Although being familiar with much of the content (Paxil Study 329) I did learn quite a lot - the history of antidepressants for one - the jumping through hoops games the BMJ, seemingly, like to play was another.
Many researchers like to revisit clinical trials (studies) and play around with the published findings, these researchers often dispute the original claims. This is all well and good but after reading Children of the Cure I have to ask myself, why bother?
In a nutshell, any available published studies, be they online or in print, are just a snapshot of what really occurred during clinical trials, this snapshot is often spun in such a way that can leave the readers, be they healthcare professionals or members of the public, thinking that something is safe and effective when in actual fact it's the complete opposite. Articles published in prestigious academic journals almost always add weight to the apparent positive outcomes of such trials, these articles are, in turn, used to convince those who are unsure about the safety and efficacy of a drug, namely prescribing doctors and psychiatrists. Such articles boast names of leading figures in particular fields, again this adds weight and is designed to convince journal editors and panel members and also prescribers that everything is hunky dory. It's the first step in dogmatism. It's carefully crafted and intended to plant a seed so deep that when later queried those who have been convinced will either ignore fresh claims, shrug their shoulders or, as in the case of Study 329, forget it ever happened.
RIAT
In 2015, the BMJ published 'Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence' which was pieced together after a bunch of researchers managed to get access to raw-data from a host of trial centres across North America. The raw-data had never been seen before, in fact the only time raw-data is seen is when trial lawyers request it in discovery - even then, most of the data is redacted (Blacked out)
The RIAT team, which is an acronym of 'restoring invisible and abandoned trials', painstakingly went through data after it was agreed by GSK to grant the team access via an online portal. All seemed fine until the team, consisting of Joanna Le Noury, research psychologist, John M Nardo, retired clinical assistant professor, David Healy, professor, Jon Jureidini, clinical professor, Melissa Raven, postdoctoral fellow, Catalin Tufanaru, research associate, and Elia Abi-Jaoude, staff psychiatrist, learned that it was a technological system that was designed to hinder their process, nae progress.
Nevertheless, the team persevered and found discrepancies that involved GSK downplaying suicide events that occurred in the Paxil arm of the clinical trials. One has to keep reminding oneself that these trials were carried out on adolescent children whom GSK were desperately trying to get a licence to 'treat' for their blockbuster antidepressant Paxil, also known by other brand names such as Seroxat, and Aropax to name but a few.
Believe it or not, this wasn't the hardest hurdle the researchers had to jump, that came much later when they submitted their findings to the BMJ. The hoop-jumping game BMJ set out would have left even the most flexible of people tied in knots.
The BMJ 'game' is new to me. I was of the opinion that the RIAT team presented their findings and it pretty much went to print. Reading Children of the Cure will leave you flabbergasted at the lengths the BMJ went to, it appears, to frustrate the team.
It's akin to when one makes an insurance claim. It's standard practice to refuse a claimant in the hope that they will go away, if they don't, well, just throw more paperwork at them and the majority will give up pursuing a claim. The BMJ are no different than these types of insurance companies. There is also the fear factor. One should be ready and willing to publish evidence that points to fraud, especially when that fraud puts adolescents at risk - my understanding, upon reading the book, is that the BMJ constantly bottled it, they thought more about repercussions to their name rather than protecting a vulnerable population.
IT DOESN'T MATTER ANYMORE - IT HAPPENED IN THE PAST
I've often heard this phrase used whenever 329 is mentioned. 'It came at a time when there were bad eggs operating GSK', another, 'it's all part of how a business is run', the most callous of all being, 'Ok, let's move forward now.' These well-worn phrases might all be well and good if, for example, SSRIs were completely banned for use in children and adolescents, I'm of the opinion that they should be.
But wait, aren't they banned, what about the recommendations? Well, recommending something is not set in stone, just as I recommend you buying this book doesn't mean that you are going to. Children and adolescents are still prescribed SSRIs, not so much Paxil these days because of the bad rap it's had over the years, a large chunk of credit for this must go to BBC journalist, Shelley Jofre who is mentioned throughout Children of the Cure. Shelley's four Panorama investigations basically opened a can of worms, all four shows highlighted how PR firms who specialise in ghostwriting (turning something so bad into something quite wonderful). The four Panorama specials also showed the complete mess that is the MHRA, a British drug regulator who, just like the BMJ are afraid to say boo to a goose for fear of reprisals.
Those that added their names to the now infamous 'Efficacy of Paroxetine in the Treatment of Adolescent Major Depression: A Randomized, Controlled Trial' should hang their heads in shame, as should the Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP)
The FDA and MHRA should also hang their heads in shame, as should Sally K. Laden, the gifted miracle worker who turned shit into gold. ALLTRIALS for practically taking one up the back passage from GSK and allowing them to select what can and can't be seen by future researchers. Prescribers who haven't bothered to look into or request raw-data from drug companies should also take a long, hard look at themselves.
We, in general, should all take a look at ourselves and ask what are we doing about this notorious spin - is it just a piece of history that we all know about but tend to think, pah, it's old news?
History has habit of repeating itself, particularly when apathy is present. Remember, ketamine is the new miracle drug on the market and is receiving many accolades from high profile psychiatrists just as Paxil was by The Marty Keller clan. Keller is an insidious man - the lengths he went to to lose Healy his dream job at the University of Toronto shows how far he was willing to go to keep his sordid (well-paid) secret under wraps.
Children of the Cure by David Healy, Joanna Le Noury, and Julie Wood is published by Samizdat Health Writer's Co-operative Inc. and can be purchased on Amazon US here and Amazon UK here.
Bob Fiddaman
The RIAT team, which is an acronym of 'restoring invisible and abandoned trials', painstakingly went through data after it was agreed by GSK to grant the team access via an online portal. All seemed fine until the team, consisting of Joanna Le Noury, research psychologist, John M Nardo, retired clinical assistant professor, David Healy, professor, Jon Jureidini, clinical professor, Melissa Raven, postdoctoral fellow, Catalin Tufanaru, research associate, and Elia Abi-Jaoude, staff psychiatrist, learned that it was a technological system that was designed to hinder their process, nae progress.
Nevertheless, the team persevered and found discrepancies that involved GSK downplaying suicide events that occurred in the Paxil arm of the clinical trials. One has to keep reminding oneself that these trials were carried out on adolescent children whom GSK were desperately trying to get a licence to 'treat' for their blockbuster antidepressant Paxil, also known by other brand names such as Seroxat, and Aropax to name but a few.
Believe it or not, this wasn't the hardest hurdle the researchers had to jump, that came much later when they submitted their findings to the BMJ. The hoop-jumping game BMJ set out would have left even the most flexible of people tied in knots.
The BMJ 'game' is new to me. I was of the opinion that the RIAT team presented their findings and it pretty much went to print. Reading Children of the Cure will leave you flabbergasted at the lengths the BMJ went to, it appears, to frustrate the team.
It's akin to when one makes an insurance claim. It's standard practice to refuse a claimant in the hope that they will go away, if they don't, well, just throw more paperwork at them and the majority will give up pursuing a claim. The BMJ are no different than these types of insurance companies. There is also the fear factor. One should be ready and willing to publish evidence that points to fraud, especially when that fraud puts adolescents at risk - my understanding, upon reading the book, is that the BMJ constantly bottled it, they thought more about repercussions to their name rather than protecting a vulnerable population.
IT DOESN'T MATTER ANYMORE - IT HAPPENED IN THE PAST
I've often heard this phrase used whenever 329 is mentioned. 'It came at a time when there were bad eggs operating GSK', another, 'it's all part of how a business is run', the most callous of all being, 'Ok, let's move forward now.' These well-worn phrases might all be well and good if, for example, SSRIs were completely banned for use in children and adolescents, I'm of the opinion that they should be.
But wait, aren't they banned, what about the recommendations? Well, recommending something is not set in stone, just as I recommend you buying this book doesn't mean that you are going to. Children and adolescents are still prescribed SSRIs, not so much Paxil these days because of the bad rap it's had over the years, a large chunk of credit for this must go to BBC journalist, Shelley Jofre who is mentioned throughout Children of the Cure. Shelley's four Panorama investigations basically opened a can of worms, all four shows highlighted how PR firms who specialise in ghostwriting (turning something so bad into something quite wonderful). The four Panorama specials also showed the complete mess that is the MHRA, a British drug regulator who, just like the BMJ are afraid to say boo to a goose for fear of reprisals.
Those that added their names to the now infamous 'Efficacy of Paroxetine in the Treatment of Adolescent Major Depression: A Randomized, Controlled Trial' should hang their heads in shame, as should the Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP)
The FDA and MHRA should also hang their heads in shame, as should Sally K. Laden, the gifted miracle worker who turned shit into gold. ALLTRIALS for practically taking one up the back passage from GSK and allowing them to select what can and can't be seen by future researchers. Prescribers who haven't bothered to look into or request raw-data from drug companies should also take a long, hard look at themselves.
We, in general, should all take a look at ourselves and ask what are we doing about this notorious spin - is it just a piece of history that we all know about but tend to think, pah, it's old news?
History has habit of repeating itself, particularly when apathy is present. Remember, ketamine is the new miracle drug on the market and is receiving many accolades from high profile psychiatrists just as Paxil was by The Marty Keller clan. Keller is an insidious man - the lengths he went to to lose Healy his dream job at the University of Toronto shows how far he was willing to go to keep his sordid (well-paid) secret under wraps.
Children of the Cure by David Healy, Joanna Le Noury, and Julie Wood is published by Samizdat Health Writer's Co-operative Inc. and can be purchased on Amazon US here and Amazon UK here.
Bob Fiddaman
