MHRA: "We Now Consider This Request Closed"

It took me a while to get to the bottom of this. The MHRA are, and have always been quite vague when it comes to answering the simplest of questions put to them. None more so then when I asked a series of questions regarding their Yellow Card Reporting System. (YCRS)

For those that don't know, the YCRS is a way of reporting adverse events from the drugs you take to the British drug regulator, the MHRA. What they do with these reports has, to me at least, always remained a mystery.

A recent series of emails between myself and the MHRA leaves me somewhat perplexed, particularly as their last one to me finished with, "we now consider this case closed".

Hmm, I don't. So, where does that leave us?

My issue with the YCRS is that, I believe, it is a system designed to fail, moreover, it does not do as it suggests, ie; "Helping to make medicines safer."

After much hulabaloo of answering questions I put to them, I finally got the answer I needed. My question being, Do the MHRA actually follow up any Yellow card report sent in by the original reporter, i.e.; do they,or have they, ever contacted the patient who sent in the original yellow card?

Their reply...

"The MHRA regularly follows up Yellow Card reports with the original reporter. If permission has been given on the Yellow Card, we will contact the reporter to request any further information that we think would be helpful to enable assessment of the case."

Finally!

I followed up their reply with, what I thought, a simple question...

We seem to be getting somewhere.

The answer, however, is quite vague. Please define 'regularly' - give me some figures.

You may think I am publicly bashing the MHRA via my blog, in truth, I do when you respond with vagueness.

Can you give me actual figures, ie; how many yellow card reports have been followed up with the original reporter, you must keep a record of this, right?

Their answer left me bemused. Years ago it would have left me frustrated but I've come accustomed to such contradictory answers from the MHRA.

We do not record the number of follow-up requests that are sent out by the Agency as knowing this information does not help monitor the safety of medicines in the UK. Rather, it is the follow-up information received that is useful for assessment of a suspected Adverse Drug Reaction (ADR). This can either be in response to a request sent out by the MHRA, or follow-up information that has been spontaneously provided by the reporter.

They added the standard disclaimers and also, bizarrely, a request for money (minimum £600) if I wanted them to perform searches for "an actual figure for the total number of all Yellow Card follow-up requests that have been sent out."

Here's their full suggestion..

Therefore to provide you with an actual figure for the total number of all Yellow Card follow-up requests that have been sent out, we would be required to manually review the case folder for each individual Yellow Card report submitted to the agency.  Under the Freedom of Information (FOI) Act, a public body is only required to collate information that is already in a recorded form, rather than creating new information beyond basic collation. Furthermore, the agency has received over 600, 000 Yellow Card reports directly from healthcare professionals and members of the public to date, with approximately 16,500 Yellow Cards reported a year. The staff time and cost of extracting the requested information from this would far exceed the £600 limit for central government set by Section 12 of the FOI Act.

You can see my confusion. If they don't keep records of follow-up requests that are sent out then why are they asking for a minimum fee of £600 to search for records that, they have already said, don't actually exist?

Furthermore, how can they make the claim that "The MHRA regularly follows up Yellow Card reports with the original reporter", when they don't actually "record the number of follow-up requests that are sent out."

I'd like to ask them but at the foot of their final email to me they told me, "We now consider this request closed."

Ho hum.

To date, the Drug Analysis Prints on the MHRA website list the number of yellow cards submitted to them and also the nature of the events, they range from completed suicide to skin rashes. There has not, to my knowledge, been any statement from the MHRA that any prescription drug currently on the market in the UK has caused a patient to complete suicide.

This attitude, I believe, keeps poor, unsafe drugs in pharmacies and keeps the MHRA from coming under fire - remember, it is the MHRA who grant licenses to the medicines you and I take.

The MHRA recently went all 21st century on us by creating a phone app for the yellow card. I have to ask what is the point in sending in adverse reactions when they don't, and I assume, never will, blame the drug for the more severe adverse reactions, such as completed suicide, suicidal thoughts and/or self harm.

I have further requests pending that are not related to the above. I suspect, due to my asking questions to seek the truth, the MHRA will probably, sooner or later, consider those requests closed too.


Bob Fiddaman.

Open Verdict Returned in Prozac Related Death

It's not often one comes across a coroner who goes against the grain.

It's not often coroners come up against surviving family members armed with knowledge about drugs used to treat apparent mental illnesses.

Yesterday, at Dublin Coroner’s Court, Coroner Dr Brian Farrell ruled against suicide as being the cause of Jake McGill Lynch's death on 20 March, 2013.

Jake was just 14 years-old when he took a .22 rifle and placed it in his mouth and pulled the trigger. One year previously he had been diagnosed with Aspergers and, after a 15 minute consultation with psychiatrist,Dr Maria Migone, he was prescribed Prozac (fluoxetine) and was told that it would help him get through his exams at school - something that Jake had been worrying over.

Six days after starting his medication, Jake walked out of his first exam halfway through - later that night he cried for three hours. A day later his Prozac dose was doubled,

On day 46, Jake killed himself.

During the 18 month long inquest evidence showed that there were links to Prozac and suicide related deaths, in particular the black box warning on Prozac in the US. No such black box warning exists in either the UK or Ireland (Jake's place of birth)

In fact some years ago after meeting with the Irish Medicines Board (the equivalent of the FDA and MHRA) Jake's parents were told that, "nobody would take Prozac if such a black box warning was put into place."

Some informed consent that is, huh?

So, what is an open verdict?

In a nutshell it means that there is insufficient evidence that somebody had intended to kill themselves. In other words, Jake may not have intended to kill himself were it not for a third party, that party being Prozac.

The coroner's verdict is kinda vague in as much that he cannot say for certain why Jake did what he did but with Prozac on the table one only has to read between the lines. It leaves open the question as to whether or not Prozac induced Jake's death.

One fifth of adolescents experience suicidal thoughts, according to Dr Houlihan, a consultant Paediatric Psychiatrist at Temple Street Children’s Hospital.

Yesterday's open verdict was welcomed by Jake's parents, Steffini McGill Lynch and John Lynch from Clondalkin.

“It’s a huge relief. It allows us to grieve now. You can’t let go of that night but this allows another chapter to close. This is the verdict he deserved because in our eyes it was drug induced,” Steffini said after the inquest concluded.

One thing is certain. Jake should never have been prescribed Prozac for 'exam jitters'. He was a normal child made to feel abnormal the minute he walked into his psychiatrist's office. He was a child, who through no fault of his own, that had to deal with two things.

1. The worry of pending exams.

2. The chemical imbalance caused by the Prozac he was prescribed.

Earlier this year "Jake's Amendment" was tabled in the Dail of the Coroner's Amendment Bill 2015, a bill that calls for coroners to widen the scope so they are able to deliver a finding of Iatrogenic Suicide. Iatrogenic Suicide is the ending of one's own life where the effect of medical treatment undertaken by the deceased, including any prescribed medication.

Although no such verdict was delivered yesterday, the open verdict certainly points to the fact that Jake did not intend to kill himself - something pushed him. You'd have to be from the plant Zog to rule out Prozac.

Eli Lilly, who market and manufacture Prozac, have placed the following warning on the package insert for Prozac in the United States.

"Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults: Monitor for clinical worsening and suicidal thinking and behavior."

The Irish Medicines Board should follow suit. I doubt if they will. The whole medicine regulatory system is run by limp-wristed buffoons who, it appears, merely shrug their shoulders when people die as a result of medications they have granted licence to.

Jake's voice has been heard. Hopefully the pro-antidepressant brigade in Ireland will cease writing column inches in the Irish media bigging up the use of these types of medications in children and young adults - I doubt that will happen too. Psychiatrists who write for the national press are, in my opinion, egotistical and bear all the hallmarks of narcissism. 

Godspeed little man.

Bob Fiddaman.

Glaxo's Beef With David Healy

I've been watching the proceedings of a current trial in the US. It involves the wife of a man who killed himself shortly after being prescribed Paxil.

If you are like me, a bit of a geek when it comes to reading court documents, then you will just love this.

It plays out like a John Grisham novel. Here we get to see the mechanics of defence lawyers, particularly when it comes to allowing expert witnesses to offer evidence against the company they are representing, in this instance, GlaxoSmithKline.

Background:

In June 2010 Stewart Dolin visited his family doctor who wrote him a prescription for Paxil for "work-related anxiety and depression".

Dolin's prescription was dispensed but he received the generic form, manufactured by Mylan.

Six days after beginning his course of the generic Paxil, Dolin left his office shortly after having returned from lunch with a business associate. He walked to a nearby Chicago Transit Authority Blue Line station at Washington and Dearborn in downtown Chicago. As a northbound train approached the station, Mr. Dolin leaped in front of it to his death. Blood tests taken with Mr. Dolin’s autopsy were positive for paroxetine.

Stewart's wife, Wendy, filed suit against GSK. (Dolin v. SmithKline Beecham Corp. et al., case number 1:12-cv-06403)

Motions:

GSK have filed so many motions in this case. Basically, they write to a judge asking him to make a decision on claims they make. In the case of Dolin they first claimed that, although Stewart Dolin had taken paroxetine, it wasn't their brand. In fact, the brand that Dolin had taken was a generic form, manufactured by Mylan and not GlaxoSmithKline.

On March 4, 2014, an Illinois federal judge determined that GlaxoSmithKline PLC can be held liable for a suicide even though the consumer took a generic version of the antidepressant Paxil, (Source)

Next form of defence for Glaxo's highly paid law team, King & Spalding, was to target the person bringing the claim against them. In this instance, the wife of the deceased, Wendy Dolin.

GSK's defence lawyers subpoenaed Wendy Dolin's cellphone and text message records, her home phone and her late husband's company phone.

Wendy then filed her own motion stating that she had already complied with what she characterized as GSK's intrusive discovery requests, and accused GSK of excessive prying that would not end without the court's intervention.

Furthermore, Wendy claimed in her motion that GSK had sent more than 30 subpoenas and over 70 records requests, and shown the Dolin children Stewart Dolin's confidential therapy notes despite Wendy Dolin's objections.

GSK has also taken hours of deposition testimony from her and grilled her about her personal medical information and her romantic life since her husband's death, according to her motion.

On September 12, 2014, Dolin and GSK came to a "resolution" regarding Glaxo's contentious subpoena. The resolution has, to date, remained confidential.

So, in attempts to, what can be seen as dragging the case out, King & Spalding have now turned their attentions on experts called by Dolin. One such expert witness is Dr. David Healy.

Healy and colleagues, earlier this month, published a damning report on Glaxo's handling of Study 329, a clinical trial involving adolescents and the use of Paxil. Glaxo had, back in 2001, claimed Paxil was safe and efficacious in this patient population. Turns out, they were lying and just spun the results, putting thousands of teens at risk - See (Restoring Study 329)

Fair to say then that Healy is not on Glaxo's Christmas card list.

Muddy the waters:

So, what does one do with criticism, what does one do to suppress the truth?

We've seen the above tactics of GSK's highly paid law team.

1. Claim it's not our drug, ergo not our responsibility

2. Throw endless subpoenas at the person bringing the claim, including delving into her late husband's phone records in the small hope they can find a crumb of evidence that will help them suppress the truth about the Paxil suicide link in adults.

3. Show the children of the deceased personal confidential therapy notes from their father.

4. Grill the widow about her medical background and romantic interests since the death of her husband.

Way to go King & Spalding, you're basically a mirror image of the clients you represent (my opinion "Todd" - see disclaimer at foot of blog - it's been there for years)

Not satisfied with raping the memory of Stewart Dolin, King & Spalding have now turned their attention to David Healy.

Now, I'm not going to blow smoke up Healy's ass, he's one of the good guys, that's all you need to know. He raises awareness because he cannot just stand by and watch bad drugs do harm. That alone should be applauded. Healy has a lot more to lose than your average blogger (myself included). He puts his career on the line by speaking out, it's one hell of a sacrifice. He could have quite easily closed his eyes but he has something that we all have, something that only those with blackened hearts suppress.

Conscience.

King & Spalding nefarious, nae rabid, attack on Healy is not too dissimilar to the raping of Stewart Dolin's memory.

So, what's this motion about?

Well, according to King & Spalding, Healy should not be allowed to give evidence in the trial, he's not credible, he has a bias, he's telling people to go out and kill.

Yup, you read that last bit correctly.

GSK's motion to exclude Healy is a work of art, the kind of art many of us don't understand. It's a huge pile of excrement carefully sculptured by the expert hands of King & Spalding's finest. Ironic that this huge pile of steaming cak is called a motion!

Here's some of the reasons why they don't want Healy to give evidence.

1. Dr Healy is not qualified to testify because of his radical advocacy and extreme bias against GSK.

Oh, boo hoo. Naughty Dr. Healy having an opinion on GSK. Since when did someone with an opinion become a radical activist?

Would this actually have something to do with the fact that Healy has, in the past, given his expert opinion in the cases of Kilker vs GSK and Tobin v GSK. In both cases jury's found GSK guilty. The Kilker case saw GSK's Paxil ruled as the cause of Lyam Kilker being born with birth defects. In the Tobin case a jury found that Paxil was the proximate cause of Donald Schell taking a gun to family members, killing them, then killing himself.

GSK, don't, it appears, think so. They claim Healy, via the medium of his blog, has, in the past, claimed that “the pharmaceutical industry ‘rapes’ patients,” that he “compares GSK’s insistence on  statistically-significant findings to sexual abuse by Catholic priests,” and that GSK’s “widespread cover-up of adverse events dwarfs the Nazis’ cover-up of the Holocaust.” 

Here's the rebuttal of Dolin's attorneys.

Dr. Healy never stated that pharmaceutical companies “rape” patients, but specifically defined a concept that he calls “pharmaceutical rape culture” which he defines as a “concept that examines a culture in which harm from pharmaceutical products is pervasive and normalized due to societal attitudes about  medicine and health care.” Dr. Healy specifically distinguishes pharmaceutical rape culture from actual rape, but draws cultural parallels to the way society reacts to the problem, i.e., blaming the victim. 

Similarly, Dr. Healy never compared GSK’s insistence on statistical significance to “sexual child abuse.”  Dr. Healy’s blog entry simply discusses how the Church’s use of Canon Law to disregard state and federal law parallels how pharmaceutical companies “actively attempt to over-ride the legal systems of the United States and other countries with claims that unless findings are demonstrated in controlled trials to a statistically significant extent that they simply aren’t happening.” 

Finally, GSK’s reference to the Holocaust is not only inaccurate, it is offensive.  Dr. Healy made a passing reference to the Nazis in his blog entry to illustrate the fact that pharmaceutical companies have actively sought to hide risks from patients and authorities using a myriad of methods.  The specific quote is: 

[Pharmaceutical companies] have taken astonishing steps to prevent decent reporting, or to denigrate reporting when it happens, and to manage the perception of risk rather than risks themselves.  If the Nazis had access to [their] bag of tricks, there would be real and widespread doubt that the Holocaust ever happened.  

At no time did Dr. Healy suggest or even insinuate pharmaceutical cover-up of adverse events “dwarfs the Nazi’s cover-up of the Holocaust.”  This sort of inflammatory and misleading...

--

Personally, and this is just my opinion, I think that King & Spalding paralegals and other staff have, seemingly, trawled through Healy's blog as a reporter for the National Enquirer would. The sole purpose is to dismiss his beliefs whilst trying to find cherry-picked sentences that they feel may incriminate him, and, furthermore, persuade a judge that Healy is some sort of crank.

For the record, the "pharmaceutical rape culture" reference was actually a blog post by another blogger.

Is it me, or does anyone else think these highly paid attorneys can't do their job properly?

Dolin's attorneys added that Healy "...discusses topical and controversial issues and he does so with poetic license."

GSK then, quite remarkably, decided to look into the phrase, "poetic license."

Weeks after the rebuttal of Dolin's legal team GSK then attached as an exhibit  a "true and correct copy of the online Oxford Dictionary definition of poetic-license."

Since when did GSK start using the Oxford Dictionary?

Here's part of a transcript from BBC Panorama. Journalist, Shelley Jofre was interviewing Glaxo spokesperson, Alistair Benbow. Ironically, the subject of definition came up.

BENBOW: Addiction is characterized by a number of different criteria which includes craving, which includes increasing the dose of drugs to get the same effect, and a number of other features and these are not exhibited by Seroxat.

JOFRE: That's not, with respect, what the Oxford English Dictionary says. It says addiction is having a compulsion to take a drug, the stopping of which produces withdrawal symptoms.

BENBOW: If you use that limited description of addictive then most prescription medicines could be defined as addictive.


So, on one hand the Oxford English Dictionary gives a true and correct definition, yet on the other hand the Oxford English Dictionary only gives a limited description!

Come on Glaxo, you can't have it both ways. If, as they claim, the dictionary (provided as an exhibit) gives a true and correct definition then Benbow telling Jofre that the same dictionary only gives limited descriptions was an actual lie... or was it just an opinion of Benbow, one that was radical and, dare I say it, biased.

GUN-TOTTING HEALY

One of the most ludicrous claims of GSK was that Healy, once again through the medium of his blog, suggested that "it would be reasonable for people who have lost loved ones due to alleged drug side effects to take violent revenge against pharmaceutical executives or editors of the New England Journal of Medicine."

Based on this one paragraph GSK accused Healy of inciting violence against GSK’s executives and medical journal editors.

(Insert laughter here)

(Change your underwear here)

As Dolin's attorneys put it, "Healy is expressing concern that discord is “brewing” and that absent action, there could be violence.  Dr. Healy expressly condemns such violence. "

As I said a the top of this post, I'm a bit of a geek when it comes to reading court documents. Whilst reading through GSK's motions I've had Nescafe shoot down my nostrils, reached the point of apoplexy, so much so that I had to bite the arm of my chair, and, been to the bathroom to avoid any embarrassment of urinating myself.

Healy's deposition was supposed to be about science, in actual fact GSK's attorneys chose, for at least 90% of the 10 hours, to talk about Healy's blog, his financial accounts, and every other avenue that they could think of - rather than deal with the science.

If anything, these motions merely highlight the lengths GSK and their legal representation, King & Spalding, will go to as to avoid the Paxil/suicide link being, once again, publicly aired.

Other experts for Dolin have also come under fire from GSK. More mud-slinging, more cleverly crafted piles of poo.

Those King & Spalding offices, I believe, need fumigating.



Bob Fiddaman. (Using Benbow's poetic licence)



Source: Public Access to Court Documents (Pacer) 

Wendy Dolin is represented by Bijan Esfandiari, Michael Baum, Frances Phares and R. Brent Wisner of Baum Hedlund Aristei & Goldman PC

Mental Media

Another shooter.

Another number of lives lost.

Another media frenzy that splits itself with reporting about gun laws and/or more calls for a better mental health system.

Born and raised in the UK I don't really get why anyone would ever want to own a gun, unless their life was in imminent danger. (American accent) "Woah, hang on buddy, it's our right to defend ourselves." - Maybe so, I guess everyone has that right. I just can't see why killing someone to defend yourself makes you the better person. Let's face it, you own a gun not to wound someone, you own it to kill someone. The guy that breaks into your house in the middle of the night and puts your family in danger - any eye for an eye, right? (Winks)

The majority of wannabe John Wayne's are pretty sane guys. (American accent...again) "Get off your horse and drink your milk".

We've come a long way since the days of John Wayne, a tough cowboy who would take on the bad guys yet wince like a baby when the woman in his life would try to clean his wounds.

Hollywood now gives us bigger characters, bigger guns, more carnage - (American accent, tinged with Austrian) "I need your clothes, your boots and the keys to your motorcycle."

Let's face it, we like to watch these movies, unless of course we live our lives like Ned Flanders, he of The Simpsons fame. (“Hey-Diddly-Ho!”)

Then we have the gun-totting games on the latest games consoles - have we gone past Nintendo yet? Forgive me, I'm a 51 year-old.

So, for the majority of us we blame the gun culture when we hear of yet another school shooting. The mainstream media, who I'm growing to dislike with a passion, will have us believe that the perpetrator had a history of mental illness and his mom, dad, brother, sister, or cat had a passion for guns.

The quotes littered in these voyeuristic insights of the 'perp' tell us that he (because it's always a 'he') had a history of mental illness. ADHD, Bipolar, and all those other illnesses that seem to have just appeared out of nowhere during the past 20 years or so.

If the media aren't blaming the "brain disease", they are blaming the movies, the kind mentioned above, or the music that the perp used to listen to. Hey, the guy wore an AC/DC cap and they play the Devil's music, right? He had a Judas Priest album in his collection and if you play track 3 backwards there's a hidden message.

Comments under such articles leave me shaking my head. Those poor misguided souls, who hang on to every word the tabloids are spewing, call for a better mental health system to be put into place. What they are missing is that the perp was probably under the care of mental health. Talk therapy, an exercise regime, a better diet are not things your average psychiatrist would recommend for those who have a troubled mind.

Medication, and lots of it. Not one drug, hell no, one isn't enough to fix his mind, let's give him two, three, four, maybe five!

The latest media ignorance has come as a result of yet another shooting (once again coming in America)  (“Hey-Diddly-Ho!”)

Christopher Harper-Mercer, according to the wonderful world media, had an obsession with the devil, black people, women, in fact, he hated everyone. So, what does he do? Well, he walks into Umpqua Community College in Oregon and kills 9 innocent people then, apparently, turned the gun on himself.

Yeh, kinda makes sense. A guy who hates everyone decides to shoot a bunch of kids... in a school.

Let's just stop for one moment and think about the medication he was undoubtedly taking. It is designed to flood the brain with chemicals, those chemicals target receptors, those things that, in essence, fire the obsessive, dark, depression thoughts we have. Now, I'm not going to show you instances where these school shooters have been on psychiatric medication. I think, if you are reading this, you'll already know about the psychiatric medication link with school shootings, if not, Google it.

The Internet is awash with conspiracy theories, psychiatric medication and school shootings have, for whatever reason, made it into a number of these conspiracy theory lists. Hey, it's the gun, it's the lack of mental health care, it's AC/DC or Judas Priest, it's the cat that once scratched the perp when he was a child... ad infinitum.

The mainstream media said so.

Do your homework folks.


Bob Fiddaman

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

Save The Children Respond Re Partnership with GSK

Those keeping an eye on the correspondence between myself and global charity, 'Save The Children', will know that I recently fired off an email to them regarding their partnership with GlaxoSmithKline - The email can be read here.

Save The Children have now responded in full and I have wrote back to them with my thoughts about their reply. First, here's their response...

Dear Bob,

Many thanks for getting in touch with Save the Children about our partnership with GlaxoSmithKline. I believe you have contacted us before on this, and we thank you for your interest.

Save the Children is aware of the reports on the historical issue of Paxil. As an organisation we take our reputation and our role to protect children very seriously and assess all our partnerships within this context.  We acknowledge there are risks associated in working with a pharmaceutical company such as GSK, but our belief is that these risks are outweighed by the benefits of the partnership in helping us achieve our ambitions for children.

As part of our partnership we continue to have open dialogue with GSK and monitor their business practices, in order that we respond appropriately should future issues arise.

Private sector partnerships are instrumental in enabling Save the Children to realise our vision and our partnership with GSK will have a lasting impact on global mortality rates. The focus of the partnership is to help to save a million children’s lives in the developing world and it combines GSK’s relevant skills, expertise and resources across its business with the funding of healthcare programmes for the poorest children in developing worlds.

For further information on our partnership, please visit: www.savethechildren.org.uk/about-us/who-we-work-with/corporate-partnerships/our-partners/gsk

Kind regards,

-- 

My reply...

Dear REDACTED,

Many thanks for your reply.

I DO admire the work of Save The Children and would, if it were not for your partnership with GlaxoSmithKline, promote your worthy cause.

However, I have a problem given Glaxo's appalling record when it comes to the safety of children.

You claim that the benefits of being in partnership with GlaxoSmithKline outweigh the risks - and that helps you achieve your ambitions for children.

I get it - I totally get it.

In the same context, however, you are more or less saying that Glaxo putting between 8,000 - 266,000 children and adolescents at risk of suicide (in just one year) is something that Save The Children can overlook because your partnership, or goals, can potentially reach an audience where more children could be saved. Is this your position?

I am sure your organisation has mathematicians or even accountants who can crunch the numbers - see here - http://fiddaman.blogspot.co.uk/2015/09/alastair-benbow-devil-is-in-details.html

Furthermore, despite Glaxo pleading guilty and paying a fine of $3 billion to resolve fraud allegations you still believe that your association with them is beneficial?

This, as you know, was a criminal offence and saw Glaxo plead guilty to, amongst other things..

Paxil: In the criminal information, the government alleges that, from April 1998 to August 2003, GSK unlawfully promoted Paxil for treating depression in patients under age 18, even though the FDA has never approved it for pediatric use. The United States alleges that, among other things, GSK participated in preparing, publishing and distributing a misleading medical journal article that misreported that a clinical trial of Paxil demonstrated efficacy in the treatment of depression in patients under age 18, when the study failed to demonstrate efficacy. At the same time, the United States alleges, GSK did not make available data from two other studies in which Paxil also failed to demonstrate efficacy in treating depression in patients under 18. The United States further alleges that GSK sponsored dinner programs, lunch programs, spa programs and similar activities to promote the use of Paxil in children and adolescents. GSK paid a speaker to talk to an audience of doctors and paid for the meal or spa treatment for the doctors who attended. Since 2004, Paxil, like other antidepressants, included on its label a “black box warning” stating that antidepressants may increase the risk of suicidal thinking and behavior in short-term studies in patients under age 18. GSK agreed to plead guilty to misbranding Paxil in that its labeling was false and misleading regarding the use of Paxil for patients under 18.

Source - Department of Justice Website - http://www.justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report

Once again, I refer you to http://fiddaman.blogspot.co.uk/2015/09/alastair-benbow-devil-is-in-details.html that breaks down the number of children and adolescents GlaxoSmithKline, through their criminal behaviour, put at risk of suicide.

Are you telling me that this sits right with Save The Children?

Without sounding flippant, are you merely telling me that Save The Children are willing to enter into partnership with anyone with a criminal record such as the one GSK pleaded guilty to?

GlaxoSmithKline made a lot of money by illegally promoting Paxil to this age group and now, it appears, are helping Save The Children with their illegal gains.

This sits rights with Save The Children and your stakeholders?

As I have stipulated, I admire, greatly, the work that Save The Children do but dismissing GlaxoSmithKline's criminal record where children and adolescents are concerned seems a tad perverse given the title of your organisation.

In essence, and from the gist of your reply, you are, I assume, saying that it's okay to put children and adolescents at risk of suicide as long as you are able to offer money to the Save The Children organisation?

Would you enter into a partnership with a multi-millionaire who kidnapped, let's say, 8,000 teenagers and threw a rope around their necks and threatened to hang them?

With respect, your response clearly suggests that Save The Children are willing to enter into a partnership despite any person/s criminal background. Remember, it took a Department of Justice investigation to force Glaxo's hand - they had previously denied any wrong-doing.

To be honest, I am flabbergasted at Save The Children's reasoning here.

Regards

-- 

I'll let you know should Save The Children respond.



Bob Fiddaman.

GSK Vs Ronnie Biggs

Two criminals, both British - lets look at their respective rap sheets.

Ronnie Biggs

1945
9 Feb
Biggs’ first court appearance at Lambeth Juvenile Court at the age of 15. The charge is stealing a pen refill and eraser of 1/2d value from a shop display.

8 June
Second appearance at Lambeth Juvenile Court for stealing four radio valves and an eggcup. Bound over for 12 months and find £1. Discharged

16 Nov
Third appearance at Lambeth Juvenile Court for stealing his brother’s watch. Bound over for a further 12 months and fined £1.

1949
17 Feb
First prison sentence – sentenced to six months for shop breaking, housebreaking, stealing and using a false ID card. Dishonourable discharge from the RAF.

28 July
Sentenced to three months in Wormwood Scrubs at the North London Magistrates Court for ‘taking and driving away a motor vehicle’.

30 Nov
Sentenced to Borstal training after being found guilty at Essex Quarter Sessions for shop breaking and stealing.

1950
21 Mar
On trial at the Old Bailey for the first time for robbery of jewellery and money, and being armed with an offensive weapon. Sentenced to three years and six months.

1953
24 Mar - Found guilty at Country of London Sessions for garage breaking and stealing a motorcar.
30 Mar - Found guilty at Buckinghamshire Quarter Sessions for house breaking and stealing a bottle of sherry valued at 18 shillings.
Concurrent sentences of three years from Country of London Sessions and four years from Buckinghamshire Quarter Sessions.

1958
1 April
Sentenced to 12 months at Dorset Quarter Sessions for ‘taking and driving away a motor vehicle’.

25 April
18 months added to sentence by Surrey Appeals under probation order for stealing paint and a bike in 1956.

1964
16 April
Biggs sentenced to concurrent sentences of 30 years and 25 years for his part in the Great Train Robbery.

GlaxoSmithKline

1992
September 18
SMITHKLINE AND ROHM & HAAS TO CLEAN UP TOXIC SITE - both agreed to reimburse the United States for past cleanup costs absorbed by the E.P.A. totaling $250,000 - No prison sentence

1996
February 10
Drug Makers Settle Suit on Price Fixing
Fifteen big drug companies formally agreed yesterday to pay more than $408 million to settle a class action lawsuit charging them with conspiring to illegally fix prices that they charged to thousands of independent pharmacies.

In the settlement, which is subject to approval by a Federal district judge in Chicago, the 15 companies agreed to pay more than $388 million in cash. One of the defendants, SmithKline Beecham P.L.C. of London, agreed to supply the plaintiffs with a generic version of cimetidine, SmithKline's Tagamet brand ulcer treatment, valued at $20 million, as well as $30 million in cash. -  - No prison sentence

September 7
SmithKline Beecham in Settlement With U.S.
In the latest big settlement by a clinical laboratory company of Federal Medicare fraud charges, SmithKline Beecham P.L.C. expects to pay the Government about $300 million this year, without admitting any wrongdoing. - No prison sentence

2001
February 8
5 Drug Makers Use Material With Possible Mad Cow Link
For the last eight years, the Food and Drug Administration has repeatedly asked pharmaceutical companies not to use materials from cattle raised in countries where there is a risk of mad cow disease. All five vaccine makers, which include GlaxoSmithKline, Aventis and American Home Products, have now agreed to stop using the suspect materials, which include blood, fetal calf serum and meat broth. - No prison sentence

June 8
Jury Awards $6.4 Million In Killings Tied to Drug
A Wyoming jury has awarded $6.4 million to the family of a man who killed three relatives and himself after taking the antidepressant Paxil, an antidepressant made by SmithKline - No prison sentence.

2003
January 24
Asthma Drug Health Risks Are Suspected
GlaxoSmithKline said yesterday that Serevent, one of its popular asthma drugs, might pose a risk of death and serious asthma-related illness in some patients. -  No prison sentence

2004
February 7
DRUG MAKER AGREES TO PAY $175 MILLION IN LAWSUIT 
GlaxoSmithKline, the drug maker, agreed to pay $175 million to settle a lawsuit contending that it blocked cheaper generic forms of its Relafen arthritis medicine, in violation of antitrust laws in the United States. -  No prison sentence

July 9
GLAXO TO PAY $92 MILLION TO SETTLE PATENT LAWSUITS - Published: July 9, 2004
GlaxoSmithKline, the drug maker, has agreed to pay $92 million to settle lawsuits accusing it of misusing patents to thwart generic competition to the antibiotic Augmentin  - No prison sentence

2005
September 20
Glaxo Settles U.S. Fraud Charges
GlaxoSmithKline PLC will pay $150 million to settle claims it overcharged the government for two anti-nausea drugs, and prosecutors say they're looking into 150 cases of drug price fraud. - No prison sentence

2006
August 11
Glaxo reaches $70 million settlement over price-fixing claims

Pharmaceutical giant GlaxoSmithKline announced yesterday that it had agreed to pay $70 million (£36.9 million) to settle a number of civil lawsuits filed in the US which accused the company of pricefixing. - No prison sentence

September 12,
GlaxoSmithKline to Settle Tax Dispute With U.S.

GlaxoSmithKline, Europe's biggest drug maker, said Monday that it would pay $3.1 billion to settle a tax dispute with the United States government that was set to go to trial next year.  - No prison sentence

2007
March 27
Schoolgirls bust Glaxo for lying about Ribena vitamin C 

Two fourteen-year-old students busted Glaxo for lying about the Vitamin C content of the Ribena drink. Glaxo fined  NZ$217,500.  - No prison sentence

Musical interlude. The charges featured in this video resulted in no prison sentences

2012

July 2

GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data.

Global health care giant GlaxoSmithKline LLC (GSK) agreed to plead guilty and to pay $3 billion to resolve its criminal and civil liability arising from the company’s unlawful promotion of certain prescription drugs, its failure to report certain safety data, and its civil liability for alleged false price reporting practices.  - No prison sentence

2014

Sept 14

China Fines GlaxoSmithKline Nearly $500 Million in Bribery Case

In the strongest signal yet, a Chinese court on Friday imposed a fine of nearly $500 million on the British pharmaceutical giant GlaxoSmithKline for bribery. Chinese authorities accused Glaxo of bribing hospitals and doctors, channeling illicit kickbacks through travel agencies and pharmaceutical industry associations — a scheme that brought the company higher drug prices and illegal revenue of more than $150 million. In a rare move, authorities also prosecuted the foreign-born executive who ran Glaxo’s Chinese unit. After a one-day trial held in secrecy, the court sentenced Glaxo’s British former country manager, Mark Reilly, and four other company managers to potential prison terms of up to four years. The sentences were suspended

2015

Sept 16

Global drug giant GSK 'published a flawed study which led to millions of children being wrongly prescribed dangerous antidepressants'
A global drugs giant published a flawed study which led to millions of children being prescribed potentially dangerous pills, new research reveals. GlaxoSmithKline misled doctors and the public into thinking their antidepressants were safe and effective, even though there was no evidence to back this up. - No prison sentence


British criminals, GlaxoSmithKline are currently partners with Global charity, 'Save the Children'.

Total Prison sentences (in years) handed out to Ronnie Biggs = 86 years 9 months
Total Prison sentences (in years) handed out to GlaxoSmithKline employees = 4 years (Suspended)


Bob Fiddaman

MHRA: Follow-Up Rate at a Price

I've been at loggerheads with the British drug regulator, the MHRA, for many years. I saw a window of opportunity a few years ago when I was (finally) given the chance to sit with their (then) CEO, Kent Woods, to discuss the struggles patients were having when trying to withdraw from SSRi- type medications. (Notes on that meeting can be viewed here) Any such meetings with them these days would be kinda frowned upon by me - their current CEO being the former World Safety Officer for GlaxoSmithKline - Safety and GlaxoSmithKline, two words, combined, that just don't sit right with me. I don't wish to sit at the same table as him or anyone connected with GSK for that matter, well, not unless they have some sort of apology to offer me. (See here)

Some months after my meeting with Kent Woods I finally gave up communicating with the MHRA. The final correspondence between myself and Kent Woods is detailed in my book, The evidence, however, is clear: the Seroxat scandal. (US - UK) - In a nutshell, the MHRA did not agree with a US Court's findings that Seroxat, known as Paxil in the US, is a tearatogen (an agent or factor that causes malformation of an embryo.)

From time to time I still send in Freedom of Information requests to the MHRA, it's all very formal, no name-calling or accusations that they are limp-wristed and incompetent.

A recent request sent in to them has been going back-and-forth - apparently my wording confused them in an original request of mine so I had to wait almost two months for their reply.

My question was, I thought, pretty straight forward but I amended it for their ease.

Please provide total number of yellow cards and total number of full investigations into the alleged adverse reaction for the following years... 2011 to date (where full investigation = how many of the affected persons, or the affected persons health care professionals, did the MHRA contact to see what happened to them or to discuss with them the adverse drug reaction)

Basically, I want to see if the MHRA ever contact any person who sends in a report of an adverse reaction, after all, the patient is the one suffering here.

It's worthy to note also that the MHRA list the number of reports sent in by patients, healthcare professionals on their website. They will list, for example, the number of reported fatalities sent in via their yellow card reporting system but, and here's the crunch, they don't provide information as to whether their team of investigators have actually discussed the adverse reaction with the patient or doctor. They also claim that just because xxx fatalities have been reported with drugs x,y and z, it does not necessarily mean that drugs x,y and z caused the deaths. How, then, can they know for sure that, for example, a suicide has been caused by a drug? Leaving the public, and doctors, second guessing just adds to the woeful way the Yellow Card Reporting System is run.

Anyway, here is their reply - looks like I need to pay money up front - £600 (minimum)

So, let's just get this straight. Me (a patient) is asking for information that, I feel, is important - in as much that I wish to try and find out if the MHRA investigative team actually respond to patients or doctors on a personal level. An example here would be a yellow-card report sent in by the family of a suicide victim, or indeed the victim's doctor - I just want to know if the MHRA would, during their investigation, contact the family to ask questions about their loved one taking his/her life and if this victim displayed suicidal thinking before he/she had taken the drug.

It seems the MHRA are avoiding the question and putting other excuses in place. (Just an opinion of mine so no need to label me vexatious)

• It is important to note that each report is different and not every report requires follow up. 
• Some reporters request they do not wish to be contacted again by the MHRA 
• The MHRA determine which cases should be followed up, on a case by case basis. 

I understand that my request would take up many man hours so I sent back the following to them. It's short and sweet and yet, my lack of confidence in the MHRA tells me that they may further stonewall me with their next reply.

Dear MHRA,

I'm somewhat bemused by your answer but, I guess, I will have to take it on trust that you are not trying to pull the wool over my eyes.

Simple question as a follow-up to your reply...

Do the MHRA actually follow up any Yellow Card Report sent in by the original reporter, ie; do they,or have they, ever contacted the patient who sent in the original yellow card?

This simple question, one would think, could be answered in the blink of an eye. However, it appears that I may now have to wait a further 21 working days for a reply that I suspect will be decorated with bricks and mortar.

I hope they prove me wrong.

That will be a first!

It's simple. How many reports have the MHRA followed up by speaking with the original reporter?

I'd draw a picture for them but art was never really my thing, I draw horses that resemble hedgehogs and even my stick-men have deformities.

If the answer to the question embarrasses the MHRA, ie they don't ever follow-up with the original reporter, then why don't they just say so instead of, seemingly, putting up these stonewalls?



Bob Fiddaman

Save The Children

Some people ask me why I'm, seemingly, hellbent on causing GlaxoSmithKline grief. I would have thought it was plainly obvious given their sombre history where kids are concerned.

The recent RIAT findings that showed (clearly) how this British pharmaceutical company hid important patient information in an effort to make money should have embarrassed GlaxoSmithKline bosses, it should have embarrassed every single person that works for GlaxoSmithKline (past and present) - more importantly this new information should have made your average person angry - sadly, there are still people who read the headlines, shrug their shoulders, and continue posting photos of their dinner on Facebook or a photo or video of a cute cat or dog. The marketing of Paxil to kids doesn't seem to bother them because... well, because it happened to other children and adolescents and not theirs. This attitude is akin to people turning their cheeks when Hitler went on his journey - "Ah well, it won't affect us, we ain't Jewish, it's not our problem."

I have a beef with apathetic attitudes, moreover I have a beef with the people with these attitudes.

I understand that everyone of us have our own agendas, I just can't fathom out what some people's agendas are?

Then there are the organizations who receive funding from GlaxoSmithKline, of which there are many.

In a perverse twist of fate we have the aptly named 'Save The Children' charity who proudly boast...

"Save the Children works in 120 countries. We save children’s lives. We fight for their rights. We help them fulfil their potential."

I have to take my hat off to any charity that puts children first and I salute Save The Children for all that they do regarding the protection of children.

Here's what I don't get...

In 2013, GSK and Save the Children formed an ambitious and strategic global partnership. At the time of joining forces, GSK CEO, Andrew Witty, had this to say...

“A partnership of this scale gives us an opportunity to do something amazing – to save the lives of one million children, and to transform the lives of millions more. At GSK we are motivated by developing innovative life-saving medicines and getting them to the people that need them.

“By joining forces with Save the Children, we can amplify these efforts to create a new momentum for change and stop children dying from preventable diseases. I hope this partnership inspires GSK employees and sets a new standard for how companies and NGOs can work together towards a shared goal.”

GlaxoSmithKline, along with the 22 original authors of the JAACAP paper, potentially put thousands of children and adolescents at risk of suicide (potential figures here)

Would it have made us all be more vocal if the risk would have been death by poisoning? Is the suicide thing debatable because the majority of us think that kids who kill themselves are mentally ill and it has nothing to do with medication inducing suicide?

How can a charity, who aim to save children's lives team up with a pharmaceutical company who did/do exactly the opposite?

With this in mind, I wrote the following to Save The Children (I have also wrote to a number of other children's charities who are affiliated with Glaxo.)

Dear Sir/Madam,

Whom may I speak with regarding your affiliation with British pharmaceutical giant, GlaxoSmithKline?

As you will probably know by now, a new study that was recently published in the British Medical Journal (BMJ) has shown that GlaxoSmithKline knowingly withheld vital patient information back from regulators and the public regarding it's best selling antidepressant Seroxat, known by the brand name of Paxil in the United States. The new findings have urged the associate editor of The BMJ to write a scathing feature on GlaxoSmithKline - this is unheard of in medical journals.

The clinical trial, known as Study 329, originally showed that adolescents/children, across the world, were at no harm in taking Seroxat, when in actual fact, there were 12 adolescents in the original study who suffered suicidal feelings whilst on Glaxo's drug.

Glaxo never informed the people they should have and, for the past 14 years, academics have been calling for the retraction of this fraudulent study. GlaxoSmithKline, despite new evidence showing how they hid the data, have declined to remove the study, a study that is still used by healthcare professionals when deciding whether or not to prescribe children Seroxat off-label.

It makes a mockery of your affiliation with them. On one hand you are running an organisation that is trying to help save children, on the other hand you are affiliating yourselves with a company who put children at risk, and continue to do so.

The new study and the background can be found here - http://study329.org/

I strongly urge you to inform yourselves and reassess your allegiance with GlaxoSmithKline.

If this is just about receiving funding from GlaxoSmithKline to help your cause then you may wish to find out exactly how much money they have made over the years regarding the sale of paroxetine (generic name) to children and adolescents.

I don't expect for one minute that you will respond to this email but as a matter of conscience I urge you to, at the very least, read the new study and the history of this whole sordid affair that has put children and adolescents at high risk of suicidal thoughts and, in some cases, completed suicide.

Regards

Bob Fiddaman

--

Those of you on Facebook, Twitter, Instagram and the other countless social media websites who wish to carry on burying your heads in the sand and ignoring what Glaxo have done here, that's fine - just leave it to the people who have been affected by pharmaceutical greed. Glaxo aren't the only company who have caused heartache for parents, husbands, wives, brother, sisters and friends of those who have died as a result of unsafe antidepressants (short video below with just a handful of instances) - Hey, they are other people's loved ones so it really doesn't matter - just continue with your fluffy bunny, dog and cat pictures on Facebook.

I often wonder if I am wrong to do what I do and if I should just, like the millions of others on Facebook, just bury my head in the sand and use my status profile to tell people that I have just ordered a chicken madras or egg foo yung for my tea... then proceed to post a photo of it on to my wall when it arrives.

Such apathetic attitudes of the general public make it easier for the likes of GlaxoSmithKline and the charities that align themselves with them.

We ALL have a part to play in protecting children, whatever our life agendas, whether or not those children are our own.

The irony of it all is that this rant of mine will be 'liked' on Facebook, people on my friend list (not all of them) will see it appear on my wall and they will instantly 'like' it without actually clicking on the link to read it - hey, it must be likable because that Fiddaman guy is having a pop at GSK again.

I created this blog almost 10 years ago - I wanted to get to the bottom of the whole Seroxat/Paxil debacle because I had taken it and suffered the horrific withdrawal effects from it. When I learned that this antidepressant, and other SSRIs were actually causing kids to kill themselves (adults too) I changed direction - this wasn't just about me, it was about others less fortunate than me. I suffered horrendous side effects but I lived to tell the tale, others were less fortunate than I.

This is for them, it's also for the Facebook Fluffy Bunny Brigade. 

Enjoy your chicken madras.


**Update - Save The Children Respond** - Here

Bob Fiddaman.