Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist
Showing posts with label TopTours. Show all posts
Showing posts with label TopTours. Show all posts

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.

Compassion.

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:
http://stichtingbusrampsierre.nl/ 

De bijsluiter van Paroxetine meldt als mogelijke bijwerking zelfmoordgedrag en agressie:
http://db.cbg-meb.nl/Bijsluiters/h28418.pdf

Studie Prescription Drugs Associated with Reports of Violence Towards Others rangschikt Paroxetine onder de medicijnen met het hoogste risico op agressie en geweld:
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0015337

--

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











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, August 09, 2016

2012 Sierre Bus Crash - Further MHRA Correspondence







Last month I wrote to both the British and European drug regulators regarding recent evidence that has surfaced in Douglas De Coninck's book, De busramp in Sierre: 1 Pill, 28 Dead. In short, the book centres around the 2012 bus crash that happened in the Sierre Tunnel, A9 Autobahn, Valais, Switzerland and alleges that the driver, Geert Michiels, 34, was in a destructive relationship and had also been medicated with GlaxoSmithKline's Seroxat. The generic name for Seroxat is paroxetine and it is better known in the US and Canada by its brand name Paxil and in Australia and New Zealand as Aropax.

My email to both medicine regulators can be read here (Email to Medicine Regulators Regarding 2012 Sierre Bus Crash)

The MHRA have now replied. As yet I have still not received a reply from the European regulator.

The MHRA reply is below ~ My follow-up questions follow the two page MHRA letter.


Click image to enlarge.






My reply to their response...

Dear MHRA,

Thank you for your recent correspondence.

I have some follow on questions that may or may not be deemed to fall under the Freedom of Information Act. If they do, then please treat them as such.

The study you refer to in your last correspondence with me, 'Suicidality and aggression during antidepressant treatment: systematic review and meta-analyses based on clinical study reports' showed that a number of clinical study reports were used of a wide range of antidepressants, one of which was fluoxetine. These reports, according to the published paper, were obtained from European and UK drug regulators.

Q1: You claim in your letter sent to me, ref GENQ-00113734, that Sharma's findings were "consistent with the outcome of previous regulatory reviews."
Given that fluoxetine was one of the antidepressants used in the Sharma study, do you still maintain that it is a safe and effective treatment for use in adolescents?

Q2: In the third paragraph of the letter you sent me you state, "With regards to your comments on the Yellow Card Scheme, this is a national scheme that collects reports for reactions occurring in the UK and therefore we cannot complete a report based on the book reference you have provided; De busramp in Sierre: 1 Pill, 28 Dead. As part of their pharmacovigilance responsibilities however Marketing Authorisation Holders are expected to monitor medical and scientific literature which discusses potential side effects to their products and to report these to the relevant national competent authorities as appropriate."

Now that you have been made aware of the De busramp in Sierre: 1 Pill, 28 Dead book, will you, as a regulator, be making any efforts to contact the Marketing Authorisation Holders regarding the findings of the author?

Q3: In Sharma's study the authors state that they had "only partial access to appendices with no access to case report forms, the harms could not be estimated accurately."

Based on this statement, have the MHRA or the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency had complete access to all appendices and case report forms?

If yes, could you please forward me all appendices and case report forms that Sharma et al never had access to.

If no, can you explain how a safety review panel (MHRA or the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency) can make an accurate decision when appendices and case report forms are missing.



Bob Fiddaman.


Related stories.

Did Seroxat Trigger the Fatal Sierre 2012 Bus Crash?

Sierre Bus Crash Revisited

Email to Medicine Regulators Regarding 2012 Sierre Bus Crash





















Monday, July 18, 2016

Email to Medicine Regulators Regarding 2012 Sierre Bus Crash







I have just fired off the following to the British drug regulator, the MHRA and the European regulator, the EMA.

I'm anticipating a response that will show a complete lack of compassion.

--


Dear regulators,

On the 13 March 2012 a bus crashed in the Sierre Tunnel, A9 Autobahn, Valais, Switzerland killing 28, 22 of them were children. 24 others, all aged between 10 and 12, were injured, including three who were hospitalized with severe brain and chest injuries.

An enquiry into the crash proved to be inconclusive but it emerged that the driver, Geert Michiels, 34, did not apply the brakes after he mounted a mini pavement in the tunnel and drove head on into a wall.

It has also emerged that Michiels was, at the time of the crash, either taking or withdrawing from paroxetine.

More in-depth information can be found in Douglas De Coninck's book, De busramp in Sierre: 1 Pill, 28 Dead. Sadly, the book is only available in Dutch print at this present time.

My questions to you all are thus:

Do you not think enough is enough now? The internet is littered with similar stories of people killing themselves or carrying out acts of homicides whilst on psychiatric medication (prescripticide).

The Sierre bus crash is one of many such incidents.

You, as regulators, have a duty to safeguard human health so accidents such as Sierre should have, at the very least, raised red flags when you monitor news items via the internet. I know you monitor my blog so it's safe to assume you monitor many other websites when prescription medication is mentioned - or do you just monitor websites that are critical of your regulation (if you can call it that) of prescription medication?

22 children died! Does this not register with you at all?

Do you intend to investigate this matter or just add it to your database without following up?

Your yellow card reporting system, as I believe, does not take anecdotal reports when in actual fact anyone filling out a yellow card report is basically telling you something anecdotal.

On behalf of all of those who died in Sierre I would like for you or any department that may monitor the media to file a yellow card report for this crash. All evidence points to the driver having taken or withdrawing from paroxetine which, as you are ALL aware of, can cause psychotic episodes.

What is the point of having regulators who shrug their shoulders when incidents such as Sierre occur?

22 children and four adults died, many of the children were thrown from the windows of the bus, even though they were wearing seatbealts, such was the impact of the crash. Some of the children's fatal injuries were so bad that they could not, at first, be identified.

At the very least you, as regulators, should be trying or proposing laws be changed with regard to operating public vehicles whilst under the influence or withdrawing from antidepressant type medication.

The public perception of medicine regulators is one which borders on presumptions that you are limp-wristed, powerless and in the pockets of the pharmaceutical industry. One only has to look to see who the CEO of the MHRA is and who his previous employers were, ironically the same employers who market and manufacture the very same drug that has been implicated in the Sierre bus crash.

What are you going to do, are you going to continue quoting an expert meeting of SSRi's took place many years ago and they were given a clean bill of health back then or are you going to actually get your hands dirty on this and start your own investigation - if only to help those affected by this tragedy.

Sitting back and watching is cowardly - I assume many of you have children or grandchildren of your own - if anything, you owe it to them to investigate the Sierre bus crash!

I'm a blogger and have carried out my own investigation, translating the Dutch media articles into English and also making contact with the author of De busramp in Sierre: 1 Pill, 28 Dead. If a blogger can do this then you, with your financial clout (provided by the pharmaceutical industry) should be able to do it.

I fear I may be urinating in the wind here because my past experiences when meeting the MHRA has been one of total dejection in as much that the MHRA give the impression that they just don't care if SSRi's cause suicide and homicide.

Stop allowing these medications to kill the people you were put in place to protect!

Did Seroxat Trigger the Fatal Sierre 2012 Bus Crash?

Sierre Bus Crash Revisited



Sincerely,

Bob Fiddaman
Author/Blogger/Researcher





Sunday, July 17, 2016

Sierre Bus Crash Revisited







Douglas De Coninck is the author of De busramp in Sierre: 1 Pill, 28 Dead. The book centres around the 2012 bus crash that happened in the Sierre Tunnel, A9 Autobahn, Valais, Switzerland and alleges that the driver, Geert Michiels, 34, was in a destructive relationship and had also been medicated with GlaxoSmithKline's Seroxat. The generic name for Seroxat is paroxetine and it is better known in the US and Canada by its brand name Paxil and in Australia and New Zealand as Aropax.

Sadly, De busramp in Sierre: 1 Pill, 28 Dead is only available in Dutch print, something that I will be calling for to be changed as the story within is of a massive public interest regarding antidepressant medication and induced psychosis. It's a book that, I believe, needs to be widely distributed and read by the public and healthcare professionals alike.

Douglas De Coninck is an investigative journalist at De Morgen, a Belgian newspaper. He lives and works in Brussels.

Background


There were 52 on board, 28 people perished, 22 of them were children. The other 24 pupils, all aged between 10 and 12, were injured, including three who were hospitalized with severe brain and chest injuries.

A full investigation into the crash was carried out by Swiss Chief Prosecutor Olivier Elsig, the results of which were inconclusive. He ruled out the involvement of a third party, shortcomings in the road surface or the tunnel infrastructure. Excessive speed, alcohol or technical problems with the vehicle were also ruled out. He, at no point, could determine whether or not Geert Michiels carried out an act of homicide/suicide with the vehicle. In fact the final report leaves more questions than it does answers.

Douglas De Coninck became interested in the story and carried out his own investigation. He has kindly given me permission to publish segments of his book (in English).

On October 05, 2015 I published my own findings on the crash in Sierre. I had painstakingly translated Dutch newspaper articles so I could get to grips with the investigation. My findings, which can be read here, included me sending an email to TopTours, a small family run  Aarschot-based coach company who owned the coach Michiels was driving on that fateful evening of  13 March 2012. Top Tours failed to respond to my email which was, in essence, a couple of questions, namely;

Do TopTours have any protocol in place where driver's are either... 
a) required to let TopTours know that they are on medication?
b) required to stay off work until they have finished their course of prescription medication?

Douglas De Coninck has since informed me that the TopTours owners grasp of English isn't that great and that my email could have been deleted. Douglas, however, has provided me with the chapter from his book that covers these questions that I had previously asked.

TopTours, like many transportation companies, including airline companies, are stuck in a quandary when it comes to issues regarding the operators of their vehicles.

This extract from De busramp in Sierre: 1 Pill, 28 Dead...

(Tom is manager of TopTours)


Since Sierre Tom asks his candidates for honest answers to the question of whether they take medication. "I'm obviously powerless," he says."What will you say when your boss asks you whether you are taking medication and you know that your job depends on it?"

Tom is right and this is something that needs to change not only with coach/bus companies but with airlines too. Lest we forget Germanwings Flight 9525 where co-pilot Andreas Lubitz, who it has since been learned had been on a cocktail of psychiatric medication, deliberately crashed the plane into the French Alps, killing all  144 passengers and six crew members.

Lubitz, according to the New York Times, was treated from January 2009 to that October with at least two drugs, the SSRi Lexapro (escitalopram) and the antidepressant Remeron (mirtazapine)

Interestingly, the NYT substantiates the statement made by Tom from TopTours with...

"There is also evidence suggesting that Mr. Lubitz might have tried to mislead the F.A.A. about his treatment, initially marking “no” in response to a question on whether he had ever been treated for mental disorders on a form dated June 2010."

The FAA are the agency responsible for the advancement, safety and regulation of civil aviation, as well as overseeing the development of the air traffic control.

One can see here how difficult it is for bus and airline companies when trying to determine whether or not operators of their vehicles are either under the influence or withdrawing from psychiatric medications. This is a law that needs changing. Requesting medical notes from applicants for newer vacancies is, one would imagine, quite simple but it's the current workforce where this proves somewhat difficult.

After negotiations with an employment advisor and my former employers, Land Rover, I was allowed to return to work on light duties. My job was basically checking visitors in and out of the factory. As the call for security lessened I was given plastic sheets to cut. Three guesses what happened next? With a Stanley blade I deliberately cut my hand, not bad enough for stitches as I recall, nonetheless, it required treatment from the on-site occupational health centre. I don't know why I cut myself ~ the whole episode is just a blur. Did I mention that I was taking 40mg of Seroxat at the time? I had reduced the dose for fear of oversleeping and missing my early alarm call for work, also rushing out of the house in the morning to catch my bus to work...and forgetting my box of Seroxat.

So, if the bus driver, Geert Michiels, was taking or withdrawing from Seroxat at the time of the crash his employers, just like my employers, would be none the wiser. Moreover, even if my employers knew I was taking Seroxat chances are they wouldn't have seen it a problem by handing me a Stanley blade given that Seroxat manufacturers, GlaxoSmithKline, robustly defend the accusations that Seroxat can cause people to self harm, just as they defend that Seroxat can cause acts of homicide and suicide in adults that take it. What chance did TopTours have?

As I mentioned, TopTours are a small family run business who knew their employees on a personal level. With regard to Michiels here's another extract from De busramp in Sierre: 1 Pill, 28 Dead...

(Evy is Michiels' wife)

Tom was the only one who knew that Geert and Evy were married. "He spoke to me one day, asked me to promise to not say anything about it. To tell nobody at all. To me he had to say it, you need that kind of information for payroll. I found it a bit weird. Normally this is something festive, wedding, but okay,  I didn't think about it, later on. Yes, afterwards, of course."
On March 6, 2013, a year after the tragedy, the eyes fell upon Tom and Katia when an interview with Michiels' wife, Evy, featured  in the weekly magazine Knack. There she repeated it again, that this was supposed to be one of his last shuttles for Toptours "He was planning to stop the end of March, to do me a favor," Evy is reported saying.

However, this is something that TopTours deny. Here's Tom, TopTours manager, again...

"Three weeks before the accident, Geert came to us to ask if there was the possibility to come and work here as a full-time driver. He had heard that one of our drivers would leave since he was moving. We told him that he had to realize that he could not earn here what he earns at De Lijn (his other job), and now he was able to combine the two. He then said that he was looking for a new job and that it was his dream to become a coach driver. This has also been stated by several drivers in the firm."

So, why did Geert Michiels tell his wife he was resigning when in reality he had asked TopTours if he could go full-time for the company?

This extract from De busramp in Sierre: 1 Pill, 28 Dead...

A few weeks after the accident Tom and his wife, Katia, went to visit Evy. After she read out a letter at the funeral in Heverlee where she said it was still unclear who was behind the wheel, and that was repeated in Het Laatste Nieuws, they hoped that they could make her stop lying (she was told the first day that Geert was driving). 
They met in the flat in the Amerstraat in Aarschot. She told Tom and Katia that she hoped they could have contact with his (Geert's) daughter, because she often went with three of them to the zoo. (This was a lie)

Further information in De busramp in Sierre: 1 Pill, 28 Dead, shows evidence where Evy is less than fruitful with the truth. It's author, Douglas De Coninck, told me that Evy also made Geert believe that she was pregnant, only a few days before the crash, however, when Tom and Katia had visited her at her flat in Aarschot weeks after the accident, she told them that she had suffered a miscarriage, adding, "It's better that way."

De Coninck, also told me...

"Evy was instrumental in the split between Geert an his original wife and 4 year old daughter, she also took him to her own doctor who prescribed Geert Seroxat after a 20 minute consultation. They married in September 2011, but Geert wanted to keep that as a secret. Evy was also instrumental in separating him from his family, he hadn't seen or spoken to his brother and parents for over one and a half years.

"Just before the crash he tried to quit Seroxat.
.
"Earlier in the book, I published text messages I found in the court files, showing how she (Evy) tries to control him day and night. He needs to respond immediately, even if he's on the road in the middle of the night in Italy. On his last shuttle, the one before Sierre, he doesn't answer any of her messages, which drives her wild.

"Geert didn't see his 4 year-old daughter for more than a year, according to family members.

"Evy also made him believe that she was pregnant, only a few days before the crash.

"This is a taboo subject in Belgium and that is why meeting Tom and Katia of Toptours made me so happy. Their testimony was a missing key in my research."

De busramp in Sierre: 1 Pill, 28 Dead is available only in Dutch print. It's paramount that this book be published in English too and not hid away from the eyes of the world. Hopefully, De Coninck can convince his publishers that the subject matter is of as much importance to English speaking people too.

It would, of course, be beneficial if GSK or the European Medicines Agency (EMA) carried out their own investigation, however, the word beneficial means something totally different to these two entities.

A huge thank you to Douglas De Coninck for allowing me to republish segments of his book.



This post is dedicated to the 28 people who perished, 22 of them children.


Rust in Vrede.





Bob Fiddaman








Monday, October 05, 2015

Did Seroxat Trigger the Fatal Sierre 2012 Bus Crash?








Sierre, Switzerland, March 2012

There were 52 on board, 28 people perished, 22 of them were children. The other 24 pupils, all aged between 10 and 12, were injured, including three who were hospitalized with severe brain and chest injuries.

The exact cause of the crash has never been determined. The driver, Geert Michiels (34), also perished in the crash. An investigation showed that Michiels was not intoxicated.

A full investigation into the crash was carried out by Swiss Chief Prosecutor Olivier Elsig, the results of which were inconclusive. He ruled out the involvement of a third party, shortcomings in the road surface or the tunnel infrastructure. Excessive speed, alcohol or technical problems with the vehicle were also ruled out. He, at no point, could determine whether or not Geert Michiels carried out an act of homicide/suicide with the vehicle. In fact the final report leaves more questions than it does answers.

Michiels had driven the coach through a tunnel, he mounted the curb, made no attempt to apply the brakes, and crashed head-on into a short wall. Photographs of the scene were taken by one of the parents whose daughter was killed in the crash. Her photo's, taken whilst visiting the tunnel sometime after the tragedy, show how Michiels mounted the pavement and made no attempt to steer the coach back into the road, opting instead to drive straight into a wall. (Photos here)

Just by looking at the photos of the scene one has to ask why Michiels did not steer the bus to the left upon mounting the curb. One also has to ask why he never took his foot off the accelerator and, more importantly, never applied the brakes. As humans we have a basic instinct of survival, it kicks in when our lives are put in danger. Imagine, if you will, a pool of water. You are swimming blissfully when an undercurrent starts to pull you down. Do you fight for survival or do you just relax and let the current pull you under?

Michiels mounted the curb (Fig 1) and continued to travel at a rate of 99/101km (about 62mph) - I refer to my pool analogy - what happened to Michiels survival instinct?



Fig 1

If fig 1 has you thinking why didn't Michiels steer to the right then you'll be surprised that the 3D image comes from the original investigation. It has fallen under heavy criticism from the parents of some of the victims. 

This from Foundation Busramp Sierre, a group calling for independent research to be carried out into the crash.

"This is a 3D reconstruction that has been released by the Swiss authorities in connection with the study, on which the trajectory of the bus in the veiligheidsnis is displayed. However, this 3D reconstruction is incorrect. In this image, the distance between the bus and side wall must have been a half bus width (approximately 1m25). The actual distance between bus and side wall was not even 25 centimeters."

The actual width of the pavement can be seen in Fig 2. As you can see it would have been quite easy for Michiels to steer to the left to avoid the oncoming wall (Fig 3)



Fig 2



Fig 3







The autopsy results of Geert Michiels (above), revealed that his left coronary artery was blocked at least 60 percent due to fat deposits. This disease (atherosclerosis) can lead to heart rhythm disturbances or even a heart attack. The autopsy also revealed traces of paroxetine in the system, paroxetine is the generic name of Seroxat, also known as Paxil.


According to information Michiels had been taking Seroxat for several years, he had been prescribed it as, at the time, he was going through a divorce. However, he was, at the time of the accident, in the process of tapering off. (more on this later). Furthermore, during the initial investigation, it was learned that Michiels took the drug for two years and that the standard dose was reduced by half in early 2012. The intention was to eventually phase out the use completely. If the standard dose was 20mg then a reduction of 10mg could possibly have been too drastic.

Unsatisfied with the findings of  Swiss Chief Prosecutor Olivier Elsig, the parents of some of the children, who died in the crash, employed the services of the Dutch-based forensic agency Independent Forensic Services (IFS).

IFS found that Michiels made two clear movements seconds before the crash, consciously and with the intention of running the bus into the wall of the tunnel.

“The driver at no time lost control of the steering wheel,” IFS researcher Selma Eikenboom told Dutch TV. “He made those movements consciously, with some force. Then he drove straight on for several seconds and into the wall. That’s not something you do if you’re feeling faint.” Asked if this demonstrated his suicidal intent, she said. “That’s a conclusion you may draw for yourself. This is technical evidence that speaks for itself.”
According to Dutch lawyer Job Knoester, acting for the parents, Michiels’ medication, Seroxat or paroxetine, has been implicated in cases of suicide and serious aggression aimed at others. “If you know that, then the matter has to be investigated,” he said. “It seems as if the Swiss didn’t want to look into the question at all.”
Armed with this new evidence the parents applied to the Swiss courts, in essence they wanted the investigation reopened. The federal tribunal dismissed the appeal.

Lawyer Job Knoester from The Hague, counsel for some parents, said after the dismissal of the appeal, "The parents want to know why their children died." He added that the Swiss court never carried out their own reconstruction of the disaster and no research had been done on the side-effects of Seroxat.

Don Schell

In February, 1998, Don Schell (60), a non-violent family man and doting grandfather, took a .22 calibre pistol and a 357 magnum in the middle of the night and shot dead the three people in the world dearest to him - his wife Rita, his daughter Deb and baby Alyssa. Then he killed himself.

In 2001, a jury of five women and three men ruled that taking Paxil was the proximate cause of the deaths of Schell and his wife, daughter and granddaughter. The jury ruled that GlaxoSmithKline, the manufacturers of Paxil, were 80 percent responsible for the deaths. It held Schell 20 percent responsible. (Source)

Geert Michiels holds all the answers to the fatal Sierre coach crash, yet, it appears, nobody is willing to investigate the link between Seroxat and homicide/suicide. Nobody is willing to allow Michiels to give his version of events from beyond the grave.

Swiss Chief Prosecutor Olivier Elsig's final report told us nothing, in fact, the report just tells us what didn't cause the crash. Investigations like this are all about eliminating so one can arrive at a conclusion - the report was inconclusive. At no point, has Elsig investigated the possible link between Seroxat and homicide/suicide, it begs the question, why?

Geert Michiels was employed by De Lijn Vlaams-Brabant, a company run by the Flemish government in Belgium to provide public transportation. The coach he was driving on that fateful evening was owned by TopTours in Belgium. I wrote the following email to them...

Dear REDACTED,
I am doing some research into tour bus driver protocols with regard to driving whilst under the influence of prescription medication.
Do TopTours have any protocol in place where driver's are either...
a) required to let TopTours know that they are on medication
b) required to stay off work until they have finished their course of prescription medication.
I have more questions but this will do for now.
Thanks in advance for your reply.
Regards

TopTours failed to reply.

I find it quite remarkable that the investigation failed to look into the fact that Michiels was tapering from a drug known to cause severe withdrawal problems, problems that have been, for years, downplayed by the manufacturer, GlaxoSmithKline. In fact, it recently came to light that Glaxo had known about the withdrawal problems (in adults) for some years, but failed to carry out their own clinical studies into this problem, furthermore, they kept this information from the public (See Seroxat - Project 1059 Laden With Withdrawal Problems)

If reports are correct that Michiels dosage of Seroxat had been halved in efforts to wean him off then we have a potential time bomb. The reduction of Seroxat by half was poor advice. I, myself, struggled tapering off Seroxat - it took me around 19 months just to taper from 40mg per day to 22mg per day - I was using the liquid formulation of Seroxat and tapering by just 0.5 mg per week. In the end, I went cold turkey and suffered horrendous side effects, one of which was seeking confrontation - I actually went out into a country park in the early hours of the morning looking/hoping I would encounter trouble. It's all detailed in my book, The evidence, however, is clear, the Seroxat scandal.

Furthermore, Michiels and his wife, Evy Laermans, were allegedly at loggerheads with his decision to drive coaches. Michiels worked part-time but had, unbeknownst to Laermans, asked the coach company if they could offer him a full-time position. Laermans knew nothing about this as her speech at a commemoration for the victims shows. She said that Geert was giving up and that he was killed during one of his last trips. (Source)

Could the disagreements between Michiels and his wife have led to him deliberately crashing the coach, could this irrational thinking have been brought on by the reduction of Seroxat?

Going cold turkey on Seroxat is not recommended, the side-effects are too severe. And here's where the investigation failed.

This from Michiels wife...

He (Michiels) had taken no pill taken before the accident.

Michiels was in withdrawal, this fact is unquestionable.

The current patient information leaflet for Seroxat says..

Possible withdrawal effects when stopping treatment.

Side effects.

  • Feeling dizzy, unsteady or off-balance
  • Feeling anxious
  • Feeling restless or agitated
  • Tremor (shakiness)
  • Feeling confused or disorientated
  • Visual disturbances

The patient information leaflet is written by GlaxoSmithKline, there is no mention of Seroxat causing completion of suicidal or homicidal acts in adults. They do, however, say...

Some people have had thoughts of harming or killing themselves while taking Seroxat or soon after stopping treatment. Some people have experienced aggression while taking Seroxat.

"Soon after stopping treatment" is the key here.

If Michiels, as his wife suggested, had stopped taking his treatment then, even the manufacturer of Seroxat claim, "Some people have had thoughts of harming or killing themselves while taking Seroxat or soon after stopping treatment."

Why was this overlooked by Swiss Chief Prosecutor Olivier Elsig?

And what of Michiels treating physician? Was he interviewed at any stage of the original investigation - he, assuming it was a he, could have thrown light on the exact dose of Seroxat Michiels was taking, he/she could have also explained why he/she decided to tell Michiels to reduce his dosage by half - what protocol was Michiels physician following here?

Here we have a bunch of parents wishing for answers - they are each left in limbo until they get these answers. Every stone must be turned, every nook and cranny should be delved into. You cannot just dismiss something on a whim then move on to other matters in an investigation. It's half-assed to claim that this was just an "accident" when such stark evidence exists that there may be more to it than that.

It must also be noted that we have a grieving wife too. Evy Laermans lost her husband on that fateful night so she too should deserve some respect here. She, rightly so, is defending the name of her husband. It would be difficult for any of the parents to feel any sympathy or indeed empathy for Michiels. Whatever way you paint it, he was in charge of the motor vehicle when it crashed. There are other factors here too. The finger of blame, or partial blame, could be pointed at Michiels doctor for suggesting such a drastic taper - then of course we have the pharmaceutical company that market and manufacture Seroxat - GlaxoSmithKline. They are, it appears covered though. The small, insignificant warning on the patient information leaflet is almost like a disclaimer for such tragedy's.

In the case of Don Schell (above) we saw the jury return a verdict. They attributed 80% of the blame to Seroxat manufacturers GlaxoSmithKline and 20% of the blame to Don Schell. The Swiss Chief Prosecutor Olivier Elsig has took the easy way out here, he has laid no blame on anyone, to do so would, no doubt, cause conflict, especially where GlaxoSmithKline are concerned. Elsig is sitting on the fence, he's not wishing to rock the boat and this attitude is hindering the process of grief for the parents.

This case should be reopened. We may never be able to determine if Seroxat played a part in this tragedy but we should certainly put it on the table and, for the record, state that it may have induced a psychotic episode in Michiels. It needs to be an official statement here and not one of grieving parents, who will always be seen as people unwilling to accept that this was just an "accident", nothing more, nothing less.

Operating any form of transport whilst under the influence of mind-altering drugs should also be looked into. The Federal Aviation Administration (FAA) don't allow pilots on certain medications to operate aircraft, why, then, should coach companies be any different? In fact, back in 2010, the FAA cited Paxil as having a "severe withdrawal syndrome."

With this knowledge, is it feasible to suggest that the coach company who hired the services of Michiels need to, at the very least, put something in place so no driver under the influence of psychiatric medication, is ever allowed to operate one of their vehicles again?

People should be talking about the possibilities in this case and not brushing them under the carpet. I doubt if the parents will ever find conclusive proof that Michiels deliberately crashed the coach into a brick wall, I doubt, if, indeed, Michiels did crash the coach deliberately, that the families will be able to determine whether or not Seroxat played a part in his decision making. It should, at the very least, be investigated and maybe listed as a possible causation.

I'm reminded of a scene from the movie Jaws. Matt Hooper (Richard Dreyfuss) is an expert in the field of sharks and shark attacks.

Hooper, examining the remains of the first victim, describes the post-mortem into his tape recorder.

Hooper: [to the m.e. and Brody] This was no boat accident!
Hooper: [to Brody] Did you notify the Coast Guard about this?
Brody: No. It was only local jurisdiction.
Hooper: [continues post-mortem] The left arm, head, shoulders, sternum and portions of the rib cage are intact...
Hooper: [lifts up the severed arm] This is what happens. It indicates the non-frenzied feeding of a large squalus - possibly Longimanus or Isurus glauca. Now... the enormous amount of tissue loss prevents any detailed analysis; however the attacking squalus must be considerably larger than any normal squalus found in these waters. Didn't you get on a boat and check out these waters?
Brody: No.
Hooper: Well, this is not a boat accident! And it wasn't any propeller; and it wasn't any coral reef; and it wasn't Jack the Ripper! It was a shark.

The parents of the children who perished in the Sierre coach crash have now formed a group. Foundation Busramp Sierre are calling for "Independent research into what really happened."


In related news, Wendy B. Dolin, wife of the deceased, Stewart Dolin, charges that GSK negligently failed to warn her and her husband of what it knew to be a significant risk of suicide associated with Paxil (Seroxat).  - The full complaint can be read here.


Bob Fiddaman

**Update Sunday, July 17, 2016 Sierre Bus Crash Revisited**

**Monday, July 18, 2016 Email to Medicine Regulators Regarding 2012 Sierre Bus Crash













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