Op 11 en 12 vond in Londen de juridische hoorzitting plaats
waarin twee ME/CVS-patiënten de rechtmatigheid van de NICE-richtlijnen aanvechten.
De rechter velt binnenkort een oordeel over
de wijze waarop de richtlijnen voor medische professionals tot stand kwamen
en, jammer genoeg, niet over de inhoudelijke "kwaliteit" van de richtlijnen
(CBT/GET is de enige evidence based "behandeling",
(bio)medische diagnose en behandeling heeft "geen nut" etc.)
Voor berichtgeving over de NICE richtlijnen en de rechtszaak:
Voor de website die speciaal over deze rechtszaak handelt: klik hier.
Judicial Review - Summary of High Court proceedings
Dr Charles Shepherd
14 February 2009
The Judicial Review of the NICE guideline on ME/CFS took place
on Wednesday and Thursday, 11th and 12th February, at the Royal
Courts of Justice in London. The hearing was held in Court 76 - a
large modernised courtroom tucked away on the third floor of this
historic maze of legal activity.
Unlike the preliminary hearing
in June last year, there was plenty of room to move around along
with comfortable non-squeaking seats and wheelchair access -
although it was difficult at times for those at the back to hear
precisely what was being said by barristers representing the two sides.
Around 50 members of the
public, along with occasional brief visits from
journalists, packed Court 76 to witness the proceedings. At times, a
'Court Full' sign had to be posted up. Not surprisingly, there
did not appear to be a single person with ME/CFS who had come up to
London to support the NICE guideline.
Outside the main entrance in
The Strand, where all the TV news bulletin shots of the High Court
are taken, a small peaceful demonstration against the NICE guideline
took place over lunch. This managed to attract quite a lot of legal
and public interest.
Almost all of Wednesday was
taken up with a legal presentation from barrister Jeremy Hyam on
behalf of the two claimants who suffer from ME - Kevin Short from
Norfolk and Douglas Fraser from London.
In relation to the effects of
the NICE guideline on practical patient care, two key issues were
Firstly, the procedures
by which the NICE guideline development group (GDG) had come to the
conclusion that the only treatments worth recommending for people
with ME/CFS were two behavioural interventions, namely cognitive
behaviour therapy (CBT) and graded exercise therapy (GET), and this
was to the exclusion of all others.
Secondly, the fact that a
number of medical/drug and supplement interventions, which may be
helpful in selected cases, were not therefore being recommended by
NICE. As a result of not being recommended, doctors would not be
willing to consider using them, and healthcare providers (ie PCTs)
would not be willing to pay for them. Some people with ME/CFS would
therefore be denied forms of treatment that could be of benefit.
In relation to the way in which
a judicial review is there to examine procedures rather than actual
decisions, it was argued that the decision making process had been
based on a foundation of insufficient evidence of clear benefit
being available to recommend the widespread use of CBT and GET.
In particular, was the way in which a systematic review of results
from randomised controlled trials involving CBT and GET (ie the York
Review) had failed to demonstrate the sort of robust consistent
evidence that could stand alone and satisfy the requirements for
this type of recommendation to be made in a NICE guideline.
for the claimants also argued that insufficient weight had then
been given to certain other key sources of evidence further down the
hierarchy of evidence that were made available to the guideline
development group - in particular the results of patient
questionnaires and stakeholder feedback which had reported that in a
significant proportion of people with ME/CFS these treatments were
either ineffective or even harmful.
When it came to the final
analysis it was argued that with several members of the GDG being
involved in clinical trials involving these two treatments, or
expressing support for their use, there was an appearance of bias in
the way that the GDG decided to recommend CBT and GET as the only
forms of effective treatment.
To support the appearance of bias
reference was made to comments contained in a letter from a patient
representative on the GDG (Tanya Harrison) who had resigned from the
group as a result of what she believed was bias towards the
psychosocial model. It was also argued that the appearance of
bias towards CBT and GET was compounded by the absence of any health
professionals on the GDG who were known to be in favour of the
biomedical model of ME/CFS
The final part of the first
day's hearing, and almost all of Thursday morning, was taken up by
counter arguments being presented by the barrister representing
NICE, namely that the research evidence in favour of CBT and GET was
sufficiently robust; that the process of collecting and analysing other
types of evidence from clinical trials, stakeholders, experience of
clinicians etc was thorough and transparent; and that no evidence of
bias towards the psychosocial model had been shown by individual
members of the GDG. Neither was there any bias in the way in which
the members of the GDG were selected by nomination of the relevant
Royal Colleges or professional bodies, and some of the accusations
relating to bias, conflict of interest, or disclosure of interest
were based on factual inaccuracies. In other words, the
procedures that were followed by NICE were as robust and fair as
could be achieved in the circumstances and that the decision to only
recommend CBT and GET was not the result of any bias on the part
of individual members of the GDG, or the group as a whole. Legal
arguments on behalf of the defendants (ie NICE) went on till early
afternoon on Thursday.
Thursday afternoon produced a
further legal argument involving the cost effectiveness of both
treatments. This was given by a barrister acting for an 'interested
party' in the case against NICE. Evidence was put forward on behalf
of this interested party to show that the cost effective analysis
for CBT was seriously flawed and that no proper cost effectiveness
analysis for GET had even been undertaken. In other words, it was
claimed that NICE was recommending two forms of treatment that had
not yet been properly shown to be cost effective. Again, this
position was vigorously challenged by the barrister representing
A great deal of time was spent
in discussing the points that are summarised above, along with legal
technicalities. However, some of the other aspects of the case
against the NICE guideline, which have surfaced in public discussion
on the internet prior to the case being heard in Court, were not
referred to or left very much out on the periphery (eg neurological
classification of the illness).
Legal arguments and discussion
went on till almost 5pm on Thursday and there is still some
unfinished business for the Judge, Mr Justice Simon, to deal with.
So it looks as though the Judge's decision on the case will be
delayed for at least a week, possibly even longer.
The ME Association has fully supported the case for Judicial Review that has been made by the two claimants -
A summary of press reports on the Judicial Review can be found
For anyone involved with
insurance companies referred to during the hearing - Exeter Friendly
Society and Liverpool Victoria - some interesting and useful
statements regarding their positions on recognition and
classification of ME/CFS were made during the hearing.
Two ME sufferers challenge ‘perverse’ guidance given to doctors
February 12 2009
PHIL MILLER, Arts Correspondent
A former violinist for the Scottish Philharmonic Orchestra launched
a High Court battle yesterday to change the "perverse and irrational"
guidance given to doctors who treat ME sufferers.