Monsanto Roundup Lawsuit


Citizens Commission on Human Rights Award Recipient (Twice)
Humanist, humorist

Thursday, March 30, 2017

Dolin Vs GSK - Glenmullen Nails It!





On Tuesday a series of video depositions were aired to the jury. Sadly, I have no access to the videos and cannot directly report on them. Thankfully, GSK's lawyer, Todd Davis, has provided fabulous entertainment akin to a desperately sad clown. Yesterday Davis ineffectively cross-examined the plaintiff's next expert witness, Dr. Joseph Glenmullen.

Dr. Glenmullen is yet another thorn in the side of GSK. He has previously served as expert witness in many Paxil lawsuits, and, just like Dr. David Healy, is disliked by GSK and their King &  Spalding attorneys. Both Glenmullen and Healy were subjected to GSK's pre-trial circus in which GSK filed motion after motion arguing that these renowned doctors should not give evidence at this trial. GSK's attempts were denied.

After yesterday, I can vividly see why GSK opposed Glenmullen as an expert. In short, Glenmullen ran circles around Davis. More on this further on down this blog post.

Glenmullen detailed Stewart Dolin's medical notes and told the jury the akathisia Stewart experienced occurred the last time he was prescribed Paxil. This was six days before Stewart's Paxil-induced death. During these six days, Stewart showed increased signs of agitation, just as he did when he was previously prescribed Zoloft years ago. In fact, when the Zoloft dose was increased, Stewart's adverse drug reaction (akathisia) worsened. When Stewart stopped taking Zoloft, his agitation subsided. Sadly for Stewart and his survivors, when he last took Paxil his adverse drug reaction ended in death. Akathisia, as Glenmullen stated yesterday, is "a drug-induced reaction, a compulsion to kill yourself." Glenmullen added that a death such as this is referred to "as a paroxetine-induced accident, not a suicide. It's paroxetine. It's the label that didn't warn that is the cause."

Regarding GSK's supposed adult suicide warning on the Paxil labeling, Glenmullen clearly nailed it. Referring to the 2010 Black Box warning displayed in court, Glenmullen told the jury how there was explicit language that short-term studies did not show an increase in the risk of suicidality with antidepressants compared to sugar pills in adults beyond age 24. He also pointed out the sentence, "Depression and certain other psychiatric disorders are themselves associated with increases in risk of suicide." He explained to the jury, "...What that tells me as a practicing psychiatrist is that if I'm treating a 57-year old patient and I put them on Paxil, Paxil couldn't make them worse. Paxil couldn't make them suicidal. It would be, and it says explicitly, their depression or other psychiatric condition."

Glenmullen further noted the black box warning is "really bad" because it implies the suicide warning is just for children, ergo a doctor treating an adult could not warn about a potential risk of suicide because the labeling suggests there is only a suicidality risk among children taking Paxil.

The jury was informed that the labeling was written in such a way so that doctors would not only NOT know about the adult suicide risk, doctors would actually increase the dose because they would assume worsening of depression and/or new disturbing behaviors had nothing to do with Paxil.

Glenmullen added, "And here's another dimension to it. If the patient gets worse and it might be the drug, what do you do? You take them off the drug to see. If they get worse and it couldn't be the drug but it's the depression, what do you do? You increase the drug, which is going to worsen the risk. So it's very dangerous. And that's why, in my opinion, it's really this lack of a warning that's responsible for his (Stewart Dolin's) death."

Glenmullen told the jury he is "100% certain" that "Mr. Dolin's was a "paroxetine-induced, Paxil-label-induced death."



Cross-examination by King & Spalding's Resident Clown

As per his norm, Davis repeatedly tried but failed to discredit the witness. He attempted to catch out Glenmullen with answers Glenmullen provided in various testimonies, including testimony that was more than 11 years ago!

A spectator in the court told me, "You should have seen the spectacle created by GSK when it came time to do their cross.  They were so unorganized with their multiple binders that the jury started to laugh."

Davis also went down the route of asking Glenmullen how much he was paid to give expert opinions in previous Paxil litigation. Leaves me wondering how much Todd Davis has been paid to defend one of the most controversial drugs in history. Further, I wonder whether he and his law team view their thousands of "settlements"as victory.

In what world is it viewed as a success to place gagging orders on families of Paxil victims so that the truth about the dangerous product is hidden?

Thus far, Davis has done a fine job of entertaining both spectators and jurors alike. Today's Davis looks more like a sad clown than the smug clown who skipped into court three weeks ago. So, there you have it: King & Spalding attorneys seem to work well together if one considers their joint performance mere entertainment. Sad clown Davis and his jack-in-the-box sidekick, Andrew Bayman, will continue their lame cross-examination of Glenmullen today.

Bob Fiddaman




Tuesday, March 28, 2017

Dolin Vs GSK - Day 8 - Get to the Point, Todd!



The Todd Stance

Oh Todd, oh Todd, oh Todd,
you make us feel so weary.
Your questioning of Stewart's doctor
really is quite dreary.
So, GSK's warning letter
is the crux of your defence?
It's not logical or rational;
it simply makes no sense.
You say you warned the doctors
of Paxil's suicide risk.
Yet Andy Bayman denies this claim,
like a repeating compact disc.
Adults are perfectly safe, he states:
It's just kids who should be warned.
But your former CEO confirms
it's your duty to inform.
You can keep your fancy haircut, Todd,
and expensive Armani suit.
You can keep your sense of what's right and wrong
in this wrongful death lawsuit.
You can keep your lack of due care
and misleading words of warning.
We know Paxil causes death, you see,
and leaves families deep in mourning.

Bob Fiddaman ~ 2017

Day 8 of the Dolin Vs GSK Paxil-induced suicide trial saw Stewart Dolin's physician and long-time friend, Dr. Marty Sachman, take the stand.

Sachman was first questioned by David Rappaport, one of the attorneys representing Wendy Dolin (Stewart's widow).

The jury heard more about Stewart Dolin, the man, and less about the fact that GlaxoSmithKline concealed Paxil's propensity to induce suicidality. Sachman told the jury, "Stew was a very reserved, quiet, intelligent, loving man. I never heard him raise his voice over our 25-year relationship. We were like brothers. We spent weekends together, travel together. He was my closest friend. A loving person and a loving family man." 

Sachman was also questioned about Stewart Dolin's anxiety, which, according to the doctor, was a result of work-related issues. He told the jury that he never thought Stewart was depressed and that Stewart always responded to the treatment he gave him from 2005-2010. On each occasion, after Sachman prescribed Stewart drugs, he would warn him of the side effects and, once Stewart felt better, would wean him off the prescription.

Two days before Stewart's Paxil-induced death, Sachman and Stewart attended a memorial service for the father of their mutual friend. Later that evening Sachman, Stewart and Wendy went to dinner together. Sachman was asked to describe what he remembered about Stewart that night. He answered, "His demeanor was, as usual, our conversation was as usual. He was calm."

Sachman then recounted his "absolute shock" upon hearing the news of Stewart's death. He told the jury, "I just think that we depend on honesty in reporting research and data. How can we treat people effectively and safely if we can't depend on that?"

Rappaport then asked Sachman about the communication between pharmaceutical companies and doctors regarding drug labeling. Sachman's answer, which King & Spalding objected to and was struck by the judge, highlighted Dr. Sachman's feelings about being deceived:

"Well, you know, physicians, myself and millions of other physicians, every day try to protect people, try to help people and protect them. We rely on truth and honesty from pharmaceutical companies and to falsify information or hold back information is totally criminal. It affects the lives of our patients."

It's appropriate Sachman used the word 'criminal' given that GlaxoSmithKline have previously pled guilty to criminal charges. Therefore, GlaxoSmithKline are criminals.

Concluding his examining of the witness, David Rappaport asked Sachman about the tie and belt he was wearing. Sachman started to weep, sharing that they belonged to Stewart. Dr. Sachman wore them to "remember him today."

Cross-examination by King & Spalding's Todd Davis.

The cross-examination by Davis centered around GlaxoSmithKline's "Dear Doctor Letters" sent out whenever GSK decides to share a problem with their products. Davis went over and over a series of these letters sent to Sachman. Sachman told Davis that he had, indeed, received these letters. Once again, King & Spalding tried to catch a witness by asking the same questions that were asked years ago during deposition. GSK's attorneys futilely tried this tactic with Dr. David Healy and Dr. David Cross earlier in the trial.

Davis droned on about the "Dear Doctor Letters" and whether Sachman read them. Finally, an understandably frustrated Judge Hart interjected and admonished Davis, "You're covering the same ground...over and over again now, Mr. Davis...Let's not go over the same thing over and over again."

Davis, however, continued to go over the "Dear Doctor Letters," and the judge again interjected, "Mr. Davis, the document speaks for itself, and the doctor has accepted it. I don't see any reason to read the document to him and ask him whether he agrees or disagrees." 

King & Spalding's "finest" then switched gears, inquiring about Sachman's prescription of Levaquin (an antibiotic) to Stewart Dolin. Davis asked Sachman if he had read the Levaquin warnings regarding the drug's propensity to cause adverse effects including suicidal acts or thoughts.

It's good to see Levaquin manufacturers use the appropriate suicidal acts in their warning label. This term is surely more understandable than the intentionally ambiguous "emotional lability" term GSK prefers. I can't help but wonder whether Davis would be equally concerned if his spouse consumed a product that states it can cause "emotional labilty" as he would if the warning listed "suicidal acts?"

Bizarrely, Davis next asked Sachman if he was aware Stewart's widow and children had taken trips in and out of the US since Stewart's death? Davis likely knows this is irrelevant, but shamelessly asked anyway in a lame attempt to imply Stewart's widow and children couldn't possibly be mourning Stewart's Paxil-induced death if the family has traveled in the last six years. An appropriate question on my mind is "Does Davis take trips in and outside the US after settling cases for GSK in which innocent consumers have died?"

Davis finished his cross-examination, and I presume the jury and judge were glad to have a break from Davis' tedious repetition. Davis is largely ineffective; GSK might want to reexamine their legal fund investment in Davis when GSK is, no doubt, embroiled in future wrongful death lawsuits.

David Rappaport - Re-direct

I won't go into too much detail regarding the re-direct because the following question and answer seemed to undue Davis' performance:

Q. Have you seen in any of the labels that you've ever seen from GSK about Paxil any reference to the fact that they had a suicide signal from attempts and suicides in the initial clinical trials that was of the magnitude of 7 to 8 times greater risk than similarly-depressed people on placebo?

A. I certainly have not.

Before leaving the stand, Dr. Marty Sachman told the jury, "I'd like to say that in the midst of all of this attempted confusion of the real issue here, if it was clear that this drug had a higher risk of causing suicide in the age group Stewart Dolin was in, I would have never prescribed it."

Three doctors have now taken the stand:  All have stated if they had known about the increase in suicidality and behavior in adults taking Paxil they would have never prescribed it.

Your move, Todd!

The trial continues today with a series of video depositions that, sadly, I won't have access to unless they are made public.


Bob Fiddaman.










Monday, March 27, 2017

More Woes for GSK as Peter Humphrey Files Suit






GlaxoSmithKline are rarely out of the news. Regular readers will know that I'm covering the wrongful death lawsuit in Chicago, Dolin Vs GSK. Now, it appears the whole squalid 'Chinagate' scandal has, once again, reared its ugly head as Peter Humphrey, who was incarcerated in a Chinese prison, along with his wife, has filed suit against GSK claiming federal racketeering and conspiracy claims under RICO, as well as state law claims for fraud, intentional infliction of emotional distress, negligent infliction of emotional distress, and civil conspiracy.

Glaxo wouldn't be Glaxo if they admitted to any wrong-doing so, in spectacular fashion, they are disputing the complaint, citing that Humphrey should go back to China to arbitrate these claims.

The suit, filed in the United States District Court of Pennsylvania, argues that the case does not have to be filed in China because...

 - Defendants are part of the GSK Group, which holds itself out as an integrated “global healthcare company.” 

 - Directors of GlaxoSmithKline plc manage the risks of the Group at a group level, rather than at an individual business unit level.

 - GSK’s General Counsel, Dan Troy is based in the United States.

GSK’s General Counsel, Dan Troy, is based in the United States and manages the companies 400 lawyers based in Pennsylvania, New Jersey, North Carolina, Belgium and the UK. As discussed further below, Troy “played an active role” in forming GSK’s response to the whistleblower’s revelations of corruption in China.

For those who don't know, Troy is the former Chief Counsel for the FDA. During his time at the FDA he ordered that all decisions to take action against false prescription advertising go through his office -- after which the enforcement actions mysteriously dropped by two-thirds. He also got to work revising the agency's regulations to allow drugmakers to promote drugs for uses not yet supported by clinical research.

Quite a revolving door and Troy is a subject I will be covering soon on this blog.

Meantime, Humphrey's lawsuit intends to highlight, once again, how GSK attempted to bribe doctors around the world by various means in order to increase the sale of their drugs. This, despite  settling a multi-billion dollar settlement agreement with the Department of Justice (DOJ) in 2012.

GSK’s China-based bribery and illegal promotional activities extended to at least June 2013.

More coming soon.

Bob Fiddaman.

More on Peter Humphrey and the Chinagate scandal here.


Friday, March 24, 2017

Dolin Vs GSK - Day 7 - Abraham Lincoln




Day 7 in Dolin Vs GSK began with the continued cross-examination of former FDA official, Dr. David Ross, by GSK's King & Spalding attorneys.

GSK is desperately trying to convince the jury that the company repeatedly sought to change the Paxil labeling but, supposedly, the FDA wouldn't allow it. GSK's attorney, Andrew Bayman, futilely tried to put words into the mouth of the witness, attempting to trick Dr. Ross into agreeing he said things he has never actually said.

It's still a head scratcher for me - on the one hand, GSK is claiming that Paxil is safe for adults, on the other they claim they told the FDA there was an increase in suicidality in adults on Paxil. How could both be true?

It appears Glaxo concedes Paxil can increase suicidality in adult consumers but that this suicidality increase does not lead to completing suicide.  However, if you die by "suicide" when consuming  GSK's product, Paxil, GSK's drug didn't cause it.

Yesterday, former FDA official, Dr. Ross, was asked by Bayman:

"Other than the 6.7 finding with respect to the secondary analysis of definitive suicidal behavior, you're not aware of anything in GSK's 2006 adult suicidality analysis that would meet the definition of reasonable evidence of an association between the use of Paxil and suicidality that would warrant a label change, correct?"

Dr. Ross, who remained unphased, replied:

"Well, the answer to that is yes, I am, but more importantly, as I said to your colleague two years ago, that's a little bit like saying, 'aside from that, Mrs. Lincoln, how did you enjoy the play?'"

This was a great response considering the excuses GSK regurgitates when faced with claims that Paxil induces adult suicidality, and severe withdrawal effects or birth defects, etc. It is the standard corporate response to repeat, "Paxil has helped millions of people worldwide."

Why would GSK attempt to place an adult suicide warning on the Paxil label if it is the company's position that Paxil does not induce suicidality in adult patients?

King & Spalding's Bayman has been trying to catch Dr. Ross in non-existent contradictions for two days. Dr. Ross, who often quite brilliantly turns the questions back onto Bayman, remains steadfast that the Paxil suicidality data created by GSK is false and misleading.

Thus far GSK has claimed it wasn't their fault they didn't warn the public, it was the FDA's failure. It wasn't Paxil that precipitated the death of Stewart Dolin; it was his underlying illness. It is GSK's position that Paxil causes suicidality in adult consumers; it's also their position that it doesn't.

Akathisia is the Paxil-induced medical condition that often precipitates suicidal thoughts and suicide itself. GSK continues to point out that there is an FDA class warning for all SSRIs stating the drugs can cause akathisia. However, what GSK attorneys don't want to mention is that their product, Paxil, is more likely to cause suicidality than other SSRI offenders. Specifically, when the clinical trial data is correctly interpreted, it shows Paxil causes an 8.9 increase in adult suicidality.

All SSRIs can and often do cause akathisia and suicide. Unfortunately, drug companies and the FDA continue, to this day, to inadeqautely define akathisia. This collective failure continues to harm patients and ill-informed prescribers.

Today's Paxil label describes akathisia simply as "psychomotor restlessness." Further, it states:

"The use of paroxetine or other SSRIs has been associated with the development of akathisia, which is characterized by an inner sense of restlessness and psychomotor agitation such as an inability to sit or stand still usually associated with subjective distress. This is most likely to occur within the first few weeks of treatment."

Once again, there is no mention that akathisia is a precursor to suicide. Of course, GSK's Andrew Bayman doesn't tell the jury this fact, either. However, GSK's BigPharma colleague, former Pfizer Medical Director Dr. Roger Lane, confirmed this fact way back in the 1980's.  Lane wrote two peer-reviewed articles about SSRI-induced akathisia. About akathisia-induced suicide, he stated, "It may be less of a question of patients experiencing fluoxetine-induced suicidal ideation, than patients feeling that ‘death is a welcome result’ when the acutely discomforting symptoms of akathisia are experienced on top of already distressing disorders."

Lane was referring to fluoxetine, which is the drug, Prozac, just as paroxetine is the drug Paxil. An expert witness for Prozac manufacturers, Eli Lilly and Company, conceded under oath that SSRIs cause akathisia. At the Forsyth v. Eli Lilly and Company murder/suicide trial, Lilly’s expert witness, Dr. Victor Reus testified that both Paxil and Prozac can cause akathisia in patients.

King & Spalding's Andrew Bayman frequently concedes in the Dolin Vs GSK trial that SSRIs can cause akathisia. Further, Bayman continues to point out that akathisia is listed on the drug class label. However, what Bayman doesn't want to emphasize is what drug company scientists have known and confirmed for years: As Pfizer's Dr. Roger Lane stated decades ago: "death is a welcome result’ when the acutely discomforting symptoms of akathisia are experienced."

GSK has downplayed the suicide risk in adults taking Paxil for nearly 25 years. It's absurd and misleading to claim that calling akathisia "psychomotor restlessness" would ever lead consumers and prescribers to interpret this intentionally vague definition as an increase in suicidality.

GSK and all SSRI manufacturers should be shouting from the rooftops the exact definition of akathisia, as should medicine regulators. Instead, yesterday the Dolin Vs. GSK jury was treated to some loud entertainment by Bayman. He tried to drown out the facts by shouting at the expert witness. It was so unprofessional that the Honorable Judge Hart had to tell Bayman to "stop shouting."

Further witnesses will be called next week as this case unfolds. Meanwhile, here's a short video produced by MISSD that helps everyone better understand akathisia.






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

Dolin Vs GSK - Day 4 - Slam Dunk

Dolin Vs GSK - 8.9 Suicide Increase For Adult Paxil Users

Dolin Vs GSK - Day 6 - Ass Kicking Semantics


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 Ross, finished today. Ross, 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 Ross, 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. Ross previously shared with the jury.

Did Bayman succeed?

Hardly. It seemed a junior-league attempt to try and trip up Dr. Ross 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. Ross.

"Are you a pharmacologist?", Bayman asked.

"No." Dr. Ross replied.

"Are you an epidemiologist?" Bayman asked.

"No." Dr. Ross 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. Ross 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.








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