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Tuesday, June 21, 2016

Revisiting Seroxat Withdrawal






One has to ask why manufacturers of products choose to ignore negative news and fail to warn the public about possible side effects of a product they manufacture.

I've been writing and researching GlaxoSmithKline for over ten years now, some would suggest that I have a bias when writing about them, in as much that I only ever write about their dirty deeds and not the 'good' side of Glaxo.

Thing is, I don't really see anything positive coming out of GlaxoSmithKline, even when it does one will find there's usually something underhand hidden in the good news that they preach. They team up with children's charities and that, to an outsider, makes them look really caring - the same outsider will quickly forget about the potential millions of children Glaxo put at risk when promoting Seroxat off-label to this vulnerable population. Yeh, we have to forgive at times, maybe just move on and forget but it's hard to do where Glaxo are concerned.

My time on Seroxat and subsequent withdrawal from it is well documented both on this blog and in my book (The evidence, however, is clear, the Seroxat scandal) I'm one of many thousands that struggled to wean off Seroxat - many of those thousands have been compensated by GlaxoSmithKline, in fact over 3,000 consumers in America were paid by Glaxo in an out-of-court settlement - in other words, they were paid and had to sign confidentiality agreements whereby they couldn't tell anyone exactly how much Glaxo paid them. Glaxo also admitted no liability, which basically means they can say that Seroxat did not cause addiction in those 3,000+ consumers - they can stick to the line that it takes roughly two weeks to safely withdraw from Seroxat. Glaxo can and will always claim that "We believe the product is not defective and that there is therefore no merit in this litigation." - I am refering to the on-going UK litigation here.

Below is a document I found online, I've posted it before on here and even tweeted it to GSK and their lawyers. The document is a series of emails regarding a clinical trial, better known as "Project 1059."

Project 1059 saw James Ballenger, MD carrying out a long-term panic disorder study in 2000, Seroxat was the choice of drug. The study was cancelled by GlaxoSmithKline (then SmithKline Beecham) after they learned that Ballenger's findings had found something that they wanted to keep quiet.

As with most clinical trials, the finding are written up by ghostwriters. The series of emails below shows how they (the ghostwriters) couldn't turn bad news in to good news. This is quite rare, particularly with Seroxat, as some years previous Glaxo had managed to turn bad news in to good regarding Study 329  - In a nutshell, that study showed Seroxat was no more effective than placebo in kids and, more importantly caused a significantly high amount of kids to have suicidal thinking.

Anyway, back to Project 1059. James Ballenger, MD had found that many people in his study were suffering when trying to stop Seroxat. This was bad news for Glaxo, so bad that they actually pulled the study. The emails below are from Daniel Burnham of SmithKline Beecham to ghostwriter Sally K. Laden who, ironically, was also at the forefront of turning the bad news of Study 329 in to good news.

 Daniel Burnham of SmithKline Beecham writes...

"The issue of discontinuation sx [side effects] vs. relapse is obviously a concern of the J Clinical Psychiatry reviewers... Thus we have decided to terminate further work on this manuscript."

The industry prefer to call withdrawal issues "discontinuation problems".

What is striking about this correspondence is Laden's response to Burnham...

“We understand your reasons for cancelling this project. There are some data that no amount of spin will fix, and these certainly fall into this category.”

So, after learning that a number of people in Project 1059 were having trouble withdrawing from Seroxat, Glaxo, knowing that this could affect potential sales, decided to pull the plug on the study, in other words they would bury the data and thus keep Seroxat in the public eye as the best antidepressant on the market that had only 'minimal' side effects.

It's important that these emails are spread far and wide - they have been publicly available for a few years now and will more than likely be used as evidence in the UK Seroxat litigation. I mean, what Judge could say that the emails below don't really prove that Glaxo knew about the withdrawal problems with Seroxat?

Here's the internal emails.





Judgement was given on Feb 4, 2016 with regard to the on-going Seroxat (paroxetine) litigation in the UK. Glaxo, as you would imagine, wanted the Judge to throw out the claims that Seroxat caused withdrawal effects in UK consumers.

In his judgment (1), Mr. Justice Foskett said...

"Overall, it would seem that in the USA between 2000 and 2005 over 3500 claimants alleged that they suffered discontinuation symptoms when they attempted to reduce or discontinue the use of Paroxetine and in 2005 a confidential settlement agreement with a total of 3,294 eligible claimants (whose claims would otherwise have gone to a jury trial) was reached with no admission of liability. From 2003 a cohort of claimants filed a "putative class action" consisting of all California residents who paid for prescriptions of Paroxetine in California in which it was alleged that they sustained economic damage and were entitled to reimbursement or other relief due to alleged "discontinuation symptoms." In January 2012 a class-wide settlement with no admission of liability was achieved. Again, the claims would have gone to a jury trial in the absence of settlement."



I'm almost certain GlaxoSmithKline will try to defend Seroxat and make claims that they have evidence that Seroxat does not cause severe withdrawal problems - I'm really looking forward to seeing that evidence because after 10 years of writing and researching GlaxoSmithKline I have not once been able to find any such evidence, in fact the only evidence I've found publicly is internal emails produced in US litigation regarding Seroxat and birth defects, suicide and withdrawal problems. If Glaxo can produce evidence that shows there really is no problem when discontinuing Seroxat then I will, as a show of good will, stop blogging and move on to something else.

Your move, Glaxo!

Bob Fiddaman.