UK Seroxat Litigation - Day 2 - Deathly Media Silence

The mainstream media still seem disinterested in the on-going UK Seroxat litigation in London. Perhaps, they are waiting for some internal documents to surface, you know, something meaty they've never seen before?

Perhaps they are waiting to see if anything pertaining to GSK's Yugoslavia trials are aired?

GSK's Yugoslavia Seroxat Trials

Back in 1988, SmithKline Beecham (SKB) initiated a trial [called the relapse trial]

At this time, SKB was seeking approval of Seroxat and the Yugoslavia trial was to show the FDA (the US drug regulator) how effective Seroxat was in treating depression – they would also try to show the FDA how it was important to keep taking Seroxat and not to stop… because if you did stop then you would go into relapse, in other words, SKB was trying to prove that stopping Seroxat meant the patient’s original illness would return.

The following two posts may be a helpful resource for media outlets, should they ever take an interest in the current Seroxat litigation. Here and here.

Should the media wish to see the data from these trials, they could always contact the MHRA. They may be surprised by the MHRA's answer.

At the very least, it should prompt some serious questions regarding the Yugoslavia Seroxat trials and the way GSK, then SKB, seemingly spun withdrawal into relapse.

Back story - MHRA Missing Key Seroxat/Paxil Withdrawal Information

Because of my involvement with the current trial, I am restricted in writing about it. I can, however, write about GSK's history. That said, tomorrow I will be writing about a case involving Seroxat and birth defects. My previous blogs surrounding this particular case saw an insight into how GSK's attorneys operate, moreover, how they quickly settled out-of-court with a Pennsylvanian woman who had contacted me. An in-depth research of her case showed that GSK had clearly not handed over all items of disclosure to her attorneys, once I went public with this, they offered the woman in question a settlement, despite GSK previously persuading judges to strike her case.

More on that tomorrow.

Bob Fiddaman

Seroxat UK Litigation Day 1

Today was an interesting day regarding litigation against GSK and its brain pellet, paroxetine.  GSK markets this product as Seroxat in the UK and Paxil in the US. It is also sold by GSK using other names to include Aropax n Australia and New Zealand. It's likely that pharma companies benefit by giving the same product different names in various countries because it makes it more difficult for consumers to search for and find relevant adverse drug effects as experienced by users across the globe. The average Aussie likely had no idea that Aropax is Paxil in the US, etc.

But back to the paroxetine court cases. Today the Supreme decided to hold off making their decision regarding the Dolin case. A previous case, Merck, Sharp & Dohme Corp. v. Albrecht has similarities to Dolin v GSK. That is, Merck's defence, like GSK's is that the FDA is responsible for changes in the labelling and not drug companies.

In the Dolin vs. GSK case, a Chicago court found in favour of Wendy Dolin in 2017. Not only did the jury determine that GSK failed to warn of the risks posed by paroxetine, they determined paroxetine caused Stewart Dolin's suffering and demise. An Illinois Seventh Circuit court later overturned the jury's decision and that decision was appealed to the Supreme Court where it now remains. It's never easy going up against GSK, despite the fact that they are officially criminals (See The United States Justice Department). I assume that the Supreme Court has decided to hold their decision on Dolin v GSK until the Merck matter is sorted.

Here in the UK, the long-awaited group action trial against GSK kicked off more than a decade after it was filed. The trial is estimated to last three months. I am one of more than 100 plaintiffs and will not be reporting on the trial just yet. But, stay tuned because I'm certain there will eventually be much to say when the dust settles.

As many of you know, I've been writing about GlaxoSmithKline and Seroxat for more than 13 years. Restrictions prevent me from writing about the current trial but I can still write about GSK's not-so-pretty sordid history, which I intend to do over the coming three months.

I will be attending some of the trial and will surely take notes because one never knows if there's another book I might write, my previous book, The Evidence, However, is Clear, the Seroxat Scandal, is quite old now and much has happened since I wrote it some 8 years ago.

For all of those who have contacted me today, these are the reasons why I am not covering the case as it presently unfolds.

It's frustrating given that Truthman and I likely know more about GSK's shady business and their Seroxat-labelled brain pellets than anyone else on the planet.

For now, we will both remain silent.

For now.

Bob Fiddaman.

The Truth About SSRI Withdrawal/Dependence

The following legal brief has rarely been seen by members of the public. Read through it and you'll understand why.

It's a fascinating read and highlights just how GSK hid the withdrawal issues surrounding their popular antidepressant, Paxil.

Many readers will find the following PDF too much to bear. Many will be angered by it, and rightly so. I hope many of you will pass it on to family, friends and even healthcare professionals.

For me, at least, it's the most damning document to ever surface out of litigation. The litigation in question saw GlaxoSmithKline settle with over 3,000 plaintiffs who had struggled to taper off Paxil. Much of the evidence was sealed as part of the 'gagging order' - However, this legal brief gives us an insight into the incestuous relationship between GSK and the FDA. It also shows us how GSK carefully manipulated the system thus putting thousands of future patients through utter misery with debilitating side-effects of withdrawal.

The Yugoslavia trials, mentioned in the document below, are very interesting. Glaxo sponsored the two phases of these trials. In Phase I all patients were given Paxil, in Phase II some were switched to placebo. It was at this stage that the placebo patients began experiencing severe withdrawal issues. Glaxo chose to define this as "relapse" data. This would give them the ammunition to announce later that patients who stayed on Paxil continued to enjoy a normal, "depression free" life, but those abandoning the drug would suffer relapse back into a depressive state.

Back in 2015 I, under the Freedom of Information Act, requested from the MHRA the protocol for this particular clinical trial and whether or not that protocol included information and/or guidance on Paxil withdrawal. The MHRA wrote me and said they "didn't hold that information."

Here's the legal brief.

Bob Fiddaman

Glaxo Settle Paxil Birth Defects

Once again GlaxoSmithKline have settled out of court with a mother who claimed that she and other mothers had not been properly warned about the risks of taking Paxil during pregnancy.

The lawsuit, which was filed 9 years ago, has recently seen both parties come to an agreement - ergo the plaintiffs (50 in all) will probably receive around $150,000 each.

Faith Gibson, who was the lead case in the litigation, used Paxil during her pregnancy and her daughter, Leah, (pictured above) was born with a hole in the heart in 2005. Meah, now aged 11, remains particularly susceptible to whichever cold or flu is going around.

Her mother said...

"In general, Meah, now 11, seems to be doing better physically. But the ordeal has affected her mentally as well.

"Any kind of pain she has in her heart or any sort of discomfort she feels in her chest, she feels like it’s something bad going on and that she might have to have surgery again.

"That side of things hasn’t subsided at all. She’s got a nasty scar on her chest to remember it by, so it’s always there."

GlaxoSmithKline said that despite the settlement in principle, it does not admit to any liability or wrongdoing but has agreed to resolve the class action case to avoid the time and expense associated with a trial and subsequent steps in the proceedings.

“We continue to be of the view that the scientific evidence does not establish that exposure to Paxil during pregnancy causes cardiovascular birth defects."

--

We all know different.

See the evidence in links below, evidence that caused a huge embarrasment to both Glaxo and their attorneys, King & Spalding.

Bob Fiddaman.

Ryan, Glaxo's Non-Viable Fetus - Part I

Ryan, Glaxo's Non-Viable Fetus - Part II - The Twists

8 Paxil Kids "Suffered Catastrophic Birth Defects"

One news item that appears to have been overlooked by the mainstream media is news coming out of the state of Illinois where a three-justice panel of the Illinois First District Appellate Court denied an appeal from Paxil (Seroxat) manufacturer, GlaxoSmithKline to bring litigation against them to a halt.

Glaxo, without defending that Paxil caused birth defects in these children, had argued that the plaintiffs who lived outside of Illinois should not be able to bring a case against them. (6 of the 8 live outside of Illinois)

Plaintiffs argued that during the illegal promotion of Paxil (ie; GSK reps telling doctors that Paxil was safe in pregnancy) over 17 Paxil-related clinical trials were carried out in Illinois.

Judge Axelrood ruled in plaintiffs favour - Glaxo appealed and that appeal has been turned down by the three-justice panel.

The panel said...

“Defendant GSK conducted a part of its general business in Illinois, and plaintiffs’ claims arose out of the very trials conducted, in part, in Illinois,” the justices wrote. “The fact that the contested plaintiffs are not Illinois residents does not destroy the jurisdiction established on the basis of defendant GSK’s activities here.”

Interestingly, the panel also found that GSK’s sustained business presence in Illinois, including 217 employees who lived in Illinois, including 79-121 employees may have been tasked specifically with marketing Paxil in Illinois.

This, it appears, has become standard fare for GlaxoSmithKline. They no longer deny that Paxil can cause birth defects, they just try to get cases tossed using state laws, when they are denied this they then claim that although Paxil can cause birth defects, any plaintiff who alleges this is either wrong or something else caused the birth defect. They will also, more than likely, delve deep into the mothers history to see if they drank or smoked during their pregnancy. They may also try and damage the reputations of the mothers by trying to find out if they were involved in extra marital affairs during their pregnancies - all this, in efforts not to pay compensation - it's the act of a vulture picking on a dead carcass ~ although, to be honest, I'd rather spend time in a room with a vulture than one of GSK's hired suits.

This from the Cook County Record...

In 2014, eight mothers filed suit against GSK in Cook County Circuit Court, alleging their children “suffered catastrophic birth defects” 

The plaintiffs alleged GSK should have known of the dangers of the drug from its clinical test results, and should have warned doctors and expectant mothers of its allegedly “significantly increased risk of congenital defects in babies whose mothers ingested” Paxil.

Instead, plaintiffs asserted GSK promoted Paxil as “being safe for pregnant women.”

GlaxoSmithKline's company motto, that they still use today, is...

We are dedicated to improving the quality of human life by enabling people to do more, feel better, live longer.

It's a mantra that, I believe, goads victims of GSK.

As a father, myself, I am outraged. If I were a mother I'd be homicidal.

Plaintiffs are represented in the above case by attorneys with the firm of Tor Hoerman Law LLC, of Chicago.

GlaxoSmithKline was defended by the firms of Dentons US LLP and Cozen O’Connor, each of Chicago.


Bob Fiddaman


Related

Ryan, Glaxo's Non-Viable Fetus - Part I

Ryan, Glaxo's Non-Viable Fetus - Part II - The Twists

JANE NIEMAN VIDEO TESTIMONY GSK V KILKER (Paxil Birth Defects)

Ex NFL Player Goes Public With Glaxo Payment

I must confess I know nothing about  American football and the National Football League (NFL). To me American football is basically rugby dressed in armour - that's as far as my ignorance goes with this particular sport. I never really understood it, the time-outs, the zones, the fact that it is called football when, it appears, everything but the feet is used to control the ball.

I know little of the players either, in America they are idolized by adoring fans, many of whom hang on to their every word.

This post is about one of those players, or rather a former player.

Ricky Williams, according to Wikipedia, is a retired American football running back who played twelve seasons in the National Football League (NFL) and one season in the Canadian Football League (CFL).

I'm guessing that Canadian football is the same egg-shaped chasing game as American football.

Williams has been in the news recently as he plans to open a marijuana-friendly gym in San Francisco. Oregon live, a web-based newspaper, writes...

"The gym is scheduled to open in November and members will be allowed to use marijuana while working out. Should those members get hungry, Power Plant has a line of edibles specifically designed for pre and post-workout training.

"McAlpine said the gym will also offer a "cannabis performance assessment" to determine how marijuana affects workouts."

Each to their own, I guess. Personally, I can't see the benefit of working out whilst smoking, unless of course Williams plans to sell healthy looking cake to those pounding the treadmills?

Williams himself is a self-confessed user of marijuana and, believe it or not, is connected to one of the reasons I started writing this blog over 10 years ago. Here's why...

In 2002 an article appeared on USA Today* that reported how Williams was facing the demons of a (ahem) mental illness, namely; social anxiety disorder (SAD). Shortly after going public with this, Williams was contacted, and then contracted, by GlaxoSmithKline.

The official line was that Glaxo would pay him to give talks about his mental illness, talks such as the one featured here, where Williams mentions Paxil 4 times. It would be interesting to see the actual contract Glaxo offered Williams, you know, just to see if mentioning Paxil by name was part of the deal.

Nobody, up until now, knew of the figure Williams received from GlaxoSmithKline but I can reveal that it was a staggering $500,000, that's half a million dollars folks!

How do I know? Well, Ricky Williams told me.

I reached out to him on Twitter via his verified account here - To be honest, I didn't think he'd engage with me but it was quite refreshing that a celebrity saw fit to respond to a member of the public.

I didn't think for one minute that he would be so open regarding Glaxo's payment to him but I do have to thank him for his honesty. (See screen capture)

Terry Bradshaw is another American footballer who was paid by GlaxoSmithKline to go on tour spreading the word about his depression. He was also taking Paxil.

In fact, both Bradshaw and Williams, who remember were household names in America, had a website which was maintained by GlaxoSmithKline called www.rickyandterry.com. Sadly, the website no longer exists.

It's alleged that Glaxo weren't happy with the performance of Williams off the field. In 2003, just one year after hiring his services, Glaxo removed www.rickyandterry.com and any reference to him on their own website.

One year later, in 2004, Williams, who remember had told people how wonderful Paxil was, was quoted in the press as saying, "Marijuana 10 Times Better For Me Than Paxil." The press article was from O’Shaughnessy’s, Journal of the California Cannabis Research Medical Group. The article went on to say that...

"Williams injured a shoulder in his second NFL season and missed six games, but still gained 1,000 yards. As he was recovering, he was induced by GlaxoSmithKline to be the celebrity patient in a campaign to sell Paxil to the 12 million Americans who allegedly suffer from “Social Anxiety Disorder.”

"Glaxo had to sell the concept that shyness is actually a medical condition “a chemical imbalance in the brain” that can be corrected by a pill. Williams, who is sincere and enthusiastic, gave interviews in which he thanked a therapist for telling him that his reluctance to be accosted by strangers at airports was an illness that could be overcome by medication."

On a personal note, I think Williams was duped twice here. Once by his therapist for suggesting that his anxiety problems for his shyness was an 'illness' that could be treated by a pill, and twice by GlaxoSmithKline who sold him a lie by suggesting that social anxiety disorder is a result of a chemical imbalance. To date not one scientist at Glaxo, or anywhere else for that matter, has found evidence that depression or, in the case of Williams, social anxiety disorder, is caused by a chemical imbalance.

William's brief history with GlaxoSmithKline shows us how they were desperate to push Paxil as a pill to cure shyness - out of all those who suffer with shyness who would you say suffer more, children or adults?

Let's just go back to the interview Williams did with some members of the public on USA Today. One of the questions was from a concerned mother.

Port St Lucie, Florida: My son is 16 and having panic attacks. He has been on medication for 6 weeks. Which medication worked for you? Did you try a few different medications before finding the one that helped? 

Ricky Williams: luckily, I tried Paxil first and it worked wonderfully for me.

Was the question authentic or was it a set-up, just so Williams could tout Glaxo's Paxil? I guess we'll never know if my cynicism is warranted here.

I don't wish to start up some sort of witch hunt on Williams here, to be honest, I thank him for his honesty. He didn't have to say anything to me, much of what he did was misguided, particularly his thoughts on suicide, all of which can be seen below.

I wish Williams well in his new venture ~ I just hope he knows what he is getting into (this time)

Bob Fiddaman.



*USA Article shown was updated in 2005