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


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

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

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

  1. Ed Silverman

Author affiliations

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

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

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

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

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

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

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

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

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

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

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

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

References

Wendy Dolin: “…GSK would stop at nothing to intimidate me…”


Reading through Bob Fiddaman’s latest post (an interview with Wendy Dolin)- I can’t help but be struck by Wendy’s admirable bravery and courage in the face of a continual onslaught of  attempted character assassinations and intimidation towards her by GlaxoSmithKline.

To say that GSK (and the money hungry, blood thirsty lawyers, academics and doctors on their payroll) are abhorrent, reprehensible and sociopathic, would be putting it very mildly.

In my opinion, GSK behave in an utterly evil manner.

They hid the side effects of Paxil (Seroxat) through manipulation of their clinical trials and data. They failed to warn properly of the dangers of Paxil induced Akathisia and suicide. They were found responsible (and liable) for Stewart Dolin’s death in a US court of law. Furthermore, despite GSK’s lawyers relentless attempts to undermine Wendy (plus her family and friends), and the attacks on Stewart’s memory,  she maintained her dignity and resolve.

Her moral and ethical strength is remarkable.

GSK could learn a lot about humanity from Wendy Dolin.

Read Bob’s latest post (below) for a poignant and moving interview with Wendy.


http://fiddaman.blogspot.ie/2017/04/exclusive-interview-with-wendy-dolin.html

Tuesday, April 25, 2017

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

Fiddaman Blog: Dolin Vs GSK


Well done to Wendy, her legal team, and Bob Fiddaman! (and Leonie, Kim, Steph and the others) Great to see justice being served!


Thursday, April 20, 2017

Dolin Vs GSK – The Verdict

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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)

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.


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

Victory For Wendy Dolin! GSK must pay $3 mln in generic Paxil suicide lawsuit..


http://www.nasdaq.com/article/gsk-must-pay-3-mln-in-generic-paxil-suicide-lawsuit-us-jury-20170420-01702

GSK must pay $3 mln in generic Paxil suicide lawsuit: U.S. jury

 

sonreuters.com; Twitter @nateraymond;

+1-617-856-1312; Reuters Messaging:
nate.raymond.thomsonreuters.com@reuters.net))

GSK must pay US$3 million in generic Paxil suicide lawsuit: US jury

REUTERS: GlaxoSmithKline must pay US$3 million to a woman who sued the drug company over the death of her husband, a lawyer who committed suicide after taking a generic version of the antidepressant Paxil, a U.S. jury said on Thursday.

The jury’s award followed a trial in federal court in Chicago in a lawsuit over the death of Stewart Dolin, a partner at Reed Smith LLP who jumped in front of an oncoming commuter train in 2010 after taking a generic equivalent of GSK’s Paxil.

The verdict by the nine-member jury in favor of Dolin’s wife, Wendy Dolin, was confirmed by GSK, which said in a statement it was disappointed and planned to appeal.

“GSK maintains that because it did not manufacture or market the medicine ingested by Mr. Dolin, it should not be liable,” GSK said. “Additionally, the Paxil label provided complete and adequate warnings during the time period relevant to this lawsuit.”

Brent Wisner, a lawyer for Wendy Dolin, said his client was “very pleased” with the verdict, adding that “justice has been served.”

Wendy Dolin filed the lawsuit in 2012 against London-based GSK and Mylan, which manufactured paroxetine hydrochloride, the generic version of Paxil her 57-year-old husband was taking before his suicide.

A federal judge dismissed Mylan from the lawsuit in 2014 but allowed Dolin to proceed against GSK because it controlled the drug’s design and label, which applied to both the brand-name and generic versions of the drug.

The label included a “black box” warning that paroxetine, like all SSRI-type antidepressants, can increase the risk of suicidal behavior by users under age 25.

At trial, Dolin’s lawyers had requested US$39 million. They alleged GSK had evidence paroxetine increases the risk of suicide by older users by as much as 670 percent, yet failed to include that on the warning label.

In his opening statement on March 14, GSK attorney Andrew Bayman said the label was appropriate and its wording was mandated by the U.S. Food and Drug Administration.

The case is Dolin v. GlaxoSmithKline, U.S. District Court, Northern District of Illinois, No. 12-cv-6403.

(Reporting by Nate Raymond in Boston and Barbara Grzincic in Baltimore; Editing by Cynthia Osterman)

Andrew Bayman, King & Spalding (GSK’s defence team)’s absurd and ridiculous closing statement..


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

Andrew Bayman, King & Spalding (GSK’s defence team) during closing arguments to the jury yesterday…. ”

http://fiddaman.blogspot.ie/

Andrew Bayman (lawyer for King And Spalding’s -Paxil defense for GSK- in the Stewart Dolin ‘Paxil/Seroxat Induced Suicide trial’) uttered possibly the most absurd and ridiculous thing I have ever heard in relation to Paxil (and believe me- after ten years blogging I’ve heard it all).

He said:

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

I find this statement hilarious. There has been 4 BBC Panorama documentaries about Seroxat (Paxil) and numerous blogs, documentaries, etc over almost two decades now- all documenting the dangers of Paxil and SSRI’s. There are dozens of SSRI support groups online, and much media attention of their dangers over the years. I’ve been blogging for ten years about the dangers of Paxil and other SSRI drugs (there’s over 1000 blog posts on here).

Bob Fiddaman has been blogging just as long about the same issues. Seroxat Secrets blogged for the guts of several years also about the dangers of Paxil/Seroxat (and his recent post shows that he is still speaking out!).

People have been speaking out for almost two decades. Thousands of people, tens of thousands of people actually….


See Seroxat Secrets- Below- and  here

Yes, I know it has been a while…

I’m just in the process of looking back at my time on Seroxat and my withdrawal from it. I can’t say what for at the moment, but watch this space….

Looking back at my blog I can remember how important it seemed at the time to use the internet to get the message out there that there were problems with Seroxat. Of course, over the past 11 years we have come to understand that there are problems with many SSRIs and other drugs. There are also problems with the way big Pharma goes about its business – from rigging drug trials to marketing unsafe drugs to the public.

I’m lucky, I have been able to move on in my life and I leave this blog on the internet to help anyone who is suffering the same way I did in the hope it may be able to help in some small way.

Back in 2005/2006 there was a only handful of us who were using the internet to warn of the problem of Seroxat. Happily now there are far more people and organisations that write about this subject and I hope it’s more widely known by the general pubic and medical professionals alike.

If you haven’t visited these sites, you should:

Leonie Fennell

Dr David Healy

AntiDepAware

GSK: Licence to (K)ill

The Pill that Steals

There’s a trial going on the US at the moment – the crux of the matter in Dolin Vs GSK is whether or not Paxil (Seroxat) caused Stewart Dolin to kill himself whilst under Paxil’s influence – and just what GSK did to hide the truth about the dangers of their drug.

The trial is being covered the mainstream media and by Bob Fiddaman on his blog, and below here are some links to the story so far.

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

I think that both Bob and I enjoy watching GSK squirm, but what’s important from a wider perspective is the way that a trial brings previously secret information into the public domain. Each trial that takes place opens the curtains a little wider.

I hope that the trial will bring closure for Stewart Dolin’s widow, Wendy. What GSK and their lawyers always forgets is that are real people and real tragedies at the sharp end of the unsafe drugs they choose to bring to market and make huge profits from.

There’s also an action nearing trial in the UK at the moment, and as I wrote previously: The publicity of a High Court hearing will mean the mainstream press  will be free to report on ALL the evidence presented. Now… I’m thinking that this will mean a lot of GSK documents that have until now remained secret will become very public knowledge. You see a case like this, while common in the USA, is unheard of in the UK and the publicity it will generate will be huge. And all those once-secret documents and the information they hold will be available the world over for future claimants to use. I think a whole new raft of claims will be kick-started in the USA alone. I wonder what GSK’s share price will look like after all this? And how institutional investors will view a company that breaks the law and lies & cheats its way to profit?

In the 21st century, ethos & culture – the way a company actually operates and conducts its business – are as important to a PLC as having a blockbuster product to sell. Ethos & culture are intrinsic parts of a modern corporate brand, going way beyond the generic, meaningless mission statement that we see from GSK “…to help people do more, feel better, live longer”.

I’d like to finish on a personal note. Perhaps, after all these years, I’m getting nearer to closure. For me, that simply means people will believe what happened to me was real.

More importantly, I hope that Doctors will understand what happened to me was real – and perhaps then we can start to help others who are going through the horrors of withdrawing from Seroxat/Paxil today.


 

There was even a protest some 12 years ago. A Paxil survivor, and activist, Rob Robinson, was so enraged about Paxil that he flew a plane around GSK’s Philly HQ!…

See the pics below from the Paxil Protest (see the archive here)

 

 

Consumers Join Forces to Protest Against Antidepressant Paxil and Kickoff Boycott of Drug Company GlaxoSmithKline (press release)

Monday, September 12, 2005
by Mike Adams, the Health Ranger
Editor of NaturalNews.com (See all articles…)
Tags: pharmaceutical fraud, health news, Natural News
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Consumer drug advocates from across the United States, Canada and elsewhere are converging on drug giant GlaxoSmithKline’s US corporate headquarters located in Philadelphia, PA this September 26th through 28th in what could turn out to be a massive demonstration against the company’s top selling drug called Paxil. The event is called the “Paxil Protest.”

“Paxil is a dangerous and defective drug. That is absolutely the case,” said Rob Robinson, the event’s organizer. “The swath of devastation, misery and sometimes death which Paxil has unleashed the world over is simply staggering. Yet GlaxoSmithKline has done everything in its power to keep the sinister truth about Paxil from going public. What’s at stake for the company is a multibillion dollar revenue stream that sales of Paxil have generated for almost ten years.”

“GlaxoSmithKline has claimed since 1992,” Robinson said, “that Paxil is ‘safe and effective’ after it was approved by the Food and Drug Administration — end of story. But it’s the beginning of the story which GSK conveniently forgets, or rather doesn’t want the world to know about, and that is the fact that Paxil’s FDA approval was based on the company’s submission of fraudulent Phase III clinical trials. As such, GSK’s claim that Paxil is ‘safe and effective’ is specious at best.”

“The truth is Paxil represents the greatest fraud ever perpetuated within the pharmaceuticals industry,” Robinson said. “But thanks to the unsparing efforts of attorneys representing Paxil victims evidence of this fraud has been uncovered in GlaxoSmithKline’s confidential files. One trial and it all comes out. And that is going to be one huge news story — on the order of Merck’s Vioxx.”

A much anticipated Paxil trial set to take place May 2nd of this year was delayed for at least another six months. Robinson says he is not surprised: “GSK has spent hundreds of millions of dollars fighting to keep the truth about Paxil from coming out, but at the end of day I’m confident the company’s efforts will fail.”

Approximately 5,000 U.S. citizens have filed suit against GlaxoSmithKline asserting they became addicted to Paxil and then suffered withdrawals when quitting the drug as a consequence of the company failing to warn them of the drug’s dangers. Several thousand more persons have sued GlaxoSmithKline in the UK on the same basis. “Paxil’s reach extends into medicine cabinets the world over, and cuts across all social classes,” Robinson said. “Paxil is an equal opportunity destroyer.”

Some lawsuits filed against GlaxoSmithKline are on behalf of patients who started Paxil — only to discover they could not stop taking the drug, even with expert medical help. (One patient in Britain was told by her doctors that ‘heroin would have been easier to wean [herself] off and recover from.’)

“Paxil withdrawal symptoms can be so severe and protracted it requires an almost superhuman strength to endure them,” Robinson said. “Not surprisingly, some people cannot, and as a consequence commit suicide. Others victims have resumed use of Paxil to escape withdrawal symptoms, but will have to take the drug for the rest of their lives whether they want to or not. In other words, they’ve become lifetime Paxil addicts.”

Robinson stated that a review of the medical literature shows that, on average, over one-third of people taking Paxil for any extended period of time experience withdrawal symptoms, and of those, 21% experience severe withdrawal symptoms. In the clinical trials of Paxil, a significant percentage of patients (up to 50% according to some studies) experienced withdrawal.

“There is a huge disconnect between what GSK tells the public about Paxil, and what the truth about Paxil is. That disconnect extends to GlaxoSmithKline’s labeling of the drug throughout the world. GSK is a very big company with an even bigger problem of telling the truth,” Robinson said.

In an October 19, 2000 deposition taken of Dr. David Wheadon, Senior Vice President of Regulatory Affairs and Product Professional Services for GlaxoSmithKline, Dr. Wheadon stated “there have been a number of systematic studies in humans looking at the potential for Paxil for abuse, tolerance and physical dependence. So actually, there is data to date to negate the statement that it has not been systematically studied, because, in fact, it has been.” However, Paxil’s June, 2005 drug labeling states “Paxil has not been systematically studied in animals or humans for its potential for abuse, tolerance or physical dependence.”

At the time of Dr. Wheadon’s testimony Paxil’s U.S. drug label claimed: “Paxil is non-habit forming, may cause mild, usually temporary, side effects in some individuals” and further that Paxil “has been studied both in short-term and long-term use and is not associated with dependence or addiction.” “Those claims are now known to be utterly false,” said Robinson.

“No discerning member of the public, or the press, will believe that Dr. Wheadon was simply mistaken or ill-informed at the time of his year 2000 deposition,” Robinson said. He (Wheadon) knows as much about Paxil as anybody at Glaxo; all one has to do is peruse his sworn testimony to see that’s clearly the case.” (Access Dr. Wheadon’s complete testimony at the Paxil Protest web site.)

Dr. Wheadon’s association with Paxil spans two decades; he was part of the original GSK team which presented Paxil’s clinical trials during the FDA’s October 5th, 1992 hearing wherein the company first sought — and later gained — the agency’s approval for the drug.

A Paxil Protest web site, launched on August 8th, 2005, has already received over a quarter of a million ‘hits.’ “The response from the public has been one of exuberance. Which is hardly surprising given the fact that this represents the first time in history a multinational drug company has successfully been targeted using the Internet as a public relations weapon,” Robinson said. “The Internet is providing the public the matchless ability to organize and direct participants ‘on the ground’ and to further respond in real time to a highly fluid and dynamic public relations environment. It’s almost like having the equivalent of an AWACS radar plane circling over a public relations battlefield.”

The Paxil Protest web site, well organized and easy to navigate, lays out a compelling indictment not only of Paxil, but also of GlaxoSmithKline. “Virtually all of what you’ll see at the Paxil Protest web site was assembled from news stories, medical journals, depositions and the like. It was simply a matter of pulling all the facts together into one big package for the public,” Robinson said. “I challenge GlaxoSmithKline to dispute the accuracy and veracity of anything published to the web site.”

The Paxil Protest web site also includes important information for Paxil users who might wish to quit the drug. “What I did not want to have happen is to have Paxil users come to the site, panic, and then abruptly quit the drug. The consequences could be disastrous. That’s why an entire web page addresses the issue of how to get off Paxil safely, or as safely as possible.”

“I am confident the public as well as the media will discover information that is newsworthy and highly informative on virtually every page of the Paxil Protest web site” Robinson said. “Plenty of story angles to be had,” he added.

Robinson, a Paxil survivor himself, said it took several years of intermittent but intensive research to assemble the information presented at the Paxil Protest web site. “My goal was to make it as easy as possible for the public to get to the truth about Paxil — the sinister truth which GlaxosmithKline hides from the world.” He describes the Paxil Protest web site as ‘the definitive Paxil Information Clearinghouse.’

As many as 1,000 or more protesters might attend the Paxil Protest. “We simply have no way of forecasting how many people might show up; after all, the call to action is going out the world over,” Robinson said.

Victims and survivors of other SSRI drugs such as Prozac, Effexor and Zoloft are also expected to attend in a show of community support.