Journal of IiME Volume 1 Issue 2 www.investinme.org The PACE TRIALS (continued) 2004: endothelin-1 is NORMAL in ME/CFS (Plasma endothelin-1 levels in chronic fatigue syndrome. Kennedy G, Spence V, Khan F, Belch JJF Rheumatology 2004:43:252-253) More recent (2007) evidence from Spain presented at the ME Research UK (MERUK) International Research Conference on 25th May 2007 at Edinburgh demonstrated that FM and ME/CFS are two different diseases with two different genetic profiles and that there are very clear distinctions, with a 95.4% specificity. Many polymorphisms in the genes were different (Genetic Profiles in Severe Forms of Fibromyalgia and Chronic Fatigue Syndrome Dr Estibaliz Olano: this presentation is available on DVD obtainable from MERUK, telephone number 01738451234). Consultant rheumatologists who have sufficient experience with both syndromes have observed clinically that in FM, the muscle pain is helped by gentle stretching and exercise, whereas in ME/CFS, exercise makes muscle pain worse. Importantly, on 3rd June 1998, Baroness Hollis from the then Department of Social Security sent a letter to Lindsay Hoyle MP (reference POS(4) 3817/88) which says: “The Government recognises that fibromyalgia syndrome (FMS) is a condition which can cause a wide variety of disabilities from mild to severe. In some cases it can be a very debilitating and distressing condition. People with FMS who need help with personal care, or with getting around because they have difficulty in walking, can claim Disability Living Allowance to help with meeting related expenditure”. From this letter, it is clear that Government already recognises fibromyalgia as a distinct entity. Further, in the Chief Medical Officer’s UPDATE of August 2003 (a paper communication from the CMO sent to all doctors in England) entitled “Improving Services for Patients” there is an item entitled “Fibromyalgia – A Medical Entity”. This means that the CMO considers fibromyalgia to be a separate, stand-alone medical entity (and the fact that it is designated a “medical” disorder means that it is not considered to be “psychiatric” disorder). Is the MRC still content that the PACE trial proposal states: “Those subjects who also meet the criteria for “fibromyalgia” will be included”, given that FM is classified by the WHO as a quite separate disorder from ME/CFS, with discrete biomedical and genetic profiles that are entirely distinct from those found in ME/CFS? How can the deliberate inclusion of patients with fibromyalgia in trials that purport to be studying “CFS” not result in skewed and meaningless conclusions when the patients being entered in the PACE trials are, from the outset, not clearly defined? Invest in ME Charity Nr 1114035 How can the deliberate inclusion of patients with fibromyalgia in trials that purport to be studying “CFS” not result in skewed and meaningless conclusions when the patients being entered in the PACE trials are, from the outset, not clearly defined? Concern about Ethical Standards in the PACE Trial Mrs Connie Nelson wrote to the MRC asking four pertinent questions about the PACE trial: (a) who will decide if the patient has been harmed? (b) in the event of such harm, what will be the speciality of the clinicians who will visit the patient at home? (c) what will be considered a “serious adverse event” within the PACE study? and (d) what would be considered “appropriate help” if the PACE study exacerbates a patient’s condition? On 26th July 2005, Dr Sarah Perkins replied: “The investigators responsible for this trial have established a robust set of procedures regarding the management of any adverse events”. Included in adverse events was listed “any episode of self-harm”. Dr Perkins explained that: “As part of the peer-review process, a comprehensive assessment of any safety and ethical issues was made before the award of the trial grant” and she said the PACE trial was “proceeding under good clinical practice guidelines, which includes independent supervision. This comprises an independent Data Monitoring and Ethics Committee”. On 25th August 2005, Mrs Nelson again wrote to the MRC asking for the composition of the Data Monitoring and Ethics Committee. She pointed out that as this was a publicly funded trial, she would like to know who was on that Committee; she also asked for a copy of the “comprehensive assessment” of safety and ethical issues undertaken as part of the peer-review before the award of the trial grant, saying that -- given the evidence that exercise makes ME/CFS patients worse -- this may help clarify why the trial was ever funded. Mrs Nelson further asked whether an ME relapse would be recognised and accepted as “clinical change”, given that many people feared that the assessor(s) may not believe in ME or in the reality of a relapse. Her final question asked if the published papers of the PACE trial would include – as is normal practice for contentious treatments – details of all drop-outs and adverse events in each trial group. On 21st September 2005, Dr Perkins provided the names of PACE Trial Steering Committee Members and the membership of the Data Monitoring and Ethics Committee. Names of particular concern to the ME/CFS community included Professor Janet Darbyshire (MRC Clinical Trials Unit); Professor Peter White; Professor Michael Sharpe and Professor Tudie Chalder. The Observers (continued on page 60) Page 59/72
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