Tagged: Bob

Bob Fiddaman Covers Day 2 Of The Dolin Paxil Induced Suicide Trial..


I don’t know  about you, but I have been fascinated by Bob Fiddaman’s coverage of the Stewart dolin Paxil induced suicide trial the last few days. His latest post uncovers some really damning material for GSK in regards to Paxil/Seroxat. It’s surprising that GSK chose to bring this case to court, surely even the dogs in the street know that GSK are nothing but an utterly reprehensible corrupt entity? and that close to NONE of their drugs can be trusted as efficacious or safe?

GSK are proven liars, felons, deceivers and fraudsters.

They lie about everything, particularly the data. They can’t be trusted. They have simply no credibility and they haven’t had a shred of it for years.

Paxil/Seroxat is particularly bad in terms of controversy because it’s utter poison.

The Seroxat Paxil scam has long been exposed, and the game has been up for a long time too.

These court cases reveal the carcass of a company- which has long been- rotten to the core.

Fair play to Fid for covering this compelling case.

I look forward to more revelations in the coming days ahead.


http://fiddaman.blogspot.ie/2017/03/dolin-vs-gsk-day-two-jack-in-box.html

Thursday, March 16, 2017

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

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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.

The Fiddaman Blog…


http://fiddaman.blogspot.ie/2017/03/glaxo-dont-want-jury-to-see-paxils.html

Glaxo Don’t Want Jury To See Paxil’s “illegitimate” Suicide Figures

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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.