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Welcome to Law and Health

June 7, 2019

“The history of ME remains one of the worst examples of unacknowledged institutional abuse in modern times.” ~ Valerie Eliot Smith 2019 

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Note: this blog works across all devices but can be viewed most easily on a computer or tablet.

Thank you for visiting this site. It was created in August 2012. The date above, 7 June 2019, relates to when I set up this “Welcome” page.

This post is pinned so it remains at the top of the Home page, regardless of what else I post. It provides a summary of my research and advocacy work and indicates where to find information in this blog. Recent posts are listed in the sidebar.

Overview

I cover a number of different topics and this is reflected in the sub-heading of this blog Law and health; due process and civil society. However, much of my research has been focused on issues facing the international community of people who live with the disease myalgic encephalomyelitis (ME) – sometimes conflated incorrectly with the condition “chronic fatigue syndrome/CFS”.

I have lived with ME since 1981 (possibly longer) and began to learn about its history and pathology thereafter, although I wasn’t formally diagnosed until 1989. In 2009, I started increasing the scope and range of my research online and in 2012 I set up this blog in order to publish my work on the so-called “Secret Files on ME“.

Starting this blog was not a planned decision but rather a rapid response to some misinformation about the “Secret Files” which was circulating online. Since then, I have used it as a platform to explore and publish more information about a variety of topics. As is the case for all advocates who themselves live with ME, the amount of work I am able to achieve has been severely restricted by the illness.

For more detail about my qualifications and experience see the About section of this blog.

Updates

I try to keep this site updated but the pace of change is rapid and, inevitably, I can’t always keep up. If you notice something like a broken link or an outdated fact, please contact me either via Facebook private message/Twitter direct message or at v.eliot-smith@qmul.ac.uk.

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MAIN TOPICS FEATURED IN THIS BLOG 

I have covered a number of different topics. You can see them in the list of “Categories” by scrolling down the right-hand sidebar. In particular, I have written about five main subjects:

  1. The Secret Files on ME
    This is where the blog started. I completed my work on getting the files opened up and made publicly available. You can read the full story in the posts in that category. You can download the actual files from The Secret Files Unwrapped Part 1: the importance of fair and accurate records and The Secret Files Unwrapped Part 2: Control, not Collaboration (one file per post).
    A full list of posts can be found in The Secret Files category.
  2. Strategic communications and the media + “Changing the narrative”
    This series of posts considers the development of a more effective strategic communications and media platform for the ME community.
    The full list of posts can be viewed in the Strategic communications and the media category.
  3. Karina Hansen, “Prisoner of Denmark”
    Karina is a young Danish woman, diagnosed with ME, who was removed forcibly from her family home in 2013. She was relocated in a “neurocenter” as a de facto psychiatric patient against her wishes and those of her family. She remained there for three and a half years. Starting in 2014, I wrote a series of articles examining her story. In October 2016, she was allowed to return home with her family. Her ordeal may not be over yet. The trauma of her experience, and that of her family, is likely to continue for the foreseeable future.
    The full list of posts can viewed in the Karina Hansen category.
  4. The National Institute for Health and Care Excellence (NICE)
    NICE is the executive non-departmental public body of the Department of Health in England which publishes guidelines on health/social care-related issues. This category discusses how NICE features ME in its guidance (“CFS/ME” or “ME/CFS”, as it confusingly terms it). In particular, these posts provide critical analysis of the ME guideline revision process from 2017 to 2021. The previous guideline dated back to 2007.
    The full list of posts can be viewed in the National Institute for Health and Care Excellence category
  5. The PACE Trial controversy
    This category contains the greatest number of posts, largely as a result of my collaboration with academic/journalist Dr David Tuller. My work on this topic is mostly concerned with the process (such as Freedom of Information requests for information about the trial) rather than the science of the PACE trial.
    Due process is an essential component of any functioning democracy. It is a vital tool in civil society for requiring transparency, accountability and scrutiny of executive action and in maintaining the protection of individual rights.
    The full list of posts can be found in the PACE Trial category.
  6. Open Justice
    This category contains a range of posts on issues relating to open justice, including some academic articles. It contains ME-related posts and some which deal with other topics. The full list can be viewed in the Open Justice category.
  7. Covid-19 and long Covid
    This is a selection of posts which refer to aspects of Covid-19 and associated issues. The full list can be found in the CoronaVirus category.

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This is a quote from my 2015 post The Secret Files Unwrapped: part 2 – control, not collaboration. Despite increased advocacy efforts, there has been too little significant progress in the acceptance, diagnosis or treatment of ME since then.

I would argue that ME patients are now in a unique category. I can think of no other disease in the modern age which, having initially been regarded as hysterical or psychosomatic in origin, has remained stigmatised and untreatable for so long. Anecdotally speaking, diseases such as MS, polio, epilepsy and HIV/AIDS were all dismissed by clinicians and politicians early on in their development; all have since progressed to a stage of diagnostic near-certainty and  officially-sanctioned treatments.

In the case of HIV/AIDS, this took about twenty years. By contrast, ME was first documented eighty years ago [ie. in 1934] but patients are still not routinely recognised as having a “real” illness and there is still no effective treatment. Funding is derisory or non-existent. This must qualify it for a unique status which justifies special pleading on behalf of its patients. This is not to detract from the interests of other serious illnesses; it is merely to restore ME to its rightful place in that group, as it was over sixty years ago [ie. 1956].

NICE shows transparency, releases documents ahead of 18 October roundtable + a note on parliamentary activity

October 15, 2021

Disclosure: I have lived with the discrete illness myalgic encephalomyelitis (ME) since 1981. I have written extensively about the current NICE process (amongst other topics) in relation to this illness. I am a barristerFor more information see About.

I work independently and I am not affiliated to any organisation or group in the ME community. 

FOR NEW READERS: there is a summary of the background to this post in my previous post here

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News release

On 12 October, the National Institute for Health and Care Excellence (NICE) issued a news release providing some further information about the roundtable event on 18 October. This meeting has been arranged to address matters arising from the “paused” publication of the new guideline for the diagnosis and management of “ME/CFS”.

2021-06-28 (4)

The latest news release can be read here. It confirmed Dame Carol Black as the “independent” chair for the meeting, named Dr Paul Chrisp and Dr Peter Barry as presenters and set out a skeleton agenda. 

Two new project documents

On 13 October, NICE followed this up with two more documents under a new heading of “Stakeholder Workshop”.

The first document sets out the discussion points for the meeting as follows:

ME/CFS Summary of issues
The following list is a summary of key themes that have been raised by stakeholders
regarding the content of the pre-publication version of the ME/CFS guideline.
1) Diagnosis – Questions have been raised regarding the diagnostic criteria that
the committee have recommended.
2) Children and young people – There is concern that the recommendations
potentially create risks for children and young people with ME/CFS.
3) Graded Exercise Therapy (GET) – There are questions about the
recommendation not to offer programmes that use fixed incremental
increases in physical activity or exercise, for example GET. In particular the
definition of GET, that positive evidence for GET has been downgraded, and
removing GET as a treatment option may lead to a reduction in services
overall
4) Cognitive behavioural therapy (CBT) – There are questions about the place
of CBT in individualised management. In particular that there is positive
evidence which has been downgraded, and that the guideline downplays the
effectiveness of CBT.
5) Methodological approach – There are questions about the approach taken
to the evidence, with suggestions that studies have been inappropriately
excluded or downgraded.

Whilst none of these topics contain any great surprises for anyone who has been following this process, these are all highly contentious areas. The fact that they are up for discussion is of great concern to many in the international ME community. 

The second document sets out the practicalities of the meeting – date, time, location etc. What is new, however, is the list of attendees which has previously been kept secret. 

External attendees:
25% M.E. Group
Academy of Medical Royal Colleges
Action for ME
British Association for CFS/ME
Chartered Society of Physiotherapy
Forward-M.E.
#ME Action
The ME Association
ME Research UK
The ME Trust
NHS England & NHS Improvement
Royal College of General Practitioners
Royal College of Occupational Therapists
Royal College of Paediatrics and Child Health
Royal College of Physicians
Royal College of Psychiatrists
Science for ME
Tymes Trust

NICE & Guideline developer attendees:
Gillian Leng Chief Executive
Paul Chrisp Director, Centre for Guidelines
Christine Carson Programme Director, Centre for Guidelines
Peter Barry ME/CFS Guideline Chair
Ilora Finlay ME/CFS Guideline Vice Chair
Kate Kelley Developer Guideline Lead
Philip Alderson Clinical Adviser
Toni Tan Technical Adviser
Rupert Franklin Senior Guideline Commissioning Manager
Rebecca Smith Associate Director External Communications
Helen Finn Senior Communications Manager
Philip Ranson Media Relations Manager

The second page of this document gives the meeting’s objectives and a more detailed version of the agenda

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Comment

This further information from NICE is most welcome. However, the reasoning behind the decision to “pause” publication of the new, final guideline is still concerning. As I said in my previous post

If [NICE] intends to publish the new guideline regardless of the outcome of the roundtable, then there is no justifiable reason why full publication has not already taken place.

However, if NICE has not yet published the guideline on the basis that there might be some changes or tweaks as a result of the roundtable event, then this either reopens a process which has already been completed or it begins a whole new consultation and evidence review.

There is no credible justification for those options. If either was to happen, it would confirm that this process is fundamentally and irretrievably flawed.

Due process

On the one hand, NICE must be held accountable for its extraordinary recent actions – hence the ongoing pre-action for a judicial review of the decision to pause publication. The new guideline must be published in order to replace the dangerously out-of-date 2007 guideline which remains operational until the new one is published. 

On the other hand, the new guideline itself, whilst an improvement on the 2007 version, is still dangerously flawed. The draft guideline from November 2020 (72 pages) was far more acceptable to most members of the international ME patient community. This final version (83 pages) has significantly diluted and reconfigured the draft version, thereby increasing the risk of serious harm to patients.

Looking at it again, my assessment of the new guideline from an earlier post in this series still stands (notwithstanding the herculean efforts of all those involved in producing it over the last four years): 

It’s rubbish. It still contains far too much latitude for abuse of patients. However, it is less rubbish than the existing guideline from 2007. It is a significant improvement on that and it is the best we are going to get for the foreseeable future. 

Accessing the final version of the new guideline document 

The unpublished final guideline remains confidential, according to NICE. However, I have disputed this claim in an earlier post. Anyone who has not yet seen this new version and wishes to do so can access it via another post on this blog where I have made it available.

To download the final, unpublished guideline, go to this post here and scroll down towards the end of the post. You will see a link from which the document can be downloaded. 

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A NOTE on parliamentary questions and government intervention in the NICE process

There have been six written questions in the House of Commons on this topic recently and oral questions in the House of Lords on 12 October 2021. Neither has proved particularly illuminating. 

Whilst NICE is ultimately accountable to the Department of Health and Social Care, its status as an independent executive non-departmental public body means that government intervention is unlikely. MP’s can lobby for individual causes (eg. as in the questions above) but their powers are limited. 

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NICE developments: preparatory action for a judicial review of the decision to pause publication of the new guideline for “ME/CFS”

October 11, 2021

Disclosure: I have lived with the discrete illness myalgic encephalomyelitis (ME) since 1981. I have written extensively about the current NICE process (amongst other topics) in relation to this illness. I am a barrister. For more information see About.

I work independently and I am not affiliated to any organisation or group in the ME community.

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Summary of events so far for new readers

In 2017, the English National Institute for Health and Care Excellence (NICE) began the process of updating the dangerously out-of-date 2007 guideline for “ME/CFS”. After several delays, the new guideline was completed and signed off by NICE’s guidance executive. On 4 August 2021, it was distributed to NICE representatives and qualifying stakeholders. The document was to remain confidential until 12.01am on 18 August 2021.

scales of justice

ME patients trying to obtain justice

According to NICE’s own manual, the distribution and publication on 4 August completed the process. No further changes could be made from this point onwards, save for minor corrections.

On 17 August 2021, NICE “paused” publication of the document but gave no credible explanation or detail of any exceptional circumstances justifying its extraordinary action. In addition, the “pause” in publication meant that NICE claimed that this final version of the guideline, already distributed to numerous parties, remained confidential. (I have disputed the validity of this claim of confidentiality in an earlier post.)

It became clear that this eleventh-hour development was the result of external interference by representatives of the Royal Colleges and NHS England who were opposed to the new guideline. This is in direct contravention to NICE’s own prescribed procedure and such an action at this late stage should have been impossible.

Since then, NICE has issued two statements. The first, on 27 August gave details of a roundtable event, to be held in September chaired by an “independent” party. This was then updated to 18 October. Selected representatives from the ME community and other parties would be invited to attend subject to signing new non-disclosure agreements (NDA’s).

The purpose of this event was to “gain support for the guideline to ensure effective implementation”, despite the process having been completed, signed off and the document already distributed to an extensive number of people.

A second statement was issued on 21 September 2021 further attempting to justify this bizarre series of events. The statement also announced Professor Dame Carol Black as the “independent” chair, someone whose history has made her completely unacceptable to many in the ME patient community.

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Pre-action for a judicial review of NICE’s decision to pause publication on 17 August 

I have written about the possibility of a judicial review of NICE’s decision on several occasions eg. here and here. I would always advise a cautious approach to such an action as the threshold for success is very high and litigation is very stressful for anyone, especially a patient living with ME. However, given NICE’s extraordinary conduct, this seems to be a valid response to the situation.

On 1 October, Peter Todd of Scott-Moncrieff solicitors issued NICE with a letter before claim under the judicial review pre-action protocol (4 pages).  The claim is being made on behalf of a child who, as such, is entitled to complete anonymity. The grounds for challenging NICE’s decision are procedural impropriety and irrationality.

On 6 October, shortly after the expiry of the time limit for a response, NICE replied. It had instructed DAC Beachcroft solicitors, the same firm that it had used to defend itself against a judicial review of the 2007 “CFS/ME” guideline. The letter sets out NICE’s defence of its decision to pause publication of the guideline. The letter can be read in full here (dropbox file – 8 pages).

I have done a full commentary on NICE’s letter at the end of this post. However, it can be summarised as follows:

Our client doesn’t agree with your client.

NICE was exercising its wide discretion in a perfectly proper manner.

*Rattles sabre* 

[Note: whilst the letter may make for difficult reading for many members of the ME community, it is a standard solicitor’s letter and its tone is completely predictable, despite sounding highly inflammatory to anyone unfamiliar with this kind of correspondence. Every lawyer is required to follow their client’s instructions. Personal views play no part in the drafting of correspondence or other documents.]

The current position

Peter Todd, who is representing the claimant ME patient, has taken an unusual and very welcome stance on full transparency and has been tweeting updates for this action. His Twitter profile can be found here.

His latest tweets about the case on 8 October have provided the following information:

Pleased to confirm the Claimant has today been granted legal aid to commence proceedings for judicial review against NICE re the decision to pause publication of the new guideline on diagnosis and management of ME/CFS…..

…..now busy preparing the papers so I can file and serve proceedings in the High Court. Ian Wise QC being instructed to settle the statement of facts and grounds monckton.com/barrister/ian- Currently envisage serving proceedings by close on Friday 15th October.

[Update 15 October (new tweet): As the roundtable is on Monday, I am deferring issuing the claim until after, so we can show that issues being raised were previously considered in the development stage, and it is an impermissible attempt at a second bite of the cherry.]

Following service of proceedings, the next stage will be an application to the High Court for permission to bring the judicial review action against NICE. In the circumstances, that hearing might be expedited but, equally, it might be some time before that takes place. Clearly, this will not happen before the roundtable event on 18 October. However, the overriding principle of challenging NICE’s decision remains, even if it later becomes notional rather than real.

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Coverage by The Canary

The Canary is an independent online publication committed to campaigning journalism. Steve Topple is a journalist with The Canary who has been following and writing about events in the ME community for some years. He has written a series of articles on the NICE saga. His latest piece can be found at this link NICE will now face court over the ME guidelines debacle.

At Steve’s request, I contributed some comments on the legal process for his article. I’m grateful for his trenchant coverage of this unfolding story. Most of what I said was used but, as I said above, I’m setting it out here in its entirety.

This challenge to NICE’s decision to pause publication of the new guideline for “ME/CFS” is most welcome. Peter Todd of Scott-Moncrieff solicitors has set out a clear, robust case on behalf of the claimant, a child with “ME/CFS” who has experienced harm from treatments recommended by NICE.

The desired outcome of this claim is that NICE follows its own procedure by publishing the new guideline immediately, irrespective of the roundtable event on 18 October. It’s important to remember that this action is a judicial review of the exercise of due process, not a re-examination of the scientific evidence.

NICE has instructed DAC Beachcroft solicitors, the firm which represented the organisation in a judicial review of the 2007 guideline for “CFS/ME”. Their response to this current claim is predictably disingenuous. It is reduced to picking away at individual points in the hope of obscuring the significance of the new guideline which represents a radical shift away from harmful treatment recommendations.

The crux of this case is that NICE has strayed so far outside its own prescribed procedures that it has exceeded its powers, thereby acting unlawfully and/or irrationally.

NICE’s main defence is that it has a wide discretion. This is quite true. Nevertheless, the sentence “[t]he Manual does not expressly provide circumstances justifying a pause in publication of guidelines, but nor does it expressly exclude this possibility” demonstrates a degree of desperation which would be comical if it were not so serious.

NICE is created and governed by statute. It has no power to make up the rules as it goes along.

In Paragraph 14 of the response, NICE concedes three important points:

  1. Because of the large number of comments on the draft guideline (issued in November 2020) NICE postponed its final publication date to 18 August 2021 in order to respond fully and complete all of the pre-publication processes.
  2. Having done that, NICE then released a confidential advance copy to all stakeholders who had commented on the draft.
  3. “Following that confidential release, NICE received a number of communications raising issues with the Guideline from representatives of Royal Colleges and NHS England.” (direct quote from the letter)

Point 3 is a clear admission that, at this stage, NICE allowed itself to be influenced by external interference. NICE is supposedly an independent body. By this stage, such interventions should simply not have been possible.

NICE’s response completely fails to address the central issue raised by the claim. If it intends to publish the new guideline regardless of the outcome of the roundtable, then there is no justifiable reason why full publication has not already taken place.

However, if NICE has not yet published the guideline on the basis that there might be some changes or tweaks as a result of the roundtable event, then this either reopens a process which has already been completed or it begins a whole new consultation and evidence review.

There is no credible justification for those options. If either was to happen, it would confirm that this process is fundamentally and irretrievably flawed.

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Finally, because it can’t be said often enough:

“The history of ME remains one of the worst examples of unacknowledged institutional abuse in modern times” ~ Valerie Eliot Smith 2019

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What’s wrong with the NICE process + what can be done about it?

September 24, 2021

Disclosure: I have lived with the discrete illness myalgic encephalomyelitis (ME) since 1981. I have written extensively about the current NICE process (amongst other topics) in relation to this illness. I am a barrister.

For the full background to this post see previous post here

NBI work independently and I am not affiliated to any organisation or group in the ME community. For more information see About.

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The story so far

In 2017, the English National Institute for Health and Care Excellence (NICE) began the process of updating the dangerously out-of-date 2007 guideline for “ME/CFS”. After several delays, the new guideline was completed and signed off by NICE’s guidance executive. On 4 August 2021, it was distributed to NICE representatives and qualifying stakeholders. The document was to remain confidential until 12.01am on 18 August 2021.

Your disconnection is noticed (2)According to NICE’s own manual, when publication took place on 4 August, the process had been completed. No further changes could be made from this point onwards, save for minor corrections.

On 17 August 2021, nine hours before general release of the new guideline, NICE “paused” publication of the document but gave no credible explanation or detail of any exceptional circumstances justifying its extraordinary action. In addition, the “pause” in publication meant that NICE could claim that this final version of the guideline, already distributed to numerous parties, remained confidential. However, I have disputed the validity of this claim of confidentiality in an earlier post.

Contemporaneous media reports suggested that this eleventh-hour development was the result of external interference by disgruntled parties who were opposed to the new guideline. This is in direct contravention to NICE’s own prescribed procedure and such an action at this late stage should have been impossible.

NICE now appears to have sacrificed its independence as an executive non-departmental public body of the Department of Health, and casually derailed its own process.

Since then…..

NICE has issued two statements which are startling both in their opacity and their breathtaking disregard for the international ME patient community which has now been kicked into a long-term, traumatising state of limbo. This is causing extreme distress to thousands of patients worldwide, with no apparent end in sight.

After the initial shock of the “pause” in publication, patients were then kept waiting until 27 August for the next statement. This gave details of a roundtable event, to be held (optimistically) in September. Unsurprisingly, on 10 September, this was updated to sometime in October [date: secret]. This meeting was to be chaired by an independent person [identity: secret], with selected representatives from the ME community and other parties [identities: secret]. The selected, secret invitees were required to sign non-disclosure agreements (NDA’s).

This series of actions by NICE ending in a draconian information blackout on what is supposed to be a transparent process means that this fiasco is now fatally-flawed. 

The second statement was issued on 21 September 2021. Let’s take a look:

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NICE’s STATEMENT OF 21 SEPTEMBER:

Paragraph 1

The roundtable meeting to discuss the updated guideline on the diagnosis and management of ME/CFS [sic] will be held on October 18th in London. It is being convened after publication of the guideline was paused when issues were raised by some professional groups during the pre-publication period. 

This sounds remarkably like a covert attempt to re-open the consultation process but including selected groups only. My response to this comes straight out of my earlier post of 25 August:

“If NICE is planning to open up a new consultation process on its guideline for “ME/CFS” then it must clarify its position immediately and communicate this with full transparency to stakeholders and the general public. If NICE fails to provide this information, then this amounts to a breach of its duty to properly exercise its statutory functions. 

If there is no proposed plan [to open/re-open the consultation process], then NICE should publish the new guideline of its own volition without further delay.” 

Paragraph 2

“The roundtable will be an opportunity for all parties to discuss key issues raised prior to publication. The decision on next steps will be made by NICE, taking into account comments made at the roundtable. NICE will release the agenda ahead of the meeting and minutes will be published afterwards.”

“The roundtable will be an opportunity for all parties to discuss key issues raised prior to publication.” According to NICE’s manual, issues raised “prior to publication” can no longer be discussed or changed. That ship sailed on 4 August.

“The decision on next steps will be made by NICE, taking into account comments made at the roundtable”. This suggests that changes could be made to what was supposed to be the final version of the new guideline. Again, completely contradicting NICE’s own manual.

“NICE will release the agenda ahead of the meeting and minutes will be published afterwards.” Who is setting the agenda? What criteria are being used? The agenda will direct the purpose and outcome of the meeting. Why the need for NDA’s? Again – transparency?

Paragraph 3

“NICE has invited relevant professional organisations to attend the meeting, plus representatives from interested patient groups.  Unfortunately there are too many patient groups to invite everyone, but we have aimed to ensure a full range of perspectives.”

“NICE has invited relevant professional organisations to attend the meeting, plus representatives from interested patient groups.” Who is invited and who decided which organisations were “relevant“? How were any of them selected? Who is excluded and why? What about all the other non-invited stakeholders who also contributed to the final version of the guideline?

Paragraph 4

“Professor Dame Carol Black has kindly agreed to act as an independent chair of the roundtable discussion.  Dame Carol is an experienced chair who is independent of NICE and of the development of the ME/CFS guideline. She will facilitate the discussion and will not take part in NICE decisions.” 

This one is quite straightforward. Dame Carol Black cannot be an independent chair in this process for three reasons.

  1. She has long associations with the Royal Colleges which have clearly been instrumental in the external interference which has created this bizarre set of events.
  2. She has been an adviser to the government on various occasions. According to Wikipedia“In 2006, the government led by Tony Blair made Black its national director for health and work and asked her to promote its policies across Whitehall, especially within the Department of Health and the Department for Work and Pensions. She described her role as being to try to keep people “healthy, well, resilient and in work.” 
    Her agenda has been to get people back to work with a focus on behavioural and psychological interventions on the basis that sick people remain long-term sick only because they think they are sick, not because they actually are sick. This dangerous fallacy lies at the very heart of the long standing dispute about the treatment of ME patients and has contributed to the neglect and abuse experienced by many in the international patient community.
  3. She has shared platforms with various members of the psychiatric lobby who have themselves cultivated and prolonged the traumatic experiences of many in the ME patient community.

Dame Carol is completely unacceptable as an “independent chair” for this roundtable event. Anyone suggesting that a chair is purely a neutral party who has no bearing on the outcome of a meeting is either inexperienced in the conduct of meetings or simply deluding themselves.

For these reasons, representatives of the ME patient community who are planning to attend this meeting should collectively refuse to accept Dame Carol as an “independent chair”.

Paragraph 5

Dr Paul Chrispdirector of the Centre for Guidelines at NICE, said: “We acknowledge that patients will be concerned about these further developments in what has been a long and difficult guideline process. We hope that by holding a roundtable discussion we can understand the issues raised by the professional bodies to inform NICE’s thinking on the next steps for publication of the guideline.”

This patronising sop to the ME patient community is beneath contempt and not worthy of further comment.

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What can be done now?

In terms of the roundtable meeting, only the selected few who are involved or invited can exert any influence over what happens there. Most members of the ME community who will be directly affected by the outcome of this meeting have been left stranded on the outside of this exclusive tent, unable to see in and observe events which may shape the rest of their lives and the lives of many others yet to be diagnosed.

There are calls for livestreaming and full disclosure of all documentation relating to this meeting. I suspect they will not be successful. The fact that attendees had to sign NDA’s doesn’t inspire confidence in the transparency of the process.

The litigation options

I have written previously about ME-related litigation and I understand that some groups within the UK’s ME patient community are currently considering their options. Whilst this is to be welcomed, nevertheless it is still inexplicable that none of the established ME charities have explored the possibility of legal action in the past (or if they have, they’ve been keeping very quiet about it).

Whilst patient groups could achieve a significant amount, action taken by recognised charities would have more impact and legitimacy than informal, uncoordinated groups. Action taken by charities would also have a better chance at pooling resources and depersonalising what is always a challenging process. The absence of such action by the charities remains a mystery.

  • Personal injury litigation by a patient/patients who have suffered harm as a result of a NICE-recommended treatment such as Graded Exercise Therapy/GET

I have already written about this in a post from last year (in the second half of the post) COVID-19, NICE and ME: towards litigation? With the NICE process on indefinite hold and no certainty around what the new guideline will contain, the case for litigation has only become stronger for anyone with sufficient resilience and resources to pursue it.

NB: such an action will require hard evidence from an identifiable claimant who is willing and able to give evidence to a court. Anonymised case histories alone will not provide sufficient evidence with which to commence legal proceedings although they may be useful for other purposes.

  • Judicial review/JR

Again, I have already written about the possibility of judicially reviewing NICE’s decisions in this process in a post from June this year Possible responses to the new NICE guideline for “ME/CFS” (again, second half of post). The rationale for considering this avenue has also been strengthened by recent events.

Time limits are of concern as any application to launch JR proceedings should take place within three months from the date of decision on which review is sought. Given the incomprehensible and unpredictable nature of NICE’s actions, the time limit may not be as rigid as first appeared (ie. three months on from the decision to “pause” publication on 17 August 2021). As I said on Twitter recently:

With the uncertainty re the outcome of the @NICEComms process (or lack of it) there may be some flexibility on time limits. Would depend on final outcome. An application to the High Court to commence proceedings out of time might succeed, in theory. But NOT a desirable situation.

Above all else, the most important part of exploring litigation is to get professional advice from an expert legal team. These are highly complex areas of law with a very wide range of issues to be considered. Don’t expect pro bono representation – it’s unlikely you’ll get it. An initial opinion, just on the merits of bringing a case, may cost upwards of £5000. Anything less will probably not be worth having. 

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FINALLY – that “final” version of the “ME/CFS” guideline…..

For anyone who hasn’t already seen it: my previous post Abuse of process & abuse of power: a NICE publication (with file download) contains a link towards the end of the post from which the final version of the guideline can be downloaded (ie. the one which was distributed on 4 August 2021 but “paused” on 17 August).

NOTE that this version, although it is marked “FINAL”, is not operative unless and until it is published by NICE itself

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Photo credit: “Amsterdam 2011” – Valerie Eliot Smith

Abuse of process & abuse of power: a NICE publication (with file download)

September 13, 2021

Disclosure: I have lived with the discrete illness myalgic encephalomyelitis (ME) since 1981. I have written extensively about the NICE process (amongst other topics) in relation to this illness. I am a barrister.

For the full background to this post see previous post here. Alternatively, there is also a summary for new readers at the end of this post. Please scroll down to access it.

NB. I work independently and I am not affiliated to any organisation or group in the ME community. For more information see About

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The current situation with the “paused” publication of the new NICE guideline for “ME/CFS”

On 17 August 2021, the National Institute for Health and Care Excellence (NICE) “paused” the publication of the new guideline for “ME/CFS”, 9 hours before it was due to be released. Many stakeholder groups and other parties had been given access to the guideline 13 days earlier, on 4 August. The document was to remain confidential until general release on 18 August.

NICE Final pic (2)According to NICE’s manual, when publication took place on 4 August, the process had been completed and signed off by the NICE guidance executive. No further changes could be made from this point onwards, save for minor corrections.

The statement which NICE then issued by way of explanation did not volunteer any information about the exceptional circumstances which might have clarified or justified this extraordinary deviation from its own prescribed procedure. 

At this point, the process of updating the guideline became flawed. 

The next development

On 27 August, NICE issued a further statement regarding a “roundtable event”. It stated:

The [roundtable] meeting, which will be held in September 2021*, will have an independent chair and will include representatives from patient organisations and charities, relevant professional societies and from NHS England and NHS Improvement, NICE and the guideline committee. 

*Latest update on 10 September (blink and you’ll miss it): apparently the roundtable will now be held in October 2021.

The flabby wording of NICE’s statement has completely failed to clarify publicly any of the vital issues:

  • The purpose of this event (NICE has previously used a roundtable to discuss implementation of a guideline but this was after final publication, not before)
  • How invitees have been selected [ETA: and who they are (it’s a secret)]
  • Why there is a requirement for invitees to sign confidentiality agreements
  • The process of the appointment of an “independent” chair

At this point, we are four weeks on from NICE “pausing” publication of the guideline. The international ME community has been pushed from what initially appeared to be a temporary hiatus into a long-term, traumatising limbo. This is now continuing to cause extreme distress to many in the worldwide community, with no end in sight.

Obfuscation as denial of fairness and justice

Rumours and purported “leaks” have been spreading far and wide. These are dangerous and unsettling. The entire process has become shrouded in secrecy and speculation.

NICE has allowed external interference to derail its procedures, in direct contravention of its own manual and against all fundamental principles of fairness and natural justice.

There is a strong argument that this process is now not just “flawed” but has become fatally flawed” ie. irretrievable. This has been brought about as a direct result of NICE’s extraordinary actions and its failure to provide adequate justification, explanation or information regarding its next steps.

It cannot now be argued that NICE is acting in good faith or with any degree of independence.

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AS I’VE SAID BEFORE ON THIS BLOG: LIKE ALL PUBLIC BODIES, NICE HAS A WIDE DISCRETION IN HOW IT EXERCISES ITS STATUTORY FUNCTIONS. HOWEVER, RECENT EVENTS SHOW THAT IT HAS NOW GONE BEYOND WHAT IS REASONABLE OR JUSTIFIABLE.

NICE’S ACTIONS SINCE 27 AUGUST AMOUNT TO AN ATTEMPT TO STIFLE LEGITIMATE DEBATE BOTH INSIDE AND OUTSIDE THE INTERNATIONAL ME COMMUNITY.

KNOWLEDGE IS POWER; NICE’S ACTIONS IN WITHHOLDING INFORMATION NOW AMOUNT TO AN ABUSE OF PROCESS AND AN ABUSE OF ITS POWER. 

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The case for community publication 

The new guideline does not become operative until it is published by NICE.

We have no idea when that is going to take place. I have argued before that community publication could and should take place – see previous post here. However, it seems that this is not an option at this stage. 

As I said in that previous post, the purpose of community publication would be:

“To provide essential information to the public about the guideline as it stood on 17 August 2021 and as a comparator with any future versions of the new guideline.” 

We have reached a point where the public interest in making the “paused” guideline available is overwhelming. In the absence of further explanation from NICE, ME patients worldwide now have an absolute right to see what that guideline looks like. Whilst NICE guidance is a British publication, it provides templates which are widely followed in many other countries. 

Harms caused?

In the intervening period between when publication was “paused” and any future publication date:

  • How many ME patients will have started a programme of treatment, as recommended by the “current” (ie. 2007) NICE guideline for “CFS/ME”?
  • How many of these patients will go on to experience severe harm and setback as a result of undertaking such treatment?
  • How will NICE compensate those patients for the harm caused by the delay in publication? 

The case for individual publication

I first flagged up the fact that I was prepared to make the new guideline available here on 20 August 2021. I have mentioned @NICEComms on Twitter on numerous occasions so NICE has been on notice of my intention since then.

If NICE wished to prevent me from publishing the document, it has had ample opportunity to do so.

As I indicated earlier, I am not affiliated to any organisation or group in the ME community. For that reason, and the reasons given above, I am making a link available (below) from which the 17 August 2021 “final” version of the guideline can be downloaded.

Before deciding whether or not to download the document, please read the short statement below which I had prepared for when the guideline was to be released on 18 August 2021. I had not seen the final version at that stage but I had been given a helpful steer in advance by someone who had. 

Like the document, my statement is pending indefinitely but it may be useful to read it first.

Again: the decision to make this information available is mine and mine alone. 

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MY STATEMENT ON THE UPDATED NICE GUIDELINE [still pending]

The new NICE guideline for the illness termed “myalgic encephalomyelitis/chronic fatigue syndrome” or “ME/CFS” is a small but welcome step in the right direction. 

While there is still a long way to go and the new guideline is very far from ideal, the removal of the most harmful treatment recommendations is a significant milestone on the road to proper recognition and treatment for this extremely disabling, occasionally fatal, illness. 

The NICE guideline committee responsible for this process is to be commended for maintaining an independent stance and for its adherence to the evidence which it reviewed. [???]

The current situation for “ME/CFS” patients is still dire. The new guideline acknowledges that there is currently no diagnostic test, no treatment and no cure for “ME/CFS”, and that many patients have experienced “prejudice and disbelief”. These are shocking admissions to be making about a devastating illness which was first documented nearly a hundred years ago.

It is to be hoped that this updated guideline will usher in a new phase in the history of this illness, thereby generating a refreshed political will and ultimately triggering a cancer-style “moonshot” initiative. This would be a vital step in the process of beginning to address the neglect, stigma and harms experienced by patients over many decades. 

Whatever happens now, it is too late for the millions of patients worldwide who have already died during the last century of “ME/CFS” disbelief. Many patients never had their illness validated nor were they treated with respect and compassion in their lifetimes. 

The time has come to call for an independent public inquiry into the history of the treatment of “ME/CFS” patients. Without such an inquiry, the systemic injustice and abuse experienced by patients cannot begin to be addressed.

This guideline opens up a new chapter in the shameful history of this maligned illness. The opportunity to redress the wrongs of the past and create a better future must be seized with urgency and enthusiasm.

[18 August 2021]

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DOWNLOAD THE DOCUMENT 

For anyone who chooses to download this document, please note that you will be downloading it directly from this blog where it is being stored in the Cloud.

83 pages: click on this link MECFS NICE Guidelines (unpublished final)

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Summary of the background for new readers

In 2017, the English National Institute for Health and Care Excellence (NICE) began the process of updating the dangerously out-of-date guideline for “ME/CFS” (myalgic encephalomyelitis/chronic fatigue syndrome), originally published in 2007. This guideline recommended treatments which many patients have long found to be actively harmful.

After several delays, the draft guideline was published on 10 November 2020. This draft removed/downgraded the most harmful treatments from its recommendations and, as such, was broadly welcomed by the patient community. On 4 August 2021, the new guideline, marked “FINAL“, was circulated to stakeholders who had commented on the draft version.

By this stage, the guideline committee had approved this final version and, according to the NICE manual, the NICE Guidance Executive would now have signed it off. The fact that it was then circulated to stakeholders indicated that the process was now closed and completed.

According to NICE’s “Main stages of guideline development“, the publication stage began at this point. Publication to the world at large was scheduled for 14 days later, on 18 August. The document was to remain confidential until then.

Just after 3pm on 17 August, less than 9 hours before the scheduled time for general publication of the new guideline, NICE notified stakeholders that it was “pausing” publication. By this stage, only exceptional circumstances could have derailed the process. Thus far, NICE has failed to provide evidence of any such circumstances.

The “roundtable event” proposal

After ten days of consternation and confusion in the ME patient community, NICE issued a statement which included the following paragraph: 

The [roundtable] meeting, which will be held in September 2021, will have an independent chair and will include representatives from patient organisations and charities, relevant professional societies and from NHS England and NHS Improvement, NICE and the guideline committee. 

Given that the process of updating the guideline had already been completed, it’s somewhat puzzling to see what purpose this event could possibly fulfil.

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Legal opinion and legal advice: the “paused” NICE guideline for “ME/CFS”

September 1, 2021

Disclosure: I have lived with the discrete illness myalgic encephalomyelitis since 1981. I have written extensively about the NICE process (amongst other topics) in relation to this illness. I work independently and I am not affiliated to any organisation or group in the ME community. I am a barrister, called to the Bar in 1987. For more information see About

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For the full background to this post see previous post here.

Summary for new readers

In 2017, the English National Institute for Health and Care Excellence (NICE) began the process of updating the dangerously out-of-date guideline for “ME/CFS” (myalgic encephalomyelitis/chronic fatigue syndrome), originally published in 2007. This guideline recommended treatments which many patients have long found to be actively harmful.

After several delays, the draft guideline was published on 10 November 2020. This draft removed/downgraded the most harmful treatments from its recommendations and, as such, was broadly welcomed by the patient community. On 4 August 2021, the new guideline, marked “FINAL“, was circulated to stakeholders who had commented on the draft version.

By this stage, the guideline committee had approved this final version and, according to the NICE manual, the NICE Guidance Executive would now have signed it off. The fact that it was then circulated to stakeholders indicated that the process was now closed and completed.

According to NICE’s “Main stages of guideline development“, the publication stage began at this point. Publication to the world at large was scheduled for 14 days later, on 18 August. The document was to remain confidential until then.

Just after 3pm on 17 August, less than 9 hours before the scheduled time for general publication of the new guideline, NICE notified stakeholders that it was “pausing” publication. By this stage, only exceptional circumstances could have derailed the process. Thus far, NICE has failed to provide evidence of any such circumstances.

The “roundtable event” proposal

After eleven days of consternation and confusion in the ME patient community, NICE issued a statement which included the following paragraph: 

The [roundtable] meeting, which will be held in September 2021, will have an independent chair and will include representatives from patient organisations and charities, relevant professional societies and from NHS England and NHS Improvement, NICE and the guideline committee. 

Given that the process of updating the guideline had already been completed, it’s somewhat puzzling to see what purpose this event could possibly fulfil. 

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Legal opinion via Twitter 

On 28 August, I composed an 18-tweet Twitter thread as follows: 

Thread on @NICEComms decision of 17 August to pause
publication of new guideline on “ME/CFS”. This thread
sets out my view on current legal position.

Like all public bodies, @NICEComms has a wide discretion in how it operates.
However, when the decision to pause was made, the process had been completed,
signed off and the final document had been distributed to stakeholders.

Thus far, @NICEComms has failed to provide any evidence of exceptional
circumstances in order to justify or clarify its decision.

Media reports suggest that external interference at the 11th hour caused the decision
to pause publication of the guideline. Publication had already been delayed by 4
months for full and final consideration therefore this is not a valid reason.

On 27 August @NICEComms released a statement proposing a roundtable meeting
in September “to better understand the issues raised and determine how it can gain
support for the guideline to ensure effective implementation”.

The process of updating the guideline commenced in 2017. It had already been
delayed several times. By this stage, this explanation is therefore not credible and the
process has lost its legitimacy.

Stakeholders who participate in the proposed roundtable meeting run the risk of
legitimising a process which now lacks legitimacy as a sole and direct result of the
actions of @NICEComms.

At this point #ME orgs should as a precautionary measure be seeking independent
legal advice before deciding further action. This advice should include possibility of
commencing judicial review (JR) of @NICEComms decision of 17 August to pause
publication. TIME IS OF THE ESSENCE.

JR proceedings must be commenced within 3 months of the date of the decision in
question. @NICEComms anounced its decision to pause publication on 17 August
therefore time runs out on 16 November 2021. By the time the roundtable meeting
has taken place, time will be running out.

Last week, I was involved, by invitation, in a group email conversation with senior
reps of the #ME community. On 25 August that conversation ceased abruptly without
the courtesy of any explanation to me. Hence this thread.
END OF THREAD.

ADDITION to thread to address concerns about reprisals against stakeholders who
decide not to engage in roundtable meeting:

This situation has come about because of an error by @NICEComms . It is not as a
result of any action by #ME patient community stakeholders. It is therefore for NICE
to correct its error, not the #ME community.

If @NICEComms chose to exclude already recognised legitimate stakeholders from
any future part in the process, then that would compound its initial error, be acting in
bad faith and would be unlikely to survive legal scrutiny.

As I said in a recent blog post:
“If NICE is planning to open up a new consultation process on its guideline for
“ME/CFS” then it must clarify its position immediately and communicate this with
full transparency to stakeholders and the general public…..

…..If NICE fails to provide this information, then this amounts to a breach of its duty
to properly exercise its statutory functions. If there is no proposed plan, then NICE should publish the new guideline of its own volition without further delay.”

So – what is the purpose of the roundtable meeting?

According to the ME Association: “Representatives from stakeholders – which
includes both MEA and ForwardME – will be invited to this roundtable meeting”.
Invited by @NICEComms ? How will that process be transparent and inclusionary?
And an “independent chair”? Appointed by whom?

@NICEComms is no longer an independent body in this guideline review process.
NICE sacrificed its independence when it capitulated to external interference. This
means that the whole process is now flawed.

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Legal advice?

As I said about halfway through the thread: “At this point #ME orgs should as a precautionary measure be seeking independent legal advice before deciding further action.” The particular emphasis here should be on “independent” ie. from professional lawyers who are experts in the field of public and administrative law. 

On 25 August, in the group email conversation with senior representatives from the ME patient community (see above thread), I was asked for my recommendations, should the group decide to seek legal advice. Given this request, it would appear that, at this stage, this group had not yet sought independent legal advice.

I replied that I could provide recommendations but I needed further information in order to do so. I also included this: 

Preparations should be made to instruct an appropriate legal team in the event that NICE fails to correct its error by either publishing the guideline or providing credible reasons for its action on 17 August.

At this point, the group email conversation stopped without explanation.

Two days later, on Friday 27 August, NICE issued the second statement, proposing the “roundtable event”. Before the end of the day, in a Q&A explaining their decision to attend the roundtable, the ME Association Facebook page stated: “ForwardME [an informal coalition of charities and groups] has received legal opinions on the various options available from a number of sources.” The meaning of this statement is unclear, particularly given the sudden change in circumstances and legal position caused by the “roundtable” announcement. 

What now?

Who knows? Presumably, the “roundtable event” will take place at some point, probably as a virtual meeting. Some people will attend. Things will be discussed. Preparations for all eventualities may or may not have been been made. 

The outcome is anybody’s guess.

This is not how due process works.

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With thanks to @BenDeNevis1 on Twitter for creating the Threadreader.

 

A debt of gratitude

August 26, 2021

Disclosure: I have lived with the discrete illness myalgic encephalomyelitis since 1981. I have written extensively about the NICE process (amongst other topics) in relation to this illness. I work independently and I am not affiliated to any organisation or group in the ME community. For more information see About.

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Yesterday, I published a post entitled “Update on the “paused” NICE guideline for “ME/CFS”: the case for individual/community publication.” For the full background to this post, please refer back to that post. 

56069A84-1601-47EF-A8AA-952FE3EE7E6DIn that previous post, about two-thirds of the way down, I made this statement:

“My assessment of the guideline

It’s rubbish. It still contains far too much latitude for abuse of patients. However, it is less rubbish than the existing guideline from 2007. It is a significant improvement on that and it is the best we are going to get for the foreseeable future.”

It’s right to say that I rarely use such strong, abrupt language. However, that assessment remains my view. 

A few hours after publishing, I received a communication from someone who was extremely angry and upset as a result of reading my post. This reader listed some of the huge improvements to the guideline and reiterated the fact that “ME/CFS” experts and patients on the Guideline Group had given up their time and energy for people with ME.

The reader then went on to say, in the strongest possible terms, that they felt that I had been very unfair in dismissing the achievements of the Guideline Group as “rubbish” (the reader is not a member of the guideline committee). 

 
I replied as follows (edited): 
Thank you for your frank response….. I appreciate it. 
I share your frustration, having spent the last ten years wrecking my own health researching and writing, as well as providing information, advice and support, both publicly and privately, often to [deeply distressed] individuals. I accept, like you, that there is a huge physical and emotional toll in doing this work……..
I am also grateful to you for having the courtesy to reply directly to me…….
Incidentally, the full context of the quote you mentioned gives a rather different tone to what I said:
“It’s rubbish. It still contains far too much latitude for abuse of patients. However, it is less rubbish than the existing guideline from 2007. It is a significant improvement on that and it is the best we are going to get for the foreseeable future.”
Thank you again for getting in touch. 
 
I’m sorry if what I said caused any offence to guideline committee members. It was never intended that way. However, I’m grateful that this matter was raised as it gives me the opportunity to offer my thanks to everyone who gave their unpaid time and sacrificed their health to work on this vitally important process.
 
I, and many others, owe you a debt of gratitude. Thank you. 
 
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Update on the “paused” NICE guideline for “ME/CFS”: the case for individual/community publication.

August 25, 2021

Disclosure: I have lived with the discrete illness myalgic encephalomyelitis since 1981. I have written extensively about the NICE process (amongst other topics) in relation to this illness. I work independently and I am not affiliated to any organisation or group in the ME community. For more information see About.

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This post follows on from my previous one on this topic, dated 20 August 2021 (see here). For the full story so far, please refer to that post.

Summary for new readers

In 2017, the English National Institute for Health and Care Excellence (NICE) began the process of updating the dangerously out-of-date guideline for “ME/CFS” (myalgic encephalomyelitis/chronic fatigue syndrome), originally published in 2007. This guideline recommended treatments which many patients have long found to be actively harmful.

After several delays, the draft guideline was published on 10 November 2020. 2021-08-21 (2) This draft removed/downgraded the most harmful treatments from its recommendations and, as such, was broadly welcomed by the patient community. On 4 August 2021, the new guideline, marked “FINAL“, was circulated to stakeholders who had commented on the draft version.

By this stage, the guideline committee had approved this final version and, according to the NICE manual, the NICE Guidance Executive would now have signed it off. The fact that it was then circulated to stakeholders indicated that the process was now closed and completed.

According to NICE’s “Main stages of guideline development“, the publication stage began at this point. Publication to the world at large was scheduled for 14 days later, on 18 August. The document was to remain confidential until then.

Just after 3pm on 17 August, less than 9 hours before the scheduled time for general publication of the new guideline, NICE notified stakeholders that it was “pausing” publication. By this stage, only exceptional circumstances could have derailed the process. Thus far, NICE has failed to provide evidence of any such circumstances.

The current position

If NICE is planning to open up a new consultation process on its guideline for “ME/CFS” then it must clarify its position immediately and communicate this with full transparency to stakeholders and the general public. If NICE fails to provide this information, then this amounts to a breach of its duty to properly exercise its statutory functions. 

If there is no proposed plan, then NICE should publish the new guideline of its own volition without further delay.

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Individual publication of the new guideline

Following my previous post, a number of people contacted me. I now have a copy of the guideline.

The main risk in publishing would be borne by me as the publisher and I am willing to take that risk. However, understandable individual concerns have been expressed by others.

I am not prepared to publish it here without the full agreement of all parties involved so I will not proceed for the time being.

[Edited to add: no one is preventing me from publishing. However, whilst I can manage risk on my own behalf, I cannot breach the trust of anyone who might provide information in confidence but then has legitimate concerns about proceeding with my publishing it. In any event, community publication would have much more impact.]

My assessment of the guideline

It’s rubbish. It still contains far too much latitude for abuse of patients. However, it is less rubbish than the existing guideline from 2007. It is a significant improvement on that and it is the best we are going to get for the foreseeable future.

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Reasons why community publication is now imperative
  1. Purpose:
    To provide essential information to the public about the guideline as it stood on 17 August 2021 and as a comparator with any future versions of the new guideline.
  2. De facto publication:
    The new guideline document has already been distributed, officially and unofficially, to a large number of recipients via 280 stakeholder groups and multiple media leaks therefore de facto publication has already occurred.
  3. Public domain:
    Information about the contents of the document has been in the public domain since 17 August via various media reports. That information is not inherently secret.
  4. Confidentiality expired:
    The confidential nature of the document expired at 12.01am on 18 August. This, combined with the de facto publication, means that the document has lost its “quality of confidence”.
  5. Public health considerations:
    The process of updating the guideline has been delayed several times. NICE has been on notice since April 2019 that patients may be experiencing harm from treatments recommended in the 2007 guideline. That guideline remains operative until NICE publishes the new version. The public health considerations and potential liability issues raised by this further delay militate strongly in favour of immediate publication.
  6. Delaying publication without clear justification is an unlawful action:
    Millions of members of the international ME community have been waiting years for this new guideline. Delaying publication further without reasonable justification and in apparent contravention of NICE’s own Guidance Development Manual would be unlawful. NICE has a wide discretion in the way it conducts its affairs but credible reasons for the delay have not been forthcoming.

In all the circumstances, the arguments for publication demonstrate that there is an overwhelming public interest in favour of publishing the guideline.

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NICE – contemptuous and contemptible: the case for community publication of the “paused” guideline for “ME/CFS”

August 20, 2021

Disclosure: I have lived with the discrete illness myalgic encephalomyelitis since 1981. I have written extensively about the NICE process (amongst other topics) in relation to this illness.

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Background

In 2017, the English National Institute for Health and Care Excellence (NICE) began the process of updating the dangerously out-of-date guideline for “ME/CFS” (myalgic encephalomyelitis/chronic fatigue syndrome), originally published in 2007. This guideline recommended treatments which many patients have long found to be actively harmful. 

2021-06-28 (4)The new draft guideline was published on 10 November 2020, followed by a 6-week stakeholder consultation period. Final publication of the new guideline was expected on 18 August 2021. The draft guideline removed/downgraded the most harmful treatments from its recommendations and, as such, was broadly welcomed by the patient community.

On 4 August 2021, as expected, the final version of the new guideline was circulated to stakeholders who had commented on the draft. By this stage, the guideline committee (now down to 18 members) had approved the final version (notwithstanding three resignations) and, according to the NICE manual, the NICE Guidance Executive would have signed it off. The fact that it was then circulated to stakeholders indicates that the process was now complete.

What happened then?

At just after 3pm on 17 August, less than 9 hours before the new guideline was due to go live, I, along with other stakeholders, received an email from NICE headed “MEDIA STATEMENT: NICE pauses publication of updated guideline on diagnosis and management of ME/CFS” (see end of this post for full statement).

The reasons NICE gives for this “pause” are unclear and not in accordance with “its usual rigorous methodology and process“, as proclaimed in the fourth paragraph of the statement. The inevitable inference from this lack of clarity is that someone, or some groups, raised objections at the eleventh hour and, completely at odds with its stated practice and procedure, NICE caved.

If this observation is correct then, at this point, NICE compromised its independence and credibility as an organisation. The inference of external meddling is boosted by media reports (eg. here [£] and here) indicating that, amongst others, the Royal College of Physicians and the Royal College of Paediatrics and Child Health did not accept the final version of the guideline.

Was this “pausing” of the guideline justifiable?

By this point, this action by NICE of “pausing” the publication should have been impossible. Such a step is not in accordance with its own manual which states quite clearly:

This step [releasing an advance copy to stakeholders] allows registered stakeholders to highlight to NICE any substantive errors, and to prepare for publication and implementation. It is not an opportunity to comment further on the guideline. [my emphasis]

Depending on what happens over the next few weeks, this action by NICE may require closer legal scrutiny.

The statement from NICE also contains the sentence: “Because of issues raised during the pre-publication period with the final guideline, we need to take time to consider next steps.” This is nonsensical. The guideline had already been published, albeit on a confidential basis, to a large number of people via the stakeholders who had commented on the draft. It had also been extensively leaked to the media (as would be expected by everyone, NICE included) in preparation for the anticipated public release on 18 August.

At this stage, the so-called “pre-publication period” and the opportunity to raise further issues had already passed. 

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Contemptuous and contemptible 

In pausing publication of the new guideline without proper explanation, NICE has demonstrated contempt for the “ME/CFS” patient community, a community described in its own draft guideline as one which may “have experienced prejudice and disbelief and feel stigmatised by people who do not understand their illness“.

Over the last few years, many severely ill patients have volunteered substantial amounts of time and exhausted their very limited resources in order to contribute to the guideline review process. This has come at massive cost to their own health and wellbeing.

In the absence of reasons and credible justification, NICE’s actions over the last few days can only be regarded as contemptible. 

Where are we now with the “paused” guideline?

NICE is an internationally respected organisation. Healthcare professionals and patients all over the world have a keen interest in both the guidance it produces and how it conducts itself. 

In the case of the “ME/CFS” guideline review process, something appears to have gone very wrong. There may be a valid reason for this misstep but the sketchy information provided so far is vague and lacking transparency. 

Earlier on in the review process, NICE sought evidence from patient groups concerning the harm which had been experienced as a result of treatments recommended in its 2007 guideline (Graded Exercise Therapy and Cognitive Behavioural Therapy). In April 2019, at very short notice, the requested survey was provided. Since that time, NICE has been on notice of the harms caused to many patients from its recommended treatments.

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THE CASE FOR PUBLISHING THE “PAUSED” GUIDELINE

From a legal point of view, there is limited precedent. However, two points should be considered:

  • The new guideline has already been distributed to a very wide range of parties, both officially and unofficially. It is now most unlikely that the information contained within the guideline can still retain its quality of confidentiality.
  • NICE began the process of updating the guideline in 2017. Initially, it was expected to take 2 years. It has been ongoing for nearly 4 years and now appears to have stalled indefinitely, with NICE having deviated from its own rule book without apparent justification. At this point, there is therefore a strong argument that the public interest in publishing the “paused” guideline is overwhelming. 

Once the final version of the guideline is made available to everyone with a legitimate interest in this process, it will then be possible for comparisons to be made between the “paused” version which was due on 18 August 2021 and any subsequent version which NICE may release. If there are unexpected substantial changes and/or modifications to the language, then that will be for NICE to justify in an appropriate forum in due course.

It is important to remember that, as things stand at the moment, the old guideline from 2007 which recommends harmful treatments for “ME/CFS” patients, remains the operative practical guidance for health and social care practitioners, the Department for Work and Pensions (DWP), local authority safeguarding teams and insurance companies. The “paused” guideline rejects such treatments but will not protect future patients until it officially replaces the old standard.

Nevertheless, publication of the “paused” version by members of the “ME/CFS” community en masse would provide a comparator to the 2007 version, one which had been signed off and therefore has a credibility well beyond the draft version (still currently available on the NICE website).

SUGGESTED OPTIONS FOR COMMUNITY PUBLICATION OUTSIDE NICE

I am a stakeholder in the NICE process but I did not comment on the draft so I do not have a copy of the “paused” guideline. Stakeholders who have received a copy of the guideline were required to sign a non-disclosure agreement (NDA). However, given NICE’s recent unprecedented action, the validity of those NDA’s must now be in doubt.

Options for community publication:

  1. Anyone who has a copy of the “paused” guideline is welcome to contact me in absolute confidence. I could then, by agreement and format permitting, publish it on this blog, on behalf of the ME patient community. For details of how to get in touch see About.
  2. The better option: if a critical number of organisations who are in possession of the “paused” guideline decide to publish contemporaneously, then mass publication would be achieved.

NICE would then need to consider whether there is (legalese alert) a proportionate response to community publication that does not interfere with the rights of individual members of the ME community in the UK under Articles 8 and 10 of the European Convention of Human Rights

 

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TEXT OF STATEMENT FROM NICE SENT BY EMAIL ON 17 AUGUST 2021

MEDIA STATEMENT

NICE pauses publication of updated guideline on diagnosis and management

of ME/CFS

NICE has today (17 August 2021) taken the decision to pause publication of its
updated guideline on the diagnosis and management of myalgic encephalomyelitis
(or encephalopathy)/chronic fatigue syndrome (ME/CFS).
The guideline recognises that ME/CFS is a complex, multi-system, chronic medical
condition where there is no ‘one size fits all’ approach to managing symptoms. The
causes of ME/CFS are still poorly understood and because of this there are strong
views around the management of this debilitating condition.
Because of issues raised during the pre-publication period with the final guideline,
we need to take time to consider next steps. We will hold conversations with
professional and patient stakeholder groups to do this. We need to do this so that the
guideline is supported.
NICE has used its usual rigorous methodology and process in developing this
guideline but despite the best efforts of the committee, that followed these to the
letter to bring together the available evidence and the real, lived experience and
testimony of people with ME/CFS, we have not been able to produce a guideline that
is supported by all.
We want to thank everyone who has contributed to this guideline and particularly the
committee and the patient groups who have worked so diligently. However, unless
the recommendations in the guideline are supported and implemented by
professionals and the NHS, people with ME/CFS may not get the care and help they
need.
In order to have the desired impact, the recommendations must be supported by
those who will implement them and NICE will now explore if this support can be
achieved.

 

Beyond the NICE guideline: MEComms© and the case for a public inquiry

July 5, 2021

NOTE: “myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome” or “ME/CFS” (NICE’s terminology) is the subject of numerous different names and a confusing variety of case definitions. For the purposes of this blog, it is ME, the complex, multi-systemic neuroimmune disease with which I have lived since 1981. Follow link here for more information about ME and About for more details about me and my work.

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Beyond the new NICE guideline

The final publication by the English National Institute for Health and Care Excellence (NICE) of the new guideline on “ME/CFS” [sic] is due in six weeks’ time, on 18 August 2021. Whatever the outcome, it would be wise for the ME patient community to look beyond that date and, collectively, begin to plan ahead.

A new and robust strategy is required, aimed at addressing the historical damage caused to members of the patient community, collectively and individually, by a psychiatric lobby which frequently promotes its own interests above that of patients.

This powerful lobby group has a number of ongoing objectives, including:

  • Promoting inappropriate, sometimes dangerous, psychological and behavioural treatments for the disease
  • Obfuscating the overwhelming need for long overdue biomedical research
  • Continuing to create an environment which is broadly hostile to the ME patient community

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Proposed MEComms©

Following my previous post which examined the rationale for a new communications strategy for the UK’s ME patient community, a number of issues arose from the feedback. These are the key points:

  1. MEComms: the proposed new coalition – “MEComms” – should be composed of representatives from a small number of established patient groups in order to share resources and for continuity. MEComms would then establish a media steering group (or committee) with an agreed mandate.
    (Note: this project will have a lower chance of success if it is initiated by a single existing group as it is unlikely to be able to achieve the necessary scale or level of community trust. Community divisions are always a challenge; as I said in my previous post, the aim should be for a unified, rather than a united, approach.)
  2. Professional expertise: MEComms must obtain expert, professional advice and support. The proposal is too complex and far-reaching to work on an amateur basis, however keen its participants. This is a patient community of severely restricted capability because of a) the excessively debilitating nature of the illness and b) a limited pool of external supporters who are willing and able to pitch in and assist. 
  3. Scale: my proposal is on a much larger scale than anything that has been tried previously. Individual groups within the ME community have instigated PR initiatives but these have been much smaller than what I am proposing and therefore had less impact.
  4. Implementation: a simplified pathway for implementing my proposal for this strategy is set out in my 2019 post “Changing the narrative #3” (scroll down to second half) There is some further detail in “Changing the narrative #4”
  5. Funding: adequate funding is vital and must be addressed before anything concrete can begin. Again, see “Changing the narrative #3” (above) and my previous post (above). This is not a project which can expect success on a pro bono basis or on a minimal budget.

Looking to the future, the initial priority would be to change the existing flawed narrative around the ME and its patient community. This is the first stage in creating a more positive environment for a longer term aim of securing a public inquiry.

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The case for a UK public inquiry into the history of the illness ME (myalgic encephalomyelitis) and the treatment of patients

The possibility of a public inquiry is a perennial idea which is bounced around the ME community from time to time but has never, to my knowledge, gained any serious traction. As the ME patient community has been traduced in public inquiry Act imagepopular culture by the hostile environment which has been carefully cultivated by the psychiatric lobby (as detailed in earlier posts on this blog), perhaps this is not surprising.

The Gibson inquiry of 2006, which was chaired by the UK member of parliament, the late Dr Ian Gibson, made a brave attempt at establishing some of the background relating to the lack of research and funding for ME. However, it was a small ad hoc inquiry with a limited remit, no powers to compel witnesses and no teeth, so its impact was minimal.

A judge-led public inquiry with a wide-ranging scope and full statutory powers is long overdue for the ME patient community in the UK. Such an inquiry would be the most effective way of acknowledging the decades of shocking treatment of patients and, belatedly, making appropriate recommendations to rectify the situation.

Most public inquiries are prolonged and highly traumatic for the participants. The recommendations may be instrumental in changing future behaviour but are not binding. Nevertheless, it’s the best option available to the ME community as a long-term goal on which to focus.

What is a public inquiry?

The Institute for Government website describes it as follows:

Public inquiries are major investigations – convened by a government minister – that can be gifted special powers to compel testimony and the release of other forms of evidence…….The only justification required for a public inquiry is the existence of “public concern” about a particular event or set of events.

What is its purpose?

The website outlines an inquiry’s purpose in these terms:

Jason Beer QC, the UK’s leading authority on public inquiries, argues that the main function of inquiries is to address three key questions:

  1. What happened?
  2. Why did it happen and who is to blame?
  3. What can be done to prevent this happening again?

All inquiries start by looking at what happened. They do this by collecting evidence, analysing documents and examining witness testimonies.

More on public inquiries

For further information, the Institute for Government site is very helpful. The official government site is rather more ponderous but still worth a look.

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A Covid-19 inquiry in the UK

There will almost certainly be a public inquiry into Covid-19 within the foreseeable future. This will probably include long Covid in its scope so, by extension, it’s possible that ME would also come within its remit. This may or may not be helpful, depending on the parameters of its inclusion, the danger being that it could be far too narrow to be of any benefit to the ME patient community.

If ME were to be included in a Covid-19 inquiry, then a further dilemma might arise: would this exclude it from a full inquiry of its own at a later date? This is a matter where expert public affairs advice would be essential in order to determine a clear, coordinated community position and gather lobby support.  

The history of ME remains one of the worst examples of unacknowledged institutional abuse in modern times ~ Valerie Eliot Smith 2019

Time scales

Public inquiries can last for a long time; for example the notoriously lengthy Saville inquiry into Bloody Sunday took twelve years to complete and finally reported in 2010. The original events in question, “Bloody Sunday“, occurred in 1972.

Assuming that the ME community decides to begin working towards getting a public inquiry into ME under way, it will still take some considerable time for the process to be finalised. Even if the community was to begin lobbying right now, it would probably be another ten years before it actually took place. This is why it is imperative that, if such a course of action is to be pursued, then it needs to start as soon as possible.

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The remit for MEComms: from strategy to inquiry

MEComms’ remit should be to commence work on the following (with appropriate professional advice and assistance):

  1. Develop a new communications/public affairs strategy and media platform 
  2. Provide accurate information and updates both outside and inside the ME community
  3. Construct a positive, accurate narrative, with a particular emphasis on proactive dissemination of information, and counter misinformation as necessary
  4. Address the reputational damage which the community has experienced by creating a counter-narrative to the previously pejorative stories peddled to the media
  5. Once 1-4 above start to take effect, commence a lobbying programme with a view to securing a full public inquiry 

However, it must be remembered that all of this will take time, effort – and, of course, resources.

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For information about my work and contact details, go to the About section.

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FOLLOW-UP to previous post on responses to the draft NICE guideline for “ME/CFS” + the need for a communications strategy rethink

July 1, 2021

This post follows up on some of the feedback from my previous post on possible community responses to the draft NICE guideline for “ME/CFS”. A number of points have been raised directly and on social media. It’s easier to address them here rather than trying to pick them off individually. 

NICE GUIDELINE RESPONSES

Re-cap

In 2017, the English National Institute for Health and Care Excellence (NICE) began the process of updating the existing guideline on myalgic encephalomyelitis (ME), originally published in 2007. Within the UK, Scotland and Northern Ireland have their own equivalent processes and legal systems. This post relates to the situation in England and Wales.

The draft consultation documentsOtVmgpckQr25e6Xxl%PU8A were published on 10 November 2020, followed by a six-week consultation period concluding on 22 December 2020. The final publication date has been delayed several times but is now expected on 18 August 2021.

[NOTE: “myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome” (NICE’s terminology) is the subject of numerous different names and a confusing variety of case definitions. For the purposes of this blog, it is ME, the complex, multi-systemic neuroimmune disease with which I have lived since 1981.]

The function of judicial review as a response to the final publication of the new NICE guidance

Judicial review is only concerned with the lawfulness of a public body’s (ie. NICE’s) decision-making process. It is not about whether or not the judge agrees with the substance of the decision. This extract from the judiciary.uk website explains more:

…[J]udicial reviews are a challenge to the way in which a decision has been made, rather than the rights and wrongs of the conclusion reached.

It is not really concerned with the conclusions of that process and whether those were ‘right’, as long as the right procedures have been followed. The court will not substitute what it thinks is the ‘correct’ decision.

This may mean that the public body will be able to make the same decision again, so long as it does so in a lawful way.

This means that the High Court will not be re-examining the evidence relating to ME as a health condition. The judge will simply be considering the process of how the decision was made. It is not a reconsideration of the merits of the scientific basis for the decision. That is a matter for the guideline committee appointed for that purpose by NICE and the court would not interfere with the substantive findings on the evidence by that committee. 

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THE COMMUNICATIONS STRATEGY RATIONALE

This topic is directly relevant to the NICE process. Popular culture still reflects a negative perception of the ME community, long Covid notwithstanding. A simple glance at the very mixed media coverage on the topic – and the comments arising from it – confirms this beyond doubt.

Decision makers at all levels are influenced by media reports and lobbying strategies, as part of either a conscious and/or a sub-conscious process. Despite some recent progress, the ME patient community is still not a player at the right level to be able to achieve significant change.

Dealing with misinformation

The “psychiatric lobby”, (to which I referred in my earlier post) is still intent on protecting its position as the controlling player in the ME narrative. Members of this group continue to promote their collective, misguided belief in the benefits of psychological and behavioural therapies as suitable treatments, thereby indirectly obstructing urgently-needed biomedical research.

One question which is often raised by the ME community is how to counter the misinformation propagated by this extremely powerful lobby. In response to one such recent inquiry, I made these points (paraphrased):

  • Our focus should not be on countering misinformation. We know from previous experience that it’s not very effective. Our long-term aim should be to develop a strategic plan which incorporates a broad media platform. This is so that the patient community can set its own media agenda and create its own narrative. Simply trying to counter misinformation off the back foot doesn’t work and looks weak and defensive.
  • There is only a limited amount that individuals and small groups can do in isolation. If different groups are trying to counter the psychiatric lobby’s narrative separately and tell the patient story inconsistently then again, we just appear disunited and powerless. The building of a patient-oriented media agenda must come from a broad coalition of groups appointed specifically for that purpose, however difficult that may be to coordinate and manage.

Yet another example of carefully-placed misinformation appeared again recently in the BMJ Opinion section. Snappily entitled “Many patients with ‘long’ covid are experiencing extreme fatigue, a situation that has re-polarised approaches to treatment and rehabilitation”, it again repeated the depiction of the ME patient community as a crowd of dangerous, deluded agitants. The article attracted some excellent responses – but they are just that – responses and therefore defensive rather than proactive.

The ME patient community urgently requires a proper communications strategy and media development plan. This should be the brief for a media steering group, as I have already described in an earlier post from 2019 (second half). The aims of such a group should include:

  • Taking control of and resetting the media narrative in an appropriate context which is a) accurate and b) sympathetic to patients
  • Addressing once and for all the unresolved legacy and reputational damage caused by the portrayal of sections of the ME patient community as dangerous activists
  • Providing reliable, up-to-date practical and scientific information about the disease
  • Being ready to produce instant, agile and coordinated responses in order to rebut partisan stories masquerading as responsible journalism
  • Obtaining professional assistance for devising an effective lobbying strategy

Good communication needs to be internal as well as external

A strong communications strategy is required to keep members of the ME community informed about ongoing actions, initiatives and planning. At the moment, the community consists of a multitude of disparate groups working in different ways, often duplicating each other’s work and resulting in an inconsistent approach to community concerns.

Whilst there will always be significant disagreements and debate between and within patient groups, a more unified (as opposed to united) range of voices would enhance the credibility of the community. 

As well as an external media platform, an internal communications network would improve the morale of the ME patient community in the UK. The two platforms should be properly joined up, internally and externally, to create a more constructive environment in which to campaign, advocate and support the wider community, and better inform its participants and its wider audiences. 

Many patient groups and charities do already make considerable efforts to keep everyone informed about what they are doing but it’s hard to keep track of all the different channels of communication. A few groups still remain quite closed so it’s difficult to know what may be taking place within their confines. 

Funding 

Funding is always a challenge but it is not insurmountable and I have previously set out a basic pathway in my post Changing the narrative #3. We know that the international ME community is quite capable of raising substantial funds if the cause is properly promoted and has sufficient credibility from within the community and from external donors. Crowdfunding campaigns by David Tuller and Keith Geraghty have proved this in recent years so the claim that we cannot raise funding is no longer justified. 

Some members of the ME community are concerned that this initiative would be wasting precious resources on “just a bit of PR”. Whilst what I am proposing would include input from a professional communications advisor, the proposal involves a much more wide-ranging and detailed strategy than has been tried previously by individual groups. 

If not now, when?

ME has been around as documented illness for nearly a hundred years. The international patient community is still struggling to secure proper recognition and treatment. This suggests that, despite enormous efforts, we haven’t yet got the message right. A radical overhaul of our priorities and strategy is long overdue.

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CHANGING THE NARRATIVE 

This is a summary of the series I wrote in 2019. The full list can be found here.

Changing the narrative #1 Introduction and setting out the rationale for the series

Changing the narrative #2 Examination of the unresolved legacy of the negative portrayal of the ME community

Changing the narrative #3 Proposes ways to address the general challenges faced by the community and reputational damage problem in particular. Includes a simplifed pathway for the process (including funding)

Changing the narrative #4 Follows up on some of the issues raised by the series

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