It is available as a formatted document at MEActionUK website and also as a plain text document from the Co-Cure website list archive. It has been circulated by Stephen Ralph of MEActionUK and by Jan van Roijen via the Help ME Circle list. Queries in relation to this commentary should be referred directly to Margaret Williams, via Stephen Ralph.
The original formatted document was published as a single document and is lengthy. For ease of reference and access, the document has been split across three postings:
A NICE DILEMMA? by Margaret Williams, Part One
A NICE DILEMMA? by Margaret Williams, Part Two
A NICE DILEMMA? by Margaret Williams, Part Three
A NICE DILEMMA? by Margaret Williams
15 December 2008
ME/CFS in the US
In the Summer 2008 issue of The CFIDS Chronicle published by The CFIDS Association of America, Anthony Komaroff, Professor of Medicine at Harvard, editor-in-chief of Harvard Health Publications and senior physician at Brigham and Womens’ Hospital, Boston (who has published more than 230 research papers on ME/CFS) wrote an article listing the top ten biomedical research findings in ME/CFS.
These are summarised at http://www.prohealth.com/library/showarticle.cfm?libid=14063 and include evidence that
(1) many patients with ME/CFS have no diagnosable psychiatric disorder and that ME/CFS is not a form of depression;
(2) there is a state of chronic, low-grade immune activation, with evidence of activated T cells and evidence of genes reflecting immune activation, as well as evidence of increased levels of cytokines;
(3) there is substantial evidence of poorly-functioning NK cells (white blood cells that are important in fighting viral infections);
(4) there is evidence of white and grey matter abnormalities in the brain;
(5) there is evidence of abnormalities in brain metabolism (and evidence of dysfunction of energy metabolism in the mitochondria);
(6) there is evidence of abnormalities in the neuroendocrine system, particularly in the HPA axis but also in the hypothalamic-prolactin axis and in the hypothalamic-growth hormone axis;
(7) there is evidence of cognitive difficulties, especially with information processing, memory and/or attention;
(8) there is evidence of abnormalities in the autonomic nervous system (including a failure to maintain blood pressure, abnormal responses of the heart rate, and unusual pooling of blood in the legs, as well as low levels of blood volume);
(9) there is evidence of disordered gene expression, especially in those genes that are important in energy metabolism and in genes connected to HPA axis activity, to the sympathetic nervous system and to the immune system;
(10) there is evidence of frequent infection with viruses, especially herpesvirus and enteroviruses.
Former top ME/CFS researcher at the US Centres for Disease Control (CDC), Dr Suzanne Vernon, stated on 5th December 2008 that there are now more than 5,000 peer-reviewed articles in the biomedical literature that tell us a lot about the disrupted biology of ME/CFS, about what happens to the immune and endocrine systems and to the autonomic and central nervous systems
When asked why this information had not been harnessed, her reply was that there is no good reason why it has not been translated to the medical community, saying: “no-one is filling that gap between the bench research and the bedside”. She noted that ME/CFS is “ultimately described as immune dysregulation and neuroendocrine disturbance”. Dr Vernon stated that “infection is the key to initiating/triggering ME/CFS and the immune system is central to sustaining (it). Hormones are critical in modulating the immune response. A unifying theme is disturbed cell signalling and cell metabolism. We know that low cortisol occurs in some patients with ME/CFS. Cortisol is a critical molecule for regulating the HPA axis and is essential for modulating the immune response”.
The results of a new study by Courjaret et al are unambiguous and straightforward: “no direct relationship between the chronic fatigue syndrome and personality disorders was shown” (J Psychosom Res 2009:66:13-20).
ME/CFS in the UK
The Courjaret study will doubtless cut no ice with those who are committed ME/CFS deniers: on 12th March 2008, one such denier (Frank Furedi), in an item entitled “The seven deadly personality disorders” stated: “Sloth has been medicalised, too. The creation of such conditions as chronic fatigue syndrome invites people to make sense of their lassitude through a medical label”
As customary, when any biomedical aspects of ME/CFS are highlighted internationally, they fall on deaf ears in the UK, a case in point being the current issue of PULSE, which publishes the views of psychiatrist Dr Christopher Bass under the heading: “Need to know – somatoform disorders”. In his article, Bass specifically includes “CFS” as a somatoform disorder. PULSE is a medical trade magazine widely distributed throughout the NHS and Dr Bass is a liaison psychiatrist who, with Simon Wessely, worked at Kings College Hospital before moving to Oxford (another hotbed of ME denial, where psychiatrist Michael Sharpe worked before he moved to Edinburgh).
Bass makes unsubstantiated claims and he repeats, vacuously, the Wessely School mantra, for example: “A cognitive behavioural therapy approach is helpful in patients with somatoform disorders because it addresses the predisposing, precipitating and perpetuating factors. CBT has been shown in many (sic) trials to be helpful in patients with medically unexplained symptoms such as chronic fatigue syndrome. Most patients with medically unexplained symptoms lasting for more than six months will have a somatoform disorder. Psychiatrists tend to use terms such as somatoform disorders while GPs and non-psychiatrist physicians use terms like chronic fatigue syndrome. The official diagnostic criteria for somatoform disorders-which include hypochondriasis, recently renamed as health anxiety to reduce stigma — include symptoms that are caused or maintained by psychosocial factors”.
In his PULSE article, Bass states that CBT has been shown to be helpful in “many” trials in patients with “CFS”, but even NICE itself in its now infamous Guideline on “CFS/ME” (CG53) could find only five such trials and it is not difficult to demonstrate that those five trials were methodologically flawed, a fact acknowledged by the team at the Centre for Reviews and Dissemination (CRD) at York who actually carried out the systematic review of the literature specifically to support the work of NICE on “CFS/ME”.
CBT/GET does not prevent death from ME/CFS
There have been a number of high profile deaths from ME/CFS in the UK. There can be few in the international ME community who have forgotten the harrowing death three years ago of 32 year old Sophia Mirza, who was forcibly but illegally detained under the Mental Health Act and who subsequently died from ME/CFS and whose autopsy revealed severe inflammation of the dorsal roots in her spinal cord. These are the sensory nerve roots, so she must have been in considerable pain for many years.
The most recent death is that of Lynn Gilderdale who died on 4th December 2008 aged 31, having suffered extremely severe ME from the age of 14. Lynn had been on a very potent combination of opioid and neuropathic pain medication via a subcutaneous pump and, sadly, her mother was arrested on suspicion of murder, so although Lynn had made a Will stating her wishes that her organs and tissues should be used after her death, her mother was in police custody and was unable to ensure that Lynn’s wishes were carried out at the time. The only organ that was retrieved immediately after Lynn’s death was the brain, and this was sent to Kings College Hospital, London (where Simon Wessely works). This exceptionally tragic case gained much media coverage, not only in the UK but also in countries including South America, the Czech Republic; Spain, Belgium, CNN Europe and Croatia.
Other recent deaths include that of Sue Firth from Yorkshire, who left two teenage sons, and Nicola McNougher from Bromsgrove, who also left two young sons. Like Lynn Gilderdale and Mrs Firth, Mrs McNougher suffered from severe ME; she was unable to tolerate the degree of pain and illness, so she went to Switzerland and chose to end her life there. Notably, Mrs McNougher was a psychotherapist; as such, she would, one imagines, have had the insight to practice cognitive behavioural techniques to her own advantage – if, that is, such techniques actually work. The evidence is that they do not work.
If CBT is so successful, where, then, was the involvement of the Wessely School psychiatrists, especially Professors Simon Wessely and Peter White, and even Professor Bass himself, in these tragic cases? Peter White is on record as affirming that CBT/GET can cure “CFS/ME” (“Is full recovery possible after CBT for CFS?”; Hans Knoop, Peter White et al; Psychotherapy & Psychosomatics 2007:76:171-176). Professor Michael Sharpe is also on record as asserting: “There is evidence that psychiatric treatment can reduce disability in CFS. In some cases, it can be curative” (“Psychiatric Management of Post Viral Fatigue Syndrome”; Michael Sharpe; British Medical Bulletin 1991:47:4:989-1005) and Simon Wessely himself is also on record as confirming that significantly more patients met the criteria for full recovery and that: “seven (23%) of the CBT patients were deemed completely recovered” (“Long term outcome of cognitive behavioural therapy versus relaxation therapy for chronic fatigue syndrome: a five-year follow up study”; Deale A, Chalder T, Wessely S et al; Am J Psychiat 2001:158:2038-2042). For the record, that same year (2001) Wessely is also on record as stating that CBT is not “remotely curative” (Editorial; JAMA 19th September 2001:286:11). Wessely does not clarify how the same intervention can result in complete recovery even though it is not remotely curative.
None of these trials, of course, included anyone who was severely affected by ME/CFS; indeed, it is entirely possible that there was not a single patient with ME/CFS in any of those studies, since most of the trials used the Oxford criteria and those criteria expressly exclude people with neurological disorders but do specifically include those with psychiatric disorders (which often have “fatigue” as a problematic symptom).
NICE “Guidelines” are to become legally enforceable in 2009
In an attempt to justify its reliance on those few (and methodologically flawed) RCTs in its Guideline on “CFS/ME”, it is anticipated that on 11th and 12th February 2009 NICE will have to explain its reasons for doing so before a High Court Judge, more particularly so given the recent announcement that “GPs will have to prove they follow NICE Guidelines or face the possibility of suspension, prosecution or the closure of their practice. Baroness Young, chair of the Care Quality Commission, revealed that guidance from NICE would become legally enforceable from 2009, with doctors to face tough annual checks on their compliance. Baroness Young told last week’s NICE annual conference that policing clinical guidance was set to be a key part of the CQC’s work, and admitted the commission had been handed ‘draconian’ powers by Ministers” (PULSE: “Threat of legal action if GPs fail to follow NICE”; Nigel Praities; 11th December 2008).
Before it can start wielding these draconian powers in relation to ME/CFS patients, NICE may be required to explain to the satisfaction of the Judge why it relied upon an evidence-base of just one systematic review that comprised only 18 clinical trials, not all of which were random controlled trials (RCTs), of which just five were RCTs of CBT and a further five were RCTs of graded exercise therapy, making a grand total of just 10 RCTs, all on a patient base of just 1,448 patients who may or may not have had ME/CFS.
This should be compared with NICE’s Clinical Guideline on multiple sclerosis (CG8), which had an evidence-base that contained 80 systematic reviews of approximately 1,107 RCTs on a patient base of 89,230 MS patients. It will be recalled that the Government states there are 240,000 with “CFS/ME” in the UK, which far exceeds the number of people with MS.
Clearly there was insufficient evidence upon which to predicate a national Guideline for “CFS/ME”, so – according to the rules – NICE should have chosen the OIR option (Only in Research), which would have been the correct procedure for the Guideline Development Group (GDG) to have followed. It chose not to do so, thereby fuelling the perception that the GDG was intent on recommending CBT/GET whatever the evidence or lack of it.
Some failures by NICE to adhere to its own Guideline Development Manual
It is anticipated that NICE will also be required to explain to the Judge why it failed to adhere to its own Guideline Development Manual in the production of its Clinical Guideline 53 on “CFS/ME” in numerous other important areas.
For example, there was the unfortunate “misprint” in the printed version of the Questionnaire that respondent stakeholders were required to complete prior to the publication of the draft Guideline, a “misprint” that potentially skewed the answers to over one third of the questions in that the instructions were misleadingly worded and seemed deliberately ambiguous, even to a clear-thinking person, let alone an ME/CFS patients with cognitive difficulties. Perhaps expediently, the instructions for the following section (starting with question 62 and relating to “Behavioural Approaches”) changed – without guidance or notification – from choosing to tick “inappropriate” in the previous section to choosing to tick “appropriate” in that section.
Without having attention drawn to this important change, few people with cognitive problems such as are found in ME/CFS would have spotted this hurdle. When notified of this, respondents were given just two days by Nancy Turnbull to correct their responses (see email sent on 3rd May 2006 at 2.26pm from Nancy Turnbull to Participants), which was an impossibility, since many completed Questionnaires were likely to have been posted back by then. NICE did not seem concerned, but perhaps this was because the outcome was a forgone conclusion, so whatever information patients submitted was of little value to the GDG, who are on record as affirming that patients’ evidence was deemed to be “biased” (J Inf 2007: 55:6:569-571) and therefore of little value, which is in direct contradiction to the Expert Patient programme rolled out in 2001 by NICE’s own paymaster, the Department of Health, in which patients with long-term diseases are to be acknowledged as experts in their own conditions).
Then there was the curious matter of NICE quietly dropping the required second consultation on the draft Guideline; although NICE instituted a nominal “consultation” period (which for some reason was over the 2005/6 Christmas/New Year break) on their wish to drop the second consultation, many stakeholders were unaware of it, even though they were required to be notified of it by NICE. The Manual is unambiguous that Guidelines in preparation that were beyond a certain stage of development (as was the case with CG53) were to continue under the old rules (which stipulated not one but two consultations). This did not happen with CG53.
Introduction of “Consensus” for CG53