NICE Judicial Review documents: Margaret Williams

Margaret Williams has issued a series of documents which have been created specifically for the NICE Judicial Review. These are being circulated by Stephen Ralph and are also available from the MEActionUK website.  I will be adding these to this page as they are released, so please check from time to time for new additions.

Stephen Ralph has created a page for all Judicial Review documents and this can be found on a button at the top of the main page of  www.meactionuk.org.uk

Alternatively you can find the page directly by clicking on this link:

http://www.meactionuk.org.uk/nicejr.htm

Please note that there is some duplication of documents already published.

 

Document 1:
http://www.meactionuk.org.uk/Background_Information_re_CBT.htm

Background information and illustrations of evidence that CBT cannot improve ME/CFS which NICE disregarded

Margaret Williams 25 July 2008

 

Document 2:
http://www.meactionuk.org.uk/Facts_re_GET.htm

Evidence that the Guideline Development Group that produced the NICE Guideline on CFS/ME (C53) failed to fulfil its remit

(particularly in relation to the potential dangers of graded exercise therapy)

Margaret Williams 7 July 2008

 

Document 3:
http://www.meactionuk.org.uk/Cardiovascular.htm

Evidence of cardiovascular problems in ME/CFS that NICE disregarded

Margaret Williams 4 August 2008

 

Document 4:
http://www.meactionuk.org.uk/Immunol_and_neuroendo.htm

Immunological, neuroendocrine and neurological evidence (including evidence of CNS inflammation) documented in ME/CFS that NICE chose to ignore in the production of its Clinical Guideline 53

Margaret Williams 31 August 2008

Radio 4: Employment Support Allowance

Employment Support Allowance

A piece about the new Employment Support Allowance including views from Mark Baker, Disability Benefits Consortium, Claire Bambra, University of Durham and new Minister for Disabled People, Jonathan Shaw.

BBC Radio Four, World this Weekend, 1pm
26/10/08

Listen again:

http://www.bbc.co.uk/radio4/news/worldthisweekend/
 (17 mins in)

Disclosure by AfME of composition of National ME Observatory Steering and Management Groups

Disclosure by AfME of the composition of the Steering and Management Groups for the National ME Observatory

AfME finally coughs up with a list of names!

I’d like to set the following on record:

On 1 October 2007, I first contacted Dr Derek Pheby, AfME National Observatory Project Co-ordinator, (CCd to AfME’s Sara Brooks):

I wrote:

“Following the 16 June meeting of The ME Association Board of Trustees, Dr Charles Shepherd published a summary of key points emerging at that meeting. In his summary, Dr Shepherd writes:

‘A meeting of the ME Observatory Steering Group took place on the same day. As this clashed with the Board meeting, the MEA could not, unfortunately, be represented.’

To the best of my knowledge, The ME Association has not made any announcement to this effect, but I assume from what Dr Shepherd has written in his summary that a representative of the ME Association, possibly Dr Shepherd, himself, has been appointed to the ME Observatory Steering Group.

Issue 61 of AfME’s InterAction magazine carries an update on the National Research Observatory which includes a list of lay members appointed to the Steering Group and a list of those appointed to a Reference Group but there is no mention of Dr Shepherd’s appointment or of any others who may have been appointed over and above lay members.

I would like to make a formal request for the following information:

1] Have any other representatives of national ME patient organisations (other than the MEA and AfME’s own staff and Trustees) been allocated seats on the Steering Group and through what process were these seats allocated?

2] Other than any ME patient organisations, have any other organisations or individuals (other than those specifically named lay individuals that comprise the Steering and Reference Groups and are named as such in InterAction) been allocated seats on the Steering, Management or any other group or groups that comprise the Observatory Project and through what process were these seats allocated?

3] Would you please provide a complete list of members of:

The Steering Group (both lay and professional)
The Management Group
The Reference group
Any other individuals or organisations involved in this Project

The list to include:

Name of individual
Organisation Represented (where appropriate)
Function within Project Group or within Project as a whole

Contact details for individuals/organisations are not required.

If a Line Management organisational chart has been produced then a copy of this would also be welcomed.”

~~~~~~~~~~~~~~~~~~~~~~~~~~~

Apart from confirming that Dr Shepherd (MEA) did indeed hold a seat on the Steering Group, Dr Pheby provided no responses to these questions, stating that “Those lay members who were appointed as a result of the exercise all consented to have that fact reported in Interaction. We were obliged to seek that consent as a result of our obligations under the Data Protection Act, which restricts what further information we can disclose about other participants in the project whose consent to disclosure has not at this stage been sought.”

Dr Pheby evidently had no inclination to obtain consent in order to release a list of names to me nor did he appear to consider that the information I had requested should already have been placed in the public domain.

On 11 October 2007, I wrote again to Dr Pheby, this time copying in Sir Peter Spencer (CEO AfME), and requested this information under the FOI Act. Receiving no response from either Dr Pheby or Sir Peter, I wrote again on 2 November.

This did evoke the following response from Dr Pheby which he had CCd to Sir Peter Spencer:

“Thank you for your further message. I apologise for my oversight in not having replied to you until now. I note that you requested some information regarding the National ME Observatory Steering Group, and invoked the Freedom of Information Act in support of your request. It should be noted that charities do not actually fall within the scope of the Freedom of Information Act.”

That is all he has to say.

On 6 November, I decided to approach Sir Peter Spencer, directly, (CCd to Dr Derek Pheby and to AfME’s Sara Brooks and George Armstrong):

I wrote:

“The Observatory is a separate organisation which is an amalgamation of academic institutions, the Lotteries Board and Action for ME. The Freedom of Information Act applies to government bodies such as academic institutions and the Lotteries Board. Additionally, the Observatory is spending half a million pounds of public money and is accountable to the public for the manner in which that money is spent and it is expected to be open to public scrutiny, through the FOI Act.

I am deeply concerned that as Project Co-ordinator, Dr Pheby evidently does not feel the Observatory should be open to scrutiny and that the Observatory (and by extension, AfME) seek to operate with a lack of transparency and without due regard for the requirements and ethos of the FOI Act. It is remarkable that AfME would appear to be supporting Dr Pheby in his evident desire to deny AfME members knowledge of who comprise the various Steering and Management Groups which share responsibility for supervision and management of this major project.

I shall be contacting The Big Lottery Fund Grants Officer with responsibility for the Observatory Project with my concerns about the Observatory and AfME’s handling of this matter, forthwith, and submitting a request for this information to be provided under FOI, by the Lotteries Board.

I wish to extend to you one last opportunity to provide the information I have requested and which I append [...] below.”

~~~~~~~~~~~~~~~~~~~~~~~

I received neither the courtesy of an acknowledgement nor a reply from Sir Peter Spencer and on 9 November 2007, I put in an FOI request for this information to The Big Lottery Fund.

I was advised by The Big Lottery Fund that they did not hold the information I had applied for and that they were under no obligation to request information from an organisation to enable a member of the public to access it, but that this information might, in any case, be subject to Section 12, and to Section 40(2) of the Data Protection Act relating to personal information.

Around this time, I also submitted an FOI for the same information to the University of York (CCd as a matter of courtesy to Professor Peter Campion) and also to the University of East Anglia – both universities being partners with AfME in the Observatory Project. Both institutions replied that they did not hold this information on file.

Professor Campion also responded to my communication, commenting that as a member of the Steering Group, himself, he expected that its activities would be as transparent and accountable as is proper for any such body and that as a researcher, he expected total confidentiality to be available to all research participants, and also that researchers themselves were not exposed to any personal risk as has happened to medical researchers, as he was sure I was aware.

Quite what “personal risk” Professor Campion perceives researchers engaged in Observatory projects might be exposed to isn’t clear nor does he elaborate on what basis he has for his apparent concerns.

I wrote again to The Big Lottery Fund expressing my concerns that the Observatory Project Co-ordinator and AfME were not operating transparently.

On 4 December, The Big Lottery Fund wrote to me with a proposition:

Since they were unable to fulfil my request because a) they did not hold all of the information I had requested; b) they estimated that the cost of compiling the information in order to comply with the request would exceed the appropriate limit and c) if the information were held by them, it could also be subject to section 40(2) relating to personal information and may not be released for that reason, that rather than respond to my individual questions they were offering to send me instead a considerable body of material which they were in the process of releasing to another individual following a separate request under FOI and that this bundle would include the initial grant application, the business plan and their correspondence with AfME.

Well, I wasn’t going to say No, was I?

So for the past 10 months, I have been sitting quite legitimately on some 450 odd sides of A4 photocopies which represent much of the file that The Big Lottery Fund were holding on AfME and the Observatory Project at November 2007 – it’s a couple of inches thick.

A number of pages were identified as having been omitted which had contained CVs and personal contact details. I was also advised that The Big Lottery Fund’s internal assessment processes, and data such as bank account details had also been left out.  Some names and contact details had evidently been blacked out before photocopying, but otherwise I was given to understand that little else was being withheld from this very large bundle of documents and correspondence.

The irony of this is, that as a result of AfME and the Observatory Project Group Co-ordinator’s decision not to place the information I had requested in the public domain (set out at the top of this report) the result has been that I have actually ended up with a vast bundle of stuff – the research proposal application documents, the research project costings, copies of the three independent expert review reports, the business plan, the research agreement, variation reports, copies of letters and emails between AfME/Observatory Project personnel and The Big Lottery Fund, internal and external correspondence relating to applications submitted by other individuals under FOI for information about the Observatory Project; staff costings, job specs, costings for equipment, travel, workshops, conference attendance, translations, transcriptions, video equipment, printing, consumables, development of a website, copies of invoices for PCs, printers, software, and various other documents provided by AfME and the academic institutions working in partnership with the Observatory Project like accounts, governing documents and charters…and what a fascinating read it is!

The Big Lottery Fund also held a copy of the ONE CLICK AfME Dossier on file.

At least two other individuals are known to be holding this material under FOI.

The names of some of those from the academic institutions involved in the Observatory Project – Pheby, Campion, Lacerda, Leite, Chia, Nacul, Howe  had already been published by AfME in its magazine or were evident from university and AfME press releases, from university websites or from UEA adverts for research volunteers. The bundle revealed that Professor Leslie Findley (National ME Centre) was not only a member of the Observatory Steering Group but that he had also been one of the three independent expert reviewers of the research proposal – so there was another name to add to the list which AfME had yet to make public.

Dr Charles Shepherd (MEA) had already let slip that he had a seat on the Steering Group. But it was not evident whether reps for AYME or The Young ME Sufferers Trust (or any other patient organisation) also had seats, since Dr Pheby and Sir Peter Spencer had been unwilling to clarify and since the bundle provided by The Big Lottery Fund did not include copies of minutes for Project Steering Group and Observatory member meetings nor a directory of Steering and Observatory Group members and others involved in the Project.

Douglas Badenoch (Minervation/PRIME) had been quite happy to confirm to me, last December, that Sally Crowe and an associate had been allocated seats on the Steering Group and that he also had an involvement, himself – PRIME’s involvement with the Observatory had been alluded to in a PRIME newsletter, so that was an easy line of enquiry. Some other names can be derived from the bundle of Observatory related documentation that’s sitting in two A4 files beside me.

Amongst the correspondence, I noticed that the Lottery Fund Grants Officer had written to AfME on 6 November 2007 requesting certain information to be provided to them by 23 November – this to include an interim monitoring report on the project tasks for year one and a request that the following documents were also submitted:

. Minutes from meetings held to date between Action for M.E., the project steering group and observatory members.
. A list of members of the project steering group.
. A list of members of the Observatory.

On 25 June 2008, I wrote again to The Big Lottery Fund that I had been advised by them on 4 and 12 December that they did not hold all of the information I had requested in my original FOI application but that it was evident from correspondence included in the bundle they had sent to me that the BLF Grants Officer had written to Dr Trish Taylor on 6 November 2007, CCd to Sir Peter Spencer, requesting certain documents.

Under FOI, I requested confirmation of whether AfME had fulfilled the request to provide the Big Lottery Fund with a) A list of members of the project steering group, b) A list of members of the Observatory, and the date on which this request was fulfilled.

On 1 July 2008, Robert Holland, Head of Corporate Governance, Big Lottery Fund confirmed that Action for ME had complied with this request on 3 December 2007.

It appears then, that when The Big Lottery Fund wrote to me on 4 and 12 December they were now holding on file some of the information that I had requested, the previous month.

I have had no further correspondence with The Big Lottery Fund or with AfME or with Dr Pheby, the Project Co-ordinator, over these matters.

I’d like to remind readers that by the end of 2007, the 16 members of the Observatory’s Reference Group were also being denied knowledge of the names of the members of the Steering Group and members of the Observatory to which they had anticipated they would be relating; lines of management accountability had not been set out for them, either. They were also being denied copies of minutes of Steering Group meetings which had already taken place – effectively, the Project’s Reference Group were groping around in the dark and had become largely tokenistic as regards input and influence.

Whilst Action for ME evidently has no qualms about publishing the names of the six lay members recruited to the Project’s Steering Group (together with their biographical details) and also the names of the 16 or 17 individuals recruited to the Reference Group in its membership magazine, InterAction, it has continued to deny its membership, the wider ME patient community and the public the names of those individuals who comprise the various Steering and Management Groups which share responsibility for the oversight of this major project. No line management organisational chart has been published and there is still no website or dedicated web pages for the Observatory Project up online – which had been a project task for year one.

Therefore, it is not possible for stakeholders like myself or for the general public to establish with whom specific questions, queries or concerns about this project should be raised, nor is it known by whom and on what basis questions will addressed, since no lines of management accountability have been set out for public use and scrutiny and since the functions of those comprising the Steering and Management Groups have not been defined, since the organisations they represent have not been declared and since the process through which they were appointed or co-opted onto these groups remains unknown.

I would like to stress that no requests for personal information such as Observatory members’ addresses, telephone numbers or email addresses have been made but it is expected that Action for ME should be prepared to be transparent about who comprises the various Steering and Management Groups tasked with responsibility for the supervision and management of a project in receipt of half a million pounds of public money, in the same way that other organisations are expected to be transparent.

But something rather peculiar has now transpired.

In September 2008, Ciaran Farrell wrote an email to Heather Walker of AfME in which he raised a number of concerns about the operation of the Observatory – including the fact that AfME and the Observatory had still to identify and publish the names of those who comprise the Steering and Management Groups and that this information has also been denied to a number of individuals who have requested it.

On 2 October, as part of her response, Ms Walker says that she will need to forward Mr Farrell’s email to those who are more directly involved [in the Observatory] and she requests his permission to do so.  But she also writes:

“However, I should add that am not aware of any secrecy with regard to membership of the steering group and that web pages about the Observatory are planned and should go up this autumn.”

Incidentally, Ms Walker also adds:

“For future reference, you may wish to know that Trish Taylor has been obliged to stand down as trustee due to ill health and Roy Cheng left the charity about a year ago.”

On 9 October, as part of a response to a further email from Ciaran Farrell, Ms Walker states:

“Composition of the management group and steering group of the Observatory is no secret – see attached…”

and she attaches the following list in a Word document. (I have indicated which individuals are lay members in square brackets, otherwise the list is as provided.)

Steering group

Dr Malu Drachler, UEA
Dr Fiona Poland, UEA
Dr Jose Carlos de Carvalho Leite, UEA
Eliana Lacerda, LSHTM
Dr Luis Nacul, LSHTM
Dr Derek Pheby, Hull
Prof Peter Campion, Foundation Prof of Primary care
Sally Crowe, PRIME/Crowe Associates
Dr Charles Shepherd, MEA
Sara Brooks, AfME
Alison Collins [Lay member]
Cecilia Finnerty [Lay member]
Joanna Doherty [Lay member]
Keith Kahn-Harris [Lay member]
Dr Kirstie Haywood, RCN Institute
Prof Leslie Findley, National ME Centre
Philip Johnson [Lay member]

Management Group

Ben Brown
Peter McAughey
Peter Spencer
George Armstrong
Nick Boatwright
Sara Brooks
Derek Pheby

Reference Group

Simoni Belem
Nicolette Bolgar
Angela Bradley
Ben Brown
Emily Burns
Nine Crummy
Sally Dench
Sarah Feehan
Frances Gibson
Sarah Harper
Catherine Hislop
Barbara Hutchison
Caroline Marr
Caroline Middleton
Sasya Morar
Margaret Norwood
Joanna Shackleton
Susan Sykes
Erzsebet Toth

Others involved in the project

Dr Simon Horton
Prof Amanda Howe
Dr Maggie McArthur
Dr Anne Killet
Dr Lee Hooper
Ian Harvey
Swee Hong Chia
Rachel Mold
Lucy O’Driscoll
Douglas Badenoch

~~~~~~~~~~~~~~~~~~~~~~~~~~~

So there we have it. At last!  Almost a year since I first requested this information from Dr Derek Pheby and from Sir Peter Spencer, CEO of AfME, though it was June 2007 when Ciaran Farrell, then a member of the Observatory Reference Group, first requested this information.

What we still don’t have defined are the individuals’ functions within the Project Group or within the Project as a whole and/or a line management organisational chart, and not all the organisations with whom the individuals above are associated have been given.  Nor has it been clarified through what process seats on the Steering Group were allocated. Nor was it confirmed, last year, whether any other patient organisations had been allocated seats on the Steering Group other than the ME Association – but one presumes not, according to the list furnished by Heather Walker.

Action for ME’s Heather Walker evidently has the authority to release these names; furthermore, she has said that “Composition of the management group and steering group of the Observatory is no secret…”

So what were Dr Derek Pheby, Sarah Brooks and AfME’s CEO, Sir Peter Spencer, playing at in denying individuals like myself and the members of the Observatory Reference Group this information in late 2007?

Why was I forced to put in an FOI to The Big Lottery Fund?

Why has it taken over a year for some of this information to be provided by AfME?

Why had the information I had requested last year not already been placed in the public domain where it could be accessed by any interested party?

Why is the Observatory website not already online?

Why does Action for ME persist in making its members jump through hoops for such basic information?

I shall be commenting further on AfME’s lack of transparency to its membership and the wider public over this and previous issues, like the AfME/MRC joint Research Summit, in the next few days.

Suzy Chapman

29 October 2008

***************************************************

Related links:

The ONE CLICK AfME Dossier by The ONE CLICK Group

The AfME Research Summit and the list they did not want us to see by ME agenda

***************************************************

Simon Wessely presentation at Columbia’s Center for Bioethics

I have contacted Prof Wessely, today, and asked if he would clarify whether the “Nice” as given in the title of his presentation by the event organisers refers to “NICE” as in “National Institute for Clinical Excellence”.

I have also asked whether a summary, transcript or podcast of Prof Wessely’s talk is going to be made available by him or by the event organisers (podcasts of some previous events listed on this site do appear to be available).  I have been unable to find a summary of Prof Wessely’s presentation on the website.  I will update when I have received a response or if a podcast is made available on the event organiser’s website.

With acknowledgement to the ONE CLICK list for the heads up on this somewhat cryptically titled presentation:

Professor Simon Wessely presentation

Columbia’s Center for Bioethics presents:

From Nothing to Nice: 20 Years In and Then Out of Chronic Fatigue Syndrome

Speaker: Simon Wessely, Director, Kings Centre for Military Hlth Res.: Head of the Dept. of Psychological Medicine, Inst. of Psychiatry, King’s College London

Sponsor: Department of Epidemiology

Oct 30, 2008
12:30 PM – 2:00 PM

Columbia University, Allan Rosenfield Building, 722 West 168th St.
Judith Jansen Conf. Room, 4th Fl., Rm. R425 Free

From the literature: ten reasons not to implement the NICE Guideline on “CFS/ME”

As a follow up to the 27 October article from Margaret Williams ( see: Prejudice-based Medicine? Reasons for Judicial Review of the NICE Guideline on “CFS/ME” )

Greg Crowhurst publishes

 

From the literature: ten reasons not to implement the NICE Guideline on “CFS/ME”

by  Greg Crowhurst

28 October 2008

Permission to repost

“Virtually all the UK ME/CFS charities condemned the Guideline as unfit for purpose: such was the outrage and disgust throughout the ME/CFS community at the way that NICE had deliberately ignored so much evidence about ME/CFS.”   
Margaret Williams Prejudice-based Medicine? Reasons for Judicial Review of the NICE Guideline on “CFS/ME

http://www.meactionuk.org.uk/Prejudice-based_Medicine.htm

1.  “Unfortunately this remains a document which not only fails to grasp the full nature of neurological ME and the implications for management, but also fails to provide adequate guidance for diagnosis. It also recommends widespread use of the psychosocial rehabilitative treatments of CBT (Cognitive Behavioural Therapy) and GET (Graded Exercise Therapy) in spite of reports of harm from ME patients. At best this means that the main thrust of the guidelines are irrelevant for most people with ME, at worst dangerous.”   
NICE guideline on diagnosis & management of CFS/ME in adults and children – WAMES statement September 2007

http://www.wames.org.uk/NICE%20WAMES%20Statement.pdf

2.  “I do not support the NICE CFS/ME guidelines. I feel they are detrimental to patients and that they fail to consider the relevant evidence about the illness.”   
Dr Ian Gibson MP

http://meagenda.wordpress.com/2008/06/01/dr-ian-gibson-mp-position-statement-on-the-nice-cfsme-guidelines/

3.  “The trustees are disappointed to note that the guidance still places undue emphasis on two treatments – cognitive behavioral therapy (CBT) and graded exercise therapy (GET) – for which the underlying evidence is inadequate and unrepresentative. Many patients have reported little or no benefit from CBT and others have experienced seriously adverse effects from GET. They are also disappointed that the GDG could not agree to recognise the World Health Organisation’s classification of M.E. as a neurological illness. In addition, the summary guideline does not convey or reflect the impact which the illness can have on the lives of those people who are most severely affected by M.E.”
Action for ME, Statement from Trustees

http://meagenda.wordpress.com/2007/08/22/afme-statement-nice-cfsme-guideline-amended/

4.  “The reasons why the NICE Draft Guidelines were almost universally condemned was due to the poor quality of analysis and their lacking in ability to serve the needs and hopes of people with ME and their families. Without drastic change to the draft guidelines the NICE guidelines would have been irrelevant and, to quote Des Turner (Chair of the parliamentary APPG for ME), “unfit for purpose”. Reaction to the NICE guidelines can still be summed up as continued dismay that NICE have chosen to highlight, yet again, Cognitive Behavioural Therapy (CBT) and Graded Exercise (GET) as the most effective forms of management (aka treatment) for ME. The emphasis still seems to be on these dangerous and unhelpful psychiatric paradigms – paradigms referred to and recommended as therapies and as treatments for ME despite ME patients and groups stating they are ineffective or  harmful.”   
Invest in ME Response to the NICE Guidelines on Clinical Practice

http://www.investinme.org/IIME%20Campaigning-NICE-Guidelines%20IiME%20Response.htm
 

5.  “I do believe that many problems stemmed from the scope of the guidelines and York Review. Given that the aetiology and pathogenesis of the condition were not part of the scope these could not be searched for, and subsequently meant that thousands of papers could not be discussed as part of the process. Just one example of this is GET; the question posed by the York team looked for papers on ‘GET and ME/CFS’, it did not however search for papers on ‘Exercise and ME/CFS’, and this meant that the many papers showing the potential harm of exercise on the bodies of people with ME/CFS, and that people with ME/CFS react adversely to exercise were not picked up, and no matter how many times I brought them up in the meetings, I was told that the scope of the guideline meant that they could not be discussed, creating a slanted view on exercise and ME/CFS, with only the papers on GET being able to be discussed.”  
Tanya Harrison , Patient Rep on the NICE Guideline Development Group (BRAME)

http://www.brame.org/contact2.html

6. “The Northern Ireland ME Association is disappointed that these new guidelines bring us no nearer a cure for this common and debilitating illness, and that so few management options are being offered to NHS patients.” 
NIMEA

http://nimea-ni.blogspot.com/2007/08/ni-mea-initial-response-to-nice.html

7.  “There can be no doubt that NICE ignored the international evidence that ME/CFS is a biomedical, not psychiatric, disorder, claiming that studying this evidence fell outwith its remit. Such a claim is mystifying, since knowledge of the existing evidence-base ought surely to be mandatory before producing a national Guideline on the management of any disorder, especially given that adherence to such a Guideline is obligatory throughout the NHS (and hence for affiliated agencies such as the Department for Work and Pensions and Social Services). Not only has the “evidence-base” upon which NICE relied for its recommended management interventions for ME/CFS been exposed as deeply flawed by virtue of the heterogeneous populations studied; the methodological inadequacy; the corrupted data; the high drop-out rates; the undeniable ineffectiveness of CBT/GET as shown by the outcomes measures, and the finding that the claimed benefits may have been illusory (see: “Inadequacy of the York (2005) Systematic Review of the CFS/ME Medical Evidence Base” by Malcolm Hooper & Horace Reid at
http://www.meactionuk.org.uk/FINAL_on_NICE_for_Gibson.html
 ) but, just as importantly, the proscribing by NICE of appropriate testing and its stipulation that any vitamin or mineral deficiency must not be corrected by prescription would seem to constitute a real and even life-threatening danger to people with ME/CFS”   
More potential dangers of the UK NICE Guideline on “CFS/ME” for people with ME/CFS -Margaret Williams

http://www.meactionuk.org.uk/Dangers_of_NICE_for_MECFS.htm

8.  “These recommendations are going to be of no value whatsoever to many people with ME/CFS. They are also going to be impossible to implement due to a lack of both funding and human resources.”  
Dr Charles Shepherd responds to the NICE guidelines

http://www.bmj.com/cgi/eletters/335/7617/446

9.  “The NICE guidelines as a whole more accurately describe patients suffering from idiopathic fatigue, as outlined by the WHO at ICD-10-f48: this endangers the lives of extremely ill and severely disabled people whose disease demands a biomedical approach. Using vague and minimal criteria to diagnose patients with this illness trivialises the serious nature of ME and focuses attention on fatigue – a symptom that many people with severe ME may not even notice in the vast range of troublesome and disabling symptoms they experience. Whilst these NICE guidelines are in use, patients with ME will continue to be misidentified, misrepresented and completely side-lined, particularly if their neurological symptoms are severe. Any service recommended then, with a biopsychosocial emphasis, is likely to be dangerous and inappropriate in helping them to deal with their illness. These guidelines, in not following the WHO classification that this is a neurological disease, are shockingly inadequate. They create a wholly inaccurate picture of this serious disabling neurological and multi-system dysfunction disease and will surely lead to poor and incorrect treatment, continuing isolation and a potential worsening of disability: even people who are mild and moderately affected, after using CBT and GET, may find themselves joining those of us, who are severely affected.”  
25% Severe ME Group *25% ME GROUP STATEMENT ON NICE ME/CFS GUIDANCE  DOCUMENT

http://www.25megroup.org/Campaigning/NICE.htm

10.  “NICE were presented with a unique opportunity to provide practical guidance that would help to ensure that people with ME/CFS were offered management advice covering all aspects of the illness that would be acceptable and beneficial. They have failed the task that was set. People with ME/CFS in England, Wales, Scotland and Northern Ireland urgently require a network of physician led multidisciplinary services based on a biomedical model of causation. Where such services already exist they are much appreciated by patients – as was demonstrated at the July 2007 meeting of the ME All Party Parliamentary Group at Westminster. They do not want a network of services that offer little more than CBT and GET.”  
NICE GUIDELINE ON ME/CFS – STATEMENT BY THE ME ASSOCIATION BOARD OF TRUSTEES

http://www.meassociation.org.uk/content/view/335/70/

Reasons for Judicial Review of the NICE Guideline on “CFS/ME”: Williams

Margaret Williams announces a Hearing listing for the Judicial Review of the NICE Guideline on “CFS/ME”. ME agenda has no connection with the legal cases – please address all enquiries concerning the Judicial Review to the legal team representing the Fraser/Short case and the legal representives for the ONE CLICK case or to the High Court, where appropriate. Enquiries relating to the content of this article by Margaret Williams should be directed to Stephen Ralph of MEActionUK

For a document setting out what a Judicial Review is, what it is not and how it works see: 

http://meagenda.wordpress.com/2008/06/18/judicial-review-judgement-guidance/

An unoffical site has been set up for supporters of the NICE CFS/ME Judicial Review, for information and updates for those planning to attend the hearing and for those able to offer assistance with arrangements and publicity.  The site can be found at:
http://www.nicemecourt.co.uk/

 ~~~~~~~~~~~~~~~~~~~~~~~

“This [NICE Judicial Review] is undoubtedly a high profile case. At the preliminary Hearing in June, there was standing room only. The Hearing is listed for 11th-12th February 2009. High Court officials are now busy rearranging the Court venue in order to ensure not only disabled access and facilities, but also to accommodate the coach-loads of people from the UK ME/CFS community who are expected to turn up to witness what will undoubtedly be a landmark legal action that will have global ramifications.”  M Williams

Prejudice-based Medicine?

Reasons for Judicial Review of the NICE Guideline on “CFS/ME”

by Margaret Williams

27th October 2008

On 2nd November 1972 the London Medical Group held a closed meeting at which aversion “therapy” was promoted as a “cure” for homosexuality. The “therapy” was drug-induced nausea whilst the “patient” had to view homosexual acts (preferably live). The aim of this so-called “re-conditioning” was to “change the emotions where the person cannot change them of his own free will”. According to one of the speakers, psychologist Hans Eysenck, aversion “therapy” was “only undertaken where it is of the patients’ own choice”. Another speaker, Dr Isaac Marks, Senior Lecturer and Consultant Psychiatrist at the Maudsley Hospital, justified such abuse as being “in society’s interest”. The proponents of this “therapy” were praised by the chairman of the meeting for their “outstanding contributions to psychology” and were referred to as “these great men”.

People who underwent this “therapy” ended up as chronically depressed asexual vegetables (
http://www.petertatchell.net/psychiatry/dentist.htm
 ).

On 28th April 2008, another closed medical meeting was held in London, this time at the Royal Society of Medicine; once again the intention was to promote another currently faddish “therapy” as a “cure” for another so-called “aberrant” disorder. This time it was not about homosexuality but about myalgic encephalomyelitis / chronic fatigue syndrome (ME/CFS), which the psychiatrists to whom the RSM offered a platform prefer to call “CFS/ME” and claim that it is a behavioural disorder. These psychiatrists (known as the Wessely School) lump ME/CFS together with on-going tiredness or chronic “fatigue” such as is seen in depression and anxiety states, even though ME/CFS has been formally classified as a neurological disorder by the World Health Organisation since 1969 and the WHO has confirmed in writing that what these psychiatrists are doing is not permitted under the WHO taxonomic principles.

People with ME/CFS have been referred to by a leading UK Wessely School psychiatrist as “the undeserving sick of our society”, so this time, the “therapy” is a mind-altering technique to disabuse patients of their belief that they are physically sick, combined with incremental aerobic exercise (because the psychiatrists believe that these patients are merely de-conditioned through self-indulgent lazing about for secondary gain in the form of state benefits).

Of course, as in 1972, the “therapy” is only to be offered to those who choose it, but those who refuse it (because they are simply too sick to participate or are sufficiently well-informed to be aware of the potential dangers) are deemed not to want to get better, so their state benefits are summarily stopped. The “Pathways to Work” programme will require Incapacity Benefit (now known as ESA, or Employment & Support Allowance) claimants with ME/CFS to undergo CBT/GET before their benefits are reinstated. Not surprisingly, the suicide rate in ME/CFS has been documented at one per month, not because patients are mentally deranged, but because without help they have no means of surviving such a devastating disorder and can no longer cope with the extreme suffering.

It ought to be a matter of national concern that this current fad is now enshrined in a Guideline produced by the National Institute for Health and Clinical Excellence (NICE) and is to be implemented throughout the nation, even though the “therapy” in question may already have resulted in an untold number of non-suicide deaths (including a Member of Parliament who suffered from ME) and may have turned countless mildly affected sufferers into severely affected physical wrecks requiring 24 hour lifelong care. These very sick people are officially described on page 68 of the NICE Guideline as “a substantial burden on society”.

In supporting the psychiatric lobby’s attempt to make ME/CFS disappear within the maelstrom of undifferentiated fatigue states, NICE has contributed to the perpetuation of unacceptable practices by officially sanctioning – indeed promoting – this Government-funded current prejudice, the consequences of which will be catastrophic, not only for those afflicted by ME/CFS, but also for those committed researchers who are on the point of a breakthrough into the aetiology of what is by any standards a life-shattering multi-system disorder. Chronic “fatigue” has no more a relationship to ME/CFS than a pimple has to a malignant tumour.

In 2005, Professor Nancy Klimas, Professor of Medicine at Miami and President of the International ME/CFS Association was clear: “Our patients are terribly ill, misunderstood, and suffer at the hands of a poorly informed medical establishment”.

The following year (2006) she repeated the message: “There is evidence that the patients with this illness experience a level of disability that is equal to that of patients with late-stage AIDS, patients undergoing chemotherapy (and) patients with multiple sclerosis”.

In 2007, evidence was presented at an international conference held in Florida that the cardiac index of these patients is so severe that it falls between the value of patients with myocardial infarction (heart attack) and those in shock.

Although this evidence and more was brought to its attention, NICE remained unmoved and recommended only behavioural interventions designed for mental disorders, talking about “unhelpful beliefs”; “the relationship between thoughts, feelings, behaviours and symptoms”, “sleep hygiene” and “over-vigilance to symptoms”.

It seems that so determined was the Wessely School that NICE should recommend this latest fad that the Guideline Development Group (GDG) was specifically instructed to ignore over 4,000 peer-reviewed papers which clearly demonstrate that ME/CFS affects all major bodily systems, especially the immune system, the neurological systems (central, autonomic and peripheral), the neuroendocrine system, the cardiovascular system, the respiratory system, the musculo-skeletal system, the gastrointestinal system, the reproductive system and the ocular system.

The Wessely School psychiatric lobby dismisses all this evidence as being “not of clinical value” and insists that patients “are assumed to have ‘mental’ disease” because there is “no pathology”. They refer to ME/CFS as a “pseudo-disease”. It seems that NICE agrees.

To be fair to NICE, it is not required to address causation in its Guidelines; however, its remit in this case was to produce a Guideline to aid diagnosis. To do so, it was necessary for NICE to identify and define the disorder in question by considering the existing knowledge-base. Indeed, NICE is required to do so under the terms of the AGREE instrument, to which it is a signatory. In its Guideline on “CFS/ME”, NICE signally failed to do so.

Virtually all the UK ME/CFS charities condemned the Guideline as unfit for purpose: such was the outrage and disgust throughout the ME/CFS community at the way that NICE had deliberately ignored so much evidence about ME/CFS that a Public Law firm (Leigh Day & Co, rated number one in Chambers’ legal directory) agreed to seek permission to challenge the Guideline in the High Court by way of Judicial Review.

The initial Hearing was on 17th June 2008 before Mr Justice Cranston (Sir Ross Frederick Cranston), who in his Judgment said: “There is no doubt that ME is a debilitating condition and many of us will know of people who have the condition. Mr Hyam (for the Claimants) has pointed to the lack of balance in the composition of the group drawing up the Guidelines. Given the great public interest, it seems to me that this case ought to go forward for a full hearing”.

NICE is therefore once again being dragged kicking and screaming into the High Court in an attempt to justify what cannot logically be justified.

For example, NICE decided to reject the WHO formal classification of ME/CFS as a neurological disorder. The ME/CFS community has obtained an abundance of evidence that this might be because the psychiatrists’ gravy train would hit the buffers if NICE acknowledged that ME/CFS is a discrete neurological disorder. NICE’s position on this is unsustainable because not only does the WHO classify ME/CFS as a neurological disorder, but since 2003 the UK Read Codes used by all GPs also classify it as a neurological disorder. Furthermore, ME/CFS is included in the National Service Framework for long-term neurological disorders, and the Department of Health (by whom NICE is funded and to whom it is answerable) also accepts that ME/CFS is a neurological disorder, as does the Chief Medical Officer himself. It will be interesting for the public to see what “evidence” NICE produces to convince the Court that its position in this regard is justified.

It will also be interesting for the public to hear NICE’s explanation about the composition of the Guideline Development Group that prepared the Guideline, in particular, how NICE justifies its decision to exclude clinicians with a professional lifetime’s expertise in ME/CFS who were willing to serve on the GDG, and instead head-hunted non-experts with undeclared vested interests. For example, Dr William Hamilton was invited to be a member of the GDG specifically because of his published work which supports the notion that ME/CFS is a behavioural disorder that is best treated by CBT/GET (as recommended by the Guideline). Dr Hamilton just happens to be Chief Medical Officer of two medical insurance companies that rigorously resist claims made by ME/CFS patients, The Exeter Friendly Society and Liverpool Victoria (LV), which took over Permanent Health. The antics of LV in respect of ME/CFS claims have been brought to the attention of Members of Parliament at an All Party Parliamentary Group Meeting at the House of Commons.

NICE may be required to clarify why it preferred the expertise of a dietician, a reflexologist who also works as a hypnotherapist, an occupational therapist and a physiotherapist to experienced ME/CFS clinicians such as Dr William Weir, Dr Jonathan Kerr, Professor Julia Newton, Dr Terry Mitchell, Dr Nigel Speight and Dr Charles Shepherd. Again, it will be interesting to hear NICE’s explanation, especially as the physiotherapist just happened to have worked with psychiatrist Professor Peter White and it was she who wrote the handbook on graded exercise for the Medical Research Council’s “CFS” trial, of which Peter White is a Principal Investigator. This physiotherapist also works for the same medical insurance company as Peter White, which pays her to recommend (and carry out) GET for claimants (so could it be said that her vote in favour of GET was a forgone conclusion?). Furthermore, she works as a “healing” therapist using Human Givens “therapy” (which claims to “empower” patients but is described by one clinician as “dodgy psychobabble”). Many people have difficulty in understanding how this physiotherapist had more to offer the patients for whom the Guideline is supposed to be intended than the Medical Adviser to the ME Association.

None of the many competing interests of GDG members was declared in the Guideline: it was not until two months after the Guideline had been published that NICE released what purported to be the List of Competing Interests of the GDG; it barely scratched the surface of GDG members’ vested interests.

Then there is the interesting matter of how this Institute for Clinical Excellence produced its “evidence” out of thin air: since even NICE could not procure non-existent evidence to support its recommendations for behavioural therapy, it decided to create its own evidence by transferring data from one study and inserting that data into a totally different study to produce what might have been the desired results if the study in question had run for five years instead of only fourteen months. The fact that the transplanted data came from a study that had used different entry criteria and whose own data had been corrupted (admitted by the authors themselves) seems not to have troubled the Institute for Clinical Excellence. Most straight-thinking people might regard such doctoring of the evidence as fraudulent.

Another interesting area is the “Consensus” methodology that was used in the production of the Guideline on “CFS/ME”. It does seem to be the case that formal consensus methodology was conspicuous by its absence: indeed, on 10th May 2006 NICE made it known that the consensus technique was to be “modified” by NICE for the development of this particular Guideline. Scrutiny of this “modification” as it appears in the Guideline makes very interesting reading. It will not escape attention that the person described in the Guideline as the “Consensus Development Expert” was Professor Rosalind Raine, whose published track record happens to be that “CFS/ME” is a behavioural disorder that should be managed by CBT/GET. Raine specifically singled out “CFS” for study (funded by the MRC) and she is clear: CBT should aim to “modify thoughts and beliefs with the expectation that emotional and behavioural changes will follow”; behavioural therapies focus on “the modification of behaviour to positively reinforce healthy behaviours” and they “emphasise the role that social factors can play in the development and maintenance of functional somatic complaints. The goal is to identify and reinforce ‘well’ behaviours while reducing reinforcement for somatic behaviours” (Lancet 2004:364:429-437). The ME/CFS community may well be justified in maintaining that NICE’s “consensus” exercise was cosmetic.

There is in addition the matter of NICE informing the Court on 17th June 2008 at the initial Hearing before Mr Justice Cranston that it had no knowledge of certain documents before that Hearing, even though receipt of some of those documents had previously been acknowledged in writing on 23rd January 2006.

There is also the serious issue of Social Services continuing to seek to remove children with ME/CFS from their parents and placing them in “care”, citing the NICE Guideline as the reason.

NICE appears to be in breach of the AGREE instrument (to which it is obliged to conform in the production of its Guidelines) on no less than seven separate counts. It will be interesting to hear why this should be so in the production of the Guideline on “CFS/ME” and the Court may be keen to hear why NICE appears to have broken its own guidelines (that it is obliged to observe) in so many respects in the production of this particular Guideline.

This is undoubtedly a high profile case. At the preliminary Hearing in June, there was standing room only.

The Hearing is listed for 11th-12th February 2009. High Court officials are now busy rearranging the Court venue in order to ensure not only disabled access and facilities, but also to accommodate the coach-loads of people from the UK ME/CFS community who are expected to turn up to witness what will undoubtedly be a landmark legal action that will have global ramifications.

Literature References:
http://www.meactionuk.org.uk/Quotable_Quotes_Updated.pdf
 

__________________________

http://www.meactionuk.org.uk

MEA: New government benefit to replace ICB is introduced today

From the ME Association’s News page

New government benefit to replace ICB is introduced today

A major change in work related benefits for sick and disabled people takes place on Monday 27 October with the introduction of the new Employment and Support Allowance (ESA). The new benefit is likely to make it harder for sick and disabled people to claim work related benefits, and the aim is to significantly reduce the numbers of people claiming work related benefits.

From now on the Employment and Support Allowance will take the place of Incapacity Benefit (ICB) for new claimants who are unable to work due to sickness and/or disability.

The MEA is very concerned about the assessment procedures and new regulations governing ESA eligibility and will be following the introduction very closely. In order to do this we obviously require feedback – both positive and negative – from people with ME/CFS who have applied for ESA.

Please pass your feedback to the MEA via: meconnect@meassociation.org.uk

The MEA has set out our concerns about the new benefit in a comprehensive written statement to the Department of Work and Pensions. Our statement can be read here

[Ed: Note: These are not the official minutes which have yet to be published.]

The All Party Parliamentary Group on ME recently held a meeting with the Rt Hon James Purnell, DWP Minister, at which a wide range of concerns were expressed. A summary of this meeting can be found here

There was an excellent interview on the changes taking place on BBC Radio 5 Live this morning. Taking part was Melissa Viney, a person with ME, who pointed out the main problems that people who have fluctuating long term conditions like ME are likely to have face with the new benefit. The link to this BBC interview is here  (move the button below the digital clock to find the start of the interview at around 01:03:50. The interview lasts for almost four minutes).

YouTube: UK All Party Parliamentary Group on ME to carry out inquiry

Another YouTube video from: action4change4me

UK All Party Parliamentary Group on ME to carry out inquiry

Added: 24 October 2008

Click here to comment

http://uk.youtube.com/watch?v=a0Jgz8kZLmk

“An analysis of the aims of the inquiry with reference to the proposed inquiry’s status and likely trajectory in terms of power, people and the politics of those involved in it and especially the role of the key ME charities.”

~~~~~~~~~~~~~~~~~~~~

Ed: APPG on ME Inquiry into NHS service provision for people with ME: Draft terms of reference

During the last meeting of the All Party Parliamentary Group on ME (held on 8 October 2008) Dr Des Turner MP, the group’s chair, presented a draft Terms of Reference for the “APPG Inquiry into NHS service provision for people with ME” – a project Dr Turner had proposed at the group’s previous meeting, in July.

Between the July and October meetings, Dr Turner met with patient organisation reps to discuss his proposed inquiry, but the ME community, itself, has been marginalised from influencing the inquiry’s remit and from the drawing up of its terms of reference.  The terms of reference were presented at the meeting in October, where it was agreed that this document would be accepted, in principle, subject to minor amendments. 

Click here for a copy of the Draft Terms of Reference in PDF format

New YouTube channel: action4change4me

New YouTube Channel  action4change4me

Ciaran Farrell

24 October 2008

I have finally got around to setting up a YouTube Channel called “action4change 4me” in which I will be examining ME and “CFS” issues as well as ME charity issues and matters concerning the charity and voluntary sector.

I have placed one video on the site, and there will be more to follow – the next one is only a few days away.

My Channel can be found at :
http://uk.youtube.com/user/action4change4me

 

Channel: action4change4me

Video 1]: Welcome to my Channel!

Media coverage: Demonstrating for the right to protest in Liverpool

Media coverage of Liverpool right to protest issue, witness statement and YouTube videos

Socialist Party

22 October 2008

Liverpool: Mass protest wins back the right to campaign!

FOLLOWING MONTHS of protest against Merseyside police harassing and arresting local campaigners, our democratic right to hold stalls and campaign has been re-established. A negotiated agreement between campaigners and police has, so far, ended harassment by the authorities.

Tony Aitman

The arrests of campaigners on 11 October (see last week’s The Socialist) backfired on those officers responsible when the protests escalated. A crowd of up to 300 shoppers and passers-by surrounded police vans containing arrested campaigners chanting “Let them go!”…

Click here for full article

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Socialist Party

15 October 2008

Political protest in Liverpool will not be silenced!

THE SOCIALIST has reported the continual harassment by the police of political campaigners in Liverpool’s Church Street, a centre for stalls and campaigners for decades. This has included the arrest of a number of activists, including Socialist Party member Tony Aitman…

Click here for full article

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Liverpool Daily Post

We will not be silenced, say protesters after clash with police

Oct 15 2008 by Liza Williams, Liverpool Daily Post

CAMPAIGN groups will return to Liverpool city centre this weekend despite clashing with police and claiming their “freedom of speech” had been violated last week.

Members of around 10 groups including Keep Our NHS Public, the Socialist Party, and Stop the War Coalition say peaceful leafleting ended in a “near riot” because of the police’s action…

Click here for full article

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Socialist Worker

Posted: 6.24pm Tuesday 14 October 2008

News & Reports

Demonstrating for the right to protest in Liverpool

Activists gathered in Liverpool city centre for a mass leafleting last Saturday in protest at police harassment of political stalls…

Click here for full article

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Whole Truth Coalition

Merseyside Police Arrest Peaceful Activists In 11th October Protest

Posted by: Andrew Cheetham in *Events*, Global Control, Headlines, Political Headlines

Witness Statement

“Last Saturday (11th) Merseyside Police broke up a legal political mass stall by various organisations on Church Street in Liverpool city centre that had been planned for some time, arresting two political activists in the process. The mass stall was arranged by various groups after the wrongful arrest of a Liverpool political activist in August for distributing leaflets and selling political newspapers on Church Street, allowed under Government legislation and Section 6 of the Human Rights Act 1998…”

Click here for full witness statement

which includes

YouTube video Part 1 9.19 mins

YouTube video Part 2 5.34 mins