Monsanto Roundup Lawsuit

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.






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








Tuesday, March 21, 2017

Dolin Vs GSK - Day 4 - Slam Dunk




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 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

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







Saturday, March 18, 2017

Dolin Vs GSK - JP Garnier Video Deposition





I was going to take a break this weekend as I'm in Washington DC taking time out from a hectic week of traveling to and from the Chicago courthouse where GSK are claiming Paxil does not cause suicide in adults. Furthermore, GSK claims Paxil did not cause 57-year-old Stewart Dolin to end his life by jumping in front of a train. GSK's argument is that Stewart Dolin had 'work-related' problems which caused him to jump. GSK claims the Paxil he was taking as prescribed had nothing to do with his akathisia-induced death.

Earlier this week three video depositions were aired to the jury, they featured former GSK CEO, JP Garnier, Former Glaxo Executive Jeffrey Dunbar and GSK biostatistician John Davies.

Much to my delight, the video depositions have now been released to the public - this is a unique move and one that makes me very happy indeed.

Today I'm going to focus on one of these three videos. It features former GSK CEO, JP Garnier. After watching the video you will hear audio that wasn't aired in court. It, once again, features former Glaxo CEO, JP Garnier. It is audio that has been public for many years and, in the context of his video deposition, shows how Garnier had an opportunity to inform the public about Paxil's suicide link but chose not to. He instead opted to hang-up the telephone live on air.

It's important that you watch the video first then listen to the audio.

In the video, we hear JP Garnier answer questions about GSK's responsibility to warn doctors and patients that Paxil can and does induce suicidality. In Dolin Vs GSK, King & Spalding (GSK's defence team) have already told the jury during opening arguments that Paxil does not cause suicide in adults. Furthermore, they have claimed they told the FDA that, after reviewing Paxil data, they wished to change the drug labeling.  According to GSK, the FDA chose to use its own wording rather than using GSK's. King & Spalding told the jury there was nothing else they could do regarding labeling. Garnier's testimony, however, suggests that was a bold-faced lie.

The video deposition was taken in 2006.

"You can change your label without even getting approval from the FDA, there's a law that allows you to do that, correct?"

Garnier answered, "Yes, but in practice, you don't want to do that."

He was then pressed, "Okay. But you can do it if you want, the law allows that to occur?"

Garnier replied, "Yes, but you do want the FDA to agree with the changes you are going to propose because they have the power to correct what you just said the day before. You know, let's say we decide to inform physicians of some new event affecting our drug, well, the next day the FDA might come back and say, well, we didn't like the way you did this, you have to redo it. So it's considerably disrupting, that's why most companies go through the FDA first, in practice, but you are right, there is a legal right for us to go directly to the public."





So, Glaxo's own CEO claimed in 2006 that there was a legal right to inform the public about any serious adverse event--including the most serious of them all, suicide.

Now, let's listen to an interview from Garnier taken in May 2008, some two years after he admitted (under oath) that he and his company had a legal obligation to inform the public about serious adverse events and that they did not have to go through the FDA to get this news out.

Garnier was being interviewed by BBC correspondent, James Naughtie, about a vaccine. However, Naughtie deviated from the subject of vaccines and chose to ask Garnier about Seroxat (known as Paxil in the US).  Garnier, when pressed, chose not to discuss. Now, didn't he have a legal right to do so, as he claimed in his 2006 video deposition? Instead, Garnier chose to hang up the phone and end the interview.

(Hmm, so much for having a legal duty to inform the public.)

I'll leave it up to you, the reader/listener, to decide whether or not you think Glaxo's former CEO had ample opportunity to inform the public about Paxil's serious adverse events.

Here's that classic audio... the discussion of Paxil starts at the 3.24 mark.





Garnier was given a public platform to inform consumers about Paxil's serious adverse events, remember, as a CEO, he had a legal right. Why then did he choose to end the conversation abruptly?

Just sayin'.

Over to you, Todd.

**COMING UP TOMORROW**

The video testimonies of former Glaxo Executive Jeffrey Dunbar and GSK Biostatistician John Davies.

Bob Fiddaman.

Related










Friday, March 17, 2017

Dolin vs GSK - Healy 'Rocks Da House'




This is complex, this is time consuming. Two days of evidence presented to the jury, judge and layperson (me included).

Cut through the endless amount of questions (they always lead to the truth where GSK are concerned) - and you will see, through Healy's evidence, the reasons why this case is a "Slam Dunk" for Dolin et al and why GSK's hot shot law team bounce up and down crying 'objection' at every given opportunity.

Objection! Because they don't want the jury to know about their previous ghostwritten articles.

Objection! Because they don't want the jury to know about GSK's previous fine of $3billion (yes, that's billion, fine for promoting Paxil off-label to kids.

Objection! Because they don't want the jury to know about the Paxil withdrawal issue because, "it's a case that is on-going against them in the UK) - Forget the case of Paxil withdrawal they've already settled with over 3,000 plaintiffs in the US, right?

Objection! Because they don't want the jury to know they lied about the fact that Paxil was safe for kids.

They even objected to Wendy Dolin's attorneys for wishing the jury had a great weekend, or words to that effect!

What I have witnessed here in Chicago is a law team representing an abhorrent company, the law team being made up of men and women (think about the birth defects Paxil has caused - I mean, their law team has a woman of child bearing years!)

Bayman (King & Spalding) also asked the Judge to reiterate to the jury that they should not "Google" about Paxil or the case in question. Yeah, right, Heaven forbid the jury stumble upon GSK's abhorrent record and/or disregard for human life, right?

I honestly don't know how a team with kids, siblings, wives, husbands or any other family members for that matter, can sit there and defend a drug (Paxil) that has caused so much heartache for families over the years. Are they devoid of any compassion, any empathy, any common sense?

My thoughts are, to some, irrelevant - Am I biased? Maybe? With a whole bunch of lawyers sitting on one side of a courtroom defending a drug that, probably, none of them have taken or, none of their loved ones have taken, I feel like I'm banging my head against a brick wall.

King & Spalding's main two men, Andrew Baymen and Todd (snigger at a name that befits a child) Davis, seem devoid of any compassion and/or rationale - they don't want to talk about ghostwritten articles, they don't want to talk about the $3 billion dollar fine their defendant got for the illegal promotion of off-label practises of many drugs, including Paxil. They don't want to talk about the withdrawal problems that Paxil can cause, and they don't want to talk about how the company they are defending put children and adolescents at risk when they sent out their work force to promote the safety and efficacy of Paxil.

For these reasons, I am de-humanized from that table (in the courtroom) that represents this truly abhorrent company. A table of psychopaths or people who just want the right to pay their monthly bills? - Psychopaths is a pretty good description, given that they know, and have  known of Paxil's severe side effects for many, many years.

Healy's expert opinion leaves me wondering if the jury want/need to hear anything more. He told the jury how...


  • In 2006, the FDA knew about the increased suicidal risk on Paxil.
  • GSK reported that there was no risk f Paxil induced suicide in 1999.
  • GSK showed 6 suicide ttempts on placebo,when the actual figure was 1, in fact it was zero!
  • GSK claimed that Paxil did NOT cause suicide and this convinced prescribing Dr's to prescribe Paxil.

Let's just take a look at some evidence aired today...these are from GSK's own internal documents. The public, or those who had or have been prescribed Paxil never got to hear about this...

 - 50 year-old female patient who became suicidal on Paxil (GSK's own admission, probable cause!)
 - 55 year-old male patient who showed "unrest and agitation" - patient was put on Paxil for 3 days when problems began, Paxil was stopped - patient felt better.
 - 59 year-old male - experienced 'restlessness', visual disturbances - Patient recovered one day after Paxil was removed!
 - 32 year-old male, on day one of Paxil treatment, developed severe akathisia - patient was confused throughout study.


Healy reminded the jury that GSK's stance was that Paxil, a drug that was used to treat anxiety and Major Depressive Disorder (MDD) could not cause adults suicidality yet it actually made, some people develop symptoms that it was, originally, meant to treat! Ergo, take Paxil to help anxiety MDD and suicidal thinking when, in actual fact, Paxil could cause these symptoms. Dr's would then increase the dose thinking that Paxil (at a lower dose) wasn't working.

Many exhibits were aired that further showed how GSK hid the suicide link with Paxil. In fact, it was learned, GSK's own re-analysis of Paxil (2006) showed an increase of 6.7 patients in Paxil adult patents. (the increase 6.7 times the greater likelihood one who takes Paxil will develop suicidality)

Oh, by the way, Stewart Dolin was 57.

Healy told the court that, based on his own clinical experience, Paxil was the most potent and problematic of all the SSRIs on the market. He also informed the jury that, as a clinician himself, he does not prescribe Paxil and added that the hospital where he works does not have Paxil on their list as a possible medication to treat a psychiatric illness.

To back up the evidence, the jury was shown an email to GSK's marketing guru, Barry Brand. The email focused on Paxil's suicide problem.

King & Spalding's, Andrew Bayman, played his 'Jack-in-the Box' routine throughout the day. His sidekick, from King & Spalding, Todd Davis, remained in the wings being as quiet as a mouse - strange because it is "Todd" who has targeted the kids of Wendy Dolin leading up to this litigation. Is Todd married? Does Todd have a regular girlfriend/boyfriend? Does he have children of his own? Is his blinking affliction down to the overuse of a psychotropic medication? Who knows?

That's poor show from me, I shouldn't mock the afflicted...then again, these schmucks have defended the indefensible for years - they've shown no remorse when people have gone on to kill themselves whilst on Paxil - why would they when they are earning vast amounts of money (by the hour) defending GSK?

GSK are King & Spalding's cash cow. They tried, through objection, to hide the truth about Paxil to the jury. They failed on a grand-scale.

Most damning, for today at least, was Healy's claim that he is one of the only people to have read the 'raw data' regarding Paxil and suicide, raw data that leaves him firmly believing Paxil can induce suicidality in adults, something that GSK have, for years, denied.

Healy also spoke how GSK used the term 'emotional lability' when reporting suspected suicidality in clinical trials, a term that would have made, even him, think there was no problem with Paxil. A term that would have made most prescribing doctors think that there was no suicide problem with Paxil!

Churlish.

GSK's table of attorneys look slick. One aging bald-headed guy even approached the judge at the end of today's proceedings to complain that Wendy Dolin's law team had wished the jury a "nice weekend" as they were dismissed.

Objection, objection, objection.

They seem like a stuck record. A team of misfits whose only mission is to blame everything but Paxil opting, instead, to blame the patients for having an 'underlying illness'.

The questioning of Healy by Dolin's attorney's finished today. He will be cross examined by King & Spalding on Monday.

I'll be there. Stewart Dolin will be there in spirit.

More on the past two days events tomorrow night, in particular evidence that shows how a witness called for GSK in this trial showed how another unrelated drug caused two patients akathisia and they 'jumped' to their death.

Stewart Dolin (57)  'jumped' in front of a train because Paxil caused psychosis and akathisia, an adverse drug reaction that is so horrible, death can be seen as a welcome alternative.

Bob Fiddaman.


Dolin back stories.









Thursday, March 16, 2017

Dolin Vs GSK - Day Two - "Jack-In-The-Box"






Day two kicked off with King & Spalding's Andrew Bayman finalizing his points to the jury that he started yesterday. He told them that, in 2006, GSK told the FDA about Paxil's increased suicide risks, he also told them that 'Dear Doctor' letters were sent out across the United States and that Stewart Dolin's doctor was aware of this. According to Bayman, the FDA changed GSK's warnings for all SSRIs and not just Paxil. Bayman also claimed that the FDA had told them (GSK) 4 times that they could not use their own wording in the label warning. Bayman also told the jury that GSK's sales force (reps) have no influence in prescribing habits - at this point I had to hold in my laughter, given that they paid a $3 billion fine recently to the DOJ for doing just that! (See - "GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud.")

More on King & Spalding's Andrew Bayman later in this post.

Next up was Brent Wisner of Baum Hedlund who is representing Stewart Dolin's, widow, Wendy Dolin.

Dolin presented the jury with three video depositions, the first being a May 2006 testimony from former GlaxoSmithKline CEO, JP Garnier. The depo was used in a previous case against GSK where Debra L. Tucker filed suit against them for the wrongful death of her brother, Rick, who, she alleged, killed himself after taking GSK's Paxil.

In the 2006 testimony Garnier was asked...

"Would you agree that a reasonable and prudent pharmaceutical manufacturer has a duty to warn prescribers of serious adverse events?"

Garnier answered, "Yes, I would agree."

It was also learned from Garnier's deposition that there is a law in place to help pharmaceutical companies should they wish to change the labelling because of new evidence that may arise regarding serious adverse reactions. He was asked...

"You can change your label without even getting approval from the FDA, there's a law that allows you to do that, correct?"

Garnier answered, "Yes, but in practice you don't want to do that."

He was then pressed, "Okay. But you can do it, if you want, the law allows that to occur?"

Garnier replied, "Yes, but you do want the FDA to agree with the changes you are going to propose because they have the power to correct what you just said the day before. You know, let's say we decide to inform physicians of some new event affecting our drug, well, the next day the FDA might come back and say, well, we didn't like the way you did this, you have to redo it. So it's considerably disrupting, that's why most companies go through the FDA first, in practice, but you are right, there is a legal right for us to go directly to the public."

The above 2006 statement from Garnier kind of contradicts what King & Spalding's attorney, Andrew Bayman, told the jury earlier in the day.

The next video deposition aired in court today was from John Christian Davies, a statistician from GSK. He confirmed that 8 of the 11 suicide attempts that have been previously mentioned in this trial were aged 30 or below, leaving 3 that were over the age of 30. GSK, in the Dolin trial, are denying that Paxil can cause suicide in adults. Hard to believe that a bunch of highly paid attorneys would think that anyone over the age of 30 are children or adolescents.

The final video deposition to be aired today was that of Geoffrey Charles Dunbar. Dunbar gave his testimony in September 2005, again it was in relation to another Paxil wrongful death lawsuit.

In 1987 Dunbar joined GSK, who were then known in the UK as Beecham Pharmaceuticals. He was given the role of director of CNS, a role whereby he oversaw Paxil clinical trials. Paxil, at this stage, was still in its infancy and hadn't yet come to market.

In the 2005 video deposition Dunbar was asked about the contentious two placebo suicides that were wash-out and run-in suicides (Back story). He said that he was not aware of them, he added that he had only recently become aware of them (bear in mind that the video deposition was taken in 2005).

Dunbar was then pressed further...

"Whether it was through oversight or negligence or intent or whatever the reason, that publication of published data was invalid, wasn't it?" 

and

"Well, regardless of intent here, isn't it true that public health on SSRIs for paroxetine was greatly misserved by your publications of this data in '91 and '92 and up through '95 as being valid paroxetine figures not designated with an asterisk for wash-out and run-in? That was a misservice to public health, wasn't it?"

Dunbar answered, "It was an error."

Dunbar was then asked, "Okay. Are you inclined to do anything to correct the record, such as notifying GlaxoSmithKline that your authorship was incorrect?"

Dunbar answered that it wasn't his intention to do so, on being asked why this was so? He answered...

"Because I think GlaxoSmithKline are very well aware of the issues we're discussing now."

Once the video depostions were played to those in attendance today, David Healy was then called to the witness stand...it was not without incident as King & Spalding made objections before Healy entered the courtroom, objections that saw King & Spalding attorney, Andrew Bayman, almost bursting a blood vessel as he tried to persuade the Judge not to allow certain lines of questioning from Baum Hedlund's Brent Wisner.

The questions thrown at David Healy today, and his subsequent answers, will be covered in a blog post tomorrow. Suffice to say King & Spalding's Andrew Bayman spent most of the day impersonating a Jack-In-The-Box as he stood from his seated position pleading objections to the Judge more times than I can count.

I personally think Bayman had an adverse reaction to the presence of Healy.

More on this tomorrow.

Bob Fiddaman.

Dolin back stories.









Wednesday, March 15, 2017

Dolin v GSK - Opening Arguments






Day one of Dolin v GSK is over and, as expected, GSK are, it appears, trying to muddy the name of the victim, Stewart Dolin.

David E. Rapoport opened the arguments on behalf of Stewart Dolin's widow, Wendy. He explained to them how, in 1989, GSK submitted  its “Integrated Summary of Safety Information” to seek approval of Paxil for adult depression. He also explained to the jury how the submission conveniently hid the link to Paxil being responsible for inducing suicide and suicidal thinking in patients during the clinical trials. (Back story) Rapoport also told the jury about Stewart's life and how he had, in the past, been prescribed Paxil and Sertraline (Zoloft).

GSK made several objections, one of which was the objection to Rapoport's use of the word "Paxil" - Part of GSK's defence is that Stewart took a generic version of Paxil made by Mylan, ergo they are not responsible for his Paxil induced suicide - I say "Paxil" because whoever manufactured it after the patent ran out did so using GSK's brand, a brand that became a household name. Stewart's prescribing doctor even referred to it as Paxil. It was a churlish objection from GSK and one that, I think, will have little or no bearing on the outcome of this trial.

All in all, Rapoport spoke for around two hours, after which the Judge called for a 15 minute recess.

Next up was GSK, represented, in part by Andrew Bayman of King & Spalding, and, as expected, they were slick and focused on Stewart Dolin's mental state at the time of his death. They tried to state that Stewart Dolin had work related problems which caused his "suicide". Interestingly, they also claimed that Paxil does not cause suicide. So, effectively, every single person that has died by suicide whilst on Paxil did not die by suicide because of Paxil. Hard to believe given the amount of men, women and children that have died by violent suicide whilst taking Paxil.

**Correction**
GSK was represented by Andrew Bayman of King & Spalding and not Dentons as previously stated.

The fact that Paxil has a black-box warning was brushed over by GSK who claimed that the black box warning was put in place for all SSRIs and was meant as a red flag for prescribing physicians to monitor their patients.

GSK's lawyer told the jury that he intended to speak for just an hour, an attempt at point-scoring exercise if ever I've seen one. However, approaching the hour the Judge intervened and told him his hour was almost up. He responded by saying he just needed to summarize which he plans to do do tomorrow morning.

Opening arguments is basically two parties setting out their stall. It was pretty obvious that GSK would go down this route (blame the victim). During the lead-up to this trial they have targeted Stewart's widow, children, friends and expert witnesses.

Tomorrow morning they will no doubt reiterate their "blame-the-victim mantra" they tried to sell today. It's the only defence they seem to have.

Bob Fiddaman.

Dolin Back Stories



Tuesday, March 14, 2017

Paxil Suicide - The Way GSK Hid the Link





It's the morning of the trial. The jury will shortly be sworn in.

The crux of the matter in Dolin Vs GSK is whether or not Paxil caused Stewart Dolin to kill himself whilst under Paxil's influence.

Dolin's widow, Wendy, intends to show the jury details of GSK's prior knowledge of the Paxil suicide link. Furthermore, how GSK hid this link with skullduggery; ie; they carried out underhanded and unscrupulous behavior to keep the truth from healthcare professionals, regulators and, more importantly, patients.

In 1989, GSK submitted its “Integrated Summary of Safety Information” to obtain approval of Paxil to treat adult depression. Amongst other adverse event statistics, the Safety Summary reported the number of suicides and suicide attempts experienced by patients who took Paxil, a placebo or a comparator drug during GSK’s initial clinical trials.

In GSK's presentation they compared the suicide attempts with patients in the Paxil group and those patients in the placebo group; and here's how they hid the fact that more patients in the Paxil group had a far higher (significant number) of suicides and suicide attempts.

During the run-in period (which is also called wash-out), patients taking part in a clinical trial are taken off of any medications they may be taking and given a placebo (commonly known as a dummy or sugar pill) instead. In this way, a person’s system is “washed out” of other drugs and all patients start the trial on a drug-free basis at “baseline,” i.e. at the actual beginning of the clinical trial.

Because people who are stopping medications during this wash-out period may experience adverse events associated with withdrawing from the medication they were on, adverse events experienced during this period are not properly counted as occurring during the clinical trial. Adverse events that occur during run-in periods cannot be included when calculating adverse event ratios for clinical trials. This is standard practise for clinical trials.

The FDA's Dr. Martin Brecher had mentioned in testimony that it is “scientifically illegitimate” to count placebo run-in/washout events. Furthermore, Michael Seika, another FDA medical reviewer, explained why run-in adverse events should not be counted. According to a December 8, 1999 GSK memo of a conversation with the FDA:

Specifically, I [Thomas Kline, Assistant Director of Regulatory Affairs at GSK] asked [Michael Seika] if a patient were to die during placebo run-in, i.e. prior to randomization, should that patient be included in the calculation for placebo deaths. He clearly stated that such a patient should not be counted in our analyses, since such a patient would not comprise the “controlled” portion of a trial.
Despite GSK knowing that counting adverse events during placebo run-in was improper they included them in their 1989  “Integrated Summary of Safety Information”

When the 1989  “Integrated Summary of Safety Information” is properly dissected we see that patients taking Paxil were at an 8.9 times greater risk of experiencing a suicide event than those on placebo.

GSK knew this but, by including the count for the placebo run-in/washout events, they were able to hide the risk of suicide from the FDA and, subsequently, prescribing doctors and patients.

By increasing the number of suicide attempts of patients taking placebo and reducing the number of Paxil patients attempting suicide, the percentages between Paxil and placebo became approximately the same - ergo Paxil patients had an equal chance of feeling suicidal if they had taken placebo. Because of this, the percentage of Paxil patients attempting suicide went down from the original submission because GSK reduced the number of Paxil suicide attempts from 42 to 40.

So, by removing the run-in suicide attempt events, Glaxo hid the fact that the correct number was 40 suicide attempts while on Paxil versus 1 attempt on placebo, an approximately 7.5 fold increase of suicide attempt risk for Paxil patients.

Paxil was approved by the FDA in 1992. The approval was based on GSK's false placebo numbers and the incorrect conclusions based on them.

Additionally, once Paxil was approved by the FDA, GSK then went out en masse via a massive promotional campaign touting Paxil as safe and effective, they did this by using the false placebo numbers.

A year prior to Paxil's official launch GSK's (then SmithKline Beecham)  Dr. Geoffrey Dunbar and Sarah Mewett presented a paper entitled 'Evaluation of Suicidal Thoughts and Acts with Paroxetine' at a medical conference, in order to address the then-recent concerns linking suicidality to SSRI antidepressants. In their presentations they claimed that “Suicides and suicide attempts occurred less frequently with Paxil than with either placebo or active controls - they made this claim using the false placebo numbers.

Furthermore, in 1995 GSK's Dunbar, along with two psychiatrists, submitted an article in the Medical Journal of European Neuropsychopharmacology. The article was published and claimed that Paxil actually reduced suicides and suicides attempts.

With this peer reviewed article in place GSK then instructed its saleforce team (reps) to play down the suicide risk associated with Paxil - (at the time reports via the media were suggesting there was a connection between Paxil and suicide)

GSK made billions of dollars from Paxil knowing that the data they submitted was false, meantime, patients on Paxil were feeling suicidal, many were completing suicide.

However, this wasn't enough for GSK.

On April 11, 2002, GSK submitted a Supplemental New Drug Application (“sNDA”) to FDA proposing the use of Paxil to treat children and adolescents with major depressive disorder and obsessive compulsive disorder. During its review of GSK's application the FDA's  Dr. Andrew Mosholder  noted that the most prominent adverse reactions in the Paxil clinical trials were “behavioral effects,” but he stated “these events were coded with terms such as hostility and emotional lability.

In other words, GSK, once again, strove to hide the suicide link in Paxil - remember, this application was for children! The actual figures showed that Paxil demonstrated a relative risk 3.0 times greater than placebo.

If you don't know the answer to why they hid the suicide information in both adult and children's Paxil clinical trials, then you probably don't know how business works. GSK hid the risks in both; they made lots of money from Paxil by getting it prescribed to adults, they wanted to do the same in the children's market - but the FDA and British drug regulatory agency never granted it a license for use in children. It was, however, still prescribed to children - once again on the back of GSK's salesforce team convincing doctors that it was safe and effective - they did this by showing prescribing doctors articles by prominent pediatric psychiatrists. What they didn't show the prescribing doctors was that the published material they were showing them was ghost-written by a PR company hired by GSK - prominent child psychiatrists merely put their names to the published material.

This, ladies and gentlemen, is how GSK operate. This is how they were able to hide the suicide link. This is how they have made billions of dollars off the back of Paxil. This is why Stewart Dolin killed himself.

I'm off to the courthouse. Will blog about days events later.

Dolin Back Stories.

Bob Fiddaman.







Monday, March 13, 2017

Stewart Dolin: The Force is With You








Well, I landed in Chicago on Friday ahead of the eagerly awaited Paxil induced suicide trial, a trial that has seen legal wrangling (stalling) from the defendent, GlaxoSmithKline. They've been targeting the children of Stewart Dolin, they've been targeting his widow, Wendy, with endless subpeonas. They've been targeting Wendy's expert withnesses, they have filed endless motions, they have, and continue to, denied that Paxil caused Stewart Dolin, a mild-mannered, loving man, to jump in front of a train and take his own life. They are, it appears, adamant that they can defend the allegations that Paxil caused Stewart to jump - Let's see shall we.

I'm here with some familiar faces, all of whom have suffered their own loss through antidepressant induced deaths. Kristina Gehrki, whose daughter, Natalie, ended her life due to antidepressants inducing akathisia. Leonie Fennell is also here with me. Leonie's son, Shane, became so psychotic on the antidepressant he was taking that he carried out an act of homicide before ending his own life. Along with Leonie, Stephany Lynch, whose son, Jake, ended his life after enduring the horrific side effects of his prescription antidepressant. Kim Witczak is also here, her husband, Woody, was prescribed an antidepressant for 'insomnia' - the side effects proving to be too much for him, or rather the akathisia. Woody also ended his own life.

What companies like GlaxoSmithKline want the public to know is that all of the above succumbed because they were mentally ill, or, they had underlying issues. The defence of Glaxo in the Dolin v GSK trial will, more than likely, centre around their claims that Stewart was having problems at work, when in fact, he was highly regarded by both his employees and employers.

This has been a long journey for Stewart's wife and children - GSK's attorneys, King & Spalding, have shown their true colours in the lead up to this case, all of which has been documented on this blog.

It's going to be very interesting to see King & Spalding's Todd Davis perform - it's something that I am very much looking forward to. It's going to be a surreal experience to watch someone defend a company who have knowingly sat on the Paxil suicide information for years, furthermore, for me at least, it's going to be the first time I see a human with zero empathy, providing, of course, that Davis shows a lack of empathy in the courtroom. - Anything uttered in court is a matter for the public record and it's my intention to blog about the events, be they the depositions of the Dolin children who were, it appears, grilled by Davis and his highly paid collegues at King & Spalding, even if video depositions aren't played throughout the trial there will be mention of them from both sides.

Glaxo, as per the norm, are defending the indefensible, in doing so they have hired the services of King & Spalding who have tried desperately hard to throw mud at Plaintiff/s and her experts.

Tomorrow sees the jury being sworn in and then the opening arguments. Glaxo will, no doubt, try and call for a mistrial, they will utter the word "Objection" time and time again. You see, Glaxo don't want the jury to know that Paxil can cause adults to kill themselves, they don't want the jury to know how seemingly normal people can go bat-shit crazy when taking Paxil - they won't want the jury to know how they have hounded Stewart Dolin's widow, family and friends since Wendy first filed.

From me, Bob Fiddaman, Kristina, Leonie, Steph and Kim, we hope justice prevails. We hope Glaxo's internal documents that they want to keep away from the public because these documents will show GlaxoSmithKline in a bad light.

Glaxo's CEO, Andrew Witty, leaves GSK next month - he beleives he has left the compny in good shape - I believe Andrew Witty is completely deluded.

Trial starts tomorrow - First blog about it will appear on here shortly after day one finishes. This will continue daily.

As I said, anything uttered in court will be shared.

Bring it on Glaxo!


Bob Fiddaman.



Thursday, March 09, 2017

Attorneys For Dolin Deliver GSK A Can Of Whoop-Ass!




Regular readers of this blog will know that I have, for a lengthy period, been covering the Dolin Vs GSK Paxil induced suicide trial, a trial that will commence next Tuesday in Chicago.

For a number of years now GSK have defended the allegations that Paxil (paroxetine) induced the death of Stewart Dolin. They have cited that Dolin was taking a generic version of their drug, ergo they were not responsible. They have cited that they wanted to change the labelling of Paxil but the FDA wouldn't let them (although evidence shows that they did everything to avoid changing the labelling) - They have blamed Stewart's work problems on his death, even though he was held in high regard by his employers and work colleagues. They have asked his widow about her love life, showed personal medical notes to his surviving children, subpoenaed phone records, attacked expert witnesses, objected to almost every single shred of evidence that goes against them and, as reported yesterday on this blog, don't want the jury in this trial to see how a former FDA official, Martin Brecher, once said, during a deposition how illegitimate their Paxil suicide figures were.

On the latter, Dolin's attorneys have responded in spectacular fashion. You see, by objecting to Brecher's testimony they have stupidly opened a huge can of worms that actually looks more embarrassing for them than the Brecher's actual testimony!

GSK claimed that they never cross-examined the FDA's Martin Brecher but a recent filing by Dolin's attorney's reads...

In fact, GSK had three attorneys sitting at Dr. Brecher’s deposition, presumably all well-qualified to ask questions of Dr. Brecher, and indeed willing to participate and make objections throughout the course of the deposition. 

Furthermore, Dolin's attorneys argue...

The final question under Rule 804(b)(1) is whether GSK had the ‘motive’ to develop Dr. Brecher’s testimony. Of course they did, as will be explained momentarily. First, however, as a Case: 1:12-cv 06403 Document #: 498 Filed: 03/08/17 Page 7 of 13 PageID #:372958 preliminary matter, Plaintiff takes issue with GSK’s broad-sweeping and overly general characterization of the In re Paxil Litigation as solely being “Discontinuation Litigation” that did not have overlap with suicidality related to Paxil use. This is simply false.

In fact, one of GSK’s attorneys at the Brecher deposition, who is also one of GSK’s attorneys in this case, explicitly noted the broad scope of the deposition, applying to many GSK and Paxil cases throughout the country:

In addition, this case has not only been noticed in the In Re: Paxil case, it's also been cross-noticed in several other cases that are pending throughout the country that Mr. Farber and his co-counsel have brought. And it's also -- I advised Mr. Farber that GSK intends to also use this deposition in cases in which discovery is currently being stayed because of various pending motions.  ~ GSK Attorney Todd Davis, DE 497, Ex. 9, p. 10.

Dolin's attorney's ask the question, How then, is it possible that GSK could have overlooked all these “other cases” and mistakenly omitted from its submissions to this Court the real details about those “other cases?”

They also ask, Why would GSK not attack the subject testimony, if it believed it to be untrue or invalid?

Fair enough questions and ones that, seemingly Todd and co seemed to have avoided.

I mean, why didn't they dispute what Brecher had to say, why didn't they attack Brecher as they have attacked Stewart Dolin's widow, children and expert witnesses? It seems this is the norm for GSK's attorneys so why let Brecher off lightly?

If the truth is known GSK knew that Brecher's testimony was damaging - anything that damages GSK is best left buried, be that scientific evidence that Paxil causes severe and debilitating adverse reactions or induces suicidal thinking and completion in some patients.

Bury the data is the norm for GSK, we've seen it time and time again regarding Paxil.

Bury the victims - well, that's left to the likes of Wendy Dolin and Neil and Rhonda Carlin whose daughter, Sara, died by Paxil induced suicide. Also the parents of Sharise Gatchell, another victim who died by Paxil induced suicide. - There have been many more who have fallen foul to Paxil, many more who have taken Paxil on trust because GSK told the scientific and medical world that it was not only safe but effective.

Stewart Dolin will have his voice heard next Tuesday as the opening arguments begin in this trial - unless, of course, GSK do what they do best and settle as his widow climbs the steps of the court house on day one.

Almost every objection they have thrown in this case are peices of turd thrown onto the tracks of the Chicago Transit Authority Blue Line station northbound line in downtown Chicago where Stewart, under the influence of akathisia caused by Paxil, leaped to his death.

GSK are, as I've said many times before, a corporation run by narcissists and psychopaths, this narcissism and psychopathic tendencies spread throughout their workforce where the only thing that seems to matter is how much bonus they will make annually on the back of promoting drugs that are, for want of a better word, shit.

Wendy Dolin is represented by the national law firm of Baum, Hedlund, Aristei & Goldman, based in Los Angeles and the Chicago law firm, Rapoport Law Offices.

Bob Fiddaman.

Dolin Back Stories.


Tuesday, March 07, 2017

Glaxo Don't Want Jury To See Paxil's "illegitimate" Suicide Figures






Yet another objection by GlaxoSmithKline in the eagerly awaited Dolin Vs GlaxoSmithKline Paxil induced suicide trial, set to begin next Tuesday in Chicago.

GSK, it appears, are now bitchin' about evidence submitted by Wendy Dolin, the widow of Stewart Dolin, that shows how (in a previous trial) the testimony of former FDA employee Dr. Martin Brecher showed that stopping or discontinuing Paxil led to undesirable side effects. (In re Paxil, Case No. CV-01 07937 MRP (C.D. Cal.))

GSK's objection states...

"Permitting Plaintiff Wendy Dolin to introduce Dr. Brecher’s testimony would be highly and unfairly prejudicial because the jury would be left with the incorrect impression that FDA determined that GSK’s reporting of suicides and suicide attempts in the Paxil NDA was “scientifically illegitimate.”

During Brecher's original deposition, taken almost 14 years ago, it was learned that Brecher, whilst employed at the FDA, told Glaxo (then SmithKline Beecham) officials that "Paxil was dangerously addictive." (1)

Glaxo are also objecting to this evidence being submitted in the Dolin trial because, "...the prior case involved a different subject matter than this case."

Brecher, whilst under oath was also questioned about the suicide figures relating to patients taking Paxil. Here's part of that deposition. Keyword here is "illegitimate."

You'll note that GSK's attorney's cite the same thing when Brecher is being asked questions that forms part of their objection in the Dolin case, ergo "It has absolutely nothing to do with this litigation."


Q (by Mr. Farber): Now, you had the NDA that was submitted in November of ’89 and you took over the job in January of ’90, correct. So you had had – this is prior to the Teicher article now in January by month at least and the NDA had been submitted two months earlier. That NDA had suicide tables and data; did it not?

A: Yes.

Q: And did you through a matter of course in your regular routine review that suicide data?

A: I believe I did.

[Objection and colloquy omitted]

Q: So the data on suicide that you had when the NDA – let’s basically -- That will be Exhibit 15.
[Colloquy omitted]

Q: Take a look at that for a minute. Ready?

A: Uh-humm.

Q: Now this table Roman numeral 11.21 talks about attempted suicides and overdoses, Worldwide Data. And at the bottom it indicates the Par safety summary of 10 November of 1989. And you’ll notice up in the right-hand corner of the Worldwide Data that it has all the population that we talked about earlier that you believed I was telling you the truth and I am, the one that says 2,963 under Paroxetine, 1,151 and 554 respectively for placebo; do you see that?

A: Uh-humm.

Q: Okay. Now, here we have attempted suicides on the top line that are further broken down into drug overdose and I’ll save you the time by figuring this out and it’s to their benefit anyway, so the drug overdose category is within the top category, it’s not – it’s not in addition to, it’s a subset of attempted suicides. And my question is the asterisk of two overdoses during the placebo run-in, you see the asterisk on the side, and of the overdoses, attempted suicide, two were – occurred during the run-in period. Let me ask you this: Based on your procedures at FDA – first of all, let – let me back up a minute. Based on your procedures at the FDA, what is a run-in period?

A: Prior to randomization subjects are discontinued from their old medication and given placebo usually for about a week, sometimes shorter.

Q: And how about wash-out, same?

A: That -- that period also washes out their previous medication.

Q: So the terms are effectively synonymous for the purposes of …

A: (No verbal response.)

Q: Okay, now, based on FDA procedure and I’ll even elevate that to scientific procedure that you understood scientific procedure to be when you were at the FDA, is it scientifically legitimate to count a suicidal act occurring during wash-out and run-in to the placebo count?

[GSK COUNSEL]: Object to the form of the question. It has absolutely nothing to do with this litigation.

MR. FARBER: You’re going to see a connection if you’re patient here.

A: No, because everybody got placebo.

Q: So it’s scientifically illegitimate way to count, correct?

A: Yeah.

--

So, it appears that the current crop of Glaxo attorneys involved in defending Paxil in a suicide trial don't want this evidence seen by a jury, just as the old crop of Glaxo attorneys didn't want the jury in a Paxil addiction case to see evidence of Paxil induced suicide.

Begs the question; what exactly do Glaxo want the jury to see, just their evidence? A case of having their cake and eating it, perhaps?

The Paxil addiction lawsuit was settled out of court, over 3,000 plaintiffs received a compensatory award (figure unknown)

In the UK, consumers of Paxil (known as Seroxat) have been waiting almost 10 years to find out if they can press ahead and sue GlaxoSmithKline with regard to severe adverse reactions caused by Seroxat. In a recent pre-trial judgment the UK Plaintiffs were told that the outcome of the class action in the USA has no relevance to the UK cases. Glaxo had previously objected that the UK Courts did not need to know this. (2)

A strange judgment given that the relevance is in the word 'Withdrawal'. Nonetheless, the UK consumers still battle on.

Opening arguments in the Dolin trial commence Tues, March 14 in Chicago. I'll be writing daily reports on the events.

Bob Fiddaman.


(1) "Paxil was dangerously addictive."
(2) SANDRA BAILEY & OTHERS Vs GLAXOSMITHKLINE (UK) LIMITED 01/03/2017


Doin v GSK back stories.

Sunday, March 05, 2017

Glaxo Settle Paxil Birth Defects






Once again GlaxoSmithKline have settled out of court with a mother who claimed that she and other mothers had not been properly warned about the risks of taking Paxil during pregnancy.

The lawsuit, which was filed 9 years ago, has recently seen both parties come to an agreement - ergo the plaintiffs (50 in all) will probably receive around $150,000 each.

Faith Gibson, who was the lead case in the litigation, used Paxil during her pregnancy and her daughter, Leah, (pictured above) was born with a hole in the heart in 2005. Meah, now aged 11, remains particularly susceptible to whichever cold or flu is going around.

Her mother said...

"In general, Meah, now 11, seems to be doing better physically. But the ordeal has affected her mentally as well.

"Any kind of pain she has in her heart or any sort of discomfort she feels in her chest, she feels like it’s something bad going on and that she might have to have surgery again.

"That side of things hasn’t subsided at all. She’s got a nasty scar on her chest to remember it by, so it’s always there."

GlaxoSmithKline said that despite the settlement in principle, it does not admit to any liability or wrongdoing but has agreed to resolve the class action case to avoid the time and expense associated with a trial and subsequent steps in the proceedings.

“We continue to be of the view that the scientific evidence does not establish that exposure to Paxil during pregnancy causes cardiovascular birth defects."

--

We all know different.

See the evidence in links below, evidence that caused a huge embarrasment to both Glaxo and their attorneys, King & Spalding.

Bob Fiddaman.

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

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