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.

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) 

Consumers Vs Pharmaceutical Companies - The UK System

It's kind of set in stone these days that Seroxat, the antidepressant manufactured and marketed by British pharmaceutical giant, GlaxoSmithKline, is a faulty product. It's been through the American court system in various types of litigation.

1. Suicide - GUILTY - APPEALED - SETTLED - Compensation paid
2. Birth Defects - GUILTY - APPEALED - SETTLED - Compensation paid
3. Withdrawal problems - RESOLVED - Victims compensated

To date, GlaxoSmithKline have not settled any cases that relate to Seroxat use and suicide, birth defects and withdrawal problems in the UK.

They are a British company yet, it appears, will only settle with American consumers of Seroxat (Known as Paxil in the US)

To go up against a pharmaceutical company in the UK is notoriously difficult. Many law firms prefer not to touch cases against pharmaceutical companies because they can drag on for many years, the risk is too high, they can either 'make' or 'break' the claimant's legal representation.

The UK Seroxat litigation is fast approaching 10 years since it was first filed. Glaxo, represented by Addleshaw Goddard, have not, at any point, expressed an interest in resolving the litigation. They, it appears, wish for the cases, involving just over one hundred claims, to go to trial... at least they do at this point in the proceedings.

The litigation has been laboriously slow - claimants have been dropped by law firms, despite those law firms attesting that their cases against GSK were strong. Public funding has been given, then put on hold, then taken away.

In America, the Seroxat withdrawal problems lawsuit involved over 3,000 claims against GSK. The whole process of filing and agreeing to resolve took as little as two years. Each of the 3,000 were awarded compensation. Each of the 3,000 had to sign confidentiality agreements - ergo, they could not tell anyone how much they were awarded by GSK.

Meantime, UK consumers who suffered Seroxat withdrawal problems, some who still do, continue to wait for their cases to be heard in trial. The date of which has yet to be determined.

Almost 10 years.

It's a showing of the iron fist by GlaxoSmithKline and it sends out a strong message to consumers of pharmaceutical products. That message being, "We won't bend over for British consumers, even though we are a British company."

Glaxo are denying that they knew there was a withdrawal problem with Seroxat, this despite settling the 3,000 or so case in America. This, despite public documents that have shown that hey did indeed know about the withdrawal problem in adults but 'hushed up' these findings.

Project 1059 revealed a series of emails between  Daniel Burnham of SmithKline Beecham and a ghostwriting company. In those emails, below, the Seroxat withdrawal issue was raised. Burnham became concerned and decided to pull the plug on Project 1059. There was no way that they could have this Seroxat withdrawal issue made public.

You can view the series of emails here.

Meantime, Glaxo CEO, Andrew Witty, continues to cover his company in garlands, he continues to refuse to meet with anyone who has suffered as a result if ingesting Seroxat. Irish blogger, the Truthman, who, like me, has been writing about GSK for almost a decade, perfectly dissects a recent interview between journalist Evan Davis and Glaxo's Witty here.

It's well worth the read, an edited version of the interview between Evans and Witty is also shared on the Truthman's post.

Glaxo, in my opinion, are psychopathic, it's hard to pinpoint who is the person behind the dodgy marketing and hiding of negative results, so, as a whole, Glaxo, to me at least are not only psychopathic but delusional too.

As for Witty, once again my opinion of him, is that he lacks compassion and empathy for those harmed by his company. He continues to harp on about how Glaxo (these days) are more transparent than any other pharmaceutical company. He fails to mention that they were forced to be more transparent by the recent $3 billion they paid the American Department of Justice for, amongst other things, a lack of transparency in sharing negative trial results.

Who knows if the UK litigation will ever see the light of day. I would love nothing more than a judge who sees through Glaxo's arguments and allows documents produced at trial to be made public and not sealed away.

The criticism of GlaxoSmithKline is warranted. As long as they continue to treat their consumers like lab rats then they will always fall under the spotlight.

We, as humans, have a desire to see more when something teasing is revealed, be that a woman in a sexy low-cut dress or a pharmaceutical company not disposing of emails that highlight how they ignored links of severe Seroxat withdrawal.

Glaxo are not sexy, in fact, the more that they reveal, the more sickened I become.

I'll eventually walk away from this blog, a change of direction and finding peace is, I feel, what I've earned over these past ten years or so. Until I feel that time is right I'll continue to cross swords with GSK - I guess that the Truthman will too.

Perfer et obdura; dolor hic tibi proderit olim. (Google it)


Bob Fiddaman.

Seroxat - Project 1059 Laden With Withdrawal Problems

GlaxoSmithKline are defending allegations that it's antidepressant, Seroxat, known as Paxil in the US, causes severe withdrawal reactions when patients have tried to taper of of it. They have settled similar allegations in the US with over 3,000 claimants, all of whom went on to sign confidentiality agreements - the official line of that particular case was that it was "resolved."

Later this year sees GlaxoSmithKline defend the same allegations, this time in the UK. The case has been running for 8 years plus and at no time have GlaxoSmithKline, via their representative lawyers, Addleshaw Goddard, made any offer of settlement to the 105 plaintiffs in the case.

So, there's a kind of stale-mate. 105 claimants allege they suffered severe withdrawal reactions when trying to wean themselves from Seroxat - Glaxo have maintained that "We believe the product is not defective and that there is therefore no merit in this litigation."

No merit?

Let's go back in time, to the year 2000.

James Ballenger, MD, was chair of the Medical University of South Carolina’s Department of Psychiatry, and he had been 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 - Severe withdrawal effects in adults that take them!


"There are some data that no amount of spin will fix."

As with most clinical studies, Glaxo had, just like they did in Study 329, hired a ghostwriter to draft the positive results from Ballenger's study.

Once again, just as in Glaxo's infamous 329 study, Sally K. Laden was handed the job of turning bad into good. Sadly, for Glaxo at least, even Laden couldn't spin the results of Ballenger's study, (known as "project 1059")

Internal emails between Laden and Daniel Burnham of SmithKline Beecham show Burnham write the following...

"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.”

This, to me at least, suggests that Laden was familiar with spinning poor results into bad.

Laden then told her bosses at Scientific Therapeutics Information, Inc. (STI)...

“Yes, Virginia, there is a God. SB cancelled our project 1059 (long term panic disorder study). Reason: the side effect data was terribly unfavorable to our favorite antidepressant. And we hate when that happens!”

Definition of 'terribly' -  very, extremely, hugely, intensely, immensely, dreadfully, incredibly, extraordinarily, seriously.


In a 2012 interview with investigative journalist Dyan Neary, Ballenger said...

“What that study in retrospect probably showed for the first time was that there’s withdrawal from the medicine…your body might miss it.”

Hmm, dependency anyone?

Question we really should be asking here is why didn't GlaxoSmithKline, when they knew of the severe withdrawal problems, carry out their own study into these problems raised in Ballenger's study? Why did they sit on this information? Myself, and others, would then not have had to endure the horrific withdrawal problems - had myself, and others, had previously know about these "terrible" side effects, we would never had taken Seroxat.

The prosecution rests, m'lud.

Here's the emails. (Click to enlarge)

Something for Glaxo's UK lawyers, Addleshaw Goddard, to mull over, perhaps.

Bob Fiddaman.

Competing interests

I am one of the 105 claimants in the UK group action.

UK Seroxat Litigation Update - June 2015

Many of the Seroxat Claimants have received notice this week that unless the Group Action secures funding soon the case against GlaxoSmithKline will be struck out of Court. For those of you who have received the Court Order through the post, don't panic, there is no need to do anything.

Solicitors, funders and insurers are putting together a funding package with no risk of exposure to costs to you and will be filing this in Court.

There really is nothing more to add publicly but if you want further information please contact me here. (No media)

Let battle commence.


Bob Fiddaman

Scum! - The GSK Video

Scum - Slang One, such as a person or an element of society, that is regarded as despicable or worthless.


Mark McGowan pretty much sums up the way a lot of people feel about GSK.

Back Stories:



GSK - The Company With Great Ethics


GlaxoSmithKline - Pinsky, Bradshaw and Promises

GlaxoSmithKline's Perverse Olympic Games

Glaxo's Qui Tam Paxil Complaint

Advair Launch 2001: GSK's “Myth of Mild” Campaign




Fid

ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK HERE

AUSTRALIAN ORDERS HERE

Glaxo's Qui Tam Paxil Complaint

Is GSK boss, Andrew Witty, about to break his promise?

Just going through the complaint made by UNITED STATES OF AMERICA, et at, ex rel
GREGORY W. THORPE and BLAIR HAMRICK, Plaintiffs, Vs SMITH KLINE BEECHAM, INC., and GLAXOSMITHKLINE PLC d/b/a GLAXOSMITHKLINE, Defendants.


The Paxil section, page 18, is interesting to say the least, particularly sec 58.

58. However, the bulk of Paxil and Paxil CR sales stemmed from GSK's unlawful promotion for off-label uses in adult patients for such diverse disorders as premature ejaculation and general social phobias, anxiety, ADHD, shyness, and bipolar disorder. As part of this scheme, GSK concealed that Paxil is highly addictive.

Now, we've always known about Paxil's addictiveness and we've always heard Glaxo spokespersons deny this.

It would be interesting to see if any exhibits produced in the above case showed that Glaxo hid evidence that Paxil is highly addictive. It would certainly open the creaky door to the UK Seroxat litigation. Although the wheels seem to have grinded to a halt on the UK litigation, it is still live, despite misinformed individuals making statements that the case has collapsed.

Anyway, the full complaint against GSK can be downloaded here. The Paxil section reads as thus:


Paxil [Known as Seroxat in the UK]

Paxil (paroxetine hydrochloride) was initially approved by the FDA on December 29, 1992 for the treatment of Major Depressive Disorder in adults. Thereafter, the FDA approved the drug for other uses, however neither Paxil, nor its extended release formulation known as Paxil CR, has been approved for any use whatsoever in patients under the age of 18.

Nevertheless, GSK has aggressively promoted Paxil and Paxil CR as a safe and effective treatment for a litany of mental issues for children, including, depression, anxiety, ADHD, shyness, and bi polar disorder, among others.

GSK's off-label marketing for pediatric use was particularly egregious because GSK knew no later than November 1998 that Paxil was ineffective in this age group and, even worse, that depressed pediatric users of Paxil were up to three times more likely to commit suicide or engage in other self-harming conduct. GSK not only knew these seminal facts, but withheld its own clinical study data that proved them to be true from the medical community and the public to protect pediatric Paxil sales.

However, the bulk of Paxil and Paxil CR sales stemmed from GSK's unlawful promotion for off-label uses in adult patients for such diverse disorders as premature ejaculation and general social phobias, anxiety, ADHD, shyness, and bipolar disorder. As part of this scheme, GSK concealed that Paxil is highly addictive.

Finally, GSK aggressively promoted Paxil as safe and effective for use during pregnancy. This marketing scheme rivals the contemptibility of its pediatric scheme. GSK characterized Paxil as having treatment benefits that outweighed the risks, when in fact GSK knew the opposite to be true. GSK knew that the drug substantially increased the risk of severe congenital birth defects, particularly holes in the heart of the fetus. The drug is now also known to cause Persistent Pulmonary Hypertension of the Newborn. When information about Paxil's link to birth defects finally became public in December 2005, the FDA reclassified the drug as Category D. Category D classification is reserved for drugs with a proven link to birth defects when used during pregnancy.

Paxil is the only SSRI with a Category D designation. GSK's concealment of evidence of birth defects deprived physicians and expecting mothers of the ability to make informed choices about the risks of its use during pregnancy. Had GSK disclosed the truth, undoubtedly the use of Paxil during pregnancy would have been severely curbed, which is exactly what GSK endeavored to avoid. This is particularly true of off-label use of Paxil, where safer alternatives would have been available.


----


Andrew Witty, Glaxo's CEO on the $3 billion settlement made by his company:


"“Today brings to resolution difficult, long-standing matters for (Glaxo). Whilst these originate in a different era for the company, they cannot and will not be ignored. On behalf of (Glaxo), I want to express our regret and reiterate that we have learnt from the mistakes that were made,” [LINK]

The UK Seroxat [Paxil] litigation is based upon withdrawal and that the claimants, in the litigation, had difficulty withdrawing from the Seroxat.

Now, I'm no Albert Einstein but I'd say that a drug being highly addictive would cause severe withdrawal problems, wouldn't you?

It will be interesting to see if Witty sticks to his word, more so to see if he and his company really have learnt from the mistakes that were made.

I'm assuming that they [GSK] and their lawyers, Addleshaw Goddard, won't be contesting the claims against them in the UK then?

A pig has just flown past my window... I'm sure it had a French accent.

Plus ça change, plus c'est la même chose.


GlaxoSmithKline are a British Company that have been successfully sued by American attorneys on numerous occasions.

With Glaxo's CEO being part of British Prime Minister's Business Advisory Committee and with the British Drug regulator, the MHRA, having two ex- Glaxo employees on their staff, is it any wonder that it's easier for the UK man/woman in the street to split an atom then it is to get justice from GlaxoSmithKline.


Fid

ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK HERE

AUSTRALIAN ORDERS HERE

Glaxo's Andrew Witty Has Personal Details Appear on Twitter

As much as I don't really care much for Andrew Witty or anyone else associated with Glaxo for that matter, I feel I must protest at recent events on the social networking website, Twitter.

An account was created that allegedly posted the home address of Glaxo's CEO, Andrew Witty.

Not nice.

I won't throw up any links, my obsessive stalker, has already done that ~ of course trying to associate me with the said account on Twitter.

I think if one is going to be critical of the pharmaceutical industry then posting a CEO's address serves no purpose, in fact it does the complete opposite.

I can understand the anger of Seroxat/Paxil users, trying to wean off an addictive drug with no help from the company that made it can be frustrating and, in many cases, life-threatening. To start posting the home address of Glaxo's CEO was below the belt.

As I understand, the accounts responsible have now been removed, and rightly so as they overstepped the mark.

Witty's address still circulates, I fear for him as my obsessive stalker, RIP Troller, Jeremy Bryce, has now republished it on his fake Seroxat Sufferers blog - again I won't link in to it because that would just be wrong. He's also done the same with my address...in 16 separate blog posts.

Glaxo's UK based lawyers, Addleshaw Goddard, should be able to track down Bryce quite easily, seeing as he apparently wrote to them back in 2009.

I've not gone soft on Witty or GSK, I still don't like the way they suppressed Seroxat data in clinical trials, I still don't like the way they refuse to help people wean off their addictive drug Seroxat, I still don't like the way they make settlements out of court to victims of their drugs without admitting liability, in general, I still don't like them nor do I like lawyers that represent them.



For the record, the following Twitter accounts have nothing to do with me:

@SirRoxat

@A_Witty_parody [now removed]

@seroxatkills [now removed]

@BryceWillStalkU

@JeremyBrycejoke

GlaxoSmithKline - The "Maladaptive" Company

There are many people/organisations that I greatly admire for their part in creating awareness in this minefield of deceit and fraud associated with the Seroxat scandal. Bloggers that have stood the test of time, Seroxat Secrets and GSK Licence To Kill have been at the forefront of spreading awareness about the dangers of Seroxat and the less than honest approach of it's manufacturer, GlaxoSmithKline.

Then we have support groups such as The Seroxat User Group, whose owner hasn't even taken Seroxat but sees there is a huge problem and has striven to help expose that problem through her advocacy work.

There's also been people like Alison Bass, Evelyn Pringle, Shelley Jofre, three journalists who have put their careers on the line, all of whom have, at one time or another, exposed the failings of GlaxoSmithKline and the regulatory systems, namely the MHRA and the FDA.

I've great admiration for the parents of both Sharise Gatchell and Sara Carlin, two teen who both took their own lives after being prescribed Seroxat. The strength of their parents to expose that dangers of Seroxat has given me strength over the years I have known them.

Charles Medawar for his tireless work in showing how the MHRA showed utter contempt for Seroxat Sufferers also deserves a mention, as do Prof David Healy, Peter Breggin and Joseph Glenmullen.

Attorney's in the US whom have shown dogged determination to get to the truth include The Tracy Law Firm, Donald J. Farber, Baum, Hedlund, Aristei & Goldman

There are many more, some I've met in person, others I hope to meet someday.

One such person is Rob Robinson, an activist who, with balls of steel, took the fight right to the doorstep of GlaxoSmithKline. If there was any justice in this world Rob, along with the aforementioned would be commended by their respective governments for exposing the dirty deeds of the UK's biggest pharmaceutical company.

The author of the Seroxat Secrets website recently posted about the recent $3 billion fine imposed on GlaxoSmithKline, the biggest fine in history to settle United States government civil and criminal investigations into its sales practices for numerous drugs. Seroxat Secrets wrote:

$3 billion – yes that’s record – but still no prison time.

It strikes me there are a couple of points coming out of this story:

1 – it seems if you have enough money you can buy your way out of trouble… even if that ‘trouble’ is criminal.

2 – Andrew Witty thinks he’s changed Glaxo – he said “…This is a significant step toward resolving difficult, long-standing matters which do not reflect the company that we are today…”

Well Andrew, this deal is in the US – what about the UK?

You’re not quite so happy for the new, improved GlaxoSmithKline to settle claims in the UK are you, now Andrew.

Could it be because you know the UK legal system works in your favour, so you can effectively ignore UK cases… in the UK cases like this are not heard in front of a jury, but in front of a high court judge – and funding is not easy to get. Basically in the UK we have no real chance to take on big business and patients not protected by the MHRA.

He is absolutely correct.

His post prompted me to browse through the archives of the Paxil Protest website, a site created by Rob Robinson, a site that was a minefield of information, a site that GlaxoSmithKline wanted shut down. One does not have to be a highly paid lawyer to see why they wanted it removed.

I've been writing about the MHRA, GlaxoSmithKline and Seroxat for 6 years. If I continued to write for a further 20 years I wouldn't come anywhere near what Robinson achieved. The man is a legend.

The following shows how effective Robinson was. It ends with a quote from Karen Barth-Menzies, yet another hero/heroine of mine. This is especially for Addleshaw Goddard, GlaxoSmithKline's UK law team.


Paxil Addiction

....there have been a number of systematic studies in humans looking at the potential for Paxil for abuse, tolerance and physical dependence. So actually, there is data to date to negate the statement that it has not been systematically studied, because, in fact, it has been.— Sworn testimony of Dr. David WheadonSenior Vice President, GlaxoSmithKline Regulatory Affairs and Product Professional Services (10/19/2000)

DRUG ABUSE AND DEPENDENCE

Controlled Substance Class: Paxil is not a controlled substance. Physical and Psychologic Dependence: Paxil has not been systematically studied in animals or humans for its potential for abuse, tolerance or physical dependence. While the clinical trials did not reveal any tendency for any drug-seeking behavior, these observations were not systematic and it is not possible to predict on the basis of this limited experience the extent to which a CNS-active drug will be misused, diverted, and/or abused once marketed. Consequently, patients should be evaluated carefully for history of drug abuse, and such patients should be observed closely for signs of misuse or abuse of Paxil (e.g., development of tolerance, incrementations of dose, drug-seeking behavior).— Paxil June, 2005 Prescribing Information

Disregard for the moment that perjured testimony, and the studies that were never done (or ever will be): Any man, woman, or child, who has crawled through the "Hell beyond Hells" that is a severe Paxil withdrawal will tell you (assuming they lived) that, yes, he or she was dependent on the drug; a prisoner, if you will, for the simple reason that continuing to take Paxil staved off horrifying, debilitating and protracted withdrawal symptoms.

It is INSANE that I and others have had to stumble into and through this hell ... and then try to figure out how to get out of it basically on our own! Its like being thrown into a chemical version of Dante’s Inferno with no map showing you how to get out — or even if you can get out at all! I think (but don’t hope) I’m close to clawing my way out, but who knows? I hate to say it, but the thought just drifted into my head: All ye who enter here abandon all hope.— Journal entry, day #89 from a Paxil withdrawal diary kept by Rob Robinson, a Paxil survivor.

In the mind of a lay person this inability to quit Paxil qualifies as "addiction" regardless of whether a Paxil user craved the drug to "get high," like a "real" addict craves, for example, heroin.

How GlaxoSmithKline has dealt with the issue of Paxil dependency (i.e. addiction) mirrors efforts it undertook regarding the issue of Paxil withdrawal. GSK flatly denies that Paxil can cause dependency or addiction and, in fact, the company has gone to extraordinary lengths to keep the label of dependency or addiction from being associated with the use of Paxil.

The truth is GSK knows Paxil can, sans studies, cause physical dependency in significant numbers of people. That is absolutely the case. It is one of the principal reasons why GlaxoSmithKline has, for years, instructed its sales reps to, whenever possible, substitute the word "discontinuation" for "withdrawal" in communications with healthcare professionals — because withdrawal implies dependency. And dependency, quite naturally, suggests addiction.

Yet the volume of anecdotal information available to GlaxoSmithKline and the world — proving Paxil can, and does, cause dependency — is widespread, dramatic, compelling and overwhelming.

Charles Medawar, of Social Audit framed the issue perfectly when he wrote:

“There is obviously some confusion about the concept of dependence ... The simplest definition of drug dependence given by W.H.O. (the World Health Organization) is ‘a need for repeated doses of the drug to feel good or to avoid feeling bad’ (W.H.O., Lexicon of alcohol and drug terms, 1994). When the patient needs to take repeated doses of the drug to avoid bad feelings caused by withdrawal reactions, the person is dependent on the drug. Those who have difficulty coming off the drug even with the help of tapered discontinuation should be regarded as dependent, unless a relapse into depression is the reason for their inability to stop the antidepressant medication.”

Thanks to Mr. Medawar’s relentless efforts to expose the truth about Paxil (Seroxat in the U.K.) GlaxoSmithKline was forced to remove from its U.K. Patient Information Leaflet the following language:

“These tablets are not addictive” and “remember that you cannot become addicted to Seroxat,” and further that the withdrawal symptoms some people experience when stopping Seroxat “are not common and (they) are not a sign of addiction.”

Shattering GlaxoSmithKline's DSM IV "No Dependency" Shield

For now forget the studies GlaxoSmithKline refers to in Paxil's prescribing information mentioned above; those studies will never be performed for the simple reason they would provide conclusive evidence that use of Paxil can induce dependency. Evidence which would present an insurmountable threat to the fortunes of GlaxoSmithKline.

Today, the GlaxoSmithKline public act which claims Paxil cannot induce dependency — based on the latest version of the Diagnostic and Statistical Manual of Mental Disorders DSM-IV-TR (a.k.a. the DSM IV) — would play well if this were the "Theater of the Absurd." But not out here in the real world where lives are being shattered and people are dying because of Paxil.
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The GSK dodge seeks refuge under cover of language which changed when the DSM III was supplanted by the DSM IV in which, according to Charles Medawar of Social Audit "the new definition of dependence specified that the presence of withdrawal symptoms — in the absence of at least two distinctive features of a drug problem — was not "dependence" at all. At a stroke therapeutic dependence ... officially ceased to exist. Once again, the problem revolved around the true meaning of "dependence" but, this time, the new definition both radically changed the meaning and defied common sense. To compound the problem the authorities then failed to explain, or even acknowledge, that this enormous shift in meaning had taken place.

The Pharmas zealously promoted the new definition, but the medical establishment welcomed it too — because it characterized "dependence" as something that no competent doctor would ever cause. As if by law, and at a stroke, "dependence" had again come to mean something like frank drug abuse. In line with tradition, dependency problems were pinned on users once again.

Internationally, the risk of New Dependence was considered so small, that the regulators never requested the SSRI Pharmas test their drugs.

For the sake of argument let's have the public give GlaxoSmithKline the benefit of the doubt, even though it's unwarranted. We can "test" GSK's specious DSM IV claim by parsing the manual's criteria for substance dependency on a point-bypoint basis

Remember, only three of the following criteria must be meet within a 12-month period for a diagnosis of substance dependency.

The Diagnostic and Statistic Manual (DSM IV), defines addiction (which it refers to as “substance dependence”) as follows:

A maladaptive* pattern of substance use, leading to clinically significant impairment or distress, as manifested by three (or more) of the following, occurring at any time in the same 12-month period:

(1) Tolerance, as defined by either of the following:

a. A need for markedly increased amounts of the substance to achieve intoxication or desired effect.

Many Paxil users must take larger doses of the drug over time as the efficacy of the drug wears off in order to achieve the desired effect.

b. Markedly diminished effect with continued use of the same amount of the substance.

Many Paxil users experience "SSRI poop out" (see D.J. Rapport, J. R. Calabrese, Tolerance to fluoxetine. J Clin Psychopharmacol 1993 Oct, 13 (5), 361.) after taking a fixed dose of the drug for a number of years. As a result they must increase their dosage in an attempt to regain efficacy. Even then, the increase in dosage sometimes has no effect.

(2) Withdrawal, as manifested by either of the following:

a. The characteristic withdrawal syndrome for the substance.

The phenomenon of Paxil withdrawal is an established fact now, and one acknowledged in the manufacturer's current drug labeling.

b. The same (or a closely related) substance is taken to relieve or avoid withdrawal symptoms.

Individuals trying to quit Paxil sometimes switch to another "SSRI" with a longer half-life (i.e. Prozac) in a attempt to simultaneously get off the drug and ameliorate its oftentimes severe withdrawal symptoms. (Like heroin addicts who use methadone.)

(3) The substance is often taken in larger amounts or over a longer period than was intended (loss of control).

Many individuals continue taking Paxil — long after they would like to stop taking the drug — to stave off extremely severe, debilitating and prolonged withdrawal symptoms that sometimes occur when stopping Paxil.

(4) There is a persistent desire or unsuccessful efforts to cut down or control substance use (loss of control).

"Same comment as for #3." Many individuals continue taking Paxil — long after they would like to stop taking the drug — because of the withdrawal symptoms that occur when stopping Paxil.

(5) A great deal of time is spent in activities necessary to obtain the substance, use the substance, or recover from its effects (preoccupation).

If Paxil was illegal many users would spend whatever time was necessary to get the drug "on the street," thus engaging in the same behaviors "real" addicts exhibit in their quest to obtain the drug they are dependent upon. A Paxil addict doesn't have to go this route since the doctor who (unwittingly) prescribed Paxil to him or her hands out refill prescriptions; all that's necessary to get more Paxil is a trip to the local pharmacy.

(6) Important social, occupational, or recreational activities are given up or reduced because of substance use (continuation despite adverse consequences)

(7) The substance use is continued despite knowledge of having a persistent or recurrent physical or psychological problem that is likely to have been caused or exacerbated by the substance. (adverse consequences)

This is the situation lived out on a daily basis for thousands of Paxil dependents who have (quite often) discovered through the Internet why it is they are unable to quit the drug without experiencing disabling withdrawal symptoms.

Paxil and proof of dependency: In basketball it's what they call "a slam dunk."

In legal documents GlaxoSmithKline appears to make much out of the word "maladaptive" as used in the DSM pre-qualifier. In this context an acceptable medical synonym for the word "maladaptive" is "dysfunctional." If Paxil dependency is not a state of dysfunction (i.e. maladaptation) then the condition doesn't exist.

Based on what the world knows about Paxil today: Paxil should be — if not summarily banned — then at a minimum classified as a "Schedule II" drug by the United States Drug Enforcement Agency. (At the same time the DEA should change its scheduling guidelines under "(C)" to read "use of" vs. "abuse of" since that language lags behind today's realities.)

Rob Robinson - Paxil Protest

"We have been trying for years to raise public awareness about these issues because we have seen, through our litigation, the secret internal company documents that no one ever gets to see, not even the FDA. Even now, we are prohibited, due to confidentiality orders, from disclosing these documents. But, you can only hide the truth for so long. Too many people have been harmed by these drugs, too many lives have been shattered." - Karen Barth-Menzies - Paxil plaintiffs' attorney