Monsanto Roundup Lawsuit

Friday, April 21, 2017

For GSK. For King & Spalding




So, I hear you are claiming that you are going to appeal because you think a unanimous decision means that, um, the jury were wrong?

So, you intend to spend another $4 to $5million to, um, save $3 million?

No doubt your three experts, Gibbons, Kraus and Rothschild will be rubbing their hands. Collectively another half a million bucks coming their way!

This is for Andrew Bayman, for Todd Davis and for Glaxo's new CEO, Emma Walmsley.


CLICK HERE TO PLAY VIDEO



That is all.

For now ;-)

COMING SOON: Exclusive interview with Wendy Dolin.

Bob Fiddaman

Back stories

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

Dolin Vs GSK - Day 7 - Abraham Lincoln

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

Dolin Vs GSK - Glenmullen Nails It!

Dolin Vs GSK - "Babes"

Dolin Vs GSK - Wendy's Cross and GSK's Petition

Dolin Vs GSK - Robert "Bling Bling" Gibbons

Dolin Vs GSK: Suicide Prevention Warning "Futile", Claims GSK Exec

Dolin Vs GSK : Jury shown List of the Dead in Paxil Clinical Trials

Dolin Vs GSK: Last Man Standing & The Return of Dr. Healy

Dolin Vs GSK: Closing Arguments

Dolin Vs GSK - The Verdict





Thursday, April 20, 2017

Dolin Vs GSK - The Verdict





“Don’t you think if these medicines caused suicide someone would have spoken up?” ~ Andy Bayman - King & Spalding.

The jury have.


GlaxoSmithKline have been found guilty by a jury today in Chicago.

The jury found for plaintiff, Wendy Dolin, who filed suit against GlaxoSmithKline after her husband, Stewart, took his life 6 days after being started on a generic version of Glaxo's controversial antidepressant Paxil (known as Seroxat in Europe)

The jury found GlaxoSmithKline liable for the death of Reed Smith LLP partner Stewart Dolin and ordered the pharmaceutical giant to pay $3 million to his widow, Wendy Dolin, reaching the conclusion that a generic version of GSK’s Paxil caused Dolin to take his own life.

Officials from GSK said the verdict was disappointing and that they plan to appeal.

(Insert feelings of shock here)

A huge congratulations to Wendy and her legal team; Brent Wisner of Baum, Hedlund, Aristei & Goldman, PC, Los Angeles and David Rapoport of Rapoport Law Offices, Chicago.

Updates coming later. In the meantime, here's some of the reasons why the jury returned a guilty verdict. Click on images to enlarge. Images courtesy of Baum Hedlund. But first, read the press release from Baum Hedlund.

PRESS RELEASE - Baum Hedlund

$3M Jury Verdict Against GSK in Landmark Paxil Suicide Case

April 20, 2017, Chicago, Illinois - - A federal jury has sided with the widow of a deceased Chicago attorney in her generic Paxil suicide lawsuit against GlaxoSmithKline (GSK), ordering the pharmaceutical giant to pay $3 million.

The jury verdict resolves allegations in the trial of Dolin v. Smithkline Beecham Corp. (D/B/A GlaxoSmithKline-GSK) over the paroxetine-induced wrongful death of Wendy Dolin’s late husband, Stewart Dolin, who was a partner at the Chicago law firm Reed Smith when he took his own life in 2010. 

“We are very pleased with the jury’s verdict and are grateful for their diligent service,” said Brent Wisner, co-lead trial counsel for Ms. Dolin in the Paxil suicide case. “We feel justice has been served, and are hopeful this verdict will result in a labeling change to warn that people of all ages are at risk. This should send a clear message to GSK and other drug manufacturers that hiding data and manipulating science will not be tolerated. Brand drug manufacturers have the ability and responsibility to make their drug labels accurate. If you create a drug and know that it poses serious risks, regardless of whether consumers use the brand name or generic version of that drug, you have a duty to warn.”

On July 10, 2010, 57-year-old Stewart Dolin began taking the prescription antidepressant medication paroxetine. The brand name version of this medication is called Paxil, which was researched, developed, manufactured and marketed by GSK. Paroxetine and Paxil are the same chemical compound and both use the same product information labeling. GSK created and was responsible for maintaining the accuracy of the Paxil label.

In the early afternoon on July 15, 2010, Stewart Dolin died when he was struck by a CTA Blue-Line train in the subway station near Washington Street in Chicago. Just before this, a nurse at the subway station who did not know Mr. Dolin noticed him pacing back and forth while looking in the direction of an approaching train that was not yet in sight. When the moving train appeared, the nurse observed Mr. Dolin leap in front of the train, where he was struck. Mr. Dolin was pronounced dead from the injuries he suffered due to the collision and his contact with the electrified track after the collision.

The lawsuit alleged GSK failed to adequately warn Mr. Dolin’s doctor about Paxil/paroxetine’s association with an increased risk of suicidal behavior in adults of all ages. The Court previously ruled that, although GSK did not manufacture the pills Mr. Dolin ingested, the company was responsible for the label and knew or should have known any failure to warn would result in harm to those taking generic versions of the drug.

“Glaxo has known for two decades that Paxil can cause people of all ages to commit suicide. The company not only hid the risk, but stuck its head in the sand and ignored countless suicides that occurred in its clinical trials,” said attorney Michael Baum, who also represented Ms. Dolin. He added that the drug’s Black Box warning – which states there is a suicide risk for children, adolescents and young adults, but the risk ends at age 24 – is “just wrong.”

During the five-week trial, GSK swore off its responsibility for ensuring the truthfulness of the label, arguing that, because the FDA never made GSK warn of a suicide risk, the company should be exonerated. According to Baum, this argument is “akin to a car speeding past a cop, the cop doesn’t stop the car, and the car crashes into another car and kills someone—the driver who killed someone cannot state it’s not his fault because the cop didn’t stop them.” 

In the end, the jury disagreed with GSK’s arguments, finding that the drug maker cannot sluff off its responsibility for its labeling just because the FDA let the company get away with it. 

Wendy Dolin was represented in her case by R. Brent Wisner and Michael Baum of Baum, Hedlund, Aristei & Goldman and David E. Rapoport and Matthew Sims of Rapoport Law Offices P.C.

For more information about the trial, visit baumhedlundlaw.com or MISSD.

Dolin v. GSK Trial Transcripts

Dolin v. GSK Trial Exhibits


Robin McCall
Media Relations & PR Manager
Baum, Hedlund, Aristei & Goldman, PC









Bob Fiddaman

Back stories

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

Dolin Vs GSK - Day 7 - Abraham Lincoln

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

Dolin Vs GSK - Glenmullen Nails It!

Dolin Vs GSK - "Babes"

Dolin Vs GSK - Wendy's Cross and GSK's Petition

Dolin Vs GSK - Robert "Bling Bling" Gibbons

Dolin Vs GSK: Suicide Prevention Warning "Futile", Claims GSK Exec

Dolin Vs GSK : Jury shown List of the Dead in Paxil Clinical Trials

Dolin Vs GSK: Last Man Standing & The Return of Dr. Healy

Dolin Vs GSK: Closing Arguments




Tuesday, April 18, 2017

Dolin Vs GSK: Closing Arguments







I will keep it short and sweet, if I may.

Here's what King & Spalding's, Andrew Bayman, told the jury yesterday during closing arguments.

“Don’t you think if these medicines caused suicide someone would have spoken up?”

My response...


Now read the evidence...


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

Dolin Vs GSK - Day 7 - Abraham Lincoln

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

Dolin Vs GSK - Glenmullen Nails It!

Dolin Vs GSK - "Babes"

Dolin Vs GSK - Wendy's Cross and GSK's Petition

Dolin Vs GSK - Robert "Bling Bling" Gibbons

Dolin Vs GSK: Suicide Prevention Warning "Futile", Claims GSK Exec

Dolin Vs GSK : Jury shown List of the Dead in Paxil Clinical Trials




Bob Fiddaman



Friday, April 14, 2017

Dolin Vs GSK: Last Man Standing & The Return of Dr. Healy





The trial is almost over, and the jury has heard from many witnesses for both plaintiff, Wendy Dolin, and Defendant, GSK. GSK's last roll of the dice saw Anthony Rothschild (pictured above) take the stand. Up to 2009, and possibly to the present, Rothschild has taken money and related grants from the National Institute of Mental Health, Cyberonics, and Wyeth. He is a consultant for numerous pharmaceutical companies to include Pfizer, GlaxoSmithKline, Forest Laboratories, Eli Lilly, and Takeda.

First and foremost, Rothschild describes himself as an expert in psychological autopsies, a method, according to 'All About Forensic Psychology', that involves collecting all available information on the deceased via structured interviews of relatives, friends and healthcare personnel. Additionally, information is supposed to be collected from available health care records and related documents. We know Rothschild had access to Stewart Dolin's medical records and other documents but did he ever interview relatives or friends of Stewart Dolin? Did Rothschild ever interview Stewart's healthcare personnel? It appears he did not.

For a day and a half, under direct examination from defence attorneys, King & Spalding, Rothschild told the jury that  Stewart Dolin's state of mind caused his death and Paxil had nothing to do with Stewart's death. Rothschild further claimed there is no relationship between SSRIs, akathisia, and suicide. He went on to state that, even if there was such a relationship, Stewart Dolin was not suffering from akathisia.

Rothschild told the jury that he treats patients with akathisia, 99% of whom were on neuroleptic and/or antipsychotic medications. When asked if akathisia was difficult to treat, Rothschild answered, "...akathisia is not that complicated to treat. You just give another medication, and you can wipe out the akathisia quickly." Rothschild went on to tell the jury that he had read Stewart Dolin's medical notes and that, in his opinion, Stewart had suicidal thinking on July 6th before starting Paxil.

Oddly, Rothschild also informed the jury that he, Rothschild, walked from the Reed Smith offices to the train station where Stewart Dolin's life ended. Why Rothschild claimed this is unclear, as there is no way Rothschild could ascertain what route Stewart Dolin took from his Reed Smith office to the train station. Rothschild also claimed that he reviewed Stewart Dolin's credit card details and that Stewart had purchased a train ticket. This, too, has not been verified, but Rothschild claimed such a purchase was made in an attempt to convince the jury that, somehow, buying a train ticket, supported Rothschild's opinion that Stewart was of sound mind and body and planned his death.

"If someone has, again, an irresistible impulse, you know, I actually have trouble working that bloody machine. I mean, if you had akathisia, why would you buy a ticket. I mean, you just jump over the thing and run down." He added, "It's just, to me, this was deliberate and planned. I mean, he had, he had to think, "I need the card to get, to buy the ticket, buy the ticket and get on the platform." It took some, you know, it was premeditated. He had planned this out ahead of time."
When asked about the witness who saw Stewart Dolin pacing before he jumped, Rothschild dismissed the restlessness, telling the jury, "A lot of people pace when they're waiting for a train."

I don't know what types of train platforms Rothschild frequents, but I've taken trains many times in my life and have never seen a person pacing the platform. I'd think it rather odd if I saw someone pacing up and down a train platform, and I would be concerned.

Rothschild then claimed he had read the police report in this case. He falsely claimed, under oath, that Michael LoVallo, a managing partner at the law firm where he and Stewart worked, told the police "that these problems at work may have been part of the reason Mr. Dolin committed suicide." However, as you will learn in cross-examination, further on down this post, LoVallo did not state this to the police.

A case for perjury, perhaps? We shall see.

Throughout King & Spalding's direct examination many visuals were used in a futile attempt to convince the jury that Stewart Dolin was frequently criticized by his work colleagues and that this criticism added to Stewart's work-related stress. However, the reality is that Stewart Dolin received excellent reviews from the vast majority of his colleagues and this was later highlighted when Rothschild was cross-examined (below). Rothschild conveniently omitted the excellent appraisals Stewart received from his colleagues.

Cross-examination by David Rapoport 

Plaintiff attorney, David Rapoport started his cross-examination of Rothschild by asking about the supposed statement LoVallo made to the police. Rapoport asked Rothschild if it was a lie. Rothschild answered, "No, it was not." However, the fact is, there was no such statement made to the police by Michael LoVallo. LoVallo does not believe that work stresses caused or contributed to cause Stewart Dolin's suicide, and Rothschild was forced to concede this fact whilst under cross-examination.

Next came the issue of Rothschild's cozy relationship with GlaxoSmithKline. In the Dolin case alone, Rothschild has been paid approximately $165,000 for his testimony. Rapoport pressed Rothschild further and asked him about previous cases where GSK has called him as an "expert" witness. When asked how many times GSK has hired him as a witness in Paxil death cases, Rothschild couldn't seem to count that high. "Going back 15 years, I can't give you an exact number, but it's probably in the neighborhood of 20 or 30."

Thanks for that info, Mr. Rothschild. You've now informed the jury that Paxil has been implicated at least 20 to 30 times in drug-induced death cases.  Did Rothschild receive poor coaching from his attorneys or did he finally decide to tell the whole truth, given that he had previously been caught lying? Of course, in each of the "20 or 30" cases where Rothschild has been paid by GSK for testimony, Rothschild has always claimed Paxil does not cause suicide.

Getting back to the issue of Stewart Dolin's train ticket, Rapoport showed Rothschild a Ventra card. The card is a pre-paid travel pass. Rothschild couldn't say for certain if Stewart used a Ventra card on the day of his death. Strange, because under direct examination Rothschild had claimed that a person with akathisia would not buy a ticket. He presumed that Stewart bought a ticket when in fact Stewart may not have had to buy a ticket at all.

Psychological autopsies

Under cross-examination, Rothschild was asked whether or not he was board certified to conduct psychological autopsies. He answered, "There is no such thing."

It's a crying shame that GSK's expert doesn't know much about the profession in which he claims to be an expert. The Psychological Autopsy Certification Training (PACT) disputes Rothschild's claim. Since 2011, The American Association of Suicidology (AAS) has offered the Psychological Autopsy Investigator Certification Program. I'm amused and aghast that GSK calls an "expert" who has no credentials in his field.

Visuals

During Rothschild direct examination by King & Spalding, many visuals were shown to the jury, visuals that lamely attempted to paint a bad picture of Stewart Dolin. Rapoport picked up on this. One such visual was a 2009 PGL evaluation where comments were left by  Stewart's employees. Rothschild didn't tell the jury about the glowing appraisals Stewart Dolin received. He didn't mention that Stewart's colleagues described Stewart as "honest, hardworking, and one who leads by example." He left out that Stewart "Seems to be decisive and takes what he does very seriously and cares about the group, seems to be a good administrator." He forgot to tell the jury that "Stew is honest and direct in his dealings with the C & S group."  "Stew is approachable and willing to listen. He sincerely wants to do his best. He's able to balance different constituencies" and so on. There were many more compliments of Stewart Dolin that Rothschild left out.

Rapoport then showed how Rothschild, in a previous testimony, claimed there is no evidence that there's a higher rate of death by suicide in children and adolescents who take Paxil versus placebo.

Finally, Rapoport asked Rothschild the following:

"So you've treated thousands of patients, some of them have committed suicide and never once have you found that a drug contributed to suicide in the patients, have you?"

Rothschild answered "No."

Rothschild was then asked further questions by King & Spalding on re-direct examination. It was basically them repeating themselves over and over until finally King & Spalding rested their defence.

David Healy returns to the stand.

In an unusual move, plaintiff's expert witness called Dr. David Healy back to the witness stand. Healy rebutted claims made by GSK's previous witnesses. GSK's "experts" previously criticized Healy's evidence, in particular, Healy's professional knowledge about akathisia.

Healy's evidence was, once again, damning to GSK.

Plaintiff's Exhibit 347
(Fig 1)

Of the 22 deaths that occurred during the Paxil clinical trials, many were violent. GSK's expert, Dr. Kraus, had previously testified that Paxil-related suicides were not violent. Healy was asked, "...of these 22 people who killed themselves while taking Paxil in GSK's clinical trials, how many of them were violent?" Healy answered, "16." He added, "There were a range of acts from hanging to gunshot wounds to throwing themselves in front of trains."

Healy was also asked if  GSK accurately reported suicide events in their Paxil clinical trials?

He answered, "No, they haven't." Furthermore, Healy told the jury, "I have been able to analyze the data from one of GSK's major depressive disorder trials and, in particular, to look at the suicidal events that happened in that trial."


On the subject of akathisia, GSK's "expert" witness, Anthony Rothschild, had earlier told the jury that there was no scientific or peer-reviewed literature supporting an association between akathisia and suicide. Asked whether or not this was true, Healy told the jury this was not true and he further referenced a book about akathisia authored by Dr. Sachdev. Healy informed the jury that this text is viewed as an authoritative work in the field. Healy also stated that GSK's "expert," Anthony Rothschild, had written about akathisia. In Chapter 2 of Rothschild's book, he wrote, "Akathisia, a syndrome marked by distinctly unpleasant symptoms of motor restlessness and anxiety may increase the risk of suicide."

What happened next was another twist in this case. More evidence, it appears, that GSK has been less than honest with the truth. In the Major Depressive Disorder (MDD) trials, GSK claimed 11 subjects attempted suicide. But Healy pointed out that this was incorrect, in reality, 12 people attempted suicide in GSK's MDD trials. When asked if GSK calculated this 12th suicide attempt in any of their analysis, Healy replied, "Apparently not."

This means that the 6.7% increased risk of suicidal behavior among adults who consume Paxil, "should be something more like 7.3," noted Healy.

The combined figure, as reported earlier in this trial, is actually a staggering 8.9%.

After Healy's rebuttal, a defeated Todd Davis from King & Spalding asked the judge to strike the testimony of Healy. The Honorable Judge Hart replied, "the motion to strike is denied."

Closing arguments from both plaintiff and defendant start next week.

Wednesday, April 12, 2017

Dolin Vs GSK : Jury shown List of the Dead in Paxil Clinical Trials








The cross examination of John Kraus continued yesterday and saw plaintiff attorney, Brent Wisner, (Baum Hedlund) highlight the deaths that occurred during GSK's clinical trials of Paxil. For the benefit of the readers, and those who have been following this trial, I feel it is worthy of going through the individuals, if only to show them a mark of respect. Kraus maintains that these 'subjects' may have died as a result of their 'underlying illness.'

The jury heard about the following suicides during Paxil clinical trials. All the subjects were taking Paxil at the time of their death.

Female, 56 - Suicide.
Unknown gender - 50 - Suicide by hanging.
Female, 42 - Suicide by overdose of doxepin.
Female, 18 -  Suicide.
Female, 58 - Suicide by hanging.
Male, 24 - Unknown if it was suicide - Patient was hit by a train and killed
Male, 34 - Suicide
Female, 48 - Suicide
Female, 46 - Suicide by hanging.
Male, 54 - Suicide, jumped under a train.
Female, 67 - Suicide - on the fourth day of the study she threw herself out of a window.
Female, 32 - Suffocation due to vomiting.
Female, 33 - Suicide, jumped from 4th floor balcony.
Male, 65 - Suicide by an unknown method.
Male, 23 - Suicide.
Female, 31 - Suicide.
Unknown gender , 86 - Suicide by hanging.
Male, 46 - Suicide/Homicide - on December 14, 1998, the patient went to the home he shared with his estranged wife and shot her, he then turned the gun on himself.
Male, 40 - Suicide.
Male, 35 - Suicide (Shot himself)
Male, 19 - Suicide (Shot himself)
Female, 58 - Suicide by hanging.

My condolences to all their families.

There were also 40 suicide attempts during the Paxil clinical trials. Kraus was asked whether he ever sat down with any of those who tried to kill themselves while taking Paxil to ask them what they actually personally experienced?

Kraus answered, "No."

On the deaths, Kraus was asked whether or not the majority were over the age of 30. He answered that "80% of them" (were over the age of 30)

Brent Wisner then looked at the judge, "No further questions, Your Honor." He said.


Bob Fiddaman

**Update**

There's been some confusion about the way clinical trials are undertaken. A reader asked if subjects in clinical trials should all be fit and healthy with no underlying illness. Although some trials are run like this, most aren't.

Pharmaceutical companies much prefer clinical trials where the subjects are suffering an underlying "disorder." They can then claim, if the trial is a success, their product can treat that disorder and any suicides or attempts can be blamed on the "illness" rather than the treatment. Remember, clinical trials are ongoing, even when the drug gets to market. This is called the 'Post Marketing Phase.'

When a patient contacts the company because of an adverse reaction, the company request all medical files from the patients doctors. They do this, they claim, to rule out any other possible cause. In reality, they do this to blame underlying illness, other medication that may have been being used at the time, and/or the prescribing doctor.

This is clearly evident in the on-going Dolin Vs GSK Paxil induced suicide lawsuit.

It's called having your cake and eating it, too.


~ Bob Fiddaman




Dolin Vs GSK - "Babes"

Dolin Vs GSK - Wendy's Cross and GSK's Petition

Dolin Vs GSK - Robert "Bling Bling" Gibbons

Dolin Vs GSK: Suicide Prevention Warning "Futile", Claims GSK Exec











Tuesday, April 11, 2017

Dolin Vs GSK: Suicide Prevention Warning "Futile", Claims GSK Exec





Futileserving no useful purpose : completely ineffective


Last Thursday GlaxoSmithKline vice-president, John Kraus, was called as a witness by defendants, GSK.

Kraus, when questioned by King & Spalding's jack-in-the-box, Andrew Bayman, was of the opinion that GlaxoSmithKline did everything in its power to warn of the FDA of the increased adult suicide risk posed by Paxil. Furthermore, Kraus stated it was the FDA's responsibility to determine that Paxil was safe and effective when used in accordance with the labeling.

On the subject of akathisia and whether or not it was a precursor to suicide, Kraus told the jury that GSK carried out its own study and found that akathisia was not associated with an increased risk of suicide or suicide-related adverse events.

This was basically all Kraus had to say. Bayman went over and over the same points. So, according to GSK's own vice president, the FDA were informed about the link between Paxil and adult suicides, but the FDA never acted on this information. Further, according to Kraus, akathisia is just a condition that "is some of the internal sense of feeling agitated, but it's accompanied by kind of a physical manifestation. This can include inability to sit still, moving up and down, things of this nature."

Kraus was not asked by Bayman whether or not he thinks Paxil caused Stewart Dolin to kill himself, neither was he asked his general opinion about adult Paxil-induced suicides. Hardly surprising given that Kraus testified in a previous adult Paxil suicide lawsuit that, "GSK could not definitively state that any increased risk would end at a particular age." (see Vanderwerf Vs SmithKline Beecham)

Yesterday Kraus was asked by Andrew Bayman why GSK never requested a meeting with the FDA to discuss possible Paxil label changes relating to the adult suicide link. Kraus somewhat flippantly, replied, "It would've been futile." He based this answer around GSK's supposed previous attempts to change the label specifically for Paxil. Kraus claimed the FDA preferred a class labeling, a system whereby the FDA prefer to group all SSRIs together. Kraus also stated GSK could not add an adult suicide warning to the black box on the Paxil labeling, citing this was up to the FDA. Kraus also asserts GSK could not add an adult suicide warning in the 'indication and usage section' of the label because it "wasn't appropriate" to add a warning to this particular section of the label. Kraus claims there was no place on the label that was appropriate to add an adult suicide warning.

In fact, claimed Kraus, there was nowhere on the label that was appropriate for an adult suicide warning.

Nice to see GSK have the consumer at heart, huh? So, according to Kraus and GSK, suicide prevention is "futile", correct?


Cross Examination

Brent Wisner was quick to point out to Kraus that the FDA does not prohibit GSK from adding warnings to Paxil labeling. When discussing GSK's refusal to meet with the FDA to address the specific Paxil labeling, Wisner asked who was it that made the decision not to meet with the FDA. Kraus admitted it was ultimately his decision.

On speaking of the two apparent placebo suicides that occurred during the Paxil clinical trials, Wisner asked Kraus if this was a lie. Kraus told the jury (under oath) that this was not a lie, suggesting instead that it was just "inaccurately written."

GSK and their witnesses do love this doublespeak, don't they?

Wisner also asked Kraus if GSK purposely withheld crucial adult suicide data from the FDA for 10 years because during those 10 years GSK had exclusive rights to sell Paxil. In other words, as long as GSK had the patent, nobody else could sell Paxil in its generic form. Kraus told the jury he didn't know because he was not a patent expert.

The subject of Paxil's promotion was raised, in particular how GSK reps used a published paper (Montgomery and Dunbar) that suggested Paxil reduced suicidality in adults. The paper was based on the two apparent placebo suicides. An internal memo to GSK's sales reps was read to the jury:

"In the analysis from controlled studies and open extension studies of Paxil calculated by patient year of exposure, there were 2.8 fewer suicides in the Paxil-treated group compared with active control and 5.6 times fewer compared with placebo. Clearly, very positive results."

The above was to be disseminated to doctors throughout the United States to alleviate concerns that Paxil did, indeed, induce suicidality in adults.

We know now, and even GSK has admitted, that the two suicides among the 544 placebo patients in Montgomery and Dunbar's 1995 publication actually occurred during single-blind placebo run-in. However, GSK has made no effort to retract the published paper by Dunbar and Montgomory, and neither have either of the authors. (Dunbar's video testimony can be seen here.) Once GSK realized they had a problem, an email was sent out by GSK's head of marketing, Barry Brand. The letter to GSK executives implied that anything submitted to the FDA regarding adult suicide would "be setting us up for potential problems." Furthermore, GSK's marketing head was named, once again, in another email shown to the jury. This email showed how GSK had concerns about raising the suicide issue with the FDA because, at the time, there was already litigation regarding SSRIs and suicide.

Wisner also showed the jury an email from GSK's Pamela Barrett who had raised this issue about adding GSK's Paxil studies into a pool. Barrett wrote that the inclusion of studies 057 and 106 in the suicidality analysis would have "skewed the data." Despite this, GSK still included studies 057 and 106 which watered down the actual number of suicides in the Paxil arm during GSK's clinical trials.

Cross-examination continues today.

Exclusive new 'In Da Paxil Club' video featuring...

John Kraus (GSK)
Andrew Bayman (King & Spalding)
Todd Davis (King & Spalding)
Andrew Witty (Former GSK CEO)
JP Garnier (Former GSK CEO)


CLICK HERE
(Opens in new browser)


Bob Fiddaman




Dolin Vs GSK - "Babes"

Dolin Vs GSK - Wendy's Cross and GSK's Petition

Dolin Vs GSK - Robert "Bling Bling" Gibbons














Saturday, April 08, 2017

Paxil Label: Doublespeak







In textbooks, manuals, and some types of web writing, boldface is often used to highlight the first instance of an important keyword that is central to the subject of a chapter or article. (1)

I guess we can now say, with confidence, that this also applies to warning labels for SSRIs.

Let's just take a look at the current Patient Information Leaflet (PIL) for Seroxat, which was last revised on  11 January 2017.

**Seroxat is the European brand name for paroxetine. In the US and Canada the brand name used is Paxil.

Click to enlarge

Why use a boldface font across the words "young adult"?

Well, according to the description quoted at the head of this blog post, "boldface is often used to highlight the first instance of an important keyword that is central to the subject of a chapter or article."

So, the 2017 warning label clearly shows that it's important for patients and healthcare professionals to know that the current paroxetine label emphasizes that being a young adult puts you at an increased risk of suicidal behaviour whilst taking antidepressants. Remember, this is taken from the current Seroxat (Paxil) PIL.

Why do we not see the same for all adults?

Also, whose idea was it to use boldface on the words "young adult"?

This is something I put to the MHRA Pharmacovigilance team:

Could you please explain why "young adult" is in boldface type font and who made the decision to include "young adult" in a boldface type font?

It's important to note, before I publish their response, that MAH stands for Market Authorisation Holder which, in essence, means the manufacturer of the product.

Below is the answer MHRA sent.  Please note: MHRA's punctuation and spelling errors are as received. Ironically, my post today is about the importance of words used in drug labeling--words the MHRA accepted. Given that the MHRA doesn't take the time to check its own correspondence, they likely apply the same carelessness when approving drug company's labels.

MHRA's haphazardness is unprofessional; But the former (MHRA's letters) simply make their communications department look bad, while the latter (MHRA's labeling) is extremely hazardous to consumers...

Wednesday, April 5, 2017

Dear Mr Fiddaman

The SPC for Seroxat includes the following:

A meta‑analysis of placebo‑controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old (see also section 5.1).

As the above suggests that this particular age group are most at risk, the MAH will have suggested the emboldening of the text within the PIL. There are fors and againsts the use of emboldening, but in this particular case it has been considered appropriate.

--

I asked for further confirmation of this and was told...

Thursday, April 6, 2017

Dear Mr Fiddaman,

The emboldening would have been proposed by the MAH, who is this case are Smithkleine Beecham limited (part of the GSK group).


Kind regards,
--

So, there you have it folks. GlaxoSmithKline suggested that words "young adults" be highlighted in boldface font. As you will see from the current Seroxat Patient Information Leaflet there is no such boldface font for adults over the age of 24.

Surely, the FDA (the American drug regulator) would have also been in the same position as the MHRA, right? Did GlaxoSmithKline also suggest to the FDA that they should boldface the words "young adults"? If so, why didn't GlaxoSmithKline suggest the same for adults over the age of 24 given that the rate of suicidal behavior for adults over 24 taking Paxil showed a nearly 9-fold increase?

Don't GlaxoSmithKline have a responsibility to protect this patient population from potentially fatal or disabling risks like this?

I'm at a loss here. Who is actually protecting the adult consumers with regard to potential suicide risks with GSK's Paxil?

It appears through all the bickering between GSK and the regulators about which entity is responsible, they've both forgotten that, in the meantime, consumers are still taking a drug that is potentially life-threatening. You cannot stress a warning in boldface to one individual age group and, seemingly, ignore another age group. This is inadequate and misleading to both prescriber and patient, regardless of how GlaxoSmithKline wish to paint it.

The current Paxil warning label shows a distraction from the whole truth, it's procrastination, it's misdirection and it's doublespeak, with the sole aim of hiding the whole truth whilst offering a morsel of truth. It's lying by omission. Magicians and illusionists do the same thing because they don't want to show you how they are conning you, they will draw your attention to one thing whilst hiding another thing (the secret) - This is exactly what GlaxoSmithKline are doing, although they have been clever, they are showing a glimpse of the truth but carefully distracting you away from it by using boldface font.

Now, where have I seen American lawyers representing GSK arguing that warnings for suicide, over the age of 24, have been placed on their labeling, and that those warnings are adequate and not vague? Not vague? I'd suggest this was a boldface lie, or, at the very least, lying by omission.

Bob Fiddaman



(1) Boldface text - grammarist.com

Court transcripts from the Dolin Paxil trial

Friday, April 07, 2017

Dolin Vs GSK - Robert "Bling Bling" Gibbons




As noted in my last blog, Robert Gibbons is considered an "expert" only by GSK and other pharmaceutical companies who pay handsomely for his inventive numbers crunching. The phrase "figures lie, and liars figure" perfectly sums up Gibbons' "scholarly" junk science.

In the Netherlands, for example, Dr. Dick Bijl, who is the current Cheif Editor of Geneesmiddelenbulletin, a monthly bulletin for prescribing physicians, was less than complimentary toward Gibbons. Gibbons authored a research paper in which he claims higher rates of suicide are caused by the FDA Black Box warning. Gibbons states children are dying by suicide because they aren't taking SSRIs! But Bijl notes Gibbon's conclusions were “astonishing” and cannot be made from the data available. In an issue as important as childhood suicide, Bijl further states the authors were “reckless.” The Dutch investigative radio program, Argos, highlighted Bijl’s concerns, quoting experts in statistics, epidemiology, and child psychiatry, who warn of the “danger” in such “misleading” research.

With the above just being one example of Gibbons junk science, it came as no surprise that King & Spalding focused their day and a half examination on Gibbons' data. Of course, none of the well-documented criticisms of Gibbons by reputable scholars and scientists were mentioned by King & Spalding's Todd Davis. To back up his claims that Paxil and other SSRIs reduce the rate of suicides, Gibbons referred to other 'academic papers.' On cross-examination by Brent Wisner of Baum Hedlund, Gibbons motives became crystal clear. Wisner pointed out that every single research paper Gibbons quoted had authors who, collectively, had lucrative financial ties to the pharmaceutical industry. Gibbons admitted GSK is paying him $1,000 per hour to regurgitate his answers. On being asked if the two research papers Gibbons criticized had authors with direct conflict of interest ties to the pharmaceutical industry, Gibbons was, I imagine, left red-faced. It turns out his criticisms of papers that note there is a link between antidepressant use and suicide were authored by academics with no Big Pharma ties.

Nevertheless, Gibbons still maintains that antidepressants reduce suicides. He even told the jury that GlaxoSmithKline's own figure of a 6.7% increase for adults taking Paxil was incorrect. Gibbons seems to be in a bubble of delusion. Who wouldn't be when being paid $1,000 an hour by many pharmaceutical companies including Glaxo, Wyeth, and Pfizer?

It's difficult to accept the word of a millionaire who lacks morals and ethics. I say millionaire because between 2002 and 2013 Robert Gibbons pulled in a staggering $4,958,346 in National Institutes of Health (NIH) grants. This amount doesn't include the handsome sum he collects from pharmaceutical industries during litigation. Gibbons has been called a pharma whore and pharma shill, amongst other names. I'd say he's far worse than that:  His junk science is putting both adults and children at harm, and likely responsible for many avoidable SSRI-induced deaths.

It is nauseating to see the pharmaceutical attorneys and their witnesses continue to lie and deceive the unsuspecting public, jurors and consumers alike.

Gibbons finished his evidence yesterday and is now in line to give evidence for GSK in another lawsuit filed against them in the UK. That lawsuit alleges that patients taking Paxil struggled with horrific withdrawals whilst trying to taper off it. Buisness as usual then for Robert Gibbons.

Being present in the courtroom during the early stages of this trial was, for me at least, a dream come true. I'm a bit of a geek when it comes to law, particularly pharmaceutical litigation. Though I was harmed by Paxil for years, my own adverse Paxil experiences pale into insignificance when I think about the trauma Wendy Dolin and her family have endured. Considering most families whose loved ones have died from Paxil never even have their day in court, the number of people adversely impacted by GSK's product is likely staggering. Another staggering number is GlaxoSmithKline's rules and regulations violations. GSK has settled out of court so many times with so many victims, I've lost count.

Some of the people who have been harmed by SSRIs have names and faces known to the general public because they have channeled their grief into advocacy so that others might live. I feel tremendous compassion and respect for these advocates, people like Neil and Rhonda Carlin, Kristina Gehrki, Leonie and Tony Donnelly, Stephanie and John Lynch, Stephanie Gatchell, Kim Witczak, and Elaine Billings. Behind them are thousands of nameless victims whose avoidable tragedies are not known by the general public.

Perhaps one day GSK and other pharmaceutical companies might publish all the data from their secret, sealed cases that were settled out of court? My, wouldn't that be a large document? GSK would need a dump truck to deliver all their binders.

King & Spalding could then advertise their data collection and legal services on national TV. I can almost see Todd and Andy now, standing next to sky-high boxes of binders.

"Hi I'm Todd, and this is Andrew. We here at King & Spalding like to polish a turd."

The trial continues next week with the continuation of evidence being given by John Kraus, who is a vice president with GSK. Kraus is a former psychiatrist. Seriously, a former psychiatrist who is now vice president of GSK?

This shit just writes itself!

Bob Fiddaman





Dolin Vs GSK - "Babes"

Dolin Vs GSK - Wendy's Cross and GSK's Petition