8 Paxil Kids "Suffered Catastrophic Birth Defects"

One news item that appears to have been overlooked by the mainstream media is news coming out of the state of Illinois where a three-justice panel of the Illinois First District Appellate Court denied an appeal from Paxil (Seroxat) manufacturer, GlaxoSmithKline to bring litigation against them to a halt.

Glaxo, without defending that Paxil caused birth defects in these children, had argued that the plaintiffs who lived outside of Illinois should not be able to bring a case against them. (6 of the 8 live outside of Illinois)

Plaintiffs argued that during the illegal promotion of Paxil (ie; GSK reps telling doctors that Paxil was safe in pregnancy) over 17 Paxil-related clinical trials were carried out in Illinois.

Judge Axelrood ruled in plaintiffs favour - Glaxo appealed and that appeal has been turned down by the three-justice panel.

The panel said...

“Defendant GSK conducted a part of its general business in Illinois, and plaintiffs’ claims arose out of the very trials conducted, in part, in Illinois,” the justices wrote. “The fact that the contested plaintiffs are not Illinois residents does not destroy the jurisdiction established on the basis of defendant GSK’s activities here.”

Interestingly, the panel also found that GSK’s sustained business presence in Illinois, including 217 employees who lived in Illinois, including 79-121 employees may have been tasked specifically with marketing Paxil in Illinois.

This, it appears, has become standard fare for GlaxoSmithKline. They no longer deny that Paxil can cause birth defects, they just try to get cases tossed using state laws, when they are denied this they then claim that although Paxil can cause birth defects, any plaintiff who alleges this is either wrong or something else caused the birth defect. They will also, more than likely, delve deep into the mothers history to see if they drank or smoked during their pregnancy. They may also try and damage the reputations of the mothers by trying to find out if they were involved in extra marital affairs during their pregnancies - all this, in efforts not to pay compensation - it's the act of a vulture picking on a dead carcass ~ although, to be honest, I'd rather spend time in a room with a vulture than one of GSK's hired suits.

This from the Cook County Record...

In 2014, eight mothers filed suit against GSK in Cook County Circuit Court, alleging their children “suffered catastrophic birth defects” 

The plaintiffs alleged GSK should have known of the dangers of the drug from its clinical test results, and should have warned doctors and expectant mothers of its allegedly “significantly increased risk of congenital defects in babies whose mothers ingested” Paxil.

Instead, plaintiffs asserted GSK promoted Paxil as “being safe for pregnant women.”

GlaxoSmithKline's company motto, that they still use today, is...

We are dedicated to improving the quality of human life by enabling people to do more, feel better, live longer.

It's a mantra that, I believe, goads victims of GSK.

As a father, myself, I am outraged. If I were a mother I'd be homicidal.

Plaintiffs are represented in the above case by attorneys with the firm of Tor Hoerman Law LLC, of Chicago.

GlaxoSmithKline was defended by the firms of Dentons US LLP and Cozen O’Connor, each of Chicago.


Bob Fiddaman


Related

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

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

JANE NIEMAN VIDEO TESTIMONY GSK V KILKER (Paxil Birth Defects)

The Good Dog Shrink

Anytime someone offers an alternative to psychiatric medication always leaves me wondering if the product being offered is more about someone's concerns about making a fast buck opposed to really wanting to help patients suffering with depression ~ That was a big sentence without any comma's - hopefully you've now caught your breath - something that I did after reading a fascinating article in Psychology Today, an online publication for professionals and members of the public.

The article in question comes from David Sack M.D. who is board certified in psychiatry, addiction psychiatry and addiction medicine.

The usual range of emotions were felt when learning that the article was penned by someone in the field of psychiatry, let's face it, that particular field is based around guess work and, at times, utter lunacy.

This was refreshing and, at the same time, thought provoking. In fact I'm glad it was authored by a member of the psychiatric field because it shows that they are not all egotistical pill-pushing psychopaths.

Sack's article, Nature’s Antidepressant: The Dog, is probably the best piece of commentary I've read this year. It's not overly long, easily understandable and, more importantly, something that has been staring the psychiatric community in the face for years - something that they have missed or, as I suspect, totally ignored.

The question Sack throws out is whether or not dogs can lower or change people's moods and he cites a study from 1996 (A long-term study of elderly people in nursing homes with visiting and resident dogs)

Of course, Sack, like any other psychiatrist, would never suggest that using dog therapy was much better than using drug therapy - I don't think anyone in the medical profession would suggest that but, there are many who have suffered the side effects of medication that would.

Sack breaks the study down - It was, he writes, "an analysis of close to 70 animal studies" that found...

• In nursing homes with a live-in or visiting dog, depression decreased significantly among the elderly residents.

• Even after just one therapy session with a dog, children with psychiatric disorders showed better mood balance.

• Long-term care patients allowed to interact with dogs reported less loneliness. And the more one-on-one time the person had with the animal, the greater the effect.

• Dogs act as “social catalysts.” Their presence in a group was found to increase smiles, conversation and spirit-lifting interactions.

Contrast the above with images you may have seen of elderly residents slumped in chairs and dribbling at the mouth because they have been stuffed full of mind altering drugs - Interestingly the pooled studies also show that dog therapy can help children after just one session - sounds better than the risks associated with antidepressants that are used on a daily basis on children, huh?

Sack goes deeper into the study and tells us it works because of something called oxytocin, don't worry it's not a pharmaceutical drug.

Oxytocin is a chemical also known as the 'love hormone'.

Sack writes...

It’s most commonly associated with childbirth and breastfeeding, and its release is believed to play a crucial role in facilitating the formation of emotional bonds. Turns out it’s also released when dogs and people interact. A recent study found that when dogs and human gaze into each other’s eyes, oxytocin levels rise in both.

Anyone who has ever owned a dog will know just how they can lift our spirits. We have taken it for granted that they are our very own antidepressant. My own experience of my own dog and looking after others is that they are, and have been, much better company than some humans I know. I mean, walking with a dog or walking with a pharmaceutical rep? It's a no-brainer, right? Allowing a dog on your lap or allowing a pharmaceutical CEO on your lap. Now I think about it some dogs have been better kissers than many of my ex girlfriends!

So, here's an idea.

Next time your child is offered a course of mind altering drugs that will strip away his or her empathy then consider a visit to a dog's home - watch your child change in an instant as pups and adult dogs respond.

Children do not need masses of drugs, they need masses of love and a dog will provide that love. A dog's love for it's owner and members of the family is unconditional. You will never find any love that comes anywhere near as close to that shown by a dog.

If visiting a dog's home persuades you to buy a dog then do so. You may just be saving two lives - that of your child (minus psychiatric medication) and that of the dog who, at the end of the day, just wants a family to love.

Introduce a dog to a child and watch that child's eyes sparkle with excitement. Introduce that same child to a powerful antidepressant and watch that sparkle disappear.

I have added this article of Sack's to my favourite list - it really is a simple yet brilliant overlooked idea.

For this, I salute a psychiatrist... and no, I haven't been sniffing bleach!


Bob Fiddaman


**Photo - Benn - My cross Boxer/Ridgeback. Sadly, no longer with us.

MDMA (Ecstasy) Vs Antidepressants

A recent article regarding MDMA (Ecstasy) from the BBC Newsbeat team had me drawing comparisons with antidepressants (SSRIs).

According to  researcher,  Professor Philip Murphy, "ecstasy is causing more mental issues." Adding that he "is worried that increasingly strong ecstasy will harm users ability to remember things efficiently."

Murphy goes on to say that ...

"The danger is much greater now than it was in the late 1990's The risk now of young people using stronger ecstasy is higher in terms of being able to regulate emotion and your ability to think clearly."

For a nanosecond I thought Murphy was talking about antidepressant use.

Let's just take a look at his findings and compare them with findings to popular antidepressants that, remember, have been granted a licence for use.

Ecstasy health risks
It can make you anxious, frightened and paranoid
It tightens your jaw muscles and can make you gurn
It raises your heart rate
Long-term use can cause depression, heart disease and liver and kidney damage.

Now, lets look at the risks associated with antidepressants.

SSRI health risks
Moodiness, anxiety, crying, nervousness, restlessness.
Grinding your teeth, especially at night.
Rapid heart rate.
Long term use may cause Depersonalization, liver damage. Antidepressant use has also been linked to thicker arteries, which could contribute to the risk of heart disease and stroke.

These are just a handful of risk with SSRI's - Compare the two lists and ask yourself why one drug is legal and the other isn't.

Ironically, MDMA was first synthesized by Merck Pharmaceuticals in Germany in 1912.

Let's go back to the researcher, Professor Philip Murphy.

Professor Philip Murphy has been researching the drug for nearly 20 years and says he's worried about the supply currently on the market.

"The danger is much greater now than it was in the late 1990s," he says.

Again, one can associate this statement with antidepressants given that sales since the 1990's have shot through the roof as Dr's prescribe them for everyday problems ranging from marital issues to grieving the death of a cat.

Parents will obviously be concerned at the growing use of ecstasy in the UK. Those same parents should also heed the dangerous side effects of antidepressants, a list of which is considerably bigger than ecstasy.

It's also rather bizarre that coroners will thoroughly investigate claims that ecstasy can induce suicide yet rarely do when carrying out inquests on people who have killed themselves whilst on an antidepressant. One such inquest was that of  Ben Stollery who, at the age of 18, took ecstasy. He was found hanged by a river bank near a canoe club. A toxicologist who found traces of MDMA in the teenager's blood, saying the teen may have suffering the effects of "Suicide Tuesday", a term used for people who use recreational drugs on a Saturday then kill themselves when they fully come down from the high the following Tuesday.

The toxicologist, after a verdict of suicide was returned, said,  "On the balance of probabilities, I do believe his state of mind was influenced by MDMA and the comedown part of this drug."

For a concise list of coroner inquests where antidepressant use has been mentioned but not investigated by the coroner go to antidepaware website here.

The benefits of using ecstasy has been described by some users as giving them a high and making them feel overwhelming empathy.

I recently wrote to both the British and European drug regulators (MHRA and EMA) and asked them to list the benefits of taking an SSRI. Once I get a response I will post on here.

In the meantime, I'll leave you with this - many a true word spoken in jest.

Contains profanity.

Bob Fiddaman.

David Brent: Prozac

As a writer of all things pharmaceutical it was good to see Ricky Gervais include the side effects of the antidepressant Prozac in his latest movie, David Brent: Life on the Road.

It was a subtle line but one I picked up on (given the nature of the work I do) - Brent, Ricky Gervais' comic creation, took Prozac and became addicted to it, it also made him gain weight. Fantastic to see Gervais highlight this, even if it was lost amongst his many other one-liners that were, at times, cringe worthy.

There's even a scene where Brent pays a visit to his therapist, being oh-so careful with what he says to her (probably because he doesn't want to be labelled and drugged again)

David Brent has moved on from Wernham Hogg, he's no longer boss, although he does claim to be his own boss - he's still totally un-PC, he's still unaware that he's totally un-PC.

We see the introduction into his life-long ambition - hitting the road with a makeshift band, Forgone Conclusion - all in it for the money with the exception of wannabe rapper Dom Johnson, played brilliantly by Doc Brown - He's black by the way, something that Brent explains when introducing him to his manager back at the office, where incidentally he has his own parking space (I won't spoil the subtle panning of the camera that reveals the parking space names)

I sat in darkness watching the 96 minute movie. There was times when I felt guilty for laughing at the handicapped and racist lines but they are what made Brent, Brent. He's awkward to have around because you just don't know what he's going to say next or, more importantly, who he is going to offend next.

He's a lovable dreamer who, unlike too many people, actually chases his dreams - for that you have to stand up and salute him.

David Brent is a fictional character yet we all know someone like him - It's the delivery of Gervais that makes Brent such an appealing character - or rather the pauses and facial expressions. Comedy, at times, is best delivered with those moments of silence, something Gervais has mastered the art of.

Brent is a tragic character yet he is someone that we can't live without - he reminds us of how we all, deep down, want to be loved and how we, at times, miss what's going on around us in search of our dreams.

The songs played by Forgone Conclusion, with Brent on lead vocals, are hideously embarrassing, they would be, given that Brent penned the lyrics. If there were a cushion in the cinema I would have put it in front of my face for the song, or rather the lyrics, he chose to perform about the "handicapped" - The introduction of which was uncomfortable, given that there was a guy in a wheelchair in the sparse audience.

David Brent is still wanting to be loved - he's still a chilled out entertainer.

He's still annoyingly funny and for 96 minutes he made me forget about the real world that I find myself submersed in on a daily basis.

I'd have a beer with him any day of the week. (And I wouldn't need paying)

Catch David Brent: Life on the Road when you can ~ Keep repeating, "It's only a movie, it's only a movie..."


Bob Fiddaman

Antidepressants Saved My Life

Following on from yesterday's blog post, Antidepressants: The Apathy and Ignorance, I have another issue that needs addressing.

There's many people who add comments to Twitter, Facebook and media article threads regarding the dangers of antidepressants. I've seen comments that suggest the authors of the said pieces are scaremongering or are irresponsible for making claims that antidepressants can induce psychosis that can, in turn, lead to acts of suicide and homicide.

The best is the comment used by many, "Antidepressants saved my life."

Really?

The issue I have with this is that, to date, there is no scientific evidence of this claim yet when you ask those who write about their lives being saved by antidepressants if they can back up their claims the only evidence they will use is along the lines of, "Yeh, take me as an example - I wouldn't be here today if it wasn't for Prozac, Seroxat, Zoloft etc".

That's the science behind their claim?

It's no more convincing than claiming that Jesus saved your life. It's a personal belief and not backed by any study by the pharmaceutical industry.

Here's the rub...

There are, however, studies that show antidepressants increase suicidal thinking yet these are, in the main, brushed aside by those who make claims that their lives were saved. Even the warning leaflets that accompany these pills warn of an increase in suicidal thinking - but guess what? There are no claims on these leaflets that the medication will 'save lives.'

Powerful marketing and an ignorant and apathetic public will claim that all medications have side effects but they are missing the point.

FACT: Antidepressants do not save lives, to suggest that they do is irresponsible.

Next time you see these claims, feel free to add the picture (below) - I designed it myself using a Google image I grabbed.

No doubt those who make these wild claims will take umbrage and may even suggest you are scaremongering and stopping people from taking their medication - almost every article, if not all, in the media usually carry some sort of disclaimer after running stories about antidepressant induced suicide/homicide. Do not abruptly stop your medication, they tell us, followed by, "Talk to your doctor."

Your doctor will no doubt tell you to ignore the conspiracy theorists - Just ask him for the proof that antidepressants save lives, the actual studies and not patient claims.

Watch him/her squirm and fob you off with silliness. Then ask him/her for the studies that show that antidepressants increase suicidal thinking.

You'll probably be escorted out of the building.

Bob Fiddaman

Antidepressants: The Apathy and Ignorance

A few weeks ago a guest post on David Healy's blog prompted a reply from me. The post, eloquently written by Sally MacGregor, was, in essence, a discussion about convincing the people whose attitudes toward antidepressant induced psychosis is, at best, apathetic.

I've experienced this many times, particularly on social media where people, or friends from yesteryear (that we don't see anymore) would rather post a photo of a cute kitten or puppy then disseminate information about antidepressants causing kids to kill themselves or women having to abort fetuses because of antidepressant induced birth defects.

I see it on a daily basis in comment sections of newspapers too, one in particular caught my attention.

It's from The Independent and the author of the piece is Katinka Blackford Newman who recently launched her new book, The Pill That Steals Lives: One Woman's Terrifying Journey to Discover the Truth about Antidepressants.

Katinka's post, featured in, The Independent, throws out the question of recent acts of violence and she, quite rightly, asks if these recent spate of attacks across Europe may be down to psychiatric medication.

The response in the comment section was typical of the apathy and ignorance that accompanies such questions.

One commentator, who clearly misses the point, writes...

"Do the independent trawl the world looking for loonies who can fill a few columns with their farcical articles.day after day I despair at how far this paper has fallen."

Another, somewhat more articulated response than the above commentator, writes...

"This is pretty irresponsible! A very tiny minority of people who take these drugs ever have a psychotic break. 

"Correlation is not causation. And I think the author is thoroughly confused about this. 

"It's bad enough to have a mental illness and experiencing the stigma without stories like this in the news: now the medicine is going to make us into mass murderers? Please. "

There's many more.

So, it's left to the choir once again to try to convince the ignorant and apathetic that they are not armed with all the facts and such negative responses to an article, whether they believe it to be true or not, really doesn't solve anything.

It left me wondering how many of these commentators actually go off and do their own research before leaving such comments - it reminds me of the scene from the movie, Dumb & Dumber where Lloyd Christmas, played by Jim Carey, covers his ears because he just does not want to take on board what his friend, Harry Dunne, played by Jeff Daniel's, is telling him.

These same commentators should be asked the question, What's the difference between ignorance and apathy?

Then again, they'd probably answer, I don't know and I don't care.

The comments left in the Independent article remind me so much of that scene from Dumb & Dumber, so much so that it's left a burning image with me for the rest of the night.

Bob Fiddaman.

A Week of Madness

The following needs few words. It's a post, one of my first, where I shall just use photos and link to the original stories.

Enjoy these rib tickling attempts at defining how depression and other psychiatric illnesses are diagnosed. Moreover, how the drugs used to treat these apparent illnesses, work.

1. The Priory Group prescribes “medication to restore the chemical imbalance in your brain’s limbic system” 

http://www.priorygroup.com/mental-health/depression

2. "Chemical properties of these drugs (SSRI’s) are restoring resilience in the brain."

http://psychintegrity.org/1786-2/

3. Eye test gives flicker of hope to psychiatric patients

http://www.scotsman.com/future-scotland/tech/eye-test-gives-flicker-of-hope-to-psychiatric-patients-1-4194535

Talk about moving the goalposts!


Bob Fiddaman

2012 Sierre Bus Crash - Further MHRA Correspondence

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

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

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

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


Click image to enlarge.

My reply to their response...

Dear MHRA,

Thank you for your recent correspondence.

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

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

Q1: You claim in your letter sent to me, ref GENQ-00113734, that Sharma's findings were "consistent with the outcome of previous regulatory reviews."

Given that fluoxetine was one of the antidepressants used in the Sharma study, do you still maintain that it is a safe and effective treatment for use in adolescents?

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

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

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

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

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

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

Bob Fiddaman.


Related stories.

Did Seroxat Trigger the Fatal Sierre 2012 Bus Crash?

Sierre Bus Crash Revisited

Email to Medicine Regulators Regarding 2012 Sierre Bus Crash

Monsanto's Roundup - Cancer Link Grows

I very rarely report on lawsuits outside of the pharmaceutical industry. But here's one that caught my attention. More so because the word 'Monsanto' regularly appears in my timeline on Facebook.

Who or what is Monsanto?

Monsanto is an American multinational agrochemical and agricultural biotechnology corporation. According to their website they deliver agricultural products that support farmers all around the world. Moreover, they claim, "Monsanto could not exist without farmers. They are our customers, the lifeblood of our company. More important, they are the support system of the world's economy, working day in and day out to feed, clothe and provide energy for our world."

Nice sentiments.

One of the products they sell is a herbicide called RoundUp, basically it's a weed killer that contains the active ingredient glyphosate. RoundUp is used by many farmers and your average householder.

Here's where Monsanto may not be supporting their farmers.

Lawsuits have been filed across the US alleging that Monsanto has known about the link between glyphosate and cancer since the 1980's but failed to inform the public about the danger. The one thing that caught my attention from the Baum Hedlund Aristei & Goldman press release is that Monsanto are denying that there is any link between Roundup and cancer.

The cancer link stems from a 2015 report from the International Agency for Research on cancer - or IARC - a division of the World Health Organization. It found glyphosate to be "probably carcinogenic." The report says glyphosate caused cancer in lab tests on animals and found that the chemical damaged DNA in human cells.

Monsanto, however, disagree with the findings and claim they have carried out their own tests and found no link between the active ingredient of RoundUp and cancer.

To date, 26 Roundup lawsuits have been filed across the US by 12 different law firms, A further 200 may follow as Monsanto's motions for dismissal have, in some instances, been denied. (1)

Due to the mounting scientific evidence indicating that glyphosate is a carcinogen, numerous countries have elected to restrict or ban glyphosate, including Roundup.

On December 26, 2015, Californian farmer, Jack McCall passed away after suffering a massive stroke due to complications from a rare version of non-Hodgkin lymphoma. His wife, Teri, has now has filed a wrongful death lawsuit against Monsanto, claiming exposure to Roundup caused her late husband to develop cancer. (2)

More about Jack McCall and further information regarding RoundUp lawsuits can be found here.

Maybe Monsanto need to take a good look at their labelling and add that RoundUp not only kills weeds and roots... but humans too.

Bob Fiddaman


(1) Mother-of-Three Sues Monsanto Claiming Roundup Caused Her Cancer
(2) What Killed Jack McCall? A California Farmer Dies and a Case Against Monsanto Takes Root.

Glaxo's Beef With David Healy Part II

Following on from Glaxo's Beef With David Healy, which I wrote about back in October 2015.

Back story.

In summary, Wendy Dolin has filed a suit against Paxil (Seroxat) manufacturers, GSK, alleging that Paxil caused the suicide of her husband, Stewart. Since filing Wendy has been subject to GSK's defence lawyers subpoenaing her cellphone and text message records, her home phone and her late husband's company phone. King & Spalding, GSK's defence team, have also asked Wendy about her love life and shown the private medical notes of her later husband to her children.

Not content with targeting a grieving wife, GSK have also singled out David Healy, an expert called by Dolin in the case against GSK.

In short, they have claimed that 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.

It's all hot air, much of which has been cherry-picked from Healy's blog and, in some instances misquoted and misguided - for example GSK's highly paid law team, who must have combed through Healy's blog by borrowing their client's rat-infested flea comb have claimed Healy has said things when in actual fact he hasn't, it's been comments left by others on Healy's blog - so much for crossing the T's and dotting the i's, huh?

Anyway, you get the gist, right?

GSK target the person filing the suit against them then, after failing, they then target that person's expert witness. You just have to love how King & Spalding operate at times.

Well, they failed in getting Healy's testimony thrown out. In fact, they wanted all four of Dolin's witnesses to not have their testimony's aired.

 They were denied these motions by Judge James B. Zagel who, in summary, said...

“I am denying all four of GSK’s motions to exclude. The Daubert criteria are satisfied when a well-credentialed expert provides well-supported opinions that are relevant and reliable.”

One would have thought that was that - but remember, we are dealing here with a pharmaceutical company (and their attorneys) who will try everything in the book when the defence of Paxil becomes so weak.


GMC BACKGROUND

In 2013 Healy found himself under the spotlight after a patient in his care suicided. This event spurned a review by Betsi Cadwaladr University Health Board (BCUHB) who, for reasons not known, hired an external consulting Psychiatrist, Dr. Robert Higgo to take a role in the review process.

The review, according to Healy, was meant to examine the circumstances surrounding the incident. Higgo, in his review, accused Healy of misconduct.and submitted his findings to the BCUHB.

In response to Higgo's allegations the BCUHB...

(1) initiated an internal investigation to examine the allegations

and

(2) sent a referral to the GMC to explore whether there was any misconduct that would raise concern about Dr. Healy’s fitness to practice medicine.

To cut a long story short, Healy was exonerated by the GMC. They concluded...

"As Dr. Healy had stated from the very beginning, that Dr. Higgo’s report was unfounded and that Dr. Healy did not engage in any conduct putting his fitness to practice medicine into question."

So, Healy was cleared. Here's where it gets interesting.

While in America, Healy was tracked down by attorneys who served him with a subpoena, the gist of which was that he should produce all documents concerning the BCUHB and GMC investigations.

No guessing who those attorneys were.

Healy refused, citing that it would jeopardise his employment as a physician and documents that were deemed privileged and confidential by BCUHB.

GSK then filed a motion to the court, basically demanding that Healy produce the documents.

The court asked to see the document in chambers (ie; just them and not GSK) so they could make a decision as to whether these documents were relevant to the Dolin case, moreover, relevant to GSK's argument that Healy's testimony in the Dolin case should be heard.

Healy handed over the documents to the court in July last year.

It was during the courts review of these documents that GSK filed motions for Healy to be dismissed as an expert witness - as previously mentioned, the court denied them this.

But, on and on they go. GSK now wish to conduct a hearing with Healy before the Dolin trial date of January 2017. Dolin, via her attorney, Brent Wisner of Baum, Hedlund, Aristei & Goldman, sent another letter to GSK indicating that...

“...in light of the recent ruling by the General Medical Council (“GMC”) clearing Dr. Healy of wrongdoing, this proceeding is no longer necessary or relevant.” 

Furthermore, plaintiff added that if GSK wish to pursue this matter then  she (Dolin) would like to conduct targeted discovery related to GSK’s interactions, if any, with GMC and Betsi Cadwaladr University Health Board (“BCUHB”)

Has the penny dropped yet?

The GMC exonerated Healy but now, it seems, GSK want their own kangaroo court to attack him even further.

In a quite genius twist Dolin's legal team have now asked the court that if GSK are granted a special hearing with Healy before trial then they request that plaintiff should be permitted to conduct targeted discovery relating to any influence GSK may have had in BCUHB’s or the GMC’s investigation of Dr. Healy.

In short, Dolin is asking for...

All documents reflecting communications between GSK or its agents, including counsel representing GSK, and Robert Poole, Robert Higgo, Giles Harborne, Matt Makin, Alberto Salmoiraghi, Peter Higson, or anyone at Betsi Cadwaladr University Health Board that mention or discuss Dr. David Healy.

All documents reflecting any payments or monies by GSK or its agents, including counsel representing GSK, to the aforementioned.

They've requested the same documents between GSK and the GMC too.

I wouldn't put it past anyone connected with GSK to find ways to sling mud at one of their biggest critics - I've heard the 'bullet left on a car story' but thought it was just folklore - I'm seriously beginning to think there was merit in that claim from a plaintiff who went up against GSK many years ago... apparently they wouldn't accept GSK's offer, next thing they know, there's an empty bullet casing left on their car...but that's another story.

Who needs John Grisham, huh?

The whole sordid affair, or rather matter of affairs, has me wondering if GSK's UK legal team will go down the same road when defending Paxil in a UK lawsuit next year. Just over a hundred people have filed a group action claiming they suffered as a consequence of withdrawing from Paxil. In 2002 GSK settled over 3,000 similar cases in the United States but, for one reason or another, GSK won't settle with those who make the same claims against them in the UK.

Will they be mud slinging Healy et al again, or bloggers for that matter?

The motion to vacate the 'special hearing' was filed by R. Brent Wisner on August 1.


Author's note.

Researching pharmaceutical companies, in particular GlaxoSmithKline, over the past ten years or so has taught me a few things when it comes to litigation.

1. The pharmaceutical company will defend cases in antidepressant related suicide, homicide, birth defects and withdrawal - even though the drug in question has been proven to cause such adverse reactions - they will, under oath, admit their drug can cause all of the above but will refute that (in the case they are defending) it did not cause x,y, or z to kill themselves or cause induced homicide, birth defects or horrific withdrawal problems.

2. They will drag litigation out for as long as they can, throwing subpoenas left, right and centre - they will object to this and that and will file motions in the hope that plaintiffs attorney's will spend more - thus settle at a later date for a meagre offer - See the Paxil birth defect case - Joanne Thomas v GlaxoSmithKline here and here.

3. They like to show their teeth. It's a way to stop further litigation against them. The actions in the case of Dolin v GlaxoSmithKline is basically a stark warning being sent out to anyone who may have ideas of going up against GSK in the future. It doesn't matter if you lost your child to suicide or had to abort your child due to birth defects caused by Paxil - or if you lost your job and marriage due to horrific Paxil withdrawal - you are dealing with a company that shows no empathy - it's an entity that is psychopathic - it cares not a jot about personal feelings - Grinding its teeth and digging its heels in is just an advertisement by proxy. The message being, Oppose us and we will make your life a complete misery. They not only do this with people who bring claims against them, they do it with expert witnesses who go up against them. One only has to look at the way they have targeted David Healy - it's not just about targeting Healy, it's about sending a message out to other future expert witnesses.

That's my take on things anyway.

Anyone know how the ruckus between David and Goliath finally ended up?

Answers on a postcard to King & Spalding.



Bob Fiddaman


Related

Court document shows how a jury, in 2001, found GSK's Paxil responsible for inducing suicide and/or homicide.

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

Former Glaxo World 'Safety Officer', Dr Ian Hudson

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

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

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

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

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

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

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

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

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

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

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

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

Here's Janne Larsson's correspondence.

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



Bob Fiddaman.


Back story

Swedish Journalist Takes on British Drug Regulator