Zantac Lawsuit

Citizens Commission on Human Rights Award Recipient (Twice)
Humanist, humorist

Sunday, July 26, 2020

Akathisia - The Taboo Terminology

Earlier this week the Royal College of Psychiatrists (RCPsych) published an updated report on suicide prevention. The report was put together by a so-called 'Patient Safety Group' (see image above) and other 'contributors', one of whom is the current President of RCPsych, Dr Adrian James.

The report focuses on adult suicides and, according to RCPsych, "provides new, practice-focused guidance for psychiatrists and other mental health professionals on suicide and self‑harm that examines what interaction is now needed between these topics."

Woe Is Me

I found the following finding quite striking. It's a contradictory statement that, on one hand, highlights the failings of the psychiatric profession's choice of treatment, whilst on the other hand calls for more help for those prescribers who experience patients dying by suicide whilst under their care:

"There is evidence that most psychiatrists have experienced the death of a patient by suicide during their career, a large number of them more than once. Half of them described increased stress in the weeks following the suicide, and a sizeable minority reported a change in their practice, including more referrals to colleagues and requests for admission. The evidence suggests that there is a lack of structured support for psychiatrists and psychiatric trainees following a death by suicide."

It's remarkable isn't it. A report on the prevention of suicide highlighting the stress of prescribers who may have contributed to the suicide by prescribing antidepressants that increase the risk of suicide.

What RCPsych seem to be doing here is telling their members, "don't worry, we have your backs and we will help you through the tough times when one of your patients kill themselves whist on the 'life-saving' antidepressant you prescribed them."

Akathisia - The Taboo Terminology

Whilst the new report references the apparent safety and efficacy of antidepressants, it makes no mention of their role in inducing self-harm, suicidal thinking and suicide completion, all three of which that appear on current patient information leaflets as 'warnings'.

There is also no mention of the taboo word, 'akathisia', a condition caused by the very same drugs that RCPsych members prescribe to patients.

They Know About Akathisia 

Last July (2019) Wendy Dolin, founder of The Medication-Induced Suicide Prevention and Education Foundation in Memory of Stewart Dolin (MISSD), flew from Chicago to London to present suicide prevention information to the then President of RCPsych, Wendy Burn, and RCPsych audience members. The presentation highlighted akathisia and included a promotional video on how to spot signs of akathisia. Dolin wasn't the only safety advocate there that day who spoke about akathisia. Dr Lade Smith also spoke about this mind-crippling condition, she was even promoted by Burn who tweeted the following:

It seems a tad strange that the latest Suicide Prevention Report fails to mention akathisia, so I asked one of the 'Patient Safety Group members, Alys Cole-King, why. Cole-King had tweeted, back in March 2020, that "akathisia matters too."

Here's her reply to me (in two parts)

Appleby Ever After

The current UK Suicide Prevention expert is Prof Louis Appleby, he too is referenced throughout the new report although I am unsure of his input.

Appleby, to me at least, is a strange one. He has blocked many voices of the #PrescribedHarm community on Twitter (myself included) but back in October last year made a startling revelation regarding akathisia and the suicide prevention plan. According to Appleby he claimed, "When we came to update the strategy a few years ago, the Government wanted as few changes as possible. We were keen to add something about antidepressants after hearing from families who felt strongly about this."

What actually ended up the the suicide prevention strategy was "There are also risks in the early stages of drug treatment when some patients feel more agitated." (page 27).

Nothing about akathisia, surprising given Appleby's own personal thoughts that akathisia "can make people feel desperate and suicidal."

So, no suicide prevention warning about akathisia in a prevention strategy and no suicide prevention warning about akathisia in RCPsych's new Patient Safety Report.

Something is amiss here.

Why are Appleby and RCPsych, seemingly, afraid to address this elephant in the room?

Answers on a postcard please.

Bob Fiddaman

Tuesday, July 14, 2020

Seroxat in the News

For those of you who took an interest in the UK Seroxat litigation, a full judgement has been posted online here.

The judgement stipulates, "...the Claimants should pay the Defendant's costs of this litigation; those costs are paid on an indemnity basis from 21 June 2018 and there should be a payment on account of costs in the sum of £4.5 million."

With one case over, newer ones may be looming with regards to Seroxat causing birth defects, unless, of course, cases like these can't go to trial due to the Statute of Limitations coming into play.

"...the researchers noted that, compared to control groups, paroxetine-exposed mini-brains developed with up to 75% fewer oligodendrocytes, the support cells that are crucial for the proper "wiring" of the brain."

"The scientists, who published their findings in February in Frontiers of Cellular Neuroscience, used the mini-brains to determine that the antidepressant paroxetine, commonly called Paxil or Seroxat, suppresses the growth of synapses, which are the connection points between neurons, and leads to significant decreases in an important support-cell population. Paroxetine, which can cross the placenta in pregnant women, currently comes with a warning against use in early pregnancy, largely due to a known risk of heart and lung defects. Some epidemiological studies also have suggested that paroxetine raises the risk of autism."

Full story here.

Bob Fiddaman

Saturday, July 11, 2020

#ShowUsYourMeds: I See Dead People

The response by some of the #ShowUsYourMeds project campaigners to my blog post (here) has left me baffled.

Apparently, if I dare to raise the issue on antidepressant-induced suicide I'm 'stigmatising' those who are currently taking and posting about their antidepressants.

Being part of an "Anti-med crew" has also been thrown around on Twitter. This, after I contributed to the project with some tweets of my own.

I'm still scratching my head and searching for reasons why those who promote these drugs without warnings are, seemingly, offended by me posting the following:


Friday, July 10, 2020

GSK wins legal case over withdrawal effects of Seroxat after 13 years and £9.33m in costs

I have much to say about this. For now, I'll wait.

This from the BMJ

by Clare Dyer

A group action in the High Court in London by scores of claimants over withdrawal problems with the antidepressant paroxetine has ended in a victory for the manufacturer, GlaxoSmithKline (GSK), 13 years after the case was first launched.1

A High Court trial was to start in February 2011 but the action was put on hold after legal aid was withdrawn and 369 claimants dropped their cases. In 2015 the litigation was revived when the remaining 124 claimants instructed new solicitors and found commercial funding.

In 2016 GSK asked the court to bring the case to a permanent halt, but Mr Justice Foskett said he wanted to see how the case progressed in stages before deciding if it should be stopped or go to trial.2

From the beginning, the claimants’ case had been that paroxetine, a selective serotonin reuptake inhibitor (SSRI) known in the UK as Seroxat, was a defective product because it caused worse problems than other SSRIs when patients tried to stop taking it. Later, their lawyers tried to expand the case to argue that paroxetine had no particular benefits compared with other SSRIs on a risk-benefit basis, but Foskett ruled that it was too late to change the basis of the case, and it could go ahead only on the narrow basis that paroxetine was the “worst in class” for adverse effects on discontinuance.

In 2018 a new judge, Mrs Justice Lambert, took over from Foskett. At a pre-trial hearing she ruled, “It is now far too late to expand the scope of the trial to include evidence of risks and benefits.”

When the trial opened in April 2019, Lambert ruled again that the claimants’ case could not extend to examining the relative risks and benefits and the claimants could not advance the case that paroxetine had no relative benefits compared with other drugs in the class.

The trial was adjourned so the claimants could take the matter to the Court of Appeal. The appeal court ruled in November 2019 that the claimants were not entitled to put their case on a risk-benefits basis because previous case management rulings had held that it was to be based on the “worst in class” scenario.

GSK had maintained from the outset that the claimants’ pleaded case, relating just to adverse effects on discontinuance, was the wrong approach and that a “holistic” view should be taken in determining the safety of a prescription drug.

After the appeal court ruling, GSK made an application asking the High Court to continue the trial with just one matter: whether it was appropriate in principle to assess whether paroxetine was a defective product by seeking to establish whether it caused adverse effects on discontinuance which were more frequent, more severe, and longer lasting than other SSRIs, and whether the effects made it more difficult to stop taking it.

Two working days before the hearing, the claimants’ lawyers told the court that they would not contest the company’s application and they agreed that judgment should be entered for GSK.

GSK told the court it had run up costs of nearly £9.33m since the case was revived in 2015. Lambert ruled that the claimants should pay the company’s costs. But GSK is expected to apply to the court for an order that the costs should be paid by the commercial litigation funder.

The losing party in the UK will not usually be ordered to pay the full costs incurred by the winning party, but only costs that are reasonable and proportionate to the matter. This is known as the standard basis.

Lambert ordered that part of the total costs to be paid to GSK, for the period from 21 June 2018, should be assessed on a higher than usual basis—the indemnity basis. This means that GSK is more likely to get back the actual costs the company incurred for that period.

The date chosen was 28 days after more than 300 people lost a High Court group action alleging that the DePuy metal-on-metal hip implant was defective.3 In that case the judge underscored the need for a holistic approach.

Following that decision, said Lambert, it was clear that the paroxetine claimants were “pursuing a case which was, quite simply, unarguable” and continuing the litigation was “unreasonable to a high degree.”


Wednesday, July 08, 2020

The #ShowUsYourMeds Project

Image courtesy of Hole Ousia

Professor David Nutt (above) says modern antidepressants are ‘probably the safest drugs ever made

Nothing grinds my teeth more than false information, moreover sloppy journalists who allow selective quotes into the mainstream media from both professionals and the layperson.

Today I was alerted to an article that appeared in the online edition of The Metro. The headline says it all, "I might not be here without them’: Photos help fight the stigma of antidepressants".

The stigma line is thrown around anytime a patient harmed by antidepressants voices an opposing opinion about them. I've been researching them for 16 years during which time I've met fellow safety advocates, none of whom have ever lambasted or ridiculed anyone for taking their prescribed tablets.

Do I think they are dangerous? Yes, I do.
Do I think they are over-prescribed? Yes
Do I think the dangers of taking them are downplayed? Yes

This does not make me, or anyone else for that matter, a critic of those who take antidepressants. I am, however, baffled at some of the responses I see on social media whenever the bad side of antidepressants is debated. 'Pill-shamer', 'antipsychiatry' and, more recently, 'white privilege' are labels that are thrown at the #PrescribedHarm community on Twitter.

The Metro article features an initiative called the #ShowUsYourMeds Project. At first glance all seems fine, if posting selfies of yourself with medication is your thing.

The project, according to The Metro, was launched by Emma Dalmayne "to make people realise they’re not alone but also to dispel a number of myths and misconceptions about antidepressants."

Dalmayne, who is the CEO of Autistic Inclusive Meets, a not-for-profit organisation created by autistic people to enable families with autistic children, talking of some of the experiences people have shared with her said, "A lot of them say they get a lot of crap for taking medication, from relatives, from mates. They say they shouldn’t be taking meds, that they could be out getting exercise and doing yoga." She added, "You can only get up and go outside and do yoga if you’re able to cope with getting out of bed. I think people believe that they will be addicted to them or that they will be a placebo, we know that depression is caused by a chemical imbalance."

I've some news for Emma Dalmayne, depression is not caused by a chemical imbalance. She has been misinformed, by whom I don't know. If by chance she reads this I urge her to contact the Royal College of Psychiatrists (RCPsych) to ask 'is depression caused by a chemical imbalance?' She may be gobsmacked at their answer.

I have nothing against Dalmayne or any of those who have posted photos of themselves with their meds, some of whom are on different cocktails, many of which that raise red flags when taken together. I doubt very much if they are aware of this though. (See 'Same Campaign, Different Name' below)

This is fake news and gives people the wrong impression that they have something wrong inside their head, they don't, not physically anyway.

An article about mental health and depression wouldn't hold any clout if it didn't feature a quote from a key opinion leader. Step forward Prof. David Nutt, himself a members of RCPsych, who speaks in spectacular fashion:

"There are people who don’t want to believe that you can be mentally ill, they like to label everything as a social stigma. They’re a minority but they’re a very loud minority. There are ‘people who believe that you can have a mental illness but they say that they’re psychological rather than physiological and therefore you don’t need to use drugs to treat them, of course there’s some truth in that many people can be helped by psychological treatment but many can’t. There are people who have been on medication treatments who have withdrawal reactions coming off or sometimes funny reactions coming on and these people have become a very vocal group.When you look at the evidence, antidepressants are extremely safe, they’re probably the safest drugs ever made. Most people don’t have problems and most people get enormous benefits from them."

Let me just read that one line again:

"When you look at the evidence, antidepressants are extremely safe, they’re probably the safest drugs ever made."

This is an outrageous statement to make and people, after reading his claim, may be persuaded to take them without first doing their own research, of which I have over 16 years of experience.

Nutt is no stranger to controversy. In 2009, Nutt was sacked from his Government drug adviser position after claiming that ecstasy and LSD were less dangerous than alcohol.

A year later, Nutt co-authored a paper that appeared in the Lancet where he claimed that alcohol was 'more harmful than heroin'.

Maybe he was trying to even the playing field on his previous claim that alcohol was more dangerous than ecstasy and LSD, or maybe he just doesn't quite have his finger on the pulse regarding the dangers of drugs, be they prescription drugs or street drugs.

His comment in the Metro regarding antidepressants being the safest drugs ever made was left unchallenged by the journalist James Hockaday. This is shoddy journalism. Maybe Hockaday should ask Nutt for the evidence he claims exists. Maybe, at the same time, Hockaday can ask Nutt why he did not declare his conflict of interests in the article. History shows that Nutt has received a pretty penny from antidepressant manufacturers GSK, Pfizer, Lilly and Lundbeck, to name but a few.

I doubt Hockaday will challenge Nutt, maybe he witnessed Nutt's response (attack) to journalist Peter Hitchens back in 2011 where he accused the respected journalist of  'baseless alarmism’ about drugs.

It seems a tad strange, to me at least, that Nutt is seemingly worried about the 'very loud minority' who are trying to raise awareness regarding the dangers of antidepressants. It is these people who are often stigmatised by RCPsych members, maybe because they've had it their way for far too long and they don't want anyone, especially former patients, rocking their very lucrative boat.

Same Campaign, Different Name

The #ShowUsYourMeds project isn't new.

Last year Hattie Gladwell, a journalist and columnist, tweeted the following:

This particular hashtag was picked up by former president of RCPsych, (See Hashtag Backfires on Twitter) Wendy Burn who, seemingly, took great delight in retweeting various Twitter users cocktail of drugs.  Burn didn't offer any warning regarding the cocktail of drugs this tweeter was taking.

Here's what reports about the interactions of Lithium, Quetiapine, Venlafaxine, and Mirtazipine:

If I had the time and/or energy I'd take a look at the #ShowUsYourMeds Project selfies with drugs. I'm sure there will be many taking cocktails that have dangerous interactions, interactions that the uploader may not have been warned about. The onus is on them to do their own research, any advice offered by me and other members of the #PrescribedHarm community is met with name-calling by many of the Twitter psychiatrists. (See The Pill Shaming Myth) 

The Metro's article, along with Nutt's outrageous disinformation*, can be read here

Bob Fiddaman

*“Misinformation” vs. “Disinformation”: Get Informed On The Difference

Tuesday, June 09, 2020


Did the headline grab your attention?

Have you just read the headline and not the rest?

Protesters haven't gunned down 50 children but seeing as you're here (probably because you needed to learn more about these fictitious children) - How about showing some concern to the children across the world being put at harm by prescribers who are constantly ignoring the warnings regarding antidepressants.

Not meaty enough for you?

Too complicated for you?

Doesn't really matter because your kids and grandchildren are safe - you'd never let them take dangerous drugs anyway, right?

I've seen the world implode these past few weeks, I've seen so many people hang their hats on causes that mean absolutely nothing to them personally, it just makes them feel good that they are standing up for the rights of other people, all be it from their laptops and mobile phones.

This past year I've seen medical professionals on Twitter goading former and current users of antidepressants. I've seen a suicide expert block users from his Twitter feed who dare to raise the antidepressant suicide link.

And now, today, I've seen a new study released that shows how children are being put at risk of suicide by prescribers. This isn't just an Australian problem, it's a global one. The seeds were sown by drug company trials, the results of which were handed over to PR firms who specialise in turning bad into good (spin)

So many people these days voice their opinions about the media being biased, it's rare for any of them to be upset about children being put at risks of a type of 'medicine'.

Facebook has throw up thousands of viral experts since the news of Covid-19 first broke, thousands of civil rights specialists are now posting on there too, and with news of a suspect in the Madeline McGann's case being announced we now have thousands of detectives on Facebook giving out their opinions as facts.

All the time they are missing the news that is being hidden in plain sight, news that could effect their children or their children's children - it will eventually, particularly if Australian 'specialists' have their way.

Although the following link won't take you to a story based on 50 children being shot, it will take you to a story that is real and has been going on for many years, a story of thousands, possibly millions of children being put at risk of suicide because drug companies want to make money, prescribers are too thick to realise they are being duped, regulators are too weak to speak out about their paymasters (drug companies) and a general public who only seem to be woken up if the cause is political or if  it's easy to find the so-called truth by reading or listening to a conspiracy theorist who has seen this or that or knows someone who works for someone.

Children are being put at risk by a toothless regulator, a medical model that is deeply flawed (psychiatry) and greedy drug company execs whose only interest is making as much money as they can off their products.

Here's the link you should all be clicking and writing about on social media

Sadly, I suspect your viral epidemiology, human rights and detective work may prevent you all from doing so.

Save a life - repost the link.

Bob Fiddaman

Monday, June 01, 2020

Children of the Cure: Who Cares?

I've just finished reading 'Children of the Cure', a book by David Healy, Joanna Le Noury and Julie Wood. 

Although being familiar with much of the content (Paxil Study 329) I did learn quite a lot - the history of antidepressants for one - the jumping through hoops games the BMJ, seemingly, like to play was another.

Many researchers like to revisit clinical trials (studies) and play around with the published findings, these researchers often dispute the original claims. This is all well and good but after reading Children of the Cure I have to ask myself, why bother?

In a nutshell, any available published studies, be they online or in print, are just a snapshot of what really occurred during clinical trials, this snapshot is often spun in such a way that can leave the readers, be they healthcare professionals or members of the public, thinking that something is safe and effective when in actual fact it's the complete opposite. Articles published in prestigious academic journals almost always add weight to the apparent positive outcomes of such trials, these articles are, in turn, used to convince those who are unsure about the safety and efficacy of a drug, namely prescribing doctors and psychiatrists. Such articles boast names of leading figures in particular fields, again this adds weight and is designed to convince journal editors and panel members and also prescribers that everything is hunky dory. It's the first step in dogmatism. It's carefully crafted and intended to plant a seed so deep that when later queried those who have been convinced will either ignore fresh claims, shrug their shoulders or, as in the case of Study 329, forget it ever happened.


In 2015, the BMJ published 'Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence' which was pieced together after a bunch of researchers managed to get access to raw-data from a host of trial centres across North America. The raw-data had never been seen before, in fact the only time raw-data is seen is when trial lawyers request it in discovery - even then, most of the data is redacted (Blacked out)

The RIAT team, which is an acronym of 'restoring invisible and abandoned trials', painstakingly went through data after it was agreed by GSK to grant the team access via an online portal. All seemed fine until the team, consisting of Joanna Le Noury, research psychologist, John M Nardo, retired clinical assistant professor,  David Healy, professor, Jon Jureidini, clinical professor, Melissa Raven, postdoctoral fellow, Catalin Tufanaru, research associate, and  Elia Abi-Jaoude, staff psychiatrist, learned that it was a technological system that was designed to hinder their process, nae progress.

Nevertheless, the team persevered and found discrepancies that involved GSK downplaying suicide events that occurred in the Paxil arm of the clinical trials. One has to keep reminding oneself that these trials were carried out on adolescent children whom GSK were desperately trying to get a licence to 'treat' for their blockbuster antidepressant Paxil, also known by other brand names such as Seroxat, and Aropax to name but a few.

Believe it or not, this wasn't the hardest hurdle the researchers had to jump, that came much later when they submitted their findings to the BMJ. The hoop-jumping game BMJ set out would have left even the most flexible of people tied in knots.

The BMJ 'game' is new to me. I was of the opinion that the RIAT team presented their findings and it pretty much went to print. Reading Children of the Cure will leave you flabbergasted at the lengths the BMJ went to, it appears, to frustrate the team.

It's akin to when one makes an insurance claim. It's standard practice to refuse a claimant in the hope that they will go away, if they don't, well, just throw more paperwork at them and the majority will give up pursuing a claim. The BMJ are no different than these types of insurance companies. There is also the fear factor. One should be ready and willing to publish evidence that points to fraud, especially when that fraud puts adolescents at risk - my understanding, upon reading the book, is that the BMJ constantly bottled it, they thought more about repercussions to their name rather than protecting a vulnerable population.


I've often heard this phrase used whenever 329 is mentioned. 'It came at a time when there were bad eggs operating GSK', another, 'it's all part of how a business is run', the most callous of all being, 'Ok, let's move forward now.' These well-worn phrases might all be well and good if, for example, SSRIs were completely banned for use in children and adolescents, I'm of the opinion that they should be.

But wait, aren't they banned, what about the recommendations? Well, recommending something is not set in stone, just as I recommend you buying this book doesn't mean that you are going to. Children and adolescents are still prescribed SSRIs, not so much Paxil these days because of the bad rap it's had over the years, a large chunk of credit for this must go to BBC journalist, Shelley Jofre who is mentioned throughout Children of the Cure. Shelley's four Panorama investigations basically opened a can of worms, all four shows highlighted how PR firms who specialise in ghostwriting (turning something so bad into something quite wonderful). The four Panorama specials also showed the complete mess that is the MHRA, a British drug regulator who, just like the BMJ are afraid to say boo to a goose for fear of reprisals.

Those that added their names to the now infamous 'Efficacy of Paroxetine in the Treatment of Adolescent Major Depression: A Randomized, Controlled Trial' should hang their heads in shame, as should the Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP)

The FDA and MHRA should also hang their heads in shame, as should Sally K. Laden, the gifted miracle worker who turned shit into gold. ALLTRIALS for practically taking one up the back passage from GSK and allowing them to select what can and can't be seen by future researchers. Prescribers who haven't bothered to look into or request raw-data from drug companies should also take a long, hard look at themselves.

We, in general, should all take a look at ourselves and ask what are we doing about this notorious spin - is it just a piece of history that we all know about but tend to think, pah, it's old news?

History has habit of repeating itself, particularly when apathy is present. Remember, ketamine is the new miracle drug on the market and is receiving many accolades from high profile psychiatrists just as Paxil was by The Marty Keller clan. Keller is an insidious man - the lengths he went to to lose Healy his dream job at the University of Toronto shows how far he was willing to go to keep his sordid (well-paid) secret under wraps.

Children of the Cure by David Healy, Joanna Le Noury, and Julie Wood is published by Samizdat Health Writer's Co-operative Inc. and can be purchased on Amazon US here and Amazon UK here.

Bob Fiddaman

Friday, May 29, 2020

The GSK Covid Vaccine: Will We Be Safe?

Media reports suggest GSK, the British based pharmaceutical giant, are close to producing 1 billion doses of a coronavirus vaccine booster in 2021. Little is known about the ingredients of the vaccine, at least in the mainstream media.

GSK have merged with the French multinational pharmaceutical company, Sanofi.

Between them, GSK and Sanofi have paid out $5,063,939,512 in violation fines, GSK paying $4,422,266,058 (billion) whilst Sanofi come in at $641,673,454 (million)

GSK, who rolled out the Pandemrix vaccine for the last global pandemic, are set to make a pretty penny if they and Sanofi can get the coronavirus vaccine booster past the regulators - this process has been made easier for them due to global drug regulators giving drug companies a rapid path by allowing them to bypass animal testing.

Animal tests are a critical step in vaccine and drug development. Normally, a new vaccine can take anything between 5 to 20 years to develop before it can be made available to the public. Animal tests are carried out to determine safety and efficacy at preventing the disease in question. Regulators, such as the MHRA in the UK and the FDA in the US, usually require that a manufacturer shows a product is safe in animals before it goes into people. 

This from the European Medicines Agency:

"The regulatory workshop was held virtually on 18 March 2020 in the context of the ongoing COVID-19 pandemic. It brought together delegates from 17 different countries, representing more than 20 medicines regulatory authorities globally, as well as experts from the World Health Organization and the European Commission, to share their views on the development of vaccines against COVID-19. The meeting was co-chaired by EMA and the US Food and Drug Administration (FDA)."

The summary report of that meeting can be found here.

Pandemrix: The Swine Flu Vaccine

Research published in the BMJ in 2013 suggested a possible link between the swine flu vaccine given to children in the UK and Europe during the epidemic in 2009 and 2010 and a rare condition called narcolepsy, which causes people to fall asleep suddenly without any warning and at any time of the day.

A further report, also published in the BMJ in 2018, asked the question, 'Pandemrix vaccine: why was the public not told of early warning signs?'

In 2019, an Irish woman, Aoife Bennett, 27, who received the Pandemrix vaccine in school in 2009 as part of a state campaign against swine flu. sued the government after developing narcolepsy shortly after receiving GSK's Pandemrix. The case was settled for an undisclosed amount of compensation to the victim.

This from The Guardian:

"Bennett told RTE on Wednesday that she was active and athletic until being vaccinated in December 2009. About two weeks later the side-effects began, she said. “Things changed very drastically.” She felt “like a sloth” and became fatigued, disoriented and prone to collapse.

"She expressed dismay that it took seven years of legal proceedings to obtain compensation.

"The defendants in the case were GlaxoSmithKline Biologicals, the health service executive, the minister for health and the health products regulatory authority, formerly the Irish medicines board."

Further, in 2017, the UK high court rejected a British government appeal to withhold payments to dozens of British children who developed the sleeping disorder after swine flu vaccines. Six million people in Britain, and more across Europe, were given the Pandemrix vaccine made by GlaxoSmithKline during the 2009-10 swine flu pandemic, but the jab was withdrawn after doctors noticed a sharp rise in narcolepsy among those receiving it.

It all seems pretty clear then that GSK's Pandemrix vaccine caused narcolepsy in some who were administered it. A way to keep such news at bay is to make settlements with those who file lawsuits.

When we look into the Swine Flu pandemic, we can see similarities into what is panning out today in 2020. The same questions should be asked about the safety of any potential Covid-19 vaccine and we shouldn't have to wait until people suffer a severe adverse reaction to it as we did with the GSK's swine flu vaccine.

Incidentally, what do GSK have to say about their product, Pandemrix, causing narcolepsy? Well, only yesterday, in efforts to convince the public that there will be no problem with their new vaccine for Covid, they claimed its previous flu pandemic vaccine, (Pandemrix) which used some of the same ingredients as Covid-19 vaccines currently under development, was not linked to a rise in cases of the sleep disorder narcolepsy

This from RTE:

"A spokesman for GSK said the "science has moved on" since concerns were raised about links between narcolepsy and its H1N1 vaccine, called Pandemrix, which was developed during the flu pandemic 10 years ago. 

"He said evidence now suggests the link is to the H1N1 flu virus itself, not the vaccine. 

"In a statement to Reuters, the company said available scientific data suggest that "the rare occurrence of narcolepsy during the 2009/10 flu pandemic was triggered by the body confusing a protein in the wild type H1N1 flu virus with a human protein relevant in regulating the sleep cycle." 

In 2010, The Daily Mail, a British newspaper, reported on how Drug firms cashed in on scare over swine flu. Dr Wolfgang Wodarg, who at the time was head of health at the Council of Europe, branded the swine flu pandemic as 'one of the greatest medical scandals of the century.'

The 2010 Daily Mail article, which is like a version of Groundhog day playing out, also highlights how Sir Roy Anderson, a scientist who advised the UK Government on swine flu outbreak, held  a £116,000-a-year post on the board of GlaxoSmithKline.

One of the current Covid scientific advisers to the UK government, Patrick Vallance, is the former head of GlaxoSmithKline's vaccine division.

Déjà vu anyone?

Finally, although I cannot prove the authenticity of the claims in  a video that was recently uploaded to YouTube,  an independent journalist claims he has recently been contacted by a GSK whistleblower who  told him vaccines trialled out on women contained an antigen that was shown to cause a 97% increase in infertility. The antigen also allegedly makes men sterile.

The video has since been removed by YouTube but can still be accessed here.

Bob Fiddaman

Wednesday, May 06, 2020

For Sara

Nessun Dorma
"None Shall Sleep"

Bob Fiddaman

Back Stories

Saturday, April 25, 2020

Study 352 - Paxil & Bipolar Documents Released

Dozens of newly-publicised documents now give the full story of GSK’s ghostwriting campaign for a Paxil (paroxetine) clinical trial report on Study 352.

Charles "Bling Bling" Nemeroff

What is Study 352?

A Double-Blind, Placebo-Controlled, Comparison of Imipramine and Paroxetine in the Treatment of Bipolar Depression. The lead 'author' on the study was Charles B. Nemeroff, a psychiatrist who had close ties to GlaxoSmithKline and other drug companies.

Anyone familiar with GlaxoSmithKline and Paxil will know all about the Paxil 329 study where they [Glaxo] hired a PR firm to draft and, later, persuaded key thought leaders, mainly child psychiatrists to endorse and promote Paxil (paroxetine) at any given opportunity. The 329 study has been dissected by many who are in agreement that it's a piece of fraud. Read more about the Paxil 329 study here.

Not content with one study doing the rounds in various journals and paediatric clinics Glaxo, in their infinite wisdom, hired the services, once again, of a ghostwriting team to pimp out a paroxetine bipolar trial, known as Study 352.

"Study 352" was published in the American Journal of Psychiatry (158:906-912; June 2001) and suggested that Paxil may be beneficial in the treatment of bipolar depression. The study, as mentioned above, cited Charles B. Nemeroff as the lead author. The name Nemeroff is synonymous in the ghostwriting and kickback field. He's made a lucrative living out of speaker fees and pharmaceutical roundtables, although this is classed as 'honoraria' [ex gratia payment]

Glaxo hired the same PR outfit, Scientific Therapeutics Information, [STI] to misrepresent information from Study 352. STI also drafted the original Paxil 329 study, specifically Sally Laden. I've wrote extensively about Laden in the past, see here, here & here.

Just like Study 329, Study 352 also made unsubstantiated efficacy claims and downplayed the adverse event profile of Paxil.

Dr. Karl Rickels

The original 352 study made the following acknowledgement:

This study was conducted with the participation of the following collaborating investigators and sites: Jay D. Amsterdam, M.D. (University of Pennsylvania School of Medicine, Philadelphia)

Amsterdam was asked by Dr. Karl Rickels if he could help out a junior colleague, Laszlo Gyulai, on the study. Rickels had been working on pharmacological treatments for mental health since the 1950's and had previously worked alongside Amsterdam.

Rickels had also previously served in the German army under Rommel. He was captured and brought to America as a POW. After the war he completed medical school and postgraduate training in Germany. When a psychiatric residency position opened at a mental hospital in Iowa, Rickels accepted the opportunity and immigrated to the United States. Later he founded the Mood and Anxiety Disorders Section at the University of Pennsylvania.

Amsterdam, who accepted Rickels offer to work alongside Gyulai, was no stranger to industry sponsored studies. According to Peter Simons, a science writer for Mad in America, "Amsterdam was also on industry panels for over a dozen pharmaceutical companies, giving sponsored talks. It wasn’t until the early 2000s that industry representatives began urging him to deviate from his prepared talks. Once he began to experience pressure to “spin” his results in favor of the drug, he said, “I stopped giving talks.”"

Study 352 Newly-Publicised Documents

According to Los Angeles based attorneys, Baum Hedlund Aristei & Goldman, "Amsterdam was an investigator who treated the largest number of patients in Study 352. However, he was intentionally left off from the review of the data and the drafting of the manuscript because the study sponsor, GSK, and the other “so-called authors” knew Dr. Amsterdam’s professional ethics would not allow him to lend his name to a ghostwritten work, and more importantly, he refused to participate in the alteration and manipulation of data for the sake of marketing Paxil.

"In 2011, Dr. Amsterdam lodged a formal scientific misconduct complaint with the U.S. Department of Health and Human Services’ Office of Research Integrity.

"In the 2011 complaint, Dr. Amsterdam alleged the individuals named above allowed their names to be added to a manuscript that was drafted by a “medical communications company” (STI) hired by SmithKline Beecham (now GSK) and misrepresented information from Study 352, which was funded by GSK and the National Institute of Health (NIH).

"The published 352 article falsely concluded that paroxetine therapy is effective in bipolar depression without any meaningful manic or other side effects. According to Dr. Amsterdam’s complaint, the published results were manipulated and manufactured by GSK and STI employees."

Amsterdam alleged that Guylai, had taken his data from the 352 study in which he had recruited the majority of patients, and that Guylai and a team were about to publish an analysis of the data under their own names. In response, Karl Rickels, chief of the mood disorders section of the UPenn Medical Center, told Amsterdam GlaxoSmithKline (then SmithKline Beecham) was in charge of the study and that the authors hadn't even seen the manuscript (CBS News)

Baum Hedlund Aristei & Goldman has now released new documents pertaining to Amsterdam's complaint which include:

  • Sally Laden of Scientific Therapeutics Information Inc. (STI), a consulting firm hired by GSK, was the ghostwriter of a Paxil clinical trial report for Study 352 (and Study 329), which effectively spun negative study results into positive results. GSK paid academics to lend their names to the clinical trial report, published as “Double-Blind, Placebo-Controlled Comparison of Imipramine and Paroxetine in the Treatment of Bipolar Depression” by the American Journal of Psychiatry. GSK wrote and reviewed the report before any of the “official” named authors were contacted for their input. The article has never been retracted despite overwhelming evidence of scientific manipulation.

  • An American Journal of Psychiatry editor with financial ties to GSK abetted the alleged fraud by intervening to ensure “Double-Blind, Placebo-Controlled Comparison of Imipramine and Paroxetine in the Treatment of Bipolar Depression” was published after the manuscript was initially rejected.

  • The University of Pennsylvania, which employs two of the study’s “official” authors, continues to further stonewall investigation into the malfeasance of its faculty in this matter despite numerous attempts on our part to conduct a thorough investigation. The correspondence letters posted on the Baum Hedlund Aristei & Goldman site between the firm, the U.S. Department of Health and Human Services’ Office of Research Integrity (ORI) and the University of Pennsylvania trace the history of events surrounding the alleged scientific fraud of Study 352. It is unclear whether Penn actually submitted the new evidence to ORI as their responses to Baum Hedlund Aristei & Goldman have been ambiguous. Baum Hedlund Aristei & Goldman believe that had ORI reviewed the evidence contained in the 40 STI documents, rather than having relied upon Penn’s investigation, ORI would have come to the conclusion that the academic consultants involved in the 352 trial committed serious scientific misconduct and would have decided in favor of Dr. Amsterdam’s complaint.

Once such document shows how the PR firm, Scientific Therapeutics Information, [STI] has worked on approximately 100 Paxil related projects for GlaxoSmithKline. Another shows a letter from Sally K. Laden to Cornelius (Neil) Pitts who, in 2001, was the Assistant Director, Clinical Research Development at GlaxoSmithKline. In this particular document we see Laden set out the cost of STIs work on the project. The final invoice for ghostwriting Study 352, according to Laden, was $13,286,81.

This letter from Laden to Nemeroff, the nominated lead 'author' for Study 352, shows how Nemeroff would liaise with GlaxoSmithKline whenever Study 352 was criticised.

If you don't feel sick yet then wait until you read the correspondence between Baum Hedlund Aristei & Goldman and the Office of the General Counsel at the University of Pennsylvania, who, it appears, deny there is any wrong-doing!

"The University recognized 
that the authors collaborated with professional writers when drafting the paper and the University concluded that such collaboration in 2001 did not constitute research misconduct. "

All new documents can be found here, GSK Paxil Clinical Trials | Court Documents.

Fid Rant

Sally K. Laden

Regular readers already know my thoughts on GlaxoSmithKline, Charles "Bling Bling" Nemeroff and Sally K. Laden. Three subjects whom, I feel and believe, are totally void of empathy when it comes to the safety of patients.

Payments from GlaxoSmithKline to Nemeroff run into millions of dollars, he is, in my opinion, nothing more than a despicable human being who cares only about the size of his bank balance, he, seemingly, cares not a jot about the safety of patients. Money, and lots of it, has blinkered his rational.  Jay D. Amsterdam, on the other hand, saw the light. He saw how money influenced decisions and put patients at risk. He did the right thing by turning his back on the never ending supply of dollar bills that ultimately meant turning something shit into something smelling of roses.

Laden, and her team at STI, should hang their heads in shame. The 352 Study, which she and her team spun from shit to roses, has been cited many times and used as some kind of half-arsed informed consent to prove that Paxil is safe and effective in the treatment of Bipolar, when in actual fact Laden, at least, knew there were problems. Remember, this isn't the first time Laden has turned Glaxo's shit into roses. She and her team have been paid handsomely time and time again. She has never learned from her mistakes and, like Nemeroff, was never able to see passed the Benjamins. For that sole reason, and the fact that she and her STI team continued to work on projects with GSK, I hold her in complete contempt.

If GSK, Nemeroff and Laden are rotten eggs then what of the University of Pennsylvania? After reading their denials of any wrong-doing, I, personally, have to put them in the same boat as the aforementioned. Protecting their prestigious University name seems to be the issue here, once again it's all, seemingly, about the image rather than protecting the safety of patients.

Drug companies have also paid institutions, such as the University of Pennsylvania, in the past. Pfizer's disclosure report for the University of Pennsylvania, for example, shows Pfizer-sponsored research, totaling $1,199,378. Karl Rickels, who remember persuaded Amsterdam to work alongside Gyulai, on the 352 study, was listed as the principal investigator for a research project with a cash payment of $73,791.

Although there is no evidence to suggest Rickels worked with GlaxoSmithKline on Study 352, it does leave me with my jaw on the floor that a former German POW works amongst the field where patient safety should be paramount.

According to his memoirs, Rickels claims he had no choice but to join the German military. This may be true but having bore witness to one catastrophic event, be it after the event or not, he, seemingly stood by and watched another catastrophic event unfold. It was Rickels who told Amsterdam that GlaxoSmithKline was in charge of the study and that "the authors hadn't even seen the manuscript."

For the second time in his life he, seemingly, stood back and said/did nothing.

GlaxoSmithKline, of course, are the main culprit here but as long as individuals and entities such as Laden, Nemeroff, Rickels and departments within the University of Pennsylvania
 have a desire for money rather than a desire for patient safety, Glaxo and other drug companies will always be able to turn shit into roses.

It's all rather incestuous isn't it.

Bob Fiddaman

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