Statements of Concern about
CBT/GET provided for the High
Court Judicial Review of February
12th December 2009
Over twenty internationally renowned ME/CFS experts provided
Statements in support of the Claimants' case for the Judicial
Review of the National Institute for Health and Clinical
Excellence (NICE) Clinical Guideline on "CFS/ME" that was
brought by ME/CFS sufferers Douglas Fraser and Kevin Short
and heard before Mr Justice Simon in February 2009 in the High
Court in London.
Many authors of the Statements expressed concern about the
recommendation by NICE that the primary management
intervention for ME/CFS should be Cognitive Behavioural
Therapy and Graded Exercise Therapy (ie. CBT/GET, which are
the subjects of the PACE Trial).
Regrettably, many of the experts' Statements were not used.
At the eleventh hour, NICE strongly objected to much of the
material that was to have been relied upon in Court,
threatening to seek a substantial "wasted costs" Order against
the Claimants' solicitor and also potentially against the
Claimants' barrister personally, a significant threat which had
a devastating effect on the case in that - without consulting
with either of the Claimants or with any of the Claimants'
non-legal advisors - the Claimants' lawyers decided to
withdraw much of their evidence, to change the pleaded case,
and to apologise to NICE and to the Court.
As is well-known, the Judicial Review failed on all counts. The
Judge ruled that the Claimants' evidence was unconvincing,
unreliable, unfounded, untrue, and entirely without merit; that
their contentions "cannot be sustained" and that their claims
were "seen to be baseless".
Mr Justice Simon subsequently granted NICE's application for
wasted costs and as a result, the Claimants' solicitors' firm
(Messrs Leigh Day & Co) were obliged to pay NICE £50,000 in
Unfortunately, the substantial evidence that was provided for
the Claimants' lawyers cannot enter the public domain (for
example, evidence that addressed NICE's lawyers' Defence
(Grounds / Arguments), Exhibits, or the 24 Witness
Statements submitted in support of NICE).
Because their case had been changed without any consultation
or agreement (a serious breach by the Claimants' lawyers), the
Claimants lodged a formal complaint against their own former
solicitors and barrister; initially, both Leigh Day & Co and the
Head of Chambers at One Crown Office Row robustly denied
any failure to act in the clients' best interests.
However, the Claimants pursued their complaint and submitted
it to both the Legal Complaints Service (LCS) and the Bar
Council Standards Board.
Whilst numerous heads of the Claimants' complaint to the LCS
about Messrs Leigh Day & Co were not able to be addressed
by the LCS (because some of them involved a complaint about
professional legal advice given or not given, about which the
LCS advised that further independent legal advice should be
sought with a view to pursuing a negligence claim) and some
procedural complaints were dismissed, the substantial
complaint (ie. failure to obtain clients' instructions before
submitting a second Witness Statement) was upheld and the
LCS ruled in favour of the Claimants.
The complaint to the Bar Council Standards Board about the
barrister was referred by the Complaints Administration
Department to the Complaints Commissioner, who requested
an Opinion from a barrister; the barrister's Opinion has now
been received by the Complaints Commissioner but the ruling
is still awaited.
Regarding the experts' Statements, it is not known if Mr
Justice Simon read even the ones that were initially provided
They were certainly not mentioned in Court and there is no
mention of them in the official transcripts or in the Judgment.
Extracts from some of the Statements for the High Court that
supported the Claimants include the following:
*) "In my view, the Guideline is biased and over
rigid in its recommendations and will put a large
number of ME sufferers at risk of harm through its
strong recommendations for the use of CBT and GET.
CBT is based on the idea that somatoform disorders
are maintained by abnormal or unhelpful illness
beliefs which lead to abnormal or unhelpful
The first requirement for a somatoform diagnosis is
that there be no physical cause for the symptoms.
This is not the case in ME/CFS"
(Malcolm Hooper, Professor Emeritus of Medicinal
Chemistry, University of Sunderland, November 2007)
*) "Two forms of treatment.are CBT and GET. CBT
is a psychological treatment. Its application in what
is certainly an organic disorder is basically irrational.
Its putative mode of action is based on the
proposition that patients with ME/CFS feel unwell
because they have an 'abnormal illness belief', and
that this can be changed with CBT.
It has never been proven to be helpful in the
majority of patients with ME/CFS. GET comprises a
regime of graded exercise, increasing incrementally
It has been almost universally condemned by most
patient groups. A number of patient surveys have
shown it to be, at best, unhelpful, and at worst, very
Its application is counter-intuitive, particularly when
one of the most debilitating and well recognised
symptoms of ME/CFS is post-exertional malaise
which can put some patients in bed for days after
relatively trivial exertion"
(Dr William Weir, Consultant Physician, November
*) "The GDG has placed undue reliance upon a small
number of RCTs that were methodologically flawed
because they did not adequately define the patient
(Dr Terry Mitchell, formerly Consultant Clinical Lead
(CNCC) of the Norfolk, Suffolk & Cambridgeshire NHS
ME/CFS Service, 23rd June 2008)
*) "The predominance of psychologists /
psychiatrists on the Guideline Development Group is
entirely inappropriate and has led to a biased
analysis in my opinion.
The GDG has placed undue emphasis on a few UK
clinical trials which support the use of psychological
treatments, however, these studies did not properly
or adequately define their patient population"
(Dr Jonathan Kerr, Hon. Consultant in Microbiology;
Consultant Senior Lecturer in Inflammation; Principal
Investigator of the CFS Group, St George's University
of London, 11th August 2008)
*) "You will see from my attached treatise that I
consider that the recommendation of CBT and GET as
blanket treatments of 'clinically excellent' first choice
is extremely dangerous to patients.
I am concerned that NICE claims that an adequate
evidence base supports CBT/GET, when in fact the
Guideline Development Group (GDG) relied almost
exclusively on a handful of extremely controversial
RCTs (random controlled trials).
I have no doubt that patients in the research quoted
by the GDG did not have ME/CFS"
(Dr Irving Spurr, Newcastle ME Research Group; 12th
*) "My overall impression reading the Guidelines for
the first time was one of alarm. I will limit my
comments to the deficiency which has the greatest
potential for harm to patients.
The NICE Guidelines do not make any reference to
the biomedical literature on ME/CFS. A physician
who is new to the field and who has not had time to
read the thousands of paper reporting measurable
abnormalities in ME/CFS may get the impression
(1) Biomedical issues are irrelevant in ME/CFS and
(2) CBT and GET actually make the core symptoms of
people with ME/CFS better.
A close read of the literature reveals that none of
the core symptoms of ME/CFS improve with CBT or
The recommendation for GET stems from the often
quoted but unproven assumption that deconditioning
causes or exacerbates ME/CFS. In fact this
assumption has been disproven (Bazelmans et al
2001; Harvey et al 2008) and cannot therefore be
used as a basis for treatment.
Informed consent is an ethical requisite in the
practice of medicine. Informed consent requires that
patients embarking on any therapy be told the
potential benefits and risks of the therapy being
Meeting this legal standard in ME/CFS requires that
patients be told about the potential benefits and
risks of CBT/GET. If patients are being coerced to
believe what is not true, psychological trauma can
If patients are pushed to increase activity beyond
their capabilities, exacerbation of symptoms can be
expected. The NICE Guidelines are biased towards a
particular model of CBT/GET that is widely viewed as
ineffective and potentially unethical"
(Dr Eleanor Stein, Psychiatrist, Alberta, Canada, 12th
*) "(Graded exercise therapy) is not therapy - it is
simply the enforcement of an opinion rather than a
treatment based upon any scientific examination of a
patient's pathology and treatment of that pathology.
I believe that those who developed (the) graded
exercise programme as a valid treatment of ME have
already been soundly criticised to the Courts. I also
believe scientific evidence that such a programme is
against the best interests of ME patients has already
The benefit of such a programme is to the interests
of the insurance industry and not the patient.
Graded exercise programmes may be significantly
dangerous to many of these ME patients"
(Dr Byron Hyde, Clinician specialising in ME, having
examined over 3,000 patients between 1984 - 2008;
Ottawa, Canada; 15th August 2008)
*) "(The GDG) produced a Guideline that
recommends CBT and GET as the prime treatment
yet there is in fact published evidence of
contra-indication / potential harm with GET. This has
been published by independent researchers (e.g.
Peckerman et al).
The NICE GDG claims that CBT/GET are supported by
significant research. In fact the GDG relied almost
exclusively on specious reports which are unproven"
(Dr Derek Enlander, Virologist specialising in ME/CFS;
formerly Assistant Professor at Columbia University
and Associate Director of Nuclear Medicine at New
York University; Physician-in-Waiting to the UK Royal
Family and to members of HM Government when they
visit New York; 18th August 2008)
*) "I regard the continuing aura of disbelief
surrounding the illness and mainly emanating from
the psychiatrists as detrimental to both medical
progress and the interests of sufferers"
(Dr Nigel Speight, Consultant Paediatrician
specialising in ME/CFS; 20th August 2008)
*) "It is with regret that I note that the NICE
Guidelines do not take into account recent
developments in the management of ME. They lean
towards a psychological and psychiatric basis, when
it is now recognised that there are a large number of
medical problems associated with ME.
Recent studies on genetics, the central nervous
system, muscle function and persistent infections
have shown that there is a great deal of medical
information available with regard to the management
(Dr Terry Daymond, Consultant Rheumatologist and
recently Clinical Champion for ME for North-East
England; 22nd August 2008)
*) "Research from the 'organic school' identified
many pathophysiological abnormalities in patients
with ME/CFS resulting from dysfunction in a number
of vital control systems of the body such as the
central nervous system, the autonomic nervous
system, the endocrinological system and the immune
The attitude of the 'psycho-social' school continues
to be to largely ignore this research. It seems they
can only maintain their hypothesis by discouraging
the search for an organic basis and by denying the
published evidence, which they are certainly doing.
This unseemly battle of ideas has been settled
politically by proclamation and manipulation, not by
science, and not by fair and open means.
CBT and GET appear to be based on the rationale
that patients with CFS/ME have 'faulty' belief
systems concerning the 'dangers' of activity, and that
these aberrant beliefs are significant perpetuating
If CBT to 'correct' these 'false' beliefs can be
combined with a graded exercise programme to
re-condition these patients, it is virtually promised
that a significant proportion of them will improve
both their attitude and their physical functioning,
and thus cure their illness.
Using CBT, patients are therefore to be challenged
regarding their 'aberrant' thoughts and expectations
of relapse that the 'psycho-social school'
psychiatrists believe affect symptom improvement
Cognitions concerning fatigue-related conditions are
to be addressed; these include any alleged
'over-vigilance to symptoms' and reassurance-
seeking behaviours, and are to be dealt with using
re-focusing and distraction techniques.
It is when a therapy such as CBT begins to interfere
with the natural warning systems, of which both pain
and fatigue are a part, that the increased risks arise.
In particular, musculo-skeletal pain and fatigue have
essential function in modulating activity when the
body is in a state of disease as in ME/CFS.
NICE, however, recommends over-riding this
essential safety-net, thus the risk of serious harm is
increased in this situation of simultaneous activity
and symptoms denial. This will become a more
serious risk in patients with more severe ME/CFS.
The Guideline does not indicate how the clinician can
tell whether patients' beliefs concerning their
symptoms are aberrant and/or when the symptoms
accurately point to the underlying state of the
(Dr Bruce Carruthers, Consultant Physician,
Vancouver, Canada, 29th August 2008)
*) "There have been only five trials of CBT with a
validity score greater than 10, one of which was
negative for the intervention; and only three RCTs of
GET with a validity score greater than 10.
The total number of available trials is small; patient
numbers are relatively low; no trial contains a
'control' intervention adequate to determine specific
efficacy, and their results are relatively modest.
In addition, some of the studies (particularly those
on GET) have used the Oxford criteria for diagnosis,
a rubric which allows selection of patients with
chronic fatigue states and which do not necessarily
exclude certain psychiatric disorders, raising the
question of the applicability of the results of these
studies to the many patients with specific biomedical
symptoms and signs consistent with myalgic
Again, the heterogeneity of the trials, the potential
effect of publication or funding bias for which there is
some evidence, and professional doubts about the
evidence base for some behavioural therapies
themselves give grounds for caution as regards the
usefulness of (CBT/GET).
A commentary in the BMJ (Bolsover 2002) is
particularly relevant: 'Until the limitations of the
evidence base for CBT are recognised, there is a risk
that psychological treatments in the NHS will be
guided by research that is not relevant to actual
clinical practice and is less robust than is claimed'.
Indeed, a large body of both professional and lay
opinion considers that these essentially adjunctive
techniques have little more to offer than good
medical care alone"
(Dr Neil Abbot, Director of Operations, ME Research
UK; Hon Research Fellow, Department of Medicine,
University of Dundee, 29th August 2008)
*) "The overall flavour of the Guideline is to lump
together all patients with 'medically unexplained
fatigue', from relatively mild to profoundly disabling
illness and to treat all patients with a standard
approach of gradual reconditioning and cognitive
By lumping such a heterogeneous mix of
patients.patients with CFS or ME are left with very
limited options, and little hope.
In addition, this document proscribes immunological
and other biologic testing on patients with (ME)CFS
in the UK, despite the evidence in the world's
medical literature that such testing produces most of
the biomedical evidence of serious pathology in
Equally unfortunate is the GDG's recommendation for
behavioural modification as the single management
approach for all 'medically unexplained fatigue'.
This month we participated in the International
Conference on Fatigue Science in Okinawa, Japan.
Dr Peter White of the UK presented his work using
behavioural modification and graded exercise.
He reported a recovery rate of about 25%, a figure
much higher than seen in US studies in (ME)CFS and,
even if possible, simply not hopeful enough to the
75% who fail to recover"
(Professors Nancy Klimas and Mary Ann Fletcher,
University of Miami; 13th September 2008)
*) Attached as an appendix to the Statement of
Professors Klimas and Fletcher was a separate
Summary of Current State of Understanding of
(ME)CFS), from which the following quotations are
"Many of the symptoms of (ME)CFS are inflammatory
in nature. There is a considerable literature
describing immune activation in (ME)CFS. Overall the
evidence has led workers in the field to appreciate
that immunologic abnormalities are a characteristic
of at least a subset of (ME)CFS and that the
pathogenesis is likely to include an immunologic
Fulcher and White (2000) suggest a role for
deconditioning in the development of autonomic
dysfunction and overall level of disability in (ME)CFS
On the other hand, Friedberg et al (2000) suggest
the long duration (ME)CFS subjects are more likely to
have symptoms suggestive of chronic immune
activation and inflammation.
We are currently working with investigators at the
Centres for Disease Control and the University of
Alberta looking at the mediators of relapse after
exercise challenge using gene expression studies,
neuroendocrine, immune and autonomic measures"
*) "My main concern about the NICE document is
that what must be great uncertainty in both costs
and particularly in quality of life difference is not
(Martin Bland, Professor of Health Statistics,
University of York, 17th September 2008)
*) "The guideline is dominated by positive and
largely uncritical recommendations for CBT and GET.
However, the guideline plays down the fact that
patient experience has consistently reported that
significant numbers of people with ME/CFS find these
approaches to be either unhelpful or, in the case of
GET, makes their condition worse.
Some of the hospital-based services are not being
physician-led but 'therapist-led'. In some cases
people are now being given little more than a
'therapist-led' management assessment followed by
an offer of CBT and/or GET.
I received some very unhappy patient feedback on
this type of service on Saturday 11th October (2008)
in Colchester, Essex, where great dissatisfaction was
expressed by many members of the audience who
attended the ME Association's 'Question Time'
(Dr Charles Shepherd, Medical Adviser, ME
Association, 24th October 2008)
*) "I am a consultant immunopathologist and before
retirement worked at St James' University Hospital,
Leeds. A key area of my professional interest was
and remains myalgic encephalomyelitis and I have
carried out research into the disorder.
For a number of years I ran clinics specifically for
patients with ME. In my opinion NICE guidelines
overemphasise the usefulness of CBT and GET to the
detriment of patients.
I have no hesitation in stating that in my opinion,
the situation for ME/CFS patients is worse, not
better, since the publication of the NICE Guideline"
(Dr Layinka Swinburne, Leeds, 22nd October 2008)
*) "As my clinical freedoms were progressively
eroded, it meant that I was becoming ineffective and
indeed possibly dangerous as a practitioner.
All that patients could be offered was CBT coupled
with GET, which I consider not to be appropriate for
many of my patients and in the case of GET
potentially damaging for some"
(Dr Sarah Myhill, General Practitioner specialising in
ME/CFS, Powys; Secretary of the British Society for
Ecological Medicine, 10th November 2008).
Seemingly untroubled by actual evidence, the Wessely School's
control over the lives of ME/CFS patients and their families
continues unabated and all attempts to bring these legitimate
concerns to the attention of Ministers of State have been
* * *