Monsanto Roundup Lawsuit

Thursday, October 20, 2016

British Drug Regulator (MHRA) Dodging the Curve Ball

throw (sb) a curve (ball)

to surprise someone with something that is difficult or unpleasant to deal with.

Many of you will know by now that the MHRA and I have this love/hate relationship.

The MHRA, for those of you who don't know, are the equivalent of the FDA in the US, Health Canada in, um, Canada, and the TGA in Australia. Their duty is protect the public from unsafe prescription drugs, both licenced ones and ones that are illegally sold, they seem to focus heavily on fake pharmaceutical drugs more than regulate the drugs they have already granted a license to.

So, I've been at loggerheads with the MHRA regarding the whole 'benefit vs risk' ratio that they lay claim to when granting a drug a licence here in the UK.

Many people focus on the risks of these drugs, in fact my own focus used to be on the risks but after stepping out of the bubble and looking in from the outside I saw something that has been staring many of us in the face, yet we've been blind-sided and focused on the risks. We all know what the risks are because these days we are told via the patient information leaflets, albeit in watered down versions.

An old advocate friend of mine, Matthew Holford, was, to my knowledge, the first person to raise the issue regarding the "benefits" of these drugs, namely; SSRI's.

I miss Matt's rantings - he was colorful in the language he used and yet had intelligence that he could use tactically. We still correspond - the guy is a legend.

Anyway, back to the MHRA.

I have asked them a simple question that they have, on numerous occasion, failed to answer. Their latest 'answer' is no different. In fact, it would appear that they are now questioning the English Oxford Dictionary. (I've highlighted in yellow). It would also appear that whoever is answering my emails (they never leave a name) has some form of Avoidant Personality Disorder.

First off, here's the question that they seem to be struggling with...

Please provide me with a "detailed list" that shows the benefits of taking Prozac.
Their previous response to this can be seen here. I questioned that response and they have now replied. Once again, no detailed list of any benefits of Prozac has been sent to me. Once again, they have put "Final response" in the subject line.

Dear Mr Fiddaman

Many thanks for your email concerning our response to your FOI request.

Concerning Question 2, a detailed list of the benefits of taking fluoxetine are presented in the Patient Information Leaflet and the Summary of Product Characteristics for products that contain this active. As we stated in our response, the beneficial effects of the product you specifically mentioned in Question 2 (Fluoxetine 20mg Capsules – PL 17907/0374) have been shown through the clinical data submitted for the grant of the marketing authorisation for Prozac 20mg Capsules (PL 00006/0195). The current list of indications or “benefits” of taking Fluoxetine 20mg Capsules are listed in Section 4.1 of the SmPC, a link to which has been provided below:

Best regards

The FOI Licensing Team.

So, once again, I have had to reply to them. Here's my response.


Dear MHRA,
I'm somewhat confused?
Are you now suggesting that 'indications' and 'benefits' have the same meaning?  I don't really want to enter into a game of semantics, but when I use the word "benefit," in this context, I want to understand how Prozac is going to help me, as the patient, overcome my depression. In other words, what positive thing is going to happen to me, which causes my depression to be alleviated, or else go away altogether?  It is not a clinical benefit to me to know that Prozac may be prescribed for depression - in fact, that information is not a benefit to anybody apart from doctors and drug companies, as far as I can establish.  Do you understand the distinction, between my definition of "benefit," and yours?
I'll cut to the chase, if I may?
I have asked you, the British drug regulator, to provide me a list of benefits, not indications.
Thus far you have sent me links that have not answered my question. In any event, I am asking specifically for a list of benefits from the MHRA and not anyone else.
You licenced a drug and cited that the benefits outweighed the risks. The risks are, as you say, clearly marked in the patient information leaflet that the drug companies provide. I have no interest in what the drug companies say, nor of the risks associated with Prozac. My question was, and still is, to you, the MHRA.
You made the decision to grant Prozac a licence after weighing up the 'benefits and risks', ergo you should be able to provide me with a detailed list of the benefits based upon which you granted Prozac a licence.
Is this going to be a series of emails between us whereby you continue to avoid the question at hand, is this how you treat all stakeholders?
PS - Once again, the subject line from you indicates that this is your 'final response'. Once again, I will decide when my question has been answered adequately, not the other way around.

Bob Fiddaman


I'll let you know when they next send me a reply avoiding the question.

Bob Fiddaman.

Wednesday, October 19, 2016

Paxil, All You Ever Do Is Bring Me Down

Following on from yesterday's series of motions filed by GSK in the Dolin v GSK Paxil induced suicide trial, today sees five more rib-ticklers from the British pharmaceutical giant.

The motions better known in legal circles as Motions in Limine (“MIL”) - To be honest, they should be known as Motions I Find Funny, MIFF, if you will.

Yesterday saw me re-write the lyrics to a classic Motown tune whereby Smokey Robinson and the Miracles, "I Second That Emotion" became, "Go Ahead and Write That Motion."

In this second part of GSK's laughable motions I will be signing off with another classic, this time from the American band, The Mavericks. More on this later.

Yesterday saw me publish the first 5 motions filed by GSK, motions that are designed to win a case that is, seemingly unwinnable from their point of view.

Here's 5 more.

Defendant GlaxoSmithKline LLC (“GSK”) moves the Court in limine for an order excluding from trial certain improper types of testimony by Plaintiff’s purported experts. 
Although Glaxo name three experts for the plaintiff (Dolin), it appears, after reading through this particular 15 page motion, that David Healy seems to be someone they have a beef with. I've already highlighted Glaxo's apparent beef with Healy here and here. In a nutshell, they do not want Healy to give evidence, their reasoning behind this is straight from the school yard. Boo-hoo.

Another gem...

Defendant GlaxoSmithKline LLC (“GSK”) moves the Court in limine for an order excluding from trial certain opinions and hearsay statements by Plaintiff’s expert, Dr. Joseph Glenmullen.
The reason, GSK claim is that Glenmullen intends to claim, as part of his expert opinion, that " Paxil/paroxetine posed a greater increased risk of suicidality than other SSRIs."

Notice the wording? It's basically an admittance that Pail can cause akathisia in adults which can lead to suicide. GSK just don't want their product to be top of the charts, which is a stark contrast to when their promotional team used sales pitches to prescribing Dr's, describing it as safe and effective, better than Prozac (Paxil's main competitor at the time) - They ere happy to be top of the list back then, yet today they'd much prefer that Paxil played second fiddle to the likes of Prozac, Zoloft, Celexa etc.

Having your cake and eating it springs to mind.

Here's a real classic...

Defendant GlaxoSmithKline LLC (“GSK”) moves the Court in limine for an order  excluding from trial any evidence of, or reference to, other claims, lawsuits, governmental investigations or charges, or media reports regarding Paxil.

So, basically GSK don't want the Judge or jury to see Paxil's history of causing birth defects, suicide, homicide, severe withdrawal problems. Furthermore, they don't want the Judge or jury to know about the illegal marketing they carried out with Paxil, a result of which saw them plead guilty to the US Department of Justice. The guilty plea resulted in a record-breaking $3 billion and documents released from that litigation showed how they had...

  • unlawfully promoted Paxil for treating depression in patients under age 18
  • participated in preparing, publishing and distributing a misleading medical journal article that misreported that a clinical trial of Paxil demonstrated efficacy in the treatment of depression in patients under age 18.
  • did not make available data from two other studies in which Paxil also failed to demonstrate efficacy in treating depression in patients under 18.
  • sponsored dinner programs, lunch programs, spa programs and similar activities to promote the use of Paxil in children and adolescents.

Putting the $3 billion aside, Glaxo also don't think it's fair that the Judge and jury see a previous case regarding Paxil and suicide. Tobin vs SmithKline Beecham saw a jury return a verdict of guilty when they were asked to deliberate one simple question. See fig 1. (Click to enlarge)

Fig 1

This request is akin to a request from a defence team asking that an accused murderer be given a fair trial, ergo no mention of the serial killing spree he went on before the crime he stands accused of today, because, well, because that just wouldn't be fair.


Defendant GlaxoSmithKline LLC (“GSK”) moves the Court in limine for an order excluding from trial any evidence of, or reference to, its 2012 plea agreement, civil settlement agreements, and associated documents.

So, they plead guilty to a whole host of violations, including fraud centered around the promotion of Paxil and yet they don't want the Judge or jury to know this? What planet are they from? Do they really think that jury members won't already know about their abhorrent history, do they honestly believe this? GSK's rap sheet extends far beyond the $3 billion fine handed down to them in 2012. In fact, I put three videos together way before the 2012 guilty plea. You can view them here, here and here.

Defendant GlaxoSmithKline LLC (“GSK”) moves the Court in limine for an order precluding Plaintiff from attempting at trial to contradict, dispute, retract, or modify judicial admissions that she has made before this Court, in filings and otherwise.

Hopefully, what's good for the goose, is good for the gander.

I guess a good question would be can Paxil cause suicide - they will answer yes.

Then hit them with the curve-ball - You have known about the suicide link since the early 1990's and, for many years denied it, what makes you think you are entitled to retract statements yet you have filed a motion requesting that Plaintiff be denied that right?

It's a fair enough question, right?


And now some music.

Sing-a-long now.

Lyrics beneath the video.

Paxil, All You Ever Do Is Bring Me Down

I can't sleep a wink anymore
Side effects from Paxil I can't ignore.
Then I just started pacing to forget
But I don't think the worst has happened yet.

All you ever do is bring me down
Turning my whole world upside down.
They all wonder why I wear a frown
That's cause Paxil, all it does is bring me down

It's funny how my whole world fell apart
Paxil changed my mood right from the start
I tried to tell myself I wasn't blue
Yet all along the company, Glaxo, knew.

[Repeat chorus twice]

The Fidericks 2016
Music by The Mavericks

Bob Fiddaman.

Back Stories

Dolin v GSK

Tuesday, October 18, 2016

GSK: Go Ahead And File A Motion - The Paxil Remix

So, here we are again, the latest in the on-going defence of GlaxoSmithKline in relation to Paxil inducing the suicide of an adult, the adult, Stewart Dolin, jumped in front of a train after experiencing akathisia caused by Paxil. His wife, Wendy, filed suit and Glaxo have, it appears, been doing their utmost to disrupt the trial by filing motion after motion. Thus far their attempts have fallen on deaf ears by the trial Judge.

As reported on this blog back in September, the trial Judge has since changed. The previous trial Judge, Judge, James B. Zagel, being replaced for reasons unknown.

Zagel had heard, and tossed, previous arguments and motions from GSK and it now appears that they are going to try, once again, to make an effort to get the new Judge to consider their motions. This just gets better and better!

The motions, known as Motions in Limine (“MIL”) have had me in a state of complete apoplexy, so much so that I've decided to rewrite a Motown classic, more on this later.

Let's take a look at some of these MILS.

First off...

To exclude from trial any evidence of, or reference to, alleged conduct by GSK or Paxil® (“Paxil”) labeling that predates 2004.

You see, prior to 2004, GSK never mentioned anything about Paxil causing some people to kill themselves.

GSK are arguing that, "Nonetheless, GSK anticipates that Plaintiff will attempt, if permitted, to try this case as if  Mr. Dolin had committed suicide many years before he did." (Insert laughter here) Maybe GSK's hired attorneys, King & Spalding, should change their name to McFly LLC.

MIL 2...

Defendant GlaxoSmithKline LLC (“GSK”) hereby files this Motion in Limine to  preclude: (1) any evidence or argument alleging that GSK could have changed the language in the Boxed Warning for Paxil® (“Paxil”) concerning suicidality without prior approval from the  United States Food and Drug Administration (“FDA”); (2) any evidence or argument alleging  that GSK “misled” FDA or violated the Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. §§ 301, et seq., and/or its implementing regulations

So, lets get this straight. GSK don't want a Judge or jury to see evidence that they misled the FDA? Nor do they want the Judge or jury to be witness to any evidence that they (GSK) could have changed the labelling for Paxil without approval from the FDA.

MIL 3...

Defendant GlaxoSmithKline LLC (“GSK”) moves the Court in limine for an order  excluding any argument, testimony, or evidence that GSK had a duty to directly warn patients of  the risks of taking paroxetine.

MIL 4...

Defendant GlaxoSmithKline LLC (“GSK”) hereby files this Motion in Limine to Exclude Any Evidence of or Reference to Its Marketing and Promotion of Paxil®(“Paxil”)

They probably don't want the Judge or jury to see these two internal memos they circulated amongst staff when Paxil was earning them billions in revenue.

Click to enlarge

MIL 5...

Defendant GlaxoSmithKline LLC (“GSK”) moves this Court in limine for an order precluding Plaintiff from introducing certain testimony or evidence relating to the use of Paxil® (“Paxil”) by pediatric patients.

Well, they wouldn't want to answer to evidence about Paxil killing kids now, would they? That would make them out to look bad and we all know tht GSK are squeaky clean when it comes to Paxil studies in children, right? Nor that they hired a ghostwriter to make it look as if Paxil was safe for kids.

Okay, as promised, it's time for a musical interlude. Hopefully you're all still following and haven't yet left the comfort of your computer chair to dry your eyes from the uncontrollable laughter.

Here's the original. (Instrumental)

Sing-a-long with the words below video.

Go Ahead And File A Motion - The Paxil Remix

Maybe to win this trial you'll cheat
But there's no denying your rap sheet.
And maybe you have reasons to stall
Your drug has killed many, after all.

In that case I don't want no part
I do believe that, your lawyers have blackened hearts.
Oh, but if you feel stalling me
If you got the notion
Go ahead, and file a motion.

Oh, but if you feel stalling me
If you got the notion
Go ahead, and file a motion.


Maybe you think that stalling will bring me down
And maybe you think you can run me into the ground.
Maybe you think that I'm just a fool
Knowing all along it was you who broke the rules.

In that case I don't want no part
I do believe that, your lawyers have blackened hearts.
Oh, but if you feel stalling me
If you got the notion
Go ahead, and file a motion.

Oh, but if you feel stalling me
If you got the notion
Go ahead, and file a motion.

Ooh, ooh

Ooh, ooh

Oh GSK, in that case I don't want no part
I do believe that, your lawyers have blackened hearts.
Oh, but if you feel stalling me
If you got the notion
Go ahead, and file a motion.

Oh, but if you feel stalling me
If you got the notion
Go ahead, and file a motion.

Go ahead, and file a motion.
[FADES] - Ooh GSK, go ahead, and file a motion.

Pokey Fiddaman & The Satiricals - 2016
Music by Smokey Robinson & The Miracles

Part II coming soon.

Bob Fiddaman.

Back Stories

Dolin v GSK

Monday, October 17, 2016

Prime Minister of the Netherlands Offers Hope To Sierre Parents

Children from the Sierre coach crash before they left for Switzerland and the ski trip that would end in tragedy.

In a show of common sense and tremendous empathy, the Prime Minister of the Netherlands, Mark Rutte, has given the parents of the Sierre bus crash victims a glimmer of hope in seeking answers as to the medication the bus driver may have been taking or withdrawing from at the time he deliberately crashed a Top Tours bus into a tunnel wall in Sierre back in 2012.

An independent investigation into the crash, carried out by Independent Forensic Services (IFS), showed that the driver, Geert Michiels, made two clear movements seconds before the crash, consciously and with the intention of running the bus into the wall of the tunnel. A previous  autopsy also revealed traces of paroxetine in the system, paroxetine is the generic name of Seroxat, also known as Paxil.

Two photos, taken from a CCTV camera situated in the tunnel show that Michiels mouted a small pavement and deliberately crashed the bus into a wall - at no time did he apply the brakes or make any attempt to steer the bus away from the oncoming wall. (Fig 1 and 2)

Fig 1

Fig 2

A letter sent to Rutte last week from one of the parents, Olga Leclercq, had urged the Dutch PM to intervene with regard to a request made for blood samples of Michiels to be released. The letter stated that the blood samples could be analysed to see if Michiels had a pre-disposition to Seroxat which may have led to the side effects of the drug causing akathisia, which is a known pre-cursor to suicide and acts of violence, including homicide. Basically his DNA will show whether he had a common genetic defect that made him more susceptible to the dangerous side effects of Seroxat.

It's a bold move from the Dutch Prime Minister and one that should be applauded.

Emails to both the British drug regulator, the MHRA, and the European drug regulator, the EMA, have fallen on deaf ears and both have, more or less, washed their hands of the Seroxat link in this crash - their excuse, as one would expect from these limp-wristed outfits, was that Glaxo have a monitring system in place to pick up on suspect adverse drug reactions when mentioned in the media. To date, GlaxoSmithKline, who market and manufacture Seroxat, have made no attempt to contact Douglas de Coninck, the author of the book, 'De busramp in Sierre: 1 Pill, 28 Dead'. The book highlights many facts regarding the state of mind of Michiels and the medication (Seroxat) that he was taking.

Eline - Age 11

One has to praise the tenacity of Olga Leclercq here. She lost her beautiful daughter, Eline (pictured above), in the crash and Olga has since been campaigning to get to the truth. The official investigation was inconclusive, leaving Olga and the parents of 21 other children in limbo.

Here's the letter from Mark Rutte to Olga - (Translated into English)

Dear Mrs, Leclercq, 
Thank you for your Letter dd  1st of Oktober, In which you ask attention for the investigation concerning the bus crash in Sierre. 
The horrible disaster of the 13th of March 2012 is for me, and also for many people in the Netherlands, Belgium and Switzerland, a very black memory.  
The suffering of the parents and other next of kin is of course on a completely different level.  
I understand very clearly, how important it is for them, that everything needs to be done to bring the cause of this crash to light. 
The Ministry of foreign affairs has, in response to your letter, declared to be happy to see how the Swiss authorities can be contacted in order to request them to release a blood sample, in order to make research possible. 
As I understand, you were in touch with Mrs REDACTED and Mrs REDACTED before.
They are also in this case the contacts.
They will contact you directly as soon as they have more information about the possible steps to take.
I realise that I cannot guarantee that these efforts will have the desired results. 
However, I find it of great importance to do everything within the possibilities to find the cause of the crash.
I would like to wish you, and through you all next of kin, a lot of strength. 
Best Regards, -
Mark Rutte

It's evident that Mr. Rutte has something that employees of the MHRA, the EMA and, indeed, GlaxoSmithKline, don't have.


Employees of all three, especially the executives, should today be hanging their heads in shame. Experience, however, tells me that they don't even know the meaning of the word.

It really is high time that this drug was pulled from the shelves given the amount of destruction it has caused since it was first licensed. Suicide, homicide, severe withdrawal, self-harm and birth defects - it's a no-brainer yet regulators much prefer to bury their heads in the sand regarding the safety of Seroxat. It's ignorant and, dare I say it, very cowardly.

It's also incumbent of us all to spread the truth about how antidepressants like Seroxat can cause this condition known as akathisia - it's been kept in the dark for far too long. Men, women and children are dying as a result of its suppression by pharmaceutical companies and global regulators. Plane crashes, bus crashes where the operator of the vehicle suffers akathisia as a result of the medication he/she has been taking ~ Do you, as a parent, really want to send your child off on a school trip not knowing if you'll ever see them again? Ask questions, demand answers - become a pain in the ass - you may just save some lives.

On behalf of truth seekers everywhere I thank Mark Rutte for offering the parents of the Sierre tragedy some hope.

Bob Fiddaman.

Back Stories.

Did Seroxat Trigger the Fatal Sierre 2012 Bus Crash?

Sierre Bus Crash Revisited

For the Sake of the Children ~ Act Now!

Did the Sierre Bus Driver Have a Pre-Disposition to Seroxat?

Thursday, October 13, 2016

Did the Sierre Bus Driver Have a Pre-Disposition to Seroxat?

The bus crash in Sierre is in the news again, at least it is in Holland.

The Telegraf's Jolande van der Graaf has recently highlighted that the parents of the Sierre bus crash victims (22 children) have wrote a letter to Dutch Prime Minister, Mark Rutte,  Belgian Prime Minister, Charles Michel and other various members of parliament. The letter, penned by Olga Leclercq, whose daughter tragically lost her life, is calling for the release of the bus driver's blood samples to determine once and for all whether or not he (Geert Michels) had a poor tolerance to Seroxat. This can be achieved through DNA testing and Leclercq has already employed the services of Independent Forensic Services, Hulshorst, Netherlands to carry out these tests.

Sadly, for the parents of the 22 children who perished, they need to persuade the Swiss authorities to release sample of Michels blood, hence the letter requesting the support of the Dutch and Belgian Prime Ministers.

It's become widely known that Seroxat (paroxetine), marketed in the US as Paxil, can cause suicidal thinking in some people who take it, it has also been proven, in US Courts, that Seroxat was responsible for, not only suicide but homicide too. (Link)

Earlier this year, after briefly meeting Olga in London, I felt compelled to write to both the British and European drug regulators, namely; the MHRA and the EMA, about the involvement of Seroxat in this sad case.. In typical limp-wristed fashion both have passed the buck onto GlaxoSmithKline, the manufacturers of Seroxat, and told me that "Companies marketing SSRIs and the national authorities that approved them will be aware of published reports suggesting that a product may have been linked to a tragic incident."

Journalist Douglas de Coninck, who wrote a book about the bus crash, (THE BUSRAMP IN SIERRE: 1 PILL, 28 DEAD) and who also exposed the fact that the bus driver, Geert Michels, was either on or withdrawing from Seroxat at the time of the crash, has never been approached by anyone from GlaxoSmithKline regarding his findings, which kind of makes a mockery of the statement issued to me from the EMA.

Seroxat, by the manufacturers own admission, can cause a symptom called akathisia, in a nutshell, akathisia is a disorder, induced by SSRI medications, which can cause a person to experience such intense inner restlessness that the sufferer is driven to violence and/or suicide.

Olga has kindly given me permission to publish the letter on my blog. It's been translated from Dutch to English.

Subject: Request for help in obtaining blood sample in connection with Buscrash Sierre 2012.

Lommel, Belgie,
Houten, Nederland,

1 oktober 2016

Dear Member of Parlaiment,

On the 13th of March 2012, a Belgian Touringcar drove head on against a wall in a tunnel in sierra, Switzerland. 28 people died of which 6 Dutch Children and 16 Belgian children. Many survivors are left with permanent injuries. The cause of this declared national disaster was never sufficiently investigated and therefore never found by the Swiss investigators, the case has been formally closed now.

During the investigation it became clear that the driver took Paroxetine, an SSRI-type antidepressant. A possible explanation of this crash could be that the driver was mentally seriously disrupted because of side-effects and that the crash was caused by this.

Paroxetine is known for these effects, Psychosis, Suicide, Akathisia, and violence. Some people have an above average sensitivity for these disastrous side-effects. Indications for this sensitivity can be found in a blood sample (by DNA testing).

During the forensic investigation, a blood sample was taken from the driver. This sample is still being kept by the Swiss authorities. This blood has never been tested for these effects.

For the relatives, who are united under Stichting Busramp Sierre, there is still a lot of uncertainty around the causes of this crash. To take this uncertainty away and to add information to the Paroxetine-file, it is vital to have the above mentioned blood-research take place. It is obvious that this research will have to be conducted in a professional way and in the presence of monitors who are accepted by all the parties concerned. 

For this research we have a strong preference for Independent Forensic Services, Hulshorst, Netherlands, who have a lot of experience in this field. To be able to do this The Swiss Authorities will need to be persuaded to release the driver’s blood.
Therefore we would like to request that you employ your influence to make a research, acceptable for all parties, of the driver’s blood possible. 

We thank you in advance for your cooperation, 

Mw. Olga Leclercq voor stichting Stichting Busramp Sierre.

Dhr. Ogé Kruijt voor Stchting Nederlands Comité voor de Rechten van de Mens.

Enkele referenties:

Stichting Busramp Sierre: 

De bijsluiter van Paroxetine meldt als mogelijke bijwerking zelfmoordgedrag en agressie:

Studie Prescription Drugs Associated with Reports of Violence Towards Others rangschikt Paroxetine onder de medicijnen met het hoogste risico op agressie en geweld:


At the very least, both the Dutch and Belgian Prime Ministers should grant the parents wishes for samples of Geert Michels blood. Twenty Two children died as a result of his actions, actions that have already shown, vi an independent inquiry, that he deliberately drove the bus into a tunnel wall.

Whilst the MHRA and EMA sit shrugging their shoulders, seemingly unconcerned about 22 children dying as a result of a drug they continue to give a clean bill of health, it is, once again, left to bereaved parents to find answers.

As for GlaxoSmithKline, their history of being fruitful with the truth is a poor one - even when found guilty they appeal (as they did in the 2001 Paxil homicide/suicide case.)

I will, of course, keep readers in the loop as this story develops.

Bob Fiddaman.

Back Stories.

Did Seroxat Trigger the Fatal Sierre 2012 Bus Crash?

Sierre Bus Crash Revisited

For the Sake of the Children ~ Act Now!

What is akathisia?

Advocates Against Prescribed Akathisia

Guest Post: Let's Bring Akathisia Out of the Darkness

Friday, October 07, 2016

Classic Avoidance by the British Medicines Regulator, the MHRA

I've just received this via email from the MHRA.

My question to them was one of simplicity. Their answer totally avoids the question. My response to their response has just been sent to them.

Firstly, here's the question I posed them...

A document on the MHRA website, namely; Con126183, claims that "...the benefits of taking Fluoxetine 20mg capsules outweigh the risks, hence a Marketing Authorisation has been granted."

The general public are aware of the risks but could you, the MHRA, please provide me with a detailed list of the benefits that persuaded you to grant a Marketing Authorisation?

Their reply, considering is was treated as a Freedom of Information request, defies belief. Firstly, they put 'Final Response' in the subject line of the email (More on this after you read their reply to the above question)

Fluoxetine has been shown to have beneficial effects in the listed indications for the product referenced above (Fluoxetine 20mg Capsules – PL 17907/0374), through the original data that was submitted from clinical trials conducted by Eli Lilly for the grant of a marketing authorisation for Prozac 20mg Capsules (PL 00006/0195). 

So... here's my reply to their, it has to be said, avoidance in answering my question...

Thanks for this but you have not answered question 2?
I asked you to provide me with a "detailed list" that shows the benefits of taking Prozac and nowhere in your response to me has this list been provided.
PS - I will tell you when any correspondence is "final".


It's a simple question to answer, right? Either they have a list of detailed benefits or they don't.

Bob Fiddaman.

Thursday, October 06, 2016

Paxil Induced Akathisia - Jury Awards $11.9 Million

Paxil (Seroxat) is in the news again, is it ever out of the news?

This time, it appears, we have a clear-cut case of Paxil inducing akathisia which, in turn, led to the induced suicide of a prisoner.

For those who do not yet know what akathisia is, here's two popular blog posts of mine that go into detail about SSRI induced akathisia (here and here)

It's news like this that Paxil manufacturer, GSK, and their highly paid defense attorneys don't want in the public domain, particularly the court documents relating to the case.

I've managed to grab some of those court documents and they are very telling.

Pizza shop owner, Mumun "Marty" Barbaros, 46, (Pictured above) was, in 2009, jail awaiting a preliminary hearing on charges that he vandalized two competing pizza shops.

PrimeCare Medical and several of its employees, who provided medical care at the county jail, were sued by the family of Barbaros for failing to properly evaluate him for suicide risk. Furthermore, the medical provider made mistakes that kept Barbaros from receiving his antidepressants.

The douments from the trial, which I've had access to, show the following...

  • Before entering jail, Barbaros was being treated for depression with Paxil.
  • For the first several days in jail, despite his request, his medication was not given to him.
  • It was during these first few days that Barbaros developed a condition  known as SSRI Discontinuation Syndrome and exhibited withdrawal symptoms.
  • On March 21, 2009, Barbaros received a dose of Paxil, according to court records it was an "inappropriate dosage" (30mg)
  • A day later Barbaros was found in his cell. He had stuffed his shredded T-shirt down his throat and died.

For years GSK, the manufacturer of Paxil, denied there was a link in Paxil usage and adult suicide. Only recently have they updated the patient information leaflet that comes as an insert in Paxil boxes.

They write...

Some patients who take Seroxat (Paxil) develop something called akathisia, where they feel restless and feel like they can’t sit or stand still.

Thing is, ladies and gentlemen, GlaxoSmithKline only ever give patients half truths. The warning on the leaflet means nothing when you learn of the real truth, which is this...

Akathisia is a disorder, induced by SSRI medications, which can cause a person to experience such intense inner restlessness that the sufferer is driven to violence and/or suicide.

Paxil is a selective serotonin re-uptake inhibitor (SSRI)

Now, more from the court documents...

On the day Barbaros was re-administered his Paxil,  he was seen "...pacing the floor and during third shift there is a notation that he exhibited bizarre behavior."

There's no elaboration, in the court documents I've read at least, on exactly what this 'bizarre behaviour' was.

Interesting to note the following though, "pacing the floor".

Let's look at the warning on the Paxil information leaflet again...

Some patients who take Seroxat (Paxil) develop something called akathisia, where they feel restless and feel like they can’t sit or stand still.

So, pacing the floor kind of tell us that Barbaros had, indeed, developed akathisia, which is a known precursor to suicide.

Had the authorities known about this then maybe, just maybe, they would have put Barbaros on suicide watch. Sadly, Glaxo's patient information leaflet for Paxil only gives us half the truth.

Would Barbaros still be alive if Glaxo extended their warning to , "An akathisia sufferer can experience such intense inner restlessness that the sufferer is driven to violence and/or suicide."?

I'm sure, if I was working for a medical health unit and I read that then I'd raise a red flag, wouldn't you? Part of me feels sorry for PrimeCare Medical Inc. If they were going by the patient information leaflet Glaxo wrote then they, like most healthcare providers, would have been completely oblivious to the Paxil suicide link in adults.

Upshot was, Barbaros killed himself. He was deprived Paxil for almost three days, in other words he had missed his regular doses. Skipping doses when taking Paxil can cause severe side-effects, I know, I've personally experienced them. Once again, Glaxo play these horrific side effects down. On his third day in jail Paxil was reinstated but not at his normal dosage. Hours later he is seen 'pacing his cell'. The next day he is found dead - death by induced suicide - prescripticide, if you will.

Shortly after his death, Monroe County Commissioner, Donna Asure, said the death has been ruled a "suicide".

You see, coroners are missing the point. Suicide is an act or an instance of taking one's own life voluntarily and intentionally.

Here's the rub, if a substance can cause a person an intense inner restlessness, so intense that the person is driven to violence and/or suicide then shouldn't we, or indeed coroners, be looking more at that substance?

Surviving family members filed suit in 2011, earlier this week they were awarded  $11.9 Million after a jury found negligence on behalf of PrimeCare Medical Inc. and several of its employees.

At no point were GlaxoSmithKline, or any of its employees, asked to testify.

It's difficult to return a verdict of death by poison as Paxil isn't poisonous - maybe death by Paxil toxicity may be the way forward for coroners when carrying out inquests into 'suicides' where its blatantly obvious that the prescribed drug played a major role. Or maybe, just maybe, they can start using the terminology, "death by induced akathisia caused by X,Y, or Z."

To date, the CEO of the British drug regulator, Dr Ian Hudson, has not retracted any of his statements in a deposition he gave in the year 2000. Hudson claimed, at the time, that he did not believe that Paxil could induce akathisia. (Video deposition)

Barbaros leaves behind a wife, Miryem, and two children.

At the start of next year Wendy Dolin, widow of Stewart Dolin, goes to trial in Illinois. Wendy alleges that Paxil caused akathisia in her husband. Moments before jumping in front of a train witnesses said they saw Stewart 'pacing the platform in an agitated manner.'

Open and shut case if you ask me.

Your move GSK.

Bob Fiddaman.

Monday, October 03, 2016

For the Sake of the Children ~ Act Now!

A post grabbed my attention earlier on Facebook.

The post was from Olga Leclercq, mother of 11 year-old, Eline (Pictured)

Here's Olga's post. My comments and research follow...

I lost my beautiful, sweet and lovely 11 year old daughter in March '12. 

The bus driver was withdrawing from Seroxat at that time, not gradually but just took half his original dosage in the few weeks before the crash. According to a statement in the media by his widow, he had not taken his medication that day. 

On the 13th of March '12 he drove his bus into a concrete wall in the tunnel in Sierre at 100 km/h, killing himself and 27 others. 

22 children, 4 teachers and his colleague died that evening, 24 children survived but are traumatized for life. 

She was on her way back from an 8 day school trip to Switzerland with her classmates and children from another school. 

We (a group of parents) kept asking the Swiss authorities to investigate a possible suïcide, they refused to do so repeatedly. 

The case is closed now and to the outside world it was just an accident, we hired independant forensic experts who confirmed our fears, it was a deliberate act. He had to make a few complicated steering manoeuvres to be able to end up against the wall the way he did. 

We need the truth to come out, there is no way we can raise awareness about the dangers of these drugs when horrible cases like this one are being swept under the carpet.

Journalist Douglas de Coninck wrote a book about the bus crash in (THE BUSRAMP IN SIERRE: 1 PILL, 28 DEAD) unfortunately it's in Dutch, but we will try to have it translated to English someday soon. 

Photo's: my daughter Eline, the bus drivers marriage photo (3 months before the crash, also before changing his dosage), the last 40 metres of the trajectory (done by Swiss investigators) and the cover of Douglas' book. 

The truth needs to be told, because our children still matter and we want to help save lives in the future.


I have wrote about the Sierre bus crash on this blog here, and here.

I've even wrote to both the British drug regulator and the European drug regulator, namely the MHRA and the EMA. Both have passed the buck. In the case of the EMA I posed the following question to them...

Now you are aware that Seroxat (paroxetine) is suspected to have played a part in the 2012 Sierre bus crash, can you tell me if information regarding the implication of Seroxat has been forwarded to GlaxoSmithKline via the EMA?

Their response was typical of a regulator devoid of any compassion and common sense...

Please also note there are robust systems in place to pick up and evaluate suspected side effects. Companies marketing SSRIs and the national authorities that approved them will be aware of published reports suggesting that a product may have been linked to a tragic incident.

In others words, we don't know if Glaxo are aware of it, but if they are they will carry out their own investigation. If Glaxo aren't aware then we, as a drug regulator, do not feel we need to bring it to their attention.

It's criminal that we have such limp-wristed regulators in place - remember, these are the people that regulate the drugs you and I take.

I've been in touch with journalist Douglas de Coninck whose own investigation implicated Seroxat - not once have GlaxoSmithKline made any attempt to learn of his findings - safe to assume then that Glaxo haven't bothered investigating the Sierre bus crash themselves.

Eline, along with 21 other children perished on that fateful day. Evidence has revealed that the bus driver, Geert Michels was either taking or withdrawing from Seroxat. Scientific evidence shows us much in this case - Michels drove deliberately into a wall. Scence also shows us that Seroxat can, for some people who take it, induce akathisia. Glaxo define akathisia (on the Seroxat patient information leaflet) as thus...

Some patients who take Seroxat develop something called akathisia, where they feel restless and feel like they can’t sit or stand still.

And that's basically it. What Glaxo fail to mention is this.

Akathisia is a disorder, induced by SSRI medications, which can cause a person to experience such intense inner restlessness that the sufferer is driven to violence and/or suicide.

Two recent posts on my blog have, collectively, amassed almost 4,000 hits in recent weeks, both cover the subject of akathisia. (1) (2)

The MHRA, EMA and GlaxoSmithKline want the investigation into the Sierre bus crash to go away - they don't want questions being asked. We owe it to the beautiful Eline to keep asking questions.

Bob Fiddaman.

(1) Advocates Against Prescribed Akathisia
(2) Guest Post: Let's Bring Akathisia Out of the Darkness

Tuesday, September 27, 2016

Guest Post: Let's Bring Akathisia Out of the Darkness

Sometimes a person comes into your life for all the wrong reasons - I've had it happen to me on numerous occasions - Neil and Rhonda Carlin (Parents Sara), Leonie Fennell and Tony Donnelly (Parents of Shane) - Stephany Gatchell (Mother of Sharise), Stephanie McGill Lynch and her husband John (Parents of Jake) - there have been many more.

No surprise, given the line of work that I do, that another parent who has suffered the heartache of losing her child to antidepressant induced suicide (prescripticide) and I should cross paths.

Kristina Kaiser Gehrki is a mother on a mission. Her story (below) is not uncommon. Pharmaceutical companies, medicine regulators, the majority of psychiatrists and even family doctors will have you believe that these are isolated incidents, yet, more and more people that I meet tell me similar stories ~ be they of losing children, siblings, parents, partners or friends to induced antidepressant suicide.

Suicide Organisations have a huge duty to protect the vulnerable (not just those who are depressed and who feel suicidal) ~ they need to put something in place that prevents the alarming number of people who die each year by suicide - they include the most vulnerable (those who find themselves caught in the system of ignorance and ill-informed professionals)

Kristina is a terrific writer, please make sure you read about her daughter, Natalie (Link to Natalie's story embedded in text below) - Yes, it's heart wrenching but it's something we cannot, nor indeed, should not, ignore.

As with all of the names above, I wish Kristina and I had never met, the only reason we have is because of another needless death ~ having said that, I truly value our friendship, as I do with those above. Not only do they share the inapt link of having lost loved ones to antidepressant induced suicide, they also share an amazing gift, an overwhelming love and compassion to make sure this doesn't happen to other loved ones - it's an act of unselfishness and we should all recognise and acknowledge that when reading and sharing their stories.

I hope one day to meet Kristina, I feel as though I already have.

Kristina, I salute you.

Bob Fiddaman.


Let's Bring Akathisia Out of the Darkness

By Kristina Kaiser Gehrki

    On February 6, 2013, my nineteen-year-old daughter died from akathisia-induced “suicide” two days after taking 200 mg. of Zoloft, the maximum legal dose allowed. Natalie's doctor increased the drug over the phone, without ever seeing Natalie. Natalie was tortured for years by doctors who prescribed drugs she didn't need. You can read her story here.

At the time of her death, Natalie was suffering from SSRI-induced akathisia. I later spoke with the American Foundation for Suicide Prevention's (AFSP) chief medical officer to discuss how AFSP might increase akathisia awareness. Their response prompted my open letter.

September 27, 2016

An Open Letter to Christine Moutier, Chief Medical Officer of the American Foundation for Suicide Prevention (AFSP)

Dear Dr. Moutier,

Remember me? I'm the Virginia mom who arrived home after a typical day of teaching high school to find my teenage daughter dead from violent, self-sustained injury. When I called you, and we spoke about Natalie's death, you requested her photo. Here it is. She was a beautiful person.

Sorry for the delay in providing Natalie's photo. Given that you're a trained psychiatrist, you likely understand navigating such profound grief takes time and energy. There is no “real recovery” from burying a child who died an avoidable death. But that's not what delayed sharing Natalie's picture. Let me explain.

As I shared on the phone, Natalie's death wasn't a typical suicide. At the time of her death, she was suffering from serotonin toxicity and akathisia, two life-threatening side effects of SSRI drugs. She was also a writer, who even up to the end, tried to make sense of what was happening to her. Here's a note left on her nightstand.

I now know upper GI bleeding is one of many listed adverse side effects of SSRI drugs. Other side effects Natalie suffered include a change of gait, memory loss, insomnia, crawling skin, violent nightmares, extreme agitation and anxiety, swollen throat, uncontrollable shaking, sensitivity to light, diarrhea and headache. She thought she had the flu, which is what Natalie texted to friends.

Walgreen's Walks for Natalie

At the time of her death, Natalie worked in the Walgreen's beauty department while attending college. (Although she worked steps away from the product that would lead to her death, Natalie's Zoloft prescription was filled at another pharmacy because of our insurance provider.)

When Walgreen's coworkers asked to organize an AFSP  “Out of the Darkness” walk for Natalie, I was initially reluctant because I knew her death was precipitated by akathisia. By this time, an international medical expert had been consulted and determined Natalie's demise and death were caused by the two Zoloft increases and the doctor's care. Nevertheless, we held the AFSP walk for Natalie since there was no walk for "Akathisia Awareness," or "Adverse Drug Reactions."

People who die from self-sustained injury while suffering from SSRI-induced akathisia don't end their lives because they are depressed. Rather, patients who end their lives while experiencing the acutely discomforting symptoms of akathisia likely feel that “death is a welcome alternative.” (Source)

Here's a photo from 2013.

Back to Our Phone Conversation

Given that prescribers repeatedly failed to share akathisia information and the FDA Black Box warnings, I had never heard of akathisia before Natalie died. But you had. Akathisia is not as rare as the public is led to believe.

When I asked about akathisia, you confirmed your knowledge. After I shared akathisia precipitated Natalie's death, you quickly inquired about Natalie's “illness.” I explained that despite years of medical “care,” Natalie's doctors never provided a specific diagnosis. I stated Natalie's symptoms included an increased focus on dieting and exercise. You replied that people with “eating disorders” often have a higher rate of suicide. That might be true, Dr. Moutier, but Natalie did not have an eating disorder: She had akathisia. 

I informed you that—over the phone, without seeing her patient—Natalie's doctor increased Zoloft to 200 mg., the maximum dose legally allowed. I shared that her doctor stated Natalie “was not depressed” and told Natalie to take more Zoloft due to “OCD-like symptoms.” Many doctors misdiagnose the symptoms of akathisia and instead blame this SSRI side effect as a sign of some worsening illness. They then wrongly increase the dosage of the offending drug, causing their patient's further demise. 

I asked if AFSP supports prescribing Black Box drugs over the phone. You replied that people who live in rural areas might not otherwise have access to see a doctor for prescriptions. While not relevant to my family as we live in a metropolitan area, it begs the question: Does AFSP support the FDA prescribing guidelines for SSRIs? These guidelines clearly state patients should be closely monitored, and caregivers informed to watch for and report any unusual changes in behavior whenever SSRIs are started, stopped or a dosage changed. As a former military wife, I am concerned about the high suicide rate among our troops, many of whom are prescribed SSRI Black Box drugs with no close monitoring. 

Your Call to Remove Black Box Warnings

After our phone conversation, I wondered why a suicide prevention organization dedicated to understanding and preventing suicide, seems to deny that akathisia causes suicidal thoughts, suicidal actions and suicide itself. (Akathisia can also cause violent harm to others.) My shock increased in June 2014, when you publicly called for an end to the SSRI Black Box warnings. (Source)

Other medical research seems to escape AFSP advocacy. In June 2016, it was reported most antidepressant drugs don't work for kids. It received national coverage, but I did not see AFSP publicizing these findings. (Most Antidepressants Don't Work for Kids, Study Finds ~ NBC News)

My Call for Akathisia Awareness & Action

It's too late for me to save my daughter. It's too late for anyone to save my daughter. But it is never too late to save others by bringing akathisia out of the darkness. Therefore, we made new signs for our AFSP walk earlier this week. I also share Natalie's akathisia-induced death on my AFSP story page.

Here are photos from 2016

Many other families who've lost loved ones to akathisia also advocate for education and awareness. They include victims of all ages. (see We can't raise the kind of money AFSP takes from pharmaceutical companies. But together we can raise akathisia awareness so that healthcare consumers and practitioners can avoid such tragedy.

I ask people to help AFSP bring akathisia “out of the darkness” simply by:

Dr. Moutier, thank you for taking my previous phone call. I've learned a lot since Natalie's passing. Above all is that a mother's love doesn't die with her child, it is simply refocused.


Kristina Kaiser Gehrki


Tuesday, September 20, 2016

Ex L’Oréal Marketeer To Take Over From Witty

Emma Walmsley, 47, is to take over the reigns from GSK's Andrew Witty on April 1, 2017 - Yup, April the first folks.

Who was it that said, "This shit just writes itself?"

Walmsley, according to the Guardian, is a married mother of four and was born in Barrow-in-Furness, Cumbria.

I don't want to dwell on this - I just hope she can show more compassion then her predecessors.

Bob Fiddaman

Guardian - Emma Walmsley profile: from marketing at L'Oréal to GSK chief

Monday, September 19, 2016

Advocates Against Prescribed Akathisia

Akathisia - now there's a word.

It's a word that should be spread far and wide, a word that should be...but sadly isn't.

The pharmaceutical industry and, indeed, global medicine regulators and, to an extent, the field of psychiatry, play it down. Your average Dr probably doesn't even know what it is, even if he/she has heard the term before they probably don't know exactly what it means, more importantly, how dangerous induced akathisia can be. If the symptoms of akathisia occur on one SSRI many doctors just assume the patient can't tolerate that particular SSRI and end up giving them another brand - It's ignorant and unprofessional, more importantly, deathly!

So, what is it and why is important that the definition of akathisia be spread far and wide?

As always, it's best to leave it to the experts on matters like these. Not psychiatrists, not pharmacologists who work for the pharma funded regulators, but survivors of those who have witnessed akathisia first hand.

One such person is Wendy Dolin (pictured) whose husband, Stewart, experienced akathisia shortly before ending his life. The akathisia, according to a lawsuit, was induced by Paxil, the antidepressant that Stewart was taking shortly before killing himself.

Wendy is the founder of Medication-Induced Suicide Prevention and Education Foundation in Memory of Stewart Dolin (MISSD). Part of that education is to teach about akathisia.

The 'What is akathisia?' page on MISSD cuts straight to the chase...

"Akathisia is a disorder, induced by SSRI medications, which can cause a person to experience such intense inner restlessness that the sufferer is driven to violence and/or suicide."

It's really that simple - no messages of "Well, it's difficult to explain and unknown if it's caused by SSRi's" - the kind of nonsense one would get back from Dr's, regulators and pharmaceutical helplines.

Akathisia is dangerous and can ultimately lead to acts of violence, including homicide, and/or completion of suicide. It's ironic that the very same pill prescribed to prevent thoughts of suicide actually induces thoughts of akathisia, which is a pre-cursor to suicide. The one small grain of hope one can take from this is that it's evident. So, a loved one of yours starts or misses a dose of any SSRI and starts to feel an inner restlessness is a sure sign that he/she is in turmoil, such a turmoil that they may drive themselves to carry out an act of violence (sometimes homicide) and/or kill themselves.

Wendy, whose story I've covered countless times on this blog, is a network member of  USA Safe Patient Network, a group of ordinary people who focus on the safety and efficacy of medical treatments. In the next few days the USA Safe Patient Network will release their monthly newsletter in which the spotlight is thrown on her advocacy work with regard to getting the message out about akathisia.

Wendy talks openly about why she became an advocate and even offers advice to those just starting out on their journey regarding raising awareness about non efficacious and unsafe prescription drugs.


It's all about preventing the unimaginable folks and Wendy does so with a void left in her life. Her husband did not have to die - he did not intentionally jump in front of a train - he was pushed by the hands of a drug company who were well aware of the akathisia link many years ago but decided to underplay the risk and keep it in-house.

USA Safe Patient Network looks like a fairly decent place to join and discuss patient safety. Kim Witczak, who lost her husband, Woody, to Zoloft induced suicide, is also a member. More about Kim in a future post. This remarkable woman goes head to head with medicine regulators out in the states and is recently back from Washington after meeting with FDA officials regarding the anti-smoking cessation drug, Chantix, also known as Champix ~ known amongst a lot of truth tellers as 'yet another suicide pill'. Anyway, more on Kim's advocacy work at a later date.

In the meantime, if you are sharing this post, be it on Facebook or Twitter, be sure to use the hashtag #Akathisia.

Bob Fiddaman.

Saturday, September 17, 2016

Lariam Pulled From Sale in Ireland

RTE News are reporting today that the anti-malarial drug, Lariam (Mefloquine), has been withdrawn from sale in Ireland.

Side effects reported with Lariam include, but are not limited to, aggression, paranoia, suicidal thinking, completed suicide.

Lariam is no stranger to controversy and a number of pending legal actions in Ireland is, according to manufacturer Roche, not the reason why it has been withdrawn.

According to Roche, "Lariam was taken off sale following "a portfolio reassessment" by the company."

They add that "it remains available in 16 European countries."

Slightly worrying.

Back in August 2015 I wrote to the British drug regulator, the MHRA, regarding the number of associated completed suicides on Lariam, a figure I pulled from the MHRA database.

They told me...

"Of the nine UK spontaneous suspected ADR reports of suicide associated with mefloquine, I can confirm that three of the cases were followed up by the MHRA with either the reporting doctor or family member. Two cases were reported to us by pharmaceutical companies and so follow-up was conducted by the Marketing Authorisation Holder.
"The remaining four cases were received between 1998 and 2002 and as such were previously stored in our legacy ADR database. We do not hold records of follow up letters to cases from our legacy database and can confirm that we have no record of any further communications regarding these cases."

Remarkably, the MHRA continue to give the antidepressant, Seroxat, a clean bill of health despite it being reported that there have been  65 reports of completed suicide via the MHRA database. Lariam, to date, has 12 reports of completed suicide associated with its use.

Lariam (Mefloquine) Roche
12 reports of completed suicides (MHRA)

Seroxat (Paroxetine) GlaxoSmithKline
65 reports of completed suicide (MHRA)

Lariam removed from sale in Ireland.

Seroxat still prescribed in Ireland.

The current CEO of the MHRA is Dr Ian Hudson.

Before joining the MHRA Dr Hudson was the Head of World Safety at GlaxoSmithKline.

Do the maths!


Just sayin'

Bob Fiddaman.