Journal of IiME Volume 1 Issue 2 www.investinme.org The PACE TRIALS (continued) Representations to the MRC setting out concerns about the PACE trials It is known that enormous public and professional concern was expressed to the MRC about the PACE and FINE trials. Some of the written representations were sent by Recorded Delivery. Few were acknowledged and all seem to have been disregarded. There can be no credible doubt that the Oxford criteria exclude those with ME as distinct from the Wessely School definition of “CFS” and this was confirmed in 1991 by psychiatrist Anthony David (colleague and co-author with Wessely) who described the Oxford criteria shortly after they were published: “British investigators have put forward an alternative, less strict, operational definition which is essentially chronic fatigue in the absence of neurological signs (but) with psychiatric symptoms as common associated features” Those legitimately expressed concerns include the following: Concern about the huge waste of money at UK taxpayers’ expense Originally the MRC PACE and FINE trials of CBT/GET were said to be costing £2.6 million, but according to Michael Sharpe, one of the Principal Investigators, the current figure is £4 million. From the figures awarded by the MRC for “fatigue” research on the National Research Register, the amount that has gone to biomedical research into ME/CFS is virtually non-existent. In March 2005, the MRC confirmed that since 2002, it had funded two further studies into “CFS/ME” (one for Professor Creed [see below] on psychiatric aspects and one on “Chronic fatigue (sic) and ethnicity”), and that it had received 12 applications for funding related to CFS/ME that were not granted. Of the applications that the MRC rejected, seven were under the heading “Pathophysiology of CFS” and included studies regarding genetics / biomarkers, immunology and neuroimaging; three were regarding epidemiology, as well as studies in primary care and clinical and laboratory characterisation of ME/CFS. As mentioned above, the ME Association pointed out that the results of these psychiatric trials may not add any significant information to what patients and their doctors already know, so on what ethical grounds does the MRC justify spending such a vast amount of money to the exclusion of studies with real potential to benefit ME/CFS sufferers? Invest in ME Charity Nr 1114035 As William Bayliss stated on an internet group on 2nd Nov 2004: “The MRC’s PACE trial has been very cleverly designed to exclude most true ME sufferers and include sufferers of mental illness. As such, the trial is a deceitful national scandal and a gross abuse of taxpayers’ money” Concern about the design of the study This is an area of extreme unrest, because the design of the study may well be relevant to the aims of the study, and these are known to be the nationwide promotion of CBT and GET as the management regimes of choice. It is apparent to many people that by using the allencompassing Oxford criteria, the trial objectives have been set so as to achieve this pre-determined agenda and to meet the requirements of political and commercial paymasters. The Oxford criteria expressly include people with psychiatric disorders in which “fatigue” is a prominent symptom (thereby, as noted above, potentially catching at least 33 other disorders that fit the Oxford criteria), but expressly exclude people with neurological disorders; indeed, the Oxford criteria claim to use people with neuromuscular disorders as controls, so by any logical reasoning, ME/CFS (an internationally classified neurological disorder) would be excluded. There can be no credible doubt that the Oxford criteria exclude those with ME as distinct from the Wessely School definition of “CFS” and this was confirmed in 1991 by psychiatrist Anthony David (colleague and co-author with Wessely) who described the Oxford criteria shortly after they were published: “British investigators have put forward an alternative, less strict, operational definition which is essentially chronic fatigue in the absence of neurological signs (but) with psychiatric symptoms as common associated features” (Postviral syndrome and psychiatry. AS David. British Medical Bulletin 1991:47:4:966-988). Given such clarification, how can it be ethical for the MRC to claim that the PACE trials will include those with Ramsay-defined ME? The MRC, however, insists that people with “CFS/ME” will be included in the trials. It is known that enormous public and professional concern was expressed to the MRC about the PACE and FINE trials. Some of the written representations were sent by Recorded Delivery. Few were acknowledged and all seem to have been disregarded. (continued on page 57) Page 56/72
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