Journal of IiME Volume 1 Issue 2 www.investinme.org The PACE TRIALS (continued) included two names of particular concern: Professor Mansel Aylward and Mr Chris Clark of the charity Action for ME. The three names on the Data Monitoring and Ethics Committee were Professor P Dieppe, Dr C Feinmann and Professor A Fletcher. Dr Perkins then stated: “Although we are committed to being as open as possible, we have decided not to release peer review comments”. Concern about misleading information supplied by the MRC In December 2005 a Member of Parliament informed a constituent that: “It is encouraging to see that epidemiological research is being conducted which may yield improved understanding of (ME/CFS)”, when the reality was that the MRC had granted Professor Francis Creed funding for yet more psychosocial research, Professor Creed being well-known for his Wessely School views about “CFS/ME” (see http://www.meactionuk.org.uk/Proof_Positive.htm). Creed is Professor of Psychological Medicine at the School of Psychiatry and Behavioural Sciences at Manchester; one of his main research areas is somatisation disorders (which the Wessely School insist includes “CFS/ME”). He is Editor of the Journal of Psychosomatic Research and has failed to respond to letters written to him in his editorial capacity asking that the Journal present a more accurate and balanced view of ME/CFS. The Member of Parliament had thus been misled. Many MPs erroneously believe that the Government has done a good job in funding the wellpublicised “CFS Centres” and are unaware that those Centres will deliver only psychotherapy regimes that have already been shown to make some ME/CFS patients worse. It seems that the Trial Investigators will have the option to “select out” patients whom they believe will not respond in the desired way to the programme or who are too unwell to remain in the trials. Concern about post-funding alterations to the study Identifier and Protocol Following the outcry by the ME/CFS community about the use of the Oxford criteria as entry into the PACE trial, the MRC announced that a “secondary analysis” would be performed using the “London criteria”. Was this approved by the Data Monitoring and Ethics Committee, given the legitimate concern about the socalled “London” criteria that was submitted to the MRC? The “London” criteria have never been published and are not available as a reference for identification. They were mentioned in the National Task Force Report in 1994 as Invest in ME Charity Nr 1114035 being one of nine different proposed definitions and descriptions. The “London” criteria have never been used in research (before criteria can be used in research, they need to be submitted for peer review and published in an accessible form). The “London” criteria have not even been consistently defined – there are different versions of them and a definitive version has not been identified. The authors of the “London” criteria remain to be established as there are divergent claims about who the authors might be. The “London” criteria have never been accepted into common usage, nor have they ever been validated or operationalised. On what scientific basis can the MRC approve any “secondary analysis” using non-existent criteria? The “London” criteria have no justifiable or validated legitimacy that would in any way provide acceptable criteria for use by the MRC. Moreover, no amount of “secondary analysis” using any additional criteria can select patients with ME/CFS who were by definition excluded from the MRC trials in the first place by virtue of neurological disorders being expressly excluded from the Oxford entry criteria (which basically catch patients with chronic “fatigue”). It should be noted that the so-called “London” criteria are not the same as the Dowsett and Ramsay clinical criteria for investigation of ME, which are exceedingly useful (Postgrad Med J 1990:66:526-530). Other post-funding amendments to the PACE trial are more worrying. It seems that the Trial Investigators will have the option to “select out” patients whom they believe will not respond in the desired way to the programme or who are too unwell to remain in the trials. The list of what constitutes an “adverse reaction” has been shortened. Regarding outcome measures, the only objective measure of improvement seems to have been dropped, in that it seems the trialists no longer propose to use an actometer (an objective measure of activity) as an outcome measure of improvement. The only symptom actually being measured is subjective “fatigue”, which is not an objective scientific measurement and cannot therefore provide a robust clinical evidence base. “Recovery” has been re-defined. It will now be defined by participants meeting all four of the following: (i) a Chalder Fatigue Questionnaire score of 3 or less; (ii) an SF36 physical function score of 85 or above, rather than the working age norm of 90 (the SF-36 measures social and (continued on page 61) Page 60/72
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