Tagged: stewart dolin

Stewart Dolin’s Doctor Says (about Paxil) : ““I don’t trust the labeling,” he said. “I don’t trust the company, to be honest.”…


And why would he?

Why would anybody trust GSK? Would you trust a felon?

The Dolin trial opened a can of worms about Paxil/Seroxat, suicidality and akathisia which GSK would rather remained tightly in the can. It’s too late now though, the worms are already out…

See Dr. David Healy’s excellent new post about wider implications of the Stewart Dolin Paxil induced suicide trial.


“……The regulatory history of Paxil and the other SSRI’s was almost Byzantine.   For years they carried no warnings of a risk for suicide.  In 2004, after thousands of troubling reports, a Black Box warning was finally issued for children and adolescents.  A number of medical experts felt the warning should apply with equal urgency to adults.

However, in 2007, the FDA decided on a uniform warning for all antidepressants, old and new.  This was the “24 and under” label attached to both brand-name and generic Paxil in 2010.  This suited GSK just fine.  The FDA invited the company to discuss whether additional warnings were needed for Paxil, but GSK never took them up on it.

More importantly, it never fully shared with the FDA—and still less with doctors in the community—what it knew about the real risks of its product.  In fact, GSK had known since 1989 that its drug could trigger akathisia, an agonizing combination of physical restlessness and emotional turmoil that could lead to suicide.  The risk applied to both teenagers and adults; at least twenty suicides had occurred in patients on Paxil in clinical trials, the majority of them in people over age thirty…..”


https://davidhealy.org/change-in-chicago-dr-welby-on-the-witness-stand/

Change in Chicago:  Dr. Welby on the Witness Stand

May, 15, 2017 | 8 Comments

Dr David Healy Blogs About The Stewart Dolin Trial Verdict… (well worth reading)


https://davidhealy.org/change-in-chicago-the-dolin-verdict/

Change in Chicago: The Dolin Verdict

May, 1, 2017 | Reply

BMJ: US drug regulators should consider adding adults to SSRI suicide warning, says campaigner


http://www.bmj.com/content/357/bmj.j2050
News

US drug regulators should consider adding adults to SSRI suicide warning, says campaigner

BMJ 2017; 357 doi: https://doi.org/10.1136/bmj.j2050 (Published 25 April 2017) Cite this as: BMJ 2017;357:j2050

  1. Ed Silverman

Author affiliations

A British doctor who campaigned for the public to be warned about increased suicide risk in young people taking antidepressants has said that US drug regulators should consider including adults in warnings.

David Healy, a psychiatry professor at Bangor University, called for the warnings after GlaxoSmithKline (GSK) was ordered to pay $3m (£2.34m; €2.75m) to the widow of a US man who killed himself shortly after starting generic paroxetine.

The jury in the case of Stewart Dolin, a 57 year old attorney, concluded that GSK had failed to properly warn the public about the increased risk of suicide when taking paroxetine. The jury reached its verdict after lawyers for Dolin’s widow, Wendy, presented evidence in the Chicago federal court suggesting that GSK knew that paroxetine posed a risk to adults but had concealed or manipulated data.

Dolin stepped in front of a train in July 2010 shortly after starting a generic version of paroxetine that was sold by Mylan Pharmaceuticals. Mylan was originally named in the lawsuit but was later dismissed because of regulations and a Supreme Court ruling that a generic company cannot be sued if the brand name company does not first change product labelling.

Warnings about the increased risk of suicidal thoughts and behaviour in children and young adults were added to the labels of antidepressants in the US and Europe more than a decade ago.1 In the US, however, labels do not warn of these risks for anyone over 24 years old.

Many consumers have tried to hold drug makers responsible for suicides in adults without success. But the legal team representing Wendy Dolin argued that GSK had artificially inflated the number of suicides and suicide attempts that occurred among people who were given a placebo during clinical trials of paroxetine. They said that this alleged move made the antidepressant look better by comparison, since it appeared to minimise the risk of suicide associated with the drug.

The lawyers also argued that GSK had used averages for all selective serotonin reuptake inhibitors (SSRIs) to demonstrate that paroxetine did not raise the risk of suicide in adults aged over 24. Court documents also indicated that paroxetine displayed a much higher risk than all but one of the SSRI drugs.

Wendy Dolin declared the verdict “a great day for consumers.” After the verdict she told the Chicago Tribune, “This for me has not just been about the money. This has always been about awareness [of] a health issue, and the public has to be aware of this.”

Healy, who spearheaded the campaign to upgrade suicide warnings on antidepressants and testified as an expert witness on behalf of Wendy Dolin, said that the findings in the case should prompt the US drug regulator to review the evidence on SSRIs and suicide risk in adults.

“When it becomes so clear cut that a jury finds there is a problem, it suggests the evidence is strong enough to look at the issue,” Healy told The BMJ. “If it’s that clear to the average man on the street, and the FDA [the US Food and Drug Administration] doesn’t do something about it, we have an odd situation.”

GSK, which markets paroxetine under the brand name Paxil in the US, has said that it will appeal the verdict. “GSK maintains that because it did not manufacture or market the medicine ingested by Mr Dolin, it should not be liable,” it said in a statement. “Additionally, the Paxil label provided complete and adequate warnings during the time period relevant to this lawsuit.”

GSK added, “The scientific evidence does not establish that paroxetine causes suicide, suicide attempts, self-harm, or suicidal thinking in adult patients. In 2007, FDA revised the labelling for the entire class of SSRI drugs (including generic paroxetine and Paxil). The label includes statements that studies did not show an increased risk of suicidality (attempts or ideation) in adults over the age of 24, and that there appeared to be a protective effect in adults over 64.”

References

Federal lawsuit filed by widow blames Paxil for attorney’s suicide


By Amy Martyn

Amy Martyn is a writer and reporter who lives in Texas with her husband and dog. When she is not writing, reading or investigating, she is on her bicycle, running or on good days taking a road trip somewhere.  Read Full Bio→

Photo
Photo via Missd.co

Before committing suicide in 2010 at the age of 57, Stewart Dolin lived what his wife Wendy described as a “perfect life.” The Dolins had been married for 36 years and raised two children together, and Stewart at the time of his death was in charge of corporate and securities law at a prominent law firm in Chicago.

“This happy, funny, loving, wealthy, dedicated husband and father who loved life left no note and no logical reason why he would suddenly want to end it all,” Wendy Dolin writes on MISSD, or The Medication-Induced Suicide Prevention and Education Foundation in Memory of Stewart Dolin, the nonprofit she created in her late husband’s memory.

“Neither Paxil nor the generic version listed suicidal behavior as a potential side effect for men of Stewart’s age.”

Wendy Dolin is one of at least several people who have come forward publicly to blame the antidepressant Paxil for a loved one’s death. Her lawsuit against Paxil manufacturer GlaxoSmithKline, after having been stalled for years, is currently being heard before a jury in a Chicago federal court.

GSK criticized over handling of data on adolescents

The antidepressant Paxil had already brought GlaskoSmithKline an estimated $11.6 billion in sales when the company in 2012 was criminally prosecuted by the United States government, on charges that it was promoting Paxil for unapproved uses as well as hiding safety data about a different drug. That case ended with the United States government fining GSK a record $3 billion.

Since then, researchers have criticized GSK for its handling of evidence that paroxetine, the key ingredient in Paxil, is linked to suicide in young adults. The corporation had conducted a clinical trial in 2001 and reported positive findings — that paroxetine is “safe and effective for adolescents.” But a re-analysis of GSK’s own data, published in the British Journal of Medicine in 2015, found that 12 of the 93 children given paroxetine in the clinical trial reported suicidal thoughts.

“There is an increased risk of suicidality in pediatric and adolescent patients given antidepressants like paroxetine,” GSK acknowledged after the 2015 paper was published, pointing out that a black box label warning consumers as such had been placed on Paxil since 2004. But the researchers who analyzed GSK’s 2001 critical trial data argued that such a warning should have been on Paxil since the beginning.”What would have happened if this data were available 15 years ago when the study was originally published?,” one of the researchers said in an interview in Scientific American.

Wendy Dolin’s case charges that Paxil’s suicidal side effects aren’t limited to adolescents. Her attorneys are asking GSK similar questions about why they didn’t warn adult patients of a potential suicide risk.

Company blames FDA

Stewart Dolin’s family says that he had suffered some work-related anxiety shortly before his death. A family friend and doctor prescribed him the generic version of Paxil, which is produced by Mylan. The doctor, Martin Sachman, testified on Monday that he wouldn’t have prescribed paroxetine had he known about the suicide risk it posed in adults.

Dolin had been on paroxetine for six days, his family says, when he stepped in front of a commuter train after work.  His death was shortly after ruled a suicide. “Stu Dolin was a close personal friend, valued colleague and a great leader in our firm,” the head of his law firm told reporters shortly after the news broke.

GSK now acknowledges in court hearings that there is evidence of suicidal behavior in adults who take Paxil. “The results provided evidence of an increase in suicide attempts in adults with MDD [major depressive disorder] treated with paroxetine, compared to placebo, and that analysis based on the confidence interval was statistically significant,” a former bio-statistician for the company testified in one deposition, describing a 2006 study conducted by GSK.

But in testimony earlier this month, GSK told the federal jury that they were unable to warn consumers about this potential side effect becase the FDA had four times rejected its attempts to alter their own warning label. “The FDA controls the label, ladies and gentleman,” one of the GSK attorneys said at the trial, according to Law360. (A GSK spokeswoman has not yet returned an interview request from ConsumerAffairs.)

Wendy Dolin, who is accusing GSK of negligence by failing to warn doctors about the suicide risk, is asking for $12 million. Her suit is filed only against GSK, not Mylan, because the courts had determined in earlier proceedings that name-brand drugmakers, not their generic competitors, are ultimately responsible for the warning labels that go on all drugs.

Restlessness or something worse?

Little is known about Akathisia, the specific condition that Wendy Dolin says was caused by paroxetine and led to her husband’s suicide. Researchers have described Parkinson’s disease-like symptoms in some adults who take antipsychotic drugs, and others describe the condition as something similar to restless leg syndrome, or inability to sit still. Some critics, including personal injury attorneys and researchers, charge that the Akathisia disorder is linked not just to physical restlessness but intense emotional restlessness as well.

Among those warning of a dangerous link between Akathisia and antipsychotics is Dr. David Healy, a British psychiatrist who co-authored the 2015 re-analysis of GSK’s data showing an increased risk of suicide in adolescents. Healy, known as a gadfly in the pharmaceutical industry as well as in the field of psychiatry as a whole, is credited with convincing British and American regulators to place more warnings on antidepressants in 2004. Testifying on behalf of the the Dolin family earlier this month, he presented the jury with a study examining a link between Akathisia and Prozac, another popular antipsychotic medication. Both Paxil and Prozac are drugs classified as selective serotonin reuptake inhibitors, or SSRIs.

“Akathisia is a disorder, induced by SSRI medications, which can cause a person to experience such intense inner restlessness that the sufferer is driven to violence and/or suicide,” writes the memorial page that Wendy Dolin created in honor of Stewart. “It has been said, ‘Death can be a welcome result.’”

GSK’s attorneys, meanwhile, deny a link specifically between Akathisia and suicide, and they also deny that Paxil had anything to do with Dolin’s death. Instead they have reportedly blamed work-related stress, which as the American Lawyer points out is a common problem in the legal field. One study published by a commission for the American Bar Association last year claims that 28 percent of attorneys struggle with depression.

An $11 million verdict

But this is not the first trial examining the link between Paxil and adult suicide. In October, a jury awarded the family of 46-year-old Mumun Barbaros $11.9 million after he commited suicide in jail. Rather than suing the drug-maker, however,  his family blamed and sued the company that provided medical services at the jail for re-starting Barbaros on Paxil after he had been off of the medication for four days.

Dr. Peter Breggin, a psychiatrist and expert witness testifying on behalf of the family, said in a statement afterward that the verdict “illustrates the growing understanding within the judicial system and the public arena that psychiatric drugs can cause people to act in harmful ways that are contrary to their character and normal behavior.”

Bob Fiddaman Reports On The Glaxo Criminals…


http://fiddaman.blogspot.ie/2017/03/dolin-vs-gsk-day-8-get-to-point-todd.html?spref=tw

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.

Bob Fiddaman’s Latest Post From The Dolin Trial…


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

Thursday, March 23, 2017

Dolin Vs GSK – Day 6 – Ass Kicking Semantics

ass kicking

To be beaten senseless because you definitely deserve it.

semantics
the branch of linguistics and logic concerned with meaning.


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

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

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

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

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

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

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

“Are you a pharmacologist?”, Bayman asked.

“No.” Dr. Cross replied.

“Are you an epidemiologist?” Bayman asked.

“No.” Dr. Cross replied.

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

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

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

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

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

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

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

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

Evidence here.

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

The Dolin Trial..


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

Photo: Diego M. Radzinschi/ALM

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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


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

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

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


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

GSK… you evil bastards…

See Bob Fiddaman’s new post for more:

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


Wednesday, March 22, 2017

Dolin Vs GSK – 8.9 Suicide Increase For Adult Paxil Users

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Nice ethical company, huh?

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

Trial continues tomorrow.

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

Bob Fiddaman.
In Chicago.

Dolin Vs GSK

Dolin v GSK – Opening Arguments

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

Dolin vs GSK – Healy ‘Rocks Da House’

Dolin Vs GSK – JP Garnier Video Deposition

Dolin Vs GSK – The Dunbar Tape

Dolin Vs GSK – Day 4 – Slam Dunk

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


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

GSK’s Dirty Little Secret

Stewart
Dolin v SmithKline Beecham

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

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

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

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

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

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

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

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

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

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

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

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

Dolin Vs GSK – The Dunbar Tape


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

Sunday, March 19, 2017

Dolin Vs GSK – The Dunbar Tape

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

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

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

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

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

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

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

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

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

Nice company, huh?

Here’s the depo.

Bob Fiddaman
 
Dolin Vs GSK
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