To whom it may concern,
Dr Terry Mitchell has given me permission to put his NICE Judicial=20
Review witness statement into the public domain. The statement was=20
provided in support of Doug Fraser and I in our attempt to have the NICE=20
'CFS/ME' clinical guideline (CG53) quashed in the High Court earlier=20
this year. The statement text is provided below and a PDF copy of the=20
original (both with personal contact details removed) can be downloaded=20
at the following URL:
http://www.angliameaction.org.uk/NICEJRdocs/Terry_Mitchell_WS.pdf
Dr Mitchell believes that ME is an organic/biomedical illness and=20
personally endorsed the Canadian Guidelines on the back cover of the=20
published UK overview version[1]. At the time of writing his witness=20
statement Dr Mitchell had probably seen more ME/CFS patients than any=20
other UK NHS clinician/specialist and it is therefore, in my view, quite=20
astonishing and very telling that NICE did not even ask him to serve on=20
the CG53 Guideline Development Group. Dr Mitchell very much wanted to=20
serve on the GDG and, though he is being too modest to mention his own=20
omission by NICE in his statement, he was clearly shocked at the GDG=20
composition: stating that he "...was hugely disappointed to find that=20
the membership of the GDG did not include any of my clinical colleagues=20
who over the years have seen large numbers of patients with ME/CFS."=20
Indeed; and by way of an illustration, NICE asks us to believe that=20
there was nothing untoward for example in the fact that they had not one=20
but two paediatricians on the GDG, both of whom just happened to have a=20
track record of supporting a behavioural view of the illness; whilst, in=20
stark contrast, the most experienced ME specialist paediatrician in the=20
UK by far, Dr Nigel Speight, was excluded. Dr Speight of course, like Dr=20
Mitchell, also believes that ME is an organic/biomedical illness.
Like many professionals, charities and patients, in the UK and abroad,=20
Dr Mitchell expresses concern at both the GDG's inadequate appraisal of=20
the total ME/CFS medical evidence base and the inadequate patient=20
selection criteria of the RCTs used by NICE to support their=20
recommendations of CBT/GET as primary 'treatments'. As Dr Bruce=20
Carruthers (Senior Fellow of the Canadian Royal College and principle=20
lead of the international expert team that produced the highly respected=20
ME Clinical Case Definition) points out regarding the highly=20
questionable behavioural approach to ICD-ME (now officially recommended=20
in the UK by NICE) in his Mitchell-endorsed 'ME/CFS Overview' document:
=93Supporters suggest that =91ideally general practitioners should diagno=
se=20
CFS and refer patients to psychotherapists for CBT without detours to=20
medical specialists as in other functional somatic syndromes=92.=20
Proponents ignore the documented pathophysiology of ME/CFS, disregard=20
the reality of patient=92s symptoms, blame them for their illness and=20
withhold medical treatment. Their studies have often included patients=20
who have chronic fatigue but excluded more severe cases as well as those=20
who have other symptoms that are part of the clinical criteria of=20
ME/CFS.=94[2]
Not without reason, Dr Mitchell also states that he "...was astonished=20
to discover that the systematic evidence review (authored by Bagnall et=20
al =96 York/CRD 2005), specifically commissioned to support the NICE=20
ME/CFS guideline, omitted the serious concerns highlighted in their=20
previous review of the same literature (JAMA 2001) that such evidence=20
was seriously flawed." He is not alone with such concerns: other medical=20
professionals have publicly stated their belief that such omissions=20
represented professional misconduct on the part of these NICE/York=20
evidence reviewers.[3]
Had NICE appointed Dr Mitchell as a GDG member as they should have done,=20
he would most certainly not have gone along with the GDG's determination=20
to abandon WHO medical taxonomy, to recklessly dilute diagnostic=20
criteria and to recommend CBT/GET as primary treatments on the basis of=20
a wholly inadequate and highly questionable RCT 'evidence-base'[4]. In=20
my view, having Dr Mitchell on the GDG would have resulted in either a=20
radically altered guideline or, more likely, Dr Mitchell becoming the=20
second GDG member to resign in protest.
Regardless of NICE's contrary assertions and Justice Simon's conclusions=20
in the High Court, I am still firmly of the opinion that the CG53=20
'CFS/ME' Guideline represents a disgraceful example of 'policy based=20
evidence' masquerading as 'evidence based policy' and one that is very=20
far indeed from being genuinely 'evidence-based' and "clinically"=20
excellent. Clearly; it is not just myself, my co-litigant Doug Fraser=20
and other patients that hold such a view.
Best wishes,
Kevin Short.
contact@angliameaction.org.uk
Notes:
[1]: See: Myalgic Encephalomyelitis / Chronic Fatigue Syndrome: A=20
Clinical Case Definition and Guidelines for Medical Practitioners - An=20
Overview of the Canadian Consensus Document by Professor Bruce M=20
Carruthers and Dr Marjorie I Van de Sande. UK =96 NHS Clinician Endorsed =
/=20
UK A4 Format =96 Version:
http://angliameaction.org.uk/docs/CanadianOverviewUK.pdf
http://data.eastanglia.me.uk/pdfs/Canadian_ME_Overview_A4.pdf
[2]: See SHS Box, page 10: Myalgic Encephalomyelitis / Chronic Fatigue=20
Syndrome: A Clinical Case Definition and Guidelines for Medical=20
Practitioners - An Overview of the Canadian Consensus Document by=20
Professor Bruce M Carruthers and Dr Marjorie I Van de Sande. UK =96 NHS=20
Clinician Endorsed / UK A4 Format =96 Version:
http://angliameaction.org.uk/docs/CanadianOverviewUK.pdf
http://data.eastanglia.me.uk/pdfs/Canadian_ME_Overview_A4.pdf
[3]: See, for example, Inadequacy of the York (2005) Systematic Review=20
of the CFS/ME Medical Evidence Base. Comment on Section 3 of: The=20
diagnosis, treatment and management of chronic fatigue syndrome=20
(CFS)/(ME) in adults and children, Work to support the NICE=20
Guidelines... Anne-Marie Bagnall, et al, Centre for Reviews and=20
Dissemination, University of York. 2005. Professor Malcolm Hooper &=20
Horace Reid, January 2006. From:
www.meactionuk.org.uk/FINAL_on_NICE_for_Gibson.html
[4]: See, for example, the witness statement provided by Dr Neil Abbot=20
in support of the High Court case against NICE CG53 at:
http://www.angliameaction.org.uk/NICEJRdocs/Neil_Abbot_MERUK_WS.pdf
******************************************************************
23 June 2008
Mr Jamie Beagent
Leigh day & Co Solicitors
Priory House
25 St John=92s Lane
London
EC1M 4LB
Dear Mr Beagent,
Re: Douglas Fraser & Kevin Short v NICE =96 Case Number: CO/10408/2007.
Until recently I was for many years the Consultant clinical lead (CNCC)=20
of the Norfolk, Suffolk & Cambridgeshire NHS ME/CFS Service. Further to=20
the query regarding the composition of the Guideline Development Group=20
(GDG) for the NICE guidelines relating to ME/CFS. I confirm that I was=20
hugely disappointed to find that the membership of the GDG did not=20
include any of my clinical colleagues who over the years have seen large=20
numbers of patients with ME/CFS. In my view this resulted in an=20
unbalanced analysis as many who were on the GDG seemed to have strong=20
leanings to the psychological / psychiatric approach to this devastating=20
illness.
The experience of those conducting clinical trials is likely to be more=20
selective and does not represent the daily burden of having to manage=20
and treat 100% of those diagnosed (using strict criteria) in a =91real=92=
=20
Norfolk/Suffolk/Cambridgeshire/Greater-Peterborough population of=20
approximately 2.5 million people at a rate of 500-550 new ME/CFS=20
patients/year. The remit of the GDG/Nice Guideline was to aid diagnosis=20
as well as patient management. I fail to see how this can be properly=20
done when the GDG has, on its own admission, failed to fully consider=20
the substantial existing clinical and peer-reviewed knowledge base.=20
Conversely, the GDG has placed undue reliance upon a small number of=20
RCTs that were methodologically flawed because they did not adequately=20
define the patient population for whom the guideline was intended.
I also have to say that I was astonished to discover that the systematic=20
evidence review (authored by Bagnall et al =96 York/CRD 2005),=20
specifically commissioned to support the NICE ME/CFS guideline, omitted=20
the serious concerns highlighted in their previous review of the same=20
literature (JAMA 2001) that such evidence was seriously flawed.
I would be very happy to provide further testimony on these and related=20
matters either in writing or to the court in person =96 health permitting.
Yours sincerely,
Terry Mitchell MA MD FRC-Path
Cc: Mr Kevin Short.
[Dr Mitchell's & Kevin Short's personal contact details have been=20
removed from the above text]
PERMISSION TO REPOST.
- ENDS -
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