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

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

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

Ian Hudson of the MHRA challenged over the safety of Concerta (Ritalin)

Former Glaxo World 'Safety Officer', Dr Ian Hudson

In an attempt to seek the truth and learn how the regulations of prescription drugs work, Swedish investigative journalist, Janne Larsson, has been, for many years now, corresponding with the British medicines regulator, the MHRA.

Larsson, it appears, is ruffling some feathers at MHRA HQ, none more so than the feathers of the always evasive CEO, Dr Ian Hudson.

You see, the MHRA and Larsson have been going over reports regarding the ADHD drug Concerta, more commonly known as Ritalin.

Head of the MHRA, Dr Ian Hudson, has told Larsson that  “the safety of Concerta is being continuously monitored” - but Larsson is having none of it.

In his latest open email to Dr Ian Hudson, Larsson suggests that Hudson's handling of this whole affair is "scandalous". After reading much of the correspondence between Larsson and the MHRA I must say he has a valid point.

His open email (link at the foot of this post) also calls into question why the MHRA, in particular, Dr Ian Hudson, have not approached Concerta makers, Janssen, with regard to a "distortion of facts" that they presented to the MHRA a few years ago.

Larsson, in his open email to Hudson, points out that Janssen says that Concerta “continues to have a favourable benefit-risk profile for ADHD in children and adults” and that it is authorized for the treatment of ADHD in adults. They also claim that that the benefits of Concerta for adults “are supported by prospective, randomized, active-comparator controlled trials” 

However, Study 3013, the longest of all the Concerta studies, shows something completely different - furthermore, the MHRA, themselves, after reviewing 3013, said, “A causal relationship with Concerta was established for aggression, tics and depression.”

Larsson accuses the MHRA of sitting on this information for over two years.

It's unlike the agency to sit on anything regarding patient welfare. I mean, they have their fingers right on the pulse, huh?

Dr Ian Hudson, is the former World Safety Officer for GlaxoSmithKline (then SmithKline Beecham)

Kind of worrisome that someone sitting on important safety information regarding Concerta used to be in control of safety at one of the most heavily fined pharmaceutical companies known in history.

Here's Janne Larsson's correspondence.

ADHD drugs – MHRA and the Concerta scandal – did this really happen?



Bob Fiddaman.


Back story

Swedish Journalist Takes on British Drug Regulator

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

Swedish Journalist Takes on British Drug Regulator

Janne Larsson is a tenacious so and so. He'll dig, stumble across something that isn't right then ask questions to try and seek the truth.

He has given me permission to publish his recent letter to the British drug regulator, the MHRA.

Larsson has, for some time now, been gunning for Janssen, makers of Concerta, also known as Ritalin.

Like any good journalist Larsson has meticulously studied the adverse events of Concerta in Janssen’s clinical trials. What he found were huge flaws. [Back story]

Here's his latest letter to the MHRA.

The approval of Ritalin for adults – where did all the aggression go?

Dear Dr Hudson,

As you may remember I wrote to you in February and March about MHRA and the scandal with the ADHD drug Concerta  [http://jannel.se/MHRA.Concerta3.pdf]

I made the “prophecy” that several drug regulatory agencies in Europe, who had allowed alarming levels of off label prescription for adults, like Sweden, would have to make sure that we quickly forgot the Concerta scandal. And the best way to do that would be to push through another application of methylphenidate for adults – like Ritalin. And to then claim “that we now have evidence”.

I said that we could expect Novartis to have learned from the failed Concerta submission, and to design more “smart” studies, showing its drug Ritalin (in all important aspects the same as Concerta) to be “safe and effective”. We could expect that the submitted studies would get a positive assessment this time – no embarrassing questions – and suddenly the concealed and alarming Concerta results could be expected to no longer exist!

We have now arrived at that point.

It has been a secret up to now how Novartis planned its conquest of Europe, or as Financial Times said, how to get everyone “on board with adult ADHD” [http://www.ft.com/intl/cms/s/2/8b721a20-b8e9-11e2-a6ae-00144feabdc0.html] . We have not known in which countries the application was submitted or via which procedure. We know now.

Novartis succeeded to get through some kind of “informal worksharing procedure”, as there was “currently no legal basis” for a formal work sharing procedure. As the Swedish Medical Products Agency stated in its assessment report:

“The worksharing procedure included all European (EU) countries where Ritalin LA is currently registered. As Ritalin LA is registered via national procedures in EU, there is currently no legal basis in EU for using ‘formal’ worksharing procedure for nationally registered products.”

We also know that Germany was leading this “informal work sharing procedure”.

I have read the Swedish “investigation” about Novartis’ submitted studies, and as expected – no embarrassing questions. Much could be said about it, but at this point I only want to take up one important, even vital aspect.

Where did all the aggression go?

As you know MHRA, leading the European investigation about Concerta concluded: “A causal relationship with Concerta was established for aggression, tics and depression.” (Preliminary Variation Assessment Report, juli 2010 page 112, [http://jannel.se/PVAR.Concerta140710.pdf )]

The investigation showed that in the three Janssen-submitted, double-blind studies (3013, 02-159 and 3002) “13 of the 596 subjects receiving Concerta … were withdrawn for aggression-related adverse events (vs. none receiving placebo)”. (Page 65, Preliminary Variation Assessment Report, Concerta, July 2010, see also FVAR, page 12, 26 April 2011.)

These 13 persons suffered so severe aggression that they had to be taken out of the trials. None of those on placebo suffered such serious aggression that they had to end the trials.

The investigation also showed that a total of 71 out of 596 subjects (11.9%) from the Concerta group had suffered aggression (compared to 17 ​​persons, 5.5%, from the placebo group). In the combined studies of Concerta in adults (placebo-controlled, and others) 202 of a total of 1369 subjects, 14.8%, suffered aggression. [10] (See FVAR, page 12, 26 April 2011.)

Clear evidence also emerged in the studies that Concerta could cause anxiety and agitated conditions in adults – ”evidence for the risk of new-onset anxiety, tension and agitation”. “Adult studies have identified anxiety as a very common risk in adults.” (See Preliminary Variation Assessment Report, page 117.)

In the investigation it was concluded: “The main new safety concern from the study data is around the frequency of psychiatric adverse events and that this is often de novo [new]. Of note is the incidence of anxiety but also rates of depression and aggressive and hostile behavior are raised.” (See Preliminary Variation Assessment Report, page 66.)

MHRA asked for and Janssen submitted (January 2011, Response Document) the following illuminating table over adverse events in the Concerta studies:

We would of course expect a similar picture in the clinical trials of Ritalin for adults.

And so we take a look at the comparable table in the Swedish investigation of Ritalin for adults. It looks like this (National Type II variation – Overview, page 35, 16 July 2014):

We can see, for the first 9 weeks, that “Psychiatric Disorders” are lumped together, with 188 persons (34.7%) in the Ritalin group affected by these, compared to 25 (13.9%) in the placebo group.

But nowhere in the 58 pages long Swedish “investigation” can we read specifics about what comprised these psychiatric disorders. We find nothing at all in the document about “aggression”. We find nothing about “new safety concerns” for aggression, hostile behavior, anxiety, depression.

While the assessment of the Concerta studies showed: “A causal relationship with Concerta was established for aggression, tics and depression”, we find nothing at all about this in the Swedish document.

So in some way the Swedish authorities together with Novartis succeeded to get rid of, or not go further with, these serious adverse effects, which must have been about the same in the studies of Ritalin as in the studies of Concerta. And which could have – as for Concerta – formed the basis for disapproval of the application. How this was done is not clear at the moment. Maybe we have a case of “recoding” the adverse events, like the famous renaming of suicide attempts by pharmaceutical companies, instead calling them “emotional lability”. Anyhow the Swedish authorities could not “afford” to ask too many questions about this.

What did the MHRA do about it?

At the moment I don’t know how much of the text in the Swedish assessment report is copied from the text originated by the Reference Member State (RMS), Germany, leading the handling of Novartis’ application.

And we come to the role of MHRA and my questions to you:

1. Did MHRA “handle” aggression, and other serious adverse events, in the same way as the Swedish authorities did? (In other words, not at all.)

2. If so, how could MHRA, considering what the agency knew about the harmful effects of the almost identical drug Concerta, fail to go further with the investigation about this manipulation of data?

3. If MHRA actually challenged the manipulated data about adverse effects in Novartis’ application for Ritalin, I assume the agency arrived at the same conclusion as in the Concerta investigation – that the drug could not be approved. I would be happy to get a copy of that important assessment report.

Yours sincerely,

Janne Larsson

Reporter

Sweden

--

 Janne Larsson has, for many years, in his free time, worked using the Swedish FOI Act to make the “misdeeds” of psychiatry, Big Pharma and government agencies public.

Bob Fiddaman

Tenacity Pays Off For Swedish Journalist Larsson

I've corresponded with many great writers since starting this blog almost 7 years ago, I've met a few in person too.

What makes a great health activist/advocate?

Well, in the main, a great advocate is someone who has experienced the darker side of the pharmaceutical industry. A person who, through no fault of their own, has endured horrific withdrawal at the hands of a pharmaceutical product or, worse, had to lay a loved one to rest because a pill that was meant to make them better actually induced suicide.

Then we have ex-pharma employees and current and retired psychiatrists, these people also add a tremendous weight to the debate regarding antidepressants.

Journalists banging the drum are few and far between but they do exist in this murky pharma world. One such journalist is Janne Larsson, a Swedish man whose investigative skills and tenacity have to be admired by the street man and revered by the top executives within pharma, medicine regulators and apparent experts in the field of psychiatry.

Plea For MHRA and EMA to Get Their House in Order

Bravo to Patrick H for starting this petition. It takes courage and resilience to stand up for what you believe in. Too many people sit around and wait for others to act, whilst others criticize those for standing up to be counted. Respect Patrick.

This from the online petition:


To the UK’s MHRA and EU’s EMA: The drugs on our shelves and those recommended by our doctors should first do no harm. As concerned citizens we call on you to put safety first and implement the reforms below:

1) Investigate and act against pharmaceutical companies employing illegal marketing activities by appointing an independent watchdog not funded by the drug industry who can be freely contacted by patients and by doctors witnessing bribery and encouragement to prescribe a drug ‘off label’- for a condition it has no licence to treat - by pharmaceutical representatives.

2) Tighten up requirements for licensing new drugs to include a thorough assessment of benefits versus risks, as well as withdrawal effects.

3) Record and minute meetings to be made publicly available, including representation from consumer groups.

4) Enforce pharmaceutical companies to publish their trial data, without hiding adverse effects, on their website for free access.

5) Take patient reported adverse reactions seriously and encourage patients who have had adverse effects to share them on the website rxisk.org so other patients and doctors are informed.


Why this is important

The profit-hungry drug company GlaxoSmithKline has been peddling a diabetes drug they knew was causing heart attacks without informing doctors or patients of the risk. Regulators in the EU knew about the dangers but failed to act fast enough, putting lives unnecessarily at risk. Previously, UK regulators knew about anti- depressants causing suicide but took over ten years to do anything about it. The same complacency is happening again with new anti-depressants and other drugs.

Earlier this month GSK pleaded guilty to criminal charges relating to anti-depressant and diabetes drug frauds and agreed to pay a $3 billion fine. That brings total fines against big pharma in the US in the last four years to almost $10 billion! But no fines in the UK or EU. Why do we put up with it?

A massive push from thousands of people right now will add to pressure from the media and force regulators to act faster and more decisively against dangerous drugs. As a citizen of the UK I need to know that my family and I are safe and that drug companies put patients before profits. But drug companies will only do the right thing if regulators force them.

Let’s join together in a gigantic outcry for the UK’s Medicines and Healthcare products Regulation Agency and EU’s European Medicines Agency to put safety first. Sign the petition!

----

I truly hope the petition will make the MHRA stand up and listen. I suspect they will, as usual, pretend to listen then do absolutely nothing about the issues raised. They are limp-wristed and powerless and claim to be the best regulator in the world. To be the best of a truly awful bunch is not something I'd be proud of.

The MHRA are in bed with the pharmaceutical industry, they are not just sleeping with them they are performing all sorts of kinky sex acts. Just follow the money trail folks, case in point being these 4 articles I wrote back in 2010.


GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part I of IV

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part II of IV - Witness For The Defence

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part III of IV - Expert Statistician


GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part IV - The Colour of Money


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ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK HERE

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European Drugwatch Agency Under Investigation

The Independent is reporting that The European Medicines Agency [EMA] is under investigation by the European Anti-Fraud Office (OLAF) over allegations of conflicts of interest.


The investigation into the European medical regulator, writes Jeremy Laurance for The Independent, relates to the scandal over the French diabetic drug, Mediator, which was withdrawn from the European market in 2009, a decade after initial signs that it could be responsible for fatal heart problems.

Mediator, a weight loss drug, was banned in Europe after it was found that it caused between 500 - 2000 deaths and, it appears, the EMA didn't act quickly enough.

The crux of the investigation stems from the fact that the EMA are 80% funded by the pharmaceutical industry, much like the UK regulator who are wholly funded by the industry.

I find it odd that an investigation would start now, surely it's been public knowledge for years that this is how the system works?

It's simple really.

A drug is put up to be granted a licence - The regulator reads the supporting evidence - The pharmaceutical company provide the positive results from the clinical trials of that drug - The regulator doesn't bother asking for the negative trial results - The drug is granted a licence.

Some years down the line consumers complain of side effects, some so severe that they cause death - The regulator review the drug and give it a clean bill of health, on the odd occasion they send out warning letters to doctor's to "monitor" the patient. This covers their ass should any future deaths occur.

Everyone is happy and conscience free.

At some point a bunch of patients may kick up a stink about the drug, the regulator will hold meetings with them, appease them and make promises to investigate. They then go all out to target fake drugs flooding the European market - they can't have poor quality drugs going up against the 'safe' drugs that they have granted licence to you see.

I see no point in a regulator that is funded by the very same people it is supposed to be regulating, it's akin to asking an alcoholic to look after a crate of Vodka or giving an arsonist a gallon of petrol and a book of matches.

A spokesman for the EMA said, "We have a robust process for dealing with conflicts of interest. It is transparent and there's no attempt to hide anything.

Yeh, and I've just seen a cow jump over the moon.

Related video:



 *Hat - Tip - Leonie Fennell



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Glaxo's Pandemrix Vaccine Restricted Use Review

The European Medicines Agency [EMA] today issued a press release regarding GlaxoSmithKline's Pandemrix vaccine. It's more bad news for Glaxo as the EMA have decided to restrict its use in children and teenagers because of a link to narcolepsy.

Narcolepsy is a chronic sleep disorder, or dyssomnia, characterized by an excessive urge to sleep at inappropriate times and in Finnish and Swedish studies there was a 6- to 13-fold increase risk of narcolepsy in young people who had received the Pandemrix vaccine.

The EMA have recommended a labeling change that limits the vaccine's use in children and teens to when protection is needed and seasonal trivalent vaccine isn't available. In other words, it won't be used as a first line treatment.


GSK have issue a press release on their webpage, the end paragraph is classic:

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.

Pardon the pun but...Zzzzzzzzzzzzz

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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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Shadow falls over European drug regulator [EMA]

In my book, 'The evidence, however, is clear...the Seroxat scandal', I highlight the UK drugs regulator [MHRA] and their cosy relationship with GlaxoSmithKline and the rest of the pharmaceutical industry.

In fact, when I first started asking questions regarding the safety of Seroxat [Paxil in US] the MHRA's responses were less than transparent - it took Freedom of Information requests [FOI] for me to get some sort of answer from them, even then the answers were vague.


It appears that the European drugs regulator are pretty much the same, according to an article published in yesterday's Independent.

The EMA were sent FOI's from Professor Peter Gotzsche and Anders Jorgensen from the Danish Cochrane Centre, they wanted to investigate two obesity drugs, orlistat and sibutramine. They requested the unpublished trial data from the EMA in 2007.

The EMA refused access to the studies citing "commercial confidentiality" whilst defending their corner by arguing that they constantly monitored drugs and updated their assessments.

Orlistat is marketed as a prescription under the trade name Xenical by Roche in most countries, or over-the-counter as Alli [GlaxoSmithKline]

Quite a coincidence that GlaxoSmithKline recently announced that it is to sell off Alli and will, in the forthcoming weeks, be contacting parties interested in its product.

Sibutramine is better known by its brand name, Reductil, [Abbott] ironically suspended by the MHRA in January 2010 after the EMA informed them to suspend its licence in Europe amid fears that it raised the risk of heart attacks and strokes in patients taking it, this some three years after the request for the unpublished trial data was made by Professors Gotzsche and Jorgensen.

Eugene Sun, an Abbott spokesperson said at the time, "We believe there are many patients who benefit from sibutramine and respectfully disagree with the recommendation to suspend the medicine."

No surprise there then.

Gotzsche and Jorgensen, unhappy with the EMA's refusal to supply the unpublished trial data in 2007, wrote to the European ombudsman who, in 2010 [Yes, three years later] criticized the EMA's refusal to grant access to the trials and added that the EMA was guilty of maladministration.

Gotzsche and Jorgensen finally received the unpublished data in February 2011, some four years after they first requested it.

This is yet another example of the regulator protecting the pharmaceutical industry. To cite "commercial confidentiality" as an excuse to not release data is woeful, what about "consumer protection"?

I am not shocked any more by the regulators decisions, it appears that protecting the manufacturers is much higher on the agenda than protecting the consumer.

Further evidence of the collusion between the regulators and the pharmaceutical industry reared its ugly head back in June 2010 when I learned that the UK Seroxat litigation's defendants, GlaxoSmithKline, had hired the services of Rashmi Shah to be called as an expert witness for them. Shah was employed by the MHRA between 1987 and 2004.

I've met with various MHRA officials on numerous occasions. Their CEO, Kent Woods, gave up over an hour of his time to sit down with me and listen to my concerns regarding the difficulties patients were having withdrawing from SSRi medications. He even agreed that the MHRA should meet with Prof. David Healy, who had drawn up a withdrawal guidance to help patients withdraw from SSRi's. The meeting between Healy and the MHRA took place, Healy showed them the protocol... it still remains on the table collecting cobwebs!

More about the MHRA, GlaxoSmithKline and Seroxat in my book, which can be purchased online in the US and Canada HERE and in the UK HERE.

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