Journal of IiME Volume 1 Issue 2 www.investinme.org The PACE TRIALS (continued) The MRC website described the FINE trial as follows: “Pragmatic rehabilitation is delivered by specially trained nurses who give patients a detailed explanation of symptom patterns. This is followed by a treatment programme focusing on graded exercise. CFS/ME does not refer to a specific diagnosis”. In response to an enquiry from a Member of Parliament, on 24th October 2003 Professor Colin Blakemore (who had just succeeded Professor Sir George Radda as CEO of the MRC) wrote: “(Your constituent) has raised three main points. The first is that research should be done into the causes of CFS/ME before looking into treatments. It is appropriate to explore potential interventions in the absence of knowledge of causation. For example, the cause(s) of diabetes is not known, but knowledge of the underlying pathophsyiology has meant that effective treatments have been developed. (Re:) the second point (referring to MRC funding priorities), the key factor in deciding whether a proposal is funded or not is the quality of the science and its potential contribution to human health. 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 (sic) to see if they are beneficial to those suffering from CFS/ME”. The UK ME/CFS community noted with bemusement that it is customary for the trial protocol to have been rigorously scrutinised, modified if necessary, and approved by the relevant Ethics Committee before funding was granted. This appeared to be a case of the psychiatric lobby rushing things through willy-nilly. As Christine Hunter of the Alison Hunter Memorial Foundation in Australia pointed out, knowing the cause and knowing the pathophysiology are two different things: pathophysiological research was a priority for diabetes, so why not for ME/CFS? (Christine Hunter’s daughter Alison tragically died from severe ME aged 19; the cause of death on the death certificate stated: “Severe progressive ME”. The pathologist confirmed that Alison had severe oedema of the heart, liver and brain. Alison also suffered seizures, paralysis and gastrointestinal paresis). On 16th January 2004, Dr Charles Shepherd from the ME Association posted an item on Co-Cure ACT:RES in which he said: “In response to recognition for more research, the MRC went on to conclude that research into the underlying cause should not command any high priority. Instead, the MRC recommended yet more money should be spent on researching lifestyles and psychological aspects of management, the results of Invest in ME Charity Nr 1114035 which may not add any significant information to what patients and their doctors already know. The situation regarding a lack of any encouragement to researchers to pursue the underlying physical cause of ME/CFS remains indefensible”. There was considerable confusion about both the start date for the trials and the entry criteria, with The Times correspondent Peta Bee claiming on 2nd February 2004 that the MRC trial was: “now in its second year” (“Fit to fight fatigue”, The Times, 2nd February 2004). The BMJ concurred: “Exercise is the best way to fight chronic fatigue syndrome. In the MRC study, now in its second”. year, patients are advised to follow a carefully graded plan. Dr Trudie Chalder, from King’s College, London, says: ‘The psychological benefits of following a fitness routine for people with CFS are great’ Since in January 2004 the MRC’s website stated that the start date was 2nd January 2004 and that the Oxford (Wessely School) criteria were being used, it was confusing to be informed just one month later by the BMJ that the trial was in its second year. It was even more confusing to be informed by the Health Minister (Lord Warner) on 26th February 2004 that the entry criteria for the trials: “have not yet been finalised” (Hansard: 26th February 2004: HL1273). Matters became yet more perplexing when the Health Minister confirmed on 10th March 2004 that: “the current estimated start of recruitment of patients into both trials is the summer or autumn of 2004. Unconfirmed criteria for both trials are that participants will meet the Oxford diagnostic criteria for CFS”. In March 2004 an advertisement for “PACE Trial Manager, Research Grade 3, Centre for Psychiatry, Institute of Community Health” to be based at St Bartholomew’s Hospital, London (closing date 6th April 2004), announced: “This is a prestigious MRC funded study of promising new treatments (sic) for a condition of considerable public health importance. Other members of the team include Professor Simon Wessely. The lead statistician is Dr Tony Johnson. The Clinical Trials Unit of the Institute of Psychiatry will be leading on database management and analysis”. Then came the following: “Mind body medicine and liaison psychiatry are relevant research areas for our centre. Recent successes include studies using the General Practice Research Database (GPRD). The GPRD studies have shown that diagnostic labels for CFS used in UK primary care have radically changed in the last 14 years and that these labels both reflect and affect prognosis”. What exactly was this radical change in diagnostic labels, who was responsible for it, and on what evidence did it rely? The ME community has little doubt about the answers to those questions. (continued on page 50) Page 49/72

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