Akathisia Stories, a co-production of MISSD and Studio C, is a podcast series that features interviews and news concerning the adverse drug reaction akathisia and medication-induced suicide.
MISSD, the Medication-Induced Suicide Prevention and Education Foundation in Memory of Stewart Dolin, is a unique non-profit organization dedicated to honouring the memory of Stewart and other victims of akathisia by raising awareness and educating the public about the dangers of akathisia. MISSD aims to ensure that people suffering from akathisia's symptoms are accurately diagnosed so that needless deaths are prevented. The foundation advocates truth in disclosure, honesty in reporting, and legitimate drug trials.
On this episode, we hear from author, blogger, researcher, and self-described humanist and humourist Bob Fiddaman. His eponymously titled blog has focused on drug company and regulatory malfeasance since making its debut in 2006. At the time, Bob, an Englishman living in Birmingham, was taking himself off of Seroxat, a GlaxoSmithKline-produced antidepressant known here in America as Paxil. After making a protracted attempt at tapering off of the drug, he eventually decided to go cold turkey, a course of action he strongly advises against.
The UK Seroxat litigation continues later this week.
Today is a day of rest. Today is also the anniversary of the death of 18-year-old Candian Sara Carlin who died by hanging in 2007. Today, but for Paxil, she would have been 30.
I will never forget Sara, even though I never met her I have an affinity with her and her family.
Last December, I reported on how the legal-based website, Law360, had interviewed King & Spalding's top asshat asset, Andrew Bayman. In the article, Bayman said the Dolin Vs GSK trial, which Bayman lost, was his biggest 'accomplishment.'
Backstories of the trial and Bayman's interview are at the foot of this post.
Yesterday, Law360 flipped the coin and wrote a marvelous piece about one of Dolin's legal counsel, Brent Wisner of Baum Hedlund Aristei & Goldman. The headline reads, "Titan of the Plaintiffs Bar: Baum Hedlund's R. Brent Wisner". Link here (PDF Courtesy of Baum, Hedlund, Aristei & Goldman)
Fitting that Law360 posted this on May 6 as it marked the 11 year anniversary of the death of 18-year-old Sara Carlin who, like Stewart Dolin, died by "suicide" after being prescribed Paxil (paroxetine)
I covered Sara's inquest on a daily basis and, just as I did for the Dolin trial, reported what mainstream media wouldn't. During Sara's inquest, I frequently spoke with her father, Neil. It was trying times for the Carlin's, more so because drug giant GSK decided to attend the inquest by sending its attorneys.
Fortunately, I was able to attend the Dolin trial and witnessed first-hand the brilliance of Dolin's counsel. Wisner (pictured above) and co-counsel, David Rapoport, carefully crafted and delivered evidence to the jury resulting in a victory for Wendy Dolin, the plaintiff and widow of Stewart Dolin. As Rapoport states in the Law360 article, "His witness examinations were consistently to the point, effective, interesting and often entertaining. He created a David v. Goliath atmosphere that I believe contributed to the plaintiff’s verdict."
I can't top Rapoport's words.
Being present at most of the trial, I witnessed two teams in action. Of course, I had a bias for the plaintiff but tried not to let that influence my reporting. It was interesting to see GlaxoSmithKline's attorneys in action as much as it was Wisner and Rapoport. In fact, I wouldn't be surprised if Andy Bayman required knee surgery after the trial due to constantly springing up from his chair at every given moment shouting 'Objection, your Honor!"
Remarkably, during Bayman's summation, he addressed the jury and rhetorically asked: "Don't you think if these medicines caused suicide someone would have spoken up?"
Unfortunately, the dead cannot speak, but prosecuting attorneys such as Brent "Titan" Wisner can and do speak for the dead. Despite GSK's effort to suppress info via its legal team and paint a false and unfavorable description of Stewart, Wisner introduced the real and likeable Stewart to the jury and the jury didn't buy GSK's attempts to falsely label Stewart as "mentally ill."
Stewart did speak during the trial and he continues to speak today through the advocacy work of his widow and the caring law firm whose record against GlaxoSmithKline is most admirable. (Law360 also touched on Wisner's work surrounding his involvement in another case, this time against Monsanto Co.)
Law360 also touched on Wisner's work surrounding his involvement in another case, this time against Monsanto Co.
Wisner, Law360 claim, "leaked internal emails from Monsanto to the New York Times which suggested the agrochemical giant may have tried to ghostwrite academic articles exploring, among other things, the health risks of its products. Wisner obtained the documents from the company in a San Francisco federal court case that alleges the company's top-selling weed killer Roundup causes non-Hodgkin's lymphoma."
I have to take my hat off to anyone who leaks drug company internal emails as for too long such emails have been kept hidden from the public.
The success of the Dolin verdict has opened the door for more Paxil lawsuits and this is a positive step for consumers. Brent's employer's, Baum Hedlund, is now investigating more Paxil suicide cases on behalf of families whose loved ones have taken their lives and/or been harmed while on Paxil.
On September 1, 2017, Baum Hedlund sent a letter to Apotex, the current manufacturer of Paxil and paroxetine, putting the company on notice that the Paxil label is inadequate. For a Free Case Evaluation visit here.
With yet another success against GlaxoSmithKline under their belt, Baum Hedlund are now taking on the might of Monsanto.
On December 26, 2015, Californian farmer, Jack McCall passed away after suffering a massive stroke due to complications from a rare version of non-Hodgkin lymphoma. His wife, Teri, has now has filed a wrongful death lawsuit against Monsanto, claiming exposure to Roundup caused her late husband to develop cancer.
More about Jack McCall and further information regarding RoundUp lawsuits can be found here.
This post is dedicated to the memories of Stewart and Sara, both of whom who should be here today, both of whom whose lives tragically ended after taking Paxil.
Today marks the 10th anniversary of this blog. What started as a gripe against the British drug regulator (MHRA) has led me on a journey, one that I could never have dreamed of.
In 2010, four years into blogging I was at a bit of a stalemate, I was finding it increasingly frustrating trying to get the answers from both GlaxoSmithKline and the MHRA as to why I suffered at the hands of Seroxat. Neither of them, to this day, have ever been able to answer me.
Then it happened. The start, or rather the change in direction of this blog of mine.
I stumbled on a post from Canada. A young woman, known as Sara Carlin, had hit the news ~ her parents were seeking an inquest into her death, a suicide in 2007 - May 6 to be precise.
The date is significant as I will mention later.
I reached out to her father, Neil, and we were soon communicating. Sara, his daughter had been prescribed the very same drug that I was asking questions about ~ Seroxat (known as Paxil in Canada)
In 2006, a year or so prior to her death, Sara had been to see her doctor (Dr Stanton) who had diagnosed her with panic disorder and depression. This, he claims, was based on a 30-minute visit to his medical office. Sara, he claimed, had told him that she was having trouble sleeping, that she was having lots of nightmares, that she had no energy and was feeling very negative and depressed.
Sara was prescribed Paxil. She, at the time, was just 17 years-old.
Sara's parents, Neil and Rhonda, were not told.
The possible increased risk of suicide with Paxil usage was not mentioned by Dr Stanton either.
What happened over the course of a year or so is well documented on this blog (just type Sara Carlin in the search box at the top left of this blog)
Neil and I became quite close during Sara's inquest, an inquest that, I believe, was incredibly biased into protecting GlaxoSmithKline and its antidepressant. Remarkably, the press just couldn't see the protective cloak thrown around Paxil during Sara's inquest, this despite the coroners lawyer, Michael Blain, going in front of TV camera's on day one of Sara's inquest and announcing that the court "don't think that the medication played a role in Sara Carlin's death" (Video) ~ This before her inquest actually started!
Furthermore, at the end of her inquest the jury was told that they could not name or blame any party in this inquest, including the three doctors from Oakville, Ontario Canada and the drug company GlaxoSmithKline.
Despite these restraints the 5 person jury returned with a list of 16 recommendations, including...
An arm's-length body independent from Health Canada dedicated to drug safety funded by the federal government with no money from drug companies with mandated responsibilities to research drug safety, investigate adverse reactions and issue warnings to the public, health-care professionals and hospitals.
A standard, plain language information leaflet for patients filling a prescription that includes what the medication is for, its risks, under what conditions the drug should not be taken, interactions, proper use, side-effects and what to do about them.
Mandatory reporting by health professionals of serious drug-related adverse events to Health Canada.
A provincial-wide suicide prevention strategy, such as Alberta has done.
Guidelines and training for family physicians on prescribing selective serotonin reuptake inhibitors or SSRI antidepressants.
Fair to say then that despite the restrictions placed on them, the jury were in no doubt certain about the cause of Sara's death.
Neil and I had an emotional conversation on the final day of the inquest and the following year we both finally met in Canada. I was introduced to his wife (Sara's mom), Rhonda, and they both welcomed me into their family home. We laughed, we cried. I even spent time alone at Sara's final resting place.
I've always had this connection with Sara, maybe it's because Sara, played a significant part in how I, as a writer, changed my direction as a blogger/activist. ~ Sara showed me the bigger picture, if you will.
Neil and I have remained in touch all these years and although we don't talk as much as we used to we still have a tremendous bond. I hope one day to travel to Canada again so I can spend more time with both he and Rhonda.
The significance of the date of Sara's death May 6, 2007, may not mean a lot to readers.
On May 6, 2012, exactly five years after Sara's passing, my eldest son phoned me to tell me that his wife had given birth to a baby girl.
They called my granddaughter Ruby-Rose, she, just like Sara Carlin, is, and always will be, a gem and a symbol of life.
Here's Neil's Q&A...
Full name: Neil Patrick Carlin Age: 64 Location: Simcoe County, Ontario, Canada
Q: Neil, as you know Sara has played huge role in putting my blog on the map - My hits went into overdrive when I was reporting on her inquest and really changed the direction of my thinking with regard to writing about the whole pharmaceutical/regulatory aspect of things. It was a tough period in your life, Rhonda's too. Can you tell me a little bit more about the outcome of Sara's inquest and if recommendations made have been implemented?
A: Thanks Bob. We truly appreciate your hard work in letting people know what was happening at her inquest. Rhonda & I are forever grateful.
There were 16 recommendations from the jury all of which we thought were quite good – a couple of them were ours. (I think you covered them quite well in one of your past blog posts so I won’t list them here) but to the best of my knowledge none have been acted upon as of this time. In Ontario, as in most parts of Canada, there is no legal requirement for a party to even acknowledge a recommendation directed at them. They do not have to respond in any way to any government agency, which seems to make a sick joke of the whole process. This issue was covered quite extensively in a series of well written articles by Doug Quan of the National Post in 2014 – Dying to be Heard. Rhonda & I were interviewed for that series with a video included at the link for those interested. (1)
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Q: Have you at any point corresponded with Paxil manufacturer, GlaxoSmithKline, with regard to Sara's Paxil induced suicide or have they ever apologised for the role Paxil played in Sara's induced suicide?
A: No to both questions. We never even received any condolence from any of the doctors involved in Sara’s care.
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Q: Since I've known you, you have always had a grasp on the role of how metabolism works with regard to antidepressant use. Can you, for the benefit of the readers, explain this in layman's terms?
A: Wow, that is a big order. You really do ask tough questions. It is a complicated process that I’m still learning about, but here’s my lay person’s explanation.
Metabolism is the process of removing toxins from the body including drugs (pharmaceutical or illicit). Psychiatric drugs including antidepressants are usually formulated as fat soluble agents so they can easily cross the Blood-Brain Barrier to exhibit their targeted effect. For complete elimination, primarily in urine & stool, they must be reduced to inactive metabolites that are more water soluble. This process occurs mainly in the liver and begins with phase I oxidative metabolism by one or more of the CYP enzyme systems or P450 enzymes as they commonly called. There have been dozens of these enzymes identified to date, although only six are thought to be responsible for most of human phase I metabolism. SSRI antidepressant drugs extensively use these enzymes, often in combination. Two areas of importance regarding drug metabolism are 1) Genetic variance in expression of these enzymes – i.e. polymorphisms. 2) Drug-drug interactions.
Paroxetine (Paxil , Seroxat, Aropax), as an example, primarily uses the P450-2D6 enzyme. Its, what’s called, a substrate of 2D6. Somewhere around %10 of the Caucasian population are, genetically speaking, considered to be 2D6 poor metabolizers - they can’t make or synthesise it in significant amounts and may experience adverse effects (because of higher than usual blood concentrations) at low or so-called normal doses.
The other big problem with paroxetine, as I see it, is that as well as being a substrate for 2D6 it is also a potent inhibitor of the enzyme. So as dosing increases, paroxetine will paradoxically shut down synthesis of its own primary metabolic pathway (2D6) resulting in what is called non-linear pharmacokinetics, which simply means that, for example, doubling the dose may more than double the circulating blood concentration. Paroxetine seems to be the only SSRI medication that exhibits this effect, at least to the degree that it does. Some will say that this is not terribly important because paroxetine has large therapeutic range. I don’t buy into that argument because if you increase anything to a large enough level something will eventually break. See this article - 'Higher Antidepressant Doses Increase Suicide Risk for Young Patients' (2). This might explain, in part, why paroxetine has been significantly associated with teenage suicide.
You can also get into significant drug interactions because of competitive inhibition - where paroxetine hogs the 2D6 enzyme pushing other drugs off. The pro drugs (where the major metabolite is the active agent) Codeine & the breast cancer drug Tamoxifen are two good examples of other drugs that need 2D6 and can be rendered ineffective by paroxetine.
That’s about as short an explanation I can give.
Q: Spending time with you and Rhonda was, for me, one of the highlights of the past ten years, truly great company. You and I both went to visit Conservative member of the Canadian House of Commons, Terrence Young. Can you tell me the role Terrance has played with regard to stringent warnings being place of prescription medication in Canada?
A: First off, I wish to say that Terence is a great man who has been and continues to be a good friend and staunch supporter of our family.
As you know, Terence testified at Sara’s inquest on the then current state of prescription drug approvals & adverse event reporting/ handling by Health Canada. He did not have anything good to say. He told the jury that Canada badly needed an independent Drug Safety agency to protect patients. The jury listened to him and recommended that the government of Canada develop an independent (from Health Canada) Drug Safety organization. At that time Terence was a sitting MP on the government side and his Minister of Health eventually helped usher through new legislation aimed at beefing up Health Canada’s post-market pharmacovigilance program. This was eventually passed into law and named Vanessa’s Law in memory of his late daughter who died of a prescription drug (Prepulsid) adverse event when she was a young teenager. I know there was a process developed toward implementation of these changes in the law and at this point I can’t tell you exactly where that whole thing presently sits or if it has yet to have had any significant impact on prescription drug safety in Canada.
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Q: Both you and Rhonda appear in Kevin P. Miller's new movie, 'Letters From Generation RX'. What do you hope that this movie achieves?
A: First off I want to tell you what a wonderful human being Kevin is. The man is a genius with a tremendous empathetic capacity for human suffering. I don’t know how someone can have such unwavering dedication & tenacity for a cause with so many grim stories. Having said that, I think Rhonda & I just wanted to be a part of the message that we think Kevin is trying to deliver. That is, for people to be very cautious regarding psychiatric drugs, and that there are alternative treatments available. Also, that people, being fully informed, should to take their health care decisions into their own hands.
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Q: Many people won't know that you're an avid guitar player. Can you tell me about the guitars you own and if you have written material for songs?
A: I’m down to a few of my favourites. I have a beautiful Marc Beneteau handmade acoustic guitar I bought nearly 20 years ago when my eldest daughter started taking lessons (and yes it is difficult to teach your own child how to play). Also a Gibson Marauder electric I bought 40 years ago when I was playing in a part-time bar band. A big 40 year old Ventura 12 string with great sound that I got on a trade. A very nice Godin Freeway bass guitar and a Cort classical guitar that is great for finger picking. I have several songs I’ve written over the years. One of my goals in retirement is to re-start my little digital recording studio (a computer with a good sound card and a couple of microphones) and to record them, just for fun of it.
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Q: Would you recommend blogging to parents, or anyone for that matter, who had lost someone dear to them through antidepressant induced suicide?
A: I don’t blog so that is probably not something I might suggest. I would only say that they should find something, anything that helps get them through in a non-destructive way. Loss of a child under any circumstance is a horrific loss to suffer through. Suicide has its own challenges and it takes a lot of time to get back a just little bit of your life as you knew it.
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Q: Difficult question, but what is your fondest memory of Sara?
A: Yes, that is a tough one as there are many, but I will say that watching her gracefully skate when playing ice hockey is one of my fondest. She started figure skating at age 5 and by 11 made hockey style skating look easy. She could skate backward faster than most could forward.
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Q: Have you ever considered writing a book about your journey?
A: I have thought about it but I doubt I ever will. We now have our first grandchild and I want to stay focused on family. However, I would consider doing short pieces on specific topics. In any case, I’m not a naturally skilled writer as are some people I know.
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Q: What do you say to people who believe that antidepressants are safe and effective?
A: There is really nothing much I can say if people have no ability to think critically about the harms and benefits of antidepressants or any pharmaceutical drug. If someone believes that medications are significantly improving the quality of their life then I’m glad for them. I will tell them that they are one of the lucky ones.
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Q: What advice would you give to Coroners faced with suspected suicides of teenagers?
A: I highly doubt that the Office of the Chief Coroners of Ontario (OCCO) would listen to any advice from me. I’ve tried, believe me.
But I would tell them that they should be doing a proper investigation without just signing off on paperwork. I firmly believe, at the very least, confirming post-mortem toxicology should be done in every case of suicide – not just teens and not only in cases of suspected overdose. Violent suicide should be a red flag for psychiatric-drug-related death. An autopsy with collection of femoral vein blood is now routinely done in these cases. Toxicology should be done in every case of sudden death in a young person. The Swedes routinely do it so why can’t we?
The cardio-toxicity of citalopram & its derivative s-citalopram is a good example of a drug that can cause sudden death that is not a suicide. The information gathered through on-going toxicology and post-mortem examination may help the understanding of how prescribing practices affect public health/ safety. The OxyContin ® disaster comes to mind here.
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Q: What advice would you give to parents whose children/teenagers are on antidepressant medication?
A: Watch carefully for untoward changes in behaviour and contact the prescriber if the drug is not helping or appears to be making their teenager worse. If the doctor won’t listen (as in Sara’s case) find another doctor who will (which we did not because of lack of knowledge). The reality is that by the age of 16 years doctors can prescribe anything to teens without parental knowledge or consent. There is not much a parent can do except to contact the doctor/s and threaten them with a complaint to their professional regulator.
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Q: For you, what is the most frustrating part about the coronial system?
A: Well at least here in Ontario, coroners must legally be medical doctors. The chief coroner routinely uses family doctors as investigating coroners in their own communities, on a fee for service basis. I think this leaves a serious potential conflict of interest when it comes to these coroners investigating the death of their colleagues’ patients or the investigation of deaths in the hospitals where they may work on rotational ER duties. I often wonder who investigates the death of one of their own patients?
There was an attempt to overhaul the Ontario death investigation system in 2012 – a recommendation that came out of the Goudge Inquiry - but that was successfully beat down (3). There appears to be no political will to overhaul the Ontario death investigation system.
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Q: Where do you see yourself in 10 years time?
A: Hopefully above ground and vertical. But seriously I want to be an active granddad still playing rock n roll and enjoying the things I do. But I know how precarious life is so I don’t think too many years ahead.
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Q: Finally Neil, some personal questions... 1. What book are you currently reading?
A: The Emperor of all Maladies: A Biography of Cancer by Siddhartha Mukherjee.
His section on tobacco-related lung cancer is quite interesting. The tactics used by the by the pharmaceutical industry today seem to be identical to the ones used by the tobacco industry decades ago. Which are to deny a causative link by stating, as often as possible, that “association does not equal causation”, and then hire academic shills to publish scientific literature to support that position, while at the same time spending millions on advertising. They learned the lessons well.
2. What was the last CD you listened to (in full)?
A: A few months ago - Crosby, Stills & Nash – their self-titled debut album, released in 1969 during my first year in college. There is a track on that album called Long Time Gone that I have always especially liked and wanted to learn to play & sing. It was a Vietnam protest song but I think the lyric lends itself to what is now happening with the psychiatric drugging of children. You should probably have asked what was the last full CD I’ve listened to that is not more than 40 years old.
3. What is the best movie you have seen this year?
A: It is always difficult to pick a best of anything, but if I must I would pick The Revenant starring Leonardo DiCaprio. Without giving away any of the plot, I will only say that I think it is a story about a man who’s driving force for survival was retribution. Something I can relate to.
4. What country would you most like to visit?
A: Scotland, where I was born. My parents immigrated to Canada when I was 5 years old and I’m the only one in my family who has not been back for a visit. Besides my wife Rhonda is a fan of the TV series Outlander and wants to see the highlands. I would include Ireland in that trip, because that’s where my ancestors are from.
5. If you had the choice of being either a defence or prosecution lawyer, which would you choose and why?
A: A criminal defense lawyer. I believe that the good ones are true advocates that keep the justice system honest. Without them we would have many more wrongful convictions. The very best are highly skilled in the art of cross-examination, especially of lying police officers.
As a writer of factual based evidence, and now fiction (manuscript, 'No Other Man', currently with agent in New York), I often walk into a lot of stories not knowing the ins-and-outs. I sit down and research or, if contacted, I offer people to write guest posts.
Back in 2007, Sara Carlin, a beautiful 18-year-old girl grabbed a piece of electrical wiring, fashioned a crude noose and hanged herself in the basement of her parents house while under the influence of the antidepressant drug Paxil (Seroxat in the UK).
I learned about Sara's plight when I stumbled upon her story in the Oakville Beaver, a Canadian newspaper. At the time, her inquest was approaching and this is when I took an interest.
It was a turning point for me personally and for the direction of this blog. Up until then I had targeted the British drug regulator for their limp-wristed approach to safeguarding the British public.
Sara Carlin changed all of that.
In her death she opened many doors for me. Her inquest, which was basically GSK & Friends Vs The Carlin Family, was reported on in the Canadian press. It was reporting that was biased beyond belief so I took it upon myself to cover the inquest by liaising with Sara's dad after each night of the inquest. I would write what the Canadian press were too afraid to write.
Now, without getting too 'spiritual' and delving into what some might deem as fiction, I was helped along the way by Sara herself. I felt her presence around me and today, which marks the 8th anniversary of her death, I still feel her presence.
In a twist of fate, divine intervention, call it what you will, my son and his wife gave birth to my granddaughter, Ruby-Rose, three years ago. She came into this world on the anniversary of Sara's death.
Sara had a profound effect on my life, she made me realise that this blog shouldn't just be a platform for me to vent my anger toward GSK and the MHRA, it should be a platform for all of those who have lost loved ones due to antidepressant induced suicide and, indeed, those who have lost children to birth defects caused by antidepressants.
As it stands today, my blog is vast approaching one and a quarter million hits, a large chunk of those hits came when I wrote during Sara's inquest. She put me on the map and for that I shall live forever in her debt.
I have become great friends with Sara's parents, Neil and Rhonda. Neil is the brother I never had and when we met in person for the first time some years ago, it was a moment that only a grieving father and passionate writer could fully comprehend. We embraced, cried then talked into the small hours, just Neil, Rhonda and I.
The Carlin family lost their daughter through the incompetence and failure of many. Treating physicians, a lacklustre regulatory system and a pharmaceutical company who chose, and continue to choose, profit over the life of a young woman who had everything to live for.
The inquest saw 16 recommendations made, to date, not one of those recommendations has been put into place. What a slur on the memory of Sara!
Sara Carlin opened my heart and my mind and, as a result, I now report on individual antidepressant induced suicides, or offer guest posts to help the grieving process of those left behind. She gave me the opportunity to give others a voice.
Take a bow angel.
I will be saluting your life later tonight with a bottle of wine.
Nessun Dorma Sara.
Bob (Your dad's soul brother)
This is for the Carlin's, they know what it means.
On May 6, 2007, Sara Carlin, a beautiful 18-year-old girl with everything to live for, hanged herself in the basement of her parents house while under the influence of the antidepressant drug Paxil (Seroxat in the UK). Paxil/Seroxat is an antidepressant documented by international drug regulatory agencies as causing worsening depression and suicide particularly in children and young adults.
Sara's case was the first Paxil related suicide story I covered extensively, in fact it was the first of any of the antidepressant suicides I covered.
I've since been to see Sara's mom and dad, Neil and Rhonda. I've been to visit Sara's resting place and had a private moment with her.
Sara's story struck a chord with me and I almost felt compelled to write about her, sometimes staying up until the small hours, just to make sure I had my facts correct.
It's 7 years today since Sara left us. I am in no doubt that her suicide was induced by the Paxil she was taking. I am in no doubt that her inquest was used by lawyers and the Coroner as a means to defend Paxil and not to highlight how dangerous it can be. I dubbed the inquest, 'Glaxo & Friends Vs The Carlin Family', the duration of the inquest, the witnesses called defending Paxil and the way they played down its propensity to induce suicide proved me right to label it in such a way.
The Coroner, the witnesses, the lawyers and, to an extent, the mainstream Canadian press, all made sure that Sara's voice would be suppressed. For that they should be totally ashamed of themselves.
Sara was another victim who fell to the Paxil promotional pandemic, a pharmaceutical company and it's lust for greed took Sara away from her mom, dad, sister, brother, relatives and friends... and once again, in the shape of lawyers representing them at Sara's inquest, they [GlaxoSmithKline] denied any wrong doing.
The outcome saw the jury make recommendations. To date, not one single recommendation has been put in to place. This is not only disrespectful, it also makes a mockery of the coronial system and puts other lives at risk.
The tragic death of Sara has, I'm sure, helped others. It was a high profile case and Canadian doctors would have been careful not to prescribe Paxil during the time the Canadian press were reporting about her.
I created the following video for Sara back in 2009, before the outcome of her inquest. I sat on it for a number of months before making it public. It's sad, so very sad. To date, the video has had almost 15,000 views.
Quite fittingly, on the 6th May 2012, my granddaughter, Ruby, was born to my son and his wife. Five years, to the day, that Sara left us.
Nessun dorma (None shall sleep) Sara.
You can read more about the Sara Carlin Vs Glaxo & Friends Inquest at the following links:
A post appeared on the WZZM 13 website a few days ago that caught my attention and caused yet another deep sigh.
78 year-old Bob Farthing [Pictured] was found dead in the back of his car on Friday 17th January. Farthing was reported missing by his family on Wednesday, Jan. 15.
Details are emerging that show Farthing was having difficulty withdrawing from the antidepressant Seroxat, better known in the US by the brand name Paxil.
Farthing's daughter, Denise Shaheen, said there is only one explanation for the disappearance. "He is struggling with the withdrawal from the drug Paxil."
After using the antidepressant for 15 years, his family says doctors were weaning Farthing off of the powerful drug and putting him on other medicine. But it was a difficult process.
"He would have a couple good days, he would have a couple bad days. His bad days were very bad days," said Shaheen. "He became very depressed, very confused."
A video report of Farthing's disappearence and death is below.
Having experienced severe Seroxat withdrawal myself I really feel for this guy.
Of course, those who defend Seroxat, namely GSK and their attorneys, will argue that Farthing had been taking Seroxat for 15 years and the withdrawal he was going through was possibly his original depression returning.
Witnesses told police Farthing appeared confused when he was spotted later Wednesday afternoon at Blodgett Hospital. He had asked for help with directions.
Farthing was also reportedly seen Thursday in East Grand Rapids' Gaslight Village, where he stopped in Edward Jones to ask for directions to Blodgett Hospital.
His daughter, Denise Shaheen, earlier said Farthing was recently taken off a medication and may have been confused or suffering from medical problems. He reported not feeling well on Wednesday, she said.
Cause of death is unknown and is currently under investigation.
The withdrawal issue surrounding Seroxat has been debated many times. There are a number of people who suffer mild or no withdrawal problems at all.
So, what is being done to help those at the other end of the scale, those who suffer severe Seroxat withdrawal?
In a word, nothing!
The British drug regulator, the MHRA, have played down the issue of withdrawal time and time again, not only with Seroxat but with other SSRis too.
In fact, I personally met with the Chief Executive of the MHRA, Kent Woods, back in 2008, some 6 years ago, to discuss the withdrawal issue regarding Seroxat and other SSRi's.
Here's a summary of the minutes from that meeting.
Guidance on the Management of Withdrawal from Seroxat (Paroxetine) and Other SSRIs
Notes of a meeting held at MHRA on 2 September 2008
Present:
Robert (Bob) Fiddaman (RF), Campaigner, Author of Seroxat Sufferers Blog
Prof. Kent Woods (KW), Chief Executive, MHRA
Sarah Morgan (SM), Head of Pharmacovigilance Risk Management, MHRA
John Watkins (JW), Communication Manager, MHRA, acting as secretary
1. RF said he would like to discuss problems of withdrawing from Seroxat. He said that though his concerns centred around Seroxat, he recognised that other SSRIs posed similar problems which ought also to be addressed.
2. He produced copies of the Patient Information Leaflet (PIL) for Seroxat in which he had highlighted the 32 places where patients were told to talk with their doctor about various issues. He felt that too much of an onus was put on doctors, many of whom did not know enough about withdrawal problems and their management.
3. In answer to a question from KW, RF agreed that the focus of the meeting should be on the information going to doctors and perhaps also on their training.
4.KW noted that doctors do not generally refer to the PILs, nor indeed to the similar but more technical Summaries of Product Characteristics (SPCs). Instead, they use the British National Formulary (BNF), revised twice each year, and guidance produced by NICE. The NICE guidance on the management of depression was currently being revised; a draft is due to go out for public consultation in December 2008 with a view to publication in June 2009.
5. He emphasised that MHRA controls neither the BNF nor NICE in any of the matters they cover, but the Agency can and does make suggestions to both organisations about the information they provide.
6. RF illustrated the practical problems encountered by patients in withdrawing. He offered each of the others a jelly baby and asked them to bite off one-third. No problem. He then produced some Tic-Tacs (mints). It was immediately acknowledged that biting off a third was very difficult. Likewise with a Seroxat tablet, said RF. The liquid preparation was much better suited to dose tapering but doctors seemed largely unaware of it. He outlined his own experience of withdrawing over a period of 21 months. The liquid, administered through a syringe, helped that process, though – for him – not even tapering took him beyond the point where he felt he had to “go cold turkey”. He did that because he did not want the drug to continue to have a hold over him.
7. During withdrawal he experienced severe “zaps” in his brain. He described his dependence on the drug as an addiction, and exemplified that by relating his feelings of wanting to “rip the shop apart” if it turned out that they were out of stock.
8. KW noted that the term “addiction” ought to be reserved for circumstances which typically entailed cravings leading to increase in dosage, but suggested it was less important to argue about terminology than to acknowledge, as he did, that there are significant problems associated with withdrawal; the issue was how best to manage withdrawal. He noted that, as with benzodiazepines, those SSRIs which both act and disappear more quickly are more likely to pose problems with withdrawal. He did not know whether a switch to slower acting SSRIs had been researched as a potential solution, as it had proved to be for benzodiazepines.
9. KW said he was aware that RF had had some very good support from his doctor and wondered how widespread such support would be. RF believed that many doctors would not be able to provide that level of help, due to not knowing how to manage withdrawal. RF had sent the Agency a very large number of personal testimonies about difficulties that others had experienced during withdrawal.
10. RF pointed to guidance on withdrawal produced by Dr David Healy; KW said he had seen it but his concern about any guidance would be whether “one size fits all”, given the range and diversity of withdrawal experiences. That should not however prevent the development of authoritative guidance.
11. RF asked what authority MHRA had to issue warnings. Could it for example require warnings to be put on packaging like those on packets of cigarettes?
12. KW replied that the place for warnings to patients is within the PIL. If they were very prominent on the packaging then that might well deter patients who really needed the medicine from taking it. The Agency has control over PILs. KW outlined the improvements to PILs in recent years, largely due to testing them with users; a programme which will end very soon has been reviewing and revising the PILs for all medicines. RF acknowledged that there had been significant recent improvements in the Seroxat PIL. KW noted that there is still room for improvement in PILs but the Agency is now starting to explore other initiatives relating to PILs. It might for example become feasible to ensure that PILs are available to patients beforehand rather than at the time they start to take their medicines.
13. RF wondered whether MHRA had thought of including Yellow Cards with or in the PILs. SM replied that we had considered asking pharmacists to include them in the bag holding the package. KW noted that every edition of the BNF had a Yellow Card at the back but there was no obvious place for making it available to patients other than placing them in pharmacies and GP surgeries. Reports from patients were still relatively new. So far only about 10% of all reports come from them, but the quality of the information they contain is every bit as good as that from healthcare professionals.
14. KW asked RF what he thought of the Seroxat PIL’s Section 5, “Stopping Seroxat”. Early in the section it says “When stopping Seroxat your doctor will help you to reduce the does slowly …”. RF felt that this was over-optimistic. He also felt that the advice about dosage reductions of 10mg a week (which SM noted was based on clinical trials) was too large an increment in view of his own experience – he needed to reduce by 1mg a week, only practicable with the liquid – and the experiences of others. And he felt that the signposting to the liquid form, “It may be easier for you to take Seroxat liquid during the time that you are coming off the medicine” was inadequate. SM agreed that steering patients towards the liquid could be made more obvious; and it could be helpful if such a steer was also given to doctors, in some document such as the NICE guidance.
15. Referring again to the management of withdrawal in relation to benzodiazepines, KW read out the advice on management of withdrawal for that class of drugs that is in the current edition of the BNF. RF said he would have found it very helpful if that kind of advice, but about Seroxat / SSRIs had been available to him at the time he started to withdraw. He wondered how many doctors used the BNF. KW reckoned that almost every doctor will use it, with many of them referring to it frequently. When he was a clinician, he always carried around a copy of the BNF in his coat pocket.
16. KW thought that the inclusion of similar advice in relation to SSRIs could be suggested to the BNF. It might also be suggested to NICE for their guidance. And a potentially useful way of drawing prescribers attention to any new advice that emerged would be MHRA’s monthly Drug Safety Update. KW again stressed that though we might make suggestions about this to the BNF and to NICE, it would be for them to decide. While MHRA’s primary role is to regulate industry – with no jurisdiction over doctors, it is within the remit of both the BNF and NICE to inform and indeed to influence doctors.
17. RF asked whether MHRA would talk with David Healy. KW said he would be happy to have that happen. But it would be useful if others with experience of managing withdrawal were also consulted. Those present at the meeting could not immediately identify anybody else in the UK but MHRA would try to do that, perhaps with the help of one of its Board members.
18. RF asked whether the management of withdrawal could be covered in the training of doctors. KW explained the difficulty any organisation would have in influencing medical schools when each school determines its own curriculum.
19. RF enquired how the Agency kept up to date on research and indeed legal issues surrounding Seroxat. Had the Agency for example been aware of the “Glenmullen report” before he drew attention to it at a time when the Agency was still investigating GSK? KW could not recall at exactly what stage he personally became aware of the document but assured RF that the Agency kept track of developments generally, not just in the context of a particular investigation. SM described how her group undertake a weekly review of the literature in respect of all drugs, covering all the major journals. And pharmacovigilance also takes account of clinical trials and trends in Yellow Card reports.
20. The meeting concluded by recognising that though the focus had been on Seroxat, there were other SSRIs that posed similar problems, and that changes in prescribing practices, such as a reduction in prescriptions for Seroxat in recent years and increases for other drugs, for example Venflaxine, mean that some of the issues deserve to be dealt with in terms of the class of drugs rather than in relation to individual members of that class.
Almost a year later the MHRA did meet with David Healy. Here's the notes from that meeting:
Meeting to discuss awareness and management of withdrawal reactions with SSRIs and related antidepressants 26 June 2009
1. Introductions and background
MHRA explained that the background to this meeting was a meeting held with Mr Fiddaman in September 2008. Mr Fiddaman had raised concerns about a lack of awareness on the part of health professionals of withdrawal reactions with SSRIs and related antidepressants. Prof Healy explained that he had had a long term involvement with the safety of SSRIs and that he received a large number of e-mails directly from people withdrawing from SSRIs asking for advice on management of withdrawal symptoms. Before the meeting Prof Healy had provided documents that he had produced relating to the management of withdrawal from SSRIs.
2. Existing advice on management of withdrawal reactions with SSRIs/SNRIs
All agreed that most health professionals get their information from guidelines issued by the National Institute for Health and Clinical Excellence (NICE) and the British National Formulary (BNF) rather than directly from the Summaries of Product Characteristics (SPC), although it was noted that the SPC was very important as it dictated the information that would be available to the patient through the Patient Information Leaflet. MHRA informed Prof Healy that they had provided input to the recent consultation for revision of the NICE depression guideline and that the revised guideline would be available towards the end of the year. MHRA had also informed the BNF that they were looking at the area of withdrawal reactions and would contact them in the future regarding proposals for updates to the relevant sections of the BNF. MHRA also raised the important role played by Prescribing Advisors in the Primary Care Trusts in influencing prescribing practice. Prof Healy said that a key point not included in the guidance currently available was the existence of liquid formulations of SSRIs which could be useful in the management of withdrawal to allow slow tapering. Prof Healy also stated that before treatment started there should be a discussion between the prescriber and the patient about the possibility of withdrawal reactions.
3. Awareness of withdrawal reactions in clinical community
Prof Healy expressed the view that general practitioners (GPs) were not aware that withdrawal reactions on stopping SSRIs could be prolonged in some patients and were not aware of how to manage withdrawal reactions in these patients. Prof Healy was concerned that GPs may instinctively advise patients to withdraw by taking tablets on alternate days and this was not an appropriate approach.
4. New evidence relevant to management of withdrawal reactions
Prof Healy was not aware of any new evidence relevant to the management of withdrawal reactions. When asked if he had a view on the size of the problem of serious and prolonged withdrawal reactions with SSRIs, Prof Healy said that this was not possible to measure. Prof Healy said that while the propensity of an SSRI to cause withdrawal reactions was often thought to be only related to the half-life of the drug, this seemed unlikely to be the case – it could also be related to the potency of the different drugs at the serotonin reuptake site. The lack of understanding of the problem contributes to a lack of effective solutions.
MHRA asked whether in his view there was any way that patients who were more at risk of prolonged withdrawal reactions could be identified. Prof Healy said that he felt that from his experience women seemed to be more at risk than men but it was unknown whether this was because more women than men were treated with SSRIs. MHRA said that their review of the issue had not identified any link between the risk of withdrawal reactions and the gender of the patient. Prof Healy considered that there was little evidence available on how to manage patients who had difficulty withdrawing from SSRIs. All agreed that this was a very difficult area to study as the management of the patient would differ depending on the patient.
5. Dependence/withdrawal for women of child-bearing years
Prof Healy had asked for the issue of use of SSRIs in pregnancy to be included in the agenda. He said that it was an important issue and the subject of upcoming court cases in the USA. Prof Healy said that it was important that women of childbearing years were appropriately informed of the risk of withdrawal reactions with SSRIs before beginning treatment and stated that in his view doctors may be liable under the Congenital Disabilities Act 1976 if they did not adequately inform patients of the risks of treatment during pregnancy.
MHRA said there had been communications about a small risk of congenital malformations associated with paroxetine and this issue was under further discussion at EU level. Prof Healy highlighted a recent publication describing an animal study looking at reproductive toxicity of a variety of SSRIs. MHRA asked for the reference and to be kept informed of any further new evidence of relevance to this issue.
MHRA noted that NICE had published its antenatal and postnatal mental health: clinical management and service guidance and that it was important that NICE was kept informed of any new evidence or advice in this area. MHRA agreed to find out whether review of the guideline was planned and to let Prof Healy know the best contact point for communication on this issue. Post meeting note: Prof Healy confirmed post-meeting that he had contacted NICE on this issue.
6. Opportunities for better communication with health professionals
Prof Healy said that the focus should be on highlighting to GPs that withdrawal reactions could be serious and prolonged in some patients and agreed that NICE and the BNF would be reasonable routes.
MHRA thanked Prof Healy for attending the meeting and agreed that it would be important to keep in contact on important new evidence in this area.
So, two meetings in the space of approx 12 months.
To my knowledge the MHRA have not kept in contact with David Healy.
I severed ties with my communications with them in 2009. I had brought the Lyam Kilker trial to their attention. Lyam was born with heart defects. His mother had taken Seroxat during her pregnancy. A jury found Seroxat to be the cause of his heart defects.
After many emails back and forth to the MHRA I decided that I was flogging a dead horse. The MHRA were just never going to acknowledge that Seroxat was a teratogen.
Here's the email I sent them.
Simon was, at the time, Director of Communications at the MHRA.
----- Original Message -----
From: fiddaman
To: Gregor, Simon
Cc: REDACTED
Sent: Sunday, November 22, 2009 8:11 PM
Subject: MHRA - I am done!
Dear Simon Gregor, and other MHRA staff included in on this email; namely Kent Woods, Alasdair Breckenridge and Sarah Morgan.
You will note from the Cc list I have included some familiar faces, I think all but one of them will be familiar to you.
The 'give2manie' email address is an email that you have probably not come across before. It is the email address of Julie Edgington, an American. Her child, Manie, was born with transposition of the great arteries [TGA].
GA means the aorta and pulmonary arteries in the heart are switched. When a child is born with TGA there is very little oxygen in the blood. The aorta receives the oxygen-poor blood from the right ventricle, but it's carried back to the body without receiving more oxygen. The pulmonary artery receives the oxygen-rich blood from the left ventricle but carries it back to the lungs.
Manie's mother, Julie, took paroxetine whilst she was pregnant.
The reason behind this email and the reason I have included the familiar faces is because I want them all to know where I currently stand with the MHRA.
Your limp-wristed response to my question, Is Seroxat a teratogen, was really the straw that broke the camel's back. You have gone back to your old ways of fence sitting on life threatening issues.
Time and time again you are faced with evidence yet you refuse to acknowledge it. Seroxat IS a teratogen, you know it and so do I... and I imagine the others included on this email do too.
Over the past couple of years the MHRA have opened their doors to Seroxat campaigners, it was a nice gesture but I firmly believe it was merely a token one. Maybe you thought by opening your doors, the problem would simmer - Keep your friends close, and your enemies closer.
Simon, you have picked my brains over the past year or so with regard to your yellow card system, a system that is troubled, outdated and, dare I say it, about as useful as a chocolate teapot.
You are very good at what you do Simon, I bear you no malice.
Moving on to your CEO, Kent Woods. Charming man, well he was for the hour meeting I had with him. Since then he has failed to answer any of my emails. Whether he thinks I'm some ruffian from a council estate should not alter the fact that I have some serious complaints that need answering.
He has had plenty of opportunities to correspond with me but has chosen not to. The 'Kent gets hundreds of emails a day' excuse does not wash with me. Even if he did, does he ignore them all or does he just choose to answer the one's he thinks are important?
Alasdair Breckenridge is big enough to proclaim on national TV that there is nothing wrong with Seroxat, and so I gather at various dinner functions he has attended. Remind me of his role again at the MHRA?
Your recent response regarding the teratogen issue was expected. It was a classic cover your ass answer - in fact I shouldn't really use the word 'answer' as you never actually answered the question did you?
As you are well aware GlaxoSmithKline were just found guilty by a Jury in the United States. Paxil [Seroxat] was found to be the cause of the heart defects Lyam Kilker was born with. If a jury can find that Seroxat caused heart defects in a child then I have to ask myself why regulator's can't. Your Chairman being a former employee of GlaxoSmithKline does not really help matters nor does your Head of Licensing, Ian Hudson, another former employee of Glaxo.
You are not protecting the public with regard to Seroxat and other SSRi's. Your stubborness is staggering. You choose to protect GlaxoSmithKline and anyone who sides with them, is, in my opinion woefully misguided and/or corrupt.
Seroxat IS a teratogen, I should not have to send you the evidence - you should already have it, you are a regulator after all.
I have decided to call it a day with the MHRA. There is no reason for me to correspond with you anymore. I cannot and will not have my name associated with cowards - because that's what you are. There is no direct accusation at individuals here - this is aimed at the MHRA as a whole.
You need to take a good look at yourselves and ask whether or not you are doing enough to protect the public, in particular children. Personally, I don't think you are.
For the other patient/advocates involved with the MHRA on the patient and public engagement (PPE) it is entirely up to you if you wish to continue engaging in talks with the MHRA. My decision is based on my own belief that the MHRA are simply not protecting the public and no matter how many doors they open to patients will not matter a jot because they will never take the side of the likes of myself or young Manie Edgington.
There are a further 630 cases to be heard in the USA regarding children being born with heart defects. The Kilker trial was a landmark case and has set a precedent, the others, I assume, will be settled out of court. No liability. No public record that Seroxat is a teratogen.
Which, will suit the regulators just fine.
I do not want a detailed explanation of the reasons why you could not answer a simple question. My main concern is doctor's in the UK are still prescribing a teratogen - because the MHRA are too limp-wristed to condemn it.
Approx two years later the MHRA announced that they were rolling out an SSRI Learning Module for healthcare professionals. It would be nice to think that the meetings with myself and David Healy had some influence on this project but the more I looked into it, the more dumbfounded I became.
On the subject of severe SSRi withdrawal the MHRA were telling healthcare practitioners to recommend "specialists" to patients.
With this in mind I sent the following to the MHRA:
Can the MHRA provide me with a list of specialists experienced in SSRi withdrawal that are a; in the UK and b; available on the NHS.?
They couldn't provide me with any such list of 'specialists.
I wrote a series of articles on the SSRi Learning Module, all of which can be found at the foot of this post.
It's not just the MHRA that should come under fire.
On May 6, 2007, Neil Carlin found his 18-year-old daughter, Sara, hanging from an electrical cord in the basement of the family’s Oakville, Ontario. A bottle of Seroxat, which her family doctor had prescribed to her 14 months earlier, was found at the scene.
The inquest into Sara's death was high profile and was covered extensively by the Canadian media. I covered the inquest myself, reporting what the media failed to report through fear of lawsuits from GlaxoSmithKline.
After a gruelling 10 day inquest a jury issued 16 recommendations on June 28, 2010.
It fell short of blaming Seroxat on Sara's death.
To date not one of the 16 recommendations have been implemented.
“We realized it’s a bullsh–t process,” Neil Carlin said. “They go through the motions to give the public a sense of confidence they’re on top of it. Nobody really cares or follows up.”
The inquest that the Carlins had pushed for became, in their eyes, nothing more than “window-dressing.”
“It’s sort of a hollow victory,” Carlin said. [1]
I've met Sara's parents. Spent some time with them in Canada. They remain firm friends.
So, with all of the above, exactly what is it we have learned? well, as consumers we pretty much know how dangerous Seroxat is. Those that regulate drugs like Seroxat have failed and continue to fail. Coroner's who carry out inquests into suicide, in the main, fail to make any connection between suicides and SSRi's. If they opened their eyes they could be doing the public a great service. Alas, they are blinkered and convinced that drugs do not cause a person to kill themselves...it's the illness.
Chief Executive of the MHRA, Kent Woods, retired last year. His position was filled by Ian Hudson.
I'll leave you with an email I sent to Hudson on Nov 8 2013. He never replied.
Dear Mr Hudson,
As I understand you are now Chief Executive of the MHRA. I'd congratulate you but we both know that I'd be lying with those congratulations given your past links to GlaxoSmithKline and Seroxat.
That aside, I have to remain professional.
My question to you is one of great concern and one that I shall be making public on my blog http://fiddaman.blogspot.com
Are you, or do the MHRA plan to reevaluate the current recommendations that pediatrics should not be prescribed SSRi's?
I ask as it has come to light that MHRA consultant, Stephen J W Evans, has recently co-authored a study where he and the other authors call for a re-evaluation of the current prescription of SSRIs in young people - Back story here.
This email, along with your answer, if you are brave enough to answer that is, will be published on my blog.
