MAY BE REPOSTED

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.

* The ME Association has fully supported the case for Judicial Review that has been made by the two claimants – see here: http://www.meassociation.org.uk/content/view/781/161/

* A summary of press reports on the Judicial Review can be found here: http://www.meassociation.org.uk/content/view/789/161/

* 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

As above:
The Homecare Industry Information Service
11/02/09
http://www.thiis.co.uk/ME-courts.aspx

Healthcare Republic
11/02/09
http://www.healthcarerepublic.com/news/GP/LatestNews/880122/charity-backs-NICE-ahead-legal-challenge-patients/

NICE judicial review
Piece about the NICE judicial review for the guidelines of M.E./CFS being held in the High Court today and tomorrow. The judicial review is being brought by Kevin Short and Douglas Fraser who argue that the guidelines can actually be harmful to people with M.E.
BBC News Online
11/02/09
http://news.bbc.co.uk/1/hi/health/7881116.stm

As above:
The Shields Gazette
11/02/09
http://www.shieldsgazette.com/news/ME-sufferers-await-landmark-judgement.4965599.jp

Onmedica.com
11/02/09
http://www.onmedica.com/NewsArticle.aspx?id=e667073f-2aab-4a23-a02b-da8df55e10d1

Judicial Review Coverage taken from ME AGENDA website

FT Adviser | 12 February | Sharon Flaherty

Insurers under fire over treatment of ME sufferers

Magazine: FTAdviser

Insurers are set to come under fire at a High Court case today (12 February) over their treatment of myalgic encephalomyelitis (ME) and chronic fatigue syndrome suffers, who are often unsuccessful in claiming on their insurance policies.

Last year FTAdviser.com revealed that an independent financial adviser had his permanent health insurance payments stopped by Norwich Union, because of the difficulty in diagnosing his condition of chronic fatigue syndrome. (See article previous here )

In the last 18 months, a dispute over the National Institute of Clinical Excellence (NICE) guidance on the condition has arisen, in part, because it emphasises that ME and chronic fatigue syndrome is a psychiatric condition rather than a physical one – something the wider ME community denies…

Read full report here

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The Herald | 12 February | Phil Miller

Two ME sufferers challenge ‘perverse’ guidance given to doctors

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EDP24 | 11 February 2009 | Sarah Brealey

http://tinyurl.com/cdxn4x

Norwich man’s ME fight goes to High Court

A Norwich man’s landmark battle for better medical treatment started in the High Court today.

Kevin Short, 47, a graduate and former engineer, is bringing the case with Douglas Fraser, a former professional concert pianist from London. They are applying for a judicial review of the guidelines for treatment of myalgic encephalomyelitis, or ME. Mr Short has had ME since the 1980s and has problems with mobility…

Read full report here

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Fenland Citizen | 11 February 2009

http://www.fenlandcitizen.co.uk/latest-east-anglia-news/Restricted-me-treatments-challenged-in.4969959.jp

‘Restricted me treatments’ challenged in high court

Two ME sufferers, including one from Norfolk, have launched a High Court battle over the “perverse and irrational” guidance they say has been issued to doctors for the treatment of their condition…

Read full report here

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It’s understood that an interview has been recorded for Radio Solent – no links yet.

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Shields Gazette | 1o February 2008 |Angela Reed Chief reporter

http://www.shieldsgazette.com/news/ME-sufferers-await-landmark-judgement.4965599.jp

ME sufferers await landmark judgement

SOUTH Tyneside sufferers of a debilitating condition hope a legal challenge will lead to the re-writing of guidance on their treatment.

Medical guidelines on the diagnosis and management of myalgic encephalomyelitis (ME) and chronic fatigue syndrome (CFS) are being challenged in a judicial review at the High Court, in a case due to start today…

Read full report here

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BBC | 11 February 2009

http://news.bbc.co.uk/1/hi/health/7881116.stm

ME pair appeal ‘unfair NHS rules’

“There is little evidence that what has been recommended actually works” Jamie Beagent, patients’ solicitor

Two ME patients are due to launch a High Court appeal against what they say is an “unfair and irrational” approach by the NHS to their condition…

Read full report here

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The Homecare industry Information Service | 10 February 208

http://www.thiis.co.uk/ME-courts.aspx

Courts challenge for M.E

Medical guidelines on the diagnosis and management of M.E. and chronic fatigue syndrome will be challenged in a judicial review at the Royal Courts of Justice.

The case against the National Institute for Health and Clinical Excellence (NICE) is generating considerable interest among the 250,000 people in the UK who have M.E., as some patients hope the legal proceedings will lead to the withdrawal of the guideline.

However, Action for M.E., the country’s biggest M.E. charity, supports the guideline…

Read full report here

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Medical News Today | 9 February 2008

http://www.medicalnewstoday.com/articles/138333.php

ME Association Fully Supports Legal Challenge To The NICE Guideline On ME/CFS, UK

The ME Association will be fully supporting the two people with ME – Douglas Fraser and Kevin Short – who have succeeded in achieving a Judicial Review into the 2007 NICE Guideline on ME/CFS.

The Judicial Review, which could result in the NICE guideline being withdrawn, is taking place at the Royal Courts of Justice in The Strand, London on 11 and 12 February…

Read full report here

Reference: http://meagenda.wordpress.com/

Margaret Williams & Horace Reid.

3rd February 2009.

May be reposted.

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 CMO’s 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 Gibson’s 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.