A NICE DILEMMA by Margaret Williams, Part Three

For a document setting out what a Judicial Review is, what it is not, and how it works see: 

https://meagenda.wordpress.com/2008/06/18/judicial-review-judgement-guidance/

An unoffical site has been set up for supporters of the NICE CFS/ME Judicial Review, for information and updates for those planning to attend the hearing and for those able to offer assistance with arrangements and publicity.  The site can be found at: http://www.nicemecourt.co.uk/

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A NICE Dilemma? by Margaret Williams  published 15 December 2008

Part Three

Community Dietician Judith Harding was a member of the CNCC Collaborative 2004 – 2006, CFS/ME Service Investment Programme 2004 -2006, “Enabling People”: Implementation of Clinical Service Developments for Multi-Disciplinary Chronic Disease Management, Penninsula Medical School, CFS/ME Programme (Clinical Lead: Professor Anthony Pinching; Programme Director: Patricia A Noons).

Dr Fred Nye, Clinical Champion of the Liverpool “CFS” Clinical Network Co-ordinating Centre, achieved notoriety in 2005 when an advertisement for “therapists” to work in his Centre caused justified offence. The advertisement informed applicants patients with “CFS/ME” have perpetuating illness behaviour; that they experience barriers to understanding; that there can be significant barriers to accepting the changes needed in behaviour, which have to be overcome in therapy in order to facilitate a successful outcome; that the Fatigue Therapist will be required to modify patients’ predisposing personality style and provide motivation to patients with CFS; that some clients may be resistant to working in a psychological framework and that there may be verbal aggression (Chronic Fatigue Treatment Service: Ref: 2570. Closing date: 31st January 2005).

In 2001, Nye published his view in the BMJ (2001:322:387-390) that “CFS” patients “develop a strong physical perception of the condition” and that “Extensive research has failed to identify any serious underlying pathology”. Such a statement is easily shown to be erroneous. Nye continued: “Reduction in activity results in cardiovascular and muscular deconditioning, which exacerbates symptoms. We have developed a treatment for CFS (that) involves educating patients about the medical evidence of physical deconditioning”. The article re-iterated the take-home message: “No serious underlying pathology has been identified in patients with CFS. Cognitive behaviour therapy targeted at changing illness beliefs and graded exercise helps some patients”. However, Nye was compelled to concede that an intention to treat analysis showed that 32% of patients still complained of fatigue one year later.

In a follow-up study published in the British Journal of Psychiatry in 2004:184:142-146, Nye had not changed his beliefs about CFS/ME. Despite his own acknowledgement in 2001 that 32% of patients in the trial still complained of fatigue at one year, the 2004 study stated that at one year, “treated patients showed significantly greater improvement in measures of fatigue”. He was obliged to record that “One patient who had received treatment died by suicide in the follow-up period (but) it seems unlikely that this was an adverse reaction to the treatment”. Nye also had to record that patients who withdrew from treatment were not followed up. Nevertheless, his take-home message was: “Providing patients with physiological explanations of symptoms of chronic fatigue syndrome to encourage graded exercise produces long-term benefits in outcome”.

Both papers used the Oxford criteria, so no conclusions can be drawn about the efficacy of Nye’s interventions for people with ICD-10 ME/CFS.

Of relevance is the fact that Nye failed to make a full disclosure of competing interests to the extent that the independence of the GDG’s decision-making process was called into question: two of his research projects were cited in the York Systematic Review and were approved of by himself as a member of the GDG, so in effect Nye was supporting and voting for his own work. Not declared either was the fact that two of Nye’s co-authors are currently in receipt of a £824,129 MRC grant for “CFS/ME” research.

It is clear from his letter in the Journal of Infection (2007:55:6:569-571) that Nye is actively hostile to patient opinion, and there are disturbing reports of abrasive treatment of patients attending his CFS/ME clinic. For someone who is a committed Anglican lay preacher (at St Faith’s, Great Crosby, Liverpool, where his wife, Mrs Linda Nye, is the parish Child Protection Officer), this is especially disquieting.

Ms Amanda O’Donovan is a clinical psychologist at St Bartholomew’s Hospital. In March 2005 she was appointed CNCC co-ordinator for the CFS/ME Centre based at Barts, headed by Professor Peter White; as Lead Clinical Psychologist, she is heavily involved with the psychosocial model of “CFS/ME” and she promotes the use of CBT/GET for “CFS/ME”. She has attempted to justify its use by insisting that CBT is used in other “physical” conditions such as stroke, diabetes, chronic pain and cancer

http://health.groups.yahoo.com/group/IMEGA-e/message/24450 ).

However, Cancer Research UK has confirmed in writing that they are unable to accept that this is the case. In the other conditions mentioned by Ms O’Donovan, CBT is used as adjunctive support, not as the primary (and only) management intervention as is the case in ME/CFS.

Dr Alastair Santhouse is a Consultant Liaison Psychiatrist who works with Simon Wessely (the foremost proponent of the psycho-social model of “CFS/ME”) at the Chronic Fatigue (sic) Research and Treatment Unit, Kings College Hospital, London. His Head of Service is Professor Trudie Chalder. Santhouse failed to declare that his employer (Trudie Chalder) is in receipt of part of a £2 million MRC grant for the PACE trial that is investigating CBT/GET for “CFS/ME”, nor did he declare that his employer’s research papers constituted 11% of the NICE “evidence-base” in alleged support of CBT/GET. His employer would thus be a prime beneficiary of a NICE recommendation of CBT/GET for “CFS/ME”. In 2004, Santhouse published “The 10 chronic fatigue syndrome commandments” (Doctor, 26th February 2004) in which he stated: “CFS is the accepted name among professionals but many patients still prefer the name ME. Attribution of illness to a purely physical cause appears to predict a poorer response to treatment. The best research evidence is for CBT and/or a graded exercise programme”. In 2005, Wessely wrote a Foreword for Santhouse (“Fatigue as a Window to the Brain”; Psychological Medicine 2005:337:a2331). It is noted that Santhouse sponsored Simon Wessely’s cycle ride to Paris in 2007. It may also be noted that Santhouse is on record as asserting: “Psychiatry is the noblest branch of medicine” and that he states of himself: “At times I am carried away by the nobility of my calling” (BMJ 2008:337:a2331).

Dr Julia Smedley is an Occupational Health Physician whose main interest is in occupational risks to healthcare workers. Her publications include “A survey of the delivery and uptake of influenza vaccine among healthcare workers” (Occup Med 2002:52:271-276); “Respiratory illness in agricultural workers” (Occup Med 2002:52:451 459); “Effectiveness of an influenza vaccine programme for care home staff to prevent death, morbidity and health service use among residents” (BMJ 2006:333:1241) and “Influenza immunisation: attitudes and beliefs of UK healthcare workers” (Occup Environ Med 2007:64:223-227). Wessely School psychiatrist Professor Michael Sharpe is very active in the world of Occupational Health and Insurance Medicine and his views permeate the world of Occupational Medicine (i.e. that ME is a “pseudo-disease” that can be “cured” by CBT and that ME sufferers who “refuse to accept the stigma of mental illness remain the undeserving sick of our society and health service”).

As the Guideline Development Manual stipulates that GDG members must be disease-specific experts, it will be interesting to hear NICE’s explanation to the Judge as to why Dr Smedley was deemed to have more clinical expertise in the disorder in question than, for example, Dr William Weir, Dr Jonathan Kerr, Dr Abhijit Chauduri, Professor Julia Newton or Dr Charles Shepherd.

However, Dr Smedley was involved with the production of the Department of Health’s NHSPlus Report “Occupational Aspects of the Management of Chronic Fatigue Syndrome: A National Guideline” published in October 2006, whose Guideline Development Group included Professor Trudie Chalder and whose “external assessors” were psychiatrists Professor Michael Sharpe and Professor Peter White. This National Guideline was based on the behavioural model of “CFS/ME” and made exaggerated claims for the effectiveness of CBT/GET in returning people with “CFS/ME” to employment. This exaggerated claim was based on six studies, three of which were co-authored by Trudie Chalder  and one was co-authored by Peter White. The National Guideline was severely criticised to the extent that 25 UK ME/CFS organisations signed a joint Statement condemning it as unfit for purpose. Its conclusions were comprehensively discredited by an authoritative American systematic review, which concluded: “No specific interventions have been proved to be effective in restoring the ability to work” (SD Ross et al. Arch Intern Med 2004:164).

Dr David Vickers, Clinical Lead, children and young people with CFS/ME service, was the second paediatrician on the GDG (the other being Dr Esther Crawley). It is notable that both Drs Crawley and Vickers are known supporters of the psycho-social model of “CFS/ME” and that the UK’s senior paediatrician whose 25 years’ experience afforded him unique expertise in  paediatric ME/CFS and who was a member of the 1994 UK Task Force on ME/CFS but who does not support the psycho-social model (Dr Nigel Speight) was not permitted to be on the GDG. Dr Vickers holds the post of Registrar to the Royal College of Paediatrics and Child Health (RCPCH). In his Application Manifesto for the post of Registrar, Vickers wrote: “The most important role is supporting the President and other Senior Officers“. The views of the RCPCH bear little relationship to children and young people with ME/CFS. The College’s view of ME/CFS is that it is a behavioural disorder. The RCPCH report, in the production of which Dr Vickers was a Delphi participant (“Evidence-based Guidelines for the Management of CFS/ME in Children and Young People”, published in December 2004) emphasised behavioural interventions: “Children and young people with CFS/ME should be considered for graded exercise or activity programmes” and contributors referred to the “emotional dimensions of the illness” and stated: “The overarching aim of CBT is to help patients modify their behaviour for their own benefit“.

Gillian Walsh is a nurse who is the Network Co-ordinator for the Manchester “CFS” Centre. She, as is Miss Bavinton, is involved with Human Givens Therapy and whilst she was on the GDG was working towards a diploma from the Human Givens Institute. She has a private Human Givens practice in Manchester, which is described as her “helping career”. She uses the letters ” M.FETT” after her name, which stand for the “Fellowship of Eclectic  Talking Therapists”.  This is explained as being a “professional body for ethical counsellors and hynotherapists who use techniques as best suits the client”. She is referred to as “an experienced counsellor and psychotherapist” and helps patients to reach their goals and aspirations. She is also a reflexologist (with a Diploma from the Centre for Advanced Reflexology) and a hypnotherapist. Her employer at the Manchester CNCC is liaison psychiatrist Dr Damien Longson, chairman (replacing Professor Anthony Pinching) of the CFS/ME Clinical Network Co-ordinating Centres Collaborative. He is also the Lead for audit of these Centres, in collaboration with GDG members Dr Esther Crawley and Dr Fred Nye, together with Professor Peter White.

Carol Wilson is Lead Occupational Therapist for the Cornwall CFS/ME Service and is CFS/ME Network Co-ordinator for South West Peninsula. The Lead consultant of the Cornwall CFS/ME Service is Professor Anthony Pinching.

Dr Philip Wood has been a consultant immunologist at Leeds since January 2002. He failed to declare that he was a member (2004-2006) of the CFS/ME Service Investment Programme (whose Clinical Lead was Professor Anthony Pinching and whose Programme Director was Patrician Noons). He also failed to declare that he was a member (2004 – 2006) of the CNCC Collaborative. His main interest is in adult and paediatric allergy, but he has an interest in “chronic fatigue” (note: this is not the same as ME/CFS). He has published one study on allergic disease in children (Eur J Pediatr 2005:164:741-747). He is a clinician in the Leeds & West Yorkshire CFS/ME Service, whose 2008 booklet “Goal Setting” says the following: “CFS/ME is a diagnosis that does not fit under one specific medical speciality. Complex referrals may be seen initially by a physician and liaison psychiatrist. Unfavourable prognosis is associated with prolonged duration of symptoms (and) untreated beliefs around the need for purely physical treatment. The Leeds & West Yorkshire CFS/ME Service finds that if the practitioner can demonstrate why a diagnosis has been made, then that patient will start to engage in taking some responsibility in managing the effects of CFS/ME. The Leeds & West Yorkshire CFS/ME Service has three components: 1) Medical assessment by Dr Philip Wood; 2) Biopsychosocial assessment and considerations of interventions in liaison psychiatry led by Dr Hiroko Akagi and 3) Therapy Services, led by Sue Pemberton, occupational therapist. We all need goals to move forward in our lives. Without specific goals we can feel demotivated. This can have an impact on how we feel about ourselves. Setting and working towards a goal releases energy. How do you feel when you have no goals? The therapist within the team will help you with goal setting”.

The “Useful Books” list contains only books by Wessely School members (Trudie Chalder’s “Coping with Chronic Fatigue”, which has nothing to do with ME/CFS; “Overcoming Chronic Fatigue” by Trudie Chalder & Mary Burgess; and a book by psychiatrist Michael Sharpe, co-authored by Frankie Campling, a Wessely School supporter). Bearing in mind that many ME/CFS sufferers are professional people, such a superficial approach is an affront to their intelligence and cannot help people deal with vertigo, cardiomyopathy, pancreatitis, dysautonomia, adrenal insufficiency or vasculitis, all of which are well-documented key features of ME/CFS.

None of these GDG “experts” had anything to offer people with ME/CFS, but everything to offer the pre-determined agenda of the NICE Guideline CG53 to recommend CBT/GET across the nation. None of them is a “disease-specific” expert as required in the Manual, but no expert dissenting voices were permitted to be GDG members. The result is the recommendation of inappropriate behaviour-modifying interventions for people with a serious multi-system disorder who are unable to benefit from the recommended interventions.

It is the case that the Wessely School were unsuccessful in obtaining their intended outcome (i.e. that ME does not exist as a nosological disorder and that CFS – onto which they patronisingly tagged ME to read CFS/ME – is a somatoform disorder) in both the 1994 National Task Force Report and also in the 2002 Chief Medical Officer’s Working Group Report on CFS. Indeed, it is reported that Peter White was jubilant when he believed he had been successful in covertly removing from the latter Report the provision for children to receive home tuition (after it had been agreed), and that he argued against the need for the final meeting before the Report’s publication. However, it is reported that the chair (Professor Allen Hutchinson) was persuaded to permit the final meeting (which Peter White believed had been cancelled), at which the provision for home tuition that Peter White had removed was re-instated. It is a matter of record that five Wessely School members were so incensed that they did not get their own way that they “walked out” and refused to sign up to the final Report. Those five members were psychiatrists Professor Peter White; Professor Elena  Garralda and Dr Anthony Cleare; Trudie Chalder (fatigue therapist), and Dr Alison Round (a community physician and co-author with GDG member Dr William Hamilton).

It seems irrefutable that, having been thwarted twice in the past, in the production of the NICE Guideline on “CFS/ME”, the Wessely School were ruthlessly determined to be successful to the extent that every single professional member of the GDG was carefully selected and could be relied upon to support the somatoform model  of “CFS/ME” and the recommendation of CBG/GET.

NICE’s explanation for this unequivocal bias is eagerly awaited. That NICE deliberately and intentionally excluded every single ME expert in the UK from membership of the Guideline Development Group is a scandal that will hopefully be exposed under the spotlight of a High Court Judicial Review.

There were many other failures of the GDG to adhere to the Manual which the Judge may choose to address at the High Court Hearing, not least the GDG’s failure to identify and define the disorder to which the Guideline purports to relate.

Conclusion

No-one could have summed up the situation better than Hayley Klinger in a letter to The Times Online on 11th December 2008: “Despite thousands of medical research papers showing immunological, neurological, endocrine, cardiac and gene expression involvement in ME, it is thought of as an illness of fatigue and even called chronic fatigue syndrome by the media and some doctors”.

And as Hilary Patten so aptly wrote in a letter to The Sun on 12th December 2008: “American research has proved ME is caused by a viral and bacterial infection. But over here, health guidelines drawn up by psychiatrists, only allow psychological interventions for sufferers. It is an absolute scandal”.

Ends

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