health responsibilities suggested some complacency and a lack of requisite competency, reducing our confidence in its ability to undertake the reforms needed to earn and deserve public trust. Nor did we conclude that the MHRA provides the discipline and leadership that this powerful industry needs. We recommend that there be an independent review of the MHRA

As the spokesperson and founder of the Online Seroxat Support Group we call on the UK Government to implement the aforementioned three points and to do as the Health Select Committee recommended in 2005, that of a completely independent review of the MHRA.

I look forward to receiving correspondence from your constituency office that the points brought up in this letter will be acted upon with immediate effect.

Yours Sincerely
Derek Scott
BSc Behavioural Science (Hons)