by Margaret Williams
12th December 2009
This article is here
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
damages.
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
(i.e. 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 for him.
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:
Malcolm Hooper Professor Emeritus of Medicinal
Chemistry University of Sunderland November 2007
“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 behaviour. 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”
Dr
William Weir Consultant Physician 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
over time.
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 damaging.
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 Terry Mitchell, formerly Consultant Clinical Lead (CNCC)
Norfolk, Suffolk & Cambridgeshire NHS ME/CFS Service 23rd June 2008
“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”
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
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 Irving Spurr Newcastle ME Research Group
12th 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 Eleanor Stein
Psychiatrist Alberta, Canada 12th August 2008
“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 that: (1) Biomedical issues are irrelevant in ME/CFS
and that (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 GET. 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 recommended.
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 result. 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 Byron Hyde, Clinician specialising
in ME having examined over 3,000 patients between 1984 – 2008 Ottawa,
Canada 15th August 2008
“(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 been
presented. 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 Derek Enlander Virologist
specialising in ME/CFS formerly Assistant Professor at Columbia University
& Assoc. Director of Nuclear Medicine at New York University
Physician-in-Waiting to the UK Royal Family & to members of HM Government
when they visit New York 18th 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 Nigel Speight Consultant Paediatrician specialising in ME/CFS 20th 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 Terry Daymond, Consultant Rheumatologist
and recently Clinical Champion for ME for North-East England 22nd 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 of ME”
Dr Bruce Carruthers Consultant Physician Vancouver, Canada 29th 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
system.
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
factors.
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 and
outcomes. 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 disease
process”
Dr Neil Abbot Director of Operations, ME Research UK Hon Research Fellow, Department of Medicine University of Dundee 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 encephalomyelitis. 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”
Professors Nancy Klimas and Mary Ann Fletcher
University of Miami 13th September 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 behavioural modification. 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 these patients.
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”
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 taken:
“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 component.
Fulcher and White (2000) suggest a role
for deconditioning in the development of autonomic dysfunction
and overall level of disability in (ME)CFS patients. 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”
Martin Bland, Professor of Health
Statistics University of York 17th September 2008
“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 allowed for”
Dr Layinka Swinburne, Leeds 22nd 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 Sarah Myhill, General Practitioner
specialising in ME/CFS Powys; Secretary of the British Society for
Ecological Medicine 10th November 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”
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 ignored.