Zantac Lawsuit

Researching drug company and regulatory malfeasance for over 16 years
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

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