pdf 256 KB - ME Research UK


pdf 256 KB - ME Research UK

Unhelpful Counsel?MERGE’s response to the Chief MedicalOfficer’s Working Group report on CFS/MEApril 2002“Brutalised by their reception in doctors’ examining rooms, they ceasedconsulting doctors, preferring instead to wait out their disease awayfrom the medical profession’s unhelpful counsel.”Hillary Johnson, Osler’s WebMERGEME Research Group for Education and SupportThe Gateway, South Methven StreetPerth PH1 5PPScotland, UK01738 451234merge@pkavs.org.ukwww.meresearch.org.ukCharity No. 1080201

Preface by The Countess of MarThis document has been prepared by MERGE in response to the great interest awakened by the WorkingGroup’s report to the Chief Medical Officer on CFS/ME in January 2002. The CMO’s report has beenwidely seen as a positive step for ME patients in terms of the recognition of the illness and the need forthe provision of medical and social care. Yet, there are several aspects of the report which have been ofconcern, not only for ME patients and their carers, but also for independent professionals with an interestin social and medical policy. Following several representations and after careful consideration, a decisionwas made by MERGE to prepare a response highlighting these concerns while pointing out the positiveaspects of the report. At the back of our minds was the Joint Royal Colleges Report of 1996, a controversialdocument which went formally unchallenged though criticism was voiced in several quarters at the time.Given this example, it is important for MERGE to put on record in a formal document - if only forhistorical reasons - several of the key issues surrounding the deliberations and production of the WorkingGroup’s report.As patron of MERGE, it is a pleasure for me to endorse this analysis of the report on CFS/ME to theCMO. I hope that it gives voice and some hope to many ME patients, some of whom have mixed feelingsabout the recommendations in the report and others who are frankly antagonistic to the underlyingpsychological philosophy that coloured the deliberations of the Working Group.MERGE’s report formed a necessary background to my statement on CFS/ME in the House of Lordson Tuesday 16th April 2002. In this statement, I pointed out that despite the fine aspirations in the report,its effect might be to “compound inaction, ignorance and even denial: inaction in not investigating thepatient’s illness or not providing any treatment - management is not the same as treatment; ignorance bypromoting inappropriate and possibly harmful interventions; and denial of the true nature of ME.” Acontributor to the ensuing debate pointed out that in the three months since publication there “appears tohave been a deafening silence... I remind the Minister that that work was described as “urgent” by theWorking Group.”I sincerely hope that MERGE’s analysis will help to reawaken interest in the research and treatment of thisdisabling illness, and that the professional and wider communities will at last come to understand just howdisabling this illness is. Whilst treatment and cure might still be distant dreams for ME patients, I hopethere will be a rapid sea change in the public perception of ME, and that there will be encouragement andsupport rather than scorn and derision for ME sufferers.The Countess of Mar

ContentsExecutivecutive e Summary ........................................................................................................................... 41.The report t - backgrground and contentent ........................................................................................... 61.1 Background to the report .................................................................................................. 61.2 Content of the report ......................................................................................................... 6Chapter 2 - Evidence from patients: Key messages..................................................... 6Chapter 3 - Nature and impact of CFS/ME: Key messages ......................................... 7Chapter 4 - Management of CFS/ME: Key messages .................................................. 7Chapter 5 - Children and young people: Key messages .............................................. 7Chapter 6 - Recommendations of the Working Group ................................................. 82.Positivositive e aspects of the report......................................................................................................102.1 Recognition of CFS/ME as an illness ............................................................................. 102.2 Recognition that CFS/ME can be clinically diagnosed ................................................. 102.3 Importance of a positive diagnosis ................................................................................ 102.4 Need for action ................................................................................................................ 102.5 Estimation of prevalence and service need .................................................................. 102.6 Suggestions for best practice ......................................................................................... 112.7 Instruction to clinicians on patient management ......................................................... 112.8 Description of CFS/ME in children ................................................................................. 112.9 Recommendations to healthcare professionals about benefit provision .................... 112.10 Appropriate attitude for healthcare professionals ...................................................... 112.11 Importance of patient consent for management strategies ...................................... 122.12 Needs of the severest suffers ...................................................................................... 122.13 Voicing of patient and carer concerns ......................................................................... 122.14 Summary ........................................................................................................................ 133. Limitations of the report ............................................................................................................. 143.1 Constrained remit ............................................................................................................ 143.2 Unbalanced composition of the Working Group ............................................................ 143.3 Problem of diagnosis and use of the composite term CFS/ME ................................... 153.4 Choice and interpretation of best management strategies.......................................... 163.4.1 Cognitive behavioural therapy............................................................................ 173.4.2 Graded exercise therapy .................................................................................... 183.4.3 Pacing .................................................................................................................. 183.4.4 Conclusions about the choice of management strategies .............................. 193.5 Failure to highlight data on the most severely ill patients ............................................ 193.6 Undue prominence given to the ‘biopsychosocial’ model of the illness ...................... 203.7 Downgrading of relevant research findings ................................................................... 213.8 Inadequate coverage of social care and welfare issues ............................................... 223.9 Words are not action - will anything actually change? .................................................. 22End piece - Patient voices............................................................................................................... 24Refeferenceserences ....................................................................................................................................... 25Postscript by y MERGE....................................................................................................................... 27Appendix ........................................................................................................................................... 28

Executive SummaryThe report of the Chief Medical Officer’s Working Group on CFS/ME of January 2002 is an advance onthe widely-criticised Joint Royal Colleges report on CFS (1996). It gives an authoritative statement thatCFS/ME is a genuine illness which imposes a substantial burden on the health of the UK population, andstresses that improvement of health and social care for people affected by the condition is an urgentchallenge. Importantly, it states that CFS/ME can be clinically recognised for treatment purposes; lists theinitial battery of tests that should be performed; and is clear that inaction by healthcare professionals dueto ignorance or denial of the condition is not excusable. These, and many more, positive aspects of thereport represent progress in terms of recognition of the illness and its consequences. However, for avariety of reasons, the report is inadequate.Most importantly, the narrowness of the remit, concerned primarily with providing best practice guidance onthe healthcare management of the illness, has ensured that the focus is on containment and coping, rather thanon solving the clinical conundrum, namely, what actually causes the illness and what steps can be taken toelucidate the cause. The constraint of the remit has several important consequences, some of which arediscussed below.It has permitted the Working Group to side-step the central issue which energises every discussion aboutCFS/ME. This concerns the diagnostic construct ‘CFS’ which most probably includes heterogeneouspatient groups (one of them with classically-defined ME), limiting the generalisability of any specificmanagement strategy or therapeutic intervention. The question, “what’s in a name?”, has particularpoignancy in the case of this illness: one increasingly plausible answer is “everything” since de factomisdiagnosis not only complicates the interpretation of clinical trial evidence, but obscures treatmentoptions and, in the long run, influences management and practice for the worse. Given that there is agrowing number of experts who consider that there is a strong case for unpacking the term ‘CFS’ andreclassifying and renaming in accordance with more specific clinical criteria, a opportunity for the WorkingGroup to seriously address this issue has been lost.As the Working Group was concerned with therapeutic management, it sought evidence from a systematicreview of forty-four randomised clinical trials on a range of clinical interventions. Two clinical “therapeuticinterventions” were identified, cognitive behavioural therapy and graded exercise therapy. By conventionalstandards of literature reviewing, formal evidence for the use of either in a general patient population isrudimentary, a fact indicated by the authors of the original review. The specific efficacy of neither isconvincingly supported by the systematic review evidence, and nor is the pragmatic efficacy supported bysurvey reports from CFS/ME patients. As regards cognitive behavioural therapy, five interpretable trialswere identified (three “positive” and two “negative”), a less than conclusive evidence base for an interventionwhich is also non-curative, expensive, beyond the resources of Health Authorities to fund given the scaleof the problem, and has been found helpful by only a small minority of patients surveyed by patientorganisations. For graded exercise therapy, only three positive clinical trials were identified, none with afully comparable control group and all consisting of patients classified by the Oxford criteria which doesnot diagnose ‘ME’ or ‘CFS (1994)’ exclusively. Again, the true usefulness of this therapy to the generalpopulation of patients is unclear given that the effectiveness of such motivational interventions is by nomeans established; that deconditioning may not, in fact, be an important factor limiting the activities ofmany CFS/ME patients; and that around half of patients surveyed indicated that graded exercise therapyactually worsened their condition. The third recommended intervention, pacing, is intuitively sensible buthardly warrants the status of a separate therapy within a healthcare management program.

Despite part of the remit “to make recommendations for further research,” the Working Group has dealtwith the research findings in 639 words out of a total of some 34,600 in the main report. A large body ofresearch literature on CFS/ME exists, however, and numerous biological abnormalities have been reported,although the aetiology of the illness remains elusive. By systematically assessing the significance of these,the Working Group may have been able to recommend a specific direction for future research. Instead,the message presented to the media, the public, and opinion formers is that the best that can be done is tomanage symptoms, most prominently with psychological strategies. Interestingly, given the volume ofpublished research evidence on pathophysiological mechanisms, the range of clinical signs and symptomsexhibited by CFS/ME patients, and a large body of professional opinion supporting a ‘biomedical’ modelof the illness, it seems negligent that clinical opinion on the Working Group was proportionately overrepresentedby professionals who tend to subscribe to the the use of biopsychosocial interventions forCFS/ME. Since four of their number resigned from the Key Group shortly before publication, afterseveral years of participation, on the grounds that the report paid too little attention to biopsychosocialaspects of the illness, a question is raised about the role of the initial composition of the Working Groupin colouring the final report.At several points, the report mentions the problems of the most severely-ill patients. Yet, a database ofinformation collected and analysed on behalf of severely-ill sufferers by The 25% ME Group, presentedto the Working Group, was not used to full advantage in the final report, though other patient data wasproduced. MERGE’s summary of this data shows that 25% of these patients described themselves asbedridden, and 57% had been either housebound or bedridden for more than six years, illustrating innumbers rather than words that morbidity in CFS/ME can be substantial, despite the opinion of manyhealthcare professionals to the contrary. The management strategies recommended by the Working Groupare inappropriate for this group of sufferers whose care remains a neglected challenge.As regards social care, the Working Group set out to consider how the NHS might best provide care forsufferers. Yet, the NHS is only one agency among many providing care, and the responsibilities of otheragencies involved in both care planning and direct service provision could have been usefully identified.Overall, the comforting statements from the Working Group about the services CFS/ME sufferers shouldreceive in the community are little more than aspirations: without the full support and practical backing oflocal social work departments, sufferers will struggle to see their needs met either fully or appropriately.Importantly, the report does not describe how or when change is to occur. The Working Party had noexecutive power and brought no additional funding to stimulate change. Even in its advisory role, it doesnot evaluate the cost implications of its recommendations, call for directives to be issued to the varioushealth agencies or professional bodies, or propose any mechanism for checking that changes will be made.Crucially, it gives no indication that the illness will be looked at again, in the medium to long term, toassess whether real, meaningful change has come about.In summary, while the Working Group’s report may go some way towards improving recognition of theillness, MERGE considers that it has avoided serious consideration of the important issues surroundingthe diagnosis and treatment of ME/CFS; that it has given undue emphasis to management strategies oflimited applicability; that practical recommendations for social care provision are lacking; and that,consequently, an opportunity to effect real change has been lost.

1. The report - background andcontent1.1 Background to the reportIn 1998, after much debate, the Working Group onCFS/ME was established to “review the practical careand support for patients, carers, and health careprofessionals alike.” Its brief was to “review managementand practice in the field of CFS/ME with the aim ofproviding best practice guidance for professionals, patients,and carers to improve the quality of care and treatment forpeople with CFS/ME.” In particular, the Group aimed to:! develop good clinical practice guidance on thehealthcare management of CFS/ME for NHSprofessionals, using best available evidence,! make recommendations for further research into thecare and treatment of people with CFS/ME,! identify areas which might require further work, andmake recommendations to CMO.Evidence and opinions were sought from many quarters,and a systematic search of the international evidence onCFS/ME commissioned. Unlike previous reports, the focuswas “to provide advice on clinical management,” in accord withthe NHS Plan of July 2000 which strives to increase theinvolvement of public and patients by promoting selfmanagement, improved information to and communicationwith patients, and greater choice of healthcare options tosupport the concept of individualised care.The Working Group consisted of three groups: the KeyGroup which was responsible for surveying the evidence,developing the main report, and agreeing the finalrecommendations to the CMO; the Children’s and YoungPeople’s Group; and the Reference Group which had an adhoc advisory/consultative role, and whose members had awide range of expertise and opinion.1.2 Content of the reportThe report, published in January 2002, consists of sixchapters, of which chapters 2 to 5 form the policy-makinginformation. The original “key message” summary of eachchapter are given in the boxes below.Chapter 2 of the report summarises the patient evidencepresented to the Working Group. It covers the generalthemes of recognition, diagnosis, acknowledgement, andacceptance of CFS/ME by the public and healthcareprofessionals. It reports patient concerns about the needfor information, and the need for professional educationabout the condition among healthcare professionals, bothin the primary and further care sectors. It discusses thespecial needs and problems of people who are severelyaffected, of children and young people, and of carers:Chapter 2 - Evidence from patients:Key messages! Patients’ voices are not being listened to andunderstood.! People affected by CFS/ME indicatedimprovements needed in three main areas:recognition, diagnosis, acceptance, andacknowledgement; healthcare service provision;care of groups with special circumstances.! Patients reported the need for more healthcareprofessionals who know about and understandCFS/ME. Public awareness campaigns,professional education, and information forpatients and carers are accorded high priority.! Experiences of primary care are polarised.Positive experiences are characterised by:willingness of clinicians to treat the patient as anequal, supportive attitudes, belief in the patient’sexperiences, and early recognition and diagnosis.! Experiences of further care are predominantlynegative. Needs identified include access tospecialists and respite-care services.! Those severely affected by CFS/ME (up to 25%of patients) feel “severely overlooked” by services.They experience isolation, lack of understanding,and particular barriers to accessing all forms ofcare.! Children and young people are profoundlyaffected by public and professional uncertaintiesover the illness. Young people also suffer fromimpact on their families and from lack of supportand expertise within the education system.! Individuals with CFS/ME from disadvantagedclass or ethnic groups face special difficulties, yetthey are under-represented in research.! Carers, particularly of young people, need morerecognition, support, and respite.“Patients are not beinglistened to or understood.Those severely affected feelisolated and overlooked.”Chapter 3 describes the nature and impact of CFS/ME. Itoutlines the decision to use the term ‘CFS/ME’ in thereport, and summarises what is known about the aetiology,pathogenesis, and disease associations; predisposing factors;triggers; maintaining factors; and possible diseasemechanisms. It discusses the spectrum of illness, subgroups,symptom profiles, severity, and the socioeconomic impactof the illness:Unhelpful Counsel? MERGE’s response to the CMO report on CFS/ME 6

Chapter 3 - Nature and impact of CFS/ME:Key messages! CFS/ME is a relatively common condition ofadults and children that is clinically heterogeneousand lacks specific disease markers, but is clinicallyrecognisable.! The broader impact of the disease, even in itsmilder forms, can be extensive; people who areseverely affected and/or with long-standingdisease are profoundly compromised, andimprovement of their care is an urgent challenge.! The aetiology (cause) of CFS/ME is unclear,although several predisposing factors, diseasetriggers, and maintaining factors have beenidentified.! The pathogenesis (disease process) underlyingCFS/ME is also unclear. Research hasdemonstrated immune, endocrine,musculoskeletal, and neurological abnormalities,which could be either part of the primary diseaseprocess or secondary consequences.! One highly heterogeneous disease might exist thatencompasses CFS/ME, or several relatedpathophysiological entities may exist; thesedistinct hypotheses should be studied.! Current evidence does not allow completedistinction between CFS and ME, or usefuldelineation of subgroups. Every patient’sexperience is unique, and the illness should bemanaged individually and flexibly.frequently worsens fatigue, malaise, and othersymptoms with a characteristically delayed impact.! All patients need appropriate clinical evaluationand follow-up, ideally by a multidisciplinary team.Care is ideally delivered according to an agreedflexible management plan, tailored from agenerically applicable range of options.! Therapeutic strategies that can enableimprovement include graded exercise/activityprogrammes, cognitive behaviour therapy andpacing; intrusive symptoms and co-morbidconditions may also require specific management.! The overall aim of management must be tooptimise all aspects of care that could contributeto any natural recovery process. Managementstrategies need regular review to guide theirapplication and adaptation to the individual.! Education and support, plus measures to tacklethe broader impact of the disease, need to beinitiated as early as practicable. Much support isprovided by the voluntary sector. Patients can beempowered to act as partners in care.! Review of the evidence highlights the lack ofgood quality research to support effectiveness ofvarious therapies. Patient responses suggest thatno approach is universally beneficial and that allcan cause harm if applied incorrectly.! The goal of rehabilitation or re-enablement willoften be adjustment to the illness; improvementis possible with treatment in the majority ofpeople.Chapter 4 puts forward suggestions for the managementof CFS/ME, based on recognition, acknowledgement, andacceptance of the condition by healthcare professionals. Itsuggests approaches to patient management, diagnosis, andclinical evaluation. It stresses the need for information andsupport, and for systems to be put in place to facilitateongoing care. Controversially, on the basis of the YorkReview and clinical experience, it identifies graded exercise,cognitive behavioural therapy, and pacing as interventionsthat might be useful for patients. It also discusses modelsfor improved service provision:Chapter 4 - Management of CFS/ME:Key messages! Initial professional responses to CFS/ME canhave major impact on the patient and carers.Clinicians should listen to, understand, and helpthose affected to cope with the uncertaintysurrounding the illness.! Early recognition with an authoritative, positivediagnosis is key to improving outcomes.Symptoms are diverse, but increased activity“Early recognition withan authoritative, positivediagnosis is key.”Chapter 5 focuses on the nature and impact of CFS/MEin children and young people, its clinical profile, socialimpact, and management. It also discusses the importanceof education and child protection, and the impact onfamily/carers:Chapter 5 - Children and young people:Key messages! CFS/ME represents a substantial problem in theyoung - “children do get it,” though many recover,even after prolonged illness.! Important differences exist between children andadults in the nature and impact of the diseaseand its management.Unhelpful Counsel? MERGE’s response to the CMO report on CFS/ME 7

! The condition potentially threatens physical,emotional, and intellectual development ofchildren and young people, and can disrupteducation, and social and family life at aparticularly vulnerable time of life.! Clinicians face additional difficulties in supportingand managing the younger patients and theirfamilies and parents/carers.! An especially prompt and authoritative diagnosisis needed in the young, while the possibility ofother illnesses and complications must also remainin mind.! Ideal management is patient-centred, communitybased,multidisciplinary, and coordinated, withregular follow-up. Community paediatric servicesneed to be available for most children, and for allwith prolonged school absence.! The clinician who coordinates care needs toconsider educational needs and impact on thefamily and parents/carers as early as practicable.! Care is best delivered according to a specific,flexible, patient-focused treatment plan, designedand reviewed regularly with patient and family.! Future services need to be developed around theneeds of the child or young person and theirfamily.Chapter 6 presents the recommendations of the WorkingGroup, dealing with recognition and definition of the illness,treatment and care, health service planning, education andawareness, and research:Chapter 6 - Recommendations ofthe Working GroupCFS/ME is a relatively common clinical condition,which can cause profound, often prolonged, illnessand disability, and can have a very substantial impacton the individual and the family. It affects all agegroups, including children.The Working Group has encountered extensiveevidence on the extent of distress and disability thatthis condition causes to patients, carers, and families.It has examined the evidence on the effectiveness ofinterventions used in the management of thiscondition. The Working Group is concerned aboutseveral issues. Patients and carers often encounter alack of understanding from healthcare professionals.This lack seems to be associated with inadequateawareness and understanding of the illness amongmany health professionals and in the wider public.Many patients complain of the difficulty of obtaininga diagnosis in a timely manner. There is evidence ofunderprovision of treatment and care, with patchyand inconsistent service delivery and planning acrossthe country.Finally, there is a paucity of good research evidenceand very little research investment for a serious clinicalproblem that in likelihood has a pervasive impact onthe individual and the community. Insufficientattention has been paid to differential outcomes andtreatment responses in children and young adults, theseverely affected, cultural, ethnic and social classgroupings. The Working Group has identifiedmeasures that should be taken with some urgency toaddress the current situation.”6.1 Recognition and definition of the illness! The NHS and healthcare professionals shouldrecognise CFS/ME as a chronic illness that,despite uncertain aetiology, can affect people ofall ages to varying degrees, and in many casessubstantially.! In view of current dissatisfaction among somegroups over the nomenclature applied to thisillness, we recommend that the terminologyshould be reviewed, in concert with otherinternational work on this topic.6.2 Treatment and care! Patients of all ages with CFS/ME must receivecare and treatment commensurate with theirhealth needs and the disability resulting from theillness.! Healthcare professionals should have sufficientawareness, understanding, and knowledge of theillness to enable them to recognise, assess,manage, and support the patient with CFS/ME.Healthcare workers who feel they need extra skillsshould seek and receive help from thoseexperienced in this area.! General Practitioners should usually be able tomanage most cases in the community setting, butmust be able to refer patients for specialist opinionand advice where appropriate (e.g. because ofcomplexity in diagnosis and treatment).! CFS/ME of any severity in a child or youngperson – defined as of school age – is bestcoordinated by an appropriate specialist – usuallya paediatrician or sometimes a child psychiatrist– in concert with the GP and a paediatric orCAMHS multidisciplinary team.! Sufficient tertiary level specialists in CFS/MEshould be available to advise and supportcolleagues in primary and secondary care.! Management should be undertaken as apartnership with the patient, should be adaptedto their needs and circumstances, and should beapplied flexibly in the light of their clinical course.Unhelpful Counsel? MERGE’s response to the CMO report on CFS/ME 8

! The support of the patient with CFS/ME andthe management of the illness should usuallyextend to the patient’s carers and family.! Clinicians must give appropriate and clear advice,based on best national guidance, on the natureand impact of the illness to those involved inproviding or assessing the patient’s employment,education (primary, secondary, tertiary, and adult),social care, housing, benefits, insurance, andpensions.6.3 Health service planning! Service networks should be established to supportpatients in the primary care and communitysetting, to access when necessary the skills,experience, and resources of secondary andtertiary centres, incorporating the principles ofstepped care. Services should be configured sothat individual professionals and aspects of theservice can meet individual needs, particularly inthe transition from childhood to adult life.! Health service commissioning through primarycare organisations, supported by health authoritiesor wider consortia, must ensure that localprovision for these patients is explicitly plannedand properly resourced, and that healthprofessionals are aware of the structure and localeof provision. Health commissioners should berequested to take immediate steps to identify thecurrent level of service provision for CFS/MEpatients within their locality.! Each Strategic Health Authority should makeprovision for secondary and tertiary care forpeople with CFS/ME, based on an estimatedannual prevalence rate of approximately 4,000cases per million population in the absence ofmore refined data.! People who are so severely affected that theirdisability renders them housebound or bed-boundhave particular constraints in regard to their accessto care. These specific needs must be met throughappropriate domiciliary services.! The NHS should make use of the wide range ofsupport and resources available throughpartnership arrangements with voluntaryagencies, enabling suitable self-management bythe patient.6.4 Education and awareness! The education and training of doctors, nurses,and other healthcare professionals should includeCFS/ME, as an example of the wider impact ofchronic illness on the patient, on carers and family,and on many aspects of society.! Healthcare professionals, especially in primarycare and medical specialities, should receivepostgraduate education and training so that theycan contribute appropriately and effectively to themanagement of patients with CFS/ME of allages.! GPs and medical specialists should consider CFS/ME as a differential diagnosis in appropriatepatients, and should at least be able to offer initialbasic guidance after diagnosing this condition(Annexes 6 and 7).! Awareness and understanding of the illness needsto be increased among the general public, andthrough schools, the media, employers, agencies,and government departments.6.5 ResearchA programme of research on all aspects of CFS/ME is required. Government investment in researchon CFS/ME should encompass health-servicesresearch, epidemiology, behavioural and socialscience, clinical research and trials, and basic science.In particular, research is urgently needed to:! Elucidate the aetiology and pathogenesis ofCFS/ME,! Clarify its epidemiology and natural history,! Characterise its spectrum and/or subgroups(including age-related subgroups),! Assess a wide range of potential therapeuticinterventions including symptom controlmeasures,! Define appropriate outcome measures for clinicaland research purposes, and! Investigate the effectiveness and costeffectivenessof different models of care.The research programme should include a mix ofcommissioned or directed research alongsidesufficient resource allocation for investigatorgeneratedstudies on the condition.The report also contains seven annexes containing evidencepresented to the committee. These comprise:1. Epidemiology2. Prognosis3. Patient evidence4. General concepts and philosophy of disease5. Management of CFS/ME - research evidence6. Management of CFS/ME - report summary7. Management of CFS/ME - children and youngpersons’ summary.Annexes 1 to 5 have not been published but are available atwww.doh.gov.uk/cmo/publications.htm. Annexes 6 and 7have been published as a separate document.Unhelpful Counsel? MERGE’s response to the CMO report on CFS/ME 9

2. Positive aspects of the reportSince the publication of the heavily-criticised 1996 JointRoyal Colleges report on CFS, there has been a black holein the professional and public recognition of the illness.The CMO report advances current thinking in several keyaspects.2.1 Recognition of CFS/ME as an illnessThe report gives an authoritative statement that CFS/MEis a real illness which requires professional help, and hasparticular problems owing to the controversy whichsurrounds it. It consolidates the acceptance of the disorderpreviously expressed by the Departments of Health andSocial Security and by the BMA as long ago as 1988:“CFS/ME is a genuine illness and imposes a substantialburden on the health of the UK population. Improvementof health and social care for people affected by the conditionis an urgent challenge.” (1.0)“Patients, their carers, and healthcare professionalsencounter different levels and varying manifestations ofdisbelief and prejudice against people affected by thecondition.” (1.0)“CFS/ME is a genuineillness. It should cease tobe a waste bucket forheart-sink patients”2.2 Recognition that CFS/ME can beclinically diagnosedThe report makes it clear that CFS/ME can be clinicallyrecognised for management purposes, and lists in Annex 6the clinical assessment investigations that should beperformed. These include:! Full clinical history! Physical examination! Mental health evaluation! Sleep evaluation! Basic screening tests, which can involve- Full blood count- C-reactive protein (CRP) concentration- Blood biochemistry tests including concentrationsof creatinine, urea, electrolytes, calcium, phosphate,glucose, liver enzymes, and markers of thyroidfunction! Simple urine analysis! Other tests determined by history or examinationThe diagnosis is based on the characteristic pattern ofsymptoms, once alternative diagnoses are excluded.“Although the disorder is clinically recognisable, CFS/MEassumes many different clinical forms and is highly variablein severity and duration, but lacks specific disease markers.”(3.0)2.3 Importance of a positive diagnosisThe report stresses that CFS/ME should cease to be a wastebucket for ‘heart-sink’ patients.“A diagnosis of CFS/ME relies on the presence of a set ofcharacteristic symptoms together with the exclusion ofalternative diagnoses.” (“A positive diagnosis of CFS/ME is needed, rather thanone of exclusion. Without a validated test for the illness,diagnosis is based on recognition of the typical symptompattern together with exclusion of alternative conditions.Thus, a positive diagnosis can usually be made from clinicalhistory, examination, and a few appropriate laboratoryinvestigations, as in other chronic illnesses of uncertainnature.” (4.2.1)2.4 Need for actionThe clear emphasis on the need for health and social careprovision in CFS/ME is perhaps the most important thrustof the report.“Appropriate management and service provision forpatients with CFS/ME and their carers are urgentpriorities.” (4.0)In the view of the report, ‘action’ includes further research,especially concerning the severely affected.“We suggest that the prevalence and impact of severedisease, the pathways to chronicity and to becoming severelyaffected, and strategies that would benefit such individualsurgently need further study.” (4.4.1)2.5 Estimation of prevalence andservice needGiven the wide variation in estimates of prevalence – partlya function of differences in case definition – the reportcomes up with a sensible estimate:“On the basis of a reasonable estimate of adult populationprevalence of 0.4%, a general practice with a populationof 10,000 patients is likely to have 30 to 40 patients withCFS/ME, about half of whom may need input fromservices. The proportion of the latter patients who areseverely affected by the disease is thought to be up to 25%.”(4.5.1)Unhelpful Counsel? MERGE’s response to the CMO report on CFS/ME 10

2.6 Suggestions for best practiceAt present, there are no guidelines on what clinicians shoulddo with CFS/ME patients. The report has attempted to fillthis gap.“The incremental development of a locally based service,including provision of domiciliary care for severely affectedpatients, would significantly improve care for all patientswith CFS/ME, but especially for this most disadvantagedof patient groups. The general components of such aservice are: medical care, support for adjustment and coping,facilities for energy/activity management, and nursing andpersonal care.” (4.5.2)2.7 Instruction to clinicians on patientmanagementIn contrast with sensational media reports about the benefitsof cognitive behavioural therapy and graded exercise, thereport is clear about the limitations of current managementstrategies:“No management approach to CFS/ME has been founduniversally beneficial, and none can be considered a cure.”(4.1.2)Chapter 4 of the report details the general principles andsome specific advice for management of the condition byGPs and healthcare professionals. Its key messages areimportant and are worth restating:! Initial professional responses to CFS/ME can havemajor impact on the patient and carers. Clinicians shouldlisten to, understand, and help those affected to copewith the uncertainty surrounding the illness.! Early recognition with an authoritative, positivediagnosis is key to improving outcomes. Symptoms arediverse, but increased activity invariably worsens fatigue,malaise, and other symptoms with a characteristicallydelayed impact.! All patients need appropriate clinical evaluation andfollow-up, ideally by a multidisciplinary team... Theoverall aim of management must be to optimise allaspects of care that could contribute to any naturalrecovery process... Patients can be empowered to act aspartners in care.! Although care packages need to be individually tailored,where appropriate they should include visits fromprimary care teams, and assessment and provision ofequipment practical assistance. (4.1.2)2.8 Description of CFS/ME in childrenThe section of the report dealing with children and youngpeople with CFS/ME is particularly well-written. There isa clear description of the impact of the illness on the child,the family, and the community. The development of anintegrated and multidisciplinary package of services isrecommended as a matter of urgency, and the statementof rights is particularly welcome:“Children’s rights are safeguarded by UN convention andneed to be respected at all times by professionals andparents/carers. The rights to be heard, to have their viewstaken into account, to access quality medical treatment, andto be protected from abuse both by individuals and bysystems need particular attention.” (5.0)2.9 Recommendations to healthcareprofessionals about benefit provisionThe report encourages healthcare professionals to besensitive about their role as facilitators of welfare provisions:“Negotiations with insurance companies and theDepartment of Social Security about proportional andrehabilitation benefits and therapeutic work can improveoutcomes, and health professionals have an important roleto play by providing support and advice in thesenegotiations. The same level of understanding needs to beshown by medical advisors to insurance companies and theBenefits Agency about the condition, its natural course,prognosis, and range of available approaches to recovery.”(4.4.5)“It is not appropriate that participation in a particulartreatment regimen is made an absolute condition forcontinuation of sickness/disability payments.” (4.4.2)“No management approachhas been found universallybeneficial.”2.10 Appropriate attitude for healthcareprofessionalsThere are also some clear warnings for healthcareprofessionals:“Healthcare professionals should adopt an understandingattitude and should not get into disputes with patients aboutwhat to call the illness, or about the belief that it doesn’texist.” (4.1.1)“Treatment should always be a collaboration between thepatient and the clinician, and not something imposed. Goodcommunication and a good therapeutic relationship canmake an appreciable difference.” (4.4)“...our conclusion is that clinicians need to apply currentknowledge despite the remaining uncertainty [about diseasecause or process]; inaction due to ignorance or denial of the conditionis not excusable.” (4.1)Unhelpful Counsel? MERGE’s response to the CMO report on CFS/ME 11

“CFS/ME should be treated in the same way as any otherchronic illness of unknown aetiology. The aim is to developa supportive relationship, and provide information andeducation to assist the patient, families, and carers towardsself management with support.” (4.1.2)“All interventions need to be administered with thoughtand care, and in accordance with revised Department ofHealth recommendations on informed consent.” (4.4.2)2.11 Importance of patient consent formanagement strategiesThe need for the active consent of patients to therapeuticinterventions is stressed at various points in the report.“The decision to recommend a particular approach is bestguided by the individual’s illness and circumstances.”“The content and development of any such approachshould be mutually agreed by both clinician and patientand informed by up-to-date specialist knowledge.”“It is not appropriate that participation in a particulartreatment regimen is made an absolute condition forcontinuation of sickness/disability payments.” (4.4.2)“Management strategies supervised by a therapist, includingactivity management, cognitive behavioural therapy, and soon, can be beneficial, provided that they are agreed and viewedas a partnership.” (4.1.2)2.12 Needs of the severest suffersOne welcome note in the report is the recognition of theparticular needs of severest sufferers. While the WorkingGroup chose not to highlight valid data collected by the25% ME group, which represents the severest sufferers, inthe final report, it nevertheless seems to have recognisedthe plight of these patients.“A minority of those with CFS/ME remain permanentlyseverely disabled and dependent on others... Currentprovision of services falls well below what is needed forthe vast majority of severely and very severely affectedpatients... Yet, even if we lack easy solutions, professionalscan still support, care, and provide for many patients’ needsby reaching such patients in their homes, maintainingcontact, and continually exploring potential options.”(“In general, this group is excluded from research, so theymay not fulfil criteria used to test evidence-basedapproaches. For example, many comment on theinappropriateness of extreme exercise regimens that havebeen studied in less adversely affected patients... Care is anurgent challenge that must be addressed in appropriate andimaginative ways, drawing from service models applied toother severe chronic disabilities.” (4.4.1)“The Working Group is concerned that it is necessary tomake these points [about severity and its consequences]for CFS/ME, when such considerations are self-evidentand part of usual clinical practice for other disorders thatare better recognised.” (3.4.3)“In many chronic illnesses, daily functioning, includingmobility, cooking, cleaning, dressing, personal care, andsocial support, can be improved dramatically by sympatheticprovision of appropriate practical assistance.” (4.3.3)“Inaction due to ignoranceor denial is not excusable.”2.13 Voicing of patient and carerconcernsUse of patient voice throughout the report strengthens thenarrative. They give voice to the patient concerns, and -importantly - justification to the antipathy towards healthprofessionals felt by many people with CFS/ME. The chiefpoints arising from the patient voices are poor recognitionof CFS/MEor by professionals, difficulties that arise overdiagnosis, and lack of professional and public acceptanceand acknowledgement.“Participants felt that the widespread lack of understandingof the condition is not specific to clinicians but includesother healthcare and social care professionals. This lack ofknowledge was identified by the majority of those consulted,together with a lack of communication and advice, especiallyin the early stages, on how to cope in general with longtermillness for families and sufferers.” (2.2.2)“There is evidence that some patients ‘fight’ for referrals,and in general GPs are confused over where to referpatients... The overall experience of specialist and hospitalservices among participants was predominantly negative...Some patients find themselves in geographical ‘black holes’that lack specialist provision.” (2.2.4)“Severely ill are severely overlooked; just ignored andinvisible... Some report that they want to believe doctorsand feel ‘frightened to say no’ or that they do not have theenergy to disagree. Fears were also expressed over: being‘branded’ as a ‘difficult patient’, losing benefits, lettingpeople down, not trying, losing the love of the family, andbeing labelled as mentally ill.” (“Some carers were clearly distressed about being ignoredby GPs, and some reported unpleasant behaviour.” (2.3.4)“A proportion of patients feel alienated from clinicalprofessionals by early responses to their symptoms, illnessexperience, and disability.” (3.5.2)“People with CFS/ME frequently experience problems withaccessing state benefits.” (3.5.1)Unhelpful Counsel? MERGE’s response to the CMO report on CFS/ME 12

2.14 SummaryThe positive aspects of the report listed above representan advance in terms of recognition of the illness and itsconsequences. Sufferers and their carers can now state, notonly that CFS/ME is a genuine illness which can be clinicallydiagnosed, but that the elements of best practice andmanagement have been sketched out and that inaction byhealthcare professionals due to ignorance or denial of thecondition is not excusable.However, the report does not describe how or when changeis to occur. It does not describe the cost implications, itdoes not call for directives to be issued to the various healthagencies or professional bodies, and it does not proposeany mechanism for checking that changes will be made.Crucially, it gives no indication that the illness will be lookedat again in the medium to long term, to assess whether real,meaningful change has come about.Unhelpful Counsel? MERGE’s response to the CMO report on CFS/ME 13

3. Limitations of the reportThe positive aspects of the report listed in Section 2 concernthe recognition of ME and the need for illness managementin a variety of forms. However, the report has limitations.Some, such as the constrained remit, are obvious, but othersare apparent only to those au fait with the issues, whetherthe research evidence or the deliberations of the WorkingParty.3.1 Constrained remitThe report describes its own remit clearly:“To review management and practice in the field ofCFS/ME with the aim of providing best practice guidancefor professionals, patients, and carers, to improve the qualityof care and treatment for people with CFS/ME, inparticular to: develop good clinical practice guidance onthe healthcare management of CFS/ME for NHSprofessionals, using best available evidence; makerecommendations for further research into the care andtreatment of people with CFS/ME; identify areas whichmight require further work and make recommendations toCMO.” (1.1)Given the controversy surrounding the illness, this remitseems primarily designed to contain and manage the clinicalproblem. By concentrating principally on management and‘guidance’, the report has ensured that the focus is oncontainment and coping, rather than on addressing theclinical conundrum of causation. Though the cause ofCFS/ME has yet to be elucidated, it is important to considerthe various possibilities at length within the context ofmanagement options. The narrow focus also neatlysidesteps the problem of the preference of some cliniciansfor the umbrella term ‘CFS’, obscuring specific diagnosisand possibly, in the long run, influencing management andpractice for the worse.The result is that the Working Group has taken three yearsto uncover the obvious - that, for a variety of reasons, theavailable ‘management strategies’ are cognitive behaviouraltherapy and graded exercise therapy, both with a very weakand rudimentary evidence base (Whiting et al, 2001), and‘pacing’, which is little more than a commonsense approachto physiological limitation. Welcome though recognition ofthe illness is, we should not forget that for patients andcarers little if anything has changed, or probably will change,as a consequence of developing ‘best practice guidance’.3.2 Unbalanced composition of theWorking GroupThe final Working Group consisted of Professor AllenHutchinson (Chair), Dept. of Public Health, Sheffield;Professor Anthony J Pinching (Deputy Chair), Dept. ofHuman Science and Medical Ethics, St Bartholomew’sHospital, London; Dr Tim Chambers (Chair of theChildren’s sub-group), Southmead Hospital, Bristol; andthree groups – the Key Group (responsible for surveyingthe evidence, developing the main report, and agreeing thefinal recommendations to the CMO), the Children’s andYoung People’s Group, and the Reference Group (with anad hoc advisory/consultative role). The Report also concedesthe input of un-named others not included in the abovegroups. The breakdown of the Working Group byprofessional interest is shown in Table 1 below. Due to amisprint in the final CMO report (page 72), the membersof the Children’s Group are designated as “Key GroupObservers”, though the existence of the Children’s Groupis mentioned at several points in the text. Table 1, however,shows the composition of both groups.Table 1. . Composition of the Wororking Group- excluding the Chair and Deputy Chair -by y profofessional interest at September ember 2001Key y groupChildren’s groupPatientrepresentativeses 3 (2*) 1Carers 1 2Representativepresentativesesof ME associations 3 4GPs 1 0Psychiatrists/psychologists3 (3*) 1 (1*)Public healthspecialists 2 (1*) 0Paediatricians0 3Nururses0 1Council/NHS 0 1(*In parentheses are the numbers of this professionalinterest group who refused to endorse the final WorkingGroup report in January 2002. Four of these wereprofessionals with an affiliation to psychiatry/psychology, one was a consultant in Public HealthMedicine, and two were patient representatives.)Given the range of clinical signs and symptoms exhibitedby CFS/ME patients, the volume of published researchevidence on pathophysiological mechanisms, and a largebody of professional opinion supporting a ‘biomedical’model of the illness, it seems negligent that three of theclinicians on the Key Group should have been psychiatrists/psychologists and that four should have been co-authorsof scientific papers supporting the use of biopsychosocialinterventions for CFS/ME. Interestingly, the Deputy Chairof the Working Group in a recent paper (Pinching, 2000)Unhelpful Counsel? MERGE’s response to the CMO report on CFS/ME 14

advocated the use of the management strategies - cognitivebehavioural therapy and graded exercise - finally identifiedas the therapeutic interventions of choice by the WorkingGroup. The composition of the Children’s Group was lessskewed towards the psychiatric or the psychological, bothof which are generally recognised to be far less appropriatemodels in children.In total, six members (46%) of the Key Group refused toendorse the final report, a remarkable attrition rate for aWorking Group reporting to the Chief Medical Officer ofEngland. The four professional resigners from the KeyGroup argued that the report paid too little attention tobiopsychosocial aspects (Clark et al, 2002). In HospitalDoctor, 17th Jan 2002, one of them, Dr Alison Round,was reported as saying that the report neglected the“biopsychosocial” aspects of the illness. Another, Dr PeterWhite, was reported to say, “All the evidence taken togethersuggests that the condition is biopsychosocial - both physicaland mental factors are involved.” This kerfuffle has notbeen universally welcomed: in a recent debate on CFS/MEin the House of Lords, Lord Clement-Jones said, “Somerecent articles written by doctors in the wake of the reportare absolutely disgraceful and ignorant. I feel strongly aboutsome of those reactive reports” (Hansard, 2002). Patientsand carers can only speculate on the kind of report thatmight have emerged (and the different emphases that mighthave been placed on psychological strategies) if theseprofessionals had ‘resigned’ at the beginning of the processrather than at the end. As a patient said wistfully, “After allthat... it’s like cuckoos leaving their trademarks but not theirsignatures.”3.3 Problem of diagnosis and use of thecomposite term CFS/METerminology is the ‘hot’ issue in ME and CFS: it energisesthe debate between patients and healthcare professionals,particularly psychiatrists. It also impacts on patientmanagement and clinical practice since the results of clinicaltrials are determined by entrance criteria used to recruitpatients to them.The issue can be simply put. The original case descriptionof the illness, ‘ME’ (Acheson, 1959; Dowsett et al, 1990)described a condition, commonly of infectious onset,characterised by:! Exercise-induced fatigue precipitated by trivial exertion(physical or mental).! Neurological disturbance, especially of cognitive,autonomic, and sensory functions. This could includeimpairment of short-term memory and loss of powersof concentration, usually coupled with emotional lability,nominal dysphasia, disturbed sleep patterns,dysequilibrium and/or tinnitus.! An extended and relapsing course with fluctuation ofsymptoms, usually precipitated by either physical ormental exercise; typically, the symptoms varycapriciously from hour-to-hour and day-to-day withvarying involvement of the cardiac, gastro-intestinal,and lymphoid systems.Since the late 1980s, however, the medical profession hasbeen urged by some of its members to adopt the termChronic Fatigue Syndrome (CFS), a more wide-rangingdiagnostic category which includes patients whose dominantsymptom is medically unexplained, on-going, or chronicfatigue (in conjunction with several other physical orpsychological symptoms) who would not necessarily fulfilthe criteria for ME.There are now several definitions of CFS. In the USA, the1994 CDC case-definition of CFS is currently utilised(Fukuda et al, 1994), supplanting its predecessor, the 1988CDC criteria, and has similarities with - but is not identicalto - the classical description of ME. However, in the UK, afrequently-used case definition is the ‘Oxford criteria’ whichincludes patients with no physical signs and inadvertentlyselects subgroups of patients with high levels of psychiatricdiagnoses (Katon & Russo, 1992; Freiberg, 1999). Thesedefinitions have been used to recruit to randomised clinicaltrials, including some of the trials of ‘psychological’interventions, cognitive behavioural therapy, and gradedexercise therapy, which form the basis of the managementstrategies uncovered by the Working Group report. Sincethe adoption of a particular case-definition of CFS willgreatly influence the outcome of particular studies, it isperhaps no surprise that psychiatric research groupsresearching biopsychosocial strategies in these patientsshould find some encouraging results. However, as manypatients and carers in CFS/ME support groups in the UKinvariably point out:! Fatigue is not their primary problem: musculoskeletalpain and post-exertional myalgia along with otherphysical signs are far more prominent, correspondingmore closely to the classical definition of ME.! The World Health Organisation InternationalClassification of Diseases (ICD) has, since 1969,classified ME separately as a neurological problem (ICD10 93.3), with ‘CFS’ incorporated into the current ICDas a sometime synonym for ME. The chronic fatiguestates per se are listed under mental and behaviouraldisorders (F 48.0), a category which specificallyexcludes ME/PVFS/CFS.For these reasons, many CFS/ME patients - particularlythe most severely affected - resent being provided with noncurativecoping strategies, such as cognitive behaviouraltherapy, by healthcare workers who have no interest in theirparticular symptom complex. In this, they are supportedUnhelpful Counsel? MERGE’s response to the CMO report on CFS/ME 15

y a growing number of experts who consider that there isa strong, perhaps overwhelming, case for unpacking theterm ‘CFS’ and reclassifying and renaming in accordancewith more specific clinical criteria (De Becker et al, 2001;Tan et al, 2002), such as the criteria for ME described above.The report alludes to the problem:“The issue of subgroups or discrete entities within CFS/MEwas the subject of much debate by the Working Group. Weare conscious that some sectors strongly hold the view thatthe term ME defines a subgroup within CFS, or even adistinct condition. The Working Group accepts that somepatients’ presentation and symptoms align more closely tothe original clinical description of ME.” (3.4.1)To complete its task, the Working Group side-stepped theissue:“We recognise that no current terminology is satisfactory,so in line with our original terms of reference [MERGE emphasis]we have used the composite CFS/ME for the purposes ofthis report, acknowledging that CFS is widely used amongclinicians and ME among patients and the community.” (3.2)“For how much longerwill anomalies innomenclature complicateand obscure clinical care?”The issues surrounding the establishment of CFS as adiagnostic category, and the inaccurate and biasedcharacterisations of CFS that have subsequently arisen, havebeen well reviewed by Jason et al (1997):“Over the past ten years, a series of key decisionswere made concerning the criteria for CFS diagnosisand the selection of psychiatric instruments, whichscored CFS symptoms as medical or psychiatricproblems. At least some of these decisions may havebeen formulated within a societal and political contextin which CFS was assumed to be a psychologicallydetermined problem (Manu et al. 1988). Manyphysicians and researchers believed that CFS wassimilar to neurasthenia and that CFS would eventuallyhave a similar fate once people recognised that mostpatients with this disease were really suffering from apsychiatric illness. Psychiatrists and physicians havealso regarded fatigue as one of the least importantof presenting symptoms (Lewis & Wessely, 1992).These biases have been filtered to the media, whichhas portrayed CFS in simplistic and stereotypic ways...One major consequence is that many CFS patientsfeel dissatisfied with their medical care... and havegone outside traditional medicine to be treated fortheir illness...“A significant complicating factor in understandingthe dynamics of this illness is that there are probablydifferent types of illnesses now contained within theCFS construct... We believe that it is crucial for CFSresearch to move beyond fuzzy recapitulations of theneurasthenia concept and clearly delineate precisecriteria for diagnosing pure CFS and CFS that iscomorbid with psychiatric disorders. It is alsonecessary to better differentiate CFS from otherdisorders which share some CFS symptoms but arenot true CFS cases.”One of the most poignant sentences in the report is:“The severely ill reflected strong loathing of the name CFSbecause fatigue is often not perceived to be their mainproblem; ME is a preferred term by many.” ( these and other patients, the question is how muchlonger anomalies in nomenclature will be allowed tocomplicate and obscure clinical care. Given that the term‘CFS’ most probably groups different kinds of patientsunder one umbrella, management recommendations arelikely to be inadequate and probably misleading.3.4 Choice and interpretation of bestmanagement strategiesIt is important to realise that the Working Group wasempowered to identify evidence for “managementstrategies” not treatments, since it is clear that none of theforty-four randomised clinical trials found and reviewed(Whiting et al, 2001) supplies convincing evidence oftreatment efficacy for a specific symptom or condition. Atfirst sight, the process of identification of ‘useful’management strategies appears clear:“Where research evidence exists we have been guided byit. (1.0) ...We used a trident approach to review andsynthesise three lines of evidence: research findings, patientreports, and clinical opinion... Members of the WorkingGroup expressed widely differing opinions on the potentialbenefits and disadvantages of these approaches. However,we agreed that all could be considered as managementoptions in line with general principles outlined here... TheWorking Group agreed that there is no cure for CFS/MEbut identified three specific strategies as potentiallybeneficial in modifying the illness: graded exercise, cognitivebehavioural therapy, and pacing.” (4.4.2)Though the report contains several caveats about all three‘management strategies’ - perhaps as a sop to the nonbiopsychosocialopinion on the committee (i.e., patientsand carers) - it is the choice of these which, in the end,provides justification for the existence of the WorkingGroup and the money spent (including that provided bythe Linbury Trust) on the CMO report. Yet how each ofUnhelpful Counsel? MERGE’s response to the CMO report on CFS/ME 16

the three strategies was determined to be “potentiallybeneficial” is not as clear as it might appear. As regards thepublished evidence, the thorough review by Whiting et al(2001) state that it is very difficult to draw overallconclusions (from the forty-four randomised clinical trials)since very little information is available on baselinefunctioning. Most of the interventions were evaluated inonly one or two studies, so the validity of generalising thefindings is limited. Since there are few patient reportsfavouring cognitive behavioural therapy, and a sizeableproportion of patients feel that graded exercise therapyworsens their condition, the inference must be that themajor recommendation for the use of cognitive behaviouraltherapy and graded exercise therapy was clinical opinion, theonly other source of evidence left to the Working Group.If this is the case, then the professional composition ofthe Key Group was the crucial factor in determining thestrength of recommendation for particular “potentiallybeneficial” management strategies.It is also important to realise that research funding is criticalto whether or not evidence is available. There are indicationsthat psychiatric and psychological research groupsconducting trials of cognitive behavioural therapy andgraded exercise therapy have been particularly well funded(Abbot & Spence, 2002); hence, the forty-four trials availablefor analysis by Whiting et al (2001). This funding bias isitself worthy of examination as it informs us that theresearch agenda in CFS/ME has been driven, in the main,by a relatively small number of clinicians with a professionalinterest in exploring biopsychosocial models of illness.These clinicians were proportionately well-representedwithin the Working Group.3.4.1 Cognitive behavioural therapyThe issues surrounding the true usefulness of cognitivebehavioural therapy for CFS/ME patients have been widelydiscussed (e.g. Lancet 2001; 358: 239-41) but can besummarised as follows:! Of the forty-four randomised clinical trials identified,only five involved some variant of cognitive behaviouraltherapy, and of these, three had a ‘positive’ result andtwo a ‘negative’ result.! Two of these trials used the Oxford criteria whichgreatly limits the applicability of the findings as far asME and CDC-defined ‘CFS’ is concerned.! Dropout rates were high - 40% in the active arm (vs.20% in the control) of the flagship trial on cognitivebehavioural therapy by Prins et al (2000). As Whiting etal (2001) state in their review: “Dropout rates may bean indication of the acceptability of an intervention”and “cognitive behavioural therapy may be acceptableto only a small number of patients, limitinggeneralisability.”! As is the case with most clinical trials, the results cannotbe extrapolated to apply to the most severely ill (up to25% in CFS/ME), nor to children or young people. Bothcategories having been excluded from these trials.! While cognitive behavioural therapy most likely hassome role in helping some patients to better cope withtheir symptoms until a cure is found, this role is limited(as it would be with cancer patients) and non-curative.! Cognitive behavioural therapy is expensive and, withsuch a variable outcome, the cost-benefit ratio isproblematic.! As well as the limitations of the clinical trials in CFS/MEpatients, there are doubts even among professionalsabout the specific efficacy of cognitive behaviouraltherapy. As a recent review commented: “...thefoundations on which it rests are not as secure as someof its proponents would have us believe.” (Holmes,2002).“The foundations ofcognitive behaviouraltherapy are not as secureas its proponents suggest.”Though the CMO report states that “application of acognitive behavioural model to CFS/ME has been foundsuccessful in most patients in the trials” (, this baldstatement is almost certainly untrue: of five randomisedcontrolled trials, two were negative, dropouts were high,and some ‘improvements’ were seen in the control groups,indicating that not all improvement can be ascribed to CBT.The same section of the report contains a remarkablestatement:“The Working Group accepts that appropriatelyadministered cognitive behavioural therapy can improvefunctioning in most patients with CFS/ME who attend adultoutpatient clinics.” ( is a masterful piece of drafting which skilfully suggestsgreat benefits of cognitive behavioural therapy while leavingseveral exits in case of attack. What is “appropriatelyadministered” cognitive behavioural therapy? What aspectof ‘functioning’ is meant? How can the Working Groupaccept that ‘most’ patients improve on the basis of theextrapolation of the results of three positive and twonegative trials to the whole population of CFS/ME patientsin the UK?There are several quotations in the report which - probablyunwittingly - go to the heart of the matter:“Cognitive behavioural therapy for people with CFS/MEis currently unavailable or very difficult to obtain in muchof the UK.” (“There was disagreement among clinicians as to the precisevalue and place of cognitive behavioural therapy, whichpartially reflected the varying models of the therapy anddisease.” ( Counsel? MERGE’s response to the CMO report on CFS/ME 17

“We also noted that misunderstanding, misplaced concern,and poor practice in this area could potentially underminethe beneficial application of this therapy or its principles inpatients with CFS/ME.” (“In one patient-group survey, only 7% of respondentsfound the therapy [CBT] ‘helpful’, compared with 26% whobelieved it made them ‘worse’. The remaining 67% reported‘no change’.” ( these quotes help to illustrate, cognitive behaviouraltherapy is non-curative (Wessley, 2001); is expensive andtime-consuming, and beyond the resources of HealthAuthorities to fund; has an irrecoverably poor reputationamong ME patients, especially the severely ill whom itincenses; has been found helpful by only a small minorityof patients surveyed; and requires skilled therapists whoneed the consent of malleable patients rather than irateunwilling ones. As a recent commentary in the BritishMedical Journal stated: “Until the limitations of theevidence base for cognitive behavioural therapy arerecognised, there is a risk that psychological treatments inthe NHS will be guided by research that is not relevant toactual clinical practice and is less robust than is claimed.”(Bolsover, 2002). Or, as one patient has said, cognitivebehavioural therapy is “not curative, not cheap, notaccepted, and not the answer for everyone.”3.4.2 Graded exercise therapyGraded exercise therapy was the other “potentially useful”therapy identified by the Working Group on the basis ofthe three positive clinical trials out of the forty-fouridentified. The limitations of these trials have been discussedin depth elsewhere (BMJ 1997; 315: 947 and electronicresponses to BMJ 2001; 322: 387), but the main points canbe summarised as follows:! The success of randomised controlled trials dependson strict comparability of control to treatment groups.In these trials there was not the same contact with thecontrols and patients, raising the possibility that factorsother than treatment were involved in the “positive”outcome.! All three trials consisted of patients classified by theOxford criterion which does not diagnose ME or theCDC-CFS criteria (Fukuda et al, 1994) exclusively. Theweakly-positive trial results may reflect this bias, havelittle relevance to CFS/ME patients, and have norelevance to the large numbers of severely affected oryoung sufferers.! Graded exercise therapy involves a patient-motivationcomponent to encourage compliance with the exerciseregimen. However, the true usefulness of such programsis by no means clear (Harland, 1999).! Its use is predicated on the belief that deconditioningis a factor in the perpetuation of illness in CFS/MEpatients. However, there is good evidence thatdeconditioning is not a significant factor (Brazelmans,2001; Van der Werf, 2000) and that it cannot accountfor delayed post-exertional symptoms or thedocumented changes in muscle metabolism (Lane et al,1998; Lane, 2000).None of these is successfully dealt with in the CMO report,though some limitations are alluded to:“One key controversy that exists over graded exercise restson whether the nature of the treatment is appropriate forthe nature of the disease, at least in some individuals.Existing concerns from voluntary organisations and someclinicians include the belief that some patients may have aprimary process that is not responsive to or could progresswith graded exercise, and that some individuals are alreadyfunctioning at or very near maximum levels of activity.”(4.4.2)“Voluntary organisations, as well as the Sounding Boardevents, note that graded exercise therapy can be effectivein some individuals, but substantial concerns exist regardingthe potential for harm.” (, some hard evidence from patient surveys isshown in the Working Group’s report, albeit in Annexe 3.This showed that of 1,214 patients using graded exercisetherapy, 34% found it helpful but 50% (610 patients)reported that it made them worse. Graded exercise therapyhad the greatest number of ‘worse’ reports of any therapy.Clearly, as a management strategy, graded exercise therapyhas its limitations for CFS/ME patients: “Best practice inthis area indicates that the initial stages of any gradedexercise programme should only be carried out by therapists(i.e., occupational therapists, physiotherapists, exercisephysiologists, sports therapists, etc.) who have the necessaryexpertise to manage CFS/ME patients.” ( At present,very few therapists are available with such expertise.3.4.3 PacingIn contrast with the two professionally-dictatedinterventions, pacing has been included as a ‘managementstrategy’ in response to patient experience - an example(some might say) of patients voting with their feet. Pacingallows patients to choose their own acceptable level ofactivity in accord with their fluctuating symptoms. It acceptsthat in the rehabilitation of sufferers, rest and relaxationalso have an important role to play (Shepherd, 2001). Thereport clearly states the rationale for pacing:Unhelpful Counsel? MERGE’s response to the CMO report on CFS/ME 18

“Clinical wisdom suggests that management of limitedenergy and supervision of any increases in physical ormental activity are an essential part of ongoing care forindividuals with CFS/ME.” (4.4.2)“A survey of more than 2,000 members of a voluntaryorganisation (Annexe 3, section 3) who were or had beenseverely unwell showed that 89% of group members foundpacing ‘helpful’.” ( pacing is intuitively sensible, its status as a clinicalmanagement strategy chosen after three years ofdeliberation by a Working Group is debatable, and there isa lingering suspicion that it has been recommended by theWorking Group only as a concession to patient-basedopinion. Whether sufferers will be allowed by healthcareprofessionals to choose this “recommended” therapeuticstrategy in preference to psychological strategies is an openquestion. Indeed, almost as soon as the Working Group’sreport was published, an item in the British Medical Journalcommented: “The clinicians argued that the psychosocialside of the condition should have had greater emphasisand were concerned that ‘pacing’... was included as a formof treatment,” and quoted one professional as saying that“...doctors would not accept pacing just because it wasrecommended in the report” (Eaton, 2002).3.4.4 Conclusions about the choice ofmanagement strategiesThe preamble to the CMO report was explicit in its aims:“Throughout, we have aimed where possible to base ourcommentary and recommendations on the best qualityevidence, and from a range that includes randomisedcontrolled trials and clinical anecdote. In the absence ofresearch evidence to inform many issues, the bulk of thereport is derived from a synthesis of patients’ and clinicalexperience. Where some data exist, albeit incomplete andnot fully agreed, we considered the trident approachtogether with the likely resource implications to inform ourconclusions.” (1.3.3)How far have these aims been achieved? By conventionalstandards of literature reviewing, formal evidence for theuse of cognitive behavioural therapy, graded exercisetherapy and pacing is rudimentary. The fact that a few moreclinical trials exist for cognitive behavioural therapy andgraded exercise therapy than for any other interventionmerely reflects the funding support which the interventionsattract in the UK (Abbot & Spence, 2002). Patient evidencesuggests that a small subgroup of patients might find eithercognitive behavioural therapy or graded exercise therapyhelpful (7% and 34% respectively) - possibly reflecting theheterogeneity of the patient grouping inside the construct‘CFS’ - but that a substantial proportion (93% or 66% ofpatient responders, respectively) either find them ineffectiveor harmful. Pacing is nothing more than a commonsenseapproach enforced on most patients by their circumstances,and can hardly be described as a therapeutic managementstrategy. To use an analogy, pacing could describe the abilityof an amputee to hobble around in difficult circumstances:a “therapeutic management strategy”, however, mightinclude a new prosthesis individually designed. Strangely,in a recondite section (but not in the easily-accessible overallconclusions) the report itself admits the truth:“Review of the evidence highlights the lack of good qualityresearch to support effectiveness of various therapies.Patient responses suggest that no approach is universallybeneficial and that all can cause harm if applied incorrectly.”(4.0)3.5 Failure to highlight data on the mostseverely ill patientsAt several points, the report mentions the problems of themost severely ill patients:“Severely ill are severely overlooked; just ignored andinvisible.” (2.3.1)“In general, this group is excluded from research, so theymay not fulfil criteria used to test evidence-basedapproaches. Some report that they want to believe doctorsand feel ‘frightened to say no’ or that they do not have theenergy to disagree. Fears were also expressed over: beingbranded as a ‘difficult patient’, losing benefits, letting peopledown, not trying, losing the love of the family, and beinglabelled as mentally ill.” (“Not enough is known about severe forms of the conditionCFS/ME that are reported to affect up to 25% of patients.”(4.4.1)Yet, a database of information collected and analysed onbehalf of severely-ill sufferers by the 25% ME Group, whichwas presented to the Working Group, has not been used tofull effect, and remains unmentioned in Annexe 3 (PatientEvidence). MERGE takes the opportunity of highlightingit in Table 2 below.The 25% group, in a questionnaire report (25% ME Group,2000), revealed that of 215 questionnaires returned someinteresting observations could be made: 55% ofrespondents had been ill for more than ten years, and 50%of them had taken more than two years to obtain a formaldiagnosis of CFS/ME. Twenty-five percent of respondentsdescribed themselves as bedridden, and 57% had been eitherhousebound or bedridden for more than six years. Asregards appropriate medical advice or treatment, 29%reported that none had been offered during the course oftheir illness. Only 25% of respondents felt that theircondition was improving, or had improved from an evenmore chronic level. Important additional findings were that76% (162/212) of respondents felt that the lack of adiagnosis or appropriate advice in the early stages of theirillness had impacted on the severity and longevity of theirsymptoms; that 38% (81/212) described themselves astotally dependent on others; and that 48% (104/215)reported no regular assessment or management of theirUnhelpful Counsel? MERGE’s response to the CMO report on CFS/ME 19

condition. The management strategies recommended bythe report are inappropriate for this group of sufferers,whose continued ill health - its aetiology, perpetuation andcure - remains a neglected challenge.Table 2. Survey y of severely erely affectected ed CFSpatients, , reproduced courtesy of the 25% groupAge (yearears)Number (%)60 28 (14)Time housebound/bedridden (yearears)10 35 (17) / 6 (3)Present conditionimproved/improving 53 (25)stable at low levelof functioning 105 (49)slowly deteriorating 56 (26)Duration of illness (yearears)2-5 31 (14)6-10 66 (31)10-14 49 (23)>15 68 (32)Illness onsetsudden 104 (49)gradual 110 (51)Time to formal diagnosis (months)60 53 (25)Time to appropriatopriate advice/treatment (months)60 24 (12)none given 60 (29)3.6 Undue prominence given to the‘biopsychosocial’ model of the illnessFrom the report of the first recorded outbreak in 1934until the late 1980s, the emphasis was on the elucidationand treatment of the biomedical aspects of the illness (e.g.,Acheson, 1959). Since then, a “biopsychosocial model” hasbeen proposed - primarily by psychiatric/psychologicalprofessionals - defined by the report as:“The biopsychosocial model of pathophysiology, applicableto all disease, suggests that once an illness has started itsexpression is affected by beliefs, coping styles, andbehaviours, while consequential physiological andpsychological effects act in some ways to maintain and/ormodify the disease process.” (3.3.4)“Illness beliefs - The way in which abnormal illnessbehaviour and illness attributions (especially about cause)may be perpetuating ill health and disability in someCFS/ME patients remains a contentious issue.” (3.3.3)Psychological factors do, of course, accompany chronicillness - every patient has a mind and feelings which areaffected by the experience of disease. The problemconcerns the ascription of causation. The view that“psychosocial factors” either precede (cause?) CFS/ME,or play a major role in maintaining the illness after it hasdeveloped, has taken root among some, but not all, membersof the medical profession, and has influenced theperception of CFS/ME in the media and among the generalpublic. Naturally, patients have come to feel stigmatisedand alienated, and perceive the influence of the model,particularly among medical practitioners, to have apernicious effect on their care. To complicate matters,patients’ beliefs that their illness is “physical” are seen byproponents of the biopsychosocial model as a sign ofpsychological dysfunction. Such psychologising of patientsillness experience is not unique to CFS/ME patients. Arecent study on Gulf War Syndrome was entitled:“Prevalence of Gulf war veterans who believe they haveGulf war syndrome” (Chalder et al, 2001). The principalauthor of this study was one of the Key Group membersof the report. Many CFS/ME patients await with interestthe next study in the series: to continue the analogy of theamputee used above, it could perhaps be on amputees (withor without CFS/ME) who believe that they have lost a limb.The CMO report itself - in select sections possibly writtento assuage its lay members - does state the central problemwith this model succinctly:“Although they may have speculated about causation, mostlywhat has been demonstrated is an association. For example,the various psychological factors claimed to be causal maybe a consequence of severe, prolonged CFS/ME.” (“Certain strongly held attitudes to the illness and copingmechanisms do seem to be associated with a poorerprognosis, but studies done so far have not enabled thedirection of causation to be determined. Some have inferredthat a poorer prognosis may be caused by such attitudes,but it can equally be argued that severe, prolonged illnessmay have a negative impact on attitudes and copingmechanisms... the various psychological factors claimed tobe causal may be a consequence of severe, prolongedCFS/ME, and for the most part the study designs adoptedwould not enable the question of causality to be resolved.”( Counsel? MERGE’s response to the CMO report on CFS/ME 20

“However, it seems likely that cognitive dysfunction inCFS/ME cannot be explained solely by the presence of acoexistent psychiatric disorder.” (3.3.4)“The biopsychosocialmodel of CFS/ME hasinfluenced its perceptionamong the general public.”Nevertheless, peppered throughout the remainder of thereport are examples of classical biopsychosocial modelism,despite the resignation of its supporters from the KeyGroup on the grounds that “the condition’s psychologicalaspects were being underplayed” (Hospital Doctor, 17thJan 2002). Thus,“An individual’s symptom profile is modified by the impactof illness on the person affected and those around them.”(3.4.2)“Re-enablement should encompass cognitive, emotional,and social aspects as well as physical aspects.” (4.1.2)“Ideally, services would be patient-centred, and adopt abiopsychosocial model or a holistic view of care.” (3.3.4)“It is thought that certain strongly held beliefs about thecause of the illness can impede progress. These include theview that the illness is entirely physical or is caused by apersistent virus. These beliefs could be partially correct -e.g., a virus could have provoked a persistent or prolongedchange in physical functioning. However, they could alsoact as obstacles to recovery or to necessary treatment.”(3.3.3)Given that the evidence of efficacy for these interventionsin CFS/ME sufferers is weak (Whiting et al, 2001), therelevance of these statements in the Working Group reportis questionable. Why should the “ideal” service (whichpatients and their carers are paying for through their taxes)be one which adopts a biopsychosocial model, given theavailable evidence? More generally, how would it be if thesame statements were applied to either asthma or angina,both of which have psychosocial elements yet arerecognised as predominantly physical illnesses? As SusanSontag says in her book, Illness as Metaphor (1978),“Theories that diseases are caused by mental states and canbe cured by will power are always an index of how much isnot understood about the physical terrain of a disease.”Some consider this insight to be particularly apt in the caseof CFS/ME at the beginning of the 21st century.3.7 Downgrading of relevant researchfindingsAt points the Working Group’s report mentions its role inassessing research evidence: “...we sought to bring togetherknowledge on CFS/ME to support initiatives to improvecare for patients. This has been an intricate process, drawingon research evidence, the experience of patients and diverseclinical opinion.” (Foreword) “... make recommendationsfor further research into the care and treatment of peoplewith CFS/ME.” (Remit, 1.1)Yet, despite this, the main body of the CMO report dealswith the research findings in 639 words (section 3.3.4) outof a total of some 34,600 in the main report. However,there is a large body of research literature on CFS/ME. Asthe CFIDS Association of America makes clear, thoughthe aetiology of the illness remains elusive, numerousbiological abnormalities have been reported in:! Immune function - in the form of cytokineoverproduction or poor cellular function (Patarca-Montero et al, 2000; Patarca-Montero et al, 2001).! Brain and CNS - with possible involvement of the basalganglia (Chaudhuri & Behan, 2000) or the functioningof the blood-brain barrier (Bested et al, 2001).! Muscle - in the form of oxidation defects (McCully &Natelson, 1999) or post-exertional deficits (e.g., Lane,2000; Paul et al, 1999).! Autonomic functioning - as neurally-mediatedhypotension (e.g., Bou-Holaigah et al, 1995).! Hormonal function - most prominently at thehypothalamic-pituitary-adrenal axis (e.g., Scott & Dinan,1999).! Cardiovascular integrity - endothelial sensitivity toacetylcholine (e.g., Spence et al, 2000).! Neuropsychological functioning - including impairedworking memory and information processing unrelatedto psychiatric illness (review: Michiels & Cluydts, 2001).“The research literature contains several hypotheses andproposals to explain how CFS/ME may be caused ormaintained. The quality of the evidence is variable, however,and many suggested mechanisms are as yet based onassociations rather than cause or linkages.” (3.3.4)Interestingly, these reasons for bypassing a full considerationof the research evidence, namely, the variable quality andlack of causal evidence, could also apply to the evidencefor the choice of management strategies (cognitivebehavioural therapy, graded exercise therapy, and pacing)and, it could be plausibly argued, to the biopsychosocialmodel itself.The downplaying of the research evidence partly reflectsthe constrained remit, which was restricted to managementstrategies. With a different remit, the report might havebeen able to recommend a direction for future fundamentalresearch after a thorough review of the literature. Instead,the message presented to the media, the public and opinionformers is that the best that can be done is to managesymptoms, most prominently with psychological strategies.Unhelpful Counsel? MERGE’s response to the CMO report on CFS/ME 21

3.8 Inadequate coverage of social careand welfare issuesThe foreword to the report states that: “In 1998, theWorking Group on CFS/ME set out to consider how theNHS might best provide care for people of all ages whohave this complex illness.”While the NHS is the major player in care provision forpatients, it is only one agency among many providing carefor people. By focusing so closely on one agency, the CMOreport has missed an opportunity to highlight more clearlythe responsibilities to CFS/ME patients of other agenciesand the professionals who work for them. The nature ofthe illness and its practical consequences, particularly forthe severest sufferers, are such that social services shouldbe closely involved in both care planning and direct serviceprovision. Consideration should be given to those mostseverly affected, identifying them as a special interest groupin terms of joint community care planning and in planningfor children and young people’s services.“The report’s message isthat the best that can bedone is to managesymptoms.”The report recognises that, on the ground at present, therange of services are not ‘joined up’.“Beyond primary care level, the issue that causes mostconcern is the lack of specialists and services... Somepatients find themselves in geographical ‘black holes’ thatlack specialist provision.” (2.2.4)“Patients can encounter arbitrary and poorly informeddecision-making on other issues such as home help andmobility badge schemes, as well as sheer resource limitation.Failure to access appropriate support from social servicescan be compounded if doctors fail to provide clear guidanceabout diagnosis and need.” (3.5.1)While the recommendations on equipment and practicalassistance (4.3.3) and the call for service networks (6.3) iswelcome, statements about the services CFS/ME sufferers‘should’ receive in the community are little more thanhowling for the moon: without the full support and practicalbacking of local social work departments, sufferers willstruggle to see these needs either fully met or metappropriately. For example, a recommendation thatclinicians should inform patients about local services is onething, but providing clinicians with the ability to referpatients to the relevant agencies themselves would be trulyuseful. Indeed, with the advent of joint social work/healthteams, this is no longer impractical. As regardsrecommendations to employers - even the NHS itself - theWorking Group’s report is light on the provision of practicaladvice about how the illness should be managed in theworkplace. A fuller exploration of this issue would havebeen a welcome extension to the report, as would adviceon good employment practice to all tax-funded employers.It is re-assuring to see that Welfare Benefits have beenaccorded their own priority by the Working Group:“A small subgroup of the Working Group was establishedto produce a paper on CFS/ME and the benefits system.This working paper was then submitted to the CMO inApril 2000. Professor Donaldson formally copied the paperto the Chief Medical Advisor of the Department of SocialSecurity to inform that Department’s Working Group,which was established to review the benefits system forpeople with chronic illness.” (1.3)Yet, how useful it would have been, for patients and carers,to have had this information summarised in the main report,and attached in full as another Appendix.The journey through public service provision is often adaunting one that can leave individuals feeling powerlessand damaged by the very system that is supposed to supportthem. The experiences of patients in the health service,service users in local authorities, and claimants in the welfarebenefits system, continually highlight the need for moreindependent advocacy services to ensure that people receivethe services and support to which they are entitled, and toreceive them with their dignity intact. Unfortunately, theWorking Group report barely addresses these issues.3.9 Words are not action - will anythingactually change?Though the CMO report makes some heroic suggestionsfor improving the quality of the patient-provider interaction,insisting that “Patients can be empowered to act as partnersin care” (4.0), it carries with it no executive power, nofunding to stimulate change, and no commitment toreconvene at a future date to report on the changes whichmay have been implemented. This severely limits itsusefulness.Given this, several aspects of the situation on the groundmake significant beneficial change unlikely in the short tomedium term. First, a significant number of patients havenot been well served by healthcare professionals. Forexample, section 3.5 (above) has shown that 61% of themost severely ill patients report waiting more than 2 yearsfor appropriate advice and symptomatic help (there is no‘treatment’). Although the Working Group is, in places, upbeatabout the prognosis for patients with the illness, e.g.,“The likelihood is that most patients will show some degreeof improvement over time, especially with treatment...Gradually progressive deterioration is unusual in CFS/ME.”(1.4.3), research studies on prognosis (e.g., Bombardier &Buchwald, 1995; Hines et al, 1993; Vercoulen et al, 1996)are less optimistic: around one third of sufferers regain upto 80% of their premorbid levels, but the remainderUnhelpful Counsel? MERGE’s response to the CMO report on CFS/ME 22

experience remissions and relapses, albeit at a ‘stable’ levelof functioning, often for years, or steadily deteriorate intosevere incapacity and dependency. This often occurs withoutany support or significant help from healthcareprofessionals: without teeth, the recommendations of theWorking Group are unlikely to alter this unfortunate picture.Again, research reports have shown that a substantialproportion of GPs do not believe they are dealing with adistinct clinical entity when they see CFS/ME patients(Stevens et al, 2000; Ho Yen & McNamara, 1991). AMERGE in-house analysis found that 20% of patients“The report carries noexecutive power, funding,or commitment to followup its recommendations.”reported changing GP at some stage during their illness,and that roughly one third found their GP’s attitude to beat best non-committal and sometimes openly sceptical. Ina recent development, “Chronic fatigue syndrome/Myalgicencephalomyelitis” was voted by 12.6% (72/570) ofrespondents to the website of the British Medical Journalas one condition that best fitted the description of a “nondisease”(BMJ 2002; 324: 7334, data supplement). Publisheditems of in-house literature for doctors perhaps clearlyreveal how some feel about these patients:“Never let patients know you think ME doesn’t existand is a disease of malingerers. Never advise an MEpatient to make a review appointment. At the end ofthe consultation, I say goodbye, not au revoir.” DrMary Church (a member of the BMA MedicalEthics Committee) quoted in the GP magazine,Pulse. 20th October 2001.“Question: What would be your initial response to apatient presenting with a self-diagnosis of ME?Possible answers:a) Are you by any chance a teacher?b) Thank you for making the effort to come along. Iam sure we will be able to help.c) For God’s sake, pull yourself together, you pieceof pond life.d) Well, lets just explore that, shall we?”Dr Tony Copperfield (a pseudonym), describedas being a GP in Essex, in Doctor magazine,2000. (The ‘correct’ answer was (c).)“I have every symptom of the disease. Thepathogenesis of ME is increasing workload; beingundervalued socially, politically, and financially; andbeing abused by those I try to help. You just have aget on with life.” Name and address withheld.Doctor magazine. 18th March 1995.“If they really insist on a physical diagnosis tell themchronic fatigue syndrome is a complex disorder inwhich multiple biopsychosocial factors are mediatedvia the anterior hypothalamus - in other words, it’sall in the mind.” Dr Douglas Carnall, Bluffer’sGuide: Chronic Fatigue. 12th January 1995.“ME is usually (in my surgery, always) a self-diagnosis:somebody comes in, sits down and says, ‘I think I’vegot ME, doc’. This is what we in general practice calla ‘heart-sink encounter’.” Dr Michael Fitzpatrick,“The making of a new disease”. The Guardian7th February 2002.These quotes sit uneasily with the aspiration in the CMOreport:“The doctor’s job should be to ‘heal sometimes, relieveoften, comfort always’.” (4.1.2)“Positive attitudes and cooperation based on mutual respectseem likely to produce best outcomes.” (3.3.3)Rather than promoting a culture in which CFS/ME patientsand their carers can begin to be ‘partners in care’, a morelikely outcome is the imposition of cognitive behaviouraltherapy and graded exercise therapy on some patients dueto the media spin surrounding the report’s conclusions.Patients should remember, however, that doctors have aduty to prescribe cognitive-behavioural interventions orexercise regimens with as much care as they prescribe drugs,and that CFS/ME patients who experience adverse effectsor relapse - as indicated by patient reports of graded exercisetherapy - may well be entitled to redress though the courts.Unhelpful Counsel? MERGE’s response to the CMO report on CFS/ME 23

End piece - Patient voicesIn the plethora of views about the research and management of this illness, the authenticvoice of the sufferer is rarely heard. For this reason some individual poignant experiencesare given below.“I was eighteen years old when I was struck down with severe, virally-induced ME. Iam now thirty-three. It has destroyed my quality of life. My feelings of loss andhelplessness are often overwhelming. My parents have to care for me and the illnesshas deprived me of a career, a social life, and the possibility of marriage and children.I am 90% bed-bound and feel wretchedly ill every waking moment. At worst I amunable to hold a conversation, watch TV, or even read. My only hope is for a researchbreakthrough in this illness. More than anything else, I want to see ME recognised anda treatment found.” Clare“The worst thing about having ME is, obviously, having ME. It is spending three yearsin your bedroom looking at the walls, in pain, isolated, unable to read, write, or talk,with a brain like spaghetti. The worst thing is having a brain which no longer works andwhich I can’t do anything about. It’s like being in solitary confinement, except that Ihaven’t done anything wrong.” Josh“The feelings of pain and sickness are with me all the time. The illness has changed mylife. I can do none of my former hobbies, and am left hanging around on the fringes ofa no man’s land between the dying and the well. It’s a double torture - having the illnessand having it unrecognised. It has been said that patients like me should just move on,but after twenty years it seems to me that the only things moving on in this illness areprofessionals - medical and charitable - making careers out of my misery. A little humilityand some humanity by those in the so-called ‘caring professions’ would go a longway towards helping me cope with what has been a truly awful experience.” Alex

References25% ME Group. Survey of housebound/bedriddenseverly-ill ME patients. (Re-analysis by MERGE.) 2000.Available from Simon Lawrence, The 25% ME Group,Troon, Ayrshire, Scotland KA10 6SQ.Abbot NC & Spence VA. The National Research Registerand ME/CFS: an analysis by MERGE. February 2002.Available from merge@pkavs.org.uk.Acheson ED. The clinical syndrome variously called benignmyalgic encephalomyelitis, Icelandic disease and epidemicneuromyasthenia. American Journal of Medicine 1959; 569:595.Bested AC et al. Chronic fatigue syndrome: neurologicalfindings may be related to blood-brain barrier permeability.Medical Hypotheses 2001; 57(2): 231-7.Bolsover N. Commentary: the evidence is weaker thanclaimed. British Medical Journal 2002; 384: 294.Bombardier CM & Buchwald D. Chronic fatigue, chronicfatigue syndrome, and fibromyalgia. Disability and healthcareuse. Medical Care 1996; 34: 924-30.Bou-Holaigah I et al. The relationship between neurallymediatedhypotension and the Chronic Fatigue Syndrome.Journal of the American Medical Association 1995; 274;961-7.Brazelmans E et al. Is physical deconditioning aperpetuating factor in chronic fatigue syndrome? Acontrolled study on maximal exercise performance andrelations with fatigue, impairment and physical activity.Psychological Medicine 2001; 31: 107-14.Chalder T et al. Prevalence of Gulf war veterans whobelieve they have Gulf war syndrome: questionnaire study.British Medical Journal 2001; 323: 473–6.Chaudhuri A & Behan PO. Fatigue and the basal ganglia.Journal of Neurological Science 2000; 179: 34-42.Clark C et al. Chronic Fatigue Syndrome: a step towardsagreement. Lancet 2002; 359: 97-8.De Becker et al. A definition based analysis of symptomsin a large cohort of patients whith CFS. Journal of InternalMedicine 2001; 250: 334-40.Dowsett EG et al. Myalgic encephalitis - a persistententeroviral infection? Postgraduate Medical Journal 1990;66: 526-30.Eaton L. Recognising chronic fatigue is the key toimproving outcomes. British Medical Journal 2002; 324: 131.Freiberg F. A subgroup analysis of cognitive behaviouraltreatment studies. Journal of Chronic Fatigue Syndrome1999; 5: 3-4 & 149-59.Fukuda K et al. The chronic fatigue syndrome: Acomprehensive approach to its definition and study. Annalsof Internal Medicine 1994; 121: 953-9.Hansard Report. The House of Lords debate onME/CFS. 16th April 2002. Col 899. Available from TheLords Hansard full text database.Harland J et al. The Newcastle exercise project: arandomised controlled trial of methods to promote physicalactivity in primary care. British Medical Journal 1999; 319:828-32.Hines GME & McLusky DR. Retrospective study of thechronic fatigue syndrome. Proceedings of the Royal Collegeof Physicians . of Edinburgh 1993; 23: 10-14..Ho Yen D & McNamara I. General practitioners’experience of chronic fatigue syndrome. British Journal ofGeneral Practice 1991; 41: 324-6.Holmes J. All you need is cognitive behavioural therapy?British Medical Journal 2002; 384: 288-90.Jason LA et al. Politics, Science, and the Emergence of aNew Disease: The Case of Chronic Fatigue Syndrome.American Psychologist 1997; 52(9): 973-83.Johnson H. Osler’s Web. Crown Publishers Inc., New York,1996.Katon W & Russo J. Chronic fatigue syndrome criteria. Acritique of the requirement for multiple physical complaints.Archives of Internal Medicine 1992; 152: 1604-9.Lane RJ et al. Muscle fibre characteristics and lactateresponses to exercise in chronic fatigue syndrome. Journalof Neurology, Neurosurgery and Psychiatry 1998; 64: 362-7.Lane RJ. Chronic fatigue syndrome: is it physical? Journalof Neurology, Neurosurgery and Psychiatry 2000; 69: 280.Lewis G & Wessely S. The epidemiology of fatigue: morequestions than answers. Journal of Epidemiology andCommunity Health 1992; 46: 92-7.Manu P et al. The frequency of the chronic fatiguesyndrome in patients with symptoms of persistent fatigue.Annals of Internal Medicine 1988; 109: 554-6.McCully KK & Natelson BH. Impaired oxygen deliveryto muscle in chronic fatigue syndrome. Clinical Science(Colch) 1999; 97(5): 603-8.Unhelpful Counsel? MERGE’s response to the CMO report on CFS/ME 25

Michiels V & Cluydts R. Neuropsychological functioningin chronic fatigue syndrome: a review. Acta PsychiatrScandinavica 2001; 103(2): 84-93.Patarca-Montero R et al. Review: Immunology of ChronicFatigue Syndrome. Journal of Chronic Fatigue Syndrome2000; 6: 69-107.Patarca-Montero R et al. Cytokine and other immunologicmarkers in chronic fatigue syndrome and their relation toneuropsychological factors. Applied Neuropsychology2001; 8(1): 51-64.Paul L et al. Demonstration of delayed recovery fromfatiguing exercise in chronic fatigue syndrome. EuropeanJournal of Neurology 1999; 6(1): 63-9.Pinching AJ. Chronic Fatigue Syndrome. Prescriber’sJournal 2000; 40; 99-106.Prins JB et al. Cognitive behaviour therapy for chronicfatigue syndrome: a multicentre randomised controlled trial.Lancet 2001; 357: 841-7.Ramsay AM. Myalgic encephalomyelitis or what? Lancet1988; 100.Royal Colleges of Physicians, Psychiatrists andGeneral Practitioners. Report of a joint working groupof the Royal Colleges of Physicians, Psychiatrists andGeneral Practitioners: Chronic fatigue syndrome. 1996,London: Cathedral Print Services.Scott LV & Dinan TG. The neuroendocrinology ofchronic fatigue syndrome: focus on the hypothalamicpituitary-adrenalaxis. Functional Neurology 1999; 14(1):3-11.Shepherd C. Pacing and exercise in chronic fatiguesyndrome. Physiotherapy 2001; 87: 395-6.Sontag S. Illness as Metaphor. Penguin Books, UK, 1983.Spence VA et al. Enhanced sensitivity of the peripheralcholinergic vascular response in patients with chronic fatiguesyndrome. American Journal of Medicine 2000; 108: 736-9.Steven ID et al. General practitioners’ beliefs, attitudesand reported actions towards chronic fatigue syndrome.Australian Family Physician 2000; 29: 80-5.Tan EM et al. The case definition of chronic fatiguesyndrome. Journal of Clinical Immunology 2002; 22: 8-12.Van der Werf et al. Identifying physical activity patternsin chronic fatigue syndrome using actigraphic assessment.Journal of Psychomotor Research 2000; 49: 373-9.Vercoulen JH et al. Prognosis in chronic fatigue syndrome:a prospective study on the natural course. Journal ofNeurology, Neurosurgery and Psychiatry 1996; 60: 489-94.Wessely S. Chronic fatigue syndrome-trials and tribulations.Journal of the American Medical Association 2001; 286:1378.Whiting P et al. Interventions for the treatment andmanagement of chronic fatigue syndrome: a systematicreview. Journal of the American Medical Association. 2001;286: 1360-8.Unhelpful Counsel? MERGE’s response to the CMO report on CFS/ME 26

Postscript by MERGEThis document is the creation of the MERGE staff, Dr Neil C. Abbot and Dr Vance A. Spence. Asubstantial contribution, including to the production and design, was made by Dr David J. Newton. Thesections dealing with social care were prepared following expert advice from Mr William Dockery.MERGE has links with the 25% ME Group which represents the severest ME sufferers in the UK andthis analysis of the CMO report has, in part, been carried out with this particular group in mind. Weacknowledge the many patients, carers and concerned professionals from the Friends of MERGE schemefor their contributions and support to the production process.MERGE exists to fund scientific investigation into the causes and treatment of myalgic encephalomyelitis(ME), to provide information and education about the condition, and to support sufferers. The charitywas founded by Dr Vance Spence and Mr Robert McRae, both ME sufferers forced to retire early fromtheir professions. With Roger Jefcoate CBE as its founding patron, and The Countess of Mar as itspatron, MERGE obtained charitable status in April 2000 and, after establishing itself successfully,commenced its five-year plan of expansion from May 2001. Ambitiously, we aim to commission and funda variety of research projects into the pathophysiological basis of the illness, and to establish a social careprogramme.I want to help MERGE fund research and support sufferersPlease send me:Further information about MERGE’s projectsInformation about the Friends of MERGE schemeI would like to make a donation to help MERGE make a difference:I enclose my cheque or postal order for £ _________ made payable to MERGEI would like you to reclaim tax on my donation through the Gift Aid scheme(You must pay an amount of income tax and/or capital gains tax at least equal to the taxthat the charity reclaims on your donations in the tax year - currently 28p for each £1 yougive.)Please send me further information about contributing to MERGE:Name _______________________ Tel/email ____________________Address _______________________ Date ___________________________________________Postcode_______________________Please send this form to:MERGE, The Gateway, , South Methvthven Street,t,Pererth PH1 5HA, , Scotland, UKTel: 01738 451234Email: merge@pkavs.org.uk

AppendixFollowing publication of the Working Group’s report to the CMO, there was some debate about thefuture direction of research into CFS/ME in the UK. In particular, great reliance was placed on the“research” evidence documented in the National Research Register.During a debate in the House of Lords on the Working Group’s report on CFS/ME (16th April 2002),mention was again made of the role of the National Research Register in informing policy in this area.Accordingly, MERGE has included the executive summary of its document, Research into ME/CFS in theUnited Kingdom: Can the National Research Register inform future policy, in this Appendix. Electronic copies ofthe full document (50 pages, with 39 pages of tables) are available from merge@pkavs.org.uk.Research into ME/CFS in the United Kingdom: Can the National ResearchRegister inform future policy?An analysis by MERGE, February 2002Dr NC Abbot and Dr VA SpenceExecutive SummaryThere is presently a debate in the United Kingdom about future direction of public policy regardingresearch into Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). Energising the debate isan apparent increase in the scale of the problem nationally and, recently, publication of a report by anindependent working group to the Chief Medical Officer of England. However, policy must be guided bygood data and great reliance has been placed on the UK National Research Register (NRR) of completedand ongoing medical studies as a resource for informing debate. This register is a database of ongoing andrecently completed research projects funded by, or of interest to, the United Kingdom’s National HealthService. This analysis of the information on ME/CFS contained within the NRR was designed to answera specific question: given the interest in the development of a research policy for ME/CFS in the mediumto long term, is the information contained in the NRR records robust and accurate enough to informpolicy-makers?The total raw number of studies on ME/CFS retrieved from the NRR was 28 ongoing and 133 completedstudies (partial records are presented in a 35-page Appendix to this report). From each, the following keydata were extracted: Title; End date; Contact person; Principal research question; Sample group description;Funding source and amount. Each record was assigned to an ad hoc “research category” (of interest toresearchers), and a “clinical category” (of more interest to the public and policy-makers) on the basis ofthe professional and/or departmental affiliation of the “contact person”.Of the 161 NRR reports retrieved, 10 appeared not to involve ME/CFS patients directly, and 12 appearedto be duplicates of existing reports. Thus, only 139 (23 ongoing and 116 completed) could be classed as“relevant” reports - representing 0.17% of the 80,000 on the entire NRR database. Eighteen reports (5ongoing and 13 completed) concerned research in Scotland. Many reports were incomplete: 35% and31% of ongoing and completed study records, respectively, had missing descriptions of the proposedsample group; 22% and 28%, respectively, had missing details of sources of funding; and the amount offunding received was not stated in more than a half of all entries. In addition, some records had verysimilar content, despite a difference in “end dates” which varied by up to 18 months, raising the possibilitythat some records describe extensions of an existing project rather than separate discrete investigations.

When classified by clinical category, 41% of reports had “contact persons” whose professional associationwas with “psychiatry, psychological medicine or mental health”. The second and third largest categorieswere neurology, neurosciences or neurophysiology (13%) and general medicine/medical care research(12%), respectively. When classified by research category, investigations with some scientific rationale andsome relevance to the pathophysiology of the illness constituted the largest group of records (43%), butmany of these were smaller exploratory studies (evidenced by relatively small sample sizes) that are unlikelyto have given a definitive answer to the initial research question. The main other categories containedclinical trials or other investigations of essentially biopsychosocial interventions (17%), followed by surveyspertaining to biopsychosocial interventions (14%), and surveys of welfare or social aspects (9%).Given that the amount of funding received was not stated in more than a half of all entries, no definitiveconclusions can be drawn from the information on source or amount of funding. However, the clinicalcategory “psychiatry, psychological medicine or mental health” is the most successful in attracting researchfunding. Overall, however, few public resources (NHS or Research Council) have been directed towardsresearching this illness.In conclusion, the NRR records tend to be incomplete; to contain inadequate descriptions of the researchproposed; and to have no cross-reference to the results emanating from the research. The records relatingto ME/CFS reveal that comparatively little research has been done given the scale of the problem in theUK and that few public resources have been directed towards research, particularly into thepathophysiological basis of the illness. Much of the research undertaken has been led by investigatorswith a professional or departmental affiliation to Psychiatry, Psychological Medicine and Mental Health,and none of the 139 studies were conducted on the most severely-ill patients.Given the recent recommendations of the Chief Medical Officer of England that government investmentin research on ME/CFS should be comprehensive and include a range of studies designed to “elucidate itsaetiology and pathogenesis, clarify its epidemiology and natural history; characterise its spectrum and/or subgroups; andassess a wide range of potential therapeutic interventions including symptom control measures”, we conclude that theNRR is not robust enough, as an information source or as a research resource, to inform thedirection of future policy.

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