The case against the NICE guideline on ME/CFS moved to Court 7 in the Royal Courts of Justice on Tuesday 17 June.
This is a short summary of key points that were made during the proceedings.
In common with many of the courtrooms in the High Court, the public gallery was cramped, acoustics were poor, and there was a lot of internal noise coming from old creaking wood – so it was impossible to consistently hear and follow all of the legal arguments.
Mr Justice Cranston first spoke about what was termed Case "B". The hearing then went on to deal with the case of two people with ME – whose identities were given in Court.
After an exploratory hearing lasting almost two hours, Mr Justice Cranston concluded that the case ought now to move forward to a full hearing. So the next stage will be a two day hearing in the autumn – once the summer law vacation is over. This is to give both sides time for further preparation.
THE CASE AGAINST NICE (Mr Hyam)
The legal arguments opened with a lawyer representing the two named people with ME briefly explaining the background and purpose to the 2007 NICE guideline on ME/CFS.
This was followed by a series of specific arguments from a ‘skeleton' document relating to why the guideline development process – ie the way in which the guideline development group (GDG) had gathered, examined and evaluated evidence about the management of ME/CFS – was flawed and why the Court should become involved in a Judicial Review.
Much of the legal case against NICE centred on the blanket recommendation that everyone with mild or moderate ME/CFS should be offered a course of cognitive behaviour therapy (CBT) and/or graded exercise therapy (GET). This, it was argued, was linked to the way in which the York Review (an academic review of evidence from clinical trials into treatment interventions carried out for NICE by a research department at the University of York) had relied on a hierarchy of evidence that placed the results from a small number of randomised controlled trials (RCTs) into CBT (7) and GET (5) at the top and evidence from patients and stakeholders right down at the bottom. However, in the case of CBT and GET the evidence from these RCTs was inadequate and should not have led to the conclusions and recommendations relating to CBT and GET in the guideline.
By marginalising or omitting evidence that did not come from RCTs, patient choice was being restricted because NICE had specifically advised against the use of other types of treatment – in particular antiviral drugs.
Consequently, doctors would not be able to obtain funding for treatments that were not recommended or were being proscribed (ie forbidden) by NICE in the guideline.
In addition, it was argued that:
- Membership of the GDG lacked balance and that specialists from certain highly relevant areas of medicine should have been included – eg an endocrinologist and virologist – but were not.
NICE had failed to carry out a satisfactory estimate of cost effectiveness. In the case of CBT, this involved an RCT where there was a statistically insignificant difference in outcomes between the active treatment and control groups. No proper cost effectiveness analysis had been carried out for GET – even though this was a central function for NICE.
- Failure to consider the cause of ME/CFS was a serious omission. In other words it was irrational to ignore causation and then go on to produce a guideline that only recommended psychological forms of treatment.
- Not only was the evidence in favour of CBT and GET flawed, there was also a potential for serious harm in the case of GET.
In conclusion, it was put to the Court that a new guideline that is not based on such a flawed development process should be produced. And although a review of the current guideline could take place in 2 to 4 years time, and important new information could be added at any time, this was not the solution to the problem. People with ME cannot wait that long.
THE CASE FOR NICE (Mr Childs)
In response, the lawyer for NICE stated that the GDG had taken the dichotomy (ie division) of opinion about ME/CFS into account when reaching their conclusions.
None of the advice provided in the NICE guideline should override a doctor's clinical judgement and patients do have an opportunity to influence their management.
And if people were unhappy with the membership of the GDG, why wasn't this raised before now?
Continuing the case would cost a lot of public money – which could be spent on better things.
In his summing up at the end of the afternoon, Mr Justice Cranston made it clear that he was in no doubt about ME/CFS being a serious and debilitating condition. He also observed that most people will know someone who has ME/CFS. But this was a Court of Law, not a Court of Science where complex medical disagreements about ME/CFS could be sorted out.
However, after listening to the various arguments about flaws in the development process; restriction of patient choice; membership of the GDG; and evaluation of cost effectiveness, Judge Cranston agreed that the case ought to proceed to a full hearing with a degree of some urgency.
Personal comment from CS: Overall, I was impressed by the arguments put forward by the legal team acting for the two patients and the choice of issues on which it has been decided to mount this legal challenge. These are significant defects to a guideline development process that should now be properly challenged at a full High Court hearing.
- A further report on the hearing will appear in the July issue of ME Essential magazine.
- Solicitors acting for the two people with ME are Leigh Day and Company. Website: www.leighday.co.uk
MEA website summary prepared by Dr Charles Shepherd, Hon Medical Adviser, The ME Association