Zantac Lawsuit

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

Thursday, November 14, 2013

Witty's Era Still Smells of 329 Rotten Eggs

We all remember Glaxo's CEO, Andrew Witty, 'tail between the legs' excuse when the Department of Justice handed down a $3 billion fine for his company's fraudulent activities don't we?

"It's all part of an era", or words to that effect, was the excuse Witty used. It was an excuse that distanced him from the problems of his company, although Whistleblowers in the $3 billion suit claim he knew exactly what was going on and that he even participated in the off-label promotion of Zyban when he was, at the time, VP in marketing circa 1997-2000.

Witty's 'era' excuse has never really held water with me. Here we have a boss who apparently oversees the running of his company. When his company is caught out for acting fraudulently he blames the past. More recently Glaxo have been in the news again, this time senior managers in China have [allegedly] been bribing doctor's with money and prostitutes in efforts to get them to prescribe more of GSK's drugs. Witty, being Witty, denies any knowledge of it. Turns out, if reports are correct, that GSK are not going to be charged for these crimes in China, instead Chinese authorities are going after the individuals who acted fraudulently.

Not on my watch guv.

I'm reminded of a rib-tickling scene from the movie Dumb and Dumber here.

Witty, in this scene, is played by Jim Carey.

What is it about Andrew Witty that makes him blame other people?

What does Andrew Witty fear by speaking with members of the public who have questions about his company's products?

Before I move on to the latest news about the Paxil 329 study... or rather the retraction of it, it's important to note that Glaxo's Andrew Witty has refused to meet with patient advocate Janice Simmons.

Simmons, who runs the Seroxat User Group, contacted Witty back in 2011. The Seroxat User Group had amassed over 60,000 emails from Seroxat patients, most of them were/are struggling to get off Seroxat. Janice cannot tell them how to combat the side effects such as; electric zaps, suicidal thoughts, intolerance to sudden loud noises, bouts of crying, headaches and visionary disturbances etc.

So, Janice decided to request a meeting with GlaxoSmithKline's CEO, Andrew Witty. To her surprise, GSK’s UK medical director Dr Pim Kon wrote back asking what she wished to discuss...adding that they cannot give advice to patients, they need to seek that from their healthcare professionals. [Yawn]

Janice informed Dr Kon that she wished to discuss the issue of Seroxat withdrawal. Kon wrote back telling Janice that they was not allowed to discuss personal matters with patients and that they should 'talk to their doctor'. [Another yawn]

You'll note that Witty chose not to reply to Janice Simmons, instead he, it appears, got Dr Kon to reply.

Seroxat is the UK brand name for paroxetine which is known as Paxil in the US and Canada.

Witty Sends In The Clowns

A few days ago a feature appeared in the British Medical Journal [BMJ] entitled 'Putting GlaxoSmithKline to the test over paroxetine'. [1] The feature contained  a fascinating exchange of letters between Jon Jureidini and GlaxoSmithKline between April 26 and November 8, 2013, in which Jureidini requests data from paroxetine study 329.

Please take note at who Jureidini addresses his correspondence to. Also take note that Jureidini never once gets a reply from the person he originally contacted.

Jim Carey at play again?

For those that don't know 'Paxil 329' was a study of Paroxetine vs Imipramine vs Placebo in Adolescents with Unipolar Major Depression.

The results of the study appeared in the Journal of the American Academy of Child and Adolescent Psychiatry and listed Marty Keller as the primary author. However, the study was not written by Keller at all, it was written by Sally Laden, a ghostwriter hired by GSK.

The results of the study were favourable. However, the paper was misleading in as much that it exaggerated benefit and downplayed adverse effects, including suicidal thoughts. In 2004 the Canadian Medical Association published an Editorial which showed that in 1998 an internal GSK document clearly acknowledged that GSK were aware that 329 was negative and they knew that paroxetine had no beneficial effect in treating adolescents [2]

The GSK internal document was prepared by the Central Medical Affairs team (CMAt), a division of GSK who back then were known as SmithKline Beecham.

This from the Canadian Medical Association:

The document provides guidance on how to manage the results of 2 clinical trials conducted into the efficacy of paroxetine (Seroxat). Given that the clinical trials results were, according to the document, “insufficiently robust” to support an application to regulatory authorities for a label change approving Seroxat for use in pediatric depression, CMAt recommended the firm “effectively manage the dissemination of these data in order to minimize any potential negative commercial impact.”
The CMAt document advised that “Positive data from Study 329 will be published in abstract form at the [European College of Neuropsychopharmacology] meeting” in November 1998 and that “a full manuscript ... will be progressed.” It also stated that “It would be commercially unacceptable to include a statement that efficacy had not been demonstrated, as this would undermine the profile of paroxetine.”

Eventually GSK had to acknowledge the failure of all three of their child and adolescent paroxetine depression studies [3] but the original results [the lies] still appear in the Journal of the American Academy of Child and Adolescent Psychiatry.

Jureidini and many others have, on numerous occasions, called for the journal article to be retracted. The editor of the journal won't retract it so maybe Witty could be instrumental in its retraction?

Here's the letters:

The final exchange sees Glaxo wishing to communicate by telephone [tactics like this get rid of paper trails]

So, despite addressing Andrew Witty, Jureidini is given the runaround by GSK's Kraus and Shannon. Where was Witty in all of this, why is he, seemingly, afraid to debate with Jureidini?

Maybe Witty is still stuck in his own era and believes that the Paxil 329 study is the responsibility of his predecessor JP Garnier. Nonetheless, it's a dog shit on Witty's doorstep yet it is one that he refuses to acknowledge or is in denial about.

We all know what happens when you tread in dog shit, right?

I sincerely hope Sir Andrew knows a reputable carpet cleaner.

Bob Fiddaman

[1] BMJ 2013; 347 (Published 12 November 2013)
[2] CMAJ March 2, 2004 vol. 170 no. 5

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