Corec Drc Me and Stigma

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Abbreviations ................................................................................................................ 2

Introduction ................................................................................................................... 2

Introduction to the evidence .......................................................................................... 3

Prejudice and stigma ..................................................................................................... 3

Children and young people ........................................................................................... 5

Problems with state benefits ..........................................................................................7

Disadvantages and discrimination in education ............................................................9

Poor healthcare and estrangement from healthcare providers ....................................10

Inhibition of research into biological causes of CFS/ME ...........................................13

Examples of recent NHS Research Ethics Committee approved research .................14

Research Titles ............................................................................................................19

Excerpts fromResearch Governance Framework for Health and Social Care ...................................21

Excerpts fromGovernance arrangements for NHS Research Ethics Committees ............................. 23

Declaration of Helsinki ...............................................................................................24

REFERENCES ............................................................................................................29


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Abbreviations

CBT Cognitive Behavioural TherapyCFS Chronic Fatigue SyndromeCFS/ME Combined term for CFS and ME. Sometimes ME/CFSCMO Chief Medical Officer (Working group report into ME/CFS 2002)COREC Central Office of Research Ethics CommitteesDLA Disability Living AllowanceDRA Disability Rights ActDRC Disability Rights CommissionDSPS delayed sleep phase syndromeDWP Department of Work and PensionsME Myalgic EncephalomyelitisME/CFS Combined term for ME and CFS. Sometimes CFS/ME

NHS National Health Service

NICE National Institute for Health and Clinical ExcellenceREC Research Ethics CommitteeMRC Medical Research Council

Introduction

Some research conducted into psychological theories of CFS/ME is unethical. Suchresearch unduly influences medical professionals attitudes and those of other professions,society and the media, creating prejudice and directly impacting on the well-being of

people with these illnesses.

People with CFS/ME suffer due to psychological theories and perceptions about theirillness.

This suffering is experienced in diverse ways which include overt and microdiscrimination in the provision of healthcare, education, state benefits and employmentrights; loss of status and stigma.

This prejudicial treatment which causes actual physical harm, deprivation and mentalsuffering is in part generated and perpetuated by research into psychosocial, psychologicaland psychiatric theories about the illness.

The exacerbation and perpetuation of such harm is a foreseeable outcome of psychologicalresearch into the illness. As such, it is a clearly identifiable risk factor for participants inresearch who have the illness. For these and other participant groups it is also a risk factoras exacerbating or perpetuating such harm to others may contradict the individuals moralvalues.

Research participants who have not been made aware of this obviously foreseeable risk,cannot be deemed to have given informed consent. Such research would therefore be in

breach of NHS and MRC guidelines as well as provisos of the Declaration of Helsinki.

It would seem unethical for researchers to conduct research of the kind that fostersprejudice about CFS/ME causing real and foreseeable harm.

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A substantial amount of research into psychological theories about CFS/ME has notcontributed knowledge of any significant value to participants, other patients or society.Such research has not helped to improve diagnosis, treatment or research into the illnessand often appears repetitive and gratuitous.

Research is expected to contribute to knowledge. If instead, research confounds theadvancement of knowledge then perhaps it is ethically unjustifiable. This appears to bethe case with some research into CFS/ME which in the UK, seems to have influencedmedical, scientific and political opinion away from research to identify the biologicalcauses of the illness.

People with CFS/ME are often very disabled. The ethical correctness of invitingexpenditure of limited energy resources on research that is unlikely to be of anysignificant benefit to participants is highly questionable.

People suffering with CFS/ME are often too ill to make their grievances known or seekredress. They must therefore depend upon the ethical principals that govern research.That dependence is failing them.

COREC could reasonably consider people with CFS/ME are a vulnerable group in need ofspecial protection [Declaration of Helsinki proviso 8]. They could ensure that research

proposals are critically examined for their potential harm to participants and others in viewof the extraordinary stigma associated with these illnesses. They could also ensure thatresearchers are aware of the potential for causing harm [i.e. are familiar with relatedliterature examples of which are quoted below] and have provided sufficient informationfor participants to give properly informed consent.

After so many years and repetitive psychological investigations into CFS/ME withinconclusive or findings of little value it is surely time to consider some of this researchgratuitous and unethical and not in the best interests of participants, science or society.

Introduction to the evidence

The references provided here are mostly without explanation or context but are generallyself explanatory. Complete reference to the sources is included in the text or can befound in the references section and many include hyperlinks to locations where theoriginal can be seen or downloaded. This evidence has been compiled to illustrate how

people with CFS/ME suffer discrimination due to their disability. Comments represent mypersonal opinions and interpretations. Peter Kemp. December 28th, 2006.

Prejudice and stigma

The following evidence shows that prejudice and stigma are widely experienced bypeople with CFS/ME because of their diagnosis. This prejudice often appears to be basedon psychological theories about CFS/ME.

Participants were stigmatised prior to and following diagnosis, and the stigma of CFS wascompounded with other stigmatising sources, such as chronic illness and psychiatricillness. Participants experienced both felt and enacted stigma. Additionally, threats of

invalidation were derived from interpersonal sources, and included disbelief, turning the

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abnormal into the normal, commandeering of symptoms, the attribution of negativequalities and responsibility, and dismissal. Threats of invalidation were particularlydistressing to participants because they jeopardised well-being, trivialised the pain andsuffering that were part of everyday life, questioned the reality and perceptions of the

participants, and relegated participants to an inferior status. (p.162) [Travers]

Participants were aware that there was something about CFS that provoked strongresponses and opinions in others that was not the case for most other illnesses.... Theyconsidered this "something" to be stigma and it was familiar to all the participants. (p.163)[Travers]

Accounts by people with CFS commonly include descriptions of lost friendships,disrupted familial relationships, and disbelief, criticism and lack of understanding fromothers (p.33) [Travers 2006]

Often CFS sufferers are stigmatised, or fear such labelling, as a 'malingerer', or are treatedas having other psychological and somatic properties attributed to their 'undefined' illness(p.128) [Millen, Peterson & Woodward 1998]

While the attribution of the label of CFS can bring some relief to the patient in that theyhave some recognisable illness, the obverse is that the uncertainty of the prognosis and thestigma associated with the illness usually lead to social and/or professional interpretationsthat they are malingers or merely lazy (p.3) [Holloway & Pinikahana]

It appears that those suffering from undiagnosed CFS are simply lazy or lacking in moralfibre often relegated to a marginal status once they are no longer able to live a 'normal' lifeeven close family members may scold or leave them (p.313). [Sachs]

The blaming of sufferers for not getting well over time, the emergence of 'mental illness'explanations of ME/CFS and stigma caused by on going denial by professional groups ofthe illness experience of ME/CFS sufferers' (pp.63-64) [Millen, N. 2002]

The lack of easy confirmation of the organic nature of the illness by a readily availableinvestigation lends itself to occasional invasion by those who are not genuine sufferers.The existence of such patients and the inability of some in the medical profession toseparate them from genuine patients with CFS/ME enhances the view that all patients withCFS/ME are neurotic and/or not genuinely ill. [Gibson Inquiry 2006]

The pattern in the interview responses indicates that, above all, two aspects werestigmatizing: The women experienced their moral characters called into question ininteraction with others. They also experienced distress from being psychologized byothers, doctors in particular. (p.5) [sbring & Nrvnen. 2002]

A consistent pattern was that the women perceived themselves to be challenged by othersregarding the veracity of their experience of being ill. This was experienced as deeplyviolating by the women and was described as a discrepancy between how one definesoneself and how one is defined by others. This questioning constitutes a threat to theidentity and may be experienced as a heavier burden than the illness itself: (p.5) [sbring& Nrvnen. 2002]

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Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is one of the mostcomplex and maligned disabilities in the community (p.157) [Mungovan & England 1998]

Because there are no definitive diagnostic tests at this stage and with disagreement amongthe medical fraternity on symptomatology and treatment, the ill-informed and the scepticsoften trivialise and ridicule ME/CFS. Even the term "Chronic Fatigue Syndrome" is

difficult for those with the condition, disallowing the more diverse and disablingsymptoms, and inviting negative responses. (p.157) [Mungovan & England 1998]

CFS is associated with ambiguity and negative perceptions, subject to ongoing debates,and with few points of agreement. These degrees of debate and personal criticism are notfound with most illnesses and as a consequence, participants experience CFS in a climatedifferent to the social world inhabited by the majority of people with chronic illnesses.(p.141) [Travers 2006]

The causal debates found within the medical community and between patients and medicalpractitioners were interpreted by participants as direct indictments on the character ormoral worth of affected individuals and as an affront to their credibility and worthiness.(p.139) [Travers 2006]

Wessely is ceaseless in his efforts to discredit ME and its hapless sufferers: in early 2002,at his instigation the British Medical Journal ran a ballot asking doctors to vote on whichdiseases they considered to be "non-diseases" which are best left medically untreated:Wessely proposed ME. Along with ear-wax accumulation, nail-chewing and freckles, MEwas voted a non-disease, and in April 2002 both broadsheet and tabloid newspapers ran

banner headlines proclaiming "Obesity and ME are not diseases, say doctors". (p.24)[Hooper et al. 2003]

The Media: The UK national newspapers frequently run headlines such as "ME's mainlyin the mind---Study reveals yuppie flu can be cured by positive thinking" (Daily Express,5th January 1996, about one of Mike Sharpe's studies) and "ME is just a myth, suffererstold" (Sunday Telegraph, 20th November 1994, about the conclusions of 150 British

psychiatrists attending a pharmaceutical conference in Jersey). On 5th May 1996 the DailyExpress carried an article by Jonathan Miller from America, which ran with the headline"Chronic Bandwagon Disease" in which he referred to CFS as "Completely FictitiousSyndrome". (p.26) [Hooper et al. 2003]

Children and young peopleIgnorance and lack of understanding of the condition are perceived to exist amonghealthcare professionals as in society, with a widespread perception that "children don'tget CFS/ME". (p.15) [Hutchinson. CMO Report 2002]

Younger people do not always understand their friend's illness, and some may share thewidespread disbelief surrounding CFS/ME. These problems are compounded by absencefrom school, which inevitably restricts contact, leading to feelings of isolation. (p.15)[Hutchinson. CMO Report 2002]

Strong polarised views which professionals may hold can deny young people access toappropriate supportive services, or result in inappropriate referrals. Professional

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controversy can contribute to creating "a difficult time at home", with the child or youngperson conscious of the burden placed on other family members. Disruptions to familyfunctioning have led some professionals to assume that the cause of the illness is"overprotective" parents, with further adverse impact on the child and family. (p.16)[Hutchinson. CMO Report 2002]

When their condition is less well known, or when the young person meets disbelief orperceives professional hostility or criticism of his or her parents/carers, the impact of theillness is compounded. (p.58) [Hutchinson. CMO Report 2002]

We were concerned to receive written submissions from parents of children with CFS/MEwho reported they were disbelieved by social services and community practitioners withthe result that their children were put on the at risk register or even made wards of courtand removed from the family home. (p.11) [Gibson Inquiry 2006]

In the UK, patients with myalgic encephalomyelitis (ME, also known as Chronic FatigueSyndrome or CFS), particularly children, have suffered gross and barbaric abuse and

persistent denigration as a consequence of the beliefs of certain psychiatrists who areattempting to control the national agenda for this complex and severe neuro-immunological disorder (p.3) [Hooper et al. 2003]

We constantly work with doctors, teachers and other professionals whose work isexemplary and whose attitude of compassion and dedication we applaud. Unfortunately,they still appear to be in the minority. Tymes Trust has evidence that the very systems setup by the government to help sick children and young people are being interpreted in waysthat either ignore children with ME, or threaten, bully and intimidate them. (p.4)[Tymestrust 2006]

The Tymestrust (2005, p.5), state:

It has been very disturbing and distressing for us to read, over a period of years,the many sad letters and emails we receive from children and young people withME and their families whose needs are not being met.

The great majority report feeling disempowered and ignored. They report decisionsthat will profoundly affect their lives being taken out of their hands, with littleunderstanding or consultation. They report ending up even more ill, with nosuitable education or medical support.

Our Advice Line Team hears the same distressing story. All too often, families andchildren contacting the Advice Line report not being given choices about how theyare cared for, or about the treatment they are offered.

They report that their education is rarely organised in consultation with them, so asto help them in the best possible way for their own needs. Instead, they are

presented with "done deals" that they have to either accept or fight against, thusbeing labelled as troublesome families with difficult children.

This leads to serious misunderstandings when doctors, teachers or social workers

feel that there must be some psychologically unhealthy motivation driving families

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that do not accept what has been arranged for them, but who instead requestsomething different.

Young patients and their families are clear about their views and expectations, and aboutwhat they do not want to see - they do not want their condition being officially"psychologised" just because there is no medical therapy that can cure the condition. (p.6)

[Tymestrust 2005]

"I was diagnosed by an Essex consultant paediatrician who was lovely, but GPs at threesurgeries didn't believe him. I was accused of school phobia, and my parents ofMunchausen's Syndrome by Proxy. I was bruised when made to sit up in hospital, treatedappallingly and without regard to human rights. I saw an Essex neurologist privately andwaited six months for an inpatient place but was then told I was too ill for this. My motherhas filled in this form with input from me as I am unable to hold a pen." (p.12)[Tymestrust 2005]

Many families thought that the personal attitude and knowledge of a medical professionalwas of greater significance than their specialty. They also thought that "incorrect illness

beliefs" are a significant and widespread problem among medical professionals, ratherthan among patients as suggested by the medical literature.

From their experience: 10% trusted the medical establishment to care appropriately for children with ME 88% did not trust the medical establishment to care appropriately for children with

ME 2% were unsure 18% said personal experience of doctors caring for children with ME had been

positive 79% said personal experience of doctors caring for children with ME had been

negative 3% said their experiences had been mixed

(pp.34-35) [Tymestrust 2005]

Problems with state benefits

The 25% Group charity surveyed members who receive Disability Living Allowance. 59%of those who responded had initially been refused the benefit. 86% of these appealedthe decision. 85% who appealed were successful.

Until medical opinion is better informed as to the nature of this illness, ME sufferers willhave to live with the double burden of fighting for their health and their benefits. [GibsonInquiry 2006]

In fact, shortly before she chose to die, her ME was much better. She was able to get to thetoilet unaided and even move around the flat for no reason other than for the joy of beingable to move and do what, we able bodied people, take for granted. She was considerably

better but in no way well enough to return to work. She had in the past experienced majorproblems with the Benefits Agency and had been treated in such a horrendous manner shehad said that she would never be able to apply for benefits again. Applying for benefits for

an invisible illness, with no diagnostic test is hell. The result largely depends on the beliefs

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of the doctor sent to examine you. [Investinme 2006] Available at:http://www.investinme.org/mestory0005.htm Accessed Nov 29th 2006.

People with ME/CFS, like others, often experience great difficulty in obtaining statesickness and disability benefits and this is reflected in the very high proportion who onlysucceed by going through the stressful and bureaucratic appeals procedures. At present

ME/CFS is defined as a psychosocial illness by the Department for Work and Pensions(DWP) and medical insurance companies. Therefore claimants are not entitled to thehigher level of benefit payments. We recognise that if ME/CFS remains as one illnessand/or both remain defined as psychosocial then it would be in the financial interest of

both the DWP and the medical insurance companies. The Groups feels that patients withCFS/ ME, which is often an extremely long term condition, should be entitled to thehigher rate DLA. The sooner there is a biomedical model of assessment for this illness the

better. If a virus causes the CFS then the patients should be entitled to the higher rateDLA. (p.30) [Gibson Inquiry 2006]

Evidence suggests that benefits agency staff often err on the side of caution. A surveyconducted by the 25% ME Group in March 2004 found evidence that 59% of ME patientswho applied for DLA were unsuccessful on their first attempt. Of those 86% appealed andof those 85% were successful in their appeal. (pp 30-31) [Gibson Inquiry 2006]

There have been numerous cases where advisors to the DWP have also had consultancyroles in medical insurance companies. Particularly the Company UNUM Provident. Giventhe vested interest private medical insurance companies have in ensuring CFS/ME remainclassified as a psychosocial illness there is blatant conflict of interest here. The Group findthis to be an area for serious concern and recommends a full investigation of this

possibility by the appropriate standards body. It may even be that assessment by a medical

'expert' in a field of high controversy requires a different methodology of benefitassessment. (p.31) [Gibson Inquiry 2006]

The categorization of an illness as being psychosomatic also means a furthercategorisation of an individual as 'deviant' rather than 'ill', so that they are deniedsympathy, support, and even benefits they are entitled to. Categorised as 'deviant', the illthen suffer increasing social exclusion and material inequalities. [Hooper et al. 2003]

There are particular problems being allocated benefits - particularly Disabled LivingAllowance and Incapacity Benefit, especially given the unpredictable nature of this illness.Applying for benefits is often a traumatic experience for ME sufferers as many, like

myself, have been met with disbelieving visiting doctors. The doctors who have visited meeither didn't believe in the illness, and told me that, or were trying to rediagnose me asthey didn't believe that ME could create such severity and debilitation, nor consist of somany severe neurological symptoms. [NICE 2006]

Respondents were asked whether they had ever been refused or had difficulties in gettingstate benefits with the label ME/CFS. 55% (162) answered that they had and 42% (124)said that they had not. The remaining 2% or 6 said that this was not applicable and another50 did not tick this at all so it is reasonable to assume that 56 had not needed to apply.25% said that they had difficulties with or been refused private benefits. 65% said thatthey had not. (p.22) [Cooper 2000]

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Disadvantages and discrimination in education

People pursuing an education while suffering with CFS/ME appear to have to work harderwhile contending with disabling symptoms yet gain achievements more slowly. Theirdiagnosis does not always bring accomodation for their disability, but sometimes leads toprejudicial treatment.

The American Report states on page 8 that "the physician should work with the school tolimit class time, if necessary, and to resume school attendance gradually", but the UKReport urges "an immediate return to school" (10.12). The American Report advises"Home tuition may be an alternative" but the UK Report states "School phobia isimportant as a complication of CFS" (10.8) and "We discourage home tuition" (10.12).(p.35) [Hooper et al. 2003]

Many students commented on how teaching staff had difficulty accepting an ME/CFSdiagnosis as a genuine illness. The greatest problem faced was the attitudes of teachingstaff towards their diagnosis. Many teaching staff caused distress by not believing

ME/CFS is a medical condition and by: Demanding an explanation of the disability;Discouraging them from joining classes; Unwilling to deal with the formal paperwork;Unwilling to accept the unpredictable nature of ME/CFSc Ignoring medicaldocumentation and insisting on an able-bodied students level of performance; Accusingthe student with ME/CFS of making excuses for poor performance; insisting ME/CFS didnot exist; Labelling the student with ME/CFS as either suffering from depression or anattitude problem; Not accepting ME/CFS as a pre-existing medical condition andrequesting more reports; Discouraging ME/CFS disclosure to other staff; Not acceptingthe medical documentation when presented. (p.167) [Mungovan & England 1998]

The most disabling symptoms identified by the students are cognitive dysfunctions for

which no accommodations are made by the academic institutions. (p.22) [Morris 2003]

Numerous problems arose with lecturers, supervisors and peers andwhenever accommodations for disability are sought. Many tend toregard students with ME/CFS as lazy, malingerers or as exhibitingattitudinal problems. Participants pointed out the concessions grantedwere often minimal and made with bad grace (to the extent that somedecided to make no further requests). (p.245) [Morris 2003]

Additionally many students, who would pursue their rights further,found that the debilitation of ME/CFS had left them too exhausted to

make further negotiation. It appeared that most students merely statethat they have CFS and accept whatever accommodation is thenoffered, irrespective of whether it meets their needs (Morris 2002a;2002b). The term Chronic Fatigue Syndrome emerges from thisinquiry as a major problem as it demonstrably prejudices not only laybut even medical understanding of the condition and of sufferers needsby impacting on the credibility of students in their interactions withlecturers, disability liaison officers and peers (Morris 2001a; 2002a).This is the lived experience of tertiary students with ME/CFS. (p.250)[Morris 2003]

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Students with ME/CFS are, in practice, constrained by othersperceptions of their condition. (p.253) [Morris 2003]

Poor healthcare and estrangement from healthcare providers

A diagnosis of CFS/ME appears to lead to many problems for patients in getting properhealthcare.

Influence of general practitioners beliefs on management The doctors stereotyping ofpatients with chronic fatigue syndrome meant that the condition ceased to be seen as adiscrete disorder and became the defining feature of that patient. This value ladenapproach may have prevented general practitioners from assessing each patient asobjectively as possible. It was not surprising that this attitude, sometimes combined with a

breakdown of the relationship between doctor and patient, led to ambivalence towardstreatment options. For most of the participants, choosing appropriate treatments forchronic fatigue syndrome was like groping in the darkeither not knowing who to refer

to (GP 86) or just feeling hopeless and more hopeless (GP 14). They might thereforeconsider mental health interventions only as part of a process of trying a range oftreatments: You would do anything for these patients (GP 45). So it is not surprisingthat general practitioners described caring for patients with chronic fatigue syndrome as aburden (GP 18): I would rather treat a whole surgery full of people with irritable bowelsyndrome than people with chronic fatigue (GP 84). (p.2) [Raine, Carter, Sensky andBlack 2004]

Many issues surrounding the management of people with CFS/ME have their origins inknowledge (or lack of) and attitudes. Key issues are: _ Poor recognition of CFS/ME by

professionals _ Difficulties that arise over diagnosis _ Lack of professional and public

acceptance and acknowledgement (p.9) [Hutchinson. CMO Report 2002]

Some were concerned that their illness is not taken seriously, that some GPs showindifference, or that they do not always understand the illness and its possible severity.Some participants suggested that GPs and the wider primary healthcare team needimproved knowledge and skills to support people with chronic or incurable illness ingeneral and with CFS/ME specifically. (pp 11-12) [Hutchinson. CMO Report 2002]

A particular concern is if a referral to mental health services is made because the illness isbeing characterised as "all in the mind". There is evidence that some patients "fight" forreferrals, and in general GPs are confused over where to refer patients, so diagnosis can be

a "hit and miss" affair. This has led patients to pursue their own specialist referrals fordiagnosis; though in that situation the expressed experiences suggest that ongoing adviceand support are lacking. (p.11) [Hutchinson. CMO Report 2002]

Sadly, the overall experience of specialist and hospital services among participants waspredominantly negative. [Hutchinson. CMO Report 2002]

Views were expressed that when GPs were confronted with a patient whose illness iscomplex and does not improve with treatment then they can feel helpless, and mayeffectively "withdraw to the sidelines" leaving the patient to feel totally alone. "Dumpedin the community - totally invisible." (p.14) [Hutchinson. CMO Report 2002]

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A proportion of patients feel alienated from clinical professionals by early responses totheir symptoms, illness experience, and disability. Actual or perceived dismissiveness,incomprehension, or even disbelief are encountered, and have profoundly negativeimpacts. (p.30) [Hutchinson. CMO Report 2002]

The Working Group is concerned about several issues. Patients and carers often encounter

a lack of understanding from healthcare professionals. This lack seems to be associatedwith inadequate awareness and understanding of the illness among many health

professionals and in the wider public. (p.67) [Hutchinson. CMO Report 2002]

Why is this report necessary? CFS/ME is one of the most contentious illnesses in modernmedicine. Due to a lack of knowledge of and research into the illness in the UK it existssomewhere between the schools of psychology and neurology. At present the onlytreatments are symptomatic and psychosocial. For the extremely affected sufferer this isnot satisfactory. Nor is the current state of affairs satisfactory to this Group. (p.7) [GibsonInquiry 2006]

The close link with depression in many ME cases may be explained by the nature of theillness. It is likely the inactivity and lethargy caused by the ME combined with

psychological aspects such as the sense that professionals do not believe them, socialstigma, lack of classification or possibility of a cure, leave the ME sufferer moredisillusioned than those with other chronically disabling diseases and thus more prone todepression. (p.26) [Gibson Inquiry 2006]

The Group heard a number of extremely disturbing testimonials from patients. Theseincluded patients whom had been dismissed by their GPs as 'attention seeking' or indeedmalicious in intent. (pp 30-31) [Gibson Inquiry 2006]

The material effects of such sloppy 'science' have had two main consequences for MEsufferers: firstly, the medical impairments of the illness have often been ignored and leftuntreated, and many sufferers therefore become severely disabled, their physical healthabsolutely devastated and their chances of a restoration to good health uncertain at best.Secondly, children in particular end up victims of institutional abuse (though this canhappen to adults too). In the case of children, they may be forcibly removed from theirconcerned parents and subjected to draconian 'treatments' that could, quite easily, betermed abuse. (p.6) [Hooper et al. 2003]

The women described the psychologizing of their health problems as especially

stigmatizing. It occurred primarily before a diagnosis was established, although it alsooccurred afterward, as the illnesses are associated with psychological causal mechanismsin the minds of some caregivers. Some interviewees felt that certain doctors, in advanceand without having carried out proper examinations, categorized their problems asfictitious or related to psychological reasons, and this was experienced as deeply violating.(p.6) [sbring & Nrvnen. 2002]

The interviewees also described withdrawing from caregivers, doctors in particular. Afterfeeling as though they were called into question or violated in another way by the doctor,the women hesitated to seek care or waited as long as possible before contacting him orher again. (p.8) [sbring & Nrvnen. 2002]

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Different strategies are developed to handle the encounters with these patients. The resultsalso illuminate the physician's interpretations of patients in moralising terms. Conditionsgiven the status of illness were regarded, for example, as less serious by the physiciansthan those with disease status. Scepticism was expressed regarding especially CFS, butalso fibromyalgia. Moreover, it is shown how the patients are characterised by the

physicians as ambitious, active, illness focused, demanding and medicalising. The patient

groups in question do not always gain full access to the sick-role, in part as a consequenceof the conditions not being defined as diseases. [sbring & Nrvnen. 2003]

In this study of 68 CFS patients referred to a hospital fatigue clinic, nearly half hadpreviously recieved a psychiatiric dignosis from a GP or hospital doctor. Two-thirds ofthem had been incorrectly diagnosed, with most showing no evidence of past or currentdisorder. In contrast, one-third of those who had never been given a psychiatric diagnosisactually had a treatable psychiatric disorder in addition to CFS. [Deale and Wessley 2000]

Some patients with CFS/ME have reported that exercise programmes have, at times, beenapplied inflexibly without consideration of individual circumstances and goals, sometimeswith significant adverse responses. (p.139) [NICE 2006]

Scepticism on the part of GPs in recognising that CFS actually exists remains a problem tothis day. Only 56% of the GP responders believe that CFS is a recognised conditiondespite findings from reports by the joint Royal Colleges and the National Task Force

being in the public domain. Of the 44% who did believe that the illness exists, nonereported using the CDC or Oxford criteria for CFS definition. This is surprising as bothcase definitions are readily available to medical and research staff and patient groupsalike. [Thomas and Smith 2005]

When questioned, only 57% of the GPs surveyed were aware that a CFS specialist wasconsulting within their local health authority region. The majority of those who were notaware of this referred patients to general medical outpatient clinics. This has been

problematical in the past. Unless the patient is fortunate enough to be referred to aphysician who, if not knowledgeable on the subject, is aware of specialist help, this willinvariably result in the patient being told that there is 'nothing physically wrong withthem'. The patient then returns to a GP who has two courses of action open to them: referthe patient to another outpatient department or try to manage the patient's conditionthemselves. This is bound to result in frustration on the part of the physician, who has the

patient's best welfare at heart, as much as the patient. [Thomas and Smith 2005]

It is important during the process of diagnosing CFS, that other illnesses presentingfatigue-like symptoms are ruled out. However, only two-thirds of the GP respondentsreported conducting further investigations to exclude these conditions. [Thomas and Smith2005]

When respondents were asked to tick 'other concerns' the kind of concern was notsolicited, but they were asked to specify what these were. The majority of respondents thatdid, referred to the negative attitudes towards the illness and particularly the disbelief andhostility encountered from the medical profession. A typical comment was ' the ignoranceof the medical profession and the attitude of the media and the public'. Another stated'finding doctors sympathetic to ME' (p.9)[Cooper 2000]

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Inhibition of research into biological causes of CFS/ME

A search on PubMed (National Library of Medicine and the National Institute of Health)on Dec 1st 2006, returned 3308 titles for Chronic Fatigue Syndrome dating from May,1997 to the present. Covering the same period a search for Multiple Sclerosis returned22990 matches.

No representative who appeared at the Oral Hearings proposed CFS/ME was entirelypsychosocial, so why has this model taken such a prominent role in the UK? [GibsonInquiry 2006]

The Group believes that the MRC should be more open-minded in their evaluation ofproposals for biomedical research into CFS/ME and that, in order to overcome theperception of bias in their decisions, they should assign at least an equivalent amount offunding (11 million) to biomedical research as they have done to psychosocial research.[Gibson Inquiry 2006]

However, there is clearly a need for research into causation, the spectrum of the illnessover time, therapeutic interventions and models of care. It is indeed surprising that, giventhe talent and interest that there is, huge frustration remains in providing funding forresearch and the different approaches to research. The NICE guidelines must surelyrecognise the inadequacy of our knowledge in all these areas and indeed we may inhibitdiscovery and make profound mistakes in the absence of a national, all round research

policy. (p.28) [Gibson Inquiry 2006]

The underlying theme in all or our hearings was the paucity of research into causes. (p.28)[Gibson Inquiry 2006]

By contrast, since April 2003 the MRC has funded five applications relating to CFS/ME,mostly in the psychiatric/psychosocial domain (Professor Francis Creed, Professor KBhui, Professor Peter White's PACE trial, Alison Wearden's FINE trial and RichardMorriss' study of "medically unexplained symptoms"). (p.29) [Gibson Inquiry 2006]

Biomedical applications in respect of ME/CFS known to have been rejected include thoseby Professor Jill Belch (herself a Principal Fellow of the MRC) and Dr Vance Spence ofDundee, as well as Dr Jonathan Kerr of St Georges, London. (p.29) [Gibson Inquiry 2006]

ME and CFS have been defined as neurological illnesses by the World HealthOrganisation. Various clinical and epidemiological research studies in countries around

the world have suggested CFS/ME to have a biomedical cause. The UK has not been amajor player in the global progress of biomedical research into CFS/ME. Although someinteresting biomedical research has been done in the UK precedence has been given to

psychological research and definitions. (p.33) [Gibson Inquiry 2006]

There is a great deal of frustration amongst the CFS/ME community that the progressmade in the late 1980s and early 1990s toward regarding CFS/ME as a physical illness has

been marginalised by the psychological school of thought. It is clear the CFS/MEcommunity is extremely hostile to the psychiatrists involved. (p.33) [Gibson Inquiry 2006]

We recommend that this condition be recognised as one which requires an approach asimportant as heart disease or cancer. There is no compelling evidence it is a purely

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psychosocial. Where the disease or diseases fit in the spectrum of psycho or biomedicaldisturbances in any individual requires much further research. However, this will dependon well-funded research that must be made a priority in our health research programme.(p.34) [Gibson Inquiry 2006]

Despite the findings of the CMO's Report some three years ago. There has been no

massive investment in funding of research into ME. Instead, we have seen a review oftreatment by NICE based on existing evidence and existing symptomatic techniques. Wemust research to find alternatives. (p.34) [Gibson Inquiry 2006]

The Immediate Future This group believes that the MRC should be more open-minded intheir evaluation of proposals for biomedical research into CFS/ME and that, in order toovercome the perception of bias in their decisions, they should assign at least anequivalent amount of funding (11 million) to biomedical research as they have done to

psychosocial research. It can no longer be left in a state of flux and these patients orpotential patients should expect a resolution of the problems with only an intense researchprogramme can help resolve. It is an illness whose time has certainly come. (p.35) [GibsonInquiry 2006]

Influenced by these psychiatrists, Government bodies such as the Medical ResearchCouncil have continued to propagate the same falsehoods with the result that patients areleft without any hope of understanding or of health service provision or delivery. As aconsequence, Government funding into the biomedical aspects of the disorder is non-existent (p.4) [Hooper et al. 2003]

In relation to ME/CFS at least, flawed, unsubstantiated theories have been uncriticallyadopted and treated as 'fact', even against the already substantial (and substantiated) body

of bio-medical evidence which continues to grow. [Hooper et al. 2003]

Despite the findings from the US that CBT is ineffective, in the UK Wessely Schoolpsychiatrists have just been granted a further 11.1 million (2.6 million from the MRCplus 8.5 million from Government) in order to "strengthen" their own very weakevidence that such mind-altering management regimes are effective and are the best"evidence-based" management option; this sum is in addition to previous funding of over4 million. (p.46) [Hooper et al. 2003]

Whilst many appeared willing to consider management therapy research, almost all peoplewith ME with whom we come in contact are very concerned that without significant

investment in biomedical research (eg tissue testing), the underlying causes of the illnesswill not be identified, hampering diagnosis and the development of treatment. (p.28)[Tymestrust 2005]

Examples of recent NHS Research Ethics Committee approvedresearch

[National Research Register 2006]

IntroductionMuch of the research conducted in the UK into psychological and psychosocial theories ofCFS/ME is not only approved by, but also receives funding from the NHS and MRC.

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Research investigating psychosocial and psychological theories about CFS/ME has beenconducted for many years and has contributed nothing of value to participants, otherpatients, science or medicine. Continuing such research appears to be entirelygratuitous. This type of research does, however, discredit people diagnosed with CFS/MEas it suggests that patients symptoms are simulated or imagined or exaggerated.Furthermore, it fosters a climate of discrimination against people diagnosed with CFS/ME

who must contend not only with disabling illness but also harassment and discrimination.

People with CFS/ME who enrol as participants in this type of research will beinadvertently contributing to derogatory theories about their illness. They are beingasked to participate in research that might contribute to them being treated withdiscrimination in the delivery of healthcare, education, state benefits and employmentrights. Have participants been warned of these readily foreseeable adverse effects oftheir participation? Are potential participants given complete information regarding theresearch objectives prior to giving Informed Consent?

Not only are participants in such research likely to contribute to additional suffering for

themselves and others, but as many will previously and currently be payers of tax andnational insurance, and as much of this is publicly funded and approved research, theyhave inadvertently helped to pay for the privilege.

TI:Core beliefs and affective information processing in chronic fatigue syndrome:Comparison with rheumatoid arthritis patients and healthy controls.PI:N0281168748PR:Wolverhampton City Primary Care TrustRE:West Midlands Regional OfficeMR:To determine the types of core beliefs (beliefs about the self, others and the world) that individuals withchronic fatigue syndrome hold and to assess whether these beliefs are different to individuals with anotherchronic illness (rheumatoid arthritis) or no illness at all. Specifically, it is predicted that individuals with

chronic fatigue syndrome will hold beliefs concerning emotion inhibition ( the tendency to suppressemotions rather than express them).MT:Questionnaire design.SA:90 participants will be recruited (30 per group)OU:1. Scores on self-report measures2. Emotional stroop task (reaction times and accuracy)3. Face processing (accuracy,distinctiveness/intensity ratings)MC:This record refers to a multi-centre study led by another centreLC:University of BirminghamEC:05/MREC07/43SD:1/6/2005ED:30/6/2006ST:Complete

AU:Dr Kirsty/KL GillingsAD:University of Birmingham, Department of Clinical Psychologuy, Edgbaston, Birmingham, B15 2TT,UKPH:07950551610EM:[email protected]:5MVPT:NPF1:University of BirminghamF3:250PK:MeSH terms not yet assigned

TI:Living with chronic fatigue syndrome (CFS), attributions, perceptions, health beliefs

and coping with illness and treatmentPI:N0263148868

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PR:University College London Hospitals NHS Foundation TrustRE:London Regional OfficeMR:To evaluate the affect of a battery of treatments received & to find out whether there were significantdifferences in treatment outcome between patients who attributed the cause of their illnessMT:Database AnalysisSA:60 patients from Complementary MedicineOU:To measure the effectiveness of a range of treatments received by CFS patients. To measure the possible

influence of health beliefs and attribution on the treatment outcomeMC:This record refers to a multi-centre study led by another centreSD:1/8/2004ED:1/12/2006ST:OngoingAU:Dr M JenkinsAD:Complementary Medicine, Royal London Homoeopathic Hospital, Greenwell Street, London, W1W5BP, UKPH:020 7391 8895FA:020 7391 8812EM:[email protected]:RRVPT:Reducing inequalities: social psychological and biological pathways to inequalities in health; the

development of tools to quantify health problems; examination of differing care arrangementsF4:NHS R&D Support FundingF5:2006/07F6:4716.8644PK:MeSH terms not yet assigned

TI:A cross-sectional comparison of chronic fatigue and chronic fatigue syndrome betweenBrazil and the United Kingdom.PI:N0116140770PR:Kings College Hospital NHS Trust R&D ConsortiumRE:London Regional OfficeMR:Primary Objectives:

1. To quantitatively compare the perpetuating factors of fatigue amoung patients with chronic (CF) betweenBrazil and the UK: somatic attribution of cause, fear of exercise, aviodance and focusing on bodilysymptoms.2. To qualitatively compare the illness model of patients meeting the case definition of chronic fatiguesyndrome (CFS) between Brazil and the UK.MC:This record refers to a single-centre studySD:29/3/2004ED:30/9/2005ST:CompleteAU:Professor S WesselyAD:Academic Dept of Psychological Medicine, GKT School Medical School, 103 Denmark Hill, London,SE5 8AZ, EnglandPH:0207 848 0796

FA:0207 346 3363EM:[email protected]:RJ2PT:Healthcare from the patient's perspectiveF1:Institute of Social PsychiatryF2:207514F4:NHS R&D support fundingF5:2005/2006F6:27794PK:MeSH terms not yet assigned

Comment: This research demeans people diagnosed with CFS/ME in the UK. No wonder

so many people with these diagnoses have difficulty getting proper healthcare whenprofessionals who read medical journals find items of research referring to, somatic

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attribution of cause, fear of exercise, aviodance and focusing on bodily symptoms. Thisis another piece of research that is funded by the NHS (69,882). Following is theBrazilian connection of this research project described at the 2ndAnnual InternationalMental Health (IMH) at the IOP (IMH 2005)

A cross-cultural comparison of chronic fatigue and chronic fatigue syndrome between

Brazil and the United Kindgom Dr Hyong Jin Cho IOP

Chronic fatigue syndrome (CFS) as a severe illness with physical causes seems to be aunique phenomenon in the West. Several cognitive-behavioural factors are believed to

perpetuate CFS: somatic attribution of cause, fear of exercise, avoidance as copingstrategy and focusing on bodily symptoms. These perpetuating factors seem to beinfluenced by several sociocultural factors uniquely observed in the West-e.g. awarenessof CFS among the population, media coverage, litigation and overemphasis on a

biomedical model of health care. Brazil is a country where CFS is practically unknownand the above-mentioned scoiocultural factors are far scarcer than in the UK.

The hypothesis are: 1) The perpetuating factors of fatigue are less prevalent amongBrazilian patients with chronic fatigue (CF: a subsyndromal counterpart to CFS) than theirBritish counterparts. 2) Brazilian patients with CF are less disabled.

A cross-sectional survey at primary care level is being conducted in So Paulo andLondon. Consecutive attendees to general practices, aged 18-45 years, are being screenedwith the Chalder Fatigue Questionnaire and GHQ-12. All patients with CF will answer thequestionnaires on the perpetuating factors and disability. They will also undergoapplication of the CFS case definitions and a psychiatric interview. We screened 3930attendees and interviewed 580 CF patients in Brazil. The survey in the UK is in progress

and we anticipate that we will have preliminary results of this cross-cultural comparisonby the occasion of the present conference, August 2005.

TI:An investigation of the role of fatigue related fear on disability for individualsdiagnosed with Chronic Fatigue Syndrome and Fibromyalgia SyndromePI:N0207138691PR:Royal Liverpool and Broadgreen University Hospitals TrustRE:North West Regional OfficeMR:An investigation of the role of fatigue related fear on disability in Chronic Fatigue Syndrome andFibromyalgia Syndrome.MT:A cohort design study consisting of a group of individuals diagnosed with either CFS or FMS. Thestudy will include both cross sectional and longitudinal data collection.SA:120 participants - approx 10 per month. The age group will be from 17 years upwards.OU:1. Test a simplified model from chronic pain studies that high fatigue-related fear leads to increaseddisability for individuals with chronic fatigue.2. To determine whether fatigue related fear is more disabling than fatigue itself and other variables knownto maintain disability.3. To examine whether the duration of symptoms of chronic fatigue is associated with fatigue related fear.MC:This record refers to a multi-centre study led by another centreLC:ccoSD:1/2/2004ED:1/9/2005ST:CompleteAU:Mrs Laura HarwoodAD:Department of Clinical Psychology, University of Liverpool, Whelan Building, Quadrangle, Brownlow

Hill, Liverpool, L69 3GBPH:01244 7945530

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FA:0151 794 5537EM:[email protected]:RQ6PT:Delivering effective health servicesF1:No External FundingF4:NHS R&D Support FundingF5:2005/06

F6:2726.7538PK:MeSH terms not yet assigned

TI:Experimental evidence to show whether people witn Chronic Fatigue Syndrome (CFS)demonstrate an attentional or memory bias towards symptom-related stimuli. ProtocolVersion 1 dated 7.10.03.PI:N0176135496PR:Oxford Radcliffe Hospitals NHS TrustRE:South East Regional OfficeMR:1. Compared to people with Multiple Sclerosis (MS) and healthy people, do people with ChronicFatigue Syndrome (CFS) pay more attention to symptom-relevant information (I.e. symptoms chaacteristicof CFS) than neutral information? 2. Compared to people with MS and healthy people, do people with CFS

remember more symptom-relevant information than neutral information? 3. In people with CFS are anydifferences in attention and memory for symptom-relevant information (compared to neutral information)related to symptoms/levels of activity/mood?MT:Questionnaire, cross-sectional studySA:30 healthy people, 30 pateints, 30 control patientsOU:Completed MMSE and NART, completed self-report measures, data collected from computer dot probetask and free recall memory task. Statistical analysis will then be used to examine significant differencesbetween conditions and groups, based on hypotheses and research questions.MC:This record refers to a single-centre studySD:5/1/2004ED:30/9/2004ST:CompleteAU:Ms Amy Silver

AD:The Ethox Centre, Institute of Health Sciences, Old Road Campus, Headington, Oxford, OX3 7LF, UKPH:01865 226431FA:01865 226364EM:[email protected]:RNUPT:Oxford Mental Health Collaborative Research Grouping (CRG) R&D ProgrammePK:FATIGUE SYNDROME CHRONIC [psychology]; FATIGUE SYNDROME CHRONIC[complications]; MEMORY DISORDERS [psychology]; MEMORY DISORDERS [etiology]; MULTIPLESCLEROSIS [psychology]; MULTIPLE SCLEROSIS [complications]SK:HUMAN; CROSS-SECTIONAL STUDIES

TI:How do the beliefs and responses of significant others' of patients with chronic fatigue

syndrome (CFS) impact on the patient's symptoms, adaptation and functioning?PI:N0207125755PR:Royal Liverpool and Broadgreen University Hospitals TrustRE:North West Regional OfficeMR:How do the beliefs and responses of significant others' of patients with chronic fatigue syndrome (CFS)impact on the patient's symptoms, adaptation and functioning?MT:This is a cross-sectional study of patients and their nominated closest adult family member (their'significant other')SA:176: 88 patients and 88 significant others. Participants will be aged 16 and over, with no upper age limit.OU:The data obtained from the study will be used to obtain a detailed understanding of significant others'beliefs and compared to the measures taken of patient functioning to produce quantitative measures whichmight predict patient functioning.MC:This record refers to a single-centre study

SD:1/5/2003ED:1/9/2005

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ST:CompleteAU:Dr Frederick J NyeAD:Tropical and Infectious Diseases Unit, RLUH, Liverpool, L7 8XP, EnglandPH:0151 706 3836FA:0151 706 5944EM:[email protected]:RQ6

PT:Delivering effective health servicesF1:Economic and Social Research CouncilF3:10000F4:NHS R&D Support FundingF5:2005/06F6:2726.7538PK:ADAPTATION PSYCHOLOGICAL; FATIGUE SYNDROME CHRONIC [psychology]SK:HUMAN; CROSS-OVER STUDIES; ADOLESCENT; ADULT

Research Titles

With parallel studies removed, the titles of completed Single Centre research approved by

NHS Research Ethics Committees show (as well as I can split them) 98 biologicalresearch and 66 psychological research. That is 40% psychological research in the UKinto Chronic Fatigue Syndrome. This is following many years and numerous projects ofsuch research that has failed to help people with these diagnoses. This list of recentresearch titles approved by NHS RECs, many of which are/were funded by the NHS andMRC shows the kind of prejudicial and often strange ideas that some researchers haveabout CFS/ME. This research influences health professionals and others opinions andimpacts on patients lives.

TI:A cohort study of chronic fatigue in Brazil: Prognosis and perpetuating factors TI:Aerobic exercise and Fluoxetine in the treatment of chronic fatigue syndrome TI:Aerobic exercise in chronic fatigue syndrome TI:Ambulatory study of the Psychophysiological Responses to Activity in Patients

with Chronic Fatigue Syndrome and Sedentary Controls TI:An investigation into the role of psychological factors in the symptomatology of

chronic fatigue syndrome (CFS); information processing of self-referent emotionalmaterial

TI:A pilot study for a community randomised controlled trial of self help versus notreatment in the prevention of chronic fatigue and chronic fatigue syndrome (CFS)following glandular fever.

TI:A pilot study of a new instrument to measure family responses to chronic

fatigue syndrome TI:A pilot study of guided self-help for adolescents with chronic fatigue syndrome. TI:A placebo, double blind, cross -over study on Immuvit (Ginseng extract) on

Chronic Fatigue Syndrome. TI:A qualatitive study of mindfulness base cognitive therapy (MBCT) group for

people with chronic fatigue syndrome (CFS). TI:A randomised controlled trial of cognitive behaviour therapy for chronic fatigue

syndrome TI:Are thoughts about activity related to the levels of physical activity seen in

chronic fatigue Syndrome (CFS) patients?

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TI:A study of the quality of life and clinical characteristics of patients with chronicfatigue syndrome attending a psychiatric fatigue clinic and an immunology fatigueclinic

TI:A study to investigate health beliefs of people with non-epileptic seizures(NES) and people with chronic fatigue syndrome (CFS)

TI:Attention training in Chronic Fatigue Syndrome: a case series evaluation. TI:Causal attributions for somatic sensations in patients with Chronic FatigueSyndrome and their relatives.

TI:Childhood experiences and parenting in adults with chronic fatigue syndrome,adults with multiple sclerosis and a nromal control group: a pilot study (097/99)

TI:Childhood experiences of illness and parenting in adults with chronic fatiguesyndrome and adults with diabetes mellitus: A pilot study.

TI:Cognitive behaviour therapy (CBT) in Chronic Fatigue Syndrome (CFS): arandomised controlled trial of a group programme for the primary care population.

TI:Cognitive Behaviour Therapy vs Relaxation for Chronic Fatigue Syndrome:Outcome at five year follow-up.

TI:Does a group occupational therapy programme for clients with chronic fatiguesyndrome improve functioning scores as measured by the functional limitations

profile? TI:Effectiveness of Counselling within the treatment of CFS TI:Evaluation of a rehabilitation programme for patients with chronic fatigue

syndrome TI:Evaluation of the Wellness Enhancement Learning programme for patients with

Chronic Fatigue Syndrome/ME TI:Experiences and expectations of Chronic Fatigue Syndrome (CFS) patients who

have undergone treatment through a CFS group based on CBT

TI:Experimental evidence to show whether people witn Chronic Fatigue Syndrome(CFS) demonstrate an attentional or memory bias towards symptom-relatedstimuli. Protocol Version 1 dated 7.10.03.

TI:Exploration of Perceived Changes in Occupational Function in Chronic FatigueSyndrome

TI:Family focussed Cognitive Behavioural Therapy for Adolescents with ChronicFatigue Syndrome

TI:Family history study of chronic fatigue syndrome. TI:Frequency of attendance in general practice before development of chronic

fatigue syndrome: a case control study

TI:Group therapy for chronic fatigue syndrome. TI:How do the beliefs and responses of significant others' of patients with chronicfatigue syndrome (CFS) impact on the patient's symptoms, adaptation andfunctioning?

TI:Identity and Illness in Context: The Case of Chronic Fatigue Syndrome TI:Information-processing biases in patients with the Chronic Fatigue Syndrome

(CFS) and comparison groups. TI:Neurobiological changes and predictors of outcome after CBT for chronic

fatigue syndrome TI:People with chronic fatigue syndrome and their perspective of 'self' TI:Personality dimensions and family functioning in chronic fatigue syndrome: A

comparison with depression

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TI:Personality traits in Chronic Fatigue Syndrome TI:Pilot study for a narrative analysis of patient accounts of Chronic Fatigue

Syndrome TI:Psychological intervention in patients with chronic fatigue syndrome. TI:Quality of Life and Performance Perception in Patients with Chronic Fatigue

Syndrome TI:Randomised controlled trial of cognitive behaviour therapy versus graded

exercise in the chronic fatigue syndrome TI:Randomized controlled trial of cognitive behaviour psychotherapy in chronic

fatigue syndrome. TI:Self esteem, attribution an coping in chronic fatigue syndrome (+1) TI:Short term intervention for people with chronic fatigue syndrome: The Patient's

Perspective. TI:Social Identity in Chronic Fatigue Syndrome TI:The effect of Transcutaneous Electrical Nerve stimulation (TENS) on pain

perception and functional ability in patients with Chronic Fatigue Syndrome. TI:The effects of Mindfulness-Based Stress Reduction (MBSR) in the treatment of

Chronic Fatigue Syndrome (CFS) in a Group Setting TI:The experience of living with chronic fatigue syndrome. TI:The Experience of Living with Chronic Fatigue Syndrome/M.E. TI:The relationship between social support and severity of symptoms in chronic

fatigue syndrome TI:University of Sheffield Integrated Health Clinic - A pilot clinic to test the

acceptability and effectiveness of an adapted model of brief interpersonalpsychotherapy for students presenting with stress-related medical symptoms

TI:Using beliefs to predict exercise tolerance in patients with chronic fatigue

syndrome

Excerpts fromResearch Governance Framework for Health and Social Care

Second edition, 2005First published: March 2001Second edition: April 2005 Crown Copyright 2005Produced by COI for the Department of Health

1.1 The Government is committed to enhancing the contribution of research to health andsocial care. Research is essential to the successful promotion and protection of health and

well-being, and also to modern, effective e health and social care services. At the sametime, research can involve an element of risk, both in terms of return on investment andsometimes for the safety and well-being of the research participants. Proper governanceof research is essential to ensure that the public can have confidence in, and benefit from,quality research in health and social care. The public has a right to expect high scientific,ethical and financial standards, transparent decision-making processes, clear allocation ofresponsibilities and robust monitoring arrangements. [p.6]

2.2 ETHICS2.2.1 The dignity, rights, safety and well-being of participants must be the primaryconsideration in any research study. Box A (see page 10) describes a scenario to illustrate

good practice in protecting research participants rights within a study. [p.11]

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2.2.3 Informed consent is at the heart of ethical research. Most studies involvingindividuals must have appropriate arrangements for obtaining consent, and the ethicsreview process pays particular attention to those arrangements. [p.11]

2.2.8 Some research may involve an element of risk to those participating in it. If there areany risks to participants, the risks must be in proportion to the potential benefit.7 Risks,

pain or discomfort must always be kept to a minimum, and explained clearly both to therelevant research ethics committee8 and to participants. It must always be explainedwhether there are arrangements for compensation in the unlikely event of non-negligentharm.

2.3 SCIENCE2.3.1 All existing sources of evidence, especially systematic reviews, must be consideredcarefully before undertaking research. Research which duplicates other workunnecessarily, or which is not of sufficient quality to contribute something useful toexisting knowledge, is unethical.

2.7.2 The key elements of a quality research culture are: respect for participants dignity, rights, safety and well-being; valuing the diversity within society; personal and scientific integrity; leadership; honesty; accountability; openness; clear and supportive management.

3.4.1 Effective and responsive services depend on good research. Through this frameworkand related provisions, the Government and its partners strive to ensure that researchconducted in health and social care in England offers the likelihood of real benefits eitherto those who participate, or to those who use services subsequently, or both. Anyone usinghealth and social care services should give serious consideration to becoming involved indeveloping or undertaking research studies.

3.6.3 For research in health or social care, the chief investigator is responsible for ensuringthe following. The research team gives priority at all times to the dignity, rights, safety and well-beingof participants.

3.7 RESPONSIBILITIES OF RESEARCH FUNDERS3.7.1 Organisations that fund research have a responsibility to ensure that it is a proper useof the funds they control and provides value for money.3.7.2 The main research funder plays a critical role in assuring the quality of a study. Itwill normally take the lead in establishing that the research proposal is worthwhile, of highscientific quality, and represents good value for money.20

3.12.6 Research ethics committees provide an independent opinion. The decision whetheror not to give permission for research in a care organisation rests with that organisation.Similarly, Directors of Social Services are responsible for considering permission for

social care research conducted within their local authorities. Subject to a favourable

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ethical opinion, health and social care organisations will not normally withhold permissionunless there are local factors that would lead to an unacceptable impact on the quality ofhealth or social care.

3.12.7 It is not for research ethics committees or reviewers to give legaladvice, nor are they liable for any of their decisions in this respect. It is

the researchers and the health or social care organisations32 who havethe responsibility not to break the law. If a research ethics committeesuspects that a research proposal might contravene the law, it isexpected to advise both the chief investigator and the appropriateauthority. Then the chief investigator and the organisation will need toseek legal advice. The same applies to those under taking ethics reviewof social care research.

4.8 Nothing in this research governance framework is intended totransfer the legal duties of health and social care organisations to

sponsors or to others. Whoever takes on sponsorship, if a study affectsa health or social care organisations duties, it remains thatorganisations responsibility to satisfy itself that there are systems toconduct the study to appropriate scientific and ethical standards.

5.9 In the case of misconduct, professional groups are subject to disciplinary action bytheir professional bodies. The Council for the Regulation of Health Care Professionals will

promote best practice and cooperation between regulatory bodies. For example, doctorsare responsible to the General Medical Council for their professional conduct asresearchers as well as clinicians. [p.52]

Excerpts fromGovernance arrangements for NHS Research Ethics Committees

[Department of Health 2001]

1.3 The Research Governance Framework states that the dignity, rights, safety and well-being of participants must be the primary consideration in any research study. TheDepartment of Health requires that all research falling within certain categories (set out in3.1) is reviewed independently to ensure it meets the required ethical standards.

1.10 The protection of research participants is best served by close co-operation andefficient communication amongst all those who share the responsibility for it. Whilst not

sacrificing the independence of their decision on the ethics of a proposal, RECs should,where appropriate, work closely with actual and potential participants, researchers,funders, sponsors, employers, care organisations and professionals - and each other - inorder to achieve this goal.

[Comment. I would very much like to see the evidence that people diagnosed withCFS/ME and their patient organizations have been actively involved prior to RECs givingethical approval of some psychological research into the illness.]

2.2 The purpose of a Research Ethics Committee in reviewing the proposed study is toprotect the dignity, rights, safety and well-being of all actual or potential research

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participants. It shares this role and responsibility with others, as described in the ResearchGovernance Framework for Health and Social Care.

2.3 RECs are responsible for acting primarily in the interest of potential researchparticipants and concerned communities, but they should also take into account theinterests, needs and safety of researchers who are trying to undertake research of good

quality. However, the goals of research and researchers, while important, should alwaysbe secondary to the dignity, rights, safety, and well-being of the research participants.

2.4 RECs also need to take into consideration the principle of justice. This requires thatthe benefits and burdens of research be distributed fairly among all groups and classes insociety, taking into account in particular age, gender, economic status, culture and ethnicconsiderations. In this context the contribution of previous research participants shouldalso be recalled.

2.5 RECs should provide independent, competent and timely review of the ethics ofproposed studies. Although operating within the Governance Framework determined bythe Department of Health, in their decision-making RECs need to have independence from

political, institutional, profession-related or market influences. They need similarly todemonstrate competence and efficiency in their work, and to avoid unnecessary delay.

2.6 In common with all those involved in research in the NHS and Social Careenvironments, RECs should have due regard for the requirements of relevant regulatoryagencies and of applicable laws. It is not for the REC to provide specific interpretation ofregulations or laws, but it may indicate in its advice to the researcher and host institutionwhere it believes further consideration needs to be given to such matters. 7.3 Standardoperating procedures shall be compatible with European and UK law, and, where

appropriate, to the relevant provisions in Good Clinical Practice.

7.30 Reports to the committee should also be required if there are any other unusual orunexpected results which raise questions about the safety of the research. (See Section Bfor further details).

7.31 Reports on success (or difficulties) in recruiting participants provide the REC withuseful feedback on perceptions of the acceptability of the project among potential research

participants. RECs may wish to request such reports where they anticipate potentialdifficulties.

Declaration of Helsinki

[World Medical Association 2006]

Ethical Principles for Medical Research Involving Human Subjects

A. INTRODUCTION

1. The World Medical Association has developed the Declaration of Helsinkias a statement of ethical principles to provide guidance to physicians andother participants in medical research involving human subjects. Medical

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research involving human subjects includes research on identifiable humanmaterial or identifiable data.

2. It is the duty of the physician to promote and safeguard the health of thepeople. The physician's knowledge and conscience are dedicated to thefulfillment of this duty.

3. The Declaration of Geneva of the World Medical Association binds thephysician with the words, "The health of my patient will be my firstconsideration," and the International Code of Medical Ethics declares that,"A physician shall act only in the patient's interest when providing medicalcare which might have the effect of weakening the physical and mentalcondition of the patient."

4. Medical progress is based on research which ultimately must rest in part onexperimentation involving human subjects.

5. In medical research on human subjects, considerations related to the well-being of the human subject should take precedence over the interests ofscience and society.

6. The primary purpose of medical research involving human subjects is toimprove prophylactic, diagnostic and therapeutic procedures and theunderstanding of the aetiology and pathogenesis of disease. Even the best

proven prophylactic, diagnostic, and therapeutic methods mustcontinuously be challenged through research for their effectiveness,efficiency, accessibility and quality.

7. In current medical practice and in medical research, most prophylactic,diagnostic and therapeutic procedures involve risks and burdens.

8. Medical research is subject to ethical standards that promote respect for allhuman beings and protect their health and rights. Some research

populations are vulnerable and need special protection. The particularneeds of the economically and medically disadvantaged must berecognized. Special attention is also required for those who cannot give orrefuse consent for themselves, for those who may be subject to givingconsent under duress, for those who will not benefit personally from theresearch and for those for whom the research is combined with care.

9. Research Investigators should be aware of the ethical, legal and regulatoryrequirements for research on human subjects in their own countries as wellas applicable international requirements. No national ethical, legal orregulatory requirement should be allowed to reduce or eliminate any of the

protections for human subjects set forth in this Declaration.

B. BASIC PRINCIPLES FOR ALL MEDICAL RESEARCH

10. It is the duty of the physician in medical research to protect the life, health,privacy, and dignity of the human subject.

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11. Medical research involving human subjects must conform to generallyaccepted scientific principles, be based on a thorough knowledge of thescientific literature, other relevant sources of information, and on adequatelaboratory and, where appropriate, animal experimentation.

12. Appropriate caution must be exercised in the conduct of research which

may affect the environment, and the welfare of animals used for researchmust be respected.

13. The design and performance of each experimental procedure involvinghuman subjects should be clearly formulated in an experimental protocol.This protocol should be submitted for consideration, comment, guidance,and where appropriate, approval to a specially appointed ethical reviewcommittee, which must be independent of the investigator, the sponsor orany other kind of undue influence. This independent committee should bein conformity with the laws and regulations of the country in which theresearch experiment is performed. The committee has the right to monitor

ongoing trials. The researcher has the obligation to provide monitoringinformation to the committee, especially any serious adverse events. Theresearcher should also submit to the committee, for review, informationregarding funding, sponsors, institutional affiliations, other potentialconflicts of interest and incentives for subjects.

14. The research protocol should always contain a statement of the ethicalconsiderations involved and should indicate that there is compliance withthe principles enunciated in this Declaration.

15. Medical research involving human subjects should be conducted only by

scientifically qualified persons and under the supervision of a clinicallycompetent medical person. The responsibility for the human subject mustalways rest with a medically qualified person and never rest on the subjectof the research, even though the subject has given consent.

16. Every medical research project involving human subjects should bepreceded by careful assessment of predictable risks and burdens incomparison with foreseeable benefits to the subject or to others. This doesnot preclude the participation of healthy volunteers in medical research.The design of all studies should be publicly available.

17. Physicians should abstain from engaging in research projects involvinghuman subjects unless they are confident that the risks involved have beenadequately assessed and can be satisfactorily managed. Physicians shouldcease any investigation if the risks are found to outweigh the potential

benefits or if there is conclusive proof of positive and beneficial results.

18. Medical research involving human subjects should only be conducted if theimportance of the objective outweighs the inherent risks and burdens to thesubject. This is especially important when the human subjects are healthyvolunteers.

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19. Medical research is only justified if there is a reasonable likelihood that thepopulations in which the research is carried out stand to benefit from theresults of the research.

20. The subjects must be volunteers and informed participants in the researchproject.

21. The right of research subjects to safeguard their integrity must always berespected. Every precaution should be taken to respect the privacy of thesubject, the confidentiality of the patient's information and to minimize theimpact of the study on the subject's physical and mental integrity and on the

personality of the subject.

22. In any research on human beings, each potential subject must be adequatelyinformed of the aims, methods, sources of funding, any possible conflictsof interest, institutional affiliations of the researcher, the anticipated

benefits and potential risks of the study and the discomfort it may entail.

The subject should be informed of the right to abstain from participation inthe study or to withdraw consent to participate at any time without reprisal.After ensuring that the subject has understood the information, the

physician should then obtain the subject's freely-given informed consent,preferably in writing. If the consent cannot be obtained in writing, the non-written consent must be formally documented and witnessed.

23. When obtaining informed consent for the research project the physicianshould be particularly cautious if the subject is in a dependent relationshipwith the physician or may consent under duress. In that case the informedconsent should be obtained by a well-informed physician who is not

engaged in the investigation and who is completely independent of thisrelationship.

24. For a research subject who is legally incompetent, physically or mentallyincapable of giving consent or is a legally incompetent minor, theinvestigator must obtain informed consent from the legally authorizedrepresentative in accordance with applicable law. These groups should not

be included in research unless the research is necessary to promote thehealth of the population represented and this research cannot instead be

performed on legally competent persons.

25. When a subject deemed legally incompetent, such as a minor child, is ableto give assent to decisions about participation in research, the investigatormust obtain that assent in addition to the consent of the legally authorizedrepresentative.

26. Research on individuals from whom it is not possible to obtain consent,including proxy or advance consent, should be done only if the

physical/mental condition that prevents obtaining informed consent is anecessary characteristic of the research population. The specific reasons forinvolving research subjects with a condition that renders them unable togive informed consent should be stated in the experimental protocol forconsideration and approval of the review committee. The protocol should

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state that consent to remain in the research should be obtained as soon aspossible from the individual or a legally authorized surrogate.

27. Both authors and publishers have ethical obligations. In publication of theresults of research, the investigators are obliged to preserve the accuracy ofthe results. Negative as well as positive results should be published or

otherwise publicly available. Sources of funding, institutional affiliationsand any possible conflicts of interest should be declared in the publication.Reports of experimentation not in accordance with the principles laid downin this Declaration should not be accepted for publication.

B. ADDITIONAL PRINCIPLES FOR MEDICAL RESEARCH COMBINED WITHMEDICAL CARE

28. The physician may combine medical research with medical care, only tothe extent that the research is justified by its potential prophylactic,diagnostic or therapeutic value. When medical research is combined with

medical care, additional standards apply to protect the patients who areresearch subjects.

29. The benefits, risks, burdens and effectiveness of a new method should betested against those of the best current prophylactic, diagnostic, andtherapeutic methods. This does not exclude the use of placebo, or notreatment, in studies where no proven prophylactic, diagnostic ortherapeutic method exists. See footnote

30. At the conclusion of the study, every patient entered into the study shouldbe assured of access to the best proven prophylactic, diagnostic andtherapeutic methods identified by the study. See footnote

31. The physician should fully inform the patient which aspects of the care arerelated to the research. The refusal of a patient to participate in a studymust never interfere with the patient-physician relationship.

32. In the treatment of a patient, where proven prophylactic, diagnostic andtherapeutic methods do not exist or have been ineffective, the physician,with informed consent from the patient, must be free to use unproven ornew prophylactic, diagnostic and therapeutic measures, if in the physician's

judgement it offers hope of saving life, re-establishing health or alleviatingsuffering. Where possible, these measures should be made the object ofresearch, designed to evaluate their safety and efficacy. In all cases, newinformation should be recorded and, where appropriate, published. Theother relevant guidelines of this Declaration should be followed.

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REFERENCES

25% Group Charity. 2004. Severely Affected ME (Myalgic Encephalomyalitis) Analysis Report onQuestionnaire. 2004 [Online] Available at:http://www.25megroup.org/Group%20Leaflets/Group%20Leaflets.htm Accessed 3rd Dec 2006.

sbring, P. & Nrvnen, A. 2002. Women's Experiences of Stigma in Relation to Chronic FatigueSyndrome and Fibromyalgia. Qualitative Health Research. February 2002. Vol. 12, No. 2, pp. 148-160.[Online pdf] Available at: http://qhr.sagepub.com/cgi/reprint/12/2/148.pdf Accessed Nov 28th 2006. [pagenumbers refer to pdf version

sbring, P. & Nrvnen, A. 2003. Ideal versus reality: physicians perspectives on patients with chronicfatigue (CFS) and fibromyalgia. Social Science & Medicine. Vol. 57, Issue 4, pp. 711-720.

Cooper, Dr Lesley. 2000. Report on Survey of Members of Local ME Groups. Sponsors: Action for MEand the ME Association. [Online pdf]. Available at:http://www.meassociation.org.uk/locgrsur.pdfAccessedDec 1st 2006.

David, Sarah. 1999. Focus on prejudice in medicine. When patients are not believed. Psychiatricmisdiagnosis and its effects. (First published by Women in Medicine, January 1999). [Online]. Available at:http://freespace.virgin.net/david.axford/me-ref20.htm#PSYCHOLOGY%20AND%20PSYCHIATRYAccessed 3rd Dec 2006.

Deale, A., Wessley, S. 2000. Diagnosis of psychiatric disorder in clinical evaluation of chronic fatiguesyndrome. Journal of the Royal Society of Medicine. Vol 93, June 2000.

Department of Health. 2001. [Online]. Available at:http://www.doh.gov.uk/research Accessed Dec 18th2006.

Gibson, Dr Ian, MP. Chair of Committee. Nov 2006. Inquiry into the status of CFS / M.E. and research intocauses and treatment.

Goudsmit, Ellen M., PhD C.Psychol., Stouten, Bart PhD, Howes, Sandra. 2005. Editorial bias in the Lancet.[Online] Available at: http://freespace.virgin.net/david.axford/melist.html Accessed Dec 4th 2006.

Holloway, G & Pinikahana, J. 1999. The Limits of Medicine and the Social Consequences for Sufferers ofChronic Fatigue Syndrome, May 1999, Institute for Behavioural Research in Health, Curtin University.

Hooper, Professor Malcolm. 2003. THE MENTAL HEALTH MOVEMENT: PERSECUTION OFPATIENTS? [Online pdf] Available at: http://www.theoneclickgroup.co.uk/documents/ME-CFS_docs/The%20Mental%20Health%20Movement%20-%20Persecution%20of%20Patients.pdf Accessed Nov 26th 2006[Hooper et al. 2003]

Hutchinson, Allen (Chairman) et al. 2002. Chief Medical Officer's Working Group Report on CFS/ME

[Online pdf] Available at: http://www.erythos.com/gibsonenquiry/Docs/CMOreport.pdf Accessed Nov 27th2006.

IMH 2005. Multiple authors. 2nd Annual International Mental Health (IMH) at the IOP. [Online]. Availableat: www.iop.kcl.ac.uk/iopweb/blob/downloads/locator/l_748_programme_for_printing4.pdfAccessed Dec24th 2006.

Investinme. 2006. [Online]. Available at: http://www.investinme.org/mestory0005.htm Accessed Nov 29th2006.

Millen, N. & Walker, C. 2001. 'Overcoming the Stigma of Chronic Illness: Strategies for Normalisation of a"Spoiled Identity"', Health Sociology Review, vol.10, no.2, pp.89-97.

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http://www.25megroup.org/Group%20Leaflets/Group%20Leaflets.htmhttp://www.25megroup.org/Group%20Leaflets/Group%20Leaflets.htmhttp://www.25megroup.org/Group%20Leaflets/Group%20Leaflets.htmhttp://www.meassociation.org.uk/locgrsur.pdfhttp://www.meassociation.org.uk/locgrsur.pdfhttp://freespace.virgin.net/david.axford/me-ref20.htm#PSYCHOLOGY%20AND%20PSYCHIATRYhttp://www.doh.gov.uk/researchhttp://www.doh.gov.uk/researchhttp://www.doh.gov.uk/researchhttp://freespace.virgin.net/david.axford/melist.htmlhttp://www.iop.kcl.ac.uk/iopweb/blob/downloads/locator/l_748_programme_for_printing4.pdfhttp://www.25megroup.org/Group%20Leaflets/Group%20Leaflets.htmhttp://www.25megroup.org/Group%20Leaflets/Group%20Leaflets.htmhttp://www.meassociation.org.uk/locgrsur.pdfhttp://freespace.virgin.net/david.axford/me-ref20.htm#PSYCHOLOGY%20AND%20PSYCHIATRYhttp://www.doh.gov.uk/researchhttp://freespace.virgin.net/david.axford/melist.htmlhttp://www.iop.kcl.ac.uk/iopweb/blob/downloads/locator/l_748_programme_for_printing4.pdf


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Millen, N. 2002. 'A sociological gaze on ME/CFS: a modern malady in need of humane medicine', TheMedical Practitioners' Challenge: Proceedings of the Third Sydney International Clinical and ScientificMeeting 2001, Alison Hunter Memorial Foundation, Bowral, NSW.

Morris, Dorothy. 2003. Doctorate Thesis for Deakin University. Double disability: Lived experience ofAustralian Tertiary Students with ME/CFS. http://tux.lib.deakin.edu.au/adt-VDU/public/adt-VDU20051110.110308/

Mungovan, A. & England, H. 1998. Bridging the Gap: Understanding the issues and needs of students andstaff with Myalgic Encephalomyelitis / Chronic Fatigue Syndrome (ME/CFS) within Tertiary Education: ANSW Regional Disability Liaison Officer Initiative, Sydney, NSW.

National Research Register. 2006. [Online]. Available at: http://www.update-software.com/Nati

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