Change in Chicago: The Dolin Verdict

May, 1, 2017 | 22 Comments

Comments

  1. Johanna, what an excellent piece of work – on a topic that gripped the rest of us for most of those six weeks of the trial. The outcome, of course, filled us with a sense of triumph – here at last were twelve people who, after listening to the evidence, came to the conclusion that matches our experience. It is satisfying in the extreme to read – but, as you rightly ask, where will it now lead us? Stewart Dolin and all others who died because of Seroxat, or other SSRIs were absolutely overwhelmed by the adverse reactions; many others remain unwell due to the same unwelcomed situations experienced on these drugs – what can be done to ensure that this situation stops at the present rather than perpetuating from generation to generation? Wendy Dolin is determined to do her best in educating the public of such problems – I’m sure that we all wish her the very best in her drive for honesty through the MISSD website. Here in the UK, I fear that the whole situation will drag its feet on and on with very little change. If – and it’s probably a very big ‘if’ – all labelling and PILeaflets were changed, what then? Shouldn’t we expect the media to cover the outcome of this trial in some way or other? I remember, when the change was made regarding the warning for adolescents in 2014 or thereabouts, being contacted by the media for my view on the change. My comment was that it was a welcomed addition but did not go far enough – that it should have included those beyond adolescence. If they were prepared to televise that, at that time, why are they so shy of speaking out about what has now been made public?

    • The date should have read as 2004 (not 2014) by the way – just incase anyone thinks that Welsh language media takes ten years to find people willing to comment on a change such as this!

  2. Had also meant to add that Bob Fiddaman’s blog posts from the trial had been marvellous – put us straight in the picture and kept us there to trial’s end. Thanks Bob. Maybe the UK press would like a copy of these from you Bob – so that they can really show the whole country how it went out there!

  3. Thanks for the well-written ‘overview’, Johanna.

    Those of us who have followed Bob in the Court Room in Chicago all the way from Birmingham with the cohort of ‘supporters’ who were those who had lost ‘loved ones’ with similar sounding ‘psychiatric’ drugs – are pretty much up to speed.

    I found it ‘odd’ that an Indian Doctor suggested to a mental hospital that I had ‘psychological’ problems’ when really he should have been flattered that I chose him to tell about a ‘driving licence’ fiasco .. we had actually bought our house on the loch from his predecessor who had bought it as a property investment .. lucky us, driving around country lanes and finding this little gem ..

    I also found it ‘odd’ that a psychiatrist should prescribe me Seroxat with much fanfare and excitement on his part and then write a critical letter to the Indian Doctor explaining about ‘blood levels’ on cessation and not have the wit to tell his patient.

    How ‘odd’ that he and his new elderly lady associate should ignore this letter and when I go through a ‘Stu Dolin experience’; I am verbally hammered to within an inch of my life.

    Flinging all manner of drugs at me for nearly two years, the aftermath, or, bloodbath, eroded all my relationships with everyone I had ever known and almost caused three family members to have breakdowns watching it play out.

    I am naturally disgusted that from the Paxil Launch in Hawaii to GlaxoSmithKline making billions without a shred of being contrite, for parents to lose their children to Paxil, and, adults either dead or forced to swallow it, as they cannot stop – how ‘odd’ that I survived ..

    Everyone will be asking – what now?

    Will the industry take note?

    I thought Wendy’s $3m a poultry sum for losing her husband.

    For GlaxoSmithKline to appeal was obviously going to happen.

    They just don’t know when to stop ..

    The Doctors turned me and my life and my wee family in to a ‘laughing stock’ and my suggestion would be to have one Witty A. in the Dock in the UK just to simply ask him why he didn’t step in to halt the ‘executions’ ..

    The whole thing stinks like rotten eggs – we are all nomads now…me non existent ‘the caravan life for me’, my daughter, now 24, backpacking all on her own in India looking for ‘meaning’ and my ex who has never stopped sending me Christmas cards, Birthday cards, constantly telling me ‘he doesn’t understand what went wrong’ and I am too humiliated to even answer ..

    FGS..GSK!

    PS and don’t start on telling me my doctors were to blame .. despite their own criminal activities, you never told them Adults could be suicidal and that is the bottom line ..

    David Carmichael
    ·

    I got back yesterday from the start of the Wendy Dolin vs. GSK trial in Chicago. I was able to watch the opening arguments and the first expert witness for the plaintiff, David Healy, testify for two days. Prior to David Healy’s testimony, there were three video depositions of former GSK executives shown to the jury from previous Paxil suicide cases that, based on the documents shown during David Healy’s testimony, were disturbingly misleading. These videos have now been uploaded to the Baum Hedlund (one of firms representing Wendy Dolin) YouTube channel. They had not been shared publicly before the trial.

  4. Wendy what a lovely photo of you and your husband, I am truly very sorry for your loss. Well done for standing up to this big company, you were incredibly brave. I am disgusted at how you and your family were treated. I also hope that now it has been proven that they will put the warning on the Pil to warn against suicides in adults in the future.

    Thank you Wendy for all you done in helping to protect patients in the future.

  5. Thank you David Healy and RxRisk. Got chills reading this. While nothing will bring Mr. Dolin’s back or take away his family’s pain, I’m very excited that they won. And it gives me some hope about the future for change!

  6. Dear Scott Gottlieb: Add new warnings to Paxil labels. You may save a life

    By Ed Silverman @Pharmalot

    May 1, 2017

    https://www.statnews.com/pharmalot/2017/05/01/paxil-suicide-warning-fda/

    Glaxo “had the option to go further, but chose not to do so,” said Dr. David Healy, a Bangor University psychiatry professor who helped spearhead a campaign to upgrade suicide warnings on antidepressants, and who served as an expert witness on behalf of the widow in the recent trial.

    So, Dr. Gottlieb, as you look over your to-do list, consider the lack of information in the Paxil labeling. And move to fix it. You might save a life.

  7. Further Reporting – UK MHRA

    The Dolin .. Verdict ..

    Tuesday, May 02, 2017

    MHRA Yell “Barracuda!”

    http://fiddaman.blogspot.co.uk/2017/05/mhra-yell-barracuda.html

    “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.”

    Navigating Choppy Waters ..

    • The MHRA seem to have a stockpile of printed matter at the ready for when members of the public dare to question their actions. When in correspondence with them, it feels as if they initially take an answer from the first pile then, when you dare to reply, showing dissatisfaction, they seem to take a reply from another pile – being more or less a paraphrase of their first response. This continues, until – in my case – you give up. That is where Bob is different. He does not give up. He continues, like a dog with a bone, until the reply he worked for is given – or at least all possible alternative replies are exhausted. The little word ‘yes’ seems missing from MHRA vocabulary; quite possibly ‘no’ is another missing word!

      • Same as writing to MP’s Mary, their very nice to you and they even write to the dept of health for you. You then get this standard letter back that looks as if it was written for anyone who writes in to complain. They just edit a few things like putting your name in and maybe the odd sentence to make it look more personnel.

        All a load of crap really, no intention of helping you at all,

      • It’s still a head-scratcher for me, Mary.

        – Confirmation from the MHRA that they knew about the 22 deaths in Paxil clinical trials, of which 80% were over the age of 30.

        – Confirmation from GSK’s Dr. David Wheadon that no deaths occurred in pediatric Paxil clinical trials.

        Then a warning label that highlights the suicide link in persons under the age of 24.

        It makes no sense.

        Then, if we look at the MHRA’s CEO, Dr. Ian Hudson, we see that in 2000, during a deposition, and whilst working for GSK as their World Safety Officer, he claimed he had seen no evidence to suggest that Paxil “caused any person, worldwide, to commit an act of homicide or suicide.”

        He’s had 17 years to rebut that statement. One would feel that as a cheif executive of an agency put in place to protect the public from unsafe drugs that he would have spoken up.

        Yup, it’s a head-scratcher.

        • All I can say, Bob, is that their understanding of the word ‘truth’ is rather difficult to make out. As Anne-Marie says, they all dish out the same type of rubbish in an attempt to pacify us. MPs contact the MHRA ‘ on a constituent’s behalf’, sounding as if they are on your side. Eventually, they receive a reply, send you a copy and consider the job done! No wonder this country is in such a mess if that is the accepted standard of communication at the top! We, in Wales, have an added complication of course – health matters are covered from Cardiff but our MP sits in Westminster. I suppose letters to us, from our MPs, cause them to have to add an extra sentence to point this out – just incase it had slipped our notice! I could accept that, if I were writing on a specific Welsh health matter – but it makes no sense when it’s to do with the MHRA, GSK or any other aspect to do with UK- wide problems. It’s just another ploy to silence us I guess.

  8. ‘Learned Intermediary Doctrine’ ..

    Wendy Dolin Takes on GlaxoSmithKline And Wins — For Now at Least

    By

    Jim Gottstein, JD

    May 2, 2017

    A Harvard-educated lawyer and long time activist for change in the mental health system writes about law as it relates to psychiatric rights

    https://www.madinamerica.com/2017/05/wendy-dolin-takes-on-glaxo-smith-kline-and-wins/

    “there is a legal principle shielding drug companies called the “Learned Intermediary Doctrine” which establishes that the doctor, with access to full information, recommended the prescription-only drug after carefully weighing the risks and benefits. The primary official way that doctors are told about the risks of a drug is through the FDA-approved “label.” The drug manufacturer can also issue what is called “Dear Doctor” letters alerting them to risks.

    But if the drug manufacturer withholds information, then one can get over the Learned Intermediary hurdle. That is the crux of this case. The argument is that because the manufacturer did not tell the doctor about the substantial risk of suicide, the Learned Intermediary Doctrine does not apply.”

  9. Great post, thanks Dr Healy.

    Also thanks to Wendy Dolin for bringing this case against Glaxo. It takes guts to go against a huge company like Glaxo. Great verdict in the fight for justice and truth about Seroxat/Paxil. Fair play to all those who fight the good fight.

    I have written extensively about Paxil, and other related issues, for over a decade. What else are GSK hiding/suppressing about Seroxat and other drugs?

    I shudder to to think…

    The Former head of the MHRA admitted that the MHRA have ‘never said that the drug (Seroxat) is safe”..

    https://truthman30.wordpress.com/2012/10/29/kent-woods-mhra/

    https://truthman30.wordpress.com/2015/09/19/the-elephant-in-the-room-seroxat-aropaxpaxilparoxetine-in-the-adult-population/

  10. I often wonder whether staff at GSK, particularly the ghost writers, the KOLs, the attractive young ladies who are sent out to tout their wares (their medications) to gullible and accepting doctors, whether they ever imagine how it would feel to see your loved one die thanks to swallowing their magic pills. I wonder if at the above described trial, anyone ever stood mentally in Wendy Dolin’s shoes and imagined what thoughts would have gone through her head when she was told that Stewart, her beloved husband, had died in the way he did.

    I don’t think they do allow themselves these kind of thoughts. By not thinking, maybe they feel that the blame will never arrive at their door. But they are so SO wrong.

    I’ve just come back from paying a visit to Malvern, Worcestershire in UK. A most beautiful place of high hills, houses huddled together along blossom tree filled avenues, a place where Elgar did his most inspired composing. My son lived there, for ten years, during many of which he endured akathisia on Seroxat (Paxil) and we watched his terrible pain. But he looked up to the hills (I think there is a Psalm that reads like that) and he loved their beauty, and he clung to life and to hope. And we, his mum and dad, watched his terrible suffering, somehow made all the worse because it took place amidst such glorious surroundings, which, because of the akathisia, he could never fully enjoy in a carefree way.

    It kills me to see the Malvern Hills now. It breaks my heart to hear Elgar’s music. I just see my dear son’s brave struggle, and his endless agony when I travel along those lanes, and see all his favourite places. No mother should EVER wish their son dead, but by the end of eleven years of this poignant hell, I admit in my heart I did, because AKATHISIA, unrecognised, unsympathetically kicked away as ‘of little import’ by those who we trust, is too awful for anyone to bear for eleven years without help or hope. Of course, like Wendy Dolin, I didn’t know then what I know now. My ‘child’ was subjected to one of the worst forms of cruelty known to humans. And I stood by in stupefied fear and confusion and watched it happen because I took my orders and understanding from the arrogant utterly stupid doctors, who, in the end, knew nothing very much at all except that their word was law and not to be trifled with. I wonder if GSK and their minions could bear this if it was happening to their loved one, thanks to the greed and lies of others.

    Wendy Dolin will go down in history, along with those who helped her, as someone who through her tenacity, brought hope to countless others like her husband. Above all, she will always be comfortable in her skin, knowing her conscience is more than clear. In contrast, I cannot imagine how GSK can sleep peacefully at night, knowing the hell they have inflicted on so many others, dead and alive.

    • Heather, your description of Malvern is so beautiful – the thoughts that are with you whenever you now visit must be devastating. The psalm to which you refer asks “I lift my eyes to the hills, where will my help come from?……”, so apt for your requirements here. All of you must have repeatedly asked yourselves that very same question. The psalmist, of course, relied on God for his support. How lucky they were – in those days of very little detailed knowledge compared to our rich expanse of information these days – to have such faith and trust in the unseen. We, on the other hand, have so many avenues of communication – and yet have to fight for the right to be given answers to our questions – questions, in the main, based on unexplained situations that we just wish to better understand. Those who play god with such details, acting as if it’s their privilege to determine the partial truths to be safely shared with the rest of us should be thoroughly ashamed of such behaviour. This latest trial verdict should have left no-one in any doubt regarding the facts that were hidden for years. The truth is out – but will it be widely believed? We shall wait and see.

      • Yes, it was Psalm 121 as Mary says, and we said it in our son’s Memorial Service in Worcester Cathedral in 2012. It was chosen partly because of his love for the Malvern Hills, and partly to comfort his many friends who attended and were so devastated by his death. The last verse says ‘The Lord will keep you from all evil, he will keep your life. The Lord will keep your going out and your coming in from this time on and for evermore.’

        This week we read in The Times and the Daily Mail that another young man, like our son, has died after taking the acne drug RoAccutane. ‘Luke Reeves, 21, had never suffered mental health problems before but his parents said his personality changed after he took RoAccutane…..they go on to say they want parents to realise how prevalent these stories are and how dangerous this drug can be. ‘Luke’s parents were reluctant to let him start the treatment after reading about potential side-effects, but they said they relented because he was so desperate to get rid of his acne. But the odds of a long term problem seem high with this medication. “We saw the side-effects but we assumed they were only while they were taking the drugs but for Luke they continued. I thought he was actually getting worse over the years”, Mr Reeves said.’ He developed OCD, sensitivity to high temperatures, became reclusive and irrational. MHRA figures show that between 2012 and 2014, 20 people took their own lives while on the drug. And what about all the others who’d discontinued it but also died?

        At the end of the article, Rav Seeruthun, medical director of ROCHE finally is quoted as admitting that ‘discontinuation of isotretinoin (RoAccutane) may be insufficient to alleviate symptoms.’ Luke’s story is Olly’s story and the story of hundreds and hundreds of others. And there is seemingly literally NOTHING we can do to stop this hellish carnage. ROCHE blames the acne itself for causing the suicides. This might hold water if the acne had persisted. But the acne will have vastly improved. It’s then that the suicides occur, so their argument is utter rubbish.

        So, more memorial services, more devastated families, more parents to join our club of bereaved and furiously frustrated people who are desperate to stop all this, who have explored all the correct mechanisms, year after year, and have ended up back where they started. The Perfect Circle. Hopeless.

  11. Do you suppose the news has filtered down to .. Murray ..

    GSK‏Verified account @GSK 3h3 hours ago
    4:13 am – 3 May 2017

    Publication of negative study results:

    What’s the real story?

    Murray Stewart
    Chief Medical Officer (pharmaceuticals) GSK at GSK

    Sharing research…

    https://twitter.com/i/web/status/859727659458338816

    The credibility…

    https://www.linkedin.com/pulse/publication-negative-study-results-whats-real-story-murray-stewart

    “We must also continue to ensure that where results from early drug discovery studies advance scientific understanding or inform patient care, they are shared openly.

    Transparency is important to the patients that participate in our studies and critical to the credibility of our research. I hope this study will inspire other companies to examine their own publication metrics, and we can collectively set the record straight.”

    # ‘collectively’ set the record straight ..

    Change in Chicago .. what’s the real story ..
    https://www.madinamerica.com/2017/05/change-in-chicago-the-dolin-verdict/

  12. GSK Acolyte wins Gong ..

    https://twitter.com/DrEdFitzgerald/status/860245500754309120/photo/1?ref_src=twsrc%5Etfw&ref_url=http%3A%2F%2Fwww.alltrials.net%2F

    The BMJ Awards 2017: Outstanding Contribution to Health

    BMJ 2017; 357 doi: https://doi.org/10.1136/bmj.j1958 (Published 04 May 2017) Cite this as: BMJ 2017;357:j1958

    http://www.bmj.com/content/357/bmj.j1958

    Ben Goldacre, a doctor with a visible public presence as a newspaper columnist who relished taking on quacks and charlatans, says the experience has proved valuable in his new role as a defender of evidence based medicine.

    “I’ve been attacked and threatened, I’ve been sued, I’ve had people try to bully me, I’ve been followed and harassed at work,” he says. “That’s lucky because now I feel comfortable that facing down bad behaviour is part of the job.” Those who fall short in abiding by the well established rules of evidence based medicine should know that the winner of this year’s BMJ Award for Outstanding Contribution to Health is unlikely to allow their transgressions to go unnoticed.

    Goldacre’s books Bad Science, which sold half a million copies, and Bad Pharma show his sure touch. When Bad Pharma was criticised by the drug industry—which argued that the practices he criticised were all in the past and had now been fixed—Goldacre’s supporters rallied behind him, providing the impetus for the formation of the AllTrials campaign, in which The BMJ has been strongly …

    What’s Behind Ben Goldacre?

    http://www.ageofautism.com/2010/08/whats-behind-ben-goldacre-.html

    From left to right

    Pallab Ghosh – BBC Science Correspondent and Chairman of ABSW
    Dr Ben Goldacre
    Dr Alistair Benbow – GSK

    by: John Stone | August 05, 2010 at 08:01 PM

    MISSD .. Change in Chicago ..

  13. Yes, positive news and Seroxat are seldom heard.

    A small victory, but appeal upon appeal will probably drag this on.

    Good to see some activity on Healys blog again.

    Nice job all of you, especially Fiddaman and all the links that can be found there.

    Atleast I get some hope from you all.

    Ove2017

  14. “Patient safety is our number one priority,” a GlaxoSmithKline (GSK) spokesperson tells me. “We believe we acted responsibly in researching paroxetine, monitoring its safety once it was approved and updating its labelling as new information became available.”

    Healy, who has been a consultant for, and expert witness against, most of the major pharmaceutical companies, has long argued that long-term side-effects are routinely ignored or misunderstood.

    https://www.theguardian.com/society/2017/may/06/dont-know-who-am-antidepressant-long-term-use

    In 2001, a landmark report on a clinical trial into paroxetine (sold as Seroxat in North America and Paxil in the UK),

    Attention to Detail…Guardian…Paxil in North America and Seroxat in the UK.

    https://www.theguardian.com/news/2002/jul/27/uknews

    Sarah Boseley, health editor
    Saturday 27 July 2002 02.05 BST

    https://www.theguardian.com/news/2002/jul/27/uknews

    Seroxat, the British-made antidepressant which outsells Prozac, causes more people distressing withdrawal problems when they try to stop taking it than any other drug in the UK.

    ‘The Guardian’ ..

  15. As a trained journalist and mother who lost her nineteen-year old daughter to Zoloft-induced death, I attended several days of the Dolin trial with the eyes of a communication specialist and the broken heart of a grieving parent. That the word “akathisia” is being better publicized is critically important. For some unwitting health “care” consumers, such as my late daughter, Natalie, the word could have meant the difference between life and death. I do what I can to publicize, advocate and educate. Great to see this article and other media references to akathisia. That the Washington Post published my recent letter to the editor about the FDA which included the word “akathisia” is gratifying, yet I realize it was published only because it fit with their current Trump rants. Nevertheless, the word “akathisia” is slowly gaining coverage. Let’s hope prescribers read about it. https://www.washingtonpost.com/opinions/is-trumps-fda-nominee-too-cozy-with-industry/2017/04/28/8eea46ec-2b53-11e7-9081-f5405f56d3e4_story.html?utm_term=.408caa3bce4e

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