Zantac Lawsuit

Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Tuesday, June 28, 2016

ADHD - Tapping into the Lucrative Market

General all-round ass-kickers and thoroughly decent humans, CCHR International, have been running a series of posts lately via their webpage that concern the recent push by the pharmaceutical industry and the field of white-coated buffoonery to target more kids with ADHD drugs.

Medikidz is a children’s medical education organisation that works closely with healthcare professionals, families, children and patients to produce unique learning materials in comic book format. The blurb on their website reads...

Over 3,500,000 Medikidz comic books have been distributed globally, involving over 400 leading specialist physician peer reviewers and 100 endorsing partners worldwide. The Medikidz mission is to create a global community of young people that is informed, empowered and health-aware.

Hey, I'm all for kids being educated about the illnesses they may or may not have. Medkidz comics range from such ailments as allergies, infections & immune system right through to cancer. Buried amongst the pile of educational material is a comic that explains ADHD. Priced at £6.99 it tells us the fictional tale of Josh. Here's the summary, along with the front cover of the comic.

Josh is spending the day hanging out with the Medikidz at Medi HQ. He’s having a great time until disaster strikes…

An accident which leaves Mediland without one of its moons makes Josh feel he has outstayed his welcome. And this isn’t the first time he’s felt like this. He feels like everywhere he goes he causes trouble and ends up being shouted at. The Medikidz decide it’s time for an adventure, and whisk Josh off to Mediland’s brain where the hard-working neurons are facing a crisis; where have all the neurotransmitter messages gone? How will they know when to concentrate, stay alert or stop fidgeting? Will Mediland have a riot on its hands (or more accurately, brain)? Through their adventure, the Medikidz show Josh that sometimes it can feel frustrating and confusing if you have ADHD, but that in fact, there is support and help all around you.

The comic comes at a time where yet more trickery by the marketing geniuses at pharmaceutical companies have rolled out treatment designed specifically for children.

Adzenys, for example, is a drug similar to Adderall in that it is marketed towards children ages 6 and up with attention deficit hyperactivity disorder, especially those who are averse to swallowing pills.

Adzenys is an extended release tablet that dissolves in the mouth and comes in an orange flavour that, according to some, is just like having a peice of candy dissolve on the tongue. Its makers, NEOS Therapeutics, Inc, claim that many children have difficulty swallowing the tablets that treat ADHD, hence the reason to make it available in a candy-like form, I guess.

Hansel & Gretel anyone?

The warnings that accompany Adzenys are extensive, so extensive in fact that I'm surprised any parent would wish for their child to take it...

Heart-related problems, new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms, decreased appetite and problems sleeping.

The above side effects aren't some conspiratorial rant, they are actually from the FDA website who also warn about disposing of Adzenys. "mix ADZENYS XR-ODT with an undesirable, nontoxic substance to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and discard ADZENYS XR-ODT in the household trash."

Scary stuff, even more so when we revert back to the comic about ADHD. CCHR International write, "...the ADHD comic book, for example, is sponsored by Shire Pharmaceuticals, which also, coincidentally, happens to market several ADHD drugs, including Adderall." 

Now, it appears, that potentially millions of kids can now explain to their friends about their diagnosed brain disorder - "Look, it's here in this comic." It will have a knock on effect as most fads do - except ADHD isn't a fad and it looks as though it's here to stay... and treat.

Adzenys XR-ODT  is a prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and above.

There are no seven wonders of the world in the eyes of a child. There are seven million.
~ Walt Streightiff

Bob Fiddaman.

Further reading

A New Low for Psycho-Pharma: Candy-flavored ADHD Drugs & “ADHD Superheroes”

Psychiatric Medication or Play Therapy?

Tuesday, June 21, 2016

Revisiting Seroxat Withdrawal

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

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

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

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

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

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

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

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

 Daniel Burnham of SmithKline Beecham writes...

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

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

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

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

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

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

Here's the internal emails.

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

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

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

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

Your move, Glaxo!

Bob Fiddaman.

Tuesday, June 14, 2016

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

Thursday, June 02, 2016

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.


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 14

Bob Fiddaman

Wednesday, June 01, 2016

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 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 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

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