Journal of IiME Volume 1 Issue 2 www.investinme.org The PACE TRIALS (continued) In his letter of 15th April 2005 to Neil Brown, Simon Burden of the MRC (referred to above) stated that researchers applying to the MRC for funding are “required to define how they will find participants in the study”. In the case of “CFS/ME” -- which is to include fibromyalgia -- the methods include financial inducements (which in other areas may be described as “bribery”). If clinicians have to be tempted by financial rewards to refer patients to these MRC trials, then something is very wrong, but such financial inducements are indeed being offered to GPs to identify and refer patients to the new “CFS” Centres and into the PACE and FINE trials. This was confirmed in July 2004 by Minister of State Dr Stephen Ladyman MP at the All Party Parliamentary Group on Fibromyalgia (now disbanded). Further, in the case of the MRC FINE trials, whilst in the Patient Information Sheet patients are assured that “Your GP is not being paid for his or her participation in this trial”, there is a different message for the GP because in the GP invitation letter it states: “Practices will be recompensed by the Department of Health for time spent in identifying and recruiting patients (£26.27 per referral)”. Does such a discrepancy accord with the MRC’s own definition of “high standards”? (On the subject of high standards, what can be the explanation for the MRC-funded FINE trial literature using the term “myalgic encephalitis”, which is not the same as “myalgic encephalomyelitis”? Is accuracy no longer considered a component of “high standards”?). ..in the Patient Information Sheet patients are assured that “Your GP is not being paid for his or her participation in this trial”, there is a different message for the GP because in the GP invitation letter it states: “Practices will be recompensed by the Department of Health for time spent in identifying and recruiting patients (£26.27 per referral)”. It is a matter of record that Whiting et al expressly excluded FM studies from the Systematic Review of the literature that was commissioned by the Policy Research Programme of the Department of Health and carried out by the Centre for Reviews and Dissemination at the University of York. The systematic review is unequivocal: “Studies including patients with fibromyalgia were not selected for the review” (JAMA 2001:286:1360-1368). Why, therefore, on whose authority and on what evidence, was it decided to include patients with FM in the MRC trials of CBT in a “CFS/ME” population? Of foremost significance is the fact that fibromyalgia 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, since ICD categories are mutually exclusive. Invest in ME Charity Nr 1114035 The literature itself is quite clear about this distinction, stating that up to 70% of those with ME/CFS have concurrent FM, and those who have both FM and ME/CFS have worse physical functioning than those who have ME/CFS alone. Some illustrations from the literature make these distinctions clear: 1991: in spite of some overlap, FM and ME/CFS do not represent the same syndrome. (Primary fibromyalgia and the chronic fatigue syndrome. AJ Wysenbeek et al Rheumatology Int 1991:10:227-229) 1996: “fibromyalgia appears to represent an additional burden of suffering amongst those with (ME)CFS” (Fibromyalgia and Chronic Fatigue Syndrome – similarities and differences. Dedra Buchwald and Deborah Garrity. Rheum Dis Clin N Am 1996:22:2:219-243) 1997: levels of somatomedin C are lower in FM patients but higher in ME/CFS patients (Somatomedin C (insulinlike growth factor) levels in patients with CFS. AL Bennett, AL Komaroff et al. J psychiat Res 1997:31:1:91-96) 1998: “recent studies suggest that (co-existent FM and (ME)CFS) may bode much more poorly for clinical outcome than CFS alone. In contrast to (significantly) elevated CBG (cortisol binding globulin) levels in patients with CFS, no differences were observed in FM patients. Differences in secretion of AVP may explain the divergence of HPA axis function in FM and (ME)CFS” (Evidence for and Pathophysiologic Implications of HPA Axis Dysregulation in FM and CFS. Mark A Demitrack and Leslie J Crofford. Ann New York Acad Sci 1998:840:684697) 1998: there is no evidence for elevated Substance P in patients with ME/CFS, whereas levels are elevated in patients with FM (CFS differs from FM. No evidence for altered Substance P in cerebrospinal fluid of patients with CFS. Evengaard B et al Pain 1998:78:2:153-155) 2001: patients with FM are NOT acetylcholine sensitive (Investigation of cutaneous microvascular activity and flare response in patients with fibromyalgia. AW Al-Allaf, F Khan, J Moreland, JJF Belch. Rheumatology 2001:40:10971101) 2004: patients with ME/CFS ARE acetylcholine sensitive (Acetlycholine mediated vasodilatation in the microcirculation of patients with chronic fatigue syndrome. VA Spence, F Khan, G Kennedy, NC Abbot, JJF Belch Prostaglandins, Leukotrienes and Essential Fatty Acids 2004:70:403-407) 2003: endothelin-1 is RAISED in fibromyalgia (Increased plasma endothelin-1 in fibromyalgia syndrome. Pache M, Ochs J et al Rheumatology 2003:42:493-494) (continued on page 59) Page 58/72
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