This is being sent on behalf of Margaret Williams

This is being sent on behalf of Margaret Williams.

On the 17th of February, a press conference was held at the Science Media Centre to announce the e-publication of the PACE Trial in the Lancet the following day. The Science Media Centre themselves issued the following press release which has just entered the public domain. For background information on the SMC please see below.

http://www.sciencemediacentre.org/pages/press_releases/11-02-17_cfsme_trial.htm

Science Media Centre Press Release

17 February 2011

Expert reaction to Lancet study looking at treatments for Chronic Fatigue Syndrome/ME

The study made the first definitive comparison of various treatments for CFS/ME to deduce the most effective treatments.


Dr Alastair Miller, Consultant Physician at Royal Liverpool University Hospital, Clinical lead for CFS services in Liverpool, Independent assessor of trial safety data for PACE trial and Principal Medical Advisor, Action for ME, said:

"Although NICE have previously recommended graded exercise and CBT as treatments for ME/CFS, this was on the basis of somewhat limited evidence in the form of fairly small clinical trials. This trial represents the highest grade of clinical evidence – a large randomized clinical trial, carefully designed, rigorously conducted and scrupulously analysed and reported. It provides convincing evidence that GET and CBT are safe and effective and should be widely available for our patients with CFS/ME.

"It is clearly vital to continue our research into biological mechanisms for ME/CFS but recent 'false dawns' for example, over the role of retroviruses (XMRV) have shown how difficult this can be. In the current absence of a biomedical model for the causation and the absence of any pharmacological intervention, we have a pragmaticapproach to therapy that works and we should use it."



Dr Derick Wade, Consultant and Professor in Neurological Rehabilitation and Clinical Director, Enablement Directorate, Oxford Centre for Enablement, said:

"CFS is common, and it is vital to know whether treatments proposed and/or used are safe and are effective. Randomised controlled trials provide the best and only reliable evidence on safety and effectiveness of any intervention in any condition. The trial design in this study was very good, and means that the conclusions drawn can be drawn with confidence.

"This is a very significant finding. It identifies that one commonly used intervention is not effective (and therefore should not be used), and it confirms the effectiveness of two treatments, and their safety. The study suggests that everyone with the condition should be offered the treatment, and every patient who wishes to be helped should be willing to try one or both of the treatments. It also means that we can allocate resources to treatments that will benefit patients and, more importantly, stop allocating treatments that do not have proven efficiency. Further research should identify ways that treatments derived from these may deliver greater benefits.

"Research needs to investigate both treatments and factors that increase the risk of developing CFS. However, it is probably more effective to research treatments, and proving a treatment is effective starts to give clues about causative factors."



Dr Fergus Macbeth, Director of the Centre for Clinical Practice at NICE, said:

"We welcome the findings of the PACE trial, which further support cognitive behavioural therapy and graded exercise therapy as safe and effective treatment options for people who have mild or moderate CFS/ME. These findings are in line with our current recommendations on the management of this condition.

"We will now analyse the results of this important trial in more detail before making a final decision on whether thereis a clinical need to update our guideline. Until then, healthcare professionals should continue to follow our existing recommendations, especially as this latest research appears to endorse them as best practice for the NHS."



Dr Esther Crawley, Consultant Paediatrician and Clinical Lead for the Bath Specialist Paediatrics Chronic Fatigue Syndrome/ME Service, said:

"All children with chronic fatigue syndrome and their parents are desperate for new research to understand how to treat this condition. The next step is to do a study like this for children to find out if these treatments work."



Prof Willie Hamilton, GP in Exeter and Professor of Primary Care Diagnostics, Peninsula College of Medicine and Dentistry, said:

"At least half of patients improved with CBT or GET. The study also allays fears that CBT or GET may be harmful. There are a minority of patients who didn't see improvement so the next step must try and find treatments to help them.

"This study matters: it matters a lot. CFS/ME is common, and causes a lot of suffering. Up until now we have known only that CBT and GET work for some people. We didn't know if pacing worked. This caused a real dilemma - especially for those in primary care. We didn't know whether to recommend pacing, or to refer for CBT or GET. Worse still, not all GPs have access to CBT or GET, so ended up suggesting pacing almost by default. This study should solve that dilemma.

"At a patient level, I now know what to suggest to my patients. Almost as important, it sends a powerful message to PCTs - and the soon-to-be-formed GP consortia - that they must fund CBT or GET. NICE proposed that before this study came out - the evidence is even stronger now."



Dr Brian John Angus, Clinical Tutor in Medicine and Honorary Consultant Physician, University of Oxford and Centre Leader for the PACE Trial in Oxford, said:

"This study is the largest ever done in CFS/ME and as such is critically important. The study should reassure patients that there is an evidence based treatment that can help them to get better and there is no need to worry about harm from the treatment. The other significant result is that looking at different ways of classifying the condition through different diagnostic criteria do not make any difference to the effect of treatments.

"We do not know what the underlying cause of CFS/ME is. There is ongoing research to find the cause, and I have been involved with this, but none of these studies has shown any consistent evidence of cause never mind any rationale for treatment. However in the meantime I see many patients in my clinic who need help with their fatigue. This was a pragmatic trial to help patients while there is no other treatment available.

"It was extremely rigorous. It was large and it was randomised. The study was carefully conducted in the manner of a drug intervention study to not only establishthe superiority of one treatment over the other but also to carefully report any side effects or harm from those treatments. Since the treatments were therapies and not drugs stringent efforts were made to ensure the 'purity' of each treatment and to rapidly report any adverse effects. As a trial this involved a huge amount of checking and cross checking.

"This should mean that GET and CBT should be widely available throughout the country. Despite NICE recommendations I still see patients who are unable to access any treatment for their CFS/ME in their local GP area. Travelling is obviously difficult for patients with CFS/ME. The increase in the availability of CBT therapists for other conditions should be mirrored for CFS/ME. "The trial was conducted to a high ethical standard. Patients were fully informed and randomised to the different treatments. It was rigorously performed. The study has definitively shown that there is no harm
associated with GET."

Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial, by Peter White et al, published in the Lancet at 00.01hr UK time Friday 18 February 2011.

To contact the above please contact the Science Media Centre on 020 7670 2980

Note for editors

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For more details see our website www.sciencemediacentre.org, please e-mail the Science Media Centre with your comments.

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Background Information:

1.The Science Media Centre:

http://www.meactionuk.org.uk/magical-medicine.pdf

p72-73

"Not only do the Wessely School flood the UK medical journals with their own beliefs about the nature of “CFS/ME”, to the extent that it would take a brave editor to publish a contrary view (editors frequently publish highly uncritical assessments of CBT which focus on the few studies that support its use, whilst ignoring those controlled trials which did not find CBT to be effective and which warned about the dangers of exercising beyond physiological exhaustion), but the Wessely School also seem to have open access to major Australian and US journals and thus to an international audience. They also frequently publish in the medical trade journals which have wide circulation, and they seem to control to a large extent what is published about “CFS/ME” in the UK media seemingly through Wessely’s involvement with the Science Media Centre (SMC), where he is on the Scientific Advisory Panel.

The SMC was set up in 1999 under New Labour to operate like a newsroom for national and local media when science stories hit the headlines, thus ensuring that only the Government’s chosen “policy” about a medical or scientific issue is reported. The SMC provides “training days” for journalists as well as brainstorming sessions on ways to improve the communication of science through the media. It also provides off-the-record briefings with key figures at the centre of controversial issues who want to communicate with the media without being quoted directly. It is used by its Director Fiona Fox to promote the views of industry and to launch fierce attacks against those who question them. It is sponsored by the Royal College of Physicians, The Science Council, the drug company Pfizer and Merlin Biosciences, amongst others. The SMC website records Professor Simon Wessely as saying: “We need to defend scientific expertise as a basis for sound policy decisions”. Its website also states: “Lucy Thorpe and her colleagues at Radio Five Live, and Professor Simon Wessely urged the SMC staff to find ‘members of the public’ to speak out for science”

http://www.sciencemediacentre.org/uploadDir/536adminconsultation_report.pdf

It is the case that Health Editors of broadsheet newspapers have confirmed that editorial policy will permit them only to publish items about ME/CFS that come from the SMC.

Other tactics used by the Wessely School to ensure dissemination of their own views have been unambiguously set out by Dr Tony Johnson (see Appendix I): “Our influence on policy-makers has largely been indirect, through scientists’ work on advisory committees, in leading editorials, in personal correspondence with Ministers, Chairs or Chief Executives (such as the Healthcare Commission or NICE), Chief Medical Officers and Chief Scientific Advisors, or through public dissemination when the media picks up on issues”.

It is public knowledge (and was announced at an International Research Conference – see above) that the Wessely School psychiatrists control the MRC; it is certainly the case that many of them sit on MRC Boards. In addition, the Wessely School travel the world giving presentations about “CFS/ME”, for example, on the very day of the ME Research UK (MERUK) International Research Conference (25th May 2007) in Edinburgh (which not a single member of the Wessely School attended), Trudie Chalder delivered a lecture at St Olav Hospital, Trondheim, Norway, on Cognitive Behavioural Treatment for CFS/ME, which she extolled. As customary, Miss Chalder’s views remain uninfluenced by the biomedical evidence that shows her beliefs about the nature of ME/CFS to be seriously misinformed. Wessely himself is apparently always available to the media: in its Notes for Editors, the online magazine ”spiked” (which is militantly opposed to ME/CFS being accorded the status of an organic disorder) says that Professor Wessely is available for comment or interview and can be contacted through Sandy Starr at “spiked” (0207-269-9234).

The extremely effective network coverage by the Wessely School has thus filled the gap between bench and bed, but not with evidence-based knowledge."



2. Dr Derick Wade:

http://www.meactionuk.org.uk/magical-medicine.pdf


p68-69

In the same year that the book by Waddell and Aylward was published, on 22nd August 2005 another of the Woodstock attendees, Professor Derick Wade from the University of Oxford and the Rivermead Rehabilitation Centre, Oxford, wrote to Dr Roger Thomas, Senior Medical Policy Adviser in the Benefit Strategy Directorate at the Department of Work and Pensions advising that – despite the WHO classification -- ME/CFS is not a neurological disorder but a “non-medical illness”.

When challenged about his views by the person about whom he had written, on 7th July 2006 Wade replied :

“ME/CFS is not a neurological condition in that there is no pathology in the nervous system.

“The sick role does have advantages in that Society provides support to people who are ill…a not-inconsiderable advantage…

“Why should all symptoms arise from disease…..Even if research such as that on the websites you gave does find abnormalities, it does not prove a causal link….Why are so many people with ME so afraid of the idea that there is no pathology?… I will end by re-stating that: I think that ME/CFS is a major problem for people with it and for Society but I do believe that: people with so-called ME/CFS do not have any disease as the primary or sole cause of their illness (and) it is wrong to fit ME/CFS into a biomedical model of illness”.

Together with Professor Tim Peto (co-leader of the Oxford PACE Trial Centre), Professor Wade attended a meeting of the Oxfordshire Priorities Forum on 21st May 2008 at Jubilee House, Oxford Business Park South, the Minutes of which record: “There is increasing evidence from good quality trials to support CBT and or GET in the management of CFS/ME (and) there is evidence for the effectiveness in children and adults…Inpatient care for CFS/ME is not supported by available evidence… The Oxford PF agreed that GET and CBT are clinically and cost effective and should be recommended in the treatment of CFS/ME.

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