Zantac Lawsuit

Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Thursday, June 10, 2010

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part IV - The Colour of Money


Previously on Seroxat Sufferers:

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part I of IV

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part II of IV - Witness For The Defence

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part III of IV - Expert Statistician

In this final installment, regarding the expert witnesses being called by GlaxoSmithKline in the up and coming UK Seroxat Group Action, I'd like to try and get an understanding of the UK law that pertains to the use of expert witnesses in trials.

Firstly, the purpose of these four articles is to determine whether or not the witnesses called by GlaxoSmithKline have a potential conflict of interest.

According to the General Medical Council [GMC] website, the role of an expert witness is thus:

The role of the expert witness

5. The role of an expert witness is to assist the court on specialist or technical matters within their expertise1. The expert's duty to the court overrides any obligation to the person who is instructing or paying them2. This means that you have a duty to act independently and not be influenced by the party who retains you.

On a possible conflict of interest, the GMC write:

Conflicts of interest

19. If there is any matter that gives rise to a potential conflict of interest, such as any prior involvement with one of the parties, or a personal interest, you must follow the guidance on disclosure in paragraph 13. You may continue to act as an expert witness only if the court decides that the conflict is not material to the case.

Now, far be it for me to accuse Glaxo's witnesses as having a possible conflict of interest. I see as I find.

Briefly, Part II highlighted Rashmi Shah, an ex employee of the Medicines Healthcare and products Regulatory |Agency [MHRA]. Shah was employed by the MHRA when Seroxat was licensed - he was also employed by them during the safety reviews the MHRA carried out regarding Seroxat withdrawal, an issue that the UK Seroxat Group Action is based upon. The MHRA have known ties to GlaxoSmithKline. Their Chairman, Alasdair Breckenridge is a former employee of GSK, then SmithKline Beecham, as is the MHRA's Head of Licensing, Dr. Ian Hudson. Hudson was employed by SmithKline Beecham over a period of 11 years. More importantly, in a public Declaration of Interests document, Hudson openly admitted that he had a significant involvement with a number of drugs during his time at Glaxo [then SKB] - one of which was Seroxat. [1]

Although Rashmi Shah has never been employed by GlaxoSmithKline, his time at the MHRA [17 years] should have made him aware that there was a withdrawal problem with Seroxat.

It should also be noted at this point that the MHRA failed to prosecute GlaxoSmithKline after a four year investigation into why GSK failed to inform the agency in a timely manner of information it had on the safety of Seroxat in the under 18’s.

The investigation, the largest of its kind in the UK, was undertaken with a view to a potential criminal prosecution for breach of drug safety legislation, and included the scrutiny of over 1 million pages of evidence. The decision taken by Government Prosecutors, based on the investigation findings and legal advice, is that “there is no realistic prospect of a conviction in this case, and that the case should not proceed to criminal prosecution.

The report found that between April 1994 and September 2002, GSK (earlier SKB), conducted 9 trials specifically looking at children. The first two, completed in 1998, failed to show that Seroxat was effective treating children, but GSK failed to update the Summary of Product Characteristics document to reflect this. Leaked documents from the period explicitly state GSK's reasons... "it would be commercially unacceptable to include a statement that efficacy had not been demonstrated, as this would undermine the profile of paroxetine".

The report notes that 32,000 prescriptions were issued to children in 1999. Seven further trials were conducted, all again failed to prove efficacy.

In a letter sent by the MHRA CEO, Kent Woods, to the then CEO of GSK, J.P. Garnier, Woods wrote:

"...I would have thought it self-evident that such information [on suicide risks in under-18s caused by Seroxat] should be made available promptly to the regulator in order than action can be taken to protect public health. However, that moral responsibility now needs to be insisted on by the unambiguous force of law."

Garnier, in an impromptu exchange of words with BBC Radio host, James Naughtie, later went on record to say that GSK had been cleared and that they had "done nothing wrong" [See audio recording left hand sidebar of this blog]

Part III saw me name Dr. Robert Gibbons as another witness for GSK in the up and coming UK Seroxat Group Action.

Gibbons pretty much wrote his own destiny when he was the co-author of a study that appeared in the American Journal of Psychiatry in 2007

Gibbons co-authored study claimed there was a correlation between a 22% decrease in SSRI prescriptions and a 14% increase in youth suicide rates between 2003 and 2004, after warnings were issued by the FDA. However, the study was criticised by many.

Gibbons had previously defended the use of SSRi's in an article called "Early Evidence on the Effects of Regulators' Suicidality Warnings on SSRI Prescriptions and Suicide in Children and Adolescents."

Gibbons slammed the Food and Drug Administration [FDA] for daring to apply a warning to the boxes of SSRi's, of which Seroxat was one. He claimed in a Newsweek article entitled "Trouble in a 'Black Box", that:

"I think the FDA has made a very serious mistake. It should lift its black-box warning because all it's doing is killing kids."

In an article by Martha Rosenberg, entitled, 'Suicide Syndrome' questions are raised to the validity of Gibbons findings. Rosenberg writes:

Of course the "SSRI deficiency" argument is as insipid as blaming the obesity epidemic on the unavailability of fen phen. But many joined Gibbons in the round of big pharma "I-Told-You-Sos" including Charles Nemeroff of Emory University School of Medicine who was later disgraced for undisclosed pharma conflict of interests.

Unfortunately Gibbons was wrong. The suicide stats he analyzed did not yet reflect the effect of the black box warnings and he ended up having to tell the New York Times the "early evidence" was actually not evidence at all but "suggestive."

This brings us nicely to Part IV and another witness to be used by GlaxoSmithKline at the High Court later this year.

His name - John Newton.

Newton apparently has expertise in the field of Epidemiology, the study of factors affecting the health and illness of populations.

Whilst Newton's expertise cannot be questioned, his links to GlaxoSmithKline should be.

In 2003, Newton was appointed Chief Executive Officer of UK Biobank, a large long-term biobank study in the UK which is investigating the respective contributions of genetic predisposition and environmental exposure (including nutrition, lifestyle, medications etc. [2]

The idea of a national DNA database linked to electronic medical records was first proposed by Sir George Poste, then at SmithKline Beecham. It was supported and promoted by Sir Richard Sykes of Imperial College, formerly Chairman of GlaxoSmithKline.

Today sees UK Biobank funded by many, including the Wellcome Trust. In fact, initial funding for the project saw the Wellcome Trust donate £20M. Furthermore, scientific management of the project is the responsibility of a private company (Biobank UK) under the directorship of a chief executive who will be responsible to the funding bodies.

"Directorship of a chief executive"

Here is the official 2003 press release regarding the appointment of Newton as chief executive to UK Biobank. The press release was posted on the Wellcome Trust website.

Who are the Wellcome Trust?

The trust was established to administer the fortune of the American-born pharmaceutical magnate Sir Henry Wellcome. Its income was derived from what was originally called Burroughs Wellcome, later renamed in the UK as the Wellcome Foundation Ltd. In 1986, the trust sold 25% of Wellcome plc stock to the public, beginning a process of separating itself from the pharmaceutical industry. In 1995, the trust divested itself of any interest in pharmaceuticals by selling all remaining stock to Glaxo plc, the company's historic British rival, creating GlaxoWellcome plc. The windfall generated by this merger has shaped the trust's subsequent philanthropic activities. In 2000, the Wellcome name disappeared from the drug business when GlaxoWellcome merged with SmithKline Beecham, to form GlaxoSmithKline plc. [3]

Is a possible conflict of interest apparent here?

My findings have been sent to the plaintiff's lawyers in the UK Seroxat Group Action.

All I need now is a job.

All offers will be considered. [Except those that involve working as a shill for pharma]

[1] Dr. Ian Hudson Declaration of Interests

[2] UK Biobank

[3] Who are the Wellcome Trust?



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