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A High Court trial was to start in February 2011 but the action was put on hold after legal aid was withdrawn and 369 claimants dropped their cases.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.”

--

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 drugs.com 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

BREAKING NEWS: PROTESTERS GUN DOWN 50 CHILDREN

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

https://www.frontiersin.org/articles/10.3389/fpsyt.2020.00478/full?fbclid=IwAR2iJVcn13j9stBg7k1j8CPkD564ipiI8pULztq_5tYZNq1G_YyQRhRxAvg

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

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.

RIAT

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.

IT DOESN'T MATTER ANYMORE - IT HAPPENED IN THE PAST

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

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

For Sara

Nessun Dorma
"None Shall Sleep"

Bob Fiddaman

Back Stories

Sara Carlin - 'Death by Paxil' Inquest

Exclusive - Sara Carlin Inquest - Day 1 June 7, 2010

Exclusive - Sara Carlin Inquest - Day 2 - June 8, 2010

Sara Carlin Inquest - Latest

Sara Carlin Inquest: Failure of the Oakville Medical Profession

Sara Carlin Inquest – Failure of Oakville Medical Profession

Sara Carlin – ‘Death by Paxil’ Inquest – The ‘Expert’

Sara Carlin Inquest – Coroner’s Witness In U-Turn… And That Man Shaffer!

SARA CARLIN Ontario, Canada

Coroner’s Inquest – Glaxo & Friends Vs The Carlin Family

Sara Carlin Inquest – Local MP Slams GlaxoSmithKline

SARA CARLIN PAXIL INQUEST VIDEO FOOTAGE

SARA CARLIN PAXIL INQUEST GLOBAL TV NEWS

SARA CARLIN INQUEST - What The Jury Should Know

Sara Carlin Inquest - "Paxil likely played important role in teen's suicide"

Sara Carlin Inquest - The Eli Lilly 'Links' & Today's Recommendations.

**Exclusive - Sara Carlin Inquest: The Bias Of Coroner's Counsel, Michael Blain & Coroner, Bert Lauwers

Sara Carlin Inquest - We Know How, Now Tell us Why!

**Exclusive - Sara Carlin Inquest - Jury Returns With Recommendations

Sara Carlin Inquest - The Influence of Terence Young

**EXCLUSIVE - SARA CARLIN INQUEST – JURY VERDICT ANALYSIS by Neil Carlin

10 Years of Blogging - Q&A With Neil Carlin

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

The Lancet Publishes Scaremongering 'Study' Amid Covid19 Crisis

Published: April 15, 2020
Multidisciplinary research priorities for the COVID-19 pandemic

The Lancet

I've read it.

It's based around one word.

Here are my thoughts.

What the published authors claim:

We explore the psychological, social, and neuroscientific effects of COVID-19 and set out the immediate priorities and longer-term strategies for mental health science research.

What this blog has found:

Mental health 'scientists' claim:

"As scientists continue to investigate the brains of people who have mental illnesses, they are learning that mental illness is associated with changes in the brain's structure, chemistry, and function and that mental illness does indeed have a biological basis." (1)

This claim has been debunked many times by professionals in the field. See here.

What the published authors claim:

"We urge UK research funding agencies to work with researchers, people with lived experience, and others to establish a high-level coordination group to ensure that these research priorities are addressed, and to allow new ones to be identified over time."

What this blog has found:

Prediction published March 30, 2020 (2 weeks prior to the Lancet paper being published)

It will be claimed that many have detachment-type disorders and new phobias. Mourning the loss of loved ones will continue to be deemed as a mental disorder if that mourning process goes beyond two weeks. Psychiatric 'medication' prescriptions will increase as will cases of autoimmune diseases, ironically caused by some of 'medications' prescribed. (2)

What the published authors claim:

"Discovery, evaluation, and refinement of mechanistically driven interventions to address the psychological, social, and neuroscientific aspects of the pandemic are required."

What this blog has found:

A distinction must be made here between what a psychiatrist does and what a neurologist does.

A psychiatrist claims to focus on and treat symptoms originating in the brain that lead to abnormal voluntary functions, i.e; human behaviours, whereas neurologists focus on and treat symptoms originating in the brain that produce abnormal involuntary functions.

Confused? I was at first until I looked closer.

One treats symptoms that "lead" to abnormal voluntary functions whilst the other treats symptoms that "produce" abnormal involuntary functions.

So, a psychiatrist treats something that isn't fully manifested whereas neurologists treat something that has manifested. They do this by using technology, usually in the form of Computed tomography (CT) or computer-assisted tomography (CAT) scans, magnetic resonance imaging (MRI), electroencephalography (EEG), nerve conduction studies and electromyography (NCS/EMG), and lumbar puncture (LP) for cerebral spinal fluid analysis.

Most psychiatrists use the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) to diagnose mental health disorders. (3)

The DSM is a manual whereby 'mental health diseases' are voted on by panel members. No technology, such as those used by neurologists, are ever used.

What the published authors claim:

"Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, might infect the brain or trigger immune responses that have additional adverse effects on brain function and mental health in patients with COVID-19."

What this blog has found:

The above looks impressive until you read that they had to add one word. If you blink you'll miss it. It's a word often used in the field of psychiatry and basically means one of two things - [1] It does [2] It doesn't. It covers both bases but only ever talks about one of them.

The word in the above sentence you are looking for is "might."

The published Lancet article hinges on this one little word, a word that sees authors push for more funding. It's a bit like you or I going to the bank for a loan and telling the bank manager that we wish to borrow money for an investment that may or may not (might) bear some fruit.

The common theme running throughout the Lancet paper seems evident, to me at least.

Imagine, if you will, the scene from Oliver Twist. You all know the one, right?

'Please Sir, I want some more'
(Lancet references to funding)

Like all good articles in the media do, they start off with the main message and finish reiterating that message. This Lancet publication is no different.

"New funding will be required to meet these priorities, and it can be efficiently leveraged by the UK's world-leading infrastructure."

"Research funders and researchers must deploy resources to understand the psychological, social, and neuroscientific effects of the COVID-19 pandemic."

"We propose a framework for the prioritisation and coordination of essential, policy-relevant psychological, social, and neuroscientific research, to ensure that any investment is efficiently targeted to the crucial mental health science questions as the pandemic unfolds."

"Given the need to develop the research priorities rapidly to inform immediate funding priorities."

(Final paragraph) "New funding will be required to meet these priorities, and it can be efficiently leveraged by the UK's world-leading neuroscience and mental health research infrastructure. The UK must connect with international funders and researchers to support a global response to the mental health and neurological challenges of this pandemic."

If the begging bowl references don't alarm you then the published piece, you'll find, is littered with words and phrases that are designed to scaremonger, more so than the media are doing with reference to Covid19.

It's quite shocking to see some of the tactics used in this paper based on something that may or may not ever happen (might)

Here's just a small example of scare tactics used by the authors:

"The need to maintain high-quality research standards is imperative."

"An immediate priority."

"There is an urgent need."

"Must deploy resources."

"The research community must act rapidly."

"Growing threats to mental health."

"Clear immediate priorities."

"Need to be repeated more rigorously."

"A risk that prevalence of clinically relevant numbers of people with anxiety, depression, and engaging in harmful behaviours (such as suicide and self-harm) will increase."

"The potential fallout of an economic downturn on mental health is likely to be profound."

"A major adverse consequence of the COVID-19 pandemic is likely to be increased social isolation and loneliness (as reflected in our surveys), which are strongly associated with anxiety, depression, self-harm, and suicide attempts across the lifespan."

"The immediate research priorities are to monitor and report rates of anxiety, depression, self-harm, suicide, and other mental health issues both to understand mechanisms and crucially to inform interventions."

"Data will be vital to determine causal mechanisms associated with poor mental health."

"The digital response is crucial."

"Paramount importance."

Now, if you, like me, have received criticism on Twitter from members of the Royal College of Psychiatrists for raising awareness about the "interventions" they speak of in this Lancet paper, you'll understand why I'm bringing all of the above to the attention of my readers.

This paper is designed to grab funding. Unlike poor young Oliver Twist, they haven't even said, "please."

The covid crisis has been an eye-opener for someone like me. I am fascinated by people-watching. I tend to watch a lot before engaging, I like to weigh up a person. There have been many media reports of people cashing-in during this crisis, you know, local shopkeepers hiking the prices of toilet paper and hand sanitizer. Many people who are ignoring government guidelines are also in the news.

What I've seen from the mental health field is no better than those selfish idiots and greedy shopkeepers as they push their agendas that covid can cause mental health problems. Nope, it will just cause behavioural problems as people adjust to their new normal. It's not a brain disorder nor will it manifest into one. Mental Health big-wigs have seized this opportunity with both hands, hence the need for them to create a problem that isn't there and then try to convince people that it may happen and to tackle it they need funding.

Oliver only wanted more porridge because he was hungry. Mental Health, it appears, want more, much more, to feed their egotistical appetites.

Hey, don't get me wrong, I'm all for sticking someone under a scanner to determine if their brain is or isn't working properly, I just don't think one can determine a brain default by box-checking a guide that was voted on by a bunch of white-coated men who "might" have just been influenced by drug company money.

Multidisciplinary research priorities for the COVID-19 pandemic: a call for action for mental health science can be read here.

Only one of the authors (panel members), Prof Clive Ballard, PhD, reports grants and personal fees ~  from Acadia and Lundbeck; personal fees from Roche, Otsuka, Biogen, Eli Lilly, Novo Nordisk, AARP, and Exciva; and grants from Synexus

Bob Fiddaman

(1) NIH Curriculum Supplement Series 2007

(2) Mother Nature (Mother Earth) and the Invaluable Lesson

(3) How to Diagnose a Mental Health Disorder

Common International Collaborative Platforms Needed for Covid Research

Following on from "Your Drugs May Pose A Greater Risk Than Your Covid" comes another important video. This interview, as with the first, is part of the #COVID19Chronicles.

Journalist, Frank Barat, and  Dr. Joan-Ramon Laporte discuss Hydroxychloroquine, the anti-malarial drug made popular recently by President Donald Trump, clinical trials, and polypharmacy (the simultaneous use of multiple drugs by a single patient, for one or more conditions.)

I've extracted some of the comments from Dr. Joan-Ramon Laporte, these are not verbatim due to time constraints on my part.

The video is worth sharing, so please share across social media platforms and to anyone you know currently working at hospitals etc.

Here are some of the comments by Dr Laporte.

According to the product characteristic label, Ibuprofen can worsen infections or mask infections.

Hydroxychloroquine (anti-malarial) has been mostly used for autoimmune diseases, which have nothing to do with viruses. It has some anti-viral action in the laboratory, in-vitro (taking place in a test tube, culture dish, or elsewhere outside a living organism)

50 clinical trials have recently been started with hydroxychloroquine, none of the researchers or pharmaceutical companies wish to share their information with other researchers or other pharmaceutical companies. The sacred cows of clinical research are still there.

The hydroxychloroquine 'experiment' in Marseille, France, was not a clinical trial as it had no comparators (no placebo group) One or two patients died but were excluded from the analysis.

The World Health Organisation (WHO) need common international collaborative platforms for clinical research.

WHO need to identify all the other drugs we are taking for other indications, like antidepressants, antipsychotics, analgesics, opiates, to see to which extent these drugs can affect your probability of getting the disease (Covid19)

In many countries many old people, who are those most vulnerable to the disease (Covid19) are taking many drugs, for example, in the UK 30% older than 65 are taking 10 or more drugs every day. This is a very dangerous cocktail, not only because these drugs can interact with one another, but also because many of these drugs increase the risk of getting pneumonia. Once a person gets the disease (Covid19) they can develop a more severe form of it depending on the drugs they are taking at the time. The fewer drugs you take, the less your probabilities of getting Covid19, this is important, particularly for elderly people.

If you have a fever and the fever is not bothering you, let the fever be because fever is a defence mechanism of our body, it's not something bad.

Bob Fiddaman

"Your Drugs May Pose A Greater Risk Than Your Covid"

Fresh off the press. Such an important video. This interview is part of the #COVID19Chronicles.

Please share far and wide. We owe it to ourselves and our loved ones.

This video struck a chord with me as I posed the following question on Twitter last week, a question that we should, I feel, all be asking.

The video, below, is an interview between journalist, Frank Barat, and Dr David Healy.

Healy's words resonate and make you wonder if this is another reason why the coronavirus fatalities in the elderly are high. Maybe this is something scientists need to be looking into as it may give them insight as to why certain people get severe cases of the Covid19 virus compared to others.

Polypharmacy 
Polypharmacy is the concurrent use of multiple medications by a patient. Polypharmacy is most common in the elderly, affecting about 40% of older adults living in their own homes. ... Definitions have ranged from two medications at a time to 18, or to more medications than clinically necessary.

"A lot of these drugs, from antidepressants to pain killers to all sorts of other drugs, may compromise our immune system to make us more vulnerable to catching Covid and the other thing they can do is they can compromise the body's ability to fight back if we get Covid making us more likely to get pneumonia. When you look at the people who seem to be dying it's older people and particularly people who are in residential homes who are on a whole lot of drugs, sometimes it seems just to keep them quiet rather than treat an illness." ~ Dr David Healy, psychiatrist, psychopharmacologist, scientist, and author

Bob Fiddaman

Medications compromising Covid Infections

Zantac (Ranitidine): The Heartburn Carcinogen

Earlier this week the US Food and Drug Administration (FDA) requested that manufacturers pull all prescription and over-the-counter ranitidine drugs, known by the brand name Zantac, from the market immediately. Zantac was given US approval in the early 1980s.

The FDA has determined that levels of  N-nitrosodimethylamine (NDMA) in the heartburn medications increase over time and when stored at higher-than-normal temperatures, pose a risk to public health.

According to the FDA's announcement, letters are now being sent to all manufacturers of ranitidine requesting that they withdraw products from the market, and consumers are advised to stop taking any ranitidine tablets or liquid medications they currently have. As a result of this immediate market withdrawal request, writes the FDA, ranitidine products will not be available for new or existing prescriptions or over-the-counter (OTC) use in the U.S.

Sanofi, one of the companies that produces the Zantac brand, stopped doing so in October. It said in a statement that “We take this issue seriously and continue to work closely with the F.D.A. to evaluate any potential safety risks associated with Zantac.”

Ranitidine was launched in the UK in 1995 as an OTC product. At the time the recommended dosage of the product was one tablet, although if symptoms persisted for more than one hour another tablet could be taken. Consumers were told, "the maximum recommended daily dose is four tablets."

The British drug regulator, the MHRA, is not following in the footsteps of their American counterparts. In October last year, they stated, "the health risk of discontinuing the medicine is higher than the potential risk presented by the contaminant N-nitrosodimethylamine."

Los Angeles trial lawyers, Baum Hedlund Aristei & Goldman, PC, who are in the process of filing lawsuits, state on their website, "Mounting evidence allegedly shows that Sanofi and Boehringer Ingelheim, the big pharma companies that make Zantac (ranitidine hydrochloride), concealed the Zantac cancer link from millions of people who took the drug for heartburn, gastric and duodenal ulcers, gastroesophageal reflux disease (GERD), sour stomach, Barrett’s esophagus, acid reflux, and other issues. This deception came as the companies made unprecedented profits from Zantac, the first drug to generate $1 billion in sales."

Baum, Hedlund, Aristei & Goldman attorney R. Brent Wisner discusses the latest revelations surrounding the popular drug Zantac (ranitidine). How did the FDA find out about the link between Zantac and cancer? What do Zantac and rocket fuel have in common? Is Zantac causing a cancer epidemic? Wisner answers your Zantac questions in this short video.

If you, or anyone you know, developed cancer after taking Zantac please contact Baum Hedlund here.


Bob Fiddaman