PERMISSION TO REPOST Below is a letter sent to the British Chief Medical Officer, Professor Sir Liam Donaldson, regarding the MRC /PACE trial. Full details regarding this issue can be found at: http://www.bryantpr.plus.com/THE%20MRC-PACE%20TRIAL%20SCANDAL.doc Anyone wishing to write to Professor Sir Liam Donaldson about this serious issue are very welcome to use parts of this letter as they wish. Best wishes Angela Kennedy ---------------------------------------------------------------------------------------------- Email address: dhmail@doh.gsi.gov.uk Snail mail address: Professor Sir Liam Donaldson Chief Medical Officer Department of Health Richmond House 79 Whitehall London SW1A 2NS (Insert date) Dear Sir Liam, THE MRC / PACE TRIAL (for ME/CFS) I am writing to you as the mother and carer of a young woman seriously ill with and severely disabled by Myalgic Encephalomyelitis ICD-10 G93.3 (which is also known as Chronic Fatigue Syndrome) to express my profound concerns regarding the MRC funded PACE trial. My concerns are summarised as follows: 1. In February of this year the Health Minister, Lord Warner, confirmed that the UK accepts the World Health Organisation neurological disease classification of ME/CFS as listed as such by the WHO under ICD-10 G93.3. However, the intent of the PACE trial will be to study only psychosocial management regimes and treatments, which have been comprehensively shown to be at best ineffective, and in many instances have made the condition of ME/CFS sufferers considerably worse. 2. This trial will be presided over by Professor Simon Wessely, who will direct the randomisation, data base design and management of the trial. Professor Wessely is very well-known for his recorded and published views that ME is simply an erroneous belief system, and not the neurological disease that it is recognised to be by international consensus and the WHO, listed under ICD-10 G93.3. 3. The doctors (psychiatrists) carrying out the research are, themselves, employed to provide the therapies being studied, and therefore have proven commercial interests in the desired outcome of this trial. As such, I believe this presents clear conflict of interest. It is therefore pertinent to call into question whether the ethical requirements for medical research have been met in this project. 4. The inherently psycho-social treatments of Cognitive Behavioural Therapy, Graded Exercise Therapy, and Adaptive Pacing Therapy (which is unrelated to the 'pacing' activity management strategy employed by many sufferers to cope with the limits the illness imposes on them), are to be tried at the newly operational ME/CFS centres recently announced by the Department of Health, UK. The combination funding for the new ME/CFS centres and the trials amounts toŁ11.1 million, which is currently being devoted to psychosocial treatments for an organic illness; treatments that have not only failed at best to benefit sufferers in the past, but have also actively damaged many. 5. In May 2003, the MRC announced that the Oxford criteria are to be used as the criteria for the PACE trial. Produced by a group of UK psychiatrists in 1991, the Oxford criteria have been superseded, are outdated, have no predictive value and are not in use by international consensus. Furthermore, the Oxford Criteria specifically exclude patients suffering from a neurological disorder and therefore by definition all 240,000 sufferers of the neurological disease ME/CFS in the UK. Moreover, patients suffering from the disease Fibromyalgia are to be included in the PACE trial. Fibromyalgia is classified in the WHO ICD at M79 as a distinct entity. Fibromyalgia is a quite separate disorder from ME/CFS, with a discrete biomedical profile that is entirely distinct from that found in ME/CFS. I believe therefore that there is no scientific rationale for including Fibromyalgia patients in the PACE trial. The Oxford criteria are also wide enough so that any person suffering from fatigue for six months or more could be included in the PACE trial. This will therefore include those people suffering from idiopathic chronic fatigue, classified by the WHO under F48 as a mental disorder, completely separate from the neurological disease ME/CFS ICD- 10 G93.3. 6. The MRC have also recently confirmed that, "Patients will be entered into the trial using the Oxford criteria but will then be further assessed against the other criteria (Fukuda and London) for secondary analysis." The MRC also have stated: "Applying the Fukuda and London criteria to the patients recruited under the Oxford criteria will enable finding out about sub groups of people including those who meet the WHO ICD-10 G93 classification." Since all patients suffering from ME/CFS will have been already excluded from the PACE trial by definition of the use of the Oxford criteria, the question immediately arises: how can they be then analyzed a second time when they have not been included in the first instance? 7. Produced by an Expert Medical Consensus Panel of eleven physicians who have between them treated/diagnosed over 20,000 ME/CFS sufferers worldwide, the Canadian Case Definition of ME/CFS, Diagnostic and Treatment Protocols sets out the most recent and carefully compiled criteria and seeks to rectify problems encountered in many studies so far. Published in 2003, these criteria most closely define those ME/CFS patients who not only suffer from severe 'fatigue', but also from a wide range of neurological, immunological, and endocrinological problems. Indeed, the national UK charity Tymes Trust (The Young ME Sufferers Trust) has enthusiastically praised the Canadian Definition of ME/CFS and recommends its clinical use. It has stated that once these criteria are put into widespread use, it will be much more difficult for people with idiopathic chronic fatigue to be categorised along with those who have ME/CFS. One would therefore have expected the Canada Protocols to have been reviewed and used within any trials relating to the treatment of ME/CFS sufferers. However, this is not the case. Indeed their very existence as an international consensus document appears to have been denied by the MRC, who have stated, "There is no international consensus. International reviewers were involved in reviewing PACE along with those in the UK and they were satisfied the INCLUSION criteria was appropriate for meeting the objective of the trial." It therefore is immediately obvious that this will actually result in the inclusion of patients within the trial who will most likely respond to the treatments, and the exclusion of those who will not - specifically sufferers of the neurological disease ME/CFS ICD-10 G93.3. 8. As has invariably been the case with regard to both treatment and research into ME/CFS, those most severely afflicted by ME/CFS will not be studied because they are too ill to be able to attend these ME/CFS centres. I am sure the serious ramifications of the concerns stated above will not be lost on you. In view of these, I and my daughter are extremely concerned about the conduct of those undertaking this trial, and we therefore request that an immediate Injunction be placed on the PACE Trial, and that a Public Inquiry be urgently undertaken into this. Yours sincerely,