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.

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

Paroxetine Guinea Pig : The Curious Case Of Italia Sudano…


There was an interesting article, about Paroxetine and older adults, which appeared in the Guardian in 2003.

A woman called Italia Sudano (an Italian born/British resident) was apparently used as a Paroxetine (Paxil/Seroxat) guinea pig, by her GP (doctor) without her consent. Her doctor was (allegedly) paid by GSK too, and this was also all done without Sudano’s knowledge. The doctor in question, Dr Robert Adams, was struck off by the GMC (General Medical Counsel) after he was found guilty, of not just unethically pimping out his patients to GSK, but also for using several other patients as guinea pigs for various other drug companies and drugs too (not to mention making thousands of pounds in the process).

This case, is disturbing, and also remarkable, but what is stranger still is- how we heard nothing more about it, apart from the report in the Guardian at the time.

The reason why I bring this case up is, currently GSK are being sued in a court in the US by Wendy Dolin, for the death of her husband, Stewart Dolin, in a ‘Paxil Induced Suicide‘ case. The Dolin case centers on GSK’s dodgy Paroxetine trials, and in my opinion, Paroxetine should never have been licensed in the first place. GSK admit that Paroxetine is dangerous for under 18’s, however, many of us who have taken the drug, are highly aware that all ages can suffer from Paroxetine’s dangerous side effects. Side effects such as akathisia, de-personalization, volatility, suicidality etc are common among all age groups (GSK just don’t give us the full facts).

It would be interesting to find out- What data did GSK obtain from cases such as Sudano’s? Were the results of these (highly unethical) live human guinea pig trials ever seen by anyone outside of GSK? Will GSK present the findings in court, in cases such as Stewart Dolin’s? Were GSK receving data from any other GP’s in relation to Paroxetine testing on patients (with or without their consent) at the time, before it, or any time since? If so, what exactly was GSK trying to study by gleaning data from the case of a 72 year old Woman put on Paroxetine, without her consent, or knowledge , from her dodgy doctor? Did Italia Sudano take a legal case against her doctor? If so- did GSK provide information as to the significance of their Paroxetine testing on her?

https://www.theguardian.com/politics/2003/feb/09/health.nhs

Patients used as drug ‘guinea pigs’

Firms pay out millions to doctors to test medicines

When Italia Sudano went for a check-up with her GP, Dr Robert Adams, she was in good health. Her husband had died a few months earlier and her blood pressure was a little high.

Yet nothing could have prepared Sudano, 72, for the nightmare that was to follow and the discovery of a trail of greed and fraud that went right to the heart of the medical profession.

She was astonished to discover that her trusted GP had been using her as a guinea pig by giving her tablets which had not been medically approved. Worse still, he was being paid to do so by a pharmaceutical company.

An investigation by The Observer has revealed that many doctors are risking their patients’ health by subjecting them to medical trials without their knowledge.

Over the next few weeks Adams asked Sudano to return for more blood tests. By the end of the second month her arms were black and blue. Her son, Joe, said they looked as though they had been slammed in a door. She said: ‘At one point I asked if he was selling my blood.’

Little did Sudano know how close to the truth her comment was. On her last visit, Adams took a bottle of pills from the top drawer of his desk and suggested Sudano take one a day. While she thought it strange she wasn’t being given a prescription, she trusted her doctor.

But within hours of swallowing the pill, she could hardly walk because she was so dazed. Her face had swollen up badly and she was in considerable pain.

She stopped taking the tablets and complained to Hertfordshire Health Authority. This sparked an investigation that led to one of the largest cases of medical research fraud ever uncovered in Britain.

It emerged that over the previous five years Adams had earned more than £100,000 from drug companies, including the European giants AstraZeneca, GlaxoSmithKline and Bayer. They were all paying him to test their new drugs on his patients. Like Sudano, many of his patients had never given their consent and had no knowledge they were being used as human guinea pigs in a medical trial. Patients with no symptoms were given drugs and others who needed proper medication were given placebos. Adams was receiving almost £1,000 for each patient.

Last month Adams was found guilty by the General Medical Council (GMC) of serious professional misconduct and suspended for 12 months. The GMC’s lawyer described it as ‘assault’ and Sudano is now looking to sue Adams.

GlaxoSmithKline was using Adams to study its anti-depressant Paroxetine, but had to cancel the trial at a cost of hundreds of thousands of pounds.

The drugs industry talks of bad apples and the odd errant doctor milking the system but insists that trials using GPs are essential for medical advances and that payment to doctors for the extra work involved is ethically correct.

But an investigation by The Observer suggests the problem of GPs using patients as guinea pigs without their consent is more widespread. Some 3,000 doctors each year are paid by drug firms to sign up their patients to tests and on average 15 patients are needed for each trial. With doctors picking up £1,000 per patient, drug companies are spending £45m on getting doctors onside. There is no suggestion the companies are implicated in moves to carry out the tests by doctors on patients secretly.

Medical fraud experts estimate that one per cent of all drug trials involve fraud, including failure to get proper consent from patients. This means hundreds of patients a year are being given unapproved and potentially dangerous drugs without their knowledge.

The Observer has discovered that in the last five years the GMC has taken action in a dozen cases involving GPs undertaking fraudulent research. Examples include:

· Dr Vasu Agrawal from Chigwell, Essex, removed samples of womb from menopausal women as part of a trial into a new hormone replacement drug called Divina Nova. Agrawal failed to tell the women they were testing a drug that could have serious side-effects. Agrawal, who forged signatures on consent forms, received almost £6,000 from Orion Pharma International.

· Dr Paul Chima from Edinburgh is estimated to have received more than £200,000 from a range of pharmaceutical companies for testing their new drugs for angina, asthma, high blood pressure and depression. He failed to warn patients of possible side-effects and offered one a £2,000 bribe not to give evidence against him.

· Dr James Boschler from south London was given £22,500 from Bayer and Solvay Healthcare. He claimed to have signed up 36 patients, but 25 of the consent forms were discovered to be forgeries.

The country’s foremost investigator of medical research fraud is Peter Jay, the former Metropolitan Police detective chief inspector who arrested serial killer Dennis Nilsen. Since 1996 Jay has run MedicoLegal Investigations, an independent body, and has taken 12 doctors to the GMC.

Jay is investigating six further cases, including one involving a GP in Manchester. Dr Mark Northfield is alleged not to have obtained consent from patients for entering them into trials to test drugs manufactured by Bayer and Roche to treat high blood pressure and heart problems. Northfield is contesting the allegations before the GMC professional conduct committee.

Jay said: ‘While the industry has become more alert to the problems over the last decade there is still clearly a worrying and persistent problem in research fraud involving doctors. This is not just an issue of patient safety, but a problem that might lead to bad drugs being approved or good drugs failing to be approved.’

The Observer’s revelations of the continuing problem of research fraud have sparked calls for industry guidelines to be toughened up. David Hinchcliffe, the Labour chair of the House of Commons Health Select Committee, described the situation as bordering on ‘scandalous’ and said his committee would look into the issue.

He said: ‘The relationship between the drug firms and the medical profession is one that needs to be thoroughly investigated. It is extremely worrying that patients’ trust is being abused by doctors who are more interested in making money from the pharmaceutical industry.’

Dr Evan Harris, health spokesman for the Liberal Democrats, suggested that doctors involved in trials should be subject to on-the-spot inspections and that a patient’s consent to take part in a drug trial should be given outside the GP’s surgery, for example to a research officer acting for the firm.

Additional research by Charlotte Coulon

antony.barnett@observer.co.uk

GSK’s Lawyers Grasp At Straws At The Stewart Dolin ‘Paxil Induced Suicide’ Trial…


http://fiddaman.blogspot.ie/2017/03/dolin-vs-gsk-day-4-slam-dunk.html

Tuesday, March 21, 2017

Dolin Vs GSK – Day 4 – Slam Dunk

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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 that 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

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