Journal of IiME Volume 1 Issue 2 www.investinme.org The PACE TRIALS (continued) reasons did the MRC rely on Wessely School studies, when there is abundant published criticism of those very studies and their flawed methodology in the literature? “This published criticism is readily accessible to all and sundry. The work of the Wessely School on “CFS/ME” has been stringently criticised in the international literature for flawed methodology; particularly for use of a heterogeneous patient population (studies using mixed populations are not useful unless researchers disaggregate their findings); for selective manipulation of others’ work, claiming it supports their own findings when such is not the case; for their focus on the single symptom of “fatigue” whilst ignoring other significant signs and symptoms associated with the cardiovascular, respiratory, neurological and immunological systems; for generating conclusions before generating the data to support such conclusions; for advising Government bodies that the reported biomedical abnormalities ‘should not deflect the clinician away from the biopsychosocial approach and should not focus attention towards a search for an ‘organic’ cause’, and for their recommendation that no advanced tests should be carried out on “CFS/ME” patients when it is those very tests that reveal the unequivocally organic nature of the disorder. We believe that the money being allocated to the PACE trial is a scandalous way of prioritising the very limited research funding that the MRC have decided to make available for ME/CFS, especially when no money whatsoever has so far been awarded for research into the underlying physical cause of the illness. We therefore believe that work on this trial should be brought to an immediate close and that the money should be held in reserve for research that is likely to be of real benefit to people with ME/CFS. - ME Association “Throughout his reply, Johnson uses the terms: ‘In designing a clinical trial (of CBT/GET) we have to estimate the number of patients’; ‘Estimation essentially requires a guess at what the results will be’; ‘In guessing what the results may be…’; ‘The assumptions we make…’; ‘Broadly, we assumed that around 60% of patients in the CBT group would have a ‘positive outcome’ at one year follow-up….’; ‘We speculated that….’, so there is now written confirmation from the MRC Biostatistics Unit that the whole PACE trial is based on guessing, speculation and assumption. Would Tony Johnson explain how this accords with the MRC’s supposed requirement for high standards?”. Invest in ME Charity Nr 1114035 The ME Association has been adamant that the PACE and FINE trials should be halted and on 22nd May 2004 posted the following on its website (which was printed in its magazine “ME Essential” in July 2004): “The MEA calls for an immediate stop to the PACE and FINE trials “A number of criticisms concerning the overall value of the PACE trial and the way in which it is going to be carried out have been made by the ME/CFS community. The ME Association believes that many of these criticisms are valid. We believe that the money being allocated to the PACE trial is a scandalous way of prioritising the very limited research funding that the MRC have decided to make available for ME/CFS, especially when no money whatsoever has so far been awarded for research into the underlying physical cause of the illness. We therefore believe that work on this trial should be brought to an immediate close and that the money should be held in reserve for research that is likely to be of real benefit to people with ME/CFS. We share the concerns being expressed relating to informed consent, particularly in relation to patients who are selected to take part in graded exercise therapy. The Chief Medical Officer’s Report (section 4.4.2.1) noted that 50% of ME/CFS patients reported that graded exercise therapy had made their condition worse, and we therefore believe that anyone volunteering to undertake graded exercise therapy must be made aware of these findings”. It is notable in this respect that Lord (David) Sainsbury of Turville, who at the time was responsible for the MRC, stated in the House of Lords: “Because the trial participants will have provided informed consent, they will receive no compensation if they become more ill, whether or not as a result of the particular treatment” (Hansard [Lords]: 18th November 2004: 4830). The ME Association notice additionally called for all further work on the FINE trial to be halted, saying the MEA “is not convinced by the evidence so far put forward in support of this approach”. From this whole episode concerning Dr Johnson’s Report, the ME/CFS community was left in no doubt about the bitter contempt for sufferers, some charities, and those MPs who support them that exists at the MRC, or that the seam of Wessely School dismissal and denigration does indeed run deep. (continued on page 56) Page 55/72 It was suggested that Johnson be asked to explain how statistics had suddenly become a matter of guesswork, speculation and assumption. In his Report, Johnson had referred disparagingly to “websites maintained by the more extreme charities” but did not mention that it was two of the UK’s major charities (The ME Association and the 25% ME Group for the Severely Affected) that were calling for the PACE trial to be halted.
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