Dr Terry Mitchell has given me permission to put his NICE Judicial Review witness statement into the public domain. The statement was provided in support of Doug Fraser and I in our attempt to have the NICE ‘CFS/ME' clinical guideline (CG53) quashed in the High Court earlier this year. The statement text is provided below and a PDF copy of the original (both with personal contact details removed) can be downloaded here
Dr Mitchell believes that ME is an organic/biomedical illness and personally endorsed the Canadian Guidelines on the back cover of the published UK overview version. At the time of writing his witness statement Dr Mitchell had probably seen more ME/CFS patients than any other UK NHS clinician/specialist and it is therefore, in my view, quite astonishing and very telling that NICE did not even ask him to serve on the CG53 Guideline Development Group. Dr Mitchell very much wanted to serve on the GDG and, though he is being too modest to mention his own omission by NICE in his statement, he was clearly shocked at the GDG composition: stating that he "…was hugely disappointed to find that the membership of the GDG did not include any of my clinical colleagues who over the years have seen large numbers of patients with ME/CFS." Indeed; and by way of an illustration, NICE asks us to believe that there was nothing untoward for example in the fact that they had not one but two paediatricians on the GDG, both of whom just happened to have a track record of supporting a behavioural view of the illness; whilst, in stark contrast, the most experienced ME specialist paediatrician in the UK by far, Dr Nigel Speight, was excluded. Dr Speight of course, like Dr Mitchell, also believes that ME is an organic/biomedical illness.
Like many professionals, charities and patients, in the UK and abroad, Dr Mitchell expresses concern at both the GDG's inadequate appraisal of the total ME/CFS medical evidence base and the inadequate patient selection criteria of the RCTs used by NICE to support their recommendations of CBT/GET as primary ‘treatments'. As Dr Bruce Carruthers (Senior Fellow of the Canadian Royal College and principle lead of the international expert team that produced the highly respected ME Clinical Case Definition) points out regarding the highly questionable behavioural approach to ICD-ME (now officially recommended in the UK by NICE) in his Mitchell-endorsed ‘ME/CFS Overview' document:
"Supporters suggest that ideally general practitioners should diagnose CFS and refer patients to psychotherapists for CBT without detours to medical specialists as in other functional somatic syndromes'. Proponents ignore the documented pathophysiology of ME/CFS, disregard the reality of patient's symptoms, blame them for their illness and withhold medical treatment. Their studies have often included patients who have chronic fatigue but excluded more severe cases as well as those who have other symptoms that are part of the clinical criteria of ME/CFS."
Not without reason, Dr Mitchell also states that he "…was astonished to discover that the systematic evidence review (authored by Bagnall et al – York/CRD 2005), specifically commissioned to support the NICE ME/CFS guideline, omitted the serious concerns highlighted in their previous review of the same literature (JAMA 2001) that such evidence was seriously flawed." He is not alone with such concerns: other medical professionals have publicly stated their belief that such omissions represented professional misconduct on the part of these NICE/York evidence reviewers.
Had NICE appointed Dr Mitchell as a GDG member as they should have done, he would most certainly not have gone along with the GDG's determination to abandon WHO medical taxonomy, to recklessly dilute diagnostic criteria and to recommend CBT/GET as primary treatments on the basis of a wholly inadequate and highly questionable RCT ‘evidence-base'. In my view, having Dr Mitchell on the GDG would have resulted in either a radically altered guideline or, more likely, Dr Mitchell becoming the second GDG member to resign in protest.
Regardless of NICE's contrary assertions and Justice Simon's conclusions in the High Court, I am still firmly of the opinion that the CG53 ‘CFS/ME' Guideline represents a disgraceful example of ‘policy based evidence' masquerading as ‘evidence based policy' and one that is very far indeed from being genuinely ‘evidence-based' and "clinically" excellent. Clearly; it is not just myself, my co-litigant Doug Fraser and other patients that hold such a view.
: See: Myalgic Encephalomyelitis / Chronic Fatigue Syndrome: A Clinical Case Definition and Guidelines for Medical Practitioners – An Overview of the Canadian Consensus Document by Professor Bruce M Carruthers and Dr Marjorie I Van de Sande. UK – NHS Clinician Endorsed / UK A4 Format – Version
: See SHS Box, page 10: Myalgic Encephalomyelitis / Chronic Fatigue Syndrome: A Clinical Case Definition and Guidelines for Medical Practitioners – An Overview of the Canadian Consensus Document by Professor Bruce M Carruthers and Dr Marjorie I Van de Sande. UK – NHS Clinician Endorsed / UK A4 Format – Version:
: See, for example, Inadequacy of the York (2005) Systematic Review of the CFS/ME Medical Evidence Base. Comment on Section 3 of: The diagnosis, treatment and management of chronic fatigue syndrome (CFS)/(ME) in adults and children, Work to support the NICE Guidelines… Anne-Marie Bagnall, et al, Centre for Reviews and Dissemination, University of York. 2005. Professor Malcolm Hooper & Horace Reid, January 2006. From:
: See, for example, the witness statement provided by Dr Neil Abbot in support of the High Court case against NICE CG53 at:
23 June 2008
Mr Jamie Beagent
Leigh day & Co Solicitors
25 St John's Lane
Dear Mr Beagent,
Re: Douglas Fraser & Kevin Short v NICE – Case Number: CO/10408/2007.
Until recently I was for many years the Consultant clinical lead (CNCC) of the Norfolk, Suffolk & Cambridgeshire NHS ME/CFS Service. Further to the query regarding the composition of the Guideline Development Group (GDG) for the NICE guidelines relating to ME/CFS. I confirm that I was hugely disappointed to find that the membership of the GDG did not include any of my clinical colleagues who over the years have seen large numbers of patients with ME/CFS. In my view this resulted in an unbalanced analysis as many who were on the GDG seemed to have strong leanings to the psychological / psychiatric approach to this devastating illness.
The experience of those conducting clinical trials is likely to be more selective and does not represent the daily burden of having to manage and treat 100% of those diagnosed (using strict criteria) in a real' Norfolk/Suffolk/Cambridgeshire/Greater-Peterborough population of approximately 2.5 million people at a rate of 500-550 new ME/CFS patients/year. The remit of the GDG/Nice Guideline was to aid diagnosis as well as patient management. I fail to see how this can be properly done when the GDG has, on its own admission, failed to fully consider the substantial existing clinical and peer-reviewed knowledge base. Conversely, the GDG has placed undue reliance upon a small number of RCTs that were methodologically flawed because they did not adequately define the patient population for whom the guideline was intended.
I also have to say that I was astonished to discover that the systematic evidence review (authored by Bagnall et al – York/CRD 2005), specifically commissioned to support the NICE ME/CFS guideline, omitted the serious concerns highlighted in their previous review of the same literature (JAMA 2001) that such evidence was seriously flawed.
I would be very happy to provide further testimony on these and related matters either in writing or to the court in person – health permitting.
Terry Mitchell MA MD FRC-Path
Cc: Mr Kevin Short.
[Dr Mitchell's & Kevin Short's personal contact details have been removed from the above text]
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