Sunday, December 13, 2009

Statements of Concern about CBT/GET for High Court Review


  Statements of Concern about
  CBT/GET provided for the High
  Court Judicial Review of February
  2009

  Margaret Williams

  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
  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 (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
  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:

  *) "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 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
  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, Psychiatrist, 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 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 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
  of ME"

  (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
  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 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"

  *) "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).

  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.

* * *
I have found the same thing in my Disability case -- the judge does not even mention anything that says I'm truly ill and cannot work.  Even his own experts are not mentioned in the decision when they don't say what he wants to hear.
 
I have a positive C-Reactive Protein test, "off the charts" high, showing some sort of infection/inflammation, which is never mentioned, because he doesn't want to see evidence that there's something physically wrong, as opposed to his theory that I just need a little counseling and a good anti-depressant.





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