Glaxo Destroyed Paxil Animal Studies

Nothing new here but this astounding story is in the news once again.

The revelation first aired some years ago in a Paxil birth defect trial (Kilker Vs GSK).

During the trial, the jury saw an exhibit showing minutes from a teleconference for a Paxil project team meeting. Page eight of the minutes stated: "It has already been discovered that raw data from four of the original Ferrosan sponsored toxicology studies conducted at Huntingdon Life Sciences were destroyed by HLS in 1993."

Now, it appears, Glaxo don't want this information rehashed in a current Paxil birth defect trial from the state of Ohio where it is alleged that Kathryn Kiker, after taking the Paxil while pregnant, gave birth to her child, who was born with a ventricular septal defect, a serious heart problem.

Glaxo, as in many cases where they wish to keep the jury misinformed, have claimed that evidence that lab notebooks from 1979 animal studies were destroyed in 1993 should not be heard by the jury, they cite that the claim “grossly distorts the regulatory practices in place at the time” and is “a manufactured controversy” likely to make jurors assume malfeasance.

Glaxo have filed many motions in this current Paxil birth defects case. They don't wish for the jury to see the 2012 plea agreement, in which Glaxo were find a record-breaking $3billion.

I'm surprised that GlaxoSmithKline continue down this road. They have done the same in the current adult Paxil suicide case of Stewart Dolin, ie; they don't want jury members to know anything about their abhorrent history of witholding evidence that shows that Paxil increases the risk of suicidal thinking and completion in both adults and children who take it.

What I find mind-boggling here is that GSK carried out a series of animal studies in animals, those studies, if supportive of their claim that Paxil is safe during pregnancy, would, for them at least, be worth their weight in gold. However, the studies did not show this so what did Glaxo do, well, it appears that they gave the go-ahead for the studies to be destroyed and kept away from public scrutiny. When being faced with a layperson jury hearing this information they claim that, um, it's irrelevant.

I'd just love to know what planet GSK and its defence attorneys are on, wouldn't you?

In any event, the judge heard their motions and denied them, leaving the door open for the jury to deliberate and discuss why Glaxo would not want animal studies in Paxil to be seen, furthermore why they stood by and allowed them to be destroyed.

The case is set to go to trial later next month.

Kiker is represented by Benjamin Anderson of Anderson Law Offices LLC and Bryan Aylstock, James Barger, Bobby Bradford, Roger Cameron and R. Jason Richards of Aylstock Witkin Kreis & Overholtz.

GSK is represented by Andrew Bayman, Halli Cohn and Meredith Redwine of King & Spalding LLP and William Darrell Kloss Jr., Adam Rusnak and Jessica Goldman of Vorys Sater Seymour & Pease LLP.

Bob Fiddaman.



Related stories.

Ryan, Glaxo's Non-Viable Fetus - Part I

Ryan, Glaxo's Non-Viable Fetus - Part II - The Twists

Q&A with Olga Leclercq

Continuing with the Q&A's from people that have played a role in my life for the past ten years or so that I've been writing this blog...

I've covered many stories of antidepressant induced suicide on this blog, each of them as heartbreaking as the next, each of them ignored by the medicines regulators, healthcare professionals and pharmaceutical industry.

If a drug can induce thoughts of self harm and suicide then we can be safe to assume that this can also put others in danger.

In 2012 this assumption became a reality and, it appears, nobody wants to either talk about it or hold anyone accountable for it. It's one of them cases where authorities have just shrugged their shoulders, in effect, pissing on the graves of those who perished.

Olga Leclercq's daughter, Eline (Pictured), was one of the 22 children who died when, for reasons (apparently) unknown, Geert Michiels (34) drove a bus into a tunnel wall in Sierre, Switzerland. (Back stories at the foot of this Q&A)

Eline (11)

It's been established that Michiels was withdrawing from Seroxat (Paxil) at the time of the crash, he had missed his dose on the day of the crash. It's also been established that Michiels deliberately drove the bus into a wall - a prior investigtion found that there were no mechanical problems with the bus and, more importantly, showed that at no point did Michiels apply the brakes of the bus.

I met Olga in London last year - what does one say to a mother who has lost a child in such horrific circumstances? I've wrote about the Sierre bus crash on numerous occasions on this blog, I've even corresponded with both the MHRA and the EMA (Medicines regulators) who have basically told me they are not interested and will not be carrying out their own investigations into this Seroxat related homicide.

Olga, along with other parents, are not letting go - why would they after the 'official investigation' was deemed to be "inconclusive"?

All of those involved in this investigation have, seemingly, ignored the most obvious cause, namely GlaxoSmithKline's Seroxat - we see coroners, globally, do the same at inquests, not only where Seroxat has been implicated, but other SSRIs too.

This needs to change and people like Olga are at the forefront of that change.

Here is my Q&A with Olga Leclercq.

--

Name: Olga Leclercq

Age: 44

Location: Lommel Belgium

Q: Olga, this may be a difficult question, so forgive me if it's painful for you. What is your fondest memory of Eline?

A: That is a difficult question because I have so many fondest memories of her. Eline was a very social girl, who loved to dance. She loved doing things together, it didn't really matter what, walking the dog, cooking, watching a movie. She often had play dates with the girls in her class, most of them died in the crash as well. She often made cute notes or drawings which she would hide everywhere in the house for us to find. I miss finding those notes and drawings, I am so glad we kept them all. 

Q: When did you first make the connection that the bus driver's use of Seroxat could have been linked to him deliberately crashing the bus?

A: Given the trajectory, we knew at a very early stage that this could not have been an accident, the trajectory is way to difficult for that. I didn't have any experience with antidepressants and when the Swiss authorities confirmed that the driver had Paroxetine in his blood, I started to look for more information. 

I never knew these drugs were linked to suicidal ideation and violence. Akathisia was something completely new to me.

We asked the Swiss authorities to investigate a possible link with the Seroxat. They refused to look into this because they claim that only the first weeks are potentially dangerous, the driver was on this medication for 2 years, he was withdrawing at the time of the crash, and in fact had not taken his dosage that day. For the Swiss authorities there is no reason to look into this any further.

Q: Have you at any point corresponded with Seroxat manufacturer, GlaxoSmithKline, with regard to the bus crash or have they ever apologised for the role Seroxat played in Eline's passing?

A: No, I never have. I know one of the attorneys that worked for them before looked at our website, but there has never been any correspondence between us and them. I doubt if they will ever take any responsibility, especially because the Swiss authorities never wanted to investigate and/or confirm a suicide. Officially it's just an accident. The case was simply closed  without a solid conclusion. Glaxo never made an attempt to look into this further. They never contacted us or the authorities to see if their drug might have been a cause, directly or indirectly. 

Q: If you could ask GSK's Andrew Witty three questions what would they be?

A: 1: Your drug Seroxat has been under discussion for more than two decades, many suicides, murders and family tragedies have been linked to your drug, how can you live with yourself? 

2: are you willing to take a therapeutic dosage of Seroxat for two years, and then stop as fast as the bus driver did, by just cutting the pills in half? Could you keep a blog, just to show everyone how safe your drug really is? 

3: What was one of your attorneys doing at our website? Did you connect the dots between the crash and your drug even before we did? I assume there must have been some curiosity about the cause of the crash, why didn't you ask the Swiss authorities to investigate further, as we have done?

Q: What do you say to people who believe that antidepressants are safe and effective?

A: Please do your homework before claiming these drugs are safe and effective. Even the drug companies themselves cannot prove their effectiveness, and/or safety.

Q: You have recently received correspondence from the Dutch Prime Minister, Mark Rutte. Can you tell me what that is about?

A: We asked for his help, we asked for the driver's blood sample a couple of times before but the Swiss authorities refused, so we were hoping for the Prime Minister's help in requesting this blood sample again. Maybe the request by the government will have more impact than the endless requests of a bunch of parents. 

Q: Why is it important to you that the Swiss uthorities release samples of the bus driver's blood?

A: We would like to have his DNA tested, through his DNA we can see if his body was able to break down his medication properly. Many people miss a certain enzyme (cytochrome P450) which means that they get toxic levels of the medication in their system. In other words: we could see if  the medication was very likely to cause this crash.

Q: Can you tell me more about the Independent Forensic Services in Hulshorst, Netherlands?

A: We turned to them for help. It was a bit more than a year after the crash and we knew that the Investigation by the Swiss authorities were not going to give us any answers about the cause of the crash, all our requests (like a reconstruction) were denied. We were very happy that IFS wanted to take a close look at our case, they did the reconstruction with the help of Eugene Liscio, a forensic 3D expert. It confirmed our fears, it was a deliberate act. The report of the reconstruction and also the other findings were sent to the Swiss procureur. But this also has been ignored. 

Q: Have you ever considered writing a book about your journey?

A: No, it would have been a good thing to do, because now I notice that I'm forgetting things. But I've never been keen on writing unlike my daughter Eline, who loved to write stories. My thoughts race from one subject to another, and I don't have the patience to sit down and write. I wish I had.

Q: Tell me about the Foundation Busramp Sierre website.

A: We started this foundation to give background information about the crash and hopefully get some support in what we do and why. Especially in Belgium there is a "let it rest" attitude, and that is something I simply cannot do. 

Q: Finally Olga, some personal questions...

1. What book are you currently reading?

A: Dr Peter Breggin: Medication Madness. The next one waiting on the shelf is Robert Whitaker, the anatomy of an epidemic and your book of course! 

--

2. What was the last CD you listened to (in full)?

A: I mostly listen to the radio, but I have a toddler who loves "Jip en Janneke" that is the cd I even hear in my sleep 😉 I hear that one in full a couple of times a week. 

--

3. What is the best movie you have seen this year?

A: I don't know

--

4. What country would you most like to visit?

A: I would love to go to back to Indonesia. 

We went there with the kids, 7 years ago. We travelled around for a month, I would love to do that again. 

--

5. If you had the choice of being either a defence or prosecution lawyer, which would you choose and why?

A: Can I choose both? I would like to stand up for everyone who had to deal with a crappy investigation. Sometimes as a defence lawyer to help wrongfully convicted but also as a proscecution Lawyer to help families like us who are basically standing with their backs against the wall. 

Bob Fiddaman.

Foundation Website

Busramp Sierre

Book

De busramp in Sierre: 1 Pill, 28 Dead.

Back Stories.

Did Seroxat Trigger the Fatal Sierre 2012 Bus Crash?

Sierre Bus Crash Revisited

For the Sake of the Children ~ Act Now!

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

Prime Minister of the Netherlands Offers Hope To Sierre Parents

Previous Q&A's

Q&A With Ablechild's Sheila Matthews-Gallo

Q&A With Leonie Fennell

Q&A With the "Truthman"

10 Years of Blogging - Q&A With Neil Carlin

Q&A With My Dad

Q&A With Musician Kirk Brandon

Q&A With Kristina Kaiser Gehrki

Q&A With Matthew Holford

Q&A With Stephanie Gatchell

Dolin's Devil's Tower - Paxil Wyoming

Devil's Tower is situated in the Bear Lodge Mountains near Hulett and Sundance in Crook County, Wyoming.

It became popular when its backdrop was used in the sci-fi movie, Close Encounters of the Third Kind - a movie about aliens visiting earth - Quite unbelievable but a good flick nonetheless.

Approx 60 miles south east of Devil's Tower is a town called Gillette. The population was estimated at 31,797 as of 1 July 2013.

In 1998 the town of Gillette was shook to its core, not because of invading aliens in huge motherships playing the five tones, it was shaken by a homicide/suicide.

Donald Schell (60) shot to death his family members, Rita Schell, Deborah Tobin, and Alyssa Tobin, before turning the gun on himself. Nobody knew, at the time, why such a loving man would carry out such a heinous crime.

Step forward surviving son-in-law, Tim Tobin, who brought a wrongful death lawsuit against Glaxo because Donald Schell was, um, basically, normal before he started taking Glaxo's wonder drug, Paxil. The jury in the Tobin v SmithKline Beecham (SKB) trial concluded that Paxil could cause someone to carry out suicide or homicide and that the drug was in fact a proximate cause of the deaths in this case.

Despite the verdict, Glaxo (then SKB) still maintained that Paxil was safe and did not cause patients to kill themselves and/or others. So, even being found guilty still, seemingly, gives Glaxo the right to plead their innocence. "Everyone in here is innocent, you know that?" ~ Red. Shawshank Redemption.

So, as I said, the town of Gillette is some 60 miles south east of Devil's Tower - which brings me nicely onto the current defence attorneys of King & Spalding et al in the Dolin v GlaxoSmithKline Paxil suicide trial.

Dolin's attorneys want to make mention of the Schell case to the jury, Glaxo are (once again) arguing/objecting, call it what you will, that the jury don't need to be made aware that their drug, Paxil, has already been found to cause suicide and homicide. Their reasons are, at best, laughable - their tactic, it appears, is to frustrate the widow of Stewart Dolin, Wendy.

Stewart had taken Paxil and had become agitated, an agitation brought on by akathisia which, in turn, was brought on by the Paxil.

Here's the reasons Glaxo have put forward regarding the submission of the Schell case.

The Tobin verdict referenced by Plaintiff’s filing concerns a trial that is wholly immaterial to this lawsuit for a number of reasons, including that the case (1) concerned labeling and warnings in February 1998 which are markedly different than those provided to the prescribing physician in this case.

(2) was decided under Wyoming law, not the law of Illinois;

(3) occurred before a host of analyses by a number of different researchers which havesuperseded the analyses discussed at that trial; and 

(4) occurred before a number of scientific analyses showed no association between the use of paroxetine and suicidal thoughts or behavior in adult patients in Stewart Dolin’s age category. Finally, the Tobin case involved multiple homicides as well as a suicide so it is factually distinguishable from the case before this Court.

As a matter of interest, concerning Stewart Dolin's 'age category', Stewart Dolin was 57, Schell was 60.

On point number 3, I'm baffled. if Glaxo, as they claim, have analyzed whether or not Paxil can or cannot induce suicide then why don't they provide that evidence? Surely if Dolin's attorney's use the Schell evidence, Glaxo can simply rebut it with the alleged analyses they have in their possession, right?

This is probably why they have thrown this excuse forward, it's just another attempt at introducing more paperwork for the layperson jury, or maybe another attempt at stalling the trial, which has been given a March 2017 date. It's business. If you have twenty or so million in the bank then you will want it remaining in the bank to gain interest. Anyone with half a brain knows how big corporate companies work. Then, of course, there is the defence attorneys being used by Glaxo, who, more than likely, are being paid by the hour - why let go of such a great cash cow, right?

Glaxo attempts at defending this trial (before it even goes to trial) have been rib-tickling, not so much for plaintiff, Wendy Dolin though who, I imagine, is totally frustrated at the whole mechanics of pharmaceutical defence attorneys.

Memo to Wendy - They are flogging a dead horse and just gaining interest on the money that they will eventually have to hand over, be it by being found guilty (once again) or by settling halfway through the trial.

I really enjoyed the movie Close Encounters - Devil's Tower has been a place that I would just love to visit. I envisage driving up to it whilst playing the original musical score from John Williams.

A remake of Close Encounters would be great huh?

In the original the government had to convince people of Wyoming that nerve gas was airborne so they had to evacuate the area. A more modern, up-to-date version could see the residents of Wyoming prescribed Paxil - they'll either be so out of it that they won't see the mothership or they will end up killing one another or beating one another to a pulp.

Play the five tones...


Bob Fiddaman.

Dolin back stories.

Policing Prescription Drugs

Much like the rock group, The Police, the medicines regulatory agency in the UK, The MHRA, seem to talk gibberish when questioned about the safety and efficacy of antidepressants, I'm reminded of the classic, De do do do, de da da da lyrics penned by Sting because he probably couldn't think of words to write.

The MHRA are constantly promoting the use of their Yellow Card reporting system, a system whereby patients and professionals are invited to submit suspected adverse reactions to prescription drugs - thing is, the MHRA get these reports, file them and...well, they do nothing. Isn't this like reporting a crime to the police and the police writing it down but not investigating it?

Caller: Hello, is this the Police?
Operator: Yes
Caller: I'd like to report a break-in
Operator: Can you tell me if the break-in is currently being carried out?
Caller: Yes it is.
Operator: Okay, do you have an address where the break-in is happening?
Caller: Yes, it's 222 Bowling Lane, Camberwick Green.
Operator: Thanks, we will log the complaint.
Caller: But I think the person who lives in the house may be in danger?
Operator: Why?
Caller: Because the person breaking-in has a gun.
Operator: Oh, I see, but the gun may not be real, it may not be loaded, it may just have blanks.
Caller: Um, so what are you going to do?
Operator: We will just write about it, no point in sending out an officer to the scene because, the person who owns the property may not be in danger?
Caller: Um, yeh, but they may be in danger?
Operator: We have given you our position on this matter.

This is how the MHRA seem to operate.

Another analogy...

Caller: Hello, is that the fire brigade?
Operator: Yes.
Caller: I'd like to report an electrical fence that hasn't been turned off, it's close to a children's play area and I fear children may touch it and die.
Operator: Can you give me the address please?
Caller: Yes, it's 555 Bowling Lane, Camberwick Green.
Operator: Okay, thanks for this, we will log the complaint.
Caller: But are you going to send someone out to investigate and maybe either turn off the electric supply or, at the very least, put up warning signs?
Operator: No, we just log reports of dangerous fences, even if someone dies touching it does not neccesarily mean the electricity caused their death.
Caller: Are you serious?
Operator: Yes, absolutely. We have warnings about touching fences on our website.
Caller: But children are hardly going to read the fire brigade website if they are playing?
Operator: The matter is closed. Goodbye.

You'd be up in arms if any emergency services treated reports this way, right? - Key word here is 'service'.

The MHRA are a public service and they are supposed to protect the public from unsafe drugs. Their idea of protecting seems to be gathering suspect reports of adverse events to drugs then adding them to a database - they do not follow these reports up, pretty much in the same way as the police and fire brigade in the analogies above.

When asked why there are so many serious adverse events reported with a prescription drug, the MHRA can therefore claim that no direct association has been made with a product causing a death - they will agree that reports have been associated but nothing has ever been proven. Of course it hasn't - why would it if the investigative 'police' fail to follow up the report?

Welcome to the world of the medicine police, folks. The only police force in the world that are allowed to shrug their shoulders, twiddle their thumbs and sit on information that may harm the public.

The problem is global, it's not just the British regulatory agency, the FDA in the US, Health Canada and the TGA in Australia are three other policing agencies that sit shrugging their shoulders after reports of possible harmful drugs are sent to them. They read, log and continue to get paid, ironically by the very same people who manufacture the suspect drugs in question.

And yet each regulatory agency reitterate the importance of reporting adverse events to prescription drugs - begs the question, why?

When you strip away all the excuses the regulatory agencies claim in defending their apparant 'policing' policies, you'll see that, in essence they are not protecting the public, in fact, they are doing quite the opposite by failing to carry out their own investigations into adverse reporting and by failing to interview witnesses who may, or may have not seen, the change in the person once the drug was administered.

This isn't rocket science, it's basic policing!

2017 rant over.


**Footnote**
The CEO of the MHRA is Dr Ian Hudson.
Dr Hudson is the former World Safety Officer for GlaxoSmithKline (then SmithKline Beecham)


Bob Fiddaman.


Back story.

The Mechanics of the MHRA