http://www.meactionuk.org.uk/Statements-of-Concern-for-High-Court.pdf
Permission to Repost
Statements of Concern about CBT/GET provided for the High Court Judicial
Review of February 2009
Margaret Williams=A0
12th December 2009
Over twenty internationally renowned ME/CFS experts provided Statements =
in
support of the Claimants=92 case for the Judicial Review of the National
Institute for Health and Clinical Excellence (NICE) Clinical Guideline =
on
=93CFS/ME=94 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=A0(ie. CBT/GET, which =
are the
subjects of the PACE Trial).
Regrettably, many of the experts=92 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
=93wasted costs=94 Order against the Claimants=92 solicitor and also =
potentially
against the Claimants=92 barrister personally, a significant threat =
which had
a devastating effect on the case in that =96 without consulting with =
either of
the Claimants or with any of the Claimants=92 non-legal advisors =96 the
Claimants=92 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=92 evidence was unconvincing, unreliable, unfounded,
untrue, and entirely without merit; that their contentions =93cannot be
sustained=94 and that their claims were =93seen to be baseless=94.
Mr Justice Simon subsequently granted NICE=92s application for wasted =
costs
and as a result, the Claimants=92 solicitors=92 firm (Messrs Leigh Day & =
Co)
were obliged to pay NICE =A350,000 in damages.
Unfortunately, the substantial evidence that was provided for the =
Claimants=92
lawyers cannot enter the public domain (for example, evidence that =
addressed
NICE=92s lawyers=92 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=92 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=92 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=92 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=92 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=92s
Opinion has now been received by the Complaints Commissioner but the =
ruling
is still awaited.
Regarding the experts=92 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:
=B7=A0=93In 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.=A0This is not the case in ME/CFS=94=A0(Malcolm Hooper, =
Professor
Emeritus of Medicinal Chemistry, University of Sunderland, November =
2007)
=B7=A0=93Two forms of treatment=85are CBT and GET.=A0CBT is a =
psychological
treatment.=A0Its application in what is certainly an organic disorder is
basically irrational.=A0Its putative mode of action is based on the
proposition that patients with ME/CFS feel unwell because they have an
=91abnormal illness belief=92, and that this can be changed with =
CBT.=A0It 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.=A0It 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.=A0Its 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=94=A0(Dr William Weir, Consultant Physician,
November 2007)
=B7=A0=93The GDG has placed undue reliance upon a small number of RCTs =
that were
methodologically flawed because they did not adequately define the =
patient
population=94=A0(Dr Terry Mitchell, formerly Consultant Clinical Lead =
(CNCC) of
the Norfolk, Suffolk & Cambridgeshire NHS ME/CFS Service, 23rd June =
2008)
=B7=A0=93The predominance of psychologists / psychiatrists on the =
Guideline
Development Group is entirely inappropriate and has led to a biased =
analysis
in my opinion.=A0The 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=94 (Dr =
Jonathan
Kerr, Hon. Consultant in Microbiology; Consultant Senior Lecturer in
Inflammation; Principal Investigator of the CFS Group, St George=92s
University of London, 11th August 2008)
=B7=A0=93You will see from my attached treatise that I consider that the
recommendation of CBT and GET as blanket treatments of =91clinically
excellent=92 first choice is extremely dangerous to patients.=A0I 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).=A0I =
have
no doubt that patients in the research quoted by the GDG did not have
ME/CFS=94=A0(Dr Irving Spurr, Newcastle ME Research Group; 12th August =
2008)
=B7=A0=93My overall impression reading the Guidelines for the first time =
was one
of alarm.=A0I will limit my comments to the deficiency which has the =
greatest
potential for harm to patients.=A0The NICE Guidelines do not make any
reference to the biomedical literature on ME/CFS.=A0A 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.=A0In 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.=A0Informed 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.=A0If patients are being coerced to believe what is not true,
psychological trauma can result.=A0If patients are pushed to increase =
activity
beyond their capabilities, exacerbation of symptoms can be =
expected.=A0The
NICE Guidelines are biased towards a particular model of CBT/GET that is
widely viewed as ineffective and potentially unethical=94=A0(Dr Eleanor =
Stein,
Psychiatrist, Alberta, Canada, 12th August 2008)
=B7=A0=93(Graded exercise therapy) is not therapy =96 it is simply the =
enforcement
of an opinion rather than a treatment based upon any scientific =
examination
of a patient=92s pathology and treatment of that pathology.=A0I believe =
that
those who developed (the) graded exercise programme as a valid treatment =
of
ME have already been soundly criticised to the Courts.=A0I 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.=A0Graded
exercise programmes may be significantly dangerous to many of these ME
patients=94 (Dr Byron Hyde, Clinician specialising in ME, having =
examined over
3,000 patients between 1984 =96 2008; Ottawa, Canada; 15th August 2008)
=B7=A0=93(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).=A0The NICE GDG claims that CBT/GET are supported =
by
significant research.=A0In fact the GDG relied almost exclusively on =
specious
reports which are unproven=94 (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)
=B7=A0=93I 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=94=A0(Dr Nigel Speight, =
Consultant
Paediatrician specialising in ME/CFS; 20th August 2008)
=B7=A0=93It is with regret that I note that the NICE Guidelines do not =
take into
account recent developments in the management of ME.=A0They lean towards =
a
psychological and psychiatric basis, when it is now recognised that =
there
are a large number of medical problems associated with ME.=A0Recent =
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=94=A0(Dr Terry Daymond, =
Consultant
Rheumatologist and recently Clinical Champion for ME for North-East =
England;
22nd August 2008)
=B7=A0=93Research from the =91organic school=92 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 =91psycho-social=92 school continues to be to =
largely ignore
this research.=A0It 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.=A0This 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 =91faulty=92 belief systems =
concerning
the =91dangers=92 of activity, and that these aberrant beliefs are =
significant
perpetuating factors. If CBT to =91correct=92 these =91false=92 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
=91aberrant=92 thoughts and expectations of relapse that the =
=91psycho-social
school=92 psychiatrists believe affect symptom improvement and
outcomes.=A0Cognitions concerning fatigue-related conditions are to be
addressed; these include any alleged =91over-vigilance to symptoms=92 =
and
reassurance-seeking behaviours, and are to be dealt with using =
re-focusing
and distraction techniques.=A0It 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.=A0NICE, 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.=A0This will become a more serious risk in patients with more =
severe
ME/CFS.=A0The Guideline does not indicate how the clinician can tell =
whether
patients=92 beliefs concerning their symptoms are aberrant and/or when =
the
symptoms accurately point to the underlying state of the disease =
process=94
(Dr Bruce Carruthers, Consultant Physician, Vancouver, Canada, 29th =
August
2008)
=B7=A0=93There 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.=A0The total number of =
available
trials is small; patient numbers are relatively low; no trial contains a
=91control=92 intervention adequate to determine specific efficacy, and =
their
results are relatively modest.=A0In 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.=A0Again, 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).=A0A commentary in the BMJ (Bolsover 2002) is particularly =
relevant:
=91Until 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=92. 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=94=A0(Dr Neil Abbot, Director of =
Operations,
ME Research UK; Hon Research Fellow, Department of Medicine, University =
of
Dundee, 29th August 2008)
=B7=A0=93The overall flavour of the Guideline is to lump together all =
patients
with =91medically unexplained fatigue=92, from relatively mild to =
profoundly
disabling illness and to treat all patients with a standard approach of
gradual reconditioning and cognitive behavioural modification.=A0By =
lumping
such a heterogeneous mix of patients=85patients with CFS or ME are left =
with
very limited options, and little hope.=A0In addition, this document =
proscribes
immunological and other biologic testing on patients with (ME)CFS in the =
UK,
despite the evidence in the world=92s medical literature that such =
testing
produces most of the biomedical evidence of serious pathology in these
patients.=A0Equally unfortunate is the GDG=92s recommendation for =
behavioural
modification as the single management approach for all =91medically
unexplained fatigue=92. This month we participated in the International
Conference on Fatigue Science in Okinawa, Japan.=A0Dr Peter White of the =
UK
presented his work using behavioural modification and graded =
exercise.=A0He
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=94 (Professors Nancy Klimas and Mary Ann =
Fletcher,
University of Miami; 13th September 2008)=A0
=B7=A0Attached 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: =93Many of the symptoms of =
(ME)CFS
are inflammatory in nature.=A0There 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.=A0Fulcher and White (2000) suggest a role for
deconditioning in the development of autonomic dysfunction and overall =
level
of disability in (ME)CFS patients.=A0On 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=94
=B7=A0=93My 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=94 (Martin Bland, Professor of Health Statistics, =
University
of York, 17th September 2008)
=B7=A0=93The 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 =91therapist-led=92.=A0In some =
cases
people are now being given little more than a =91therapist-led=92 =
management
assessment followed by an offer of CBT and/or GET.=A0I 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=92s =
=91Question
Time=92 meeting=94=A0(Dr Charles Shepherd, Medical Adviser, ME =
Association, 24th
October 2008)
=B7=A0=93I am a consultant immunopathologist and before retirement =
worked at St
James=92 University Hospital, Leeds. A key area of my professional =
interest
was and remains myalgic encephalomyelitis and I have carried out =
research
into the disorder.=A0For a number of years I ran clinics specifically =
for
patients with ME.=A0In my opinion NICE guidelines overemphasise the =
usefulness
of CBT and GET to the detriment of patients.=A0I 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=94=A0(Dr Layinka Swinburne, =
Leeds,
22nd October 2008)
=B7=A0=93As my clinical freedoms were progressively eroded, it meant =
that I was
becoming ineffective and indeed possibly dangerous as a =
practitioner.=A0All
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=94 (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=92s 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.
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