Journal of IiME Volume 1 Issue 2 The PACE TRIAL By Professor Malcolm Hooper Eileen Marshall Margaret Williams The FINE trials were discussed in the last issue of the Journal of IiME. Using flawed diagnostic criteria, which exclude neurologically ill patients, these trials were criticised in an article by one participant. Another set of trials, also funded by the Medical Research Council (MRC), are the PACE trials. Both are described by the MRC as ‘..complementary trials into various treatments options for CFS/ME which aim to improve quality of life for those who are ill.' As with the FINE trials the PACE trials are equally controversial – taking a substantial amount of funding from an illness which has seen little spent on biomedical research. Professor Colin Blakemore, former head of the MRC, stated in the last issue of the Journal of IiME that the PACE trial is a ‘large clinical trial of new approaches to treating CFS/ME “. The PACE trial, he said, cost (£2,076,363).“and “The PACE trial will be comparing three treatments given to patients in a clinical setting, one of which is Adaptive Pacing Therapy (APT). This treatment is popular with many patients but has not been scientifically evaluated before. With the help of Action for ME, APT has been adapted to enable the researchers to test it rigorously within the trial. “. Later in the article Professor Blakemore states “The PACE trial;” uses “Cognitive Behavioural Therapy, graded exercise, adaptive pacing and usual medical care for chronic fatigue syndrome“. In the following extracts, taken from the document CORPORATE COLLUSION? the background to the PACE trial is examined in more detail. The MRC PACE trial into “CFS/ME” On 15th May 2003 the MRC announced the funding of two trials to evaluate the effectiveness of “rehabilitative treatments” for “CFS/ME”. The first trial, known as the PACE trial (Pacing, Activity and Cognitive behavioural therapy: a randomised Evaluation) was to take place in six clinics over a period of four years. Action for ME declared that it was proud to announce its support for the four-year study which “will evaluate pacing against other exercise and behavioural-led approaches in the care of people with ME”. The PACE trial was to be led by Dr (now Professor) Peter White of Barts, Dr (now Professor) Michael Sharpe of Edinburgh, and Dr (now Professor) Trudie Chalder of Kings College, London. It was to be co-funded by the MRC, the Scottish Chief Scientist’s office, the English Department of Health and the Department for Work and Pensions. The second trial was the FINE trial (Fatigue Intervention by Nurse Evaluation), a form of what the MRC terms “rehabilitation therapy” to be delivered by specialist community nurses in patients’ own homes -- though what “fatigue intervention” has to do with severely affected ME patients who require tube feeding was not specified. It was to be led by Alison Wearden PhD at the University of Manchester and was to be wholly funded by the MRC. The MRC media release proclaimed that with the PACE trial, “people can be helped towards recovery”; in the media release, Peter White said: “I’m particularly pleased that the study has been designed in collaboration with the leading patients’ charity Action for ME”. Invest in ME Charity Nr 1114035 The Authors: Margaret Williams, Eileen Marshall and Professor Malcolm Hooper are well respected authorities on ME as well as being ME patient advocates and form an established team whose aim is to expose and prevent the injustice perpetrated on patients with ME/CFS in the UK by those whose job is to help, not abuse, such patients. Professor Hooper is Emeritus Professor of Medicinal Chemistry University of Sunderland. Both Eileen Marshall and Margaret Williams formerly held senior clinical posts in the NHS. One month later, the ME/CFS community became aware that on 12th-13th June 2003, Peter White delivered a lecture entitled “Central Nervous System and Autonomic Nervous System Responses to Exercise in Patients with CFS” in Bethesda, Maryland, USA, at which Dr White explained that the cognitive behavioural model of CFS posits that the symptoms and disability of CFS are perpetuated predominantly by dysfunctional illness beliefs and avoidant coping. White said that beliefs associated with a poor outcome in CFS include the belief that exercise is damaging, that the cause of CFS is a virus, and that CFS is a physical illness. (continued on page 49) Page 48/72 www.investinme.org

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