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 !**@! 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: