The Dolin Trial… Glenmullen Enters The Fray..


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
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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.

John Grant On Paxil (Seroxat)


 

 

Interesting interview with singer John Grant, about his life, his experiences with Paxil, depression, anxiety etc.

“…The next big step is getting off the prescription medicine.

The antiretrovirals are not going anywhere, but he is wondering about the anxiety drugs.

“When I left Germany I got on the drug Paroxetine.

I’ve been taking that for 20 years now, and I don’t want it.

But the side effects of coming off it are too terrible.

They have a thing called the zaps. It feels like someone is throwing lightning bolts at your head.

It’s horrible.”..

For full interview see link here

 

Seroxat/Paxil Lawsuit Shows That Seroxat Increases Suicide Risk Over 800 Percent…


http://www.naturalblaze.com/2017/03/pivotal-lawsuit-shows-widely-used-antidepressant-increases-suicide-risk-over-800-percent.html

Pivotal Lawsuit Shows Widely Used Antidepressant Increases Suicide Risk Over 800 Percent

suicideBy Annabelle Bamforth

A trial is currently underway in Illinois as a widow seeks to hold pharmaceutical manufacturer GlaxoSmithKline accountable for improper labeling and minimizing a potentially serious side effect of a well-known antidepressant.

Paroxetine is a widely prescribed antidepressant and anti-anxiety drug under the class of drugs known as selective serotonin reuptake inhibitors (SSRIs). Paroxetine is most commonly known as the brand name of Paxil, manufactured by GlaxoSmithKline (GSK). 

Since 2012, Wendy Dolin has been engaged in a legal battle against GSK following the suicide of her husband, Stewart Dolin. Wendy says that in the summer of 2010, Stewart was prescribed a generic version of Paxil for anxiety issues related to work. According to Wendy, Stewart Dolin complained of becoming increasingly anxious and restless and was unable to sleep while taking the drug. On July 15, 2010, less than one week after beginning this medication, Stewart committed suicide by walking in front of a train.

Wendy began searching for answers in the wake of her husband’s suicide and said she learned that he had been displaying signs of akathisia, a disorder characterized by an individual’s inability to relax or sit still. Psychiatrist Joseph Glenmullen said in 2006 that “Patients have described [akathisia] to me as listening to nails scratching on a black board 24/7, or your bones rattling like tuning forks. It is this inner agitation that is by far the most dangerous.” In 2012, Wendy filed a legal complaint against GSK seeking to hold the manufacturer liable for her husband’s death. The complaint noted that “a scientist working for another SSRI manufacturer, Pfizer, wrote in a 1998 medical journal article that the suicidal impulses resulting from akathisia may be explained as a feeling that ‘death is a welcome result’ when the ‘acutely discomforting symptoms of akathisia are experienced on top of already distressing disorders.’”

The critical issue in Wendy Dolin’s lawsuit is not simply paroxetine itself. It’s no secret that lawsuits against pharmaceutical companies are usually complicated under most circumstances, but this case is particularly notable as a tragic example of the gray area of liability when a patient is prescribed a generic drug, as well as the problems between the FDA and drugmakers that exist when it comes to publishing safety labels for patients and doctors.

It’s important to distinguish that Stewart Dolin was not prescribed the brand of Paxil, but a generic brand of paroxetine that was manufactured by another company, Mylan. Brent Wisner, Wendy Dolin’s attorney, described the issue as a “donut hole of liability” in which both the generic and the original manufacturer deny responsibility. “That’s where you have the generic maker on one hand saying, ‘We don’t know about these risks. We can’t be held responsible for them… plus, we can’t change the label,’” Wisner said according to an NBC investigative report. Winner added that “the brand name makers are saying, ‘Well, we didn’t make the pill.’”

Generic drugs are often prescribed in place of specific brands, mainly to save costs, as generic drugs cost far less than brand names on average. In Illinois, where the Dolin family resided, “state pharmaceutical laws actually require such a substitution unless a doctor has advised against it. Some of the few courts that have sided with plaintiffs in generic-drug injury cases have also highlighted this conundrum for generic-drug plaintiffs,” according to a Law360 report on Wendy’s case.

Wendy and Wisner claim that the warning label that was given to the generic brand was “factually incorrect and misleading.” In their lawsuit, they allege that “the paroxetine label in existence at the time of Stewart Dolin’s death did not warn of the drug’s association with an increased risk of suicidal behavior in adults despite GSK’s knowledge of a statistically significant 6.7 times greater risk in adults of all ages. In fact, the label stated the opposite – that the suicidality risk did not extend beyond the age of 24.” Stewart Dolin was close to 57 when taking paroxetine.

The lawsuit alleges that GSK whitewashed the suicide risks of Paxil in its data given to the FDA. The complaint explains that in 1989, GSK”s “Integrated Summary of Safety Information,” required to gain approval from the FDA, included a presentation identifying the number of suicide and suicide attempts during clinical trials. The suit alleges that GSK’s summary “skewed the statistical analysis of the data presented and obscured the true risk” by including suicide attempts “of placebo patients that had taken place in the placebo run-in (or wash-out) phase” before the clinical trials began. “Run-in” or “wash-out” refers to a time period of removing any other drugs in a trial participant’s system; any “adverse events” that take place during those periods are not appropriate or generally accepted for inclusion in calculations during clinical trials, the suit claims.

The Cook County Record reports that while those warning labels on Paxil and paroxetine were approved by the FDA, GSK said it was not allowed by the FDA to include an additional warning of a “statistically significant increase in the frequency of suicidal behavior in patients treated with paroxetine.” GSK claims that the FDA wanted to maintain homogeneous warnings among all antidepressants.

However, U.S. District Judge James Zagel noted that GSK “never asked for a formal meeting, nor did it seek additional labeling regarding Paxil-specific data” in a February 2016 ruling, and further wrote that “Moreover, GSK never sent a separate supplement and declined the FDA’s invitation for a meeting to discuss the inclusion of … the adult warnings.”

The trial against GSK is in progress and is expected to last a few weeks. Bob Fiddaman, a blogger and author who has written extensively about his own experiences with paroxetine, has been covering the developments of the trial. Fiddaman wrote that a “startling revelation” was unveiled on March 22nd:

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.

Fiddaman wrote that Dr. Ross, who worked for the FDA for ten years, offered lengthy testimony. Fiddaman points out that Dr. Ross discussed the problematic relationship between the FDA and drug manufacturers. The FDA relies heavily on the accuracy of the data that is provided by drug companies, which is problematic when the companies present arguable data.

GSK’s argument has summarily been that they do not bear liability because the drug that was prescribed to Stewart Dolin was not manufactured by Mylan, not GSK. The company has stated that “we remain consistent in our stance that since GSK did not manufacture or market the generic paroxetine ingested by Mr. Dolin, it should not be held liable in this trial.”

Annabelle Bamforth writes for TheFreeThoughtProject.com, where this article first appeared.

The Scandal Of The Orphans Of Ireland Comes Back To Haunt GlaxoSmithKline…


http://www.telegraph.co.uk/news/worldnews/europe/ireland/10887561/Irish-care-home-scandal-grows-amid-allegations-of-vaccine-testing-on-children.html

 

 

“…The country’s ten care homes were said to have participated in the trials, which took place between 1960 and 1976, and involved 298 children. In one of the trials, 80 children became ill after they were accidentally administered a vaccine intended for cattle.

“…GlaxoSmithKline, which took over the drug firm that ran the trials, Burroughs Welcome, said the activities, if true, were “very distressing” and that it would cooperate with any investigation. There were no laws on medical testing in Ireland until 1987….”

In June 2001 an inquiry was ordered into trials on 58 children in 1960 and 1961, at six homes – including Bessborough. Results of those trials were published in the British Medical Journal in 1962. But that inquiry was halted when Professor Patrick Meenan, one of six authors of the study and then aged 86, said he should not have to appear on grounds of his age and ill health. A subsequent inquiry was blocked by Irene Hillary, a former professor of microbiology, in 2004…”

Fid Covers Day 7 Of The Dolin Trial…


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

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.