Margaret Williams & Horace Reid.

3rd February 2009.

The Judicial Review of the NICE guidelines on CFS/ME

will be held on Wednesday & Thursday 11th & 12 of

February 2009. The case is being brought by two

adult patients living in the UK.

The constraints of this type of legal challenge

(Judicial Review) have already been indicated by the

judge who initially granted leave to proceed. Mr

Justice Cranston made it clear in June 2008 that a

court is not an appropriate forum for medical debate.

Arguments will therefore centre on technical issues,

such as whether NICE followed its own prescribed

procedures.

Much to the disappointment of many patients, there

will be no debate on the aetiology, definition, or

biomedical status of ME. However in an intense

two-day hearing, other crucial issues will be

addressed.

Guideline Development Group Bias.

It has been the practice of the psychiatric lobby to

attempt to pack important CFS/ME committees with

their own supporters, to achieve their desired

outcomes of CBT & GET. They did this successfully in

1996 with the Royal Colleges report, repeating the

trick with the CMOs committee in 2002. With NICE

the liaison psychiatrists have been more subtle.

Instead of personally serving on the Guideline

Development Group (GDG), it seems that they have

managed to stack the group with sympathizers,

whilst biomedical ME specialists critical of their

approach were excluded. A Freedom of Information

request has revealed that Professor Anthony Pinching

among others was deeply involved in the GDG

selection process.

The many competing interests of the individuals on

the GDG (declared and undeclared) may now be

subjected to the scrutiny of a High Court judge.

Failure to Declare Conflicting Interests.

Take for example the case of Dr. Fred Nye. Incredible

as it may seem, as a member of the GDG he was

allowed to adjudicate on the quality and relevance of

his own research. His RCT, co-published with Powell

and Bentall, constituted 25% of the positive

evidence base supporting the NICE recommendation

on GET. It is difficult to understand how the

chairman and fellow members of the GDG could

regard him as a neutral and objective participant

when the value of GET was being debated.

At some stage Dr. William Hamilton, another GDG

member, did declare his connection with the

Liverpool Victoria and Exeter Friendly insurers. But

NICE failed to appreciate that his appointment gave

him an opportunity potentially to import an

inappropriate commercial agenda into the clinical

area. Many health insurers have subjected ME

patients to sharp practice; their notoriety came to

the attention of Dr. Ian Gibsons committee in 2006.

His Parliamentarians condemned the blatant conflicts

of those individual researchers who mingled their

commercial and clinical interests. In its appointment

of Dr. Hamilton, NICE failed to heed these warning

voices.

A number of other prominent GDG members failed to

declare their close connection with interested parties

such as Professors Simon Wessely, Peter White, and

Trudie Chalder. Their names and multiple omissions

may soon be disclosed.

Scrutiny of the CBT/GET Evidence Base.

The Wessely School continually boast that their

favoured treatments CBT & GET are evidence based;

but their claims lack objective validation. All too

often they peer review their own work. In the 2006

NHS Plus exercise, for instance, on Occupational

Health guidance for CFS/ME, Professors Chalder and

White sat in judgment on their own research,

without declaring a competing interest. Their fellow

NHS Plus participant, Professor Michael Sharpe,

apparently noticed nothing amiss.

It is clear that the court cannot entertain clinical

arguments on the merits of NICE-endorsed

treatments for any disorder. However the Judge may

be asked to consider whether NHS recommendations

for 240,000 UK ME patients can justifiably be based

on the miniscule amount of evidence supporting CBT

& GET. The much-vaunted Wessely School evidence

base will be subjected to impartial public scrutiny.

As AYME has hinted in its website post of 19/1/09,

the case has the active support of many leading

biomedical researchers, at home and abroad. Dr.

Bruce Carruthers, lead author of the Canadian

national ME guidelines, plans to be present in court

throughout the two day hearing.

AYME & NICE.

AYME contemplate two outcomes: the 2007 NICE

CFS/ME guideline could be struck down altogether; or

it might survive, and be subject to routine revision in

due course.

Routine revision, already envisaged, would simply

give NICE an opportunity to repeat past errors. The

psychiatrists would likely get their way once more,

and the legitimate concerns of ME patients would be

ignored as usual.

NICE Must Begin Again.

Striking down Clinical Guideline 53 is the more

desirable option. The present guideline would cease

to have effect, and NICE would have to begin again

from scratch. Those who allegedly manipulated the

composition of the CFS/ME GDG would be exposed

and discredited. No- one would dare to resort to such

tactics again. If it is proved that the GDG was

infiltrated by the commercial interests of the medical

insurance industry, and became a pawn of a clinical

special interest group, then NICE will be much more

circumspect next time. And the CBT/ GET research

bubble will be definitively burst.

Patient & Media Support Needed.

It is important that ME patients and their families

come in person to London next week. The presence

of large numbers inside the building, and outside

along with TV cameras, will impress upon the court

the importance of this issue to a quarter-of-a-million

UK ME patients. (Observer spaces inside the

designated courtroom will be extremely limited).

National and local ME charities in the UK and abroad

should alert the media to the global significance of

this court case, in the long- running medical

controversy about ME.