Comments on the NICE Guideline on “CFS/ME”-2

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Part -2

(Comments on the NICE Guideline on " CFS/ME " )

May be reposted

The Guideline acknowledges the Canadian Consensus

Definition yet ignores its message; Dr Bruce

Carruthers, Fellow of the Canadian Royal College and

principle lead of the international expert team that

produced the highly respected ME/CFS Clinical Case

Definition, states in the Overview:

" A hypothesis underlying the use of

Cognitive Behaviour Therapy (CBT) for

ME/CFS is based on the premise that the

patient's impairments are learned due to

wrong thinking and 'considers the

pathophysiology of CFS to be entirely

reversible and perpetuated only by the

interaction of cognition, behaviour, and

emotional processes. The patient merely

has to change their thinking and their

symptoms will be gone. According to this

model, CBT should not only improve the

quality of the patient's life, but could be

potentially curative'. Supporters suggest

that 'ideally general practitioners should

diagnose CFS and refer patients to

psychotherapists for CBT without

detours to medical specialists as in other

functional somatic syndromes'.

Proponents ignore the documented

pathophysiology of ME/CFS, disregard

the reality of patient's symptoms, blame

them for their illness and withhold

medical treatment. Their studies have

often included patients who have chronic

fatigue but excluded more severe cases

as well as those who have other

symptoms that are part of the clinical

criteria of ME/CFS. Further, their studies

fail to cure or improve physiological

impairments… "

Research that indicates potential dangers

of the recommended management regime

was ignored

Research that directly impinges on the safety of the

NICE recommendations for graded exercise (which

was available to the GDG) was also excluded from

consideration and / or ignored. This was a serious

omission. The AGREE Instrument (Appraisal of

Guidelines Research and Evaluation Instrument) with

which NICE is obliged to comply in the formulation of

all its Guidelines is specific: " The health benefits,

side effects and risks should be considered when

formulating the recommendations " . Of particular

significance is an important paper that was published

in 2005 (well within the 2004 – 2007 life of the

GDG's deliberations); that paper demonstrated that

exercising muscle is a prime contender for excessive

free radical generation, free radicals being highly

reactive molecules which can cause damage to the

cells of the body. Incremental exercise challenge

induces a prolonged and accentuated oxidative

stress, and existing evidence has shown a good

correlation between muscle pain thresholds on

exercise with various blood markers of oxidative

injury (Oxidative stress levels are raised in chronic

fatigue syndrome and are associated with clinical

symptoms. Gwen Kennedy, Vance Spence, Jill Belch

et al. Free Radical Biology and Medicine

2005:39:584-589).

The recommended graded exercise plan specifies

that the intensity of GET should be incrementally

increased, leading to aerobic exercise. This is in

direct contradiction to international ME/CFS experts

such as Professor Cheney from the US, who in

1999 explained why aerobic exercise should not be

used: " The most important thing about exercise is

not to have them do aerobic exercise. I believe

that even progressive aerobic exercise, especially

in phase one and possibly in other phases, is

counter-productive. If you have a defect in the

mitochondrial function and you push the

mitochondria by exercise, you kill the DNA "

(Lecture given in Orlando, Florida, February 1999, at

the International Congress of Bioenergetic Medicine).

Professor Cheney has made a particular study of

cardiac anomalies in patients with ME/CFS since the

1980s and emphasises the unassailable tenet that if

metabolic demand (as in aerobic exercise) exceeds

the impaired cardiac output of ME/CFS patients, even

very briefly, the result is death. This information was

submitted to NICE and was available to the GDG,

including the evidence that 82% of ME/CFS patients

have abnormal cardiac impedence and that patients

have a high heart rate but a low cardiac output

caused by a problem with energy production, with

ischaemic changes in the inner ventricular wall. If a

patient has abnormal oxygen consumption, muscles

will not have enough oxygen and exercise will result

in relapse. Patients' ability to work is impaired, as

shown unequivocally by an abnormal serial exercise

stress test which is 100% objective. This information

was ignored by the GDG but impacts upon the

recommended management regime.

(For more information on Professor Cheney's cardiac

work in ME/CFS, see

http://www.meactionuk.org.uk/Klimas_Wessely_NICE_-_Redefining_CBT.htm

and for a summary of current research on the

cardiovascular anomalies that have been

demonstrated in ME/CFS, see

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

).

Professor Pinching advised adapting the level of

activity to levels that can include an incremental

increase (page 87 of comments on chapter 1).

Pinching also referred to " the commonest

co-morbidities that are well-documented in the

literature " as being depression and anxiety, yet

the literature shows such levels to be no higher in

ME/CFS than in disorders such as multiple sclerosis.

All these studies and conference reports have direct

bearing on the safety of the recommended

management regimes and as such, under the terms

of the obligatory AGREE Instrument, there can be no

credible excuse for NICE to have ignored them.

In endeavouring to justify CBT/GET for use in

ME/CFS, the Guideline states: " an evidence-based

psychological therapy is used in many health

settings, including cardiac rehabilitation and

diabetes management " . This claim has been

investigated by numerous people and has been found

to be inaccurate, since unlike in ME/CFS, it is used as

an adjunct where necessary, not as the first-line

treatment of choice across the board. In no other

medical disorder apart from ME/CFS are patients

offered exercise as the only " treatment " option.

Although it is clear that the type of CBT now

recommended by the Guideline differs from

Wessely's original prescription, it cannot be known

whether the CFS Centres set up by Pinching will

continue to employ Wessely's version (about which

there are so many adverse reports – see the RiME

collations) or the more supportive version as outlined

in the Guideline, nor is it known who will re-educate

and monitor the existing staff in these Centres,

which is a matter of real and justified concern.

The Guideline refers (on page 186) to the Wessely

School mantra of " predisposing, precipitating and

perpetuating factors in CFS/ME " as a key area upon

which future research should be focused: unless this

model of research is applied to all other medical

conditions, it is inappropriate for this special

pleading to apply only in the case of " CFS/ME " and

reflects the Wessely School's discredited assertion

that " CFS/ME " is a " faulty belief system " that can be

" corrected " by CBT and aerobic exercise. The reality

is that more than one Coroner has accepted ME/CFS

as a cause of death.

In line with the Wessely School beliefs, the

Guideline restricts investigations that may be

performed on those with ME/CFS and it also

stipulates that thyroxine must not be administered

to such patients, which ignores the evidence of

thyroid dysfunction and the fact that basic NHS tests

are too blunt to pick up this serious dysfunction.

The Guideline states that no research evidence was

found to support the experience of some people with

" CFS/ME " that they are more intolerant of drug

treatments and suffer more severe adverse side

effects. There is an abundance of evidence (though

not RCTs) from Professor Marty Pall in the US

explaining the exact mechanism of such

hypersensitivity and it is notable that the Guideline

Development Group accepted anecdotal evidence

when it suited their aim (for example, acceptance of

the " boom and bust " concept, for which there is no

RCT evidence), but rejected it in other places (such

as Professor Pall's evidence), which is inconsistent.

One patient representative on the GDG who resigned

just prior to publication of the Guideline is on record

as stating: " I do believe that the guideline has not

fully taken into account the patient and biomedical

evidence, because if it had, then it would not be

recommending the widespread use of CBT and GET.

It is said that patient evidence is not given high

weighting due to it being biased " . If this is true,

then it is another illustration of a clear breach of the

AGREE Instrument to which NICE is obliged to

conform.

The Guideline recommends domiciliary support for

the severely affected, yet in a climate of

unprecedented financial restrictions offers no

reassurance that funds will be available to

implement such support.

The NICE Guideline contains examples of

carelessness, for instance, the date of reference 50

is given as being " 1921 " when it should be

" 2005:19:21:38-43 " , as well as other incorrect dates.

Another striking example of carelessness is to be

found in the table of Stakeholders' Comments and

GDG Responses, where inexcusably, many comments

from one respondent have been attributed to others,

for example, comments submitted by LocalME have

been attributed to both Newport Pharmaceuticals Ltd

and to North Staffordshire Combined Healthcare NHS

Trust.

Evidence that the GDG has not conceded to all the

demands of the Wessely School

The Wessely School clearly endeavoured to get its

own way (see quotations below from the responses

submitted by Simon Wessely and White to the

Questionnaire) but on a number of fronts they did

not succeed. The Wessely School got all its own way

with the 1996 Joint Royal Colleges' Report and were

infuriated that patients' views were given such

weight in the 2002 Chief Medical Officer's Working

Group report; this time, NICE seems to have treated

them on the same basis as any other stakeholder

among many, to the extent that this NICE Guideline

now includes the Canadian definition, in full, over

several pages. That is a significant step forwards.

Specifically, the NICE Guideline does not state that

ME/CFS is a behavioural disorder, a psychiatric

illness, a somatic/functional disorder, and illness

belief, depression or anxiety.

It emphasises the need for an individualised

management plan that should be provided in ways

suitable for the individual, and it highlights the

importance of shared decision-making between

healthcare professionals and patients.

Section 5.5 of the draft Guideline stated: " a view

held by a few individuals on the GDG was that

CFS/ME could not be identified or managed unless a

broader view was taken " . This " broader view " was

that a " biopsychosocial " approach to ME was

required, lumping it together with other states of

chronic " fatigue " and thereby affording psychiatrists

the right to be involved in the care of all ME

patients, regardless of whether those psychiatrist

were needed or wanted. One of the patients'

representatives (BRAME) challenged the fact that if

only " a few " members of the GDG group held that

view, why was their opinion allowed to dominate the

recommended management regime?

This seems to have forced the GDG into a remarkable

admission: the Guideline does not accept any of the

favoured theories of the Wessely School: " In

considering the explanation for CFS/ME, we have

followed the report of the Gibson Inquiry, which

accepts that there is insufficient evidence to fully

substantiate any of the current theories of causation,

and that more high quality biomedical research is

needed " .

The conclusions of the Gibson Report were concise:

* The Canadian Criteria are " a useful contribution in

defining ME/CFS "

* " The opposing opinions about the nature of the

disease are very problematic "

* The Gibson Report refers to " The inability of some in

the medical profession to separate (other disorders)

from genuine ME/CFS patients "

* " ME/CFS have been defined by the World Health

Organisation as neurological illnesses "

* " In the UK, precedence has been given to

psychological definitions "

* " Regarding CFS/ME as a physical illness has been

marginalized by the psychological school of thought " .

Professor Baker, Chair of the Guideline

Development Group, appeared to express

exasperation at the polarised views about the nature

of the disorder, saying in the Preface to the

Guideline: " A further problem created by the lack of

adequate research evidence is the sometimes widely

divergent and hotly contested beliefs about CFS/ME,

including those about its cause. In developing the

Guideline, we kept in mind the overall goal of

improving care for people with CFS/ME, with the

patient's preference and views firmly in the driving

seat. Rather than aligning ourselves with one or

other perspective on CFS/ME, we have sought to

provide practical guidance for professionals and

patients " .

Quotations from the responses to the Questionnaire

by some Wessely School members

Illustrations from Wessely School members

demonstrate their insistence that " CFS/ME " is a

behavioural disorder.

Extracts from the submission by Wessely's Chronic

Fatigue Research Unit at King's College, London:

" We do not agree with what is written about the care

of those with severe disability and CFS, and the best

treatment options for that group. For example, it is

stated that 'patient experience suggests that some

of these interventions may be harmful or

ineffective'. We would argue on the basis of our

extensive experience that what is being reported in

these negative accounts is rarely either CBT or GET.

It would be more accurate to state that 'some

patients' rather that 'patient experience', since the

latter seems to imply that it is all patient

experience. It seems likely that the same approach

that works in outpatients would also be successful in

severely affected " .

" We disagree with the numerous statements in the

guidelines that patients in the published CBT/GET

trials are 'mild to moderate'. Nearly all of the

published studies came from secondary or tertiary

care. One would expect that these will be patients

with high morbidity and the data shows that to be

the case " . (One can only wonder how Wessely can

convince himself that people who are well enough to

attend an outpatient department can be described as

" severely affected " ). " Overall, this is strong evidence

that the published work on CBT and GET concerns

those with chronic illness and substantial disability.

This needs to be addressed since if this is not

corrected, there is a danger than NICE will

inadvertently give credence to the oft expressed but

erroneous view that CBT/GET only works in those

who do not have 'real ME', those who have

psychiatric disorders, or who are not very disabled " .

This submission goes on to assert that there is

evidence of emotional instability assessed 25 years

before the onset of " CFS/ME " and that this " adds to

the existing evidence that personality and

depression increase the risk of CFS " and asserts " the

statement on page 90 (of the draft Guideline) should

reflect this new and definitive research " .

The submission states: " We note the omission of

any reference to what is now a well cited and

accepted body of research on the role of psychiatric

disorders and CFS, which is definitely of interest to

clinicians considering treatment options. It is

sometimes said that depression or anxiety is merely

a consequence of disability. However, there is now a

well-replicated body of evidence that shows this not

to be the case. It has been established that the

rates of psychiatric disorder in the CFS patients are

too high to be explained as a simple reaction to

disability. Such is the consensus in this area that

studies are no longer being performed " .

Commenting on page 134 of the draft Guideline

which related to Wessely's own paper in the Lancet

(1999:354:936-939) 'CFS has been described as part

of a broader condition that includes a range of

disorders including fibromyalgia, irritable bowel

syndrome etc', this submission states: " True, and

this will be well received by many doctors, since it

reflects their views and emphasises ways in which

we can increase our knowledge of one 'syndrome', to

which the GDG response was that it accepts the

conclusions of the Gibson Report.

The submission from White's Chronic Fatigue

Services at St Bartholomew's Hospital said: " We

think it illogical to mix symptoms and disability. We

do not think the evidence supports separating severe

from very severe. We emphasise that CBT and GET

can also help patients who do not wish to return to

normal health " .

" There are too many symptoms included, which will

encourage practitioners to attribute symptoms such

as palpitations to CFS/ME " .

" The (draft) guideline emphasises the importance of

investigations, with little guidance about examining

the patient. Examination should include a proper

mental state examination. The guideline could

usefully provide guidance about illness insights and

beliefs " .

" The emphasis here would be appropriate for

someone suffering from an incurable chronic disease,

which CFS/ME is most often not " . The GDG response

was terse: " The Guideline Development Group had

to balance a positive outlook with the recognition

that some people will not recover " .

" Equipment and aids may hinder recovery as much as

help it " , to which the GDG response was: " The view

of the GDG is that equipment can help to maintain

independence " .

" The advice regarding drug treatment should (not

imply that) neuropathic pain and IBS are part of

CFS/ME " , to which the GDG response was: " The

section has been revised to reflect comments from

stakeholders " .

" Weight loss is not part of CFS/ME at any age " , to

which the GDG response was: " The view of the GDG

is that some children may lose weight and require

nutritional support " .

" Sometimes acting as an intermediary between a

patient and employer may encourage dependence

rather than fostering recovery " , to which the GDG's

response was: " Facilitating a dialogue with

employers about adjustments to work often helps to

remove barriers for the patient " .

" Referral to specialist care should depend on the

severity of the disability, not severity of symptoms " ,

to which the GDG replied: " The GDG considered the

wording to be appropriate " .

Quoting from the draft Guideline that said: " We need

reliable information on prevalence and incidence of

this condition to plan services " , White's

response was: " Do we really? " , to which the GDG

replied: " The GDG considered the research

recommendations to be appropriate " .

As the above illustrations show, the Wessely School

did not succeed in all its demands.

In the light of this submission, it is noted that on

16th August 2007, St Bartholomew's CNCC (Clinical

Network Co-ordinating Centre) issued the following

Statement: " We can confirm that Barts CNCC does

not consider CFS/ME to be a psychiatric illness " .

Evidence that the Wessely School knows that CBT

and GET provide no lasting benefit in ME/CFS

Despite their ruthless determination to implement

CBT and GET across the board for people with

ME/CFS, Wessely School members have previously

acknowledged that there is no long-term benefit from

CBT, for example:

* at the American Association for CFS (AACFS, now the

IACFS/ME) International Conference at Cambridge,

Massachussets on 10-11th October 1998, Wessely

School psychiatrist Sharpe went on record

stating that the benefits of CBT faded with time

* in a personal communication dated 12th October

1998 to Professor Fred Friedberg, Sharpe

stated about his often-quoted 1996 study (BMJ

1996:312:22-26) that outcome measures have begun

to decline 17 months after treatment termination

(quoted in JCFS 1999:5:3/4:149-159)

* on 3rd November 2000, Sharpe again confirmed

" There is a tendency for the difference between

those receiving CBT and those receiving the

comparison treatment to diminish with time due to a

tendency to relapse in the former "

(www.cfs.inform/dk )

* the very modest benefit in only some patients who

have undergone CBT has been shown to last for only

6-8 months and " observed gains may be transient "

(Long-term Outcome of Cognitive Behavioural

Therapy Versus Relaxation Therapy for Chronic

Fatigue Syndrome: A 5-Year Follow-Up Study.

Deale, Trudie Chalder, Simon Wessely et al. Am J

Psychiat 2001:158:2038-2042)

* in his Summary of the 6th AACFS International

Conference in 2003, Lapp, Associate Clinical

Professor, Duke University and Director,

Hopkins-Hunter Centre, NC, stated about CBT that Dr

Clauw (who had studied 1,092 patients) found

that at 3 months there were modest gains, but at

follow-up at 6 and 12 months, those modest gains

were lost (this being an example of " evidence-based "

medicine)

* Wessely himself is on record stating that CBT

doesn't work for all: in his Editorial (JAMA 19th

September 2001:286:11) he stated that CBT and GET

are only " modestly effective " and that neither is

" remotely curative "

* Wessely is also on record as stating: " It should be

kept in mind that evidence from randomised trials

bears no guarantee for treatment success in routine

practice. In fact, many CFS patients, in specialised

treatment centres and the wider world, do not

benefit from these interventions " (The act of

diagnosis: pros and cons of labelling chronic fatigue

syndrome. Marcus JH Huibers and Simon Wessely.

Psychological Medicine 2006:36: (7): 895-900).

It should not be forgotten that after a course of CBT,

there is no objective evidence of improvement (only

subjective) and that the transient gains may be

illusory (Interventions for the Treatment and

Management of Chronic Fatigue Syndrome – A

Systematic Review. Whiting P, Bagnall A-M et al.

JAMA 2001:286:1360-1368).

Some initial responses to the final Guideline

Action for ME issued a Statement supporting the

Guideline: " We believe that the guidelines represent

an opportunity to drive forward the improvement of

services for those with ME and it is for that reason

we support them " . AfME did note that the Guidelines

still contain flaws and " are still influenced by the

history of research in this area, which has produced

findings that can not be generalised to all people

with ME and which therefore once again place an

over-emphasis on cognitive behavioural therapy and

graded exercise therapy " .

The response of the Northern Ireland ME Association

noted its disappointment that these new guidelines

bring us no nearer a cure, and noted that the NHS in

Northern Ireland is poorly equipped to implement

these new national guidelines.

Invest in ME noted that the reasons why the draft

Guidelines were almost universally condemned was

due to the poor quality of analysis and their lacking

ability to serve the needs of people with ME and

their families, and that initial reaction to the final

version can be summed up as continued dismay that

NICE has again highlighted CBT and GET as the most

effective forms of management.

Ellen Goudsmit PhD commented on the confusion,

the bias and the inconsistencies in the Guideline;

she noted the dominance of the CBT School; the

promotion of unproven techniques such as activity

management; the lack of recognition of subgroups of

" CFS " ; the lack of differentiation of ME or CFS from

somatisation disorder and the recommendation that

CBT should be offered to mild cases, given NICE's

interest in saving money, when counselling and

self-help may be enough.

Short of Anglia ME Action quoted Dr

Myhill on the central problem of ME/CFS being

mitochondrial failure resulting in poor production of

ATP, which shows that CBT, GET and antidepressants

are irrelevant in addressing the root cause of this

disorder; he feared that scientific and democratic

integrity are now dead in the UK, having been sold

out by the Government which has placed corporate

interests over and above the interests of patients

and he commented: " To be ill and abused for it is

nothing less than a living hell " .

Greensmith PhD: replying to an article in the

Daily Mail on 23rd August 2007 which said: " Well

thought–out exercise regimes can help patients

overcome the debilitating symptoms, although there

used to be resistance from ME campaigners to

psychiatric approaches " , Greensmith wrote: " The

NICE report with its lax terminology and its reliance

on questionable experimental designs and

interpretations, produced by a disproportionate

number of advisers with a psychiatric backgrounds –

already in favour of and using these treatments –

was much too narrow to make any material

difference to ME patients. ME sufferers will not, in

practice, be treated as equal partners. Things will

not change until the biomedical research supported

by appropriate funding, comes first "

Overall assessment of the Guideline

Overall, this Guideline has accepted much that was

submitted by the ME/CFS community. It was,

however, limited by the narrowness of its remit: as

in all reports about ME/CFS commissioned to support

policy, the remit seems to have been deliberately

constructed in a way that would achieve the outcome

desired by the Wessely School, which meant that a

significant amount of published biomedical literature

was not considered by the GDG, which is to the

continuing detriment of patients.

On the issue of guidance about diagnosis, there can

be little doubt that the Guideline has failed those

with ME/CFS (although it does recommend biomedical

research and does recommend the need for informed

discussion around diagnosis). The ignoring of such a

significant published body of biomedical

abnormalities when those abnormalities clearly

assist in diagnosis is indefensible, especially as that

body of evidence would be invaluable in

distinguishing between ME/CFS and behavioural

disorders.

On the issue of " treatment " , the Guideline does

highlight the need for a range of treatment options

to be discussed.

Key questions remain. Given that the notion of

ME/CFS as a mental disorder has been so

assiduously and successfully established in the

perception of healthcare professionals and agencies

of the State over the last 20 years by the Wessely

School (and when something is repeated often

enough, it becomes regarded as fact), and given that

it is perception that influences people, how much

notice will healthcare professionals who are deeply

mired in Wessely School misinformation about

ME/CFS take of the useful parts of the Guideline?

Will they simply ignore it and carry on as at present,

with many of them dismissing ME/CFS as

non-existent or else as a behavioural disorder?

Will the Medical Royal Colleges accept the

Guideline? It is, by definition, only a guideline.

The Wessely School did not accept the findings of

the 1994 National Task Force Report and the result

was the Joint Royal Colleges' Report of 1996. What

will be their response to this Guideline?

Three members of the Wessely School ( White,

Cleare and Trudie Chalder) have already

made known their plans for future CBT studies in

" CFS/ME " to a group of MPs (the Gibson Inquiry) and

their belief that CBT can reverse the HPA axis

dysfunction seen in ME/CFS.

The Wessely School has already obtained funding for

their " Biomedical Research Unit " at the Institute of

Psychiatry, which is funding a project called

" Emotional Processing in Psychosomatic Disorders " .

The Section of General Hospital Psychiatry at the IoP

was advertising for a psychology graduate to work on

the project, which will " involve working across the

Section on Eating Disorders and the Chronic Fatigue

Research and Treatment Unit " . The closing date for

applications was 13th July 2007. The job reference

was 07/R68.

Applicants were informed that " The Chronic Fatigue

Syndrome Research and Treatment Unit receives

about 400 referrals per year. The multi-disciplinary

team assesses and treats patients with chronic

fatigue syndrome and carries out research into both

causes and treatment efficacy. Anorexia Nervosa

(AN) and chronic fatigue syndrome (CFS) are classical

psychosomatic disorders where response to social

threat is expressed somatically. Aberrant emotional

processing is a strong candidate as a maintaining

factor for these disorders. The post holder will work

under the immediate supervision of Professors Ulrike

Schmidt (AN) and Trudie Chalder (CFS) " .

Other IoP job advertisements for " CFS " that can be

found on the website include one for a " Cognitive

Behavioural Psychotherapist " for the Chronic Fatigue

Research and Treatment Unit, accountable to

Professor Trudie Chalder, which requires the

applicant to possess " the ability to maintain a high

degree of professionalism in the face of highly

emotive problems, verbal abuse and the threat of

physical abuse " and " an understanding of the needs

of people with mental health problems " .

Will anything really change for hapless ME/CFS

patients as a result of this NICE Guideline?

The end