Wednesday, July 22, 2009

Statements of Concern about Psychotherapy and Exercise for CFS

Permission to Repost

Statements of Concern about Cognitive Behavioural Therapy and Graded
Exercise Therapy provided for the High Court Judicial Review of February

Margaret Williams

22nd July 2009
Over twenty renowned ME/CFS experts provided Statements in support of the
Judicial Review of the NICE Guideline on "CFS/ME" heard in February 2009 in
the High Court in London. They were specifically written in support of the
challenge to the NICE Clinical Guideline on "CFS/ME" and they express
concern about the recommendation by NICE that the only management of ME/CFS
should be CBT and GET (the same interventions that are the subjects of the
Medical Research Council's PACE Trial).
None of the Statements was accorded the recognition that they merit.
Extracts from those Statements (some of which were of considerable length)
are now being placed in the public domain in the interests of ME/CFS
sufferers and those who support and care for them.
•        "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"
  (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 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 William Weir, Consultant Physician,
November 2007)
•        "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 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 GDG 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 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
Eleanor Stein, Consultant Psychiatrist, Calgary, Alberta, Canada, 12th
August 2008)
•        "(Graded exercise therapy) is not therapy – it is simply the
enforcement of an opinion rather than a treatment based upon any scientific
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 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 contraindication
/ 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 of ME"
  (Dr Terry Daymond,
Consultant Rheumatologist and recently Clinical Champion for ME for the
North-East; 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 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 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
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"  (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 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" (Professors Nancy Klimas and Mary Ann
Fletcher, University of Miami; 13th September 2008) 
•        Attached as an appendix to their Statement 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"
•        "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" (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' meeting"  (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).

No comments: