MAGICAL MEDICINE: HOW TO MAKE AN ILLNESS ... - Invest in ME

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Given that the Oxford criteria (ie. the Wessely School’s own criteria funded in part by Peter White
himself) specifically exclude those with ME (ICD‐10 G93.3) but specifically include those with
psychiatric disorder, the criteria that were to be used for the PACE Trial cannot be described as having
validity, but it seems that the MRC Trial Steering Committee and the Data Monitoring and Ethics
Committee and the West Midlands MREC were uncritical of this important determinant. Moreover, it is
scientifically invalid for the Wessely School to assert that the Oxford criteria do not exclude those with
ME on the basis that the Wessely School do not accept that ME is a neurological disorder.
It is notable that in 2009, Simon Wessely wrote with approval of the need for homogeneity in clinical trials,
citing a 1923 paper: “Because of the difficulties of interpretation inherent in an investigation of this nature, it seemed
desirable to reduce the study as nearly as possible to the terms of the experiment. Consequently, all patients were
divided into two groups as nearly identical as possible” (Wessely S. Surgery for the treatment of psychiatric
illness: the need to test untested theories. www.jameslindlibrary.org ).
On what credible basis, therefore, do those involved with the MRC PACE Trial disregard this well‐
established scientific precept for the need for clinical trial participants to be as identical as possible?
The PACE Trial Investigators have intentionally mixed at least three taxonomically different disorders in the
trial cohort ‐‐ those who the Investigators claim to suffer from ME (ICD‐10 G93.3); those with fibromyalgia
(ICD‐10 M79.0) and those with a mental/behavioural disorder (ICD‐10 F48.0).
A comment by GR of the UK (one of 69) in the Mail Online on 10 th October 2009 is apposite: “To include those
with no underlying organic disorder with those who do is a recipe for disaster”
(http://www.dailymail.co.uk/health/article‐1219207/Chronic‐fatigue‐caused‐retrovirus‐say‐scientists.html ).
The MRC was asked more than once how such heterogeneity could not result in skewed and meaningless
results, but failed to respond.
Selection of PACE Trial participants
Every entrant to the PACE Trial was to commence by seeing a doctor at a “Fatigue Clinic” and the doctor
was told what to say to each potential participant. The whole ethos of this MRC PACE Trial may have been
biased because it seems that there may have been misinformation provided from the start.
The “Invitation to join the PACE trial” leaflet insisted that participants must be diagnosed with “CFS/ME”
only by members of the Wessely School: “You must be diagnosed by us as having CFS/ME. Fatigue or lack of
energy must be your main problem”.
That immediately ought to rule out patients suffering from ME (ICD‐10 G93.3), because chronic tiredness or
“fatigue” (ICD‐10 F48.0) bears no relationship to the post‐exertional physiological exhaustion that is the
hallmark of ME. “Fatigue or lack of energy” would include those with chronic “fatigue” and it is understood
that the results of the PACE Trial are to be used to deliver CBT/GET for everyone throughout the UK with a
diagnosis of “CFS/ME”, which could be detrimental to those with true ME/CFS.
It cannot be emphasised enough that to amalgamate different disorders as a single construct is contrary
to the WHO’s taxonomic principles, which state that it is not permitted for the same condition to be
classified to more than one rubric, and the Wessely School’s insistence that ME/CFS has dual
classification in the ICD has been conclusively dismissed by the WHO.
Given that participants were carefully selected by the Wessely School themselves (the Trial literature states
that people would be selected only if they were deemed ”suitable” by the Wessely School), it seems that the
trial is not “randomised” as claimed by the Investigators – it is only randomised within the trial. Such