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.

Glaxo Blew It!

"You had your chance and you blew it." ~ Robert De Niro

I don't suppose for one minute that the likes of Andrew Witty (GlaxoSmithKline) would ever take advice from a 51 year-old blogger from Birmingham - to be honest I don't care if he takes it - I'm offering this for free, it's not just for Witty, it's for other pharmaceutical company CEO's who, for whatever reason, think that problems raised can easily be swept under the carpet.

I've been writing this blog for almost ten years now, the research that goes into many of the blog posts I write can be, at times, very time consuming, none more so when it comes to GlaxoSmithKline who, for one reason or another, always seem to be grabbing the headlines in the international press. If they aren't paying out settlements for fraud, they are being accused of fraud - it's a never-ending trail of cancerous cells that just can't be obliterated.

The latest in Glaxo's long history of popping in and out of court rooms is the alleged claim that Seroxat causes severe withdrawal problems - surely not?

One only has to enter the search terms 'Seroxat + withdrawal+addiction' into Google to find out how Glaxo, who monitor what is said about their products, actually do nothing when faced with a barrage of criticism from patients (nae consumers) - ie; they don't address a problem when it arises, they ignore it because they know to engage with patients can be detrimental to the business, ergo can damage sales.

That's where they are going wrong.

Glaxo have had ten years to sort out the problem British patients have been facing with their (once) best-selling antidepressant Seroxat - truth is, they have done nothing about the reported adverse reactions or rather they, just like the British drug regulator, the MHRA, shrugged their shoulders at them. What's a couple of hundred people suffering on a product compared to those who say nothing, anyway?

There's the old 'ignore them and they will go away' factor that comes into play here too. The MHRA and GlaxoSmithKline take this approach, again, this is where they go wrong.

Do you think I would have dedicated almost ten years of my life to researching and writing about pharmaceutical companies and medicine regulators if they had opened their doors to me and shown me how I was wrong and they were right? Of course to do so would mean they would have to summon the evidence that I was wrong - they haven't and they can't.

This isn't me being obstinate or, as the MHRA like to call me, vexatious. This is plain and simple - they refuse to engage with me and people like me because we are question-askers, we ask the right questions and we are not guided by lawyers or editors who tell us that we can't ask this or that.

It's about transparency and I've yet to see any transparency from GlaxoSmithKline or from any other pharmaceutical company come to that.

Now, all that is about to change. News early last month that the UK Seroxat litigation can proceed to trial must have come as a blow to GlaxoSmithKline because those very same questions that they have been avoiding will be asked in an open court, complete with a public gallery. Glaxo, via their lawyers, had previously asked the Judge to halt the trial, citing various reasons. The Honorable Mr Justice Foskett denied them this (Full 31 page ruling here)

Documents will be, for the first time, aired to the British public. All and sundry (including health care professionals) will be able to read about the severity of Seroxat withdrawal. Those same people will learn that, for years, Glaxo denied this even though they knew about it. (See Seroxat - Project 1059 Laden With Withdrawal Problems)

It's vindication for those who have suffered severe withdrawal effects of Seroxat, worse still for those that still are. How many of these people have had to try and tell their husbands or wives that they just don't know why they are suffering these crazy symptoms? How many of those that have suffered have endured the opinions of their health care professionals telling them, "It's the illness and not the drug"? How many have had to explain to their children why they are suffering electric zap sensations and that their brains feel like they are frying? Perhaps those who have suffered have had to explain to their kids why 'mommy and daddy' can no longer live together or why they can't have the Christmas presents they asked for because the crazy withdrawal from the medicine keeps them in bed or doubled up in the fetal position for hours on end, "That's the reason why I lost my job, son." Maybe they've had to apologise to their children for losing their temper on them (aggression being yet another side-effect of withdrawing from Seroxat) - If only Glaxo would have been truthful, huh?

GlaxoSmithKline, as I said, have had almost ten years to hold up their hands and admit that they got it wrong - they chose not too because they thought the problem would go away. Back in 2011 Witty was approached and asked if he would meet the Seroxat Users Group to discuss the very same thing they now find themselves defending in court - the Seroxat withdrawal issue - he declined (See GSK's Andrew Witty in Patient Aftercare Snub)

Truth is, bloggers tend to get the bit between their teeth because they sense a great injustice has been done - then, as they plod along, year after year, they find that this is not just an individual problem, there are more people out there suffering, not just the horrific withdrawals either - suicide, self-harming, birth defects are just three of the many reported adverse events associated with Seroxat.

In the early 2000's Glaxo settled out of court with over 3,500 American consumers who claimed Seroxat had caused serious withdrawal problems. They did so with confidentiality agreements, also known as "gagging orders". Pharmaceutical companies do this to suppress the truth, it's also what litigation is all about - it keeps those documents (previously unseen) away from the public, press and healthcare professionals.

It very much looks like those documents may just see the light of day in the UK as 105 consumers of Seroxat head to court later this year. I, for one, can't wait to finally see that I have been correct all along and that Glaxo have not only being keeping the secrets of Seroxat away from me but from others too, including my doctor and your doctor.

I'm echoing here what a fellow blogger has wrote over at Seroxat Secrets. He pretty much hits the nail on the head with, "...And all those once-secret documents and the information they hold will be available the world over for future claimants to use. I think a whole new raft of claims will be kick-started in the USA alone. I wonder what GSK’s share price will look like after all this? And how institutional investors will view a company that breaks the law and lies & cheats its way to profit?"

Of course it could go either way, not, as I suspect, on evidence provided though. Glaxo's representative lawyers, Addleshaw Goddard LLP, will have already tactically planned how they wish to defend these allegations be it by dragging out the case for as long as they can in the hope that the claimants will have their funding dry up. Sadly, for Addleshaw Goddard that is, this isn't an option. Funding is in place and, according to The Honorable Mr Justice Foskett, assurances have been given that the claimants have more funding should the need arise. A tactic of big corporations is to drag out cases for as long as possible, it's a great tactic because it means eventually the small man will have to back down. All the time the fat-cat lawyers are getting paid by those they represent, a win-win situation. It appears the latest judgment by The Honorable Mr Justice Foskett will not allow this to happen. Round One, it appears, to the claimants.

Then, of course, Addleshaw would have been going through precedents to see if they can get the case thrown out because a ruling made by Judge X in the year XXXX. That's their job, to defend the indefensible...by any means.

Glaxo defence lawyers may or may not throw a curve-ball, they may plead with the Judge that the documents presented in court are sensitive therefore should not be made public - it appears as though it's a gamble they are prepared to take which means correspondence between themselves and the MHRA will be "outed" as they say. If they are going to go down then why not drag the limp-wristed medicines regulator with them, huh?

It's been almost 10 years in the making.

Eat your heart out John Grisham.

Bring it on.

Claimants are represented by Jacqueline A. Perry QC, Niazi Fetto and Timothy Killen (instructed by Fortitude Law)


Defendants are represented by Malcolm Sheehan QC and Andrew Kinnier (instructed by Addleshaw Goddard LLP)


Bob Fiddaman.

Seroxat Withdrawal Litigation

Judgment has been received from the Honourable Mr. Justice Foskett to proceed with the Seroxat Withdrawal Group Litigation. Any of the group Claimants who have not received forms from Fortitude Law in the past 2 weeks should contact Fortitude Law via email at sjrichards@fortitudelaw.uk or telephone on 0203 667 3775 without delay.

Bob Fiddaman.

Exclusive: UK Seroxat Litigation to Press Ahead

FOR IMMEDIATE RELEASE

Judgement was given on Feb 4, 2016 with regard to the on-going Seroxat (paroxetine) litigation in the UK. (1)

Defendants, GlaxoSmithKline, sought an order that would have had the effect of bringing these proceedings to a permanent halt.

In arriving at his conclusion to not grant GlaxoSmithKline their order, Mr. Justice Foskett said...

"The Defendant is anxious (it might be said, over-anxious) to stop this litigation in its tracks. The motivation may simply be a total conviction that there is, in effect, no case to answer and that it is wrong to be harassed with unmeritorious claims. Alternatively, it may derive simply from a desire not to have to face in this jurisdiction the kind of claims brought in the USA and elsewhere. It may, of course, be a combination of both."

Mr. Justice Foskett had previously asked both parties to supply him with a summary of other litigation throughout the world concerning Paroxetine. In his Judgement Mr. Justice Foskett said...

"Although the list of actions provided to me on behalf of the Claimants is longer than that provided by the Defendant, a cursory comparison suggests that they largely cover the same material. 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."

It's good to see this on-going litigation finally get the thumbs-up to move forward to trial, and in my view the Honorable Mr Justice Foskett has to be applauded here for meticulously combing through arguments from both parties.

Mr Justice Foskett's Judgment seems to have paved the way for both parties to, at the very least, now plan where they are going with this.


The case between: SANDRA BAILEY AND OTHERS (Claimants) and  GLAXOSMITHKLINE (UK) LIMITED (Defendant) will now proceed to trial.

Claimants are represented by Jacqueline A. Perry QC, Niazi Fetto and Timothy Killen (instructed by Fortitude Law)

Defendants are represented by Malcolm Sheehan QC and Andrew Kinnier (instructed by Addleshaw Goddard LLP)


Bob Fiddaman.



Declaration of Interests: I am one of the claimants.

(1) Bailey & Ors v Glaxosmithkline (UK) Ltd [2016] EWHC 178 (QB) (04 February 2016) 

Fortitude Law Take on Seroxat Cases in UK

The Seroxat group action has been running for almost 10 years now. GSK have, for whatever reason, refused to make any kind of settlement to the 107 claimants who have alleged that they suffered severe withdrawal at the hands of Seroxat and, more importantly, were not warned about this dependency problem.

In 2010 the group action came to a grinding halt. A legal battle, behind the scenes, was unfolding and claimants, of which I am one, had their public funding withdrawn. This is quite common in UK action against pharmaceutical companies.

Sufficed to say, the group action was put on hold (stayed) whilst the legal wrangles were ironed out.

Good news is, we now have new representation.

Fortitude Law, a law firm based in London, are now representing the UK claimants and are set to return to the High Court to confront GlaxoSmithKline and show them evidence that Seroxat caused these withdrawal reactions to the claimants. I assume it will be the same evidence that US courts were shown back in 2002 when 3,000 or so claimants alleged that Seroxat caused them dependency. Glaxo resolved that case yet refuse to do the same in the UK.

The Fortitude Law website has now gone live and they have a contact form on there for people wishing to ask questions about the current group action.

Fortitude Law can be found here.



Bob Fiddaman.