Journal of IiME Volume 1 Issue 2 www.investinme.org The PACE TRIALS (continued) role functioning); (iii) a Clinical Global Impression (CGI) score of 1 (the self-rated CGI has a score range of 1 – 7 and provides only a subjective interpretation), and (iv) the participant no longer meeting the trial entry criteria. To most people, “recovery” means being able to return to full-time work and being able to be self-supporting. Did the MRC Data Monitoring and Ethical Committee approve such significant changes to the trial protocol after funding had been granted? If so, was this in collusion with one of the MRC trial sponsors (ie. the Department for Work and Pensions)? As it seems there will now be no objective evidence from the MRC PACE trials of no activity improvement, will this particular sponsor of the trials continue to maintain that there is no physical disability in ME/CFS patients who are claiming benefit? Of particular concern was the refusal of the MRC to heed the evidence that aerobic exercise (as in graded exercise that is part of the PACE trial) might be dangerous for some patients with ME/CFS and the fact that the Principal Investigators of the PACE trial were not screening for potentially life-threatening cardiac anomalies in trial participants. Concern about the competing interests of the psychiatric lobby who are running the MRC trials Concerns have been expressed that it is simply wrong for the psychiatrists who are carrying out these MRC trials to be paid for studying the regimes which they themselves formulated (Gen Hosp Psychiatry 1997:19:3:185-199), particularly in view of the proven evidence of their commercial interest in obtaining their desired outcome from these regimes. Concern about the MRC’s refusal to heed the existing evidence that CBT/GET does not work As outlined above in the section on NICE, the proponents of the CBT/GET regime themselves are on record as stating that in relation to ME/CFS, it is not “remotely curative”, that relapses occur, that the very modest benefits do not last, and that “many CFS patients, in specialised treatment centres and the wider world, do not benefit from these interventions”. Further, as noted above, the CRD Systematic Review of CBT/GET studies (the Wessely School “bible”) points out that there is no objective evidence of improvement and that the subjective gains may be illusory (JAMA 2001:286:1360-1368). Invest in ME Charity Nr 1114035 As also mentioned above, the MRC’s Chief Executive Officer, Professor Colin Blakemore, stated on 24th October 2003: “Neither the PACE nor the FINE trials will provide a cure for CFS/ME but that is not their purpose. The trials are intended to assess a number of possible treatments to see if they are beneficial to those suffering from CFS/ME”. Given that this information is already known, the ME/CFS community pleaded with the MRC to halt the PACE and FINE trials and to use the money in a more constructive way. The MRC ignored these requests. Concern about the persistent refusal to heed the evidence that graded exercise may be dangerous for people with ME/CFS Substantial published evidence of the organic basis of Ramsay-defined ME/CFS (ICD-10 G93.3) was submitted to the MRC. There are over 4,000 such papers. It was all dismissed or ignored. Of particular concern was the refusal of the MRC to heed the evidence that aerobic exercise (as in graded exercise that is part of the PACE trial) might be dangerous for some patients with ME/CFS and the fact that the Principal Investigators of the PACE trial were not screening for potentially lifethreatening cardiac anomalies in trial participants. Cardiac problems in ME have been documented in the medical literature for over half a century – the fact that normal loss of blood flow may be persistent in ME was documented by Gilliam in 1938. Other cardiac problems have been consistently documented in the literature since that time, for example, Wallis (1957); Leon-Sotomayer (1965) and Ramsay (1950s-1980s). In his 1988 CIBA Foundation lecture, Professor Peter Behan from Glasgow confirmed that he was regularly able to demonstrate micro-capillary perfusion defects in the cardiac muscle of ME patients. Also in 1988 he noted that: “Evidence of cardiac involvement may be seen: palpitations, severe tachycardia with multiple ectopic beats and occasional dyspnoea may occur and are quite distressing. It is of great interest that some patients have evidence of myocarditis” (see Crit Rev Neurobiol 1988:4:2:157178). In 2001, in her Research Update presentation to the Alison Hunter Memorial Foundation Third International Clinical and Scientific Conference on ME/CFS held in Sydney, Professor Mina Behan from Glasgow (now deceased) stated: “Convincing evidence of cardiovascular impairment can be demonstrated”. [For the early references, see “The Clinical and Scientific Basis of ME/CFS” edited by Byron Hyde, Jay Goldstein and Paul Levine, published in 1992 by The Nightingale Research Foundation, Ottawa. See also BMJ 1989:299:1219; Postviral Fatigue Syndrome ed. Rachel Jenkins and James Mowbray, pub. John Wiley & Sons, 1992; Inf Dis Clin Practice 1997:6:327333; Proc Soc R Coll Physicians Edinb 1998:28:150-163; Hum. Psychopharmacol.Clin.Exp 1999:14:7-17; Clin Physiol 1999:19:2:111-120; JCFS 2001:8:(3-4):107-109]. (continued on page 62) Page 61/72
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