Comments on the NICE Guideline on “CFS/ME”-1

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Comments on the NICE Guideline on " CFS/ME "

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

Margaret

29th August 2007

The National Institute for Health and Clinical

Excellence (NICE) was set up in 1999 and is funded

by the Department of Health, to whom it as

accountable. It is not therefore " independent " of the

machinery of State.

Its " consultation " processes are, according to

Booker, merely an empty exercise: the

Government and its bodies pretend to " consult "

those affected by their actions, then carry on doing

exactly what they intended in the first place. In

other words, the " consultation " period is a farce, as

the Government is not remotely interested in looking

at the evidence (Sunday Telegraph, 20th June 2004).

As noted by Kemp, topics for the Institute's

work programme are selected by the Department of

Health, but once a topic has been referred, the

development and communication of the subsequent

advice is entirely the responsibility of the Institute.

As Kemp noted: " This seems to suggest that NICE

can be told what to do. This does not sound like

independence in the true sense of the word. The

remit is so heavily loaded that I believe a truly

independent institute would reject it out of hand.

The remit is effectively telling NICE what to

recommend; ie. 'management of adjustment and

coping' and 'rehabilitation strategies'. NICE have

been told what to recommend for people with

CFS/ME and judging from their draft guideline,

have complied " (ME/CFS and FM Information

Exchange Forum, 21st November 2006).

It was on 23rd February 2004 that the Department of

Health and the Welsh Assembly formally requested

NICE to prepare a clinical and service guideline. The

remit was:

" To prepare for the NHS in England and Wales,

guidance on the assessment, diagnosis,

management of adjustment and coping, symptom

management, and the use of rehabilitative

strategies geared towards optimising function and

achieving greater independence for adults and

children of CFS/ME " .

On 29th September 2006 NICE issued a draft

Guideline on " CFS/ME " for consultation. There were

many serious problems with the draft Guideline,

starting with incorrect and confusing information

about the way in which responses to the consultation

Questionnaire should be submitted. The problems of

terminology and classification were not addressed;

some Guideline Development Group members had a

published track record of supporting the psychosocial

model of " CFS/ME " favoured by the Wessely School;

in clear contravention of the AGREE Instrument (see

below), the vested interests of Guideline

Development Group members were not declared

(including the fact that one GDG member had spent

15 years working for the medical insurance industry

and was Chief Medical Officer for a major medical

insurance company); due to the narrow confines of

the remit, there was a failure to heed the biomedical

evidence that disproved the psychosocial model of

ME/CFS; the names of the advisers to the Guideline

Development Group were withheld (but were later

confirmed by Carole Forbes, Systematic Review

Project Manager at the CRD, to be the same people

who had advised the Systematic Review team at the

CRD, which included Simon Wessely,

Pinching and from AfME -- from which

resigned in March 2006); the Questionnaire

contained a series of " misprints " relating to

questions 29-61, making a nonsense of responses to

those questions and meaning that answers to over

one third of the questions were likely to be

erroneous; the way in which answers were to be

provided was changed in such a subtle way as to

make it unlikely that patients with cognitive

impairments would notice, thereby potentially

achieving results that respondents did not intend;

out of an ME/CFS UK population of between 0.2 to

0.4% (ie. up to 240,000 people), only 399

questionnaires were sent out and out of these, only

219 were completed, rendering such a tiny and

unrepresentative response easy for NICE to ignore

statistically; the Key Questions upon which the

questionnaire was based (in order to fit the NICE

scope, the scope being the document that set out

what the Guideline will cover) seemed designed to

preclude anything other than a psychosocial model;

NICE relied upon the Systematic Review provided for

it by the CRD at York, when that Systematic Review

had already been exposed as flawed, even to the

extent that it may have contained research

misconduct in that it had deleted previously

published evidence in order to cast the management

regime favoured by the Wessely School in a good

light.

Most importantly, NICE failed to conform to the

AGREE Instrument (The Appraisal of Guidelines for

Research and Evaluation) which requires that NICE is

obliged to give equal weight to three main sources of

data: " evidence-based " medicine, usually deemed to

be random controlled trials (RCTs); the opinion and

experience of physicians with expertise in the area,

and the opinion and experience of the patient group

for whom the Guideline is intended. This did not

happen in its draft Guideline on " CFS/ME " .

Despite the fact that the UK medical defence unions

have advised doctors that exercise regimes (which

form part of a cognitive behavioural therapy regime)

must be prescribed with just as much caution as

pharmacological interventions, it seemed that NICE

may have overlooked the implications of this advice:

in its Draft Guideline on " CFS/ME " , the only

recommended management regime was cognitive

behavioural therapy (CBT), including graded exercise

therapy (GET) and, for the severely affected,

" Activity Management " .

For further analysis of the draft Guideline, see the 54

page document compiled on behalf of The 25% ME

Group for the Severely Affected: " Some Concerns

about the National Institute for Health and Clinical

Excellence (NICE) Draft Guideline issued on 29th

September 2006 on Diagnosis and Management of

Chronic Fatigue Syndrome / Myalgic

Encephalomyelitis in Adults and Children " available

online at

http://www.meactionuk.org.uk/Concerns_re_NICE_Draft.htm

Other cogent criticisms of the draft NICE Guideline

included one submitted by a member of the

Association of British Neurologists:

" The draft guideline is fundamentally flawed

because it presupposes certain interventions (CBT

and GET) to be highly effective in CFS/ME for

routine clinical use despite lack of adequate

evidence. The Guideline is also selective in its

review of existing literature and is heavily

influenced by (the) psychiatric view of the

condition. Indeed, it almost seems that a select

group of psychiatrists with a polarised view of this

complex condition is directing the development of

the guideline from 'behind the scene'. There has

been no review of general and post-exercise

pain. The draft guideline reflects an incomplete

and psychiatrically polarised view of CFS/ME. The

importance of appropriate diagnosis of CFS/ME

from common psychiatric conditions has not been

mentioned even once. No-where in this guideline

have the exclusion criteria for CFS/ME (eg.

generalised anxiety disorder, somatisation) been

adequately defined and properly discussed. The

guideline needs to be thoroughly revised to reflect

our current understanding of this condition rather

than the supposition of the psychiatrists. It would

be immoral for NICE not to recognise the huge

dissatisfaction about this draft guideline amongst

most patients, carers and clinicians. The guideline

should not re-define CFS/ME to 'fit in' CBT and

GET as the recommended treatment options.

Listen to patients " .

A further submission from the Association of British

Neurologists said the following:

" (The Guideline Development Group) is tactically

promoting Oxford criteria over the more widely

used and recognised international CDC criteria –

again, a clear evidence of psychiatrists' influence

on this group " .

Referring to a paragraph in the draft Guideline:

" This paragraph deals with a publication (Wessely

et al, Lancet 1999) which was published as a

HYPOTHESIS and which remains to be proven.

However, the GDG seems to have taken it as a

matter of fact. Please refer to the criticisms of this

article in the Lancet. Being only a hypothesis, (it)

is totally irrelevant for the purpose of a dedicated

guideline on CFS/ME " .

" The GDG should also be criticised for its total lack

of reference to the neurological aspect of fatigue

and its overemphasis and over-reliance on the

psychiatric literature from a group of

psychiatrists " .

" With the possible exception of some

psychiatrists, most specialists prefer the

international criteria to diagnose CFS/ME " .

" Clearly there is very little compelling evidence at

present that these patients benefit from CBT and

GET " .

" There is selective omission of research literature

on reproducible neuroendocrine tests, with an

overemphasis on research data from certain

psychiatrists " .

Another well-argued criticism was submitted by Dr

Pheby, Project Co-ordinator, National CFS/ME

Observatory. For some reason, his comments were

not published by NICE and he received a

communication from the NICE Guidelines

Co-ordinator stating: " A number of comments and

responses are still being held by the Institute and

are not included in the table. These are comments

which may contain defamatory or libellous

wording " . Pheby wrote back: " Your statement is

clearly defamatory of us. This is completely

uacceptable, and a serious slur not only upon my

reputation but also upon the reputations of the

prominent and highly respected academics who

are involved in the Observatory project. If you

wish to argue that your statement was not

intended to apply to us, and that your omission of

our comments was in error and unintentional,

then this lack of care calls seriously into question

the quality of the exercise you have undertaken " .

Pheby's original comments on the NICE draft

guideline included the following:

" The National ME Observatory is a research

collaboration, funded by the Big Lottery Fund,

comprising the London School of Hygiene and

Tropical Medicine, the University of East Anglia,

and the Hull-York Medical School. It was

established earlier this year (ie. 2006) in order to

address the serious problem about a totally

inadequate corpus of scientific knowledge about

CFS/ME.

" The belief that evidence-based guidelines can be

constructed on such an inadequate evidence base

is, in our opinion, misguided. Indeed, many of the

recommendations in the draft guideline appear

not to be evidence-based at all (and) reflect what

limited research was carried out in the 1990s and

before.

" The draft states: 'When the adult or child's main

goal is to return to normal activities, then the

therapies of first choice should be CBT or GET'.

This is very misleading. It implies that there is a

group of people with CFS/ME who may not have

as their main goal a return to normal activities. We

have never encountered this. It also implies that,

of a range of possible therapeutic approaches,

CBT and GET are the two which emerge as being

the most effective, whereas the reality is that

there has been very little clinical trial activity

involving other treatment. The statement is also

misleading because it does not consider the extent

to which outcomes of trials of CBT and GET do not

appear representative of the population with

CFS/ME as a whole.

Referring to the statement in the draft Guideline that

said: 'Healthcare professionals who are

responsible for the care of (people) with CFS/ME

should have appropriate skills and expertise in the

condition " , Pheby commented: " What the

document does not state is what skills and

expertise are appropriate, nor how they are to be

acquired. Given that CFS/ME is a relatively

common condition, and that a wide range of

healthcare professionals are likely to be involved,

this has considerable implications for education

and training (which) in turn have substantial

organisational and resource implications which will

have to be addressed.

" The diagnostic criteria detailed in paragraph

1.2.1.2 do not conform to any existing clinical case

definition for CFS/ME and appear to be based on

poor evidence.

" CBT and GET should not be regarded as the first

choice of treatment or as providing a cure. To put

rehabilitation before prevention or early

intervention falls short of the patient-centred

approach which the draft guidelines claim to be

advocating.

" Greater evidence should be placed on medical

interventions, including symptom control and

improved access by patients to services,

information and resources.

" …promoting the use of CBT and GET in severely

affected people (is) extremely dubious, since

there is a dearth of evidence supporting the use

of these approaches in such patients, and plenty

of anecdotal evidence, as well as evidence from

surveys conducted by patients organisations, of

these methods being at best of limited value and

at worst damaging. (In relation to the use of CBT

and GET in children and the severely affected, the

draft guideline) states that 'There is no evidence

for the use or effectiveness of these strategies in

these two patient groups', and yet the guideline

recommends that they may be used in such cases.

" The draft, as it stands, has obvious defects,

which make it unsuitable for general application

throughout the NHS. It demonstrates lack of

understanding of CFS/ME (and) the

evidence-base is inadequate to support the

conclusions and recommendations made. The

review claims to be evidence-based but in fact is

mostly based on expert opinion, rather than on

evidence. There is no indication that the

document reflects a balanced view of expert

opinion on CFS/ME. The report gives the

erroneous impression that the role of these

management options has been satisfactorily

evidenced and widely agreed by professional and

lay groups involved in this field.

" The recommendations serve only to underline

the extent to which the existing evidence base is

inadequate.

" We strongly recommend that the draft be

rewritten to reflect more accurately the current

state of scientific knowledge, and also the views

of stakeholders (and) patients' organisations,

which do not appear to have been taken much

into account. NICE guidance is of such importance

in the NHS, and has such huge repercussions on

patterns of treatment and care. It therefore

needs to be accurate. Where there are

differences of opinion among experts, such

differences should be reflected in the document " .

Following the decision of NICE not to publish his

submission in the table of Stakeholder Comments,

Pheby commented on an internet group: " I was

dismayed to find that our comments were missing

from the published tables of comments, and they

have clearly had no influence in the final version. I

don't like the implication that our comments may

have been defamatory. It may well be that our

comments said things NICE did not want to hear,

but that's an entirely different matter " .

Other criticisms were submitted, including the

following:

The Association for Psychoanalytic Psychotherapy

noted the absence of any evidence that CBT is

superior to other psychological interventions such as

counselling.

The Royal College of General Practitioners (Wales)

said: " A guideline based on dysfunction and

disability will inevitably remain focused on

rehabilitation rather than on cure and

prevention " .

PRIME (Partnership for Research in ME/CFS) noted

the GDG's acknowledgement that there are

insufficient studies using outcomes that are

important to patients (noted with thanks by the

GDG) and that most studies often assess only

fatigue and sleep, and that few studies include

outcome measures that explore the wider impact of

ME/CFS.

These illustrations give an indication of the strength

of opposition to the dominant Wessely School beliefs

about " CFS/ME " .

Report of an " Evidence-based

Commissioning Collaboration: Diagnostic

Tests for Chronic Fatigue Syndrome

/Myalgic Encephalomyelitis " (The Trent

Institute Report)

Pending the production of the NICE Guideline, an

interim Report was produced by the Trent Institute.

This Report was an illustration of the total circularity

of the Wessely School influence about ME/CFS that

pervades the UK, and was written to support the

NICE Guideline on " CFS/ME " .

It was completed on 22nd November 2004 and was

produced by the Trent Institute of Health Sciences

and Public Health Research, which is a collaboration

between the Universities of Leicester, Nottingham

and Sheffield in conjunction with other areas

including Southampton, Aberdeen, Liverpool, Exeter

and the West Midlands. The Evidence-based

Commissioning Collaboration (EBCC) is made up of

the North East Yorkshire and North Lincolnshire

Primary Care Organisation; the North Derbyshire,

South Yorkshire and Bassetlaw Commissioning

Consortium; The Trent Commissioning Consortium

and the West Yorkshire Primary Care Organisation.

All these bodies were collaborating on behalf of their

respective Primary Care Trusts. The objective of the

Collaboration was to share research knowledge about

the cost-effectiveness of service interventions to

inform the commissioning process.

The specific objective of this Report was " To

develop a brief report outlining the current

recommendations for the use of diagnostic tests in

Chronic Fatigue Syndrome " .

The Trent Report used the MRC " CFS/ME " Research

Strategy and the much-criticised Royal Australasian

College of Physicians Guidelines for CFS. It

supported the use of the Oxford criteria for " CFS/ME " ,

which have no predictive validity and have not been

adopted anywhere but in the UK.

This Report stated: " There is widespread

controversy surrounding the existence of

CFS/ME " .

The Report's conclusions were that the only

laboratory tests recommended for people with

" CFS/ME " are those " aimed at detecting alternative

medical conditions " .

At its Steering Group meeting held on 15th

November 2004, it was documented that the Trent

Report was to present " a holding position pending

the preparation of NICE guidance " .

It was further documented that " CFS/ME was not a

disease as such " and that the role of the report's

collaborators was to " educate GPs " .

It was agreed that Professor Wessely's book should

be added to the Report's references (Wessely S,

Hotopf M and Sharpe M (1999) Chronic Fatigue and

its Syndromes; Oxford University Press).

The Report was supported by Mark , Clinical

Network Lead for CFS/ME for South Yorkshire and

North Derbyshire, whose comments were: " The

content and conclusions of the report is in line with

my understanding of the literature on this

subject " .

It is profoundly disturbing that those involved with

this report appeared unaware of the vast body of

international literature on ME/CFS that is of a very

different nature from their recommended list of

references: for them to prepare a realistic report that

is fair to patients, that body of literature ought not

to have been ignored.

The (finalised) NICE Guideline on

" CFS/ME " : 22nd August 2007

On 22nd August 2007 the finalised NICE Guideline

was published (Chronic fatigue syndrome / myalgic

encephalomyelitis (or encephalopathy): diagnosis

and management of chronic fatigue syndrome /

myalgic encepyalomyelitis (or encephalopathy) in

adults and children. Turnbull N et al. Royal College

of General Practitioners, London, 2007.

Professor Pinching (the patients' " champion "

responsible for the much-criticised Centres that

deliver only CBT and GET) is singled out by the

Guideline Development Group for special thanks, as

is the team from the Centre for Reviews and

Dissemination. The Hooper & Reid analysis of the

CRD Systematic Review was ignored, which means

that the so-called " evidence-base " upon which NICE

recommends CBT and GET remains intrinsically

flawed, relying as it does on only seven RCTs of

dubious quality, all of which exclude children and the

severely affected.

However, the final Guideline is like the proverbial

Curate's egg: good in parts. It is clear that, to its

credit, the Guideline Development Group has taken

heed of many submitted representations but that the

Wessely School has retained control of the

recommended management strategies, although to

nothing like the extent they sought (see below), and

that even those management strategies (CBT and

GET) have been modified from those previously

employed by the Wessely School (which sought to

force patients to change their beliefs and accept that

they were not suffering from a physical disorder,

about which Dr Ellie Stein – herself a psychiatrist --

said at the ME Research UK International Conference

in Edinburgh on 25th May 2007: " I would never in

my practice use the Wessely model of CBT – I find

it disrespectful to try to convince somebody they

don't have an illness they clearly have " ).

Having been given the remit by the Department of

Health, NICE could hardly produce a Guideline saying

that the reality is that there is no treatment apart

from symptomatic (such as analgesia and

anti-emetics), especially for what is clearly an

immense and increasing problem. It is a reflection of

existing policy that so few management options are

available for those with ME/CFS.

Some of the helpful points in the Guideline include:

* recognition that the physical symptoms can be as

disabling as multiple sclerosis, systemic lupus

erythematosus and congestive heart failure and that

the disorder places a substantial burden on sufferers,

their families, their carers, and hence on society

* recognition that the healthcare professional

should acknowledge the reality and impact of the

condition (this addresses the fact that up to 50% of

GPs still do not accept that the disorder exists)

* recognition that the WHO classifies CFS/ME as a

neurological illness at G93.3, noting that some

members of the GDG felt that the NICE guideline

should recognise this classification but that others

felt doing so did not reflect the nature of the illness

and risked restricting research into causes and future

treatments (the inclusion of the WHO classification

seems to reflect a rejection of the Wessely School's

determination not to accept the WHO classification,

as well as a rejection of the Wessely School's wish

to justify their PACE trials funded by the MRC for

their psychosocial model of " CFS/ME " )

* recognition that there is great variability of

symptoms, which may fluctuate in intensity and

severity

* recognition that it can cause profound, prolonged

illness and disability

* recognition that treatment and care should take

into account patients' individual needs

* recognition that people with " CFS/ME " should have

the opportunity to make informed decisions about

their care and treatment and should participate as

partners in all decisions about their healthcare

* recognition that the healthcare professional

should offer information about local and national

self-help groups and support groups

* recognition that people with " CFS/ME " should have

the right to refuse or withdraw from any component

of their care plan without this affecting other aspects

of their current or future care

* every person with " CFS/ME " should be offered

assistance negotiating the healthcare, benefits and

social care systems

* recognition that some people with severe

" CFS/ME " may remain housebound

* recognition that there is no pharmacological

treatment or cure for " CFS/ME "

* recognition that many people find exclusion diets

helpful in managing bowel symptoms

* recognition that rest periods are a component of

all management strategies for " CFS/ME "

* recognition that healthcare professionals should

work with the person with " CFS/ME " to develop

strategies to minimise complications that may be

caused by nausea, swallowing problems and

difficulties with buying, preparing and eating food

* recommendation that for people with moderate or

severe " CFS/ME " a wheelchair, blue badge or stairlift

should be considered as part of an overall

management plan (this is particularly welcome, as

people with a psychological disability will not

normally qualify for a blue badge)

* recognition that advice to undertake unstructured,

vigorous exercise may worsen symptoms

* recognition that strategies for managing " CFS/ME "

should not include an imposed rigid schedule of

activity and rest

* if chronic pain is a predominant feature,

healthcare professionals should consider referral to a

pain management clinic

* people with " CFS/ME " should be advised that

relapses are to be expected

* people with severe " CFS/ME " may need to use

community services, including nursing and respite

care

* recognition that consideration of the aetiology of

" CFS/ME " was outside the scope of the Guideline: for

that reason, the GDG has not made

recommendations about the causes of " CFS/ME " but

recommends that research in this area would be very

helpful

* recognition of the anecdotal evidence that

CBT/GET in children and the severely affected may

be harmful or not effective

* recognition that reliable information on the

prevalence and incidence of this condition is needed

to plan services

* recognition that when used for patients with

" CFS/ME " , the aim of cognitive behavioural therapy is

to support the sufferer and does not assume that

symptoms are psychological (ie. the aim is not to

convince patients that they do not suffer from a

physical disorder as was the case with the Wessely

School regime -- the Medical Research Council PACE

trial states that CBT 'will be based on the illness

model of fear avoidance)

* recognition that in " CFS/ME " , the aim of graded

exercise is to assist the patient to be as

independent as possible (ie. not to force patients to

" exercise back to fitness " : in the MRC PACE trial, GET

" will be based on the illness model of both

deconditioning and exercise avoidance " )

* recognition that in the NICE guideline, pacing is

defined as energy management and the keys to

pacing are knowing when to stop and rest by

listening to and understanding one's own body (this

is anathema to the Wessely School and represents a

significant rejection of their beliefs that what they

call " body-watching " should be a target for

intervention)

* recognition that some peoples' understanding of

pacing is as " adaptive pacing therapy " in which

people with " CFS/ME " use a management strategy

plan, whereas patients' own understanding of pacing

is a self-management strategy, and that people with

" CFS/ME " generally support this approach

* recognition that there are different stages in the

natural course of " CFS/ME "

* recognition of the need for employers and schools

to be better informed

* recognition that there should be avoidance of a

dogmatic belief in a particular view.

Concerns about the published Guideline

Even though the nature of CBT and GET in relation to

" CFS/ME " is explained (and is clearly different from

the earlier Wessely School model in which people

were admonished to exercise no matter how sick

they were and to abandon their " aberrant illness

beliefs " ), the major problem with the NICE Guideline

remains its recommendation that CBT/GET " should

be offered to people with mild or moderate

CFS/ME because currently these are the

interventions for which there is the clearest

research evidence of benefit " .

Not only is this is misleading, because the

" evidence " upon which that statement is based has

been shown to be seriously flawed as was pointed

out to NICE in the clearest terms (the Hooper & Reid

report), but some of the recommendations remain

offensive to people with ME/CFS, as well as

potentially damaging.

For example, reference is still made to " unhelpful

beliefs " , to " the relationship between thoughts,

feelings, behaviours and symptoms and the

distinction between causal and perpetuating

factors " and to the fact that the CBT plan will

include " identifying perpetuating factors that may

maintain CFS/ME symptoms " and will address " any

over-vigilance to symptoms " (which is contradictory

to the Guideline's own recommendation that keys to

pacing are listening to and understanding one's own

body).

This is wholly unacceptable: it demeans people with

ME/CFS and it ignores the substantial evidence (over

4,000 published studies showing underlying

biomedical abnormalities) that ME/CFS is not a

psychosocial disorder.

It is insufficient for the GDG to claim that

consideration of the biomedical evidence did not

come within its remit – it was charged with providing

guidance on the diagnosis of " CFS/ME " , so the

literature which demonstrates the clear biomedical

aetiology should have formed part of the literature

review.

To be continued (part 2)