Sara Carlin Inquest - The Influence of Terence Young

Oakville MP - Terence Young


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.

Sadly, Terence knows only too well of drugs that are not carefully scrutinized by health regulators and doctors. In his book, Death by Prescription: A Father Takes on His Daughter's Killer - The Multi-Billion Dollar Pharmaceutical Industry, Terence describes how his 15 year old daughter, Vanessa, was prescribed Prepulsid for an eating disorder.

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:

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!

**Exclusive - Sara Carlin Inquest - Jury Returns With Recommendations.


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ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

**Exclusive - Sara Carlin Inquest - Jury Returns With Recommendations.

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