*CFS/ME* -Reasons for Judicial Review of the NICE Guideline -Prejudice-based Medicine?

[Guest guest]

For Dutch readers: the NICE Guideline on " CFS/ME "

is comparable with the fraudulent rapport of the

*Gezondheidsraad* (Health Council of the

Netherlands). The authors belong to the 'Wessely

School' (see below). They also:

" ....ignore over 4,000 peer-reviewed papers which

clearly demonstrate that ME/CFS affects all major

bodily systems, especially the immune system, the

neurological systems (central, autonomic and

peripheral), the neuroendocrine system, the

cardiovascular system, the respiratory system, the

musculo-skeletal system, the gastrointestinal

system, the reproductive system and the ocular

system.... " (see below)

The former Minister of Health and President of the

" Commission CFS " of the *Gezondheidsraad* said to

a group of severe, bed- or housebound ME sufferers,

lying on stretchers, because they couldn't sit up:

" ....ME patients can be cured by Graded Exercise.....!

This rapport can be found:

Dutch: http://www.gr.nl/pdf.php?ID=1167 & p=1

English: http://www.gr.nl/pdf.php?ID=1169 & p=1

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I have edited the article below in such a way, that it

is easier readable for ME/CFS patients. For private

members the original text is attached in .doc format.

~jvr

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Prejudice-based Medicine?

Reasons for Judicial Review of

the NICE Guideline on " CFS/ME "

Margaret

27th October 2008

On 2nd November 1972 the London Medical Group

held a closed meeting at which aversion " therapy "

was promoted as a " cure " for homosexuality. The

" therapy " was drug-induced nausea whilst the

" patient " had to view homosexual acts (preferably

live). The aim of this so-called " re-conditioning " was

to " change the emotions where the person cannot

change them of his own free will " .

According to one of the speakers, psychologist Hans

Eysenck, aversion " therapy " was " only undertaken

where it is of the patients' own choice " . Another

speaker, Dr Isaac Marks, Senior Lecturer and

Consultant Psychiatrist at the Maudsley Hospital,

justified such abuse as being " in society's interest " .

The proponents of this " therapy " were praised by the

chairman of the meeting for their " outstanding

contributions to psychology " and were referred to as

" these great men " . People who underwent this

" therapy " ended up as chronically depressed asexual

vegetables

(http://www.petertatchell.net/psychiatry/dentist.htm ).

On 28th April 2008, another closed medical meeting

was held in London, this time at the Royal Society of

Medicine; once again the intention was to promote

another currently faddish " therapy " as a " cure " for

another so-called " aberrant " disorder.

This time it was not about homosexuality but about

myalgic encephalomyelitis / chronic fatigue syndrome

(ME/CFS), which the psychiatrists to whom the RSM

offered a platform prefer to call " CFS/ME " and claim

that it is a behavioural disorder.

These psychiatrists (known as the Wessely School)

lump ME/CFS together with on-going tiredness or

chronic " fatigue " such as is seen in depression and

anxiety states, even though ME/CFS has been

formally classified as a neurological disorder by the

World Health Organisation since 1969 and the WHO

has confirmed in writing that what these

psychiatrists are doing is not permitted under the

WHO taxonomic principles.

People with ME/CFS have been referred to by a

leading UK Wessely School psychiatrist as " the

undeserving sick of our society " , so this time, the

" therapy " is a mind-altering technique to disabuse

patients of their belief that they are physically sick,

combined with incremental aerobic exercise (because

the psychiatrists believe that these patients are

merely de-conditioned through self-indulgent lazing

about for secondary gain in the form of state

benefits).

Of course, as in 1972, the " therapy " is only to be

offered to those who choose it, but those who refuse

it (because they are simply too sick to participate or

are sufficiently well-informed to be aware of the

potential dangers) are deemed not to want to get

better, so their state benefits are summarily

stopped.

The " Pathways to Work " programme will require

Incapacity Benefit (now known as ESA, or

Employment & Support Allowance) claimants with

ME/CFS to undergo CBT/GET before their benefits are

reinstated. Not surprisingly, the suicide rate in

ME/CFS has been documented at one per month, not

because patients are mentally deranged, but

because without help they have no means of

surviving such a devastating disorder and can no

longer cope with the extreme suffering.

It ought to be a matter of national concern that this

current fad is now enshrined in a Guideline produced

by the National Institute for Health and Clinical

Excellence (NICE) and is to be implemented

throughout the nation, even though the " therapy " in

question may already have resulted in an untold

number of non-suicide deaths (including a Member of

Parliament who suffered from ME) and may have

turned countless mildly affected sufferers into

severely affected physical wrecks requiring 24 hour

lifelong care. These very sick people are officially

described on page 68 of the NICE Guideline as " a

substantial burden on society " .

In supporting the psychiatric lobby's attempt to

make ME/CFS disappear within the maelstrom of

undifferentiated fatigue states, NICE has contributed

to the perpetuation of unacceptable practices by

officially sanctioning – indeed promoting – this

Government-funded current prejudice, the

consequences of which will be catastrophic, not only

for those afflicted by ME/CFS, but also for those

committed researchers who are on the point of a

breakthrough into the aetiology of what is by any

standards a life-shattering multi-system disorder.

Chronic " fatigue " has no more a relationship to

ME/CFS than a pimple has to a malignant tumour.

In 2005, Professor Klimas, Professor of

Medicine at Miami and President of the International

ME/CFS Association was clear: " Our patients are

terribly ill, misunderstood, and suffer at the hands of

a poorly informed medical establishment " .

The following year (2006) she repeated the

message: " There is evidence that the patients with

this illness experience a level of disability that is

equal to that of patients with late-stage AIDS,

patients undergoing chemotherapy (and) patients

with multiple sclerosis " .

In 2007, evidence was presented at an international

conference held in Florida that the cardiac index of

these patients is so severe that it falls between the

value of patients with myocardial infarction (heart

attack) and those in shock.

Although this evidence and more was brought to its

attention, NICE remained unmoved and

recommended only behavioural interventions

designed for mental disorders, talking about

" unhelpful beliefs " ; " the relationship between

thoughts, feelings, behaviours and symptoms " ,

" sleep hygiene " and " over-vigilance to symptoms " .

It seems that so determined was the Wessely School

that NICE should recommend this latest fad that the

Guideline Development Group (GDG) was specifically

instructed to ignore over 4,000 peer-reviewed papers

which clearly demonstrate that ME/CFS affects all

major bodily systems, especially the immune

system, the neurological systems (central, autonomic

and peripheral), the neuroendocrine system, the

cardiovascular system, the respiratory system, the

musculo-skeletal system, the gastrointestinal

system, the reproductive system and the ocular

system.

The Wessely School psychiatric lobby dismisses all

this evidence as being " not of clinical value " and

insists that patients " are assumed to have 'mental'

disease " because there is " no pathology " . They refer

to ME/CFS as a " pseudo-disease " . It seems that

NICE agrees.

To be fair to NICE, it is not required to address

causation in its Guidelines; however, its remit in this

case was to produce a Guideline to aid diagnosis. To

do so, it was necessary for NICE to identify and

define the disorder in question by considering the

existing knowledge-base. Indeed, NICE is required to

do so under the terms of the AGREE instrument, to

which it is a signatory. In its Guideline on " CFS/ME " ,

NICE signally failed to do so.

Virtually all the UK ME/CFS charities condemned the

Guideline as unfit for purpose: such was the outrage

and disgust throughout the ME/CFS community at the

way that NICE had deliberately ignored so much

evidence about ME/CFS that a Public Law firm (Leigh

Day & Co, rated number one in Chambers' legal

directory) agreed to seek permission to challenge the

Guideline in the High Court by way of Judicial

Review.

The initial Hearing was on 17th June 2008 before Mr

Justice Cranston (Sir Ross Frederick Cranston), who

in his Judgment said: " There is no doubt that ME is a

debilitating condition and many of us will know of

people who have the condition. Mr Hyam (for the

Claimants) has pointed to the lack of balance in the

composition of the group drawing up the Guidelines.

Given the great public interest, it seems to me that

this case ought to go forward for a full hearing " .

NICE is therefore once again being dragged kicking

and screaming into the High Court in an attempt to

justify what cannot logically be justified.

For example, NICE decided to reject the WHO formal

classification of ME/CFS as a neurological disorder.

The ME/CFS community has obtained an abundance

of evidence that this might be because the

psychiatrists' gravy train would hit the buffers if NICE

acknowledged that ME/CFS is a discrete neurological

disorder.

NICE's position on this is unsustainable because not

only does the WHO classify ME/CFS as a neurological

disorder, but since 2003 the UK Read Codes used by

all GPs also classify it as a neurological disorder.

Furthermore, ME/CFS is included in the National

Service Framework for long-term neurological

disorders, and the Department of Health (by whom

NICE is funded and to whom it is answerable) also

accepts that ME/CFS is a neurological disorder, as

does the Chief Medical Officer himself. It will be

interesting for the public to see what " evidence "

NICE produces to convince the Court that its position

in this regard is justified.

It will also be interesting for the public to hear

NICE's explanation about the composition of the

Guideline Development Group that prepared the

Guideline, in particular, how NICE justifies its

decision to exclude clinicians with a professional

lifetime's expertise in ME/CFS who were willing to

serve on the GDG, and instead head-hunted

non-experts with undeclared vested interests.

For example, Dr Hamilton was invited to be a

member of the GDG specifically because of his

published work which supports the notion that

ME/CFS is a behavioural disorder that is best treated

by CBT/GET (as recommended by the Guideline).

Dr Hamilton just happens to be Chief Medical Officer

of two medical insurance companies that rigorously

resist claims made by ME/CFS patients, The Exeter

Friendly Society and Liverpool (LV), which

took over Permanent Health. The antics of LV in

respect of ME/CFS claims have been brought to the

attention of Members of Parliament at an All Party

Parliamentary Group Meeting at the House of

Commons.

NICE may be required to clarify why it preferred the

expertise of a dietician, a reflexologist who also

works as a hypnotherapist, an occupational therapist

and a physiotherapist to experienced ME/CFS

clinicians such as Dr Weir, Dr Kerr,

Professor Newton, Dr Terry , Dr Nigel

Speight and Dr Shepherd.

Again, it will be interesting to hear NICE's

explanation, especially as the physiotherapist just

happened to have worked with psychiatrist Professor

White and it was she who wrote the handbook

on graded exercise for the Medical Research Council's

" CFS " trial, of which White is a Principal

Investigator.

This physiotherapist also works for the same medical

insurance company as White, which pays her to

recommend (and carry out) GET for claimants (so

could it be said that her vote in favour of GET was a

forgone conclusion?).

Furthermore, she works as a " healing " therapist

using Human Givens " therapy " (which claims to

" empower " patients but is described by one clinician

as " dodgy psychobabble " ). Many people have

difficulty in understanding how this physiotherapist

had more to offer the patients for whom the

Guideline is supposed to be intended than the

Medical Adviser to the ME Association.

None of the many competing interests of GDG

members was declared in the Guideline: it was not

until two months after the Guideline had been

published that NICE released what purported to be

the List of Competing Interests of the GDG; it barely

scratched the surface of GDG members' vested

interests.

Then there is the interesting matter of how this

Institute for Clinical Excellence produced its

" evidence " out of thin air: since even NICE could not

procure non-existent evidence to support its

recommendations for behavioural therapy, it decided

to create its own evidence by transferring data from

one study and inserting that data into a totally

different study to produce what might have been the

desired results if the study in question had run for

five years instead of only fourteen months. The fact

that the transplanted data came from a study that

had used different entry criteria and whose own data

had been corrupted (admitted by the authors

themselves) seems not to have troubled the

Institute for Clinical Excellence. Most

straight-thinking people might regard such doctoring

of the evidence as fraudulent.

Another interesting area is the " Consensus "

methodology that was used in the production of the

Guideline on " CFS/ME " . It does seem to be the case

that formal consensus methodology was conspicuous

by its absence: indeed, on 10th May 2006 NICE

made it known that the consensus technique was to

be " modified " by NICE for the development of this

particular Guideline.

Scrutiny of this " modification " as it appears in the

Guideline makes very interesting reading. It will not

escape attention that the person described in the

Guideline as the " Consensus Development Expert "

was Professor lind Raine, whose published track

record happens to be that " CFS/ME " is a behavioural

disorder that should be managed by CBT/GET.

Raine specifically singled out " CFS " for study (funded

by the MRC) and she is clear: CBT should aim to

" modify thoughts and beliefs with the expectation

that emotional and behavioural changes will follow " ;

behavioural therapies focus on " the modification of

behaviour to positively reinforce healthy behaviours "

and they " emphasise the role that social factors can

play in the development and maintenance of

functional somatic complaints. The goal is to

identify and reinforce 'well' behaviours while

reducing reinforcement for somatic behaviours "

(Lancet 2004:364:429-437). The ME/CFS community

may well be justified in maintaining that NICE's

" consensus " exercise was cosmetic.

There is in addition the matter of NICE informing the

Court on 17th June 2008 at the initial Hearing before

Mr Justice Cranston that it had no knowledge of

certain documents before that Hearing, even though

receipt of some of those documents had previously

been acknowledged in writing on 23rd January 2006.

There is also the serious issue of Social Services

continuing to seek to remove children with ME/CFS

from their parents and placing them in " care " , citing

the NICE Guideline as the reason.

NICE appears to be in breach of the AGREE

instrument (to which it is obliged to conform in the

production of its Guidelines) on no less than seven

separate counts. It will be interesting to hear why

this should be so in the production of the Guideline

on " CFS/ME " and the Court may be keen to hear why

NICE appears to have broken its own guidelines (that

it is obliged to observe) in so many respects in the

production of this particular Guideline.

This is undoubtedly a high profile case. At the

preliminary Hearing in June, there was standing room

only.

The Hearing is listed for 11th-12th February 2009.

High Court officials are now busy rearranging the

Court venue in order to ensure not only disabled

access and facilities, but also to accommodate the

coach-loads of people from the UK ME/CFS

community who are expected to turn up to witness

what will undoubtedly be a landmark legal action

that will have global ramifications.

Literature References:

http://www.meactionuk.org.uk/Quotable_Quotes_Updated.pdf

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