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"FIDDAMAN BLOG" - 5 new articles

  1. Revisiting Seroxat Withdrawal
  2. The Omnipotent Ricky Williams
  3. Harambe The Gorilla: Have We Got Our Priorities Wrong?
  4. Ex NFL Player Goes Public With Glaxo Payment
  5. GSK ~ A Class Act
  6. More Recent Articles
  7. Search FIDDAMAN BLOG
  8. Prior Mailing Archive

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.



    

The Omnipotent Ricky Williams








Following on from my last post, Ex NFL Player Goes Public With Glaxo Payment, I have decided to block ex- NFL star Ricky Williams from my Twitter account.

Williams, who in the early part of the 2000's received half a million dollars from GlaxoSmithKline, was asking me for payment just to answer a bunch of Paxil related questions.

The reason I blocked him is self explanatory, in as much that I don't deal with huge egos and, it has to be said, narcissistic behaviours.

A picture paints a thousand words.




This one's for you, Rick.



 







Bob Fiddaman











    

Harambe The Gorilla: Have We Got Our Priorities Wrong?





There's been a huge reaction to the story that broke earlier this week regarding Harambe the gorilla. The majority of people are outraged that such a beautiful animal was shot dead after a toddler fell into a gorilla exhibit at a Cincinnati Zoo.

Many people, including the 478,000+ supporters who have signed an online petition, are calling for the parents of the toddler to be prosecuted, citing 'parental negligence' amongst other things. Memes have been appearing all over social media accounts also calling for the heads of the parents and asking why the 17 year-old gorilla needed to be killed.

These same people, rightly or wrongly, are entitled to their opinions. One does, however, have to ask them one simple question. If it were your child that fell 12ft into a gorilla pen, would you just want to wait and see what happened?

Animal cruelty pulls at the heart strings - we see photos of badly treated dogs or cats and we are quick enough to let our feelings known by signing petitions or sharing posters and memes to our social media pages supporting the need for animal cruelty to stop ~ and rightly so.

I'm an animal lover, first and foremost. I'm also a lover of human beings.

Here's just one story that hasn't had nearly half a million people signing a petition or many more voicing their opinions on social media.



During the month of November, in 2012, 14-year-old Amy El-Keria (above) used her football scarf to hang herself in the Priory at Ticehurst in Sussex, UK.

Whilst at the Priory, Amy was forcibly sedated with medication on at least two occasions.

The author of AntiDepAware, Brian, followed the case closely, he writes...

"There were also several incidents where Amy was physically restrained by staff, sometimes for 15 minutes at a time. The last incident occurred the day before her death, when Amy was restrained by five members of staff for 15 minutes and orally sedated.
"The jury also heard that the Priory had a high reliance on agency staff, including some with no psychiatric experience, and insufficient time to read patients’ paperwork or clinical notes.
"On the day she died, Amy told a member of staff she wanted to kill herself. Later that evening, a member of staff found her door locked and realised Amy had decided to try to end her life."

Yet still we have no memes for Amy. We have no petitions calling for heads to roll at The Priory Hospital in Sussex.

Why?

Amy was a troubled young girl, she, like millions of other children world-wide, had been labelled - she was, according to those who treated her, mentally ill.

Her  mother, Tania El-Keria, said: "Amy was my most loved youngest daughter, sister, niece and granddaughter with her whole life ahead of her. She had a warm heart and a great sense of humour. She never liked to see people treated unfairly and would be the first to stand and say ‘that’s not right.

"For 14 years we kept Amy safe. In less than three months under the care of the Priory she was dead. The only thing that has kept me going since her death nearly four years ago has been the need to achieve justice for my Amy."

No public outcry. In fact, if the story managed to appear on the news feed of Facebook many people, including the majority of those who expressed an opinion about Harambe the gorilla, will have ignored it, not even bothered to click on the link where they would have learned so much about the way children are being mistreated by adults who are, apparently, there to help.

Amy wasn't shot but she did fall. She fell into the system and once in it there was no marksmen their to help fend off her immediate threat.

Our priorities really need looking at when we are outraged that a gorilla was killed because of parent neglect and yet we show no emotion or we refuse to read the story of the innocent 14 year-old Amy El-Keria.

Shame on you all.


Amy, aged 14http://antidepaware.co.uk/amy-aged-14/


Bob Fiddaman

    

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
    

GSK ~ A Class Act



Courtesy of Google Images



I had one of those Nescafe down the nostrils moments earlier. Snot accompanied the Nescafe as it projected down my left nostril, much of it spraying the screen of my laptop.

GSK, it appears, have been implementing ethics into the way they give incentives to sales staff by rolling out new sales training, performance review and bonus structure.




In an interview with HR Magazine, GSK's Dannii Portsmouth, (Pictured top of post) said, “We don’t think we've done anything inappropriate in the past, but we think the expectations of society have changed.”

(Insert laughter here)

Portsmouth is GSK's Director, HR Business Lead, UK & Ireland Pharmaceuticals - to suggest that; a) the company who employ her have done nothing inappropriate in the past and b) it's down to the expectations of society, is classic GSK spin.

Here we have a company spokesperson trying to put right many wrongs but she fails at the first hurdle with a statement of denial. "We don’t think we've done anything inappropriate in the past."

Really?

So, why plead guilty then?

One word: Incredulous!




GSK has agreed to plead guilty and pay $3 billion as part of this criminal and civil resolution.


GSK has agreed to plead guilty to three misdemeanor violations of the Food, Drug and
Cosmetic Act:



Regarding Paxil, GSK will plead guilty to distribution of a misbranded drug due to false and misleading labeling, in violation of 21 U.S.C.



Regarding Wellbutrin, GSK will plead guilty to distribution of a misbranded drug due to inadequate directions for use, in violation of 21 U.S.C.



Regarding Avandia, GSK will plead guilty to failure to report data to the FDA, in violation of 21 U.S.C.



So, nothing "inappropriate " huh, Dannii?

Oh, and what about the statement of apology to the Chinese government and its people?

You remember that, right Dannii?

The fine of  $490m (£297m) after a court found your company guilty of bribery after having made an estimated $150m in illegal profits.

Still,  nothing "inappropriate. " 

What about the out-of-court settlements made to over 3,000 claimants who were addicted to your company's antidepressant, Seroxat?

Or the countless settlements made with mothers who, as a result of ingesting Seroxat during pregnancy, gave birth to children with birth defects or had to abort their foetuses because the chances of survival after birth were slim, to say the least. Case in point, Joanne Thomas from Pennsylvania. You, or rather your company, gave her the run-around, she lost her case against you, appealed, lost that too - then, miraculously your company settled with her after your law team messed up by not disclosing everything to her attorneys - naughty Glaxo - (see here and here)

Still, nothing "inappropriate. " - I mean, what's 800 or so kids being born with severe heart or cranial defects? Just part of the business, huh Dannii?

Don't even get me started on Study 329, Dannii!

I could go on and on to show you exactly where GSK have been inappropriate but what's the point?

Glaxo employees, Portsmouth included, have a knack of burying their heads in the sand when it comes to Glaxo's dark history - Maybe that's the only way they get to sleep at night, who knows?

First rule of ethics, admit to your inappropriateness then seek to make sure it doesn't happen again.

The expectations of society have always been the same, we expect you to be honest and truthful, we expect to live and not suffer at the hands of your drugs.

End of rant.

Dannii Portsmouth's musings can be read, in full, here.


Bob Fiddaman.


*Disclaimer*

This blog post was not sponsored or endorsed by Nescafe.














    

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