Zantac Lawsuit

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

Monday, June 07, 2010

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


Initially, this was going to be a two-parter, however, more research has led me to another witness for GlaxoSmithKline in the UK Seroxat Group Action - more about him in Part III.

Part IV will show you how another of GSK's witnesses, they are using for the up and coming UK Seroxat Group Action, works for a company who are in receipt of huge funds from The Wellcome Trust.

Following on from my previous post where I have tried to highlight instances where both GlaxoSmithKline and the MHRA either failed to spot or chose to ignore warnings about Seroxat withdrawal.

I turn my attention now to the UK Seroxat Litigation.

The defining issues of this group action are thus:

Does Seroxat have a capacity to cause adverse effects consequent upon or following discontinuance (withdrawal) such as prevent or make more difficult the ability of users to discontinue, withdrawal from or remain free from taking Seroxat to a greater extent than all other Selective Serotonin Re-uptake Inhibitors (SSRIs)

As I have said, my previous post highlighted the reasons why I think this litigation will be a failure for GlaxoSmithKline. I'm not a lawyer, nor do I work for lawyers. I can, however, determine what is wrong from right.

Before I move on to name one of the 'expert witnesses' for GlaxoSmithKline in this litigation I will recap on the evidence I have found just by searching the Internet.

In 1993, the Committee on Safety of Medicines ("CSM"), the UK's counterpart to the FDA, reported 78 cases of withdrawal after discontinuation of paroxetine, reporting that "such reactions have been reported more often with paroxetine than with other SSRI's." ("Current Problems in Pharmacovigilance" (1993; 19:1).

GSK, then SKB, and the MHRA, then the MCA, did not react to this warning.

In 1997, Dr. Haddad reported that the highest incidence of discontinuation reactions among the SSRI's was paroxetine. (J Clin Psychiatry 1997; 58 Supp l7:17-1; discussion 220.)

In 1997, Young and Currie of Newcastle reported on their survey indicating that a sizeable minority of physicians were aware of the existence of antidepressant withdrawal reactions. This included psychiatrists, 28% of whom expressed no awareness that antidepressant medications could induce discontinuation reactions. The conclusion of the authors was that "education about discontinuation reactions is needed for both psychiatrists and family practice physicians." (J Clin Psychiatry 1997;58 Suppl &:28-30.)

This particular paper is of interest to me as it was co authored by Allan Young. At the time of the publication [1998] Young was Senior lecturer in psychiatry at Hadrian Clinic, Newcastle General Hospital, Newcastle upon Tyne. The conclusion of Young, along with the other two authors of the publication, Peter Haddad and Michel Lejoyeux, is evident for all to see - "education about discontinuation reactions is needed for both psychiatrists and family practice physicians."

It is interesting because Allan Young will be one of the expert witnesses on behalf of the defendants, GSK, in the UK Seroxat Group Action. It seems rather odd, to me at least, that GSK would want a witness who has in the past wrote about antidepressant withdrawal reactions.

This is just one of the witnesses for GSK. Another is Dr. Rashmi Shah.

Dr. Rashmi Shah is the owner of Rashmi Shah Consultancy Ltd, located in Slough, Berkshire, UK.

Shah's previous employment history will shock quite a few people who read this article.

Shah was employed by the MHRA between 1987 and 2004. Positions held were:

Senior Medical Officer, Senior Clinical Assessor and Senior Medical Assessor.

An employee of the MHRA for 17 years.

Now a witness for the defence [GSK] in the UK Seroxat Group Action.

Shah retired from the MHRA in 2004.

A summary of the Committee on Safety of Medicines meeting, held on the 25th of November, 2004, attests to this:

1. Apologies and Announcements

1.4 The Chairman informed the Committee that Rashmi Shah's was retiring and that this was his last meeting and on behalf of the Committee thanked Rashmi for his outstanding contributions to the work of the Committee over a 17 year period and wished him well in his retirement.

I, along with many others, have always been weary of the relationship the regulators have with the pharmaceutical industry so this revelation should come as no surprise.

It would appear that the MHRA's long standing relationship with GlaxoSmithKline will continue through the High Court in London.

For those of you that don't know, the MHRA spent four years investigating GlaxoSmithKline.

The investigation focused on whether GSK had 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 punishment for Glaxo? A "Whose been a naughty boy?" type of letter sent to the then CEO of GSK, JP Garnier. Garnier 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]

It's also worthy to point out that the Chairman of the MHRA, Alasdair Breckenridge, is a former employee of GSK, then SmithKline Beecham [SKB] - As is the Head of Licensing at the MHRA, Dr. Ian Hudson.

Breckenridge has appeared on national TV defending Seroxat, he has also made his feelings known about Seroxat in various publications, one such being the New Statesman in 2005. Here's what the Chairman of the MHRA [and ex- SmithKline Beecham employee] had to say about Seroxat:

“If you go back – and I read this out to the Health Select Committee to the data sheet on Seroxat when it was licensed in 1991, we spelt out word for word the problems of withdrawal from Seroxat, in words that we could not improve now. This idea that the regulators have been hiding the data is just not true. The so-called scandal of Seroxat is something I want to nail every time I speak in front of compatriots because it is absolute rubbish”.

What Breckenridge 'read out' to the Health Select Committee is even more confusing:

“…What the expert working group did was to look at three issues about antidepressants: firstly, the question of withdrawal; secondly, the question of suicidal ideation; and, thirdly, the question of dose. The problem of withdrawal has been well known with antidepressants, especially Seroxat, and I happen to have before me the information sheet, the data sheet which we published, which the MCA published in 1990 when Seroxat was first licensed. If I can just read it to you, it says, ‘As with many psychoactive medicines, it may be advisable to discontinue therapy gradually as abrupt discontinuation may lead to symptoms, such as dizziness, sensory disturbances, sleep disturbances, agitation or anxiety, nausea, sweating and confusion’. That was in 1990″.

There was no mention of this on any patient information leaflet that accompanied Seroxat in 1990. There was no advice to 'discontinue therapy gradually' either.

Breckenridge further embarrassed himself and the MHRA with his performance on BBC TV's Panorama [Taken on Trust BBC TV 2004] where he was reduced to a stuttering wreck by journalist, Shelley Jofre. [A condensed version of his performance can be seen HERE -

I don't know why Breckenridge remains at the MHRA, it's hard to decipher what he actually does. I can only assume that he won't ever be allowed to appear in front of a TV camera anymore defending Seroxat, not after his display of arrogance back in 2004.

The MHRA's Head of Licensing, Dr. Ian Hudson, is also a former employee of SmithKline Beecham [now GSK]. Hudson is no stranger to litigation, particularly where GlaxoSmithKline are concerned.

In the Tobin vs SmithKline Beecham trial in 2005, Hudson gave the following deposition

Hudson had previously worked for GlaxoSmithKline for 11 years where he held the position of Worldwide Director of Safety.

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.

Sarah Boseley, then health editor for The Guardian newspaper wrote in 2000, "Alarm as drug company chief joins watchdog."

A top executive at one of the world's leading pharmaceutical companies is to become director of drugs licensing at the medicines control agency, raising questions about the independence of the MCA from the industry that it is supposed to police.

Ian Hudson will take up his new job in February. He has worked in the drugs industry for the past 11 years and until recently was director and vice- president of Worldwide Clinical Safety, at SmithKline Beecham, and was to have led the worldwide drug safety group after the merger of SKB with Glaxo Wellcome, which came into effect yesterday.

Boseley also wrote in 2002, "Antidepressant Seroxat tops table of drug withdrawal symptoms."

Seroxat, the British-made antidepressant which outsells Prozac, causes more people distressing withdrawal problems when they try to stop taking it than any other drug in the UK.

Seroxat - known generically as paroxetine - leads the top 20 table of drugs causing withdrawal problems, with 1,281 complaints from doctors under the "yellow card" scheme set up for the reporting of medicines' side-effects. More reports have been filed about Seroxat than about the rest of the top 20 put together. In the top six, five of the drugs said to be causing withdrawal problems are SSRIs - second after Seroxat comes Efexor (venlafaxine), with 272 complaints.

So, now, 6 years on from Alasdair Breckenridge's embarrassing performance on BBC TV where he defended GlaxoSmithKline's Seroxat and 5 years on from Head of Licensing for the MHRA, Dr. Ian Hudson, offering his services as a witness for GSK, we have yet another MHRA connection in Rashmi Shah.

This shower of regulatory authoritarians [MHRA] have sat with Seroxat advocates, myself included. They have nodded and empathised upon hearing personal stories of withdrawal. All the time, it appears, they knew there was a withdrawal problem with Seroxat but instead of tackling it head on, they decided, like GlaxoSmithKline, to ignore the warning signs from as early as 1993 [Current Problems in Pharmacovigilance] (1993; 19:1).

It's staggering that they have the audacity to collect their wages each month from their bank accounts.

It's astounding that they failed to prosecute GlaxoSmithKline after a four year investigation.

It's appalling that they have not one but two ex-GSK employees working for them, one a Chairman who doesn't really seem to do much, the other the Head of Licensing, one who grants licenses to the drugs you and I take.

It's sickening that an ex MHRA employee, in Rashmi Shah, is now defending Seroxat by being a witness for GlaxoSmithKline in the UK Seroxat Group Action.

I cut off all communications with the MHRA last year after they failed to answer a simple question I put to them, Is Seroxat a teratogen?

It would appear that the MHRA have merely been offering token gestures to Seroxat advocates, all the time keeping a close eye on what their paymasters [GSK] might think of them discussing Seroxat with patients.

I'm not the first to pick up on the MHRA's close ties with GlaxoSmithKline. In 2004, the Daily Mail, a UK tabloid, ran with the headline, "Agency blamed for promoting Seroxat."

The mental health charity, Mind, said the MHRA were playing Russian Roulette with people's lives over the common antidepressant drug Seroxat.

Mind chief executive Richard Brook said the MHRA had not listened to the experiences of people who had taken Seroxat.

"Many of these people have suffered terrible side effects when taking or trying to come off the drug and some people, it is believed, have died," he said.

There is a terrible stench throughout the MHRA Headquarters, it reeks of back slapping and complete and utter disdain for the patient, particularly those who have ever had to experience the horrific side-effects of Seroxat.

The MHRA are not just in bed with GlaxoSmithKline - they are copulating with them.

I am not totally sure but it's my belief that the expert witness owes a duty to the court to give independent and unbiased evidence, and must avoid assuming the role of advocate for his client.

Rashmi Shah worked for the MCA/MHRA for 17 years. Shah was an employee of the MCA/MHRA when they first granted a licence for GlaxoSmithKline's Seroxat. He was also employed by them during the time when they received many adverse reaction reports about Seroxat.

I, for one, shall be looking forward to Rashmi Shah's unbiased evidence when, or if, this group action lands in the High Court later this year.

Coming up in Part III - How another of GSK's witnesses once called for the FDA to lift its black box warning on antidepressants.

Other stories of interest:

Antidepressant Seroxat tops table of drug withdrawal symptoms

Glaxo 'played down Seroxat side effects'

Agency blamed for promoting Seroxat

Antidepressant addiction warning

Alarm as drug company chief joins watchdog


Drug firm issues addiction warning

Keep Seroxat dose low, doctors told

Why I resigned over 'happy pill' cover-up




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