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Author of The evidence, however, is clear, the Seroxat scandal
Citizens Commission on Human Rights Award Recipient (Twice)
Humanist, humorist

Wednesday, May 24, 2017

Under Cover Terrorists




There's so much hatred doing the rounds lately - I guess it takes an act of violence on children, innocent children, to get people riled.

And rightly so.

Terrorist Salman Abedi, who carried out the abhorrent act in Manchester two nights ago has been condemned by many. He walked into a foyer knowing what he was about to do, he did so because, it is believed, he had taken the written word from an ancient scripture literally. He probably believes that his actions will be rewarded by some fairy in the sky. "Here you go, Salman, here's some virgins for you, great job."

Many people, including friends and family, hang their hat on the mythical, Let's face it, there's no concrete evidence that God, any God, exists, yet we see throughout history how many atrocities have been carried out in the name of God.

Personally, I'm an atheist. As such, I avoid being manipulated by indoctrination of fairy tales. Not having a God in my life suits me just fine.

The world I move in has seen many child killers, but the public apathy suggests it's okay to kill children and, indeed, adults, if the perpetrators are multi-billion dollar industries.

During the past two days Facebook has seen people voice their shock and horror over the Manchester atrocity. Folks who normally post photos of what they are about to eat or weather updates have been so shocked and moved that they have voiced their opinions and condemned the actions. The Manchester atrocity was enough to get people enraged.

What if I told you that back in 2012, a white coach driver by the name of Geert Michiels carried out an act or terrorism? What if I told you he had no affiliation to any terrorist cell? Michiels deliberately drove his coach into a tunnel wall killing 28 passengers, 22 of whom were children. Would you still be inclined to vent your outrage on Facebook or any other social network?

Geert Michiels, 34, didn't have a weapon of destruction strapped around his body, but he was driving one.

But hey, he had no motive, no indoctrination, no manipulation of the mind... or so we are led to believe.

What if indoctrination came in the shape of a pill, what if that pill changed your outlook on life, on society as a whole? Wouldn't such a pill be snapped up by terrorist organizations such as those responsible for the events in Manchester? If one can manipulate the mind of a 22 year-old by preaching quotes from an ancient book then such a gift as one simple pill could speed up the process of manipulating someone who was once normal into a mass killer.

A full investigation into the coach crash was carried out by Swiss Chief Prosecutor Olivier Elsig, the results of which were inconclusive. He ruled out the involvement of a third party, shortcomings in the road surface or the tunnel infrastructure. Excessive speed, alcohol or technical problems with the vehicle were also ruled out. He, at no point, could determine whether or not Geert Michiels carried out an act of homicide/suicide with the vehicle.

From the investigation, and subsequent independent investigations, it was learned that Michiels was taking or withdrawing from Seroxat at the time of the crash. Seroxat is better known as Paxil in the US and Canada and Aropax in Australia.

It's become widely known that Seroxat can cause suicidal thinking in some people who take it, it has also been proven, in US Courts, that Seroxat was responsible for, not only suicide but homicide too.

Seroxat, by the manufacturers own admission, can cause a symptom called akathisia, in a nutshell, 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.

Seroxat was Geert Michiels 'bomb'. The drug caused adverse reactions that triggered a series of events in his brain. It was his indoctrination by proxy that eradicated his normal empathy and induced atypical thoughts of killing his passengers and himself. This became his mission in a split second. We know from the recent Dolin Vs. GSK trial that akathisia can be switched on and off in a second. We also know that for persons experiencing akathisia death can be a welcome result. This statement was made by Dr. Roger Lane who, in a 1998 article on akathisia, said, "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." - At the time, Roger Lane was working for pharmaceutical giant, Pfizer.

Pfizer make Zoloft, an akathisia-inducing drug.

Yet we see no world-wide condemnation of pharmaceutical companies or indeed those who are supposed to regulate the drugs you and I take.

22 people died in Manchester. - Salman Abedi's mind has been manipulated by indoctrination.
28 people died in Sierre. - Geert Michiels' mind had been manipulated by Seroxat.

I anticipate that Facebook posters won't be spreading the Sierre story far and wide.

Bob Fiddaman

Back stories

Did Seroxat Trigger the Fatal Sierre 2012 Bus Crash?

Sierre Bus Crash Revisited

Did the Sierre Bus Driver Have a Pre-Disposition to Seroxat?

What is akathisia?

Advocates Against Prescribed Akathisia

Guest Post: Let's Bring Akathisia Out of the Darkness







Friday, May 19, 2017

Guest Post by JulieAnn Carter-Winward





I've been traveling a lot lately and am very tired. A recent death of a dearly beloved aunt has meant that I'm putting blogging on hold for a while. Being apart from my partner, whom I love dearly, is also difficult to cope with but it's only for a short time so at least we both have something to look forward to when we meet again in a month or so.

Just as well that I have a guest post to offer readers today.

It mentions the "A" word, you know, the one that many doctors, regulators and industry insiders like to 'play down', like to pass off as nothing more than an 'inner restlessness'.

For once, it's not about SSRIs, it's about a drug that I am not totally familiar with.

The guest post is well worth the read, it's part one of two.

~ Bob Fiddaman


Train Wreck: How Mental Health Care Got Derailed
By JulieAnn Carter-Winward



Have you ever been punched in the gut? Or fallen, had the wind knocked right-the-hell outta ya? Yeah, me too. It can be a humbling experience. But if you know me at all, you’d know: I am anything but humble.

My name is JulieAnn Carter-Winward, and I live in the U.S. of A., where everything “right” comes from, (“herb,” pronounced “erb,” not “herb” with an “h,” you hoity-toity Brits.) I’m kidding, of course. I pronounce it like British folk because, well, there’s a “h” in it.

AH, but I digress: yes, “humility” is a virtue of which I possess very little—and that’s actually sort of ridiculous, because I have countless reasons to be humble. I mean…I suck at a lot of stuff. Seriously suck.

My lack of humility, we could even call it pride or—dare I say it? Hubris—yeah, okay so I’d thought the sin of hubris would be what would eventually buckle my legs and knock the breath clean out of me.

I could not have imagined that my nemesis would be an innocuous, little, round, white pill.

BUT, although Mr. Fiddaman’s blog has focused on SSRIs up until this point, I need to tell you: this little pill was not an SSRI. 

Just like “Charcoal gray is the new black” or “Spoken Word” is the new “Beat Poetry,” or “Fifty Shades of Gray” is the new “Housewife Porn,” (shudder), the new SSRIs are the “second-generation atypical anti-psychotics,” or AAPs. Why? Because drug companies are now claiming AAPs can do what SSRIs cannot, and have not done: treat depression.



Bob Fiddaman has diligently revealed the truth behind the smoke, mirrors, dollar bills and coins behind antidepressant clinical trials, research, (rabid) prescribing and use—all to shed light on the potential lethal consequences of these medications: drug-induced akathisia.

But SSRIs are merely one way to whack the backs of an unsuspecting public’s knees; people searching for the “Little Pill that Could.” The “I think I can, I think I can,” or, more aptly, the “I think it will, I think it will…” hmm, will what?

Make this constant sadness disappear from my life!

Help my son get his life back together. I want to see him smile--it’s been so long.

Get my husband back to his old, jocular self again.

When it comes to antidepressants, these are all wishful thoughts at best, placing hopes in an engine powered by promises, not proof. Thanks to people like Mr. Fiddaman and others, SSRIs have been exposed for what they truly are: engines that not only can’t get you over the hill of unhappiness, but won’t—and on top of it, could very well derail you emotionally or those you love, within days, weeks, or months.

Enter AAPs. Yes, there are some new pills in town, and they’ve been approved by the FDA for not only bipolar depression, but run-of-the-mill, #1-cause-of-disability-in-America-today depression as well. AAPs are the new “add-ons,” booster meds, or, as I like to call them, the caboose medication to add to your impotent drug train, traversing the uphill battle of depression. 

Yet, AAPs, like an errant caboose, can whip around and bite you in the ass when things go the wrong way—knocking you to the ground, breathless—that, or six feet under it.

I should know. I was tied to the tracks.

If you’ve read Bob’s blog long enough, you’ve read tragic, heartbreaking stories of Wendy Dolin as well as other survivors left behind in the wake of loss, after drug-induced akathisia drove their loved ones to take their own lives. I have read stories of people who have had akathisia (past-tense); I felt the horror of their experiences in their words, the utter agony they recall with dread, almost as if they fear it a specter, and to invoke the very name of it would recall its visitation upon them again. Yes, thanks to Mr. Fiddaman’s diligence, SSRIs, and those who manufacture, sell, and prescribe them, are getting an uncomfortable spotlight shined right in their faces.

Today, however, right here and now, you are reading the words of someone who has tardive akathisia; “tardive” means “late appearing,” and in the medical field, that means the side effect doesn’t manifest until after the drug has been discontinued.

I stopped taking the AAP, Latuda, (lurasidone HCl, made by Sumitomo Dainippon Pharma Co., Ltd., and marketed in the U.S. by Sunovion,) almost 11 months ago, and I still battle akathisia, daily. The emotional pain, the quivering muscles but along with the persisting akathisia, I have developed other neurological movement disorders, and they appeared nearly 7 months after discontinuing Latuda: tardive dyskinesia and tardive dystonia.

What makes me rather unique is that for some people, the drug masks “inner akathisia,” the emotional pain, while the patient is on it. Not always, but sometimes. For example, akathisia can also be a withdrawal symptom. Just ask anyone who has tried to get off benzodiazepines. But Latuda did not mask my pain, and it grew, over years, until I was frozen with pain almost every day. I have lived with inner akathisia pain, for over a decade. I have been SSRI-free for years. The only medication I took with akathisia as a known side effect was the AAP, Latuda.  

But I don’t know that “living” is the correct word to describe what my life had been, and some days still, is like. More accurately, I white-knuckle my way through most days. Before my diagnosis last summer in 2016, I lived with a pain with no name, a pain so relentless, there were days when I could barely walk upright. It was misdiagnosed as “agitated depression,” “treatment-resistant depression,” and “severe panic and anxiety,” but no medication gave me relief.

I knew, knew in my BONES, that it wasn’t psychological. This was not a job for my therapist. No, this was physical, biological, and my doctor and I knew it had to do with medication. But he had no idea what “inner akathisia” was. I not only wanted that train to derail, I almost derailed it myself, more times than I care to admit here.

Akathisia dogs my every step; places a pall over every feeling and thought I have, every day. My mind can’t wrap itself around the pain at times—a pain like akathisia should be fatal. At the very least, it should have the compassion to BE fatal and allow the sufferer to die a death that is not self-imposed. It is hell on earth, and it has nothing to do with gods or devils.

I get whacked, despite the drug’s absence, and no one knows why it persists, other than I was on AAPs for 13 years, or how to help me. Am I now, then, finally humbled?

Hell no. I’m pissed.

And as a wise man once wrote…well as the guy who made the magnet on my refrigerator wrote: “It is unwise to anger a poet.” Oh, it’s a little different than that. 

I’ll fix it.



There. All fixed.

When Bob invited me to write about my experience, I had to laugh a little. Write about it? Hell, I’ve been writing about it for years. Years and years—as in, I have so many poems and stories about the mysterious “Pain” that dogged my daily existence, that I have an entire BOOK of writings about akathisia, a book I’m compiling as we speak. So yes, Bob, I’ll write about it, and this is the intro.

If you’d like a broader spectrum/look-see into the history of antipsychotic medications, and the evolution of the drug companies with regards to mental health, as well as my personal take on it and my experiences that led me to this point, please visit my webpage at:


Hopefully, in and of Bob’s good graces, I’ll be writing a bit more next month to address and inform you all about an upcoming awareness project premiering at the end of June. It’s a short YouTube film. I hope you will not only find it engaging, but that you will all help me spread the film’s message like a wildfire across the info-kindling that is the ether.

Thank you for reading. It’s time for me to step away. The Pain-- it’s here. So familiar, and yet it feels fresh and new, every day. Like a wound that is never allowed to heal. A torture, where every day a masked man comes and gouges out the same place on my body. I’d beg him, beg him, to please, give me another pain, in ANY other place.

I often think about that. I think about him, agreeing, but giving me this choice:

 “All right, instead of gutting you in the bloody hole in the upper part of your stomach, I will slash your arms and legs to shreds. But here’s the catch: I will only do that if you let me slash your limbs for a decade. If you refuse, I will continue gutting the usual spot, but only for one more week. Choose.”

Truth be told? I don’t know what I would do. I think I would choose the decade of limbs being slashed. If it meant my gut would be spared one more blow? God help me, I’d consign to the former. The pain…I can’t describe in words. I am undone by it; but I have work to do, and I need to help those who I can help. I need to keep holding on, and I will.

 So yes, I’m sinking, here and now, down to my knees…

…but so help me God, I will not allow my chin to drop—  

not until the makers of Latuda KNOW ME BY NAME.
 
 
~J.A. Carter-Winward

Thursday, May 11, 2017

Guess Who's Being Sued Again?





Drug: Lamictal (lamotrigine)
Marketed and manufactured by GlaxoSmithKline.

According to the Daily Mail, the lawsuit, filed by Khaliah Shaw, 26, alleges that within a month of taking the drug, she had developed a rash on her face, while the skin on her lips had started to peel off. Although she visited her local ER, she was initially diagnosed with the flu.

Two days later, it is claimed, Miss Shaw woke up in excruciating pain, with the skin on her face, neck, back and chest falling off and her mouth covered in blisters.

The reaction left her skin permanently scarred, and she is slowly losing her sight.

Shaw, along with many others, are suing GlaxoSmithKline for promoting the product without warning of the risks, claiming more than $3.45 million in medical costs.

Shaw lost up to 90 percent of her skin.

More articles...

Woman's skin burned from inside out after dosage error, lawsuit claims

Wrong Treatment Melts Woman’s Skin Inside Out

Student, 26, who was almost blinded and lost 90% of her skin after taking common anti-seizure drug sues GlaxoSmithKline for more than $3 million


The GSK company mission statement is to, "help people do more, feel better, live longer."

Bob Fiddaman





Friday, May 05, 2017

Disdain Shown Toward Kids by Australian Medicines Regulator





dis·dain
noun

the feeling that someone or something is unworthy of one's consideration or respect; contempt.



So, Australia, a country I hold dear to my heart, apparently has a limp-wristed regulator in charge of it's drugs. Here's a news story from TodayTonight, a current affairs show broadcast in Adelaide, Australia, that may shock you. It was aired on Thursday May 4.

I can't find the words.

I know how Aropax (more commonly known as Paxil and Seroxat) can screw with your head. I know how it can make you feel like you want to kill yourself. I know the horrific withdrawal effects can make you feel like punching walls, and even people.

I know how GlaxoSmithKline wanted children to take it.

Also featured in this video is the story of a young girl who took Zoloft. Pfizer, it's manufacturer, don't seem to mind if kids take their drug either.

I honestly have never known an industry as sick as this one. It's difficult to put in to words because there seems to be such an incestuous relationship with pharmaceutical companies and global regulators. This relationship grows yearly and, it appears, not one medicine regulator seems to give a damn about children (as depicted in this video segment) being prescribed mind-altering drugs that aren't safe for adults, let alone 5 year-olds!


video


For more information on the SSRI problem in Australia join the Australian Antidepressants Class Action & Awareness Facebook group.


Bob Fiddaman

SSRI Deaths in Clinical Trials







Following on from MHRA Yell "Barracuda!", I have sent the following request (under the terms of the Freedom of Information Act) to the MHRA.

I can't see any reason why they can't answer, given they already confirmed to me, in writing, about the 22 deaths that occurred in Paxil clinical trials.

1. How many deaths occurred in the pediatric trials for Paxil/Seroxat. How many were by suicide and how many of those patients were taking Paxil/Seroxat at the time of their death?

2. How many deaths occurred in the pediatric trials for Prozac. How many were by suicide and how many of those patients were taking Prozac at the time of their death?

3. How many deaths occurred in the persons aged 24 or over in clinical trials for Prozac. How many were by suicide and how many of those patients were taking Prozac at the time of their death?

4. How many deaths occurred in the pediatric trials for Celexa/citalopram. How many were by suicide and how many of those patients were taking Celexa/citalopram at the time of their death?

5.  How many deaths occurred in the persons aged 24 or over in clinical trials for Celexa/citalopram. How many were by suicide and how many of those patients were taking Celexa/citalopram at the time of their death?

6. How many deaths occurred in the pediatric trials for Lexapro/escitalopram. How many were by suicide and how many of those patients were taking Lexapro/escitalopram at the time of their death?

7. How many deaths occurred in the persons aged 24 or over in clinical trials for Lexapro/escitalopram. How many were by suicide and how many of those patients were taking Lexapro/escitalopram at the time of their death?

8. How many deaths occurred in the pediatric trials for Zoloft/Sertraline. How many were by suicide and how many of those patients were taking Zoloft/Sertraline at the time of their death?

9. How many deaths occurred in the persons aged 24 or over in clinical trials for Zoloft/Sertraline. How many were by suicide and how many of those patients were taking Zoloft/Sertraline at the time of their death?

Bob Fiddaman








Thursday, May 04, 2017

Facebook Comments






I've managed to add a Facebook comments box at the end of each of my blog posts. I've been trying to figure out how to do this for a while. Much of my work gets shared or 'liked' on Facebook and now you can leave a comment by using the comment box below each post.

The comment feature on this old blog of mine has been problematic for many years. Hopefully, now, it will be easier for you all to leave a comment.

Bob Fiddaman.



Tuesday, May 02, 2017

MHRA Yell "Barracuda!"




I think I am familiar with the fact that you are going to ignore this particular problem until it swims up and bites you on the ass!Matt Hooper - Jaws


The above photo and caption are from the movie Jaws. Power and money-hungry Mayor Larry Vaughn, played by Murray Hamilton, refuses to acknowledge that the residents of Amity are at risk of a shark attack. If Vaughn doesn't close the beaches, the shark could harm and kill citizens. Matt Hooper, played by Richard Dreyfuss, is an oceanographer with a special interest in the study of sharks. He uses his knowledge to try and convince Vaughn to protect the town, but Vaughn ignores him. Given the popularity of Jaws (it won an Oscar), I assume we all know the outcome of Vaughn's callous ignorance, right?

I'm not Matt Hooper, but lately, I feel like him. For years I've been at loggerheads with the MHRA as I seek answers to improve public health. Today's blog spotlights my latest correspondence to/from the MHRA about the increased risk of adult suicide posed by Paxil.

The MHRA and FDA know SSRIs are not recommended for consumers under the age of 24 because these products increase the suicide risk. In the US there is a black box warning, and in Europe, the patient information leaflet highlights this increased risk of suicide for any consumers under age 24. It is actually printed in bold face font. (See Doublespeak)

What we don't know is how and why regulatory authorities chose to highlight the product's dangers in consumers under 24 and not communicate the increased suicide risk for consumers over 24.

Let's look at the facts regarding Paxil clinical trials. (Paxil is known as Seroxat in Europe.)

In GSK's Paxil pediatric trials, which included more than 1,000 patients treated with Paxil, there were zero completed suicides. We know this because GSK's vice president for regulatory affairs, Dr. David Wheadon, admitted this in a written statement. What we don't know is how many of the children who were given Paxil developed suicidal thoughts and actions. MHRA and the FDA apparently feel this information is not important for the public's viewing.

In GSK's Paxil adult trials, we know 22 deaths occurred, 80% of which were people over age 30. (See here.) What we now know, thanks to the evidence made public in the Dolin vs. GSK trial, 42 people taking Paxil developed suicidal thoughts and actions.(See here)

So, to sum up: No deaths occurred in Paxil pediatric trials, and 22 deaths occurred in Paxil adult trials. Twenty of these deaths were completed suicides, and 80% of these were people over age 30.

Surely, the MHRA never had this information?

Wrong.

Here's a series of emails between myself and the MHRA. Spelling and grammatical errors from the MHRA are as received.


From: Bob Fiddaman
Sent: 31 March 2017 14:54
To: Pharmacovigilanceservice
Subject: Re: Drug labeling

On the current Seroxat Patient Information leaflet (Revised 11/01/2017) it states, under the subheading "Thoughts of suicide and worsening of your depression or anxiety disorder"...

If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.

You may be more likely to think like this:

· If you have previously had thoughts about killing or
harming yourself.
· If you are a young adult. Information from clinical
trials has shown an increased risk of suicidal
behaviour in adults aged less than 25 years with
psychiatric conditions who were treated with an
antidepressant.

Q: 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?

--

From: Pharmacovigilanceservice
To: Bob Fiddaman
Sent: Wednesday, April 5, 2017 10:44 AM
Subject: RE: Drug labeling

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.

Kind regards,

Chris Penny 
Pharmacovigilance Service Team Manager

--

From: Bob Fiddaman
Sent: 16 April 2017 15:52
To: Pharmacovigilanceservice
Subject: Re: Drug labeling

Chris,

Just so you know.

Plaintiff’s Exhibit 347: Each picture depicts a real person who completed suicide while taking Paxil in a GSK-clinical trial. The red “Vs” mean their specific suicides were violent in nature. There were multiple suicides using firearms, including a murder suicide by one patient. There were also two deaths from people jumping in front of trains.

When it comes to suicide attempts, GSK did not keep track of all the attempted suicides in their clinical trials because, according to their company witness, it would be too burdensome.

My question.

The MHRA knew about these adult completed suicides, correct?


Attachment added to email
--

From: Pharmacovigilanceservice
To: Bob Fiddaman
Sent: Wednesday, April 19, 2017 12:03 PM
Subject: RE: Drug labeling

Dear Mr Fiddaman

I can confirm that the MHRA is notified of all serious adverse events, as laid out in the Pharmacovigilance Clinical Trial legislation.

Kind regards,

Chris Penny 
Pharmacovigilance Service Team Manager

--

From: Bob Fiddaman
Sent: 19 April 2017 17:08
To: Pharmacovigilanceservice
Subject: Re: Drug labeling

Dear Chris,

For clarification. Were the MHRA notified of the 22 deaths that occurred in paroxetine (Seroxat) clinical trials carried out by GSK (SmithKline Beecham) and that 16 of those deaths (80%) were attributed to adults over the age of 30?

--

From: Clinical Trial Helpline
To: Bob Fiddaman
Cc: Pharmacovigilanceservice
Sent: Friday, April 21, 2017 5:19 AM
Subject: RE: Drug labeling

Dear Mr Fiddaman,

As stated in the previous email from Chris Penny the MHRA is informed of serious adverse reactions occurring in clinical trials in compliance with current legislation.


The deaths that you are referring to took place between approximately 1983 and 2003. This data would have been submitted to European Competent Authorities and the suicidality risk of paroxetine was formally addressed at a European level in 2003/2004. Class labelling for a risk of suicide and related thoughts and behaviours was adopted for all the SSRIs based on data reviewed in 2004.


Best wishes,

Rosalind
Clinical Trials Unit
MHRA

--

From: Bob Fiddaman
Sent: 21 April 2017 16:29
To: Clinical Trial Helpline
Cc: Pharmacovigilanceservice
Subject: Re: Drug labeling

Thanks Rosalind.

One final question.

The MHRA have no plans to update the Seroxat label regarding Seroxat-induced suicide in adults over the age of 24, correct?

--

From: Clinical Trial Helpline
To: Bob Fiddaman
Cc: Pharmacovigilanceservice
Sent: Tuesday, April 25, 2017 2:05 PM
Subject: RE: Drug labeling


Dear Mr Fiddaman,

As stated before, class labelling for a risk of suicide and related thoughts and behaviours was adopted for all the Selective Serotonine Reuptake inhibitors (SSRIs) based on data reviewed in 2004. Paroxetine is an SSRI. Suicidal ideation and behaviour is already addressed in the Paroxetine Summary of Product Characteristic (SmPC).


Best wishes,

Rosalind
Clinical Trials Unit
MHRA

--

So, there you have it, folks. The MHRA decided to highlight the increased risk of suicide among consumers under age 24, and they decided not to highlight the increased risk of suicide among consumers over 24.

Why didn't the MHRA feel the need to highlight the 22 adult deaths that occurred in the Paxil trials? It appears the MHRA believes Paxil isn't safe for children, but is safe for adults?

Why, in 2017, is the MHRA still not updating the Paxil warning label for adults?

Why do the MHRA continue to highlight the risk of patients under the age of 24?

I think I know why. GSK already knew that their ideal target market for Paxil was not going to be children. GSK is not allowed to promote Paxil to children (but they still did and were fined for their criminal behavior.)

But GSK was not about to lose Paxil profits when it came to capturing the adult market. MHRA helped them out by emphasizing in the patient information leaflet that the risk is only for consumers under 24. By intentionally printing these specific words, "young adults," in bold face type, MHRA is essentially telling older consumers: "Pay no attention to this increased suicide warning if you are over 24. This product poses no increased risk of death."

Obviously, MHRA should warn older adults by highlighting the 22 deaths and including older adults in the warning. Perhaps MHRA's CEO, Ian Hudson, doesn't want to do this because, whilst under oath in 2000, he stated he had seen no evidence to suggest that Paxil "caused any person, worldwide, to commit an act of homicide or suicide."

I'll leave the final words to Ian Hudson, um, Mayor Vaughn who, despite knowing about the risks created by keeping the Amity beaches open, had this to say...

"You yell barracuda, everybody says, "Huh? What?" You yell shark, we've got a panic on our hands on the Fourth of July."


Bob Fiddaman

Related

Former Glaxo Safety Officer Becomes Head of MHRA

EXCLUSIVE: Dr Ian Hudson: In Defence of the Suicide Pill (Full Video Deposition)

Paxil Suicide - The Way GSK Hid the Link

Dolin Vs GSK - 8.9 Suicide Increase For Adult Paxil Users




Tuesday, April 25, 2017

Explosive News!






I am going to take a rest for a week or so from blogging.

That's not the exposive news folks.

My next post will show correspondence between myself and the MHRA and will show confirmation that they knew about the 22 deaths that occured in Paxil clinical trials, 20 of which were suicides, 80% of which were carried out by patients over the age of 30. 100% of whom were taking Paxil (Seroxat).

In the meantime, all of this needs to sink in.


Plaintiff's Exhibit 347 - Dolin Vs GlaxoSmithKline


Bob Fiddaman.


Exclusive: Interview With Wendy Dolin





Wendy Dolin

Wendy Dolin's name has been cemented in history, as has that of her late husband, Stewart Dolin.

Her victory against pharmaceutical giant, GlaxoSmithKline, was never simply about Paxil causing the death of an adult. Many people in my circles already knew Paxil can and does cause akathisia and death among people of all ages. But GlaxoSmithKline and its paid experts have played down this truth for many years. Other pharmaceutical companies that manufacture SSRIs, (Pfizer-Zoloft, Eli Lilly-Prozac, etc.) have also actively concealed that akathisia is a serious adverse side effect of their products.

Wendy's husband needlessly died as a result of GlaxoSmithKline failing to warn about akathisia. Furthermore, GSK failed to warn that akathisia can lead to suicide.

I started writing about Wendy's case two years ago. I never knew back then the impact it would have on me as a writer, a consumer, and a human. It was inevitable that our paths would cross. Most of the stories on my blog feature real people harmed by drugs the pharmaceutical companies call "antidepressants." These people are not fictional characters; their loved ones are not simply statistics. All are real people who, as a result of corporate greed and deceit,  lost a family member. I have personally met the majority of the families featured on my blogs, families who, through no fault of their own, have been left devastated by unimaginable, avoidable deaths. These courageous family members are left to pick up the pieces of a life obliterated by the pharmaceutical industry and its incestuous relationships with medicine regulators, such as the FDA and MHRA.

My own personal belief is that pharmaceutical CEO's and executives should be imprisoned for withholding important safety information from consumers, particularly when withholding such critical information leads to suffering and/or death. This was surely the case in Dolin Vs GlaxoSmithKline. I also believe experts called to defend products in pharmaceutical litigation should be imprisoned if the evidence they produce at trial is shown to be false and if it is deemed perjury. One only has to look through the court transcripts in this case to see several statements by experts that were simply untrue.

Wendy, her family and close circle of friends, have remained dignified throughout the trial and pre-trial. On the other hand, the tactics of GlaxoSmithKline's hired attorneys, King & Spalding, has been nothing short of repugnant. If their pre-trial tactics were legal, then the legal system needs a complete overhaul. Wendy's interview today shares some of the shenanigans GSK pulled years ago before the trial began.

I have a particular disdain for King & Spalding, probably more so than GlaxoSmithKline. That disdain has been strengthened after interviewing Wendy and, of course, after being present during the first two weeks of this trial.

I think it's safe to assume King & Spalding don't like me either. I can live with that safe in the knowledge that I am, in essence, trying to do part of a job coroners should be doing. I try to give the dead voice. King & Spalding, it appears, not only try to stifle the voices of the living, but they also try to suppress and manipulate the voices of the dead.

I'm really proud of Wendy and her children, just as I am of others who take on the mighty pharmaceutical industry, be it through lawsuits, blogging or other advocacy work. It's a dark, seedy world. I should know, I've been writing and researching about Big Pharma for more than ten years.

~ Bob Fiddaman

Here's my interview with Wendy Dolin.

Congratulations on last week's successful trial against GSK. You worked tenaciously since filing the case in 2014. I imagine today's feelings of victory are bittersweet for you and your family.

Many people are unaware how traumatic the pre-trial process can be when challenging pharmaceutical companies and their attorneys. Can you share your experiences?

I knew when I filed this lawsuit, it was going to be a very difficult process. But I was unprepared for the sheer number of depositions and subpoenas GSK demanded. I was told this was a record number of requests. I understood the need for certain information, but it became very clear early on that GSK's goal was to send a powerful message to me: That is, when you have the audacity to challenge GSK, all attempts will be made to harass everyone you care dearly about. GSK also repeatedly tried to humiliate me. For example, depositions that should have been a few hours became eight hours in an attempt to wear people down. GSK asked the same question over and over and over again hoping to manipulate, confuse and take people's comments out of context.

Some of the irrelevant but personal questions GSK asked me included, "How many times do you go to temple? Are you dating anyone? Who are my partners at work?" They even requested Stewart's high school transcripts. All were totally irrelevant and useless questions posed by attorneys from King and Spalding and Dentons. They were calling my friends, not identifying themselves and trying to get people to somehow say terrible things about my relationship with Stewart. There was nothing to say, of course, and GSK's attorneys just embarrassed themselves. It became a joke amongst my friends as to who would be called next and who did GSK think they were dealing with that they thought their sweet talking female attorney was somehow going to get information?

All of these questions were offensive, but what is truly the most offensive and egregious act was showing my children Stewart's therapy notes during depositions. As a therapist, as a mother and a compassionate human being, I am aware there was no purpose to have done such. I have talked to therapists, physicians and pharmaceutical lawyers and all agree there was nothing gained by this other than to show me that GSK would stop at nothing to intimidate me.

So, let me get this straight, attorneys for GSK telephoned your friends to try and dig up dirt on you? What sort of questions were they asking your circle of friends?

The good news regarding the phone calls is that most of my friends very shortly into the conversations realized something wasn't quite right, and therefore they shortly ended the conversations. They asked "Do you know Wendy and Stewart Dolin?" or "What can you tell us about Wendy and Stewart Dolin's relationship?" Most people said, "Whose side are you on?" To which, GSK attorneys replied, "You could be getting a subpoena, and that is not a very pleasant experience, so maybe you would like to tell us now what you know before the subpoenas arrived." Several of the people GSK attorneys contacted were never, ever going to receive subpoenas but as part of my deposition, GSK wanted to know who were our closest friends and who were we with the weekend before Stewart died. What also was interesting is that GSK attorneys called my friends on their cellphones rather than their landlines. I never gave out any numbers. I don't know for sure, but I think perhaps GSK's attorneys naively thought they would somehow catch my friends off guard and get more info.

Interesting.

Thank you. The word akathisa is relatively unknown to many. Can you tell me when you first heard the word and how it related to Stewart's death?

After Stewart, died nothing made sense. On Friday, August 13th a friend called me and said, "akathisia killed Stewart." And of course, I replied, "What?" She suspected early on that she thought Stewart's death was related to Paxil since that was the only thing that was different in his life that week. When I first heard the word, akathisia, I was walking my dog at the time. When I got home and wrote the word down, I decided to google "akathisia, Paxil, and suicide." All of a sudden this wealth of information appeared.  One of the first articles that appeared was one by Dr. Peter Breggin titled "How GlaxoSmithKline Suppressed Data on Paxil-Induced Akathisia: Implications for Suicidality and Violence." Then another article showed a connection between SSRIs and suicide and violence and included a definition of akathisia. It listed characteristics of akathisia. For the first time, what didn't make sense now became perfectly clear. Stewart's physical inner and outer restlessness, agitation and anxiety that I observed his last week of life now made sense. It was in this article that I first had the revelation that the drug I thought Stewart was ingesting to deal with his work related stress and anxiety instead created suicidal thoughts and actions, both of which he did not have previously.

The article went on to state that Akathisia is so terrible, "Death Can Be A Welcome Result." This is an actual quote by Dr. Roger Lane, the chief medical officer for Pfizer. Pfizer makes Zoloft, which like Paxil, is also a SSRI. It was at that moment I knew I needed to do something to help protect others and improve public health. How can this devastating drug side effect not be unknown to most health care professionals or patients?

After learning about akathisia, did you research attorneys who might help you seek justice?

I was told that Baum Hedlund was the best law firm in the country regarding pharmaceutical litigation. I was told very early on by Baum Hedlund that the generic issue would be a large hurdle.

Moving on to MISSD. Can you tell me what MISSD is all about and why it was important to create this organisation?

When Stewart died, I wanted to start an organization to raise awareness regarding akathisia. It is incredible how the organization name came to me. So many people were saying to me how awful it is when someone dies so young and how much they will miss their loved one. I kept hearing the name "miss." That's how the name MISSD came to me. It stands for The Medication Induced Suicide Prevention and Education Foundation in Memory of Stewart Dolin.

After choosing the name, I gathered together close friends and family and was privileged to have the incredible Kim Witzcak as a board advisor. I have the best and most dedicated board. Since akathisia is what killed Stewart and very few people had ever heard of it, including health care providers, we decided our mission would be to educate the public regarding akathisia. The mission of MISSD is simple: To educate the public that when starting, stopping or changing a dosage of a medication like SSRI's, the drug side effect akathisia can occur. MISSD highlights the symptoms of akathisia and what to do if you are experiencing akathisia. We are a non-profit organization and take no money from pharmaceutical companies. This is important to note because many nonprofits do take money from the pharmaceutical companies and I believe this can create an unethical relationship.

MISSD presents at local, national and international conferences. We have created a booth and have exhibited in conference halls at too numerous to count. Last year our organization created an animated video about akathisia which has received almost 15,000 hits. In addition to the educational booth, pamphlets have been produced in English and Spanish that communicate the warning signs of akathisia, and we also have power point presentations. Two months ago my incredible board members and I presented at Loyola University Graduate School of Social Work.

MISSD is obviously near and dear to my heart. MISSD has saved lives and provided comfort to many people who have experienced such terrible loss.  We have a "Share" link on our MISSD website, and I keep seeing similar stories posted over and over again. They always start out "My loved one was fine, and then, gone, out of the blue, with no explanation." In the middle of the trial, a woman texted me stating her husband ended his life after starting Paxil. I believe he was prescribed Paxil not for depression, but in an attempt to deal with side effects from chemotherapy. As I keep hearing these real stories, it makes me more determined to spread the word of MISSD.

We are particularly interested in working with military groups given that the military suicide rate is at a record high. MISSD believes there is a correlation between the number of drug cocktails our veterans are prescribed and the increases in suicide and suicidality. In March, MISSD helped sponsor an event called "K9's for Veterans" where I talked to more than 400 military vets and their family and friends regarding akathisia.  After I had spoken, so many people came up to me and said thank you. They said, "that happened to me" or "It happened to someone I know." MISSD is important to my board and me because it is helping prevent needless deaths. We are all so proud and thankful for our supporters who have helped us make a positive impact. I believe MISSD is the first organization in the world to raise awareness about akathisia. We are a safe patient advocacy group. When we all realized Stewart's death could have been prevented, MISSD was our way to take action. Our knowledge of akathisia became a defining moment in all of our lives. We had to share this side effect so that the public can be better informed than we were.

What sort of response have you had from the launch of MISSD, have you come across any opposition from regulators or pharmaceutical companies?

No opposition from any regulators. At one point in my lawsuit, GSK wanted information on my board members, donators and GSK attorneys (either Andy Bayman or Todd Davis) presented print outs from our MISSD website. They wanted MISSD to be explored. Judge Zagel promptly stated MISSD was out of the lawsuit. The fact that GSK was worried about MISSD was gratifying because it confirmed we were shedding light on a subject they preferred to keep hidden.

The recently released MISSD video surely helps spotlight akathisia. What has been the overall response from the video?

Fantastic. We realized that if we were going to present to schools, hospitals, etc., we needed a powerful educational tool. We wanted a tool that was simple, short, and to the point. The video is creative and state of the art. Wherever we show the video, it is always very well received. It has been incredibly gratifying how well we have been received by the public. I think this is due in part because MISSD is not anti-drug, it is simply dedicated to raising awareness of akathsia and saving lives. Our mission resonates with so many people. Everything MISSD does is done very professionally, and we are viewed as a very important safe patient organization. Our initial fundraiser was primarily attended by friends, family members and associates of our board members. This is no longer the case. Today MISSD events are well attended, and I meet many new people for the first time at every event. They explain that they first found MISSD online as an important resource after their loved one died from prescription drug-induced akathisia. The families of akathisia victims who attend MISSD events come from all backgrounds and all parts of the country. We usually have more than 300 people at each event.

You've had many people visit Chicago from across the world, some of them also have tragic stories regarding the loss of loved ones due to prescription drug-induced akathisia. When did you realise the extent of this problem? 

When Kim Witczak presented the Selling Sickness conference in Washington, D.C. in 2013, I met many people, such as Mathy Downing and Sara Bostock, who lost loved ones to akathisia. This was important as I started to realize I was certainly not alone.

Later when I spoke in Copenhagen with Kim and Mathy and met Steffini Lynch and Leonie Donnelly, it further emphasized this was a universal problem. Recently as the MISSD presence has expanded, I realize that through our website many people have come to Chicago to MISSD events and found comfort and support from the mission of MISSD.

The jury unanimously agreed that GlaxoSmithKline is liable for not updating the Paxil label regarding the increased suicide risk created when adults take Paxil. In essence, the jury stated they believe, after hearing all the evidence presented by both sides, that Paxil caused Stewart's suffering and death. Furthermore, the jury believes GlaxoSmithKline knew about these potential risks yet failed to warn consumers.

During the trial it came to light that 22 patients died in Paxil clinical trials, 20 of these died by suicide, and the other two deaths are suspected to be suicides. All 22 victims were taking Paxil at the time, and 80% of these patients were over the age of 30. GSK likes to argue that it was an "illness" that caused these deaths and not Paxil. What would you say to the surviving family members of these clinical trial victims if you had a chance to meet them?

That is a great question because it brings up so many issues. GSK talks at length about underlying illness. Yes, there are people that kill themselves because they have had a lifelong history of mental health issues. They struggle and medications have been life-saving in many situations. However, when you talk to love ones of people who died from akathisia you hear from many of them that the drugs were prescribed for issues such as insomnia, test anxiety, or situational stress. The drug companies seem to want to pathologize what it means just to be human.

During the trial, my sister sat through opening arguments and texted me, "I don't know who they are talking about." GSK tried to create a view of Stewart that quite frankly didn't exist. But specifically, regarding prescription drug-induced suicides, I would tell the surviving family members to realize the death was not the fault of their loved one.  People sometimes say that when someone ends their life, it was their choice. I am not sure that that is a correct statement either. But death by akathisia is not a choice. It is not a suicide. It is a fatal drug reaction.

Additionally, I would tell surviving family members to get involved. There is a favorite quote of mine from the anthropologist Margaret Mead, "Never doubt that a small group of thoughtful, committed citizens can change the world; indeed, it's the only thing that ever has." Talk to others, spread the word regarding akathisia, contact government agencies. As we learned from this lawsuit, GSK blamed the FDA; We need to be proactive and contact our regulatory agencies to say inadequate warnings are just not acceptable. What this lawsuit has shown is that akathisia is a real, legitimate adverse drug reaction. The public needs to be aware of akathisia signs and symptoms.

Do you have any advice for consumers who are considering pharmaceutical industry litigation?

I think the person has to be aware that this process is emotionally and physically difficult. In addition to having the necessary courage and conviction, it is imperative to have top lawyers. My lawyers from Baum Hedlund and David Rapoport were incredible. They are professional and highly knowledgable. But they are also amazing human beings who understand the injustice that was done to Stewart. Our work together felt less like a lawsuit and more like a personal journey and commitment shared by all of us.

We know Glaxo is appealing the verdict. This means the funds the jury award for Stewart's avoidable death and suffering will be held until the appeal process is finished. There have been a few online comments left on media articles in which a few posters have suggested this trial is just about money. How do you respond to people who suggest such?

I always want to respect people's divergent opinions, and I can understand from the outside looking in one interpretation of the lawsuit might be that is about money. However, this notion is furthest from the truth. I would hope these individuals actually understood what critical information was highlighted in this trial because this information affects their lives as well as Stewart's. I hope people would educate themselves regarding drug safety, drug studies, the role of the FDA, generics, etc. The vast majority of people have had very, very positive reactions to the verdict. There will always be people who disagree, and that is their prerogative.

I knew from the moment this lawsuit was filed that GSK was always concerned that this was a generic drug.  I was told before we even went to trial, that, if GSK lost, they would appeal. In fact, I believe there was a lawyer in the courtroom for GSK that was there for the sole purpose of  gathering information to start the appeal process. Appeals take several years and, of course, I could lose on appeal. It has been suggested that GSK wants to take this case to the Supreme Court because they are so afraid of what this guilty verdict means. As it stands, the legal ramifications for this verdict are so damaging for pharmaceutical companies that reaching the Supreme Court is very possible. That could take 5-7 years.

Clearly this case has never been about money. For me, it has always been about awareness, highlighting akathisia and ultimately changing the black box warning to include all ages. If those individuals who think this case is about money actually read the entire articles, they would learn about MISSD and all the work I do to increase akathisia awareness. While I am eternally grateful to the generosity of our supporters, I have also used my own resources to help educate the public about akathisia. I do this in honor of Stewart and to help others avoid similar tragedy.

Thank you, Wendy.

Please, if there is anything you want to say to the readers of my blog, feel free to do so.

I am so grateful to the overwhelming support of many people from all over the world. A special thanks to you, Bob, for all you have done over the past years to raise awareness of drug side effects, specifically akathisia, and my lawsuit. You have devoted so much of your time and resources to this case, and I am eternally honored by your efforts. You are remarkable. Thank you so much.

Links

What is Akathisia? (Short Educational Video)

MISSD

Baum, Hedlund, Aristei & Goldman

Rapoport Law Offices, P.C

Dolin Vs GSK Paxil Trial Court Transcripts

Dolin v. GSK Paxil Trial Exhibits

--

Dolin Vs GSK Blog Coverage

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

--








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





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