UK NICE Guidelines High Court Hearing granted

Discussion in 'Fibromyalgia Main Forum' started by Bluebottle, Jun 17, 2008.

  1. Bluebottle

    Bluebottle New Member


    STOP PRESS - Mr Justice Cranston ruled in the High Court this afternoon that the application for a judicial review of the NICE clinical guideline into ME/CFS should go forward. The full review, which is expected to last two days, will take place sometime in the autumn. The ME Association will post a report into today's exploratory hearing tomorrow morning.

    This press release was issued a few days ago by Leigh Day & Co, Solicitors

    High Court hearing on NICE Judicial Review to take place on June 17th 2008

    Patients of a devastating illness, Myalgic Encephalomyelitis (M.E.) have today welcomed the news that there is to be a hearing in the High Court in London on the 17th June to decide whether or not to grant permission for a Judicial Review of NICE guidelines on the illness which is sometimes referred to as CFS/ME.

    NICE issued their Guideline for doctors in August last year amid protests from patients and medical researchers that they had not followed correct protocols in producing the Guideline. Patient groups fear that some patients could be pressured into accepting treatments which at best may be useless and at worst could cause real harm.

    The hearing will take place in the High Court at the Royal Courts of Justice on the Strand on 17 June 2008. The hearing is listed to last for half a day and Court will hear legal argument from lawyers representing two ME sufferers as well lawyers for NICE. The precise time and location of the Court room will be published on HM Courts Service website on the afternoon of 16 June.

    For further information please contact Jamie Beagent at email address is being protected from spam bots, you need Javascript enabled to view ----------------------------------------------------------

    (I know it's only the first step, but it's great news!)

    [This Message was Edited on 06/17/2008]
  2. mezombie

    mezombie Member

    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 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:

    MEA website summary prepared by Dr Charles Shepherd, Hon Medical Adviser, The ME Association

  3. mezombie

    mezombie Member


    From Kevin Short:

    Dear All,

    The 17 July 2008 UK High Court decision on the NICE ME/CFS Guideline Judicial Review is a major breakthrough. From the very bottom of my heart: thank you to all who worked quietly and diligently behind the scenes, gave of their time, energy, money and support and thank you very much to those who enabled me to be there. We have a long way to go and a lot to do in a short time before we have a shot at achieving success but: hope is now restored. Whilst outcomes are of course not guaranteed, for the first time
    in the UK, even though it is on narrow points of procedural law and not on wider medical science issues, we at long last have the prospect of a fair hearing before an institution with real power to act in our favour.

    Now the really important bit for the hearing itself... the first thing both counsel and our solicitor said yesterday was they felt the fact that the court had been full of patients had a significant impact upon the outcome. Justice Cranston clearly expressed compassion towards ME patients generally as well as the litigants in particular. Again, this morning, I have been contacted by our solicitor to say that patient support prior to the hearing
    and in the public gallery was crucial. I believe therefore that it is absolutely imperative our solicitors now try to secure a courtroom with a large public gallery and we/you all work to absolutely pack it with well-behaved (that part is very important) and informed patients and carers
    for both days of the autumn hearing. If patients cannot attend then send a relative or friend in your place. Even if so many people attend that some have to wait outside in the hall this will send an absolutely invaluable message to the Judiciary, press and beyond. We simply have to let the establishment know that we will not go away and we will not stop struggling until we get proper science, proper medicine, proper care and nothing short of justice.

    PLEASE can folk start organising to attend the hearings now? Spread the word as widely as possible within the ME community and friends and family. It is impossible for me to be involved much in this aspect of things myself as I
    have to focus on matters legal. Why not consider organising discounted block-booked overnight accommodation at a nearby travel-lodge or student residences: perhaps with a coach or two to ferry folk from accommodation to
    the court on both days? This is highly doable and would be self-financing by the individuals. The importance of this hearing cannot be overemphasised. Please therefore; someone or some team of individuals please get organising!
    I know it is a lot to ask but we have got to garb this opportunity one hundred per cent.

    We will let you know dates, times and room number as soon as we know them. I am afraid that the Royal Courts of Justice building is not particularly
    disabled-friendly but I managed to get around in a wheel chair and we should not be put off. Please, please, please DO go to the hearings if you can and if you cannot please send someone in your stead. Information regarding court
    location, access and services can be found at the web address below.

    Many thanks and very best wishes to you,

    Kev Short.

    [Permission to Repost].

  4. Bluebottle

    Bluebottle New Member

    Thanks zombie!
  5. becc

    becc New Member

    This is very good news. It sounds like the case against NICE was made very well.

    I particularly like the comment attributed to Mr Childs, that "continuing the case would cost a lot of public money - which could be spent on better things." We all know the various governments of the world have been greatly concerned with spending public money wisely when it comes to ME/CFS!

  6. tansy

    tansy New Member

    Thanks for posting these updates. Many of us have felt it would take politicians, or the law, to address the misinformation, prejudices, and criminal waste of taxpayers money on Tx that are not producing the claimed results.

    The Gibson Parliamentary Enquiry recommended a judicial review of the vested interests involved; the govt have refused to implement that or any of the other recommendations.

    "... 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."

    This is very encouraging.

    tc, Tansy
    [This Message was Edited on 06/20/2008]

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