Bob Fiddaman’s Latest Post From The Dolin Trial…


http://fiddaman.blogspot.ie/2017/03/dolin-vs-gsk-day-6-ass-kicking-semantics.html?spref=tw

Thursday, March 23, 2017

Dolin Vs GSK – Day 6 – Ass Kicking Semantics

ass kicking

To be beaten senseless because you definitely deserve it.

semantics
the branch of linguistics and logic concerned with meaning.


The plaintiff examination of former FDA Medical Advisor, Dr. David Cross, finished today. Cross, who was examined by Brent Wisner of Baum Hedlund, read from a document shown on the screen to the jury. The paper was published in J Clin Psychiatry and authored by, amongst others, John E. Kraus, an employee of GlaxoSmithKline. The published article, ‘Meta-analysis of efficacy and treatment-emergent suicidality in adults by psychiatric indication and age subgroup following initiation of paroxetine,’ tries to play down the risk of Paxil-induced adult suicide. Further, the paper claimed that there was no difference in suicidality among patients who took paroxetine and those who took a placebo.

Finalizing his questions to Dr. Ross, Brent Wisner informed the jury that the article was actually written in 2008. Bayman, King & Spalding’s resident jack-in-the-box retorted that it was 2011, a year after Stewart Dolin died. Bayman seemed confident and had a smug look on his face at the thought of getting one over a prosecuting attorney. The smug look was wiped from his face by Wisner when Wisner informed Bayman–and the jury–that the paper was submitted to the journal in 2008 and published in 2011. This was two years before Stewart Dolin’s Paxil-induced death. Bayman’s jack-in-the-box spring lost its bounce as he slumped back down in his chair licking his wounds like a scolded schoolboy.

I do love to see Brent Wisner in action, and it is even more fun to see Wisner kicking GSK’s ass.

King & Spalding’s cross-examination of Wendy Dolin’s expert witness, Dr. David Cross, commenced today. It was merely a game of semantics, blame shifting and one person (Bayman) trying futilely to catch another in contradiction.

Andrew Bayman once again was in charge of the calvary, his sole mission being to undo all the data Dr. Cross previously shared with the jury.
Did Bayman succeed?

Hardly. It seemed a junior-league attempt to try and trip up Dr. Cross regarding a deposition he gave more than two years ago. It was also an effort to try to show the jury that, despite all the evidence showing Paxil has a 9-fold increase in inducing suicidality in adults, GSK is not responsible for clearly communicating this life-threatening information to healthcare professionals and the public.

Bayman kicked off by trying to discredit the credentials of Dr. Cross.

“Are you a pharmacologist?”, Bayman asked.

“No.” Dr. Cross replied.

“Are you an epidemiologist?” Bayman asked.

“No.” Dr. Cross replied.

Bayman, whose team can’t seem to defend the statistics previously shown at trial regarding the number of adults endangered by Paxil, was trying to convince the jury that Dr. Cross wasn’t qualified to provide evidence regarding FDA rules and label regulations.

It left me wondering if Glaxo’s former CEO, JP Garnier, would ever be asked if he were a criminologist. To my knowledge, the Monty Burns look-a-like holds no Ph.D. in criminology, yet, under his guidance, GSK committed various crimes which they have already plead guilty to committing.

Indeed, Bayman himself has defended GSK’s nefarious activities on countless occasions, as have the law firm for whom he works. Does this make Bayman and his fellow co-workers qualified experts in septal heart defects, homicide, and addiction, all of which have previously been the subject of King & Spalding trials regarding Paxil use?

Bayman also went down the tired road of ‘It wasn’t Paxil, it was the underlying condition.’ A line we hear on a daily basis from pharmaceutical companies defending the latest prescription drug-induced lawsuits.

Yesterday the jury were shown that Paxil labeling does not mention the suicide risk in adults. They were also shown that there is little or no explanation of the word ‘Akathisia’ that accompanies the patient information leaflet for Paxil.

Bayman argued that the word ‘Akathisia’ is in the labeling. Maybe so, but who, exactly, knows what akathisia means, particularly when the medical term remains ambiguously undefined, as GSK wants it. There is no mention on the label that Akathisia often creates suicidal thoughts and actions. Instead, the SSRI class labeling states akathisia is ‘motor restlessness’ – a vague description for a prescription-drug induced condition that often causes suicide!

Despite there being a 9-fold increase of suicidality in adults taking Paxil, and that GSK has known this for 25 years, there is no mention of this in today’s Paxil label. Bayman glossed over this by deflecting the blame to the FDA. He claimed the FDA have responsibility for the language on the labeling, ergo, it’s not GSK’s fault, it’s the FDA’s fault. In any event, Bayman claims that GSK tried to change the labeling. Perhaps this might be true, yet, oddly Bayman has shown the jury no proof that GSK ever attempted to petition the FDA to communicate the real suicidality risks Paxil causes. Even if GSK did petition the FDA to correct the Paxil label, GSK apparently then sat back and did nothing after the FDA did not amend the label despite having a legal, moral and ethical duty warn consumers of the real Paxil-created risks. Even GSK’s former CEO, JP Garnier, admitted this moral responsibility in a video deposition shown the jury last week.

Garnier said under oath, and I quote, “…there is a legal right for us to go directly to the public.”

Evidence here.

So, Bayman trying to convince the jury the suicide warning was down to the FDA contradicts what the top boss at GlaxoSmithKline says.
A strange defence, unless of course Bayman thinks JP Garnier was lying under oath?
Garnier lying? Surely not!
The trial continues tomorrow.
From this point I’ll be giving periodic updates and not daily ones.

The Dolin Trial..


Roy Strom, The Am Law Daily March 22, 2017    | 0 Comments

Photo: Diego M. Radzinschi/ALM

The bad blood between Dr. David Healy and GlaxoSmithKline plc brewed up long before the psychiatrist took the stand in a Chicago federal court last week to testify that the pharmaceutical giant hid the risk of suicide in its blockbuster antidepressant Paxil.

Healy’s testimony is the bedrock of a claim brought by the widow of a Reed Smith partner who committed suicide in 2010 while taking a generic version of Paxil. GSK argues that Stewart Dolin’s death was the result of stress from a diminished role at the firm following a 2007 merger. Dolin’s widow, who claims her husband died from an adverse reaction to Paxil, is seeking $12 million from GSK.

All GSK has wanted is for the fast-talking psychiatrist to stop testifying.

Healy, a professor at a British university and a practicing physician in Toronto, has been a thorn in the pharmaceutical giant’s side since about 1999, when he wrote “The Antidepressant Era” and first began raising concerns about GSK’s clinical trials related to antidepressants known as SSRIs, or selective serotonin reuptake inhibitors. In 2005, The New York Times profiled Healy, noting that he was “internationally known as both a scholar and a pariah.”

“You don’t really know who you can trust,” Healy told the paper.

Healy has been a longtime expert witness in cases against GSK. His all-day direct examination in Chicago last Thursday was followed by a six-hour cross-examination this week. Healy said he had testified in more than 10 cases against GSK, something the company’s lawyers at Dentons and King & Spalding made a spirited effort to prevent in the Dolin case.

Healy’s testimony, for instance, was admitted in a suit in the Southern District of Indiana involving the sister of a priest who committed suicide after taking paroxetine, the trade name for Paxil. That case appears to have settled in 2011. And in 2015, Healy was an author of a new review of clinical Paxil trials on teenagers, which led to headlines that the drug was unsafe for teens.

The heart of Healy’s testimony contends that GSK artificially inflated the number of suicides and suicide attempts committed by members of the placebo group during clinical trials for Paxil. That had the effect of minimizing the risk of suicide associated with the antidepressant, meaning there was no warning of suicide risks on the drug’s label.

In the Dolin case, GSK’s lawyers filed a motion to exclude Healy’s testimony in the Dolin case, writing a 46-page memorandum with 70 attached exhibits arguing that Healy was a financially biased witness with an axe to grind against GSK.

The filing asserts that the lead plaintiff lawyer in the Chicago case, Michael Baum, a senior managing partner of Los Angeles-based Baum, Hedlund, Aristei & Goldman, is an investor in a company founded by Healy. That company runs a website, RxISK.org, which GSK’s lawyers said helps promote suits against the pharmaceutical industry. The filing also said Healy’s personal blog showed his bias against GSK, including his purported belief that the company helped get him fired from a previous professor position and may have been behind an investigation that could have led to his medical license being revoked in the U.K.

U.S. District Judge James Zagel ruled that Healy (pictured right) could testify in the Dolin case. But at the trial, presided over by U.S. District Judge William Hart, lawyers could not ask Healy about his blog or his personal relationship with GSK.

King & Spalding life sciences and health care litigation co-chair Andrew Bayman asked Healy if his website was intended to make it easier for the public to file suits and to garner work for himself as an expert. Healy testified that he bills $750 an hour to testify and $400 an hour to review cases.

But as was the case with many of the points that Bayman tried to pin Healy down on, the psychiatrist was prepared with a response to that charge in court Monday.

The website “has nothing to do with supporting lawsuits. This is all about minimizing the problem so there won’t be lawsuits,” Healy said, adding that Baum’s investment in his company, “would probably put him out of business.”

Proceedings in the Dolin case are continuing this week in Chicago. Some of his former Reed Smith partners are expected to take the stand.

More Dolin Trial Bombshells: Former FDA Offical Testifies That Paxil Is Not Safe And Doesn’t Work!…


“…David Ross. The former FDA Medical Advisor was asked if he prescribed Paxil to his patients.

Amid the objections from King & Spalding’s Andrew Bayman, he answered,

“No. I don’t believe that it works and I don’t believe that it’s safe.”….


Well, well, it seems that as the days go by more and more shocking revelations come out from the Stewart Dolin ‘Paxil Induced Suicide’ Trial in the US…

GSK… you evil bastards…

See Bob Fiddaman’s new post for more:

http://fiddaman.blogspot.ie/2017/03/dolin-vs-gsk-89-suicide-increase-for.html


Wednesday, March 22, 2017

Dolin Vs GSK – 8.9 Suicide Increase For Adult Paxil Users

Day 5 – Dolin Vs GSK Paxil Induced Adult Suicide – Chicago.

There was a startling revelation today in the Dolin Vs. GSK trial: Attorneys representing widow Wendy Dolin showed the ratio of Paxil-induced suicidality in adults is a staggering 8.9.  It is not 6.7, as previously claimed and reported by Glaxo. The 6.7 figure is astoundingly high in itself, but the 8.9 ratio is flabbergasting!

Plaintiff witness, Dr. David Ross, said this figure is ‘astounding.’ What you should remember here is that GSK’s 1989 drug application for Paxil said the suicidality odds ratio was 2.6.

Over the years as GSK’s lies were uncovered and more bodies were buried because of Paxil, GSK later changed the Paxil-induced suicide rate to 6.7. But today the world knows the actual Paxil-induced suicidality figure for adults is 8.9. This number is almost a nine-fold increase in adult Paxil patients experiencing suicidal thoughts, suicidal thinking and completed suicide–thoughts that are created by akathisia and other adverse reactions to Paxil and not by any underlying pre-existing condition.

Today at the trial, expert witness, Dr. David Ross, who worked for the FDA for ten years, testified extensively. While working at the FDA, Dr. Ross was responsible for reviewing new drug applications (NDA’s), i.e., he oversaw the statistics.

His evidence started with 6 points about GSK’s responsibilities (or lack of…)

1. Paxil is associated with an increased risk of suicidal behavior in adults beyond the age of 24.

2. GSK was not upfront about Paxil’s suicidal behavior risk.

3. In 2010, GSK had the ultimate responsibility for the Paxil label. GSK was responsible for ensuring the Paxil label did not contain any false, misleading, or inaccurate information about safety.

4. Federal regulations required GSK to warn doctors that Paxil induces adult suicidal behavior, starting in 1992.

5. GSK could have warned doctors by changing the Paxil label. There is no evidence the FDA would have stopped GSK from issuing a Paxil-specific warning in the non-class labeling sections. In fact, the FDA specifically invited GSK to discuss such changes.

6. GSK did not warn doctors of the true Paxil-induced suicidal behavior risks for adults beyond the age of 24.

Dr. Ross further reiterated to the jury what David Healy previously stated: that the responsibility for accurate drug labeling lies with the product manufacturer and not with the FDA. Dr. Ross added, “…the FDA does not do drug trials, we only know what we are shown.” He added, “You have to rely on the drug company.” He also informed the jury that the FDA’s annual budget is $1.3 billion, most of which comes from drug companies.

Another striking statement Ross shared with the jury was, “The FDA is in charge of enforcing the law, and GSK is in charge of following the law.”

Today’s evidence clearly shows that GSK has not followed the letter of the law enforced by the FDA.

Attorney Brent Wisner from Baum Hedlund asked Dr. Ross if he thought GSK’s label regarding adult suicide was adequate. Dr. Ross answered, “No.” and further added, “It was false and misleading and remains so today.”

Ross also told the jury that if he saw a nearly 9-fold increase in suicide in a drug (any drug) that he “Would not prescribe the drug.” In fact, Ross would categorize a 9-fold increase of any drug as a “frequent adverse event on labeling.”

He also told the jury that the term “Emotional lability” that GSK used instead of suicidality, “conceals what is really going on.”

Remarkably, two GSK employees, along with a third author who received funding and/or similar perks from GSK, published a medical journal paper stating Paxil actually reduced suicide in adults. Ross told the jury that he believed this published paper which contains obvious statistical errors should be retracted. The published article, “Reduction of suicidal thoughts with paroxetine in comparison with reference antidepressants and placebo”, by Montgomery, Dunner, and Dunbar was then used by GSK reps to promote the safety of Paxil in adult patients to prescribing doctors, even though GSK knew it was the complete opposite!

Indeed, it was a very bad day for GSK. The standard “Objection!” was lamely shouted out by King & Spalding’s resident Jack-in-the-box, Andrew Bayman, more times than I care to recall. The majority of his objections were overruled by the Honorable Judge Hart.

I’ve long been a critic of both the British and American drug regulators (the MHRA and FDA). Despite ten years of successful blogging, I’m never too old to learn something new, even when the new information is quite tragic: Today I, and the jury learned that drug companies such as GSK hold medical regulators by the balls. Drug companies provide information (to include false data from faulty clinical trials) and medical regulators have to accept drug company information as the truth. GSK should expect ramifications from global regulators after today’s evidence. An almost 9-fold increase in suicidal behavior in adults taking Paxil is appalling, particularly when we know that, for years, GSK continues to claim there is no causal association between suicide and adults taking Paxil.

This lopsided relationship has terrible ramifications for mental health authorities and suicide nonprofits who unconcernedly take drug company hush money. For years both have claimed antidepressants are a safe and effective treatment for a variety of possible ailments (anxiety, OCD, adult depression, e.tc.) A nearly 9-fold increase in suicidality strongly suggests that both mental health and mental health nonprofits have been duped by the pharmaceutical industry, along with prescribing doctors, medical regulators, and an unsuspecting public.

Just think folks: GSK even tried to get a license for Paxil to be prescribed to children after they knew of the Paxil-induced suicide increases in adults!

Nice ethical company, huh?

I’ll leave the last words to today’s witness, David Ross. The former FDA Medical Advisor was asked if he prescribed Paxil to his patients. Amid the objections from King & Spalding’s Andrew Bayman, he answered, “No. I don’t believe that it works and I don’t believe that it’s safe.”

Trial continues tomorrow.

For now, it’s time for a Guinness, in honour of Stewart Dolin.

Bob Fiddaman.
In Chicago.

Dolin Vs GSK

Dolin v GSK – Opening Arguments

Dolin Vs GSK – Day Two – “Jack-In-The-Box”

Dolin vs GSK – Healy ‘Rocks Da House’

Dolin Vs GSK – JP Garnier Video Deposition

Dolin Vs GSK – The Dunbar Tape

Dolin Vs GSK – Day 4 – Slam Dunk

Paroxetine Guinea Pig : The Curious Case Of Italia Sudano…


There was an interesting article, about Paroxetine and older adults, which appeared in the Guardian in 2003.

A woman called Italia Sudano (an Italian born/British resident) was apparently used as a Paroxetine (Paxil/Seroxat) guinea pig, by her GP (doctor) without her consent. Her doctor was (allegedly) paid by GSK too, and this was also all done without Sudano’s knowledge. The doctor in question, Dr Robert Adams, was struck off by the GMC (General Medical Counsel) after he was found guilty, of not just unethically pimping out his patients to GSK, but also for using several other patients as guinea pigs for various other drug companies and drugs too (not to mention making thousands of pounds in the process).

This case, is disturbing, and also remarkable, but what is stranger still is- how we heard nothing more about it, apart from the report in the Guardian at the time.

The reason why I bring this case up is, currently GSK are being sued in a court in the US by Wendy Dolin, for the death of her husband, Stewart Dolin, in a ‘Paxil Induced Suicide‘ case. The Dolin case centers on GSK’s dodgy Paroxetine trials, and in my opinion, Paroxetine should never have been licensed in the first place. GSK admit that Paroxetine is dangerous for under 18’s, however, many of us who have taken the drug, are highly aware that all ages can suffer from Paroxetine’s dangerous side effects. Side effects such as akathisia, de-personalization, volatility, suicidality etc are common among all age groups (GSK just don’t give us the full facts).

It would be interesting to find out- What data did GSK obtain from cases such as Sudano’s? Were the results of these (highly unethical) live human guinea pig trials ever seen by anyone outside of GSK? Will GSK present the findings in court, in cases such as Stewart Dolin’s? Were GSK receving data from any other GP’s in relation to Paroxetine testing on patients (with or without their consent) at the time, before it, or any time since? If so, what exactly was GSK trying to study by gleaning data from the case of a 72 year old Woman put on Paroxetine, without her consent, or knowledge , from her dodgy doctor? Did Italia Sudano take a legal case against her doctor? If so- did GSK provide information as to the significance of their Paroxetine testing on her?

https://www.theguardian.com/politics/2003/feb/09/health.nhs

Patients used as drug ‘guinea pigs’

Firms pay out millions to doctors to test medicines

When Italia Sudano went for a check-up with her GP, Dr Robert Adams, she was in good health. Her husband had died a few months earlier and her blood pressure was a little high.

Yet nothing could have prepared Sudano, 72, for the nightmare that was to follow and the discovery of a trail of greed and fraud that went right to the heart of the medical profession.

She was astonished to discover that her trusted GP had been using her as a guinea pig by giving her tablets which had not been medically approved. Worse still, he was being paid to do so by a pharmaceutical company.

An investigation by The Observer has revealed that many doctors are risking their patients’ health by subjecting them to medical trials without their knowledge.

Over the next few weeks Adams asked Sudano to return for more blood tests. By the end of the second month her arms were black and blue. Her son, Joe, said they looked as though they had been slammed in a door. She said: ‘At one point I asked if he was selling my blood.’

Little did Sudano know how close to the truth her comment was. On her last visit, Adams took a bottle of pills from the top drawer of his desk and suggested Sudano take one a day. While she thought it strange she wasn’t being given a prescription, she trusted her doctor.

But within hours of swallowing the pill, she could hardly walk because she was so dazed. Her face had swollen up badly and she was in considerable pain.

She stopped taking the tablets and complained to Hertfordshire Health Authority. This sparked an investigation that led to one of the largest cases of medical research fraud ever uncovered in Britain.

It emerged that over the previous five years Adams had earned more than £100,000 from drug companies, including the European giants AstraZeneca, GlaxoSmithKline and Bayer. They were all paying him to test their new drugs on his patients. Like Sudano, many of his patients had never given their consent and had no knowledge they were being used as human guinea pigs in a medical trial. Patients with no symptoms were given drugs and others who needed proper medication were given placebos. Adams was receiving almost £1,000 for each patient.

Last month Adams was found guilty by the General Medical Council (GMC) of serious professional misconduct and suspended for 12 months. The GMC’s lawyer described it as ‘assault’ and Sudano is now looking to sue Adams.

GlaxoSmithKline was using Adams to study its anti-depressant Paroxetine, but had to cancel the trial at a cost of hundreds of thousands of pounds.

The drugs industry talks of bad apples and the odd errant doctor milking the system but insists that trials using GPs are essential for medical advances and that payment to doctors for the extra work involved is ethically correct.

But an investigation by The Observer suggests the problem of GPs using patients as guinea pigs without their consent is more widespread. Some 3,000 doctors each year are paid by drug firms to sign up their patients to tests and on average 15 patients are needed for each trial. With doctors picking up £1,000 per patient, drug companies are spending £45m on getting doctors onside. There is no suggestion the companies are implicated in moves to carry out the tests by doctors on patients secretly.

Medical fraud experts estimate that one per cent of all drug trials involve fraud, including failure to get proper consent from patients. This means hundreds of patients a year are being given unapproved and potentially dangerous drugs without their knowledge.

The Observer has discovered that in the last five years the GMC has taken action in a dozen cases involving GPs undertaking fraudulent research. Examples include:

· Dr Vasu Agrawal from Chigwell, Essex, removed samples of womb from menopausal women as part of a trial into a new hormone replacement drug called Divina Nova. Agrawal failed to tell the women they were testing a drug that could have serious side-effects. Agrawal, who forged signatures on consent forms, received almost £6,000 from Orion Pharma International.

· Dr Paul Chima from Edinburgh is estimated to have received more than £200,000 from a range of pharmaceutical companies for testing their new drugs for angina, asthma, high blood pressure and depression. He failed to warn patients of possible side-effects and offered one a £2,000 bribe not to give evidence against him.

· Dr James Boschler from south London was given £22,500 from Bayer and Solvay Healthcare. He claimed to have signed up 36 patients, but 25 of the consent forms were discovered to be forgeries.

The country’s foremost investigator of medical research fraud is Peter Jay, the former Metropolitan Police detective chief inspector who arrested serial killer Dennis Nilsen. Since 1996 Jay has run MedicoLegal Investigations, an independent body, and has taken 12 doctors to the GMC.

Jay is investigating six further cases, including one involving a GP in Manchester. Dr Mark Northfield is alleged not to have obtained consent from patients for entering them into trials to test drugs manufactured by Bayer and Roche to treat high blood pressure and heart problems. Northfield is contesting the allegations before the GMC professional conduct committee.

Jay said: ‘While the industry has become more alert to the problems over the last decade there is still clearly a worrying and persistent problem in research fraud involving doctors. This is not just an issue of patient safety, but a problem that might lead to bad drugs being approved or good drugs failing to be approved.’

The Observer’s revelations of the continuing problem of research fraud have sparked calls for industry guidelines to be toughened up. David Hinchcliffe, the Labour chair of the House of Commons Health Select Committee, described the situation as bordering on ‘scandalous’ and said his committee would look into the issue.

He said: ‘The relationship between the drug firms and the medical profession is one that needs to be thoroughly investigated. It is extremely worrying that patients’ trust is being abused by doctors who are more interested in making money from the pharmaceutical industry.’

Dr Evan Harris, health spokesman for the Liberal Democrats, suggested that doctors involved in trials should be subject to on-the-spot inspections and that a patient’s consent to take part in a drug trial should be given outside the GP’s surgery, for example to a research officer acting for the firm.

Additional research by Charlotte Coulon

antony.barnett@observer.co.uk

GSK’s Lawyers Grasp At Straws At The Stewart Dolin ‘Paxil Induced Suicide’ Trial…


http://fiddaman.blogspot.ie/2017/03/dolin-vs-gsk-day-4-slam-dunk.html

Tuesday, March 21, 2017

Dolin Vs GSK – Day 4 – Slam Dunk

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Andrew Bayman – King & Spalding’s finest

Imagine, if you will, a schoolyard bully who tries to impress his fellow bullies. Imagine, if you will, the kind of person who wants to be popular among his peers yet every time he tries to impress them he gets things wrong, so wrong.

Let me introduce you to King & Spalding’s, Andrew Bayman.

Bayman, who on day one of Dolin Vs GSK, claimed that Paxil does not induce suicide, today got to cross-examine Dolin’s first expert, Dr. David Healy.

This was something I was really looking forward to. On one hand, I wanted to see how good King & Spalding were, let’s face it, they’ve made a lot of money defending large corporate companies over the years. As Glaxo’s first choice of defence attorney’s one would assume that they would try and throw the kitchen sink at any expert witness who speaks out against their client, moreover, their client’s product, as is in this case, GlaxoSmithKline’s Paxil.

So, how does one defend the indefensible?

Step forward Andrew Bayman, a guy who struts his stuff by flicking out his arms suggesting that he is ready to spar with any opponent who dares cross the might of King & Spalding or, indeed, GlaxoSmithKline.

It’s fair to say that Bayman failed to deliver today, in fact, if I was GSK’s CEO I’d be deeply disappointed in the performance of King & Spalding’s finest.

So, how does one go about disputing evidence put forward by the world’s leading SSRI expert, David Healy? Does one dispute the science behind the evidence?

As you’d expect from GSK, their attorneys do everything but discuss the science.

I’ve seen excuses made by Glaxo over the years but one today almost had me biting the arm of the front pew where I was seated.

Bayman, in efforts to discredit Healy, asked him about his popular website, Rxisk.org, moreover about the donations to the said website.

Bayman, upon learning that Healy’s Rxisk website received a small donation from an American attorney, went down a road that was laughable, nae embarrassing. In the words of Del Boy, a popular British fictional wheeler and dealer, he made himself look like a right ‘plonker’ (Google it, Todd, you’ll see I’m right)

Bayman, flicking out his arms like a gunslinger from a John Wayne movie, made the assumption that Healy’s Rxisk was merely a platform to attract patients with stories of SSRI side effects so he and his attorney friend, who made the small donation, could, in future, litigate on behalf of any of the patients who leave comments on Healy’s website.

Healy, into his third day of questioning, smiled.

The answer he gave Bayman was simple.

Healy told Bayman, and the jury, that any attorney who donated money to Rxisk.org would possibly be in an awkward position. In fact, upon receiving this small donation Healy told the donator that Rxisk was all about seeking the truth about SSRI’s and any such truth outed would possibly lessen lawsuits filed against the makers of SSRI’s.

Bayman seemed to be at a loss for words with this reply.

Next, faux pas was Bayman showing the jury, via the various screens dotted around the court, a selection of text taken from a book Healy wrote back in 2013. Also various published papers by Healy.

Upon asking Healy if he had written the text highlighted, Healy responded by telling Bayman to scroll down the page to see the reference. There he would see that the highlighted text Bayman had chosen to show the jury was actually a quote by, um…wait for it…someone else.

All day, Bayman was cherry-picking selective text from various articles written by Healy. All day long Healy told him that if the sentence was read in full context then he (Bayman) would see what it actually meant.

You see, Bayman’s job was to try and make David Healy slip up. He wanted the jury to see that Healy contradicts himself. He failed on a grand scale.

“No further questions” came at around 3.40pm and, I must admit, I was surprised that Bayman was severely lacking in the questioning skills that I have become accustomed to reading John Grisham novels.

It was a good day for Dolin and her law team of David Rappaport and Brent Wisner, they made few objections, preferring instead to let Bayman dig himself a hole and look rather incompetent to the watching jury.

I felt embarrassed for Bayman, it was one of those moments one gets when watching David Brent in The Office (UK version) (Google it, Todd)

He tried to serve aces all day long – he just kept hitting the net.

It’s enlightening to know that this is GSK’s defence. Target whoever stands in their way and forget about the 10 years or so that they failed to tell the FDA about Paxil’s suicide risk. A point that Healy also picked up on when he told the jury that if GSK had told the FDA all those years ago about Paxil’s propensity to induce suicide, then many lives could have been saved.

Court resumes again tomorrow morning.

Bob Fiddaman.

Dolin Vs GSK

Dolin v GSK – Opening Arguments

Dolin Vs GSK – Day Two – “Jack-In-The-Box”

Dolin vs GSK – Healy ‘Rocks Da House’

Dolin Vs GSK – JP Garnier Video Deposition

Dolin Vs GSK – The Dunbar Tape

Debate In The UK Parliament About GSK’s Dodgy ‘Narcolepsy Causing’ Pandemrix Vaccine…


https://www.theyworkforyou.com/whall/?id=2017-03-08a.318.1&p=24853

Joan Ryan Labour, Enfield North 11:00 am, 8th March 2017

Before the next debate begins, I am pleased to say that, on International Women’s Day, we have a woman Member opening her first Westminster Hall debate and a woman Minister to respond, and of course I am in the Chair. On this day, I thought that was worth remarking on. I call Tracy Brabin to move the motion.

Photo of Tracy Brabin Tracy Brabin Labour, Batley and Spen

I beg to move,

That this House
has considered compensation and the Pandemrix vaccine.

It is a pleasure to serve under your chairmanship, Ms Ryan, on the occasion of my first Westminster Hall debate. I thank my hon. Friend Stephen Twigg for his extensive work on this issue on behalf of his constituent Lucas Carleton. I also thank Mr Speaker for allowing this debate to take place. It is vital that Parliament considers this matter and public awareness is raised.

I will set out the effect that Pandemrix has had on several predominantly child patients and their families and discuss the need for the Government to acknowledge and express regret for what has happened to those patients and provide them with support. I will explain the challenges of accessing the necessary medication for affected people, and I will conclude by making recommendations to the Government.

Before I set out the issue at hand, I wish to be clear that, overwhelmingly, vaccines save lives. Thanks to vaccines, we have seen the eradication and near-eradication of diseases such as smallpox and polio, and I have no intention of discouraging parents from ensuring that their children receive tried and tested vaccinations. Quite the opposite—I want the Government to rebuild and maintain trust in our world-class inoculation programme. However, on occasion, certain vaccines have been shown to have damaged patients, sometimes with life-altering consequences. All precautions should be taken to prevent that from happening, and pharmaceutical companies and the Governments that give those companies indemnity should take immediate and full responsibility when that is shown to have happened and, having accepted responsibility, do all they can to support affected people.

I worked to secure this debate because I believe that Parliament and the Government must listen to and support individuals and families who have been affected by narcolepsy and cataplexy as a result of the Pandemrix vaccine. I became aware of this issue when my constituent Di Forbes came to one of my regular advice surgeries. Di has travelled to Parliament to watch these proceedings, and I hope that she will be able to travel home to Batley and Spen having received some assurances from the Government. Di explained to me the damage that the Pandemrix vaccine has caused her son Sam and the unacceptable battle that she has faced while seeking financial support to secure his long-term care and the appropriate medication for his condition.

By way of background, the Pandemrix vaccine was developed by GlaxoSmithKline and given to 6 million people during the global H1N1—swine flu—pandemic in 2009 and 2010. Owing to the nature of that pandemic, the European Commission, on the advice of the European Medicines Agency, fast-tracked the vaccine’s licensing. The UK Government then undertook a vaccination programme, based on advice from the Joint Committee on Vaccination and Immunisation. In short, Pandemrix was licensed for use in the EU, including the UK, without the usual clinical trials having been completed.

Photo of Julian Sturdy Julian Sturdy Conservative, York Outer

I congratulate the hon. Lady on securing this important debate. My constituent Ben Foy suffers from narcolepsy and cataplexy caused by the Pandemrix vaccine. I raised his case in the House in 2014, 2015 and 2016, and I now do so in 2017. The Department for Work and Pensions accepts the causal link between my constituent’s illness and the Pandemrix vaccine that he received, on NHS advice, in 2010. Does she agree that the Government have a moral obligation to quickly resolve the issue of payments to those who have been so badly affected by Pandemrix, not drag the process out with unsuccessful appeal after unsuccessful appeal, which is what seems to be happening at the moment?

Photo of Tracy Brabin Tracy Brabin Labour, Batley and Spen

I will come on to that point, but I totally and utterly agree. As the hon. Gentleman will know, the Government’s foot-dragging is causing unacceptable and upsetting suffering and distress for the families involved.

Although I acknowledge the difficult balancing act involved in weighing the risk of a pandemic against the risk of fast-tracking a vaccine’s licensing, that does not excuse the fact that some patients were not made aware of the facts, nor does it excuse the Government from subsequently attempting to avoid responsibility for the damage caused. Making the vaccine available at the time of the pandemic clearly came with a degree of risk. GSK was given an indemnity from any liability by the UK Government. My constituent has made it clear to me that she was not informed that the vaccine had not been fully tested or that GSK had obtained an indemnity. Therefore, as the result of advice given to his mother by the NHS, my young constituent Sam received the vaccine on 27 April 2010. He was four and a half years old.

Four months later, concerns were raised in Finland and Sweden about the association between the vaccine and narcolepsy. Following that, a study by the UK Health Protection Agency and others, which was funded by the Department of Health and the HPA, found that around one in every 52,000 to 52,750 Pandemrix jabs led to narcolepsy. The results of that study were published in The BMJ in 2013 and were consistent with the findings of the aforementioned Finnish and Swedish studies. Pandemrix stopped being given to children in the UK in 2011, but that was too late for Sam and dozens of children like him.

Sam has been affected by 14 severe or chronic neurological issues, including narcolepsy and cataplexy. He suffers from night terrors in which he can see and smell dead people. He suffers from a damaged heat regulation system, automatic behaviour, micro-sleeps, temper issues, joint and muscle pain, anxiety and depression. Sam is now 11 years old and has faced unimaginable strain. In addition to being prohibited from enjoying a normal childhood, he lives in a world in which most people know little about his condition and misunderstand his symptoms. Shockingly, on one occasion while Sam was passed out in the street as a result of his condition, a dog walker allowed her dog to urinate on him. No 11-year-old should be expected to face the indignity and pressures that children such as Sam live with as a result of the Pandemrix vaccine.

Tragically, Sam has tried to commit suicide several times. We know from a coroner’s report that one 23-year-old woman took her own life after telling her family that living with narcolepsy after receiving Pandemrix had become unbearable. This is all too desperately sad.

The link between Pandemrix and narcolepsy has had a profound effect on families. My young constituent’s parents have found themselves under immense pressure, and in October 2016 his mum Di had no choice but to call a liquidator into her engineering business. It was impossible for her to work and ensure that her son’s complex care needs were met. Life is unacceptably hard for Di and Sam. They are very grateful to Narcolepsy UK, which receives no assistance from the Government but has been a source of huge support for them.

The Vaccine Damage Payments Act 1979 was intended to help to ease the burden on individuals for whom a specified vaccine had caused severe and permanent disability.

Photo of Jim Shannon Jim Shannon Shadow DUP Spokesperson (Health), Shadow DUP Spokesperson (Transport), Shadow DUP Spokesperson (Equality)

I congratulate the hon. Lady on bringing forward this important case. The Court of Appeal has ruled very clearly on this matter and issued a telling judgment that opens the door to people who have suffered as a result of this so-called vaccine. I believe that its decision enables those people to get the compensation that they need, both physically and morally. Does she feel that the Government must now follow suit and give the go-ahead for compensation to be released?

Photo of Tracy Brabin Tracy Brabin Labour, Batley and Spen

The hon. Gentleman is right. There have been some one-off payments, but they need to be made across the board. The 1979 Act provides for affected patients to receive one-off tax-free payments of £120,000, which would go some way to securing their long-term care needs.

Prior to September 2013, the Government said there was insufficient evidence to establish a causal link between the Pandemrix vaccination and the development of narcolepsy. However, following the aforementioned study commissioned by the Department of Health that recognised the link between Pandemrix and narcolepsy, the Government have conceded and recognised the link.

In spite of the Government’s acceptance of the link between Pandemrix and narcolepsy, they have delayed the processing of applications by denying them, disputing the severity of the disability. They have even appealed a case in which they were ordered to make a payment to one such affected child. In my view, for the Government to make such appeals through the courts system is a poor use of public money and an insult to those families whose lives have already been turned upside down. I hope that the Minister will disclose how much public money has been spent in the courts to delay making payments to those affected by Pandemrix.

Sam’s parents made an application for a vaccine damage payment, which was unsuccessful on the basis that he is not severely disabled enough. For those vaccinated after 31 August 2010, the reason given for refusal is that the vaccine does not fall within the remit of the Act. All appeals against the decision to decline payments are being held up while the Government battle the family of the aforementioned child through the courts. Most recently, the decision for the child to be awarded the payment was upheld at the Court of Appeal. I sincerely hope that Government will accept that outcome and take the case no further.

To give some context to the UK Government’s position, Sweden, Finland, Norway, Iceland and France have already compensated those who developed narcolepsy as a result of the Pandemrix vaccine. Sam is in receipt of disability living allowance, meaning that the Government recognise he is disabled. Why, therefore, do they not consider him to be disabled enough to qualify for a payment under the Vaccine Damage Payments Act? I say to Ministers: spend one day shadowing Sam or another constituent who is living with narcolepsy caused by Pandemrix, and I assure them that they will consider the disability severe enough for a long overdue payment from Government.

In addition to financial support through the Vaccine Damage Payments Act, children affected by Pandemrix require assurances over the long-term development and supply of the drugs that will alleviate their symptoms. Currently, my young constituent receives the drug Xyrem, which is expensive and not licensed for use in children. Sam receives it through a scheme funded directly by the UK Government and GSK, which has been a godsend to him and his family. However, there is a postcode lottery when it comes to access to Xyrem. Many trusts refuse to prescribe the drug, and until recently Sam’s prescription had to be collected from Sheffield Children’s hospital—a 60-mile round trip.

I am advised that the scheme that Sam and others like him currently benefit from is due to end in a year’s time. Sam’s mum advises me that he could not function without it, and as such I ask that the Government either commit to continuing the scheme in the long term or ideally provide an alternative that is secure and accessible to all. I also encourage them to consider opportunities to support research into medicines to alleviate the symptoms suffered by those affected. Clinical understanding of the condition is limited and there is definitely room for improvement.

I have a handful points on which I would be grateful for a response from the Minister. First, by virtue of GlaxoSmithKline requiring an indemnity, there was recognition that the vaccine carried a risk. Reliable studies now link the vaccine to narcolepsy. I would therefore welcome recognition from the Government of what has happened to those affected by Pandemrix and an apology to those families affected both by the incident and by subsequent refusals to provide support. It may be useful if the Government published the terms of the indemnity provided to GSK so that the public are aware of the acknowledgement of the risk carried by the vaccine.

Moreover, in response to my recent written parliamentary question 64695, the Minister said she has no plans to amend the Vaccine Damage Payments Act. I ask her to think again, particularly when considering support for those affected who received the vaccine after August 2011, because it is clear that when the law fails to work for children like my young constituent, it is time for the law to change.

We know that the Swedish, Finnish, Norwegian, Icelandic and French Governments have already made payments to those affected. The Government should therefore support those who have been affected, and they should be concerned about and apologise for the delay in making payments and its effects. They should also put an end to legal action to prevent payments to those who have been damaged by Pandemrix and they should end the delay in processing claims and appeals. They should also recognise that such delays can and will undermine public confidence in vaccinations, which is something that all those with concern for public health will wish to avoid.

I end with some words from Di, describing how Pandemrix has changed her life. Di said to me:

“Life after the vaccine is totally changed. Our son needs 24/7 care, including getting up several times during the night. He is in almost continuous, intolerable pain, had severe headaches every day. He’s not able to go anywhere without careful planning, needs schedule naps, has several specialist meetings every month, so misses school. Sam is scared for his future and we are frightened for his safety.”

Photo of Nicola Blackwood Nicola Blackwood The Parliamentary Under-Secretary of State for Health 11:16 am, 8th March 2017

It is a pleasure to serve under your chairmanship, Ms Ryan, on International Women’s Day. I congratulate Tracy Brabin on securing this, her first Westminster Hall debate, on an important and sensitive topic. She gave a moving account of her constituent Di and her son Sam’s battles with narcolepsy and cataplexy, as did my hon. Friend Julian Sturdy on behalf of his constituent, Ben Foy. The hon. Lady clearly articulated what she would like to see happen as a result of the debate. I am grateful to her for her opening statement in support of the life-saving effects of vaccinations and her recognition of our world-class immunisation programme. It is important that we remember that as we discuss some of the issues at hand today.

As the hon. Lady has focused the debate on the specific vaccine Pandemrix, it is right that I start by explaining why it came to be used in the UK, although she did outline some of that. Pandemrix was developed for use in a flu pandemic. Flu pandemics pose a challenge for any Government, and they occur when a flu virus emerges and spreads around the world and most people do not have immunity.

Each pandemic is different. The nature of the virus, the population groups most likely to be affected and its impact cannot be known in advance. It is impossible to predict the severity of a new virus strain. Large swathes of the population can become infected over a relatively short period of time if transmission spreads rapidly. The potential impact of pandemic flu makes effective measures to limit the spread and morbidity of virus infection a public health priority. Countermeasures are employed in combination, including vaccination when possible.

As the hon. Lady knows, the most recent flu pandemic was H1N1 swine flu in 2009-10. All Governments have a responsibility to protect public health in such a situation. The decision to commence the swine flu vaccination programme, made by previous Ministers in 2009, was based, as she said, on the expert advice of the Joint Committee on Vaccination and Immunisation. Pandemrix was one of two vaccines used in the UK in that pandemic. Thankfully, the H1N1 strain of swine flu turned out to be relatively mild, but we should not forget that it still caused more than 450 deaths in the UK.

The hon. Lady clearly described the consequences and impact that narcolepsy and cataplexy have on Sam’s life. I assure her that I do not underestimate how distressing narcolepsy and cataplexy can be. As someone who lives with a complex chronic illness that causes me to collapse in the street at times, I know how vulnerable that can make both those who live with the condition and their families feel. It is important that anyone who lives with narcolepsy receives the appropriate care and attention to manage their condition.

The hon. Lady set out her understanding that Pandemrix has caused narcolepsy for some individuals, including her constituent, Sam, as did my hon. Friend the Member for York Outer in the case of his constituent, Ben Foy. Causation is currently one of the issues in dispute in the ongoing legal proceedings in which the Department of Health is involved, alongside the claimants and the vaccine manufacturer. Those legal proceedings are much wider than the issue of causation and cover many other areas. Until those proceedings are resolved one way or the other, it is not appropriate for me to comment on that in detail; it is a process that should be allowed to continue without interference from a politician. However, I assure the hon. Lady that I am deeply concerned about this and will keep a close eye on it as Minister.

The hon. Lady wants to ensure that Sam and people like him are adequately compensated for the development of narcolepsy following Pandemrix vaccination, and has set out the changes she would like to see to the vaccine damage payments scheme to address that. It is important to be clear that the VDPS was not designed to be a compensation scheme; there is no assessment of what losses were actually suffered. Someone who wishes to seek compensation needs to pursue a claim against the vaccine’s manufacturer. There are ongoing personal injury claims in this case, and it is important that those proceed without interference as well.

The VDPS was established in 1979 to help ease the burdens of individuals for whom, on very rare occasions, vaccination has caused severe disablement. The extent of that disablement is assessed on the same basis as for the industrial injuries disablement benefit scheme. The VDPS provides a one-off, tax-free lump sum payment of £120,000 for those who are severely disabled as a result of a vaccination against the diseases listed in the 1979 Act and diseases that have been specified since 1979 by various statutory instruments. Those vaccinations are within the childhood vaccination schemes.

The hon. Lady noted that Sam’s mother applied to the VDPS but her claim was rejected. The hon. Lady claims that was because Sam was not severely disabled enough, but my understanding is that, although the DWP agrees that Pandemrix can cause narcolepsy in theory, it did not do so in this particular case; the DWP did not accept causation in this particular case, rather than its not accepting that Sam was severely disabled enough. I have a different understanding from the hon. Lady, so perhaps she would like to write to the DWP for clarification.

I should also clarify that the Department of Health is responsible for policy and legislation for the VDPS, but the DWP is responsible for assessing claims, making payments against successful claims and handling appeals. To qualify for a VDPS payment, a claimant has to meet two legal tests. The first is to establish, on a balance of probabilities, that the disablement was caused by vaccination against a disease covered by the VDPS, and the second is that the resulting disablement is severe—60% or more—assessed on the same basis as for the industrial injuries disablement benefit scheme.

Decisions take into account advice from medical advisers who are fully registered doctors with a licence to practise and who have also undertaken special training in disability assessment. They review each claimant’s medical records and advise the DWP’s decision maker on causation and disablement. It is therefore important that the hon. Lady clarifies what happened in her constituent’s case, as it is for my hon. Friend the Member for York Outer in the case of his constituent.

Each claim is decided upon its own evidence. If a claimant disagrees with the outcome, they have the right to request a reversal of the Secretary of State’s decision. There is then an opportunity to provide further information to support that request, and the case will be reconsidered. They can also challenge the decision to reject the claim through a first-tier tribunal.

The hon. Lady also raised more general questions about how the VDPS operates and has suggested changes that she thinks are needed. I will address as many of those questions as I can in turn; if I do not get to some of them, I will write to her. She suggested that anyone who has had a Pandemrix vaccination should be eligible for a VDPS payment if they have developed narcolepsy following a vaccination. The Vaccine Damage Payments Act is based on diseases, not specific vaccines, so it is not possible to include Pandemrix in that legislation. However, the list of specified diseases covered by the Act already includes pandemic influenza A—swine flu—for which vaccination was administered from 10 October 2009 to 31 August 2010. That was a temporary addition considered appropriate by the Ministers at the time. Pandemrix-related claims are therefore already eligible under the VDPS, so long as other eligibility criteria are also met. I am aware that some individuals received a Pandemrix vaccination outside the timescale covered by the Act, and that that was the subject of a debate in the House; perhaps the hon. Lady would like to look at that, and if she has any further questions for me, I will be very happy to answer them for her and her constituent.

The hon. Lady also made the case that the level of the VDPS payment is not adequate to meet the needs of someone with narcolepsy. As I mentioned earlier, that is because the VDPS is not a compensation scheme and the sum paid is not based on an assessment of losses; it is a one-off, tax-free lump sum payment to help ease the burden. It must be seen in the context of wider help and support for the severely disabled within our benefits system, but payments through the scheme cannot meet all of their needs. There are no plans at the moment to increase the value of the payment, but as I mentioned earlier, it is open to individuals to pursue personal injury claims for compensation, in addition to applying to the VDPS.

Jim Shannon raised the recent Court of Appeal judgment on how disablement is assessed. I can confirm that the Government will not appeal that decision. DWP medical advisers will now consider future prognosis in addition to the current level of disablement when assessing claims. Previous cases in which causation has been accepted will be reconsidered in accordance with the Court of Appeal judgment where claimants consent to a further investigation of their medical history.

Photo of Nicola Blackwood Nicola Blackwood The Parliamentary Under-Secretary of State for Health

It will start as soon as it can be implemented.

I will also follow up on the point that the hon. Member for Batley and Spen made about Xyrem. The scheme for its supply is due to continue until the personal injury claims are settled, at which point it will be reviewed. I hope that reassures her. I will be happy to look into the issue that she raised about a postcode lottery to try to understand how that situation can be eased.

We do not have a huge amount of time left, so I will bring my remarks to a close. I assure the hon. Lady that I have every sympathy for Sam and others affected by narcolepsy; I have a small amount of understanding about quite how distressing that can be. The hon. Lady should not consider the VDPS in isolation as a means of supporting Sam and others like him. It is part of a much wider package of care and support that is available to people with disabilities, including the NHS, social care and the benefits system. It is important not to leave the debate with the impression that vaccines are dangerous. Vaccine safety is of paramount importance, and with modern technology and stringent manufacturing and control processes, vaccines are the safest they have ever been. I hope that, by the end of the debate, hon. Members will know that the Medicines and Healthcare Products Regulatory Agency and the Government’s independent expert advisory Commission on Human Medicines keep the safety of all vaccines under review. Serious side effects are, thankfully, very rare.

While it is important to have a scheme such as the VDPS in place—I am grateful to have had the opportunity to hear the views on it of the hon. Lady and of my hon. Friend the Member for York Outer, who is no longer in his place—it is also important to acknowledge that we have a world-class immunisation programme that is the envy of many other countries that are not able to prevent the diseases we do in the UK. Immunisation is a vital way of protecting individuals and the community as a whole from serious diseases. Uptake for UK immunisation programmes is more than 90% of the target population for most childhood vaccinations. Vaccinations save lives, and I strongly encourage families to take them up when offered. I assure the hon. Lady that I have listened to everything she has said and will consider it going forward as the Pandemrix case continues.

Question put and agreed to.

Sitting suspended.

Leonie Reports From The Stewart Dolin Paxil/Seroxat Suicide Trial..


https://leoniesblog.com/2017/03/19/dolin-v-smithkline-beecham-corp/

GSK’s Dirty Little Secret

Stewart
Dolin v SmithKline Beecham

So, myself and my friend Stephanie were in Chicago this week. We had traveled across the Atlantic to hear the opening arguments of Dolin v. Smithkline Beecham Corp (now GlaxoSmithKline – GSK). For more background to this case, see here.

We arrived straight into an unprecedented weather event, Storm Stella – described in the media as a weather bomb, having undergone bombogenesis (haven’t a clue either). Thus, while we were a little worried that the trial might be postponed, we were more concerned with the liklihood of two Irish females freezing to death. However, despite hitting a cool minus-8, with some pretty bizarre white-out conditions, we survived and the trial went ahead as planned (with the Hon. William T. Hart presiding).

This case centers on Wendy Dolin, the plaintiff, alleging that her husband’s death in 2010 was drug-induced and that GSK failed to warn of the increased risk of suicide in older adults taking the antidepressant Paroxetine. Her lawyers, Baum Hedlund, contend that GSK hid a ‘dirty little secret’ – that the drug can cause akathisia, often coded under the innocuously-sounding ‘inner turmoil’. However, this drug-induced condition is far from harmless and injury to oneself and/or others, can quickly follow. Furthermore, as alleged in this case, it can often prove fatal; see here.

At the time of his death, Stewart Dolin was 57 and was a corporate lawyer with ReidSmith. While suffering from work-related stress, he was prescribed Paroxetine by his physician, Dr. Martin Sachman – a family friend. Paroxetine is perhaps more widely recognised by its trade name Paxil, or Seroxat in Europe. Six days after being prescribed a generic form of the drug, Stewart died by jumping in front of a Chicago train. He was affluent, well-liked by colleagues and well-loved by his family. Per one of his colleagues “Stu Dolin was a close personal friend, valued colleague and a great leader in our firm. His energy and spirit benefited everyone around him. The lawsuit claims that GSK failed to adequately warn doctors (including Dr. Sachman) of the increased risk of suicidal behavior in adults. Indeed, GSK’s opening argument proclaimed that ‘Paxil does not cause suicide’. That was then contradicted by GSK’s very own literature, where a 2006 analysis showed a 6.7 times greater risk of suicidal behaviour in adults (of all ages) taking Paxil, over placebo.

Doctor David Healy was on the stand for 2 full-days, as an expert witness for the plaintiff. His testimony included an account of how GSK had hidden suicide events from the Food and Drug Administration (FDA), thus manipulating the suicide-ratio and effectively hiding the bodies. Explaining drug-induced suicides to the jury, his world-leading expert status in psychopharmacology was unquestionable. No doubt, GSK ‘s legal team will attempt to annihilate that particular status before he exposes any more ‘dirty little secrets’. Like how 100% of Paxil consumers will experience sexual dysfunction – another life changing adverse-effect he mentioned in court, and another one not precisely admitted to by the manufacturers.

Not surprisingly, GSK’s lawyers (King and Spalding), became increasingly apoplectic, interjecting every few minutes with their objections, which proved fascinating in itself. The last hour before the court adjourned for the week-end proved to be very enlightening indeed, with their team looking increasingly agitated. Doctor Healy was then asked some questions by the plaintiff’s legal team:

(1) Do you have any doubt that Paxil can cause suicide? He answered ‘No’.

(2) In your opinion, did GSK warn doctors of the increased risk of suicide in adults? Again he answered ‘No’.

There seemed little doubt to anyone listening that Paxil could cause Akathisia and/or a drug-induced suicide. However, no doubt GSK will have many experts to refute that, whatever the evidence has shown. Having listened to this week’s testimonies, there is absolutely no doubt in my mind that Steward Dolin’s death was induced by the Paxil he was taking in the final 6 days of his life. However, the trial will most-likely go on for another few weeks when the jury will ultimately decide. Sadly, as is normal in these legal cases, every aspect of Wendy and Stewart’s private life will be publicly torn to shreds, with their every move dissected to try and put doubt into the jury’s mind. Whatever the outcome, Stewart’s wife Wendy, is one very, very brave lady.

Clearly, GSK’s lawyers are particularly polished and well used to court proceedings. That said, following the jurys’ retirement for the weekend, there was a last minute crucial objection from their legal team. One of their lawyers raised a final grievance – that a lawyer for the plaintiff’s side had the cheek to say ‘have a good weekend’ to the jury. Seriously? Drug induced suicide was the issue here and this farewell gesture caused offence to GSK’s legal team?

Anyway, if you would like to see the three video depositions that were shown to the court; they were uploaded yesterday. You really don’t need to be a body language expert to determine how truthful these GSK experts are being – or not.

GSK Biostatistician John Davies Deposition in Paxil Suicide Case:
https://www.youtube.com/watch?v=C9_WvgqYkag
Former Glaxo Executive Jeffrey Dunbar Deposition in Paxil Suicide Case:  https://www.youtube.com/watch?v=K5OL0DC4xQE
Damning Testimony from Former GlaxoSmithKline CEO Jean-Pierre Garnier in Paxil Suicide Case: https://www.youtube.com/watch?

Dolin Vs GSK – The Dunbar Tape


http://fiddaman.blogspot.ie/2017/03/dolin-vs-gsk-dunbar-tape.html

Sunday, March 19, 2017

Dolin Vs GSK – The Dunbar Tape

As promised, here’s more evidence that surfaced last week at the Dolin Vs GSK Paxil Induced Suicide trial.

This video features Dr. Geoffrey Dunbar, an executive at GlaxoSmithKline between 1987-97. His job was to oversee all the Paxil clinical trial results. He also helped author drafts regarding Paxil suicides, these drafts were later passed on to the FDA.

The data showed a 9-fold increase in suicidality with patients taking Paxil. Remarkably, the report sent to the FDA showed the complete opposite, in fact, the report showed the FDA that Paxil actually prevented suicide!

In the 2005 video deposition, Dunbar admits his reports included improperly counted suicidal behavior events and that publications in which he participated writing had incorrectly conveyed Paxil reduced suicidal behavior.

In essence, GlaxoSmithKline, along with the help of Dunbar, spun a 9-fold increase in suicide related events for patients taking Paxil to zero suicide related events.

For doctors and patients this meant that Paxil could hit the market with no concerns, and even if someone did kill themselves whilst taking Paxil, the event would be blamed on the person’s illness rather than the Paxil they were taking.

In the video below you will hear Dunbar say that it was “an error” that the suicide figures were wrong. That’s some error, right? On one hand the data shows a 9-fold increase in suicide related events for patients on Paxil, yet the complete opposite ended up in a draft to the FDA.

Furthermore, upon learning of his “error” he, to date (2005) had still not informed GlaxoSmithKline officials. He just ‘assumed’ that GSK had rectified a published article that he co-wrote, an article that he admitted, under oath, would have “presumably” influenced the people who read it.

So, there you go then. Paxil was promoted as being safe, when in actual fact GSK knew it was dangerous.

Nice company, huh?

Here’s the depo.

Bob Fiddaman
 
Dolin Vs GSK

GSK’s False Seroxat Suicide Statistics: Was Paroxetine A Misservice To Public Health Or Merely An Error?..


In this video, former GSK executive (and psychiatrist), Jeffrey Dunbar, gives his deposition, in a Paxil (Seroxat) induced suicide trial from 2006.

This is really astounding footage to watch.


Former GlaxoSmithKline executive Dr. Geoffrey Dunbar deposition in Paxil suicide case. In his testimony, Dr. Dunbar says that he helped author the drafts of the Paxil suicide report that the U.S. Food and Drug Administration (FDA) asked for in 1991. The calculations in this report showed and suggested that instead of Paxil increasing the suicide risk by nearly 9 times, the drug decreased suicidal behavior.

He admits in his deposition that his reports include improperly counted suicidal behavior events and that publications in which he participated writing had incorrectly conveyed Paxil reduced suicidal behavior.

This deposition was played for the jury in the trial of Dolin v. Smithkline Beecham Corp. (D/B/A GlaxoSmithKline-GSK). The case stems from the alleged paroxetine-induced death of Stewart Dolin, a partner at the law firm Reed Smith. Paroxetine is the brand name version of this medication is called Paxil which was researched, developed, manufactured and marketed by GlaxoSmithKline (“GSK”).

The lawsuit claims that GSK failed to adequately warn Mr. Dolin’s doctor about Paxil/paroxetine’s association with an increased risk of suicidal behavior in adults of all ages. According to the lawsuit, when Mr. Dolin was prescribed paroxetine in 2010, the drug’s label did not accurately warn physicians of the drug’s association with an increased risk of suicidal behavior in adults, despite GSK’s 2006 analysis showing a statistically significant 6.7 times greater risk in adults of all ages, as well as comparable statistically significant suicidal behavior evidence as far back as 1989 in Paxil’s clinical trials performed for its initial marketing approval.

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