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CrossFit Health provides a Platform for Truth in Science currently being sabotaged by "The Mess"

In a recent post, CrossFit Health discusses the results of a review which indicates "a significant share of treatments, even if they are in widespread use, will be found ineffective when tested in a rigorous clinical trial"

Researchers looked at over 3,000 randomized controlled trials in JAMA and the Lancet (from 2003-2017), and in the New England Journal of Medicine (from 2011 to 2017). Over 13% of these RCTs (396) in fields ranging from cardiovascular disease to obstetrics and gynecology, included reversals of medication, procedure, vitamin/supplement, and device; over half which were later confirmed by systematic review. Read more about it at CrossFit Health

Did you know the importance of reading published studies in their entirety (rather than just the abstract) to understand their implications? A recent review on research published in psychiatry journals (2012-2017) demonstrated a greater than 50% liklihood for abstracts not to reflect accurately on actual results. Read more about it at CrossFit Health.

Have you heard about systematic fraud and data fabrication discovered by English anesthetist John Carlisle throughout thousands of Randomized Controlled Trials? His data detective-work contributed to the high-profile retraction of PREDIMED. Read more about it at CrossFit Health

Do we indeed "commit to paradigms, and then..bend the data to [them]"?  Have you heard that "Generations of doctors were taught the faulty lipid hypothesis “because Ancel Keys’ rebuttal of his own data was not accepted by the federal government"?  Read more about it at CrossFit Health.

This is a critical discussion we need to be having on the quality of current published research, scientific objectivity, and the degree to which we can trust modern medical science.  If you currently have confidence, understand that "Scientific research has been plagued by conflicts of interest, data dredging, and bias, leading some researchers to assert that approximately 90% of published research relied upon by doctors is flawed". Read more about this story at CrossFit Health.

I was honored to publish a guest post a few years ago from Dr. Malcolm Kendrick highlighting all that can go wrong with our current standard of care model.

Independent Regulation needed for Big Pharma

2 Feb 2016 

More stark proof that our pharmaceutical industry needs strict and independent regulation. Another case where raw data is reanalyzed YEARS after publishing (14 years), and a pharmaceutical agency is found GUILTY of illegally promoting drugs for treatment of children (they claimed had “remarkable efficacy and safety”) despite the fact in the original raw data: “there were clinically significant increases in harms, including suicidal ideation and behavior and other serious adverse events”.

http://www.bmj.com/content/351/bmj.h4320.full

RCFN is honored to host this guest post by Dr. Malcolm Kendrick:

Study 329 – where the hell is the outrage?

by Dr. Malcolm Kendrick

To quote from the BMJ ‘No correction, no retraction, no apology, no comment…’

Study 329 was started in 1994 by Smith Kline Beecham, which shortly become part of the larger conglomerate Glaxo Smith Kline (GSK). Study 329 looked at the use of paroxetine, an anti-depressant, in adolescents with depression.

Following this study paroxetine was promoted and marketed heavily by GSK as demonstrating, in the words of GKS marketing materials: ‘REMARKABLE Efficacy and safety’. Over two million prescriptions were then written for children and adolescents in the US.

However, in 2002 the FDA considered study 329 to be a ‘failed trial.’ In 2003 the UK recommended that paroxetine should not be used in children and adolescents with depression because it increased the risk of self-harm and potentially suicidal behaviour.

In 2004 the FDA placed a black box warning on all antidepressants in adolescents and children stating that they increased the risk of suicidal thinking and suicidal behaviour in these groups. In 2012 GSK finally agreed to pay £2Bn for fraudulently promoting paroxetine.

But the story does not end here. A group of researchers, who had been heavily critical of this trial, finally managed to get hold of the raw data and carried out a re-analysis under the restoring invisible and abandoned trials (RIAT) initiative. Yes, this saga has been a long one.

The reanalysis was recently published in the BMJ with sadly predictable results. The primary conclusion was that ‘Neither paroxetine nor high dose imipramine showed efficacy for major depression in adolescents, and there was increase in harms in both groups.’

 

This is in stark contrast to the original trial results. When it was first published it appeared to demonstrate very clearly that paroxetine was both safe and effective in adolescents with depression. According to GSK it demonstrated ‘.remarkable efficacy and safety’ However, using exactly the same trial data, reanalysed by independent researchers, we now find that paroxetine was both useless and damaging.

So, what has been the consequences for those involved in the initial trial and the writing up thereof? For those who read the BMJ, you will know that I am now quoting verbatim here:

  • Despite subsequent FDA and MHRA warning about increased risks of suicidal thinking and behaviour and GSK receiving a record fine, partly for illegal off-label promotion of the drug, the original report has not been retracted or even had a correction
  • Academic and professional institutions have failed to publically address the many allegations of wrongdoing
  • None of the named authors had intervened to correct the record. An internal enquiry by the Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP) concluded that no further action was necessary
  • Brown University remains silent over its involvement in the study. It refuses even to confirm or deny whether any investigation took place1

I will add to this that a co-author of study 329, Karen Wagner, named eight times in the 2011 US Department of Justice complaint against GSK, is currently the president elect of the American Academy of Child and Adolescent Psychiatry – whose journal, the JAACAP, is where the original study was published.

 

Taking stock. What do we have? A study was done, and published, demonstrating that paroxetine was safe and effective. The trial data were heavily promoted, resulting in millions of children and adolescents being prescribed paroxetine.

The reality is that this drug was completely ineffective and increased the risk of suicide (amongst other things). This has all been known for many years. The latest re-analysis simply confirms everyone’s worst fears.

 

So surely someone, somewhere, got punished? No they did not. Not only that, but the original published study has not even been retracted. It still sits in the medical database. A young and innocent researcher could come across it, and reference it, and use data from it to support a grant application for a study to use antidepressants in children.

If this were not all completely and absolutely one hundred per-cent fact, you might think we have a possible plot line for a dystopian novel here. A story of terrible corruption where large corporations can distort data through one hundred and eighty degrees, and get away with a fine. A world where bent researchers promote research that results in more children committing suicide, and then move on positions of greater power and authority – with no censure from anyone. To become presidents of major medical societies, for example.

 

Frankly I don’t think I would dare to write a novel with a plot so completely outrageous. Surely someone, somewhere, would be punished for this behaviour. Surely the paper would be retracted. Surely a co-author of such a study would not be in line for a prestigious position. Surely the public would rise up in outrage.

In truth, it seems, nothing is going to happen at all. I must dig out 1984 and read it again, just to depress myself even further.

1: BMJ 2015;351:h4629

 

Dr. Kendrick gave RCFN permission to reprint his article above, which first appeared on his website

Many failed studies never see the light of day giving medical professionals a skewed idea of drug efficacy (and here's the transcript for that TED talk by Dr. Ben Goldacre) .

 

Sign the petition here supporting all raw results from research being published!

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