Dr Charles Shepherd, Medical Adviser to the ME Association has published a summary of the Judicial Review High Court Proceedings
ME Association | 15 February 2009 | Dr Charles Shepherd
Judicial Review – summary of High Court proceedings
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 examined:
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. Counsel 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 trails 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 NICE.
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.
a The ME Association has fully supported the case for Judicial Review that has been made by the two claimants – see here
b A summary of press reports on the Judicial Review can be found here
c 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.
Summary prepared by Dr Charles Shepherd
14 February 2009