An Opinion Piece by Peter Kemp MA
In April 2015, Richard Horton, Editor in Chief of The Lancet, wrote:
“The case against science is straightforward: much of the scientific literature, perhaps half, may simply be untrue. Afflicted by studies with small sample sizes, tiny effects, invalid exploratory analyses, and flagrant conflicts of interest, together with an obsession for pursuing fashionable trends of dubious importance, science has taken a turn towards darkness.” [emphasis added]
(http://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(15)60696-1.pdf)
Horton bemoaning the decline of research standards makes him appear like a campaigner for truth and justice. M.E. patients who continue to suffer the consequences of the misreporting of the PACE Trial, might be inclined to view his protestations as hot air escaping from an over-inflated ego.
Following the publication of the PACE Trial in The Lancet, Richard Horton appeared on an Australian radio programme in company with Professor Michael Sharpe (a Principal Investigator of PACE). It appears that Horton’s presence was in order to defend the Lancet’s publication of this Controlled Clinical Trial, which has now cost the UK public around £5 million.
Horton told ABC’s Health Report about the PACE Trial researchers: “…So they were really stepping back and comparing two philosophies, not just two treatments, two philosophies of what chronic fatigue syndrome was” (http://www.abc.net.au/radionational/programs/healthreport/comparison-of-treatments-for-chronic-fatigue/2993296)
The ‘two philosophies’ Horton refers to, are the opinions and theories of whether M.E. and CFS are biological or mental illnesses. The researchers whom he states ‘were really stepping back’ - have serious and long-standing conflicting interests. Interests which might allow only one ‘philosophy’ about M.E.
However, it seems that part of Horton’s philosophy is that people with conflicting interests, no matter how long-standing and exclusive of other ‘philosophies’; no matter how invested their careers, reputations and income, can simply switch them off and become 100% objective.
The PACE Trial took 8 years to complete. Did the all the researchers step-back from their conflicting interests for the entire duration? Or did they only step-back when working on or thinking about the PACE Trial? In 8 years, didn’t they get confused about when they were supposed to be ‘stepping back’ and when they could indulge their Conflicting Interests? Is Richard Horton for real?
As for the PACE Trial ‘comparing two philosophies’, the Trial Protocol written by the researchers made any such comparison completely impossible.
The design of the trial excluded objective measures necessary to make a comparison; necessary to establish harms and benefits; necessary to conduct objective medical research. Tampering with the published Trial Protocol and especially the Primary Outcome Measures during the trial were self-evidently for the purposes of supporting only one ‘philosophy’ – that of the researchers.
The Control group (the ‘other’ philosophy) could never demonstrate improvement except by chance or nature. They received no treatment for their illness. No provision was made to demonstrate the physical nature of the illness and support the OTHER philosophy. Comparison, from the outset, was impossible.
The simple explanation for these and numerous other obvious biases is that the PACE researchers were never objective. They designed, executed and published research that was only ever intended to support one ‘philosophy’ - theirs. The Trial could never produce data that proved that M.E. is a physical disease. The worst case scenario from the researcher’s position, was that their ‘treatments’ would fail (as in fact, they did) in which case they had built-in protection which meant that their ‘philosophy’ could not be challenged except on ethical and research principals, because there were no objective physical measures to prove them wrong.
By design, even if the PACE Investigators favoured treatments had utterly failed and left half the participants more ill than when they started – all the researchers would have to do, is explain to the media that the participants receiving GET and CBT were too phobic, too hypochondriac and too hysterical to benefit from the treatments. Incredible as it seems, this is precisely what they did with the assistance of Horton and The Lancet.
Exploiting their media influences via the Science Media Centre, the PACE researchers succeeded in getting the PACE Trial reported worldwide as a triumph for mind over body and thereby branding M.E. a psychological illness – even though only 15% of participants got any improvement. Objectively, the results disproved the researcher’s theories, but they spun the results and made their ‘philosophy’ appear valid.
The 15% figure is supported by a statement made by Professor Michael Sharpe in the same radio programme that featured Horton: “We have a number needed to treat; I think it's about seven to get a clinically important treatment benefit with CBT and GET.” A ‘number needed to treat’ (NNT) of 7, correlates with only 15% of treated patients getting any benefit. Neither of these figures appeared in the Lancet report.
The only way that the researcher’s biased notions could be countered was with objective physical measures and properly recorded, investigated and reported harms. These were either omitted, altered, removed or tailored, all of which ensured that ‘comparing two philosophies’ was impossible.
It seems that the PACE Trial was never ‘impartial’ or had any intention of comparing ‘two philosophies’. It looks like a sting, a Catch-22, a fixed-match; with a key enabler of the scam being Horton himself.
Horton also stated on ABC Radio: “This is why I think the criticisms about this study are a mirage. They obscure the fact that what the investigators did scrupulously was to look at chronic fatigue syndrome from an utterly impartial perspective.”
Horton claims that the PACE researchers were ‘utterly impartial’. If this is so, then why was the media reporting of PACE so misleading? What steps have the researchers taken to correct it? Why was the most significant figure of only 15% gaining any improvement absent from the report. Why did the researchers tamper with the Primary Outcome measures, exclude measures that could have proved them wrong, and now refuse to allow others access to the raw data for analysis?
Following this wholesale capitulation of scientific and publishing ethics; Horton now has a massive conflict of interest entirely of his own making. He did not just publish the PACE Trial, he defended the research and the researchers in public. If the misrepresentation of the PACE Trial is exposed, then his reputation will suffer.
Horton also remarked on criticisms of the PACE Trial: “This isn't a purely scientific debate; this is going to the heart of the integrity of the scientists who conducted this study.”
At last, a Horton remark that I can agree with. However, Horton’s position appears to be that the ‘integrity of the scientists who conducted this study’ should not be questioned. My view is their integrity absolutely should be questioned given their gross conflicting interests and numerous breaches of the fundamental rules and ethics of research. I think that exacting questions should asked and credible answers demanded.
But those questions should not be asked of the PACE researchers or Richard Horton; because by now, the whole collaborative are subject to the most potent perception distorting and reality warping influences known: conflicting interests, power, arrogance, egotism and self-serving bias.
The questions must be asked of the raw data.
Peter Kemp
Jan 2016
Competing Interests:
I stepped-back from my competing interests before writing this, so shut up.