Image: Sara Carlin
Before I go any further, I would just like to thank the 5 person jury at this inquest.
They, it appears, have seen through all the bullshit and underhand tactics of all those whom have tried to protect the name of GlaxoSmithKline's Paxil - more on them in another post, many of which will follow over the coming days/weeks.
GlaxoSmithKline's lawyer, Teresa Walsh and Coroner's Counsel, Michael Blaine, have been resoundly beaten, I believe, by the Carlin's family lawyer, Gary Will of Will Barristers.
In a heart felt phone conversation with Neil Carlin, Sara's father, told me that both he and Rhonda [his wife] "...are extremely pleased with the outcome of the inquest into our beloved Sara’s Paxil (Seroxat, Aropax, paroxetine) related suicide with the recommendations that the jury have given in their verdict." He added, "The jury were under very strict restraints in their ability to name or blame any party in this inquest, including the three doctors from Oakville Ontario Canada - and the drug company GlaxoSmithKline - maker of the SSRI antidepressant Paxil."
Neil also told me, "We feel that through the breadth & depth of their 16 recommendations, the jury has carefully listened to the evidence they have heard over these past several weeks & through the quality of those recommendations have identified the root cause of Sara’s death. It is our belief if these recommendations are implemented & followed in the future, that they will surely avoid the tragic waste of young life as occurred in our Sara’s case."
Neil pointed out to me that he and his wife "...believe that recommendations 8,10,11,12,14,15 and 16 are especially noteworthy"
The recommendations announced today by the jury have, it appears, slammed The Ontario College of Physicians and Surgeons (OCPS) and the Ontario College of Family Physicians (OCFP). Furthermore, they have, it appears, slammed the Canadian drug regulatory authority, Health Canada.
Over the course of the next week, maybe two, I am going to comment on the recommendations.
Tonight, I'm going to start with recommendation number 8. It's of vital importance as I see it as a jury completely shocked by what they have heard during the course of the two week inquest into the death of Sara Carlin.
Before I begin, I draw your attention to the way in which this jury were charged by the Coroner, Bert Lauwers.
Last week Lauwers told the jury:
"Do not include any narrative or any rationale in your verdict. I mean answer the 5 questions & provide recommendations if you think they are warranted. And then do not add a story line to that...don't in fact try to explain the reasons why you have given us the recommendations based on your verdict.
No recommendation expresses or implies a conclusion in law or comment on legal responsibility in law"
In layman's terms this basically means that the jury was not permitted to assign blame to any party including Paxil/GSK.
The reasons for this are obvious. Glaxo could have...and probably would have filed a lawsuit against those responsible for implicating their brand. So the jury deliberated with their hands tied.
The 5 person jury, made up of three men and two women, were all lay people. They, like the Carlin family, have all had to sit and listen to witness statements. They have had to go home at night with the image of Sara Carlin in their heads, an image that doctor's and lawyers tried so desperately hard to tarnish.
It would appear that the jury have, quite rightly so, seen through the appalling tactics of Glaxo and friends.
Here's recommendation 8 of 16 recommendations announced by the jury today.
B. Ontario College of Physicians and Surgeons
Ontario College of Family Physicians
8.The Ontario College of Physicians and Surgeons (OCPS) and the Ontario College of Family Physicians (OCFP) should develop practice guidelines and training to family physicians on administering and monitoring the use of selected serotonin reuptake inhibitors (SSRI's). Those guidelines should include, but not be limited to the folloving:
8.l. Prior to prescribing SSRI's the physician should;
- give the patient a physical examination
- request laboratory investigations, including drug screen, where appropriate
- inform the patient of the benefits and risks, inclusive of rare and serious side effects of SSRl's
- inform the patient of all reasonable alternative treatments and benefits and risks of such alternative treatments
- inform the patient of the treatment plan should SSRI's be prescribed
- discuss with the patient alcohol and substance abuse as cofounders in the illness
8.2. Emphasize to physicians that best practice for monitoring patients for drug-related adverse events arising from the introduction of SSRIs includes a regime in which the physician should monitor the patient with weekly visits for the first month, bi-weekly visits for the second month, and with a following visit in the third month. This eflectively would monitor the period of time with the greatest risk for the development of serious drug-related adverse events.
8.3. Encourage physicians to utilize tools created to monitor both disease symptoms and adverse events of patients undergoing treatment with SSRI's. An example of such a tool is the Using Selective Serotonin Reuptake Inhibitors (SSRl's) in Children and Adolescents and the SSRl Monitoring Form for Children and Adolescents devcloped in June of 2009 by the British Columbia Children's Hospital in Vancouver, British Columbia.
8.4. Emphasize to physicians that while having due regard for the relevant health privacy legislation in the jurisdiction of the medical practitioner relevant to capacity and consent; patients undergoing treatment should be encouraged, repeatedly if necessary, to allow communication and engagement of family members, guardians and/or trusted friends by their treating physicians to ensure that the patient and their support are aware of the nature of their disorder, and the potential side effects of prescribed medications and can then assist in monitoring for adverse drug-related events.
The jury here have made these recommendations based on the evidence provided. Remember, the only SSRi mentioned in this inquest was GSK's Paxil. Also remember the charge made to the jury before they retired where they were, in essence, told not to place blame.
It's plainly obvious, to me at least, that recommendation number 8 is damning for the way the doctors were involved with Sara Carlin's care, or not, as the case may be.
Remember it was Dr. Tom Stanton, Sara's doctor, who first prescribed her Paxil. It was Stanton who did not warn Sara that Paxil could possibly cause her to have thoughts of suicide or indeed kill herself.
Sara later saw Dr. Benjamin, remember her? She was the doctor that upped Sara's dose from 20mg to 30mg. She is also the doctor who chooses to use her maiden name whilst appearing at inquests and whilst practising as a doctor. She is in fact Mrs Merrick, her husband being none other than Andrew Merrick, the Director of Corporate Affairs for Eli Lilly Canada.
I see recommendation 8 as a direct result of the way both Benjamin [aka Merrick] and Stanton both treated Sara, that's just my opinion - readers can draw their own conclusions by reading the back stories provided at the end of this article.
I also see it as 5 normal people saying "enough is enough." No parent should have to go through this ever again - no jury should have to sit, watch and listen to sobbing, grieving family members.
Just by this one recommendation alone, the Carlin family has made huge strides into safeguarding the lives of children in Canada, in particular, Ontario.
One has to ask why something so obvious as this has never been either recommended or implemented before. Surely Health Canada have some sort of responsibility with regard to patient care?
Why has it taken the death of a young girl for recommendation number 8 to surface?
Sara Carlin is the 26th person in Canada whose death has been associated with GlaxoSmithKline's Paxil, I think it's safe to assume there is an association, even if the jury were not allowed to make such a claim.
26 reported deaths - that is, to Health Canada. We all know how lax the adverse reporting system [yellow card] is here in the UK with our own regulator, The MHRA. I think it would be safe to assume that the figure of 26 could quite easily be multiplied by 10, some quarters even suggest a multiplication of 100.
The Carlin family have been through a terrific ordeal these past two weeks, an ordeal that they should never have had to go through.
Had these recommendations been offered and implemented some years ago then Sara Carlin would have, at the very least, been offered a physical examination. Her prescribing doctor's could have requested laboratory investigations, including drug screen. She could have been told about the benefits and risks, including the rare and serious side effects of Paxil, such as suicidal thoughts and/or actually carrying out those thoughts. Such as substance and alcohol abuse.
It's too late for Sara Carlin now but in her death she has, with the strength of her parents and the tenacity of lawyer, Gary Will, had her voice heard loud and clear by the 5 person jury.
A voice that from the onset of this inquest has tried to be stifled by Glaxo and friends.
No doubt GlaxoSmithKline will see this as some sort of vindication that Paxil was not mentioned as being part of the reason why Sara Carlin killed herself - In truth, they were heading into this inquest on a 'win, win' basis. They knew Paxil could not be implicated.
What Glaxo failed to realise was 5 normal people from everyday backgrounds sat and watched as witness after witness took the stand making claims that Sara was an out of control teenager who drank and took drugs. A picture painted by Glaxo and friends that just did not sit right with the jury.
The jury will go down in history for being part of better safety regulations for the way Paxil and other SSRi type drugs are prescribed to this vulnerable group in future years.
Sara Carlin will go down in history as the reason these recommendations were made. For that, the citizens of Ontario, Canada, should live forever in her debt.
I'll be posting more about the other recommendations over the coming days and weeks and I will be interviewing Neil Carlin at some point.
Finally, during the past two weeks, there has been abhorrent behaviour regarding Sara's death from an obsessive individual.
Once the dust has settled and I have wrote about these recommendations, I am going to name and shame him. I am also going to name those [group moderators] that have allowed his vile posts through on to Yahoo Groups.
That can wait.
In the meantime, my thoughts are with the Carlin family.
For what they have gone through and what they have achieved today deserves a standing ovation.
More on the recommendations later this week.
You can read more about the Sara Carlin Vs Glaxo & Friends Inquest at the following links:
Sara Carlin Inquest – Latest
Sara Carlin Inquest – Failure of Oakville Medical Profession
Sara Carlin – ‘Death by Paxil’ Inquest – The ‘Expert’
Sara Carlin Inquest – Coroner’s Witness In U-Turn… And That Man Shaffer!
SARA CARLIN Ontario, Canada
Coroner’s Inquest – Glaxo & Friends Vs The Carlin Family
Sara Carlin Inquest – Local MP Slams GlaxoSmithKline
SARA CARLIN PAXIL INQUEST VIDEO FOOTAGE
SARA CARLIN PAXIL INQUEST GLOBAL TV NEWS
SARA CARLIN INQUEST - What The Jury Should Know
Sara Carlin Inquest - "Paxil likely played important role in teen's suicide"
Sara Carlin Inquest - The Eli Lilly 'Links' & Today's Recommendations.
**Exclusive - Sara Carlin Inquest: The Bias Of Coroner's Counsel, Michael Blain & Coroner, Bert Lauwers?
Sara Carlin Inquest - We Know How, Now Tell us Why!
On May 6, 2007, Sara Carlin, a beautiful 18-year-old girl with everything to live for, 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). Paxil/Seroxat is an antidepressant documented by international drug regulatory agencies as causing worsening depression and suicide particularly in children and young adults.
Please help inform others of the risks of these drugs. Forward this video to everyone you know.
RIP Sara Alison Carlin
Fid
ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING
Fid,Keep up the good fight.
ReplyDeleteI thank you for your blog becoming Sara's voice in a dark and corrupt pharmaceutical industry world.
I thank the Carlin family for enduring what I KNOW is beyond what they thought capable of doing.
Small voices in the night, are the loudest.
Sara's parents stood up - they were counted.
ReplyDeleteMy thoughts are also with Steph Gatchell, mother of Sharise, who died in similar circumstances and also the parents of other children whom have lost loved ones as a result of Paxil and other SSRi induced suicides.
Thanks for your support Stephany. Very much appreciated.
Fid
"...No recommendation expresses or implies a conclusion in law or comment on legal responsibility in law..."
ReplyDeleteLOL. Translation: you can say what you like, but nobody's under any obligation to pay any heed, and we can all just carry on, as before. Shades of the Parliamentary Health Select Committee's recommendations, really...
Matt
Great coverage of this important matter Fid!
ReplyDeleteHey Evie Pringle!
ReplyDeleteI remember first reading your work some time ago. You are very much part of the reason why I write. I have kind of learned the mechanics of writing as I have plodded along.
It's a great honour for one of my all time favourite writer's to commend my coverage.
Thank you
Fid
You have done a great job here with these post, which finally have rendered some excellent results. I guess if you just keep beating the drum of truth and justice long enough, some one is bound to stop and listen sooner or later.
ReplyDeleteKeep beating that drum loudly Fid
Thanks Stan
ReplyDeleteFid
This is terribly bad, but why was she prescribed an anti-depressant for anxiety? Anti-depressants have such limited efficacy, and a short course of benzodiazepine therapy (ie: lorazepam, bromazepam, etc.), along with sitting down with a psychologist likely would have delivered a more favourable outcome.
ReplyDeleteFinally a bit of press in a newspaper with a larger audience.
ReplyDeletehttp://www.thestar.com/news/gta/article/829837--carlin-family-praises-suicide-inquest-results
Where can I find the other recommendations?
ReplyDeleteGoogle 'Pharmalot Sara Carlin' and hit the first link you come to.
ReplyDeleteThanks Fid off to take a look.
ReplyDeleteAfter reading the recommendations I think most of them can be messed with by red tape and double talk that I have seen in Canadian psych health care over the years that I have used these services.
ReplyDeleteIt seems to me the bottom line is and will remain the truth needs to be told about these drugs.
As long as the truth as the people who have taken them is ignored all the recommendation in the world can be half done or done just enough to appease the regulators. With no real change being noticed by the people who access these services.
The truth is still not being told. Yes there maybe some airing of antidepressants dirty laundry as far as the drinking and drug use goes that is a small start as it may be passed on by doctors speaking to patients as a dangerous affect of the antidepressant use. This is only one of the many dangers that needs to be spelled out to patients. This is where I think our doctors are failing if they were to sit and explain the many pages of side effects to patients I don't think anyone would take these drugs. Even if they did to this the patients brains are altered by the drug and they may not be able to see the changes the drugs cause.
It is my experience with antidepressants that repeated trips to the shrink who did monitor me carefully as directed in the recommendations failed to notice the side effects of the antidepressants. I believe there is a problem in detecting in part because I was so detached from myself I could not possibly have told him what my brain could not conceive... I actually could not think straight and could not help him to understand what I was going thru. I was too dense on the drugs to know I was dense. I had no idea of the psych side effects hence was not looking for the possibility of them. I was manic too manic to think straight. Only after quitting the drugs do I have the presence of mind to look up and understand what mania is. For me this is the double bind of antidepressant use that has not been addressed by these recommendations patient/family education and informed consent are touched on but I doubt they will bring about the change we need.
The second issue that has not been addressed as I see it are the physical side effects. During my many visits to the psych doctor I relayed several health issues that were serious side effects of the drugs he was prescribing to me. Gastro and other types of bleeds, ovarian cysts, repeated infections I could go on but the list is almost endless like the 30 + pages of side effects for said drug. During all of this he did not once notice I was suffering from physical side effects of the drugs. In all fairness neither did he doctors many of whom were specialist in their field. Doctors were not aware of the side effects period. Thinking back which is all I have now I can clearly see if I had quit the drugs earlier my problems would have gone away.
contd..
ReplyDeleteWhen I reached tolerance this same doctor did not know what the issue was. I suffered because of his lack of knowledge. I think many others continue to suffer the same fate. He is also unaware of withdrawal and for sure unaware of protracted withdrawal that I am still suffering from. At our last apt he told me I am the only patient he has had with such an effect. I do wonder if I am the only patient he has ever had that has taken themselves off the drugs and still continues to see him a possible explanation.
I do not think my doctor is any worse than the norm and have to think that because he is the head of a large hosp psych department that he is actually better than most.
There is still a long way to go and I see this same doctor to try to break some new ground with him. I may indeed be his case study I do not know I will go as long as he will see me in the hope of some enlightenment on his part. To date he has suggested other medications and I have delined. I am presently 32 off my antidepressants I quit cold turkey out of desperation and received no medical help with withdrawal. Canadians and all people deserve better.
Sara Carlins case was a start in Canada but only a start we cannot drop the ball now. I will be seeking out Terrance Young you can be sure of that.
Hey there Mr Fiddaman from across the pond
ReplyDeletehttp://www.drugsafetycanada.com/2010/07/carlin-inquest-on-paxil/
not much new here but thought you may be interested in the link contain in that post which would take you here
http://www.drugsafetycanada.com/about/health-canada/
It could work.
So when you come across the pond to the states are you planning a visit to Canada?
Last time I visited Terence's site, it was down, so thanks for the link.
ReplyDeleteRe my trip to States - Yes, I am planning a visit to Canada after the award ceremony.
Update
ReplyDeleteOntario Coroner’s Jury Calls for an Independent Drug Agency for Canada
You may know I have introduced a Private Member’s Motion onto the order paper of Parliament designed to create an independent drug safety agency for Canada.
I do not have a date for debate in parliament yet. However, the call for such an agency has been repeated as far back as the Gagnon Commission in 1992, and by numerous interprovincial groups, members of parliament, by the Canadian Medical Association Journal and most recently by The Romanow Commission on the Future of Healthcare in Canada. It is little wonder why: Forty one drugs that Health Canada officials told us were safe have been taken off the market since the 1960s for killing or injuring patients, including Johnson & Johnson’s Prepulsid, the drug that killed our fifteen year old daughter Vanessa in 2000.
A recent number of youth suicides in Oakville are related to Paxil, which makes 1 out 50 young people that take it want to kill themselves. Some of them carry it out. This information is easily available, but almost never given to patients by our doctors or GlaxoSmithKline – the company that markets Paxil – because it is bad for sales. In June, at the most biased legal proceeding I have ever witnessed, the presiding Ontario Coroner directed the jury that they could not name Paxil as a cause of death, yet the majority of their recommendations showed they knew Paxil played a key role. It is important to note that Health Canada issued five warning letters about Paxil in recent years that they know from experience few doctors ever read, a well established pattern that is a cause of thousands of deaths.
Based on the five years of research I did for my book Death by Prescription, only when Canada has an independent drug agency focused on safety, similar to the Nuclear Safety Commission, will Canadians get truly effective safety warnings to support the safe use of prescription drugs.
Yours truly,
Terence Young
Terence - mail me at fiddaman64@blueyonder.co.uk
ReplyDelete