Letters to Jones from Older People and Disability Division, Leeds and the MRC Further in these protracted elaborations, I have now received formal replies to my first letter and enclosures sent to the UK’s Chief Medical Officer on 14.3.2005 and from Professor Colin Blakemore, MRC, to both my letters and enclosures. This is what Mrs Natalie Pemberton from the Department of Health in Leeds wrote to me on 13.5.2005: ‘Dear Mrs Jones, Thank you for your further letter dated 14th May (sic) to the Chief Medical Officer about the PACE Trial. Due to the large amount of correspondence Sir Liam receives, I have been asked to reply on his behalf and I can only apologise for the lengthy delay in doing so. I am sorry that you remain concerned about the PACE Trial. As with allserious illnesses, it is important that patients, their families and the healthcare professionals looking after them have the best scientific information available and the trial has been designed to help them decide for themselves what management strategy is likely to be the best for them. There is currently relatively little information about the benefits (sic) graded exercise therapy and a scientific trial is the only way to find out which is the most effective approach. Any medical treatment has the potential to cause harm and this will be addressed in the trial. The patient information sheet for the trial includes a discussion on the controversy around the graded exercise therapy, and has been passed as satisfactory by four independent ethics committees. Patients’ responses, including deterioration, will also be carefully monitored by an independent data monitoring and ethics committee, which has the power to recommend changes to the trial and even to stop it. Patients will be allowed to withdraw from the trial at any time. As you may be aware, there have been a number of randomised controlled trials of carefully administered graded exercise therapy for patients with CFS/ME, which have not found any pattern of harm to patients. A survey by Action for ME, who have actively supported the PACE trial and have been involved in its design, also found that where patients had reported negative effects, this was probably due to inappropriate advice on how to do graded exercise therapy, or by patients trying the therapy unsupervised by an appropriate professional. Regarding research into biological and environmental factors as possible cause of CFS/ME, both the Department of Health and Medical Research Council (MRC) are fully aware of the importance of understanding the causes of this disabling condition. Since the publication of the MRC’s CFS/ME research strategy in 2003, the Council have received a number of proposals relevant to CFS/ME, including a number of epidemiological studies. However, following robust review by scientific peers these proposals were unfortunately judged not to be of sufficiently high standard to fund. We do appreciate that this will be frustrating for patients and patient organisations but, on the plus side, this may be a hopeful indication that there is a great deal of interest amongst researchers in looking at a broad range of approaches to the condition and the MRC will continue to encourage high quality research in this area. It is important to note that the MRC does not have set budgets for specific illnesses or conditions, so their support of the PACE Trial will not preclude the funding of other proposals from the (sic) across the whole spectrum of CFS/ME research. Whilst I appreciate that his may not be response you were hoping for, I do hope that you will find it helpful insofar that it clarifies the Department’s position. Yours sincerely, (Signed) Mrs Natalie Pemberton Policy Manager, Older People and Disability Division’ ------------------------------------------------------------- The following is the reply dated 11.5.2005 from Professor Colin Blakemore, MRC, received on 17.5.2005: --------------------------------------------------------- ‘Dear Mrs Jones, Thank you for both your letters. I apologise for being late in replying to your earlier correspondence. You refer to a number of previous submissions to MRC and are concerned that these have been ignored by the MRC. The many submissions, website addresses, references to papers, comments and opinion that have been brought to our attention in relation to CFS/ME research are always read, so that staff involved in managing this research portfolio can be informed not only by research evidence but also the wider context of research into this condition. The peer-reviewed papers you reference may be also used by research groups in their proposals if they consider them relevant to their own research questions. Your overarching concern is to see more research into biomedical causes of CFS/ME. I can only reiterate that MRC welcomes high-quality proposals across the whole range of its broad portfolio. These compete for approximately £170m available for grants. Of the grants that are considered to be excellent and internationally competitive under peer review (by scientists with specialist knowledge of the area of science under review), around 70% are funded. In the past two years MRC has received a number of proposals across a wide range of relevant topics including: Genesis of CFS; Population-based study of CFS; Determinants & prognosis of CFS; Stress responses in CFS; Spectroscopic studies of CFS; Clinical and laboratory characterisation of CFS/ME patients; Treatment of CFS: two randomised controlled trials; Facilitated self-help of CFS; Factors in CFS/ME in young people. In each case, the application was considered by our scientific Board in competition with other demands on funding. Unfortunately, none of these applications met the high scientific standard required for support. You raise again concern over the PACE and FINE trials and your recent letter included a submission from Margaret Williams, which was also sent through by a number of other people. As you know the purpose of the trial is to establish which of a number of interventions work best for people with CFS/ME. I understand that you question the value of this research but I reiterate that the trials were peer reviewed, and awarded funding on the basis of the excellence of the science. The trial protocol received ethical approval and the management of the trial conforms to recognized standards of research governance, including the establishment of an independent steering group. I appreciate that your letters are based on frustration at lack of progress in research into this severe and distressing condition and a preference for spending money in one area rather than another. Whilst the MRC does not envisage ring-fencing funds for CFS/ME, the highlight notice will continue and we welcome further proposals across all areas of CFS/ME research. Yours sincerely, Signed Colin Blakemore.’