Is this the end of the road for medicine regulators?
The 16 recommendations made by the jury in the Sara Carlin inquest were made public on the 28th June via the Oakville Beaver.
I'd previously wrote about a couple of the recommendations here and here after a copy of the verdict was passed on to me hours after the decision.
Today, I want to look at the final recommendation on the list. A recommendation that obviously came about as a result of the tentative jury listening to the evidence of Oakville MP, Terence Young.
Recommendation number 16 reads as thus:
There should be an arms length body independent from Health Canada called the Drug Safety Board, which is solely dedicated to drug safety, which reports to Parliament, which is funded by the Federal Government and which receives no money from drug companies. Amongst its mandated responsibilities should be drug safety research, investigating adverse reactions and issuing warnings to the public and health care professionals and hospitals.
If this particular recommendation is implemented then I see it as a major achievement and one that will go a long way into the way drugs are monitored without bias.
I am assuming that, if implemented, it would face fierce opposition from pharmaceutical companies as their money would no longer be influential. There would be no 'ifs' or 'buts' - if a drug was causing problems there would be no pussy-footing around - it would be reported to the public promptly and directly.
This is further evidence that the jury in the Sara Carlin inquest saw through Glaxo and friends ad preferred the evidence given that actually gave Sara Carlin a voice, a voice that the opposition tried so hard to suppress.
The ramifications of implementing recommendation number 16 could just possibly shake drug regulators to the core. If implemented in Canada, I see no reason why it could not go global.
Maybe then, the MHRA, FDA, TGA and Health Canada could concentrate solely on busting small piracy firms who churn out fake medicines that lose their paymasters millions of pounds each year - a practise that seems to take high priority over people dying from adverse reactions to prescription drugs.
I was hoping to speak with Terence about his proposal for a new Drug Safety Board, sadly Terence is away on business in the USA.
Another time.
I'll be interviewing Sara's father, Neil, soon. He has much to say.
Ed Silverman over at Pharmalot has now picked up on Sara's inquest.
You can read more about the Sara Carlin Vs Glaxo & Friends Inquest at the following links:
Following on from last night's post, 'Jury Returns With Recommendations', I'd now like to focus on another couple of recommendations made by the 5 person jury in the Inquest of Sara Carlin. These, I believe, come about as a direct result of listening to MP for Oakville, Ontario, Terence Young.
It was Young who took the stand late on in the inquest and slammed Health Canada for the way in which they regulate drugs - no surprise then that the following recommendations made by the jury point to the role that Health Canada should play.
D. Health Canada
Issuing Regulatory Warnings
10. In order to maximize the effect of Health Advisories detailing drug-related adverse events, Health Canada should consider that the Health Advisories;
- be succinct
- clearly set out the warning
- should clearly set out the body of evidence giving rise to the warning
- should be specific
- should be profiled in a way to attract physician's attention
Consideration should be given to utilizing knowledge translation experts to assist in providing this infonnation to physicians.
Drug Manufacturers Reporting Clinical Trials with Negative Results
11. Health Canada, as a regulator of companies seeking drug approval, should make their approval contingent on receiving results of all clinical trials from the drug manufacturers.
E. The Regulated Health Professions
Reporting of Serious Adverse Drug Reactions
12. All colleges legislated under the Regulated Health Professions Act, 1991 should require mandatory reporting to Health Canada by its members of serious drug-related adverse events as defined by Health Canada:
Click on image to enlarge
I think point 12 here is of huge significance and it is one that I personally echo with regard to the British drug regulators, The MHRA.
If this recommendation can be implemented in Canada then I see no reason why other countries cannot follow suit.
If regulatory bodies such as Health Canada and the MHRA want a system that works then reporting adverse drug reactions MUST be made mandatory - it's common sense.
Dr Tom Stanton who first prescribed Sara Paxil did not even report Sara's death to Health Canada, despite her being on a drug that is known to cause suicide. Quite why he did not choose to do this... well, only he knows.
Terence Young was damning of both GlaxoSmithKline and Health Canada in his deposition to the Coroner's Court.
Just over the Canadian border in the USA, a black box warning had been slammed on Johnson and Johnson's Prepulsid. Despite this, Canadian doctor's had carte blanche in prescribing this medicine to groups of all ages.
Vanessa Young, at the young age of 15, suffered a heart arrhythmia and died.
I remember writing a review for Terence's book on Amazon. The final para I wrote applies to Sara Carlin as well:
Prepulsid was a bullet for Vanessa Young, the gun into which that bullet was loaded was held by the manufacturers, Johnson and Johnson, their hand was steadied by Health Canada and incompetent doctors who prescribed a drug that killed her.
Terence and his family also faced the ordeal of an inquest, they, just like the Carlin's, had to sit and listen to the systematic bullshit machine churn out excuse after excuse of regulatory failure.
Vanessa died as a result of taking a prescription drug in the year 2000. 10 years on another family are going through the same rigmarole of an inquest regarding a drug that has been to prescribed to an adolescent. Will 2020 see yet another family from Ontario suffering the anguish of this highly and deeply flawed regulatory system?
I sincerely hope not.
These recommendations, if implemented, should help.
On a personal front, I'm tired of writing about Paxil and GlaxoSmithKline. I'm frustrated at the lack of support/care that is shown by the UK Medicine Regulator [MHRA]
I have received many emails during the course of my reporting on this inquest. Two of which came from mother's, one who had a son who killed himself whilst on Prozac, the other from a mother whose daughter killed herself in such a violent way whilst on Paxil.
It sickens me to read about death, particularly when I'm merely a blogger who has tried desperately hard to bang the head of the MHRA against a brick wall to wake them up to this problem, the very same brick wall that I have faced many times when writing to them. I'm not the only one, many have tried to get them to understand exactly what is going on. In truth, I personally don't think they want to understand the size of this problem. It paints them in a bad light and would give them a conscience - so they ignore for reasons that I can only describe as personal gratification.
The regulatory system is in a mess globally. Nobody has the balls big enough to tackle this issue - it's left to people whom have lost children, husbands, wives, family and friends as a result of complete incompetence and an ignorance that is so utterly cowardly that it defies belief.
It's a total shambles that is having a serious knock-on effect with regard to the way in which medicines are prescribed world-wide.
Whatever country you live in, I can guarantee you that your medicine's regulator needs to be changed because I have not come across one that knows what they are doing. They are a body that shrugs its shoulders because they don't know what else to do.
I refuse to correspond with the MHRA anymore - I abhor shirkers...and shirkers is exactly what the MHRA are.
Throughout this inquest my mind has being going back and forth, from Sara Carlin to Sharise Gatchell.
Stephany Gatchell must feel a sense of great loss whilst reading the various articles around the Internet that pertain to this inquest. Her daughter, Sharise, just like Sara, was a beautiful young girl who had everything to live for. She was prescribed Paxil [UK brand name, Seroxat] - She hanged herself.
I often wonder how many kids have died and how the parents of those kids have put the deaths down to the 'illness' rather than the 'cure'
This is without doubt one of the most difficult periods of my life. I'm just writing about it - I have not had to endure the death of a loved one as a result of being prescribed an unsafe drug but hearing of the tragic losses has enveloped me.
I'm sick of hearing about another death to an SSRi.
I'm sick of reading how Pharma have its claws into the education system in America [teen screen] where if a child so much as coughs or belches in the classroom they are deemed as having some form of mental illness and practically force-fed dangerous drugs. Or a child who wants to be a child by grabbing attention in the classroom, urged on by their lunchtime drink of Coca Cola to make them hyperactive - again, pharma pounce - it's an illness and we have got the remedy.
I'm sick and tired of King and Spalding, Addleshaw Goddard [GSK Lawyers] visiting my blog because I happen to have an opinion about their clients. If you want a debate with me then please feel free to do so. I'm betting you that you won't win.
As for the MHRA, they continue to visit, to read my opinions... then back to their daily routines of busting criminals for selling fake Viagra. Have to protect their paymasters, you see.
I am burning out.
I need a holiday.
I need a Shania Twain look-a-like... no, I need Shania Twain to give me a rub down :-)
Hey, I can still find humour!
To all those that have wrote me - I feel your pain, your anguish and your sense of loss.
To all the regulators around the world - grow a pair of nuts and shake the pharmaceutical industry by the scruff of the neck.
It's 2010 and we are losing our faith in doctor's, the very same people who once told us they could make us better are now killing us with the drugs that are slipping through the system through various forms of spin and manipulation.
It's a spiral of decline where ignorance is bliss and the death of a human is regarded as being coincidental.
Shame on you all.
More of the recommendations coming soon.
You can read more about the Sara Carlin Vs Glaxo & Friends Inquest at the following links:
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:
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
I'm finding it increasingly difficult to remain calm here.
I am totally confused by this inquest.
Sara's parents, Neil and Rhonda Carlin, requested this inquest because they both felt that GlaxoSmithKline's Paxil had a part to play in their daughter's suicide.
The Coroner's Court granted them an inquest, after initially turning them down. On appeal, the Carlin's won that right to have Sara's voice heard.
The inquest went on for the best part of two weeks. We heard apparent experts give opinions, Sara's family and friends, her prescribing doctor's.
It now appears that the jury cannot give reasons as to why Sara died. They can only determine how she died.
Isn't this something we already know?
It is abundantly clear, to me at least, that this inquest seems to have been orchestrated in such a way that has basically allowed Sara Carlin on to a stand - but with restrictions - in other words - you can tell us how you died but you cannot give us the reasons why you took a wire, wrapped it around your neck and hanged yourself.
Sorry to be blunt but in essence, after reading the Coroner's charge to the jury, it is obvious that they have been instructed in such a manner as to stifle the voice of Sara Carlin.
"We speak for the dead to protect the living" is the Coroners Court proud boast.
I cannot see any instance where any party connected to the Coroner's Court have actually spoken for Sara Carlin - in fact, quite the opposite.
They have invited her in to a court, put her on a stand, if you will - then misdirected. In other words, "We" are telling your story for you Sara, we are telling the jury about your drinking and substance abuse. We are telling the jury that you were so out of control that it couldn't have been Paxil.
So, why are they doing this?
Well, it's simple really.
If Sara Carlin killed herself because she was depressed, then there is no third party to blame.
If Sara killed herself as a result of substance abuse, then their is no third party to blame.
If, it was alcohol that made Sara kill herself, again, no third party to blame.
If, however, Paxil is implicated into the reasons why Sara Carlin killed herself, we have a number of people to blame.
Firstly, the manufacturer - GlaxoSmithKline
Secondly, the doctor's who prescribed Sara Paxil, Dr. Stanton and Dr. Benjamin.
Finally, the Canadian Medicines regulator, Health Canada.
Now, I know this inquest, or indeed any inquest, is not to determine who was to blame - I'm well aware of that but I feel the public need to know why and not how.
As far as I can see the Coroner's Court don't believe Sara killed herself as a result of taking Paxil, they made their mind up on that issue long before they 'offered' Sara Carlin a voice at the inquest.
With Paxil out of the equation they could focus on Sara Carlin's teenage life, the life of your average teen not only in Ontario but other districts around the world.
I'm 46 this year. When I was Sara's age, I drank - sure I drank. As did my friends.
Did I drink so much that I could be deemed 'drunk'?
Absolutely.
So did my friends.
I have three children, all in their 20's.
Did they drink when they were 16, 17 and 18?
Of course they did.
Did I know?
No, I didn't - well, not while they were 16.
17 and 18, yes.
Sara Carlin came from a good family, she was raised well. Her schooling and achievements a testament to her parents.
Did the fact that she, like every other teenager I know, dabbled in drinking, make her a bad person?
Then, we have the testimony of an ex-boyfriend, whom went on record stating that he and Sara went on an 11 day drinking binge before her death.
Here's the rub:
My children have all been through their teens. I have met many of their cousins and friends.
Still, to this day, they brag about how many pints of lager they can drink, how many shorts [spirits] they can down and how pissed they were on such and such a night.
It's bravado in the most perverse sense... and we are all guilty of it.
How many times in your life have you said, 'Whoa, I drank a bucket load last night'?
As responsible adults seem to take up the majority of readership on this blog, we all know the evils of booze - why do we know?
Because we have ALL experienced it - okay there may be a few who will disagree but I'm sure the majority of those reading this will say too much booze is bad - We know because we have all been 16, 17 and 18.
We didn't kill ourselves as a result.
Neither did Sara Carlin.
An 11 day binge?
What exactly is a binge?
Well, according to my doctor, 6 cans of lager is binge drinking.
I can just imagine teenagers accepting that 6 cans of lager can be deemed as binge drinking - 6 cans of lager to teenagers is merely a mouthwash!
I am speaking through experience and not saying that every single teenager is like this but there are many who are.
It's a cultural thing, same as rock n' roll was in the 50's, same as recreational drugs was in the 60's.
Are we so blind that we cannot see that nothing has changed from our days of youth?
Sara Carlin was your teenage daughter, she was your teenage son. She was popular and because of her popularity was invited to parties.
Are we to blame Sara Carlin for acting in a way that your average teenager performs almost every weekend?
Now... throw Paxil into the mix.
Have GlaxoSmithKline ever carried out any systematic studies with regard to digesting Paxil and alcohol?
Do they know the implications of mixing the two?
A simple, 'Do not take alcohol with your medication' warning on the patient information leaflet is not good enough - particularly when no study has ever been carried out to determine what happens if you mix Paxil with alcohol.
Here we have a prescription drug called Paxil, it's called Seroxat in the UK, Aropax in Australia - there are reasons for the brand name change - Terrence Young wrote about this in his book, Death By Prescription, he also touched on this when giving evidence at Sara's inquest - I have also wrote briefly about it in my book.
The orchestration of Sara Carlin's inquest is so evident that those responsible should be utterly ashamed of themselves for suppressing causation.
Put 12 teenagers in a room full of hidden camera's, just 12 random teenagers.
Put alcohol in the room and watch.
Hey, we have all seen what happens when alcohol is introduced into TV's Big Brother house.
Now think about this.
Tell those 12 teenagers to take Paxil for the duration of their stay in the house.
Can we say, hand on heart, that there would be no difference?
Now, take the Paxil off them - will they crave so much for another 'hit' that they will substitute that craving with a substance that is easily obtainable, for example booze?
To rule out Paxil as a possible cause, as the Coroner's Court has from day one of Sara Carlin's inquest is absurd. To use Sara's lifestyle in such a manner that paints her as some out of control juvenile delinquent is serving only one purpose. Protect the name of those responsible for prescribing it, regulating it and manufacturing it!
End of.
The Coroner's charge to the jury reads like a complicated instruction manual. I will upload segments of it later today. It's an instruction to 5 lay persons that, as far as I can ascertain, has been orchestrated in such a way that has gagged not only Sara Carlin's voice but has restricted 5 lay persons in getting to the bottom of why she killed herself.
We know how - we want to know why!
Therefore, they, the jury, cannot serve the interest of the public with such restrictions placed on them.
You can read more about the Sara Carlin Vs Glaxo & Friends Inquest at the following links:
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
It would appear that the inquest into the death of Sara Carlin has been orchestrated from day one to protect the doctors, Health Canada, Glaxo and Paxil.
I've had an insight into the Coroner's charge to the jury and will soon be uploading segments of it to this blog.
Before the jury retired to deliberate earlier this week they were given a total of 26 recommendations by the Carlin family.
The Coroner, Bert Lauwers [apparently independent] then charged the jury in what appears to be a, 'it wasn't Paxil, it wasn't Paxil' type of speech.
You may remember Coroner's Counsel, Michael Blain. He appeared in front of TV camera's on day one of the inquest. He openly stated, "The courts acknowledge that this medication can increase thoughts of suicide in particular patients but they don't think that the medication played a role in Sara Carlin's death."
I sure would like to look into the crystal ball that Blain has access to. Who made him Judge and Jury? Did he travel to and from the Coroner's Court in a Delorean?
Well Blain [not to be confused with TV trickster David Blaine - ahem] you didn't really give the Carlin family a fair crack of the whip here did you?
What is it an inquest is supposed to offer?
Let me just remind readers:
The motto for the Office of the Chief Coroner of Ontario is "We Speak for the Dead to Protect the Living."
Are we, then, to assume that Coroner's Counsel, Michael Blain, was speaking for Sara Carlin when he appeared in front of TV camera's during a short court recess on day one?
Are we to assume that Coroner, Bert Lauwers was speaking for Sara Carlin when he charged the jury?
How about offering the Carlin's lawyer, Gary Will just 20 minutes to cross-examine witnesses while Blain was given an hour or so?
There's also a matter of a symbol that seems to have been overlooked by all the media outlets - Was it a C or and O with a line through it?
I guess we could have a poll on this blog? From what I've seen even Mr. Magoo could determine what the symbol reads!
That, and parts of the Coroner's charge to the jury coming soon.
I may even upload the entire speech for you all to read.
The five person jury, made up of three men and two women return to the Coroner's Court on Monday.
Meantime - :
Here's hoping the Coroner and Coroner's Counsel have a splendid weekend with their sleep patterns unaffected:
Here's a taster of the Coroner's charge to the jury: [Keep in mind that the Coroner is supposed to be independent]
“...And a Coroner may comment on the weight given to any particular evidence ….I generally do not exercise this power as I believe you the jury are likely to come to the conclusion that I would arrive at”
“I direct you to the expert opinion of DR. John Fernandez which is exhibit 4. He was the only person called with respect to giving a medical cause of death. You will recall that…so I would take his report and his determination seriously. He gave the cause of death as hanging by ligature and he put in brackets – electrical cord – while under the influence of cocaine & ethanol and with a therapeutic level of paroxetine”
On the question of manner of death:
“I believe the answer here is absolutely clear and is suicide.”
“The OCCO has taken the position – the jury must complete the section of its verdict with the category of just one of those findings – natural, accident, suicide, homicide or undetermined – we don’t want you toad any narrative on to it or put anything else in place – it is just one of those findings”
“I think we can dispense with the options of natural, homicide, accident and undetermined”
He then goes on about Juurlink’s report ie. it’s the disease not the drug.
“There were a few surprises to me as a Coroner that occurred at this inquest (1) The amount of alcohol use & abuse in the young people (2) The prevalence of cocaine use – This is not evidence but merely my opinion – I am concerned about the Health & safety of our youth – I have never heard the terms pre-drinking & post-drinking. (3) Dr Links power point presentation – 19% of high school students have considered suicide in the past year – 15% have made a plan – 9% a suicide attempt in the past year”
He then goes through Links report in detail - not Links’ evidence.
Final instructions include:
“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”
“ We now ask you to speak for Sara Carlin”
Overall, one of the most concerning things in his charge is to instruct the jury to review and rely upon the expert reports in their deliberation - not their sworn evidence – which on a number of points they conceded that PAXIL may possibly have been a contributing factor. Not surprisingly – he barely ever mentions Dr. Nathan Scharf the only doctor who specializes in child & adolescent psychiatry – and does not mention his report at all. He mostly pushes (in detail) the Juurlink & Links report to the jury – never mentioning that Juurlink is not a trained, qualified or licensed in the practice of psychiatry.
There's a lot more to this inquest than what the Ontario newspapers have been reporting.
From day one, it appears, the Coroner, Coroner's Counsel, Doctor's, Doctor's lawyers, GlaxoSmithKline and their lawyers have basically tried to stifle Sara Carlin's voice.
Quite the opposite of their motto:
"We Speak for the Dead to Protect the Living."
Keep checking back for more over the weekend.
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
You can read more about the Sara Carlin Vs Glaxo & Friends Inquest at the following links:
...but they still don't acknowledge they did anything wrong.
Drugmaker GlaxoSmithKline has agreed to settle almost 200 cases in which plaintiffs allege the use of the antidepressant Paxil caused birth defects.
Despite settling many of the Paxil cases, GSK continues to argue it acted appropriately regarding the drug.
"GSK believes it acted properly and responsibly in conducting its clinical trial program for Paxil, in marketing the medicine, in monitoring its safety once it was approved for use and in updating pregnancy information in the medicine's label as new information became available," Alspach said.
The Oakville Beaver has now posted the list of recommendations.
Lawyer Gary Will, on behalf of the Carlin family, submitted 26 recommendations to the jury examining the suicide of Sara.
As you will note, the Carlin's have put forward these recommendations for the future safety of other children and adolescents in Canada.
It's taken a gruelling two weeks for them to get to this stage.
Another inquest into the death of a child/adolescent taking Paxil or any other SSRi/SNRi should never have to happen again.
If these recommendations are carried then the citizens of Canada, indeed the world, owe the Carlin's a huge thanks. They have sacrificed pain to get to this point and it has been a journey faced with lawyers who have tried to paint Sara Carlin in a bad light. This also, should never be forgotten.
Neil, Rhonda and Meghan Carlin have been to Hell for every single parent in Canada. They have sat and listened to 'expert' witnesses claim that it was Sara's drinking and substance abuse that caused her to kill herself and that it had nothing to do with Paxil. They have relived the moments when they found their beautiful daughter hanging from a wire in their basement on May 6th 2007. They have faced TV camera's upon entering and leaving the Coroner's Court. They have read one sided articles with eye-catching headlines from the Canadian mainstream media who print the 'meaty' bits just to sell their newspaper.
The majority of Newspapers reporting on this inquest have failed the Carlin's, they, like GlaxoSmithKline, have put profit before morality.
The Carlin's have also had to endure Michael Blain, Coroner's Counsel, appear in front of a TV camera and state during a court recess on Day One of the inquest.
The video, now hosted on YouTube sees Blain categorically state:
"The courts acknowledge that this medication can increase thoughts of suicide in particular patients but they don't think that the medication played a role in Sara Carlin's death."
Quite an astonishing statement considering this was day one of Sara's inquest.
Before viewing the recommendations put forward today by the Carlin family, I'd like to show you what the papers didn't. They have their reasons I guess but by failing to show the public of Canada exactly what the Carlin's have been up against at this inquest is unforgivable.
First, I'm going to throw a question out:
Just what makes a good [reliable] expert witness?
One would assume someone who is impartial and has nothing to gain by defending this or that.
Certain questions have to be raised regarding the witnesses called by the Coroner's Counsel and GlaxoSmithKline in the Inquest of Sara Carlin. In fact, one of the biggest failings thus far in this inquest was the Coroner's Counsel, Michael Blain, desire to appear in front of TV camera's during a short recess on day one of the inquest.
For me, Michael Blain had a duty to remain impartial in this case.
Other witnesses called to give testimony also, it would appear, have more of a reason not to chastise SSRi type drugs.
See if you can join the dots here.
Dr. Lynne Benjamin -> Dr. Paul Links -> Andrew Merrick
I'll help.
The odd one out, at first glance, would appear to be Andrew Merrick as he had nothing to do with this inquest...at first glance.
However, something of significance, that neither the Toronto Star or Oakville Beaver showed with their various reports of this inquest, becomes apparent when you join the dots.
It's difficult at first as Dr Lynne Benjamin, the doctor who increased Sara's Paxil from 20mg to 30mg, prefers not to use her married name.
Her married name being Merrick - her husband being Andrew Merrick, Director of Corporate Affairs for Eli Lilly Canada.
So where does Dr. Paul Links fit in?
Dr. Paul Links is a professor of psychiatry at the University of Toronto, deputy chief of psychiatry at St. Michael's Hospital, and past president of the Canadian Association for Suicide Prevention.
He was called as an expert, one would assume, because he works daily with suicidal patients and holds an academic chair dedicated to the study of suicide, the Arthur Sommer Rotenberg Chair in Suicide Studies at the University of Toronto.
GlaxoSmithKline invested more than $178 million in Canadian research and development (R&D) in 2007 alone, ranking it among the top 15 contributors to R&D in Canada, across all industries.
Here's some instances where the University of Toronto pops up on the Canadian GlaxoSmithKline page.
$1 million endowed Chair in Pharmaceutics at the University of Toronto.
GlaxoSmithKline is contributing $3.75 million to the Structural Genomics Consortium (SGC), a three-year project led by Dr. Aled Edwards at the University of Toronto. The SGC will contribute to the discovery of new products for unmet medical needs.
Links has also, in the past took an “unrestricted educational grant” from Eli Lilly Canada, the very same Eli Lilly Canada where Andrew Merrick is Director of Corporate Affairs, the same Andrew Merrick who is married to Dr. Lynne Benjamin.
Quite why the media have failed to report this is quite bewildering.
Benjamin's deposition is quite staggering, a snippet of which is included in this post.
There is an issue, again not reported by the mainstream media, whereby Benjamin, after talking with Sara Carlin, prescribed her 30mg of Paxil.
In Benjamin's two notes there seemed to be a discrepancy. One said that she had increased Sara's Paxil dosage from 20 to 30mg, the other mentions an increase to 25mg using Paxil CR.
Paxil CR is a controlled release version.
Under cross examination from the Carlin's lawyer, Gary Will, Benjamin was asked about this discrepancy.
GARY WILL: You made a decision to increase her [Sara's] Paxil dosage from 20 to 30
DR. LYNNE BENJAMIN: Yes, I did.
GARY WILL: Now, er, did you know what the actual prescription was that you wrote... was it for 30 milligrams?
DR. LYNNE BENJAMIN: I wrote that I increased her Paxil to 30 milligrams, yes.
GARY WILL: Who actually wrote her prescription?
DR. LYNNE BENJAMIN: I wrote the prescription at the end of her visit.
GARY WILL: And was that prescription for 30 milligrams?
DR. LYNNE BENJAMIN: Yes
GARY WILL: And you note in the other note that the Paxil dosage was CR 25.
DR. LYNNE BENJAMIN: Right.
GARY WILL: Did you write a prescription for Paxil CR 25?
DR. LYNNE BENJAMIN: I don't think I did, I think I wrote the initial prescription for 30.
GARY WILL: Right. You didn't write her two prescriptions?
DR. LYNNE BENJAMIN: I had no reason to do that.
GARY WILL: But you did in this case?
DR. LYNNE BENJAMIN: No.
GARY WILL: Do you have a memory of what prescription you wrote her?
DR. LYNNE BENJAMIN: My memory is of 30...but I'm also going by what I wrote to jog my memory.
GARY WILL: You'd agree it's a little confusing?
DR. LYNNE BENJAMIN: Yes it is.
GARY WILL: Could have been 25 or it could have been 30?
DR. LYNNE BENJAMIN: Well the 25 CR is the equivalent to 30 and I think that's why I made the error.
GARY WILL: But, er, Paxil CR 25 is a Paxil medication but it's a slow release medication.
DR. LYNNE BENJAMIN: It's supposed to be more effective... or in some cases.
GARY WILL: More effective for what?
DR. LYNNE BENJAMIN: Uh, the company I guess recommended to us that it would be...get better blood levels for treatment of anxiety and depression.
GARY WILL: Is that what GSK told you?
DR. LYNNE BENJAMIN: I have been aware of that through CME, some how. [The Canadian Journal of CME]
I can't quite grasp Benjamin's selective memory here. There is much, much more that I will post at a later date.
The whole of Canada owes the Carlin's an immense show of gratitude. Health Canada should be totally embarrassed by all of this. They, like the MHRA and FDA have heard countless stories regarding suicide and Paxil. They have not done enough and it now takes the parents suffering the loss of their dead daughter to put forward recommendations that these limp-wristed agencies should have, could have done years ago. Had they have then Sara Carlin would probably still be alive today as would UK teenager Sharise Gatchell, another teenager who hanged herself whilst on Paxil.
Neil, Rhonda, Meghan, I salute you all. Your bravery throughout this ordeal has been inspirational.
Finally, I want to pay tribute to Sara Carlin. A beautiful looking teenager whose life is now but a memory for those that knew her.
Sara, you too have given me the drive to do what I do. You and the countless others who have lost their lives to these family of drugs give me great strength to continue to do what I do.
In the name of justice and common sense - you, Sara, will forever be etched in my memory as the one person I wish I could have met, if only to say, everything will be alright. If only to show you what Paxil can do to kids of your age.
Sara Carlin, 18 years on this earth, your death a constant reminder of the failure of the regulatory system, the medical profession and a pharmaceutical company who prefer profit before human life.
You shall go down in history Sara. The jury owe you that.
Bob Fiddaman.
Here are the recommendations put forward by the Carlin family earlier today.
This, I recommend, is Sara's Law:
1. We recommend that all doctors be required to provide informed consent to all patients being prescribed antidepressant drugs, including Paxil and all other SSRI and SNRIs, using the model currently considered good clinical practice in British Columbia for anyone under 18 years of age. (Ex. 20)
This includes an SSRI/SNRI monitoring form and information sheet being provided to patients (and their families) and a requirement for the doctor to discuss the true risk/benefit analysis with the patients, and document that discussion.
This discussion should also include a discussion of all reasonable alternative treatments and any material risks and benefits of such alternative treatments.
This discussion should include all material risks and the risk of suicide and record exactly how the patient will be monitored for suicide.
2. Patients should have a published Bill of Rights which incorporates as a principle: “The Right to Informed Consent”. This means good, complete and balanced information based on scientific evidence of a drug’s efficacy and safety.
3. That in all cases where a drug has not been approved for use in children where there are potential life threatening adverse consequences that the doctor must discuss the drug with the parents or legal guardians of the patient unless there is a written direction from the patient that which prohibits this communication.
4. That the College of Physicians and Surgeons of Ontario provide practice guidelines and training to family physicians on administering and monitoring the use of antidepressants (SSRIs) in adolescents.
5. The information provided to patients should be standardized and handed out with the drugs and be in plain language.
6. The information provided to patients should include: (i) the benefits of the drug, not just “it might help”. That includes the real effects of the drug, how many people it helped and under what conditions, and how much better it was than a placebo; (ii) the risks of taking the drug: not just the common side effects, but the things that might happen and the rare serious side effects. A layperson should be able to understand the true level of risk in their personal situation and make an informed choice; (iii) the alternative treatments to the drug: including what would happen if you do nothing, any lower cost treatment that might work as well, or a lifestyle change that might help the condition.
7. Drug labels and patient safety information leaflets should make patients prescribed a drug aware of any safety issues related to that drug in other countries, including but not limited to any related deaths or serious injuries due to drug reactions.
8. Consumer Package Inserts should state up-front in plain language, any warnings patients may need to decide whether or not this drug is safe for them, or if they wish to go back to their doctor for more advice.
9. Monographs should not list only officially reported adverse reactions, which are a tiny fraction of real reactions, but the fact that reported adverse reactions represent only a tiny fraction of actual events.
10. Any and all clinical studies that are sponsored by drug companies or their affiliates should be registered when begun and the results reported to a Canadian drug safety agency by law.
11. The Dear Healthcare Professional letters issued by drug manufacturers and/or Health Canada when issuing a drug warning should include other suggested alternative treatments.
12. Patients should know when a drug has never been tested on a large group of people or never tested on children.
13. Drug companies should provide software and updates to doctors which list all contraindications for their products in plain language on the Internet available by download to PCs and hand-held computers on demand.
14. Drug companies should be required to report all serious adverse events associated with their drugs from all foreign jurisdictions within 30 days of the adverse event.
15. Any company that blocks the dissemination of significant safety / efficacy information on drugs sold in Canada, or withholds such information, should face significant penalties commensurate with their financial position.
16. That drug manufacturers be required to report the results of all clinical trials to Health Canada.
17. That drug manufacturers be prohibited from requiring researchers to sign non-disclosure contracts.
18. Patients should also be able to get this approved information from an independent drug safety agency by calling a free 1-800 # as well as information regarding their right to be properly informed.
19. There should be an arms length body independent from Health Canada called the Drug Safety Board which is solely dedicated to drug safety and which reports to Parliament and is funded by the Federal Government, which receives no money from drug companies. Amongst its mandated responsibilities should be investigating adverse reactions and issuing warnings to the public and health care professionals and hospitals.
20. Health Canada, or the new Drug Safety Board, should study the extent to which serious adverse events remain unreported. This data should then be used when sending out information to physicians or the public concerning reported adverse events by cautioning the reader that actual adverse reported events likely only represent 10% of the actual adverse events.
21. Health Care Professionals should be required by law to report any suspected adverse drug reaction to Health Canada, or the new Drug Safety Board, within 48 hours. This would act as an early warning system with new drugs, and help identify rare but serious reactions and dangerous contraindications.
22. There should be a presumption that all health care records concerning a patient are to be forwarded to the patient’s family physician unless there is a written direction from the patient that particular records are not to be forwarded to the family physician.
23. Ontario should adopt a Provincial Suicide Prevention strategy.
24. Canada should adopt a National Suicide Prevention strategy.
25. The Province should develop a strategy to create a single prescription drug database to facilitate research into drug safety issues.
26. The Provincial Ministry of Education should incorporate into its high school curriculum courses directed towards dealing with alcohol and drug abuse issues.
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
Nessun Dorma
Fid
ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING
Closing arguments were heard yesterday at the inquest of Sara Carlin, the beautiful teenage daughter of Neil and Rhonda Carlin, who hanged herself in May 2007.
The jury will now deliberate all the evidence they have heard over the past two week or so.
Already CNEWS Across Canada Is running with the headline "Paxil likely played important role in teen's suicide"
They write:
Lawyer Gary Will, who represents the Carlin family, said Paxil "played a very important role and it might have been contributor" with other factors in the May 6, 2007 suicide of the outstanding athlete and scholar.
"She took her life in a most horrible, violent way. And these antidepressants known as selective serotonin reuptake inhibitors (SSRIs, including Paxil) induce suicides that are often violent," Will told the jury in his closing comments
The Globe and Mail lead with, Inquest probes link between medication and teen’s suicide, the first paragraph reading:
To Sara Carlin’s family, a prescription drug meant to cure her anxiety triggered a deep depression that led her to hang herself. To the company that makes the drug, the Oakville teen was already troubled and her medication was working
.
I will be summarising this inquest over the coming days. There is a lot more to this than meets the eye. I'm not particularly happy with the witnesses called, nor am I happy with the way the Canadian press have not drawn links to these witnesses and their possible conflict of interests.
The testimony of these witnesses has to be scrutinized by the jury and, I believe, they must pay particular attention to the testimony of one of Sara's doctors, Dr. Lynne Benjamin. It was Benjamin who increased Sara's dose of Paxil from 20mg per day to 30mg per day. Benjamin's testimony is interesting where she tries to explain away two separate notes for the same visit Sept 26-06 – on one she prescribes immediate release Paxil 30 mg – on the other note she prescribes Paxil CR 25 mg.
Dr Lynne Benjamin has not used her married name throughout this case, that's her prerogative.
For the record Dr Lynne Benjamin is married to Andrew Merrick.
Andrew Merrick is Director of Corporate Affairs for Eli Lilly Canada, something the Canadian press seemed to have overlooked.
I will write more about this and other witnesses over the coming days and tell you of the law firms and institutes that have been visiting this blog since I first started reporting on it.
In the meantime, here are the back stories in chronological order:
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
Nessun Dorma
Fid
ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING
Much has been made about Sara Carlin's drinking, so much so that Glaxo's lawyers, doctor's lawyers and witnesses and even the Coroner's Counsel have all used it to try to [1] Discredit Sara Carlin and [2] Protect Paxil, Health Canada, GlaxoSmithKline and the doctor's that prescribed Paxil to Sara.
Paragraph 16 reads: "Day 25: A pattern is emerging. Since starting on Paxil, I've been drinking like a fish. For some reason, vitamin P combines incredibly well with alcohol. It's more fun to drink than it was before. I want to be drunk every night. I don't get hung over now, and I remain pretty lucid even when sloshed."
Paragraph 22 through 24 read: "Day 35: Drinking a lot, several nights a week. Liquor + Paxil = Wow!
"Pre-Paxil, I was a social drinker. Now I'm walking a mile in someone else's brain chemistry. I can see why some of you like to drink so much, maybe even need to drink so much. It's fun for me now, in a way it just wasn't before. On liquor and Paxil, strangers mean novelty, not fear. Group conversations are a chance to play raconteur, not a chance to smile weakly and shut up."
"And it's so much better than sobriety. Sober for me these days means extreme detachment. Movies, once a favorite hobby, do nothing for me now. Likewise booksI just don't connect with the plots or characters. I can't recall laughing (while sober) in the past couple of weeks. I'm never sad, but never happy. Why wouldn't I drink?"
The closing arguments will be heard tomorrow. The Jury will listen intentively then will depart for deliberation.
The five person jury have an ideal opportunity to make change in the way Paxil and all other antidepressant medication is prescribed off-label to children and adolescents.
GlaxoSmithKline and Health Canada will not make these changes without the jury's recommendations. They will continue to pass the buck and bury their heads in the sand.
It's time for change - put Canada on the map and save the lives of future Sara Carlin's.
The following are all from the excellent resource website, SSRi Stories.
Health Canada need to take a look at this website.
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.
