A NICE Dilemma? by Margaret Williams published 15 December 2008
Introduction of “Consensus” for CG53
A notable innovation in the production of CG53 was the use of “consensus” by the GDG (said to be because the evidence-base was so poor). By letter dated 26th January 2006, a NICE Communications Executive (Sarita Tamber) confirmed: “With regard to the CFS/ME guideline, because of the lack of evidence it was decided to use formal consensus methods with the GDG. As you are aware, NICE guidelines are based on research evidence but NICE is aware of the lack of evidence on CFS/ME”. Consensus methodology is rigorously defined, but in the case of CG53, NICE decided to use its own “modification” that was specially formulated for this particular Guideline (as confirmed by Dr Mercia Page of NICE in her evidence to the Gibson Inquiry). The person who advised the GDG about the consensus methodology to be used was Professor Rosalind Raine, Professor of Health Services Research at University College, London. Professor Raine’s published views on “CFS/ME” just happen to be that it is a behavioural disorder that should be managed by CBT/GET. Her views are to be found, for example, in the BMJ 2002:325:1082 (“Systematic review of mental health interventions for patients with common somatic symptoms”) and the BMJ 2004:328:1354-1357 (“General practitioners’ perception of CFS and beliefs about its management”).
After reviewing many of the same studies assessed by the York Review team for “CFS”, Raine’s main conclusion in her 2002 paper is that patients in secondary care with chronic fatigue syndrome may benefit from CBT.
In her 2004 paper, CBT was described as “effective clinical management” for chronic fatigue syndrome and she warned that GPs’ perceptions “may be a barrier to mental health approaches“.
The Medical Adviser to the ME Association, Dr Charles Shepherd, was one of the hundred or so respondents in the e BMJ Rapid Responses: “As a doctor who likes to receive balanced information in the BMJ, I was concerned at what appears to be a clear bias by the authors in favour of the psychosomatic explanation for ME/CFS”
( http://www.bmj.com/cgi/eletters/328/7452/1354#61348 ).
Also in 2004, Raine published “An experimental study of determinants of group judgments in clinical guideline development”, Lancet 2004:364:429-437. It was funded by the MRC, so perhaps unsurprisingly, “cognitive behavioural therapy, behavioural therapy, psychodynamic interpersonal therapy, and antidepressants for irritable bowel syndrome and chronic fatigue syndrome were selected for study”.
Raine explains in this article that CBT “is provided by CBT therapists who aim to modify thoughts and beliefs with the expectation that emotional and behavioural changes will follow” and that behavioural therapies focus on “the modification of behaviour to positively reinforce healthy behaviours” which “emphasise the role that social factors can play in the development and maintenance of functional somatic complaints. The goal is to identify and reinforce ‘well’ behaviours while reducing reinforcement for somatic behaviours eg. excessive diagnostic testing or restricting mobility”.
Although not technically a member of the GDG, Professor Raine was in charge of the voting system used by the GDG and must have wielded considerable influence on the outcome. That the “consensus” method used was in reality little more than a voting system has been confirmed by GDG member Dr Fred Nye (J Inf 2007: 55:6:569-571).
Another curious failure on the part of NICE was the outright refusal of the GDG to accept the WHO international classification of ME/CFS as a neurological disorder as listed in the ICD-10 at G93.3. This makes it all the more notable that in November 2007 the Customer Service Centre at the Department of Health sent out correspondence which stated: “The Government has long recognised the World Health Organisation (WHO) classification of CFS/ME as a neurological disease, and this is the definition used in the final clinical practice guidelines published by NICE on 22nd August”. That was an outright lie.
It is a lie that is being perpetuated, because on 25th November 2008, the Northern Ireland Minister for Health, Social Services and Public Safety, Michael McGimpsey MLA, confidently stated: “There have been a number of studies and reports in recent years clarifying that (ME) is a very real and debilitating neurological condition. Most recently this has been established in a NICE clinical guideline on the diagnosis and management of ME and CFS issued in August 2007” (ref: COR/1471/2008). The NICE Guideline specifically and perversely refused to accept “CFS/ME” as a neurological condition, so it is unacceptable that NICE’s own paymasters (the DoH) should be advising constituents otherwise.
Failure of NICE to adhere to the Guideline Development Manual in the selection of GDG members
Perhaps the most rampant failure of procedure (and evidence of bias) is to be found in NICE’s disregard of the Manual’s directions about the required composition of the GDG. Bias may have been inevitable from the outset, because two people who were involved in the selection of the GDG members were Professor Anthony Pinching and Patricia Noons, who “advised” the GDG chairman Professor Richard Baker (who was himself chosen by Nancy Turnbull, Chief Executive of the National Collaborating Centre for Primary Care).
Pinching was chairman of the CFS/ME Service Implementation Steering Group and Pat Noons was Programme Director of the CFS/ME Service Investment; both therefore had a clear interest in ensuring that CBT/GET was to be recommended by the NICE GDG. Pinching’s views are well-known: “The clinical features are fatigue not related to on-going exertion. Over investigation can be harmful and counterproductive to the management of these patients, causing them to seek abnormal test results to validate their illness. The benefits of graded exercise have been shown by randomised controlled trials (citing four Wessely School studies). A behavioural response is crucial. The essence of treatment is activity management and graded rehabilitation”. (Anthony J Pinching. Prescribers’ Journal 2000:40:2: 99-106).
Patricia Noons has a reputation of being unhelpful to ME/CFS patients, for example, internet notice boards contain the following: “Patricia Noons came to one of our steering group meetings and she was less than helpful. All she was interested in was — just get these clinics set up as soon as possible, it doesn’t matter what the patients think“; “Even if the Clinical Champion (CC) wanted to be different, it was almost impossible for them to be so, as the Department of Health and the CNCC (Clinical Network Co-ordinating Centres) set the agenda. I have seen with my own eyes the pressure that was placed to conform to the ‘rules’ by the ex-coordinator from the Department of Health (Pat Noons)”. Even more tellingly, in 2004 Patricia Noons was involved with Trent Report, which was unambiguous: “CFS/ME was not a disease as such“. She was also involved with the 2006 NHSPlus Guideline “Occupational Aspects of the Management of CFS: A National Guideline” which has been rejected by 25 ME charities as unfit for purpose. That Guideline was developed in consultation with stakeholders, DWP, NICE and Pat Noons at the Department of Health, as documented in the official Minutes of the All Party Parliamentary Group on ME held on 17th May 2007 at the House of Commons.
Possibly because of the intention that CBT/GET was to be the primary management regime to be recommended by the NICE Guideline, not a single disease-specific expert who does not subscribe to the Wessely School behavioural model of “CFS/ME” was permitted to be a GDG member (their written applications were rejected by NICE in writing).
This was in direct contradiction to NICE’s own Guideline Development Manual, which stipulates the need for a balanced membership of a GDG.
NICE disingenuously claims that the GDG was representative of the wide body of professionals who deal with “CFS/ME” on a day-to-day basis, but that statement is to be challenged in the High Court.
Consideration of the known views of members of the Guideline Development Group (GDG)
The GDG chairman, Professor Richard Baker, a general practitioner for two days a week, had no prior knowledge or experience of “CFS/ME” whatever. Although he failed to declare it, he is described as “a pioneering thinker in Primary Care Mental Health“. In his evidence to the Gibson Inquiry on 10th May 2006, Baker pointed to the MRC PACE trial as a good example of work being undertaken in the UK, to which Dr Ian Gibson MP responded by pointing to the criticism that has been voiced about the MRC trial and its underlying research, which some have accused of being biased towards a psychiatric model of “CFS/ME”. Baker’s response was telling: he reaffirmed that, after talking to the MRC trial researchers (ie. the Wessely School), he did not believe this to be the case.
Jessica Bavinton (physiotherapist) previously worked with psychiatrist Professor Peter White at St Bartholomew’s Fatigue Clinic; she is involved in the MRC PACE trial (reporting to the trial’s Principal Investigator, Professor White) and is a treatment leader, having written the GET manual for that trial; with Peter White, she is involved in the medical insurance industry (for example, with Scottish Provident and Swiss Re, of which Peter White is Chief Medical Officer) to carry out “assessments” on “CFS/ME” claimants, for whom she carries out “lots” of such assessments. Letters dated 7th August 2007 from Scottish Provident (i.e. before publication of the Guideline) are unequivocal: one is addressed to Jessica Bavinton at Conan Doyle Consulting Rooms, 2 Upper Wimple Street, London W1G 6LD and says: “Dear Jessica, I would appreciate it if you would visit Mrs W at home. We are looking for your assessment of (her) inability to perform any occupation together with any other observations / thoughts that you may have”. Another letter to the client says: “We are arranging for a claims visit. This will be done by Jessica Bavinton who specialises in performing home visits of this nature”. On 13th August 2007 the client spoke to Miss Bavinton on the telephone and made a transcript of what Miss Bavinton said: “She told me she specialises in ME; she does ‘lots’ of these assessments for insurance companies; she refused to tell me what ‘treatments’ she advocates for ME patients; the insurance company may well fund (Miss Bavinton’s) treatments”.
Miss Bavinton is not only a physiotherapist, she has been working for a Diploma in Human Givens therapy with the Human Givens Institute, aiming to work privately in this field. Human Givens therapy has been described by a medical practitioner as “dodgy psychobabble”. It purports to deal with “mental distress” in people who are depressed, anxious, phobic, or who have problems with addiction. In 2004, Miss Bavinton published an article called “The mended fin” (Human Givens Publishing, 2004: volume 11, no.1) which claims to show how the human givens approach empowers patients by promoting emotional health and clear thinking. In a TimeBank article published in 2002 (for which the web page is no longer available), Miss Bavinton said: “I get a greater understanding of people and their responses to life, deepening my understanding of myself, but one of the most special feelings is knowing I directly contribute towards the number of people smiling in my community and that makes me smile”.
Miss Bavinton is also in private practice working for Positive Health Strategies Ltd at King Edward VII Hospital, Midhurst, West Sussex. The Director of Positive Health Strategies is Dr Brian Marien, a psychologist and CBT therapist who for ten years worked with Peter White at the Chronic Fatigue Clinic at St Bartholomew’s Hospital, London and who is now the Clinical Lead for the Sussex NHS “CFS” service. The company information describes her as “currently leading on a project involving the dissemination of good practice to therapists nationwide. Jessica is a Human Givens Therapist, which enables her to take a fully integrated approach incorporating management of emotional health” ( http://web.archive.org/web/20060118223755/www.phsmedical.co.uk/theteam.html ).
Miss Bavinton also facilitates fee-paying instruction classes on GET for health professionals on “How to introduce GET for patients with ME/CFS as recommended in the NICE Guideline”, one of which took place at Frenchay Hospital Bristol, on 12th September 2008. This was the first phase of Graded Exercise Therapy Training. An advanced course is scheduled for December 2008. This training event was also held in Manchester in July 2008.
It is notable that Miss Bavinton was deemed by the GDG selectors to have more clinical expertise in “CFS/ME” than NHS consultants with a professional lifetime’s experience of ME/CFS, such as infectious diseases expert Dr William Weir, neurologist Dr Abhijit Chaudhuri (jointly nominated by consultant neurologist Professor Leslie Findley and the Medical Adviser to the ME Association, Dr Charles Shepherd), paediatrician Dr Nigel Speight, consultant clinician Dr Jonathan Kerr, Professor Julia Newton and Dr Charles Shepherd. It is also notable that no representative of either the ME Association or the 25% ME Group for the Severely Affected was permitted to be a member of the GDG, and that their written applications were perversely rejected by NICE. This refusal by NICE to permit any representative from the ME Association, or from the 25%ME Group for the Severely Affected should be compared with NICE’s Guideline on multiple sclerosis (CG8), where the GDG was replete with MS charities’ representatives.
Consultant paediatrician Dr Esther Crawley is a leading supporter of CBT/GET and is dismissive of the regular and consistent patient reports which identify adverse effects; she is now Medical Adviser to AYME (Association of Young People with ME), which has adopted the psycho-social model and actively promotes CBT/GET. As that charity’s founder, Jill Moss, was a GDG “expert co-optee”, this effectively gave that charity two bites at the same cherry, whilst denying any representation from the other children’s charity TYMES Trust (The Young ME Sufferers’ Trust) which does not support the behavioural model of “CFS/ME”.
It is a matter of record that AYME (and its sibling adult charity Action for ME) have been the recipients of a Section 64 grant, which would require the charities’ promotion of CBT/GET for “CFS/ME” and would preclude their openly supporting a Judicial Review of the NICE Guideline on “CFS/ME”. A S64 grant is the way in which the Secretary of State for Health, through Section 64 of the Health Services and Public Health Act 1968, has the power to make grants to voluntary organisations in England whose activities support the Department of Health’s policy priorities (in this case, CBT/GET for “CFS/ME”).
Dr Tony Downes is described simply as a “GP”, but this is misleading, because his special interest is in Primary Care Mental Health Services. He sits on the Executive Committee of the Mental Health Research Network, Wales, alongside Professor Richard Bentall, Professor of Clinical Psychiatry at Bangor University. (Professor Bentall and his co-author, GDG member Dr Fred Nye, contributed two of the 18 trials that constituted the NICE “evidence-base”). In 2006, the Royal College of General Practitioners’ Mental Health Task Group issued a curriculum statement (No.13) designating CFS as a mental health disorder that was suitable for treatment in Primary Care. (For the record, one of the authors of the RCGP’s curriculum statement No.13 was Wessely’s wife, Dr Clare Garada, who was a Senior Policy Adviser to the Department of Health).
In addition to his involvement with WaMH (the Wales Mental Health Group in Primary Care), Dr Downes is involved with the Centre for Mental Health, whose Manifesto “Speaking our Minds” contains the following: “The Centre will place high emphasis on mental health” and it quotes Dr Tony Downes at the beginning: “A well mind is a healthy person and a healthy people is a well nation. Mental wealth (sic) is key to a nation’s economic health and a ‘feel good’ culture is vital to successful government. Government policy should promote mental wealth (sic) creation and distribution. Government and the people should work as co-producers of mental health and share in the resulting mental wealth”.
The Manifesto quotes Wessely almost verbatim: “Up to 50% of hospital outpatients have symptoms unexplained by modern medicine (medically unexplained symptoms, somatisation). The health and social costs resulting from wasted time through the acquisition of an unhelpful label and the inappropriate investigations and referrals for functional disorders and syndromes (ie. mental disorders) are considerable”. (Wessely and the medical insurance industry refer elsewhere to ME as an unhelpful label, as it implies real, organic disease, so dropping the label ME was helpful for the insurance industry, and the Royal College of General Practitioners’ [Wales] submission to NICE was unambiguous: “Please use the term CFS and stop perpetuating ME”). On page 5 the Manifesto talks about “respect for the roles of social, economic (and) occupational problems in determining and shaping psychological disability”.
It can thus be seen that for Dr Tony Downes to be described by NICE as simply an innocuous “GP” was disingenuous, to say the least.
Consultant neurologist Dr Richard Grunewald has a special interest in the interface between neurology and psychiatry, especially “functional” neurological symptoms. He is associate editor of “Behavioural Neurology”, whose editors regard “behavioural neuroscience” as “exciting and expanding fields of research”. In 2005, he published a paper in the JNNP:2005:76:307-314 on “predisposing, precipitating and perpetuating factors” (a Wessely School phrase that permeates the NICE Guideline) and he stressed the need for the involvement of liaison psychiatrists (Wessely is a liaison psychiatrist). Grunewald emphasised that the term “functional” is more acceptable to patients than the terms “psychosomatic” and “medically unexplained”. He also emphasised that “functional symptoms can be classified as manifestations of somatoform disorders” and noted that “functional symptoms were previously called ‘hysterical’ “. He went on to talk about “feigning illness or exaggerating symptoms”.
On 14th October 2006 at a Sheffield ME Group Conference organised by Mrs Ute Elliott, Chair of the Sheffield ME Group (who was one of the three patients on the GDG), Dr Grunewald spoke about ME. Amongst other things, he said: “There is widespread ignorance about ME and the literature doesn’t help”. That is an insupportable assertion, because there are over 4,000/5,000 peer-reviewed papers on ME/CFS. Grunewald continued: “When the NICE Guidelines are published I hope this will be the beginning of a sea change. ME is always the result of stress. The way that has been found most effective is to address this with a multi-disciplinary approach including graded activity programmes and addressing psychological issues. Some models (of ME/CFS) are unhelpful such as the virus model. There doesn’t seem to be any doubt that for the majority of people there is not a viral trigger”.
Again, this is an insupportable statement, because there is an extensive international literature about viral involvement in ME/CFS, especially enteroviruses. Grunewald continued: “The symptoms of ME are so physical but I’m afraid (the questioner) will not find a physical cause. I find the development of the NICE guidelines exciting because they represent a change that’s coming in the NHS approach”.
In 2007, Grunewald published a paper in the journal Psychotherapy: Theory, Research, Practice, Training (“Engagement in psychological treatment for functional neurological symptoms – barriers and solutions”, 2007:44:3:354-360) in which he reiterated his views about “predisposing, precipitating and perpetuating factors” for “functional neurological symptoms“, saying such symptoms are “costly to health services and the economy” but that “patients with functional neurological symptoms are often hostile to the idea of psychological treatment for symptoms, which they typically attribute to an undiscovered physical cause” (quoting Wessely School psychiatrist Michael Sharpe) and that “it has long been recognised that patients with a long history of chronic symptoms and entrenched support systems reinforcing illness behaviour can be particularly difficult to engage” because such patients “were concerned that compliance would prevent further medical investigations which they felt were necessary”. Grunewald’s solution was that these patients should receive psychotherapy (as the NICE Guideline CG53 recommends).
Also in 2007, Grunewald published another paper extolling the virtues of psychotherapy for people with somatoform disorders, especially for “non-neurological functional symptoms” (in which he specifically includes CFS), in which he concluded: “”Psychotherapy may be a cost-effective intervention for patients presenting with functional neurological symptoms” (J Psychosom Res 2007:63:625-632). Citing his own (2005) work, Grunewald asserted: “It is likely that some functional neurological symptoms are factitious or malingered“; citing Michael Sharpe (2004), he asserted: “Patients with functional symptoms are much more likely than patients with ‘neurologically explained’ disorders to attribute their problems to purely physical causes rather than to emotional or social difficulties”; citing Simon Wessely (2002), he asserted: “Functional symptoms are costly to the health service and to the economy”.
Grunewald’s view about the estimated cost-effectiveness of his favoured psychotherapy would have endeared him to NICE: “the described therapy is inexpensive, especially because cost savings from withdrawal of inappropriate medical treatment were not factored into the estimation of cost-effectiveness”.
Dr William Hamilton is listed as a GP and researcher. However, he is a long-standing collaborator with Professor Peter White (Family Practice 2005:22:383-388; JRSM 2004:97:571-575) and is a leading proponent of CBT/GET for “CFS/ME”, which he regards as psychogenic. He is Chief Medical Officer of two medical insurance companies (Exeter Friendly Society and Liverpool Victoria, which took over Permanent Health); LV in particular actively discriminates against “CFS/ME” patients. As such, he was unfit to sit on the GDG: the Guideline Development Manual requires that anyone with vested and conflicting interests must declare those interests before being appointed to a GDG, so it is anticipated that the Judge will enquire whether Dr Hamilton failed to declare such interests, or whether he did so, but the chairman (Professor Richard Baker) failed in his duty by permitting Hamilton to sit on the GDG.
Hamilton’s views about CFS are unequivocal: “The higher number of GP consultations in patients who develop CFS can be explained by perceiving symptoms more readily as illness. Cognitive behavioural therapy, which addresses beliefs about symptoms and illness, in particular those that can block recovery, is the only treatment shown to be helpful. We consider that more emphasis should be given to this area, both for funding treatment and for research on CFS” (British Journal of General Practice 2001:51 (468):553-558).
Hamilton’s conclusions were attacked by Professor JC Murdoch in the BJGP, to which Hamilton took exception. He replied by asserting: “No abnormality has been demonstrated with CFS. Extensive searches for immunological, infectious or endocrine explanations have drawn a blank”, an astonishing assertion that is readily disproved by a survey of the scientific and medical literature. More troubling is Hamilton’s interpretation of his own study and his demand that CFS researchers and clinicians examine their beliefs against his findings and see how well they match (Co-Cure RES. NOT: 21st December 2001).
In an earlier paper, Hamilton stated that his information came from an insurance company records. Contrary to the international evidence, his own study found no specific viral or immunological explanation for CFS and he concluded: “abnormal illness behaviour is of greater importance than previously recognised” (JRCP Lond 1998:32:44-48).
It seems to be the case that Dr Hamilton was head-hunted to be a member of the GDG under the chairmanship of Professor Baker specifically because of his published views on CFS/ME. This is clear from the R&D (Research and Development) annual reports by NHS organisations in England for 2006:
“Dr Hamilton’s CFS/ME work has generated publications that have been widely read and his work generated the invitation to join the NICE guideline development group for the treatment of CFS/ME which is due to report in 2007”