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

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To the consternation of medical scientists and contrary to accepted scientific practice, the Wessely School
decided to include fibromyalgia patients in the MRC PACE Trial, which means that the PACE Trial includes
at least three distinct disorders ‐‐ ME/CFS (ICD‐10 G93.3); fibromyalgia (ICD‐10 M79.0) and psychiatric
fatigue (ICD‐10 F48.0).
At the International Science Festival held on 9 th April 2004 in Edinburgh, Michael Sharpe spoke in a debate
entitled “Science and ME” and was specifically asked if patients with fibromyalgia (FM) were to be included
in the PACE Trial of “CFS/ME”. Sharpe replied in the affirmative, implying that patients with FM needed to
be included in order to reach the recruitment target. He said (verbatim): “We want broadness and heterogeneity
in the trial”.
On 15 th April 2005 the MRC confirmed by letter to a correspondent (Neil Brown): “When researchers put
together a proposal they are required to define the population they are studying”. Why this basic requirement is not
applicable to the PACE Trial and quite how the outright abandonment of this principle might affect the
statistical analysis of the PACE Trial has not yet been clarified.
That FM patients were to be included in the PACE Trial was further confirmed on 12 th May 2004 by
Parliamentary Under Secretary of State at the Department of Health, Dr Stephen Ladyman, at an All Party
Parliamentary Group on Fibromyalgia, who announced that doctors were being offered financial
inducements to persuade patients with FM to attend a “CFS” Clinic to aid recruitment to the PACE Trial
(EIF: Spring/Summer 2004, page 19).
This caused written representations to be made to the MRC, because FM is classified as a distinct entity in
ICD‐10 at section M79.0 under Soft Tissue Disorders and it is not permitted for the same condition to be
classified to more than one rubric, so concern was expressed as to how the intentional inclusion of disparate
disorders could yield meaningful results, especially as FM was expressly excluded from the Systematic
Review of the literature on CBT/GET carried out by the Centre for Reviews and Dissemination at York,
whose authors were categoric: “Studies including patients with fibromyalgia were not selected for review” (JAMA
2001:286:11:1360‐1368). The literature is quite clear that those with both FM and ME/CFS have worse
physical functioning than those who have ME/CFS alone, and that “fibromyalgia appears to represent an
additional burden of suffering amongst those with (ME)CFS” (Rheum Dis Clin N Am 1996:22:2:219‐243). Jason et
al also pointed out that FM and Multiple Chemical Sensitivity (MCS) “represent additional illnesses of interest
where issues of diagnostic accuracy are concerned” (JCFS 1999:5:3‐33).
FM has a distinct biological profile that is different from ME/CFS, so it is unclear how the intentional
inclusion of different disorders in an MRC trial evaded detection by the allegedly rigorous monitoring
process. The MRC was asked how the deliberate inclusion of different disorders could not result in
skewed and meaningless conclusions when, from the outset, patients being entered into the PACE trial
were not clearly defined, a question that elicited no response.
Apparently neither the MRC nor the West Midlands MREC is concerned with diagnostic accuracy.
Peter White states about fibromyalgia (Psychol Med 2009:15 April: 1‐9:PMID: 19366500): “the increased
incidence of the diagnosis may more reflect a change in the fashion for the diagnosis of fibromyalgia by GPs”, a
common charge made by the Wessely School in relation to “CFS/ME”, for example, Wessely himself
decreed: “It is regrettable that ME has become a disease of fashion, even a ‘fad’ ” (Recent Advances in Clinical
Neurology, Churchill Livingstone 1990, pp 85‐131).
White also asserts: “There is little doubt that patients with fibromyalgia have close comorbidities with
several disorders that are regarded by many as functional disorders. These include: irritable bowel
syndrome (and) CFS/ME. I have argued against this idea, suggesting that the commonality is abnormal
illness behaviour, as seen in the process of somatisation” and he concludes: “The final area of commonality
between fibromyalgia and CFS concerns the social risk markers for maintenance of both disorders”