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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

The 2021 film “The Tangled Story of ‘ME/CFS’” gives an account of the historical and political context of ME, as seen through the eyes of a range of expert researchers, clinicians and advocates. To view this film (1 hour 11 minutes) go to this link

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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 details about my qualifications and experience, and the complex terminology behind “ME”, “CFS” and “ME/CFS”, 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 If you notice something like a broken link or an outdated fact, please contact me either via Facebook private message/Twitter direct message or email at v.eliot-smith@qmul.ac.uk.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. 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
  4. 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.
  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. My views on how this can be addressed can be found in this post from July 2021 Beyond the NICE guideline: MEComms and the case for a public inquiry and in the category Strategic communications and the media.

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 [nearly a hundred] 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 seventy years ago [ie. 1956].

Limitation of Consent to Treatment: template form + Guidance Notes (with downloads)

April 5, 2022

NOTE: the illness termed “myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome” or “ME/CFS” by England’s National Institute for Health and Care Excellence (NICE) is the subject of many different names and case definitions.

In this blog post, I refer to the NICE guideline so the term “ME/CFS” has to be used, rather than ME (myalgic encephalomyelitis). ME is the complex, multi-systemic neuroimmune disease with which I have lived since 1981. See About for more information about ME and about my work. I am a barrister.

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I was recently asked by a UK ME advocate, Eleanor Rosen, if I could help with drafting a Limitation of Consent form. This form would create a document which ME (or “ME/CFS”) patients could prepare in advance and take with them to medical appointments which they anticipate might be challenging.

Consent

According to the British NHS website, consent must be “voluntary” and “informed”, and the person giving it must have “capacity”. For more information, follow that link to the NHS site.

The starting-point would be that consent is generally implicit in the mere act of being present at a medical appointment. However, that would not necessarily extend to a situation where the appointment is imposed on a patient by a health or social care professional.

Equally, it is arguable whether or not consent to an appointment automatically extends to consent to treatment. Historically, some patients with ME or “ME/CFS” have experienced problems because they have been prescribed so-called “treatments” which have turned out to be harmful.

Purpose of the form

Despite being first documented nearly a hundred years ago, ME has remained an illness which frequently causes severe tensions between patients and healthcare professionals. The purpose of the proposed Limitation of Consent form would be a) to act as a memory aid during the appointment for the patient (or parent/guardian/carer) and b) to provide written support for withdrawal of consent if they become concerned about the direction the appointment is taking.

The updated NICE guideline from 2021 makes it clear that ME is a “fluctuating medical condition” (para 1.6.4) and specifies types of treatment which are not recommended for ME patients. It is clear from the guideline that ME (without co-morbidities) is not a psychiatric, psychosocial, medically unexplained or functional neurological disorder. Nevertheless, patients are too frequently steered towards, or forced into, those directions, often with disastrous results.

Legal and evidential validity

A Limitation of Consent document, whilst it has no legal force, provides a statement that can be produced and shown to the healthcare professional who is conducting the appointment, if the patient feels that they are being treated in an inappropriate manner. The document explains that, from this point onwards, consent for treatment is being withdrawn.

This document cannot provide legal protection or any other guarantee. Nevertheless, the hope is that patients may feel reassured that, if difficulties arise during an appointment with a healthcare professional, they have a written document prepared which indicates their withdrawal of consent to treatment. It may also provide useful evidence at a later date if there is any dispute about if/when consent to treatment was withdrawn.

Before an appointment

It is advisable to make efforts to find out in advance of an appointment what approach any particular clinic/healthcare practitioner takes with this illness. Where patients already know or strongly suspect that the approach may be unhelpful, then the better option is to seek more appropriate treatment elsewhere (if such exists).

This form is designed for situations where patients are uncertain, or simply anxious, about an imminent appointment. It is intended for use as a fallback, rather than as a pre-emptive strike. Submission of the form in advance of an appointment could run the risk of setting up a hostile reaction so any such move should be approached with caution.

Applicability

The form is primarily for use by patients in England. However, theoretically, it could be used in any country which recognises the NICE guideline NG206 for “ME/CFS”.

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The Limitation of Consent to Treatment form and accompanying Guidance Notes

Eleanor provided me with an initial outline and we have produced two pdf documents (see below for simple text versions). The Guidance Notes must be read before using the form.  

DOWNLOAD THE DOCUMENTS from these links (note that they will open in the same window):

  1. Download Limitation of Consent form from: Limitation of Consent MECFS form
  2. Download accompanying Guidance Notes from: Limitation of Consent Guidance Notes

For information purposes, the unformatted text of each document is below 

LIMITATION OF CONSENT TO TREATMENT FOR PATIENT WITH ME/CFS
NB: please read Guidance Notes before using this form
Complete this form before your appointment and keep a copy.
Take this form with you so you can show it to your doctor if
you become concerned about the direction of the appointment.
Patient’s name _________________________________
Address _______________________________________
Date of birth ___________________________________
PATIENT STATEMENT: I was diagnosed with the illness
ME/CFS (myalgic encephalomyelitis/chronic fatigue syndrome)
as defined in the NICE guideline NG206 of 29 October 2021.
[Complete where possible] This diagnosis of ME/CFS was made
on _________ at _________________ by_________________
I consent to be seen and treated only by healthcare
professionals who are familiar with the above NICE guideline
and who understand that ME/CFS:
a) is “a fluctuating medical condition” [para 1.6.4]
b) is not appropriate for treatment with graded exercise
therapy [para 1.11.14]
c) is not appropriate for treatment with cognitive behavioural
therapy other than as a purely supportive treatment [para
1.12.28]
d) must not be treated with the Lightning Process or other
similar therapies [para 1.12.27]
e) is an illness where the most severely affected patients “may
not be able to swallow and may need to be tube fed” [page 8]
I do not consent to be seen or treated by any healthcare
professional who treats ME/CFS primarily as a psychiatric,
psychosocial, medically unexplained, functional neurological or
other similar disorder.
If I am referred to, or seen by, any such professional, then my
consent to treatment is withdrawn immediately.
Name___________________________ [patient/parent/guardian/carer]
Signature & date__________________________________

LIMITATION OF CONSENT FORM – GUIDANCE NOTES
Important: please read before using form
1. Defining consent
The British NHS website gives a useful overview of consent to
medical treatment. The full version can be found at this link.
These extracts provide a summary of the considerations and
requirements for informed consent to be given by/on behalf of
a patient:
• Consent to treatment means a person must give
permission before they receive any type of medical
treatment, test or examination.
• This must be done on the basis of an explanation by a
clinician.
• Consent from a patient is needed regardless of the
procedure, whether it’s a physical examination, organ
donation or something else.
• The principle of consent is an important part of medical
ethics and international human rights law……
• For consent to be valid, it must be voluntary and
informed, and the person consenting must have the
capacity to make the decision. [my emphasis]
2. Legal force of the Limitation of Consent form
The Limitation of Consent form is an informal document, not a
legal one. It can neither compel anyone to take a particular
course of action nor can it prevent a particular course of action.
Remember that this form will contain private and confidential
medical information.
3. Purpose of the form
The purpose of this document is to assist ME/CFS patients by:
• Providing a written memory aid which can be prepared in
advance of medical appointments by a patient,
parent/guardian (of a child under 16) or carer.
• Providing written support for patients who need to explain
that they do not consent to be treated by certain types of
healthcare professionals.
This document cannot give any guarantee or protection beyond
that purpose.
NB. This document will not assist if there is a genuinely held
belief by the healthcare professional that there is a psychiatric
issue, whether primary or co-morbid, however misguided that
may be.
In those circumstances, the only option is to remind the
professional that the patient is entitled to a second opinion
from their preferred ME/CFS medical specialist.
4. Significance of the most recent NICE guideline NG206
A healthcare professional who believes that a psychiatric,
psychosocial, functional neurological or medically unexplained
approach is the correct way of treating an ME/CFS patient, is
likely to be unfamiliar with the most recent NICE guideline.
In those circumstances, it should be pointed out that this
healthcare professional may not be an appropriate person to be
dealing with an ME/CFS patient at this point.
This may be particularly important in cases relating to a child,
a very severely affected patient and/or a patient who urgently
requires tube feeding [see page 8 of the NICE guideline].
5. Evidential value of the form
This document’s evidential value is limited as it simply confirms
what the patient is saying at the time of the appointment.
It is possible that this document could be used as evidence in
proceedings at a later stage if there is a dispute about if/when
consent was withdrawn. However, this will depend on the
circumstances of each individual case.
6. Recording an appointment
Recording an appointment with the clear consent of all other
attendees would be useful. Evidence acquired by secret
recording is not normally admissible and therefore is not
advisable.
7. Lasting power of attorney for patients who are
severely affected
Adult patients who are very severely affected by illness and
unable to communicate with healthcare professionals may be
deemed to lack capacity.
Patients who may be in this situation should consider setting up
a lasting power of attorney [see gov.uk website]. This enables
a relative or carer to speak for them and make decisions on
their behalf.

A manifesto for change: from strategy to inquiry

March 16, 2022

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

NOTE: the illness termed “myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome” or “ME/CFS” by England’s National Institute for Health and Care Excellence (NICE) is the subject of a wide array of 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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Rainbow over the City

In August 2022, this blog will have been in existence for ten years. My research has been ongoing for far longer than that. The thesis of my work, as documented within this blog, is that, for a variety of reasons, the progress of change for the international ME community during the last fifty years has been painfully and unnecessarily slow.

The ME community urgently needs to adopt a more assertive, proactive and robust approach to its activism. A much more targeted media presence should be cultivated and a complete re-set of the toxic culture surrounding ME is urgently required. This approach should be mediated by obtaining independent, professional advice on strategic planning, media handling (digital + legacy) and political lobbying.

The current practices by many groups of picking off individual journalists who may appear to be sympathetic or sending out huge numbers of unpersonalised media releases is demonstrably unsuccessful. Equally, defensive responses to unhelpful and inaccurate articles, whether in writing, by interview or on social media, are clearly not cutting it, judging by the very mixed bag of media coverage over the last 40-50 years.

Whilst high-quality research at an appropriate scale is to be welcomed (such as the ongoing DecodeME study in the UK), state funding for research remains derisory and private funding is necessarily limited. Total funding in all countries falls far short of being commensurate with disease burden. This will not change at any speed or scale until the entire culture surrounding this illness is changed.

The ME community must take control of the narrative and keep it where it belongs – with patients.

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Progress?

ME has probably existed for centuries. It was first documented in 1934, nearly a hundred years ago. However, in 1970, progress of the illness was hijacked by psychiatrists and their subversion continues to this day.

The new NICE guideline (see note above), which was published in October 2021, was a considerable improvement on the previous version from 2007. Nevertheless, it stands as a deeply disturbing testament to the shocking lack of progress over the last fifty years.

All that is available generally is management of symptoms or individual trial and error with unproven treatments (for those who are able to access and afford them).

These are the highlights of the new NICE guideline:

  • The “improvement” in the new guideline is that, unlike its 14-year predecessor, it no longer recommends treatments which are known to be actively harmful to patients
  • It demonstrates that, despite nearly a hundred years of accumulated knowledge and documentation, there is still no clear diagnostic pathway, treatment or cure
  • Paragraph 1.1.2 states that it must be recognised “that people with ME/CFS may have experienced prejudice and disbelief and could feel stigmatised by people (including family, friends, health and social care professionals, and teachers) who do not understand their illness.” It should also be noted that “people with ME/CFS may have lost trust in health and social care services and be hesitant about involving them.”

How many more times will it need to be said? AFTER NEARLY A HUNDRED YEARS, THIS IS NOT OK.

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Beyond the new NICE guideline

In recent years, the various ME charities and patient groups worldwide have increased their focus and resources on advocacy and media strategies. However, whilst these efforts are laudable, they are not at a scale which will achieve the requisite changes at the necessary pace.

There is also insufficient evidence of the deep level of understanding of strategic planning and expertise in media handling which is required to address the challenges and secure the change of narrative so urgently needed by the international patient community.

The degree of sophistication in approach varies between individual organisations and between countries but overall strategies are failing to protect and promote the interests of patients.

“The politics of health is complex and nuanced and there are many, many competing interests. But ME has been at the bottom of that pile of interests for many, many years. It’s time that changed.” ~ Valerie Eliot Smith in the 2021 film “The Tangled Story of ME/CFS” (follow link to view)

In July 2021, I wrote a post exploring where the ME community should be focusing its efforts after publication of the NICE guideline. Below is a substantially revised and updated version of that post.

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

The determination of this powerful group to exert inappropriate influence over public policy was nowhere more evident than in its attempt in 2021 to interfere with the final publication of new NICE guideline.

This insidious attempt at subverting the process delayed the publication by nearly three months and succeeded in further diluting the original text. It wasted time and money, and caused enormous unjustifiable distress to an already traumatised patient community.

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

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

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Proposed MEComms

Following an earlier 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 used previously. ME charities and groups do have media strategies in place but these are much smaller than what I am proposing and have insufficient impact to facilitate change at the required level.
  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 previous posts Changing the narrative #3 and #4 (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 ME and its patient community. This is the first stage in creating a positive and constructive environment with the 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. However, as ME patients have been so traduced in popular culture by the hostile environment 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, attempted to establish 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 absolutely 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  is the best option available to the ME community as a long-term goal on which to focus.

[See end of this post for some FAQ’s on public inquiries including, right at the end, a brief consideration of the Covid-19 inquiry]

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A MANIFESTO FOR CHANGE: THE REMIT

From media strategy to public 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 be ready to 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, and by, the media
  5. Once 1-4 above start to take effect, commence a lobbying programme with a view to securing a full public inquiry

This will take time, effort and, controversially, a long overdue review and redistribution of resources.

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PUBLIC INQUIRIES – FAQ’s

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.

Who pays for a public inquiry?  

Broadly speaking, the cost of an inquiry is borne by the governmental department that orders it (eg. Department for Health and Social Care) ie. it’s paid for by public money.  This covers legal representation for core participants who fall within the scope of the inquiry. However, anyone outside that who wants to be represented has to cover their own costs. See more at this link.

What is the likely time scale?

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.

What about the UK public inquiry into Covid-19? 

The draft terms of reference for this inquiry are now available. There is only the briefest mention of so-called “long Covid”. Whilst in theory a discussion about long Covid and, by extension, other post-viral conditions, might be helpful to the ME community, it is most unlikely that this would constitute a comprehensive examination of ME’s pre-existing and far more complex background.

My concern about this as a possible development is that, if ME is slotted into a convenient sub-plot of the long Covid narrative, this would diminish or invalidate a separate inquiry into its own long and tortuous history, the exact opposite of what is required.

It is to be hoped that the ME organisations in the UK are alive to this possibility and will deal with it appropriately if it arises.

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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Photo credit ~ Valerie Eliot Smith 2016

Governance under scrutiny: identities revealed in charity complaint

January 20, 2022

This blog deals with issues relating to law and health, due process and civil society. This post follows on from a previous post regarding the handling of a complaint that I made to a major ME charity in the UK and my subsequent appeal to the Charity Commission.

I have lived with the discrete illness myalgic encephalomyelitis/ME (sometimes referred to, confusingly, as “ME/CFS”) since 1981. I work independently and I am not affiliated to any organisation or group in the ME communityI am a barrister. For more information see About.

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Re-cap

In my recent post on 10 January 2022, I published an account of my complaint to a major ME charity

Storm over City

Storm clouds over the City

about two emails that I received from a senior officeholder at the charity. The main text of the previous post is repeated at the end of this post [scroll down to access]. It sets out in full the background circumstances and text of the emails.

In August 2021, I had been invited to contribute a group email discussion which was started by a senior member of an ME collaboration (not the sender of the subsequent emails). Arising out of this group thread, I received the two emails, sent to me as the sole recipient, which gave rise to my complaint.

The email discussion had been commenced on a professional basis. I had been contacted via my public academic address. The sender of the offending emails was using his official charity email address and was therefore acting in his capacity as a senior representative of the organisation. This was an abuse of his position as an officeholder of the charity.

The complaint

In September 2021, I complained to the charity, summarised as follows:

“During the course of a group email exchange, Mr AB sent two emails which were inappropriate, threatening, intimidating and sexist. They were also intended to shut down legitimate discussion about the current situation regarding the ‘paused’ publication of the NICE guideline for ‘ME/CFS’ [contrary to a stated aim of the charity]. These actions call into question Mr AB’s fitness to continue in the role of X.”

The charity dismissed my complaint. The next stage in the appeal process is to the Charity Commission. In December 2021, the Commission dismissed my appeal.

The public interest 

Since publishing the first post on this topic, I have received a number of messages, both public and private, expressing considerable concern about both the conduct of the sender and the organisation’s dismissal of my complaint. I have been asked to identify the organisation and officeholder by many people, particularly those who donate to ME charities.

As a result of these enquiries, I have decided to identify the charity and the officeholder. Those who donate time, money or other resources to charities are entitled to know how the charity’s representatives conduct themselves and what behaviour is deemed acceptable by the organisation.

Taking all the circumstances into account, the public interest falls overwhelmingly in favour of identification.

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Identification

The charity concerned is the ME Association. The officeholder is the Chair of the Board of Trustees, Neil Riley.

I contacted the charity for comment before publishing this. Their response was as follows:
[ETA: Rick Osman, as Vice Chair of the Board of Trustees at the MEA, undertook the internal investigation into my complaint and responded to my request for comment on this post. He was not the sender of the emails; that was Neil Riley, Chair of the Board]

Dear Ms Eliot Smith, Thank you for your email of 17 January 2022. We are sorry that you felt upset by the exchange of emails and, with your agreement, the MEA’s complaints procedure was followed to investigate your grievance. Neither that review nor your subsequent complaint to the Charity Commission found any grounds to uphold your complaint and we consider the matter closed. Yours sincerely,Rick OsmanVice chair

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FROM THE FIRST POST ON THIS TOPIC:

10 January 2022

The background

In August 2021, the international ME community was thrown into a state of consternation and confusion by an unprecedented “pause” in final publication of the new NICE guideline for “ME/CFS“. After a stressful and chaotic few months, the guideline was eventually published on 29 October 2021 with some ex post facto amendments.

The complaint

During the initial period of chaos immediately after the publication was “paused” by NICE (the English National Institute for Health and Care Excellence), I was in contact with various organisations and individuals. I was invited to contribute a group email discussion which was started by a senior member of an ME collaboration.

Arising from this group thread, I received two emails which were sent to me as the sole recipient. These are the emails which gave rise to my complaint. The sender was – and still is – a senior and longstanding official in his organisation, a major ME charity.

In September 2021, I made a formal complaint to the charity, summarised as follows:

“During the course of a group email exchange, Mr AB sent two emails which were inappropriate, threatening, intimidating and sexist. They were also intended to shut down legitimate discussion about the current situation regarding the “paused” publication of the NICE guideline for “ME/CFS” [contrary to a stated aim of the charity]. These actions call into question Mr AB’s fitness to continue in the role of X.” 

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

The emails which are the subject of my complaint

The first email was sent in response to a blog post I had written about the current situation with, and contents of, the “paused” publication. The email read as follows:

So, three years of long days in committee for our ME/CFS experts and patients on the Guideline Group. Giving up their time and energy for people with ME
They change the use of CBT, stop CBT [sic] and improve the previous Guideline hugely………….and you dismiss their achievement as “rubbish”!
Clearly that makes a good blog grabber but I would have expected a more measured and thoughtful approach from a public commentator.

I replied, in an email which I sent separately from the group thread:

Thank you for your frank response, AB. 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 desperate 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. So far, as you know, I am only hearing from xxxxx in the group email. I am therefore unable to gauge reactions to my contributions or answer questions and address the very real concerns that group members will have. 

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.”

Please feel free to share the contents of this email with any other members of the group.

Thank you again for getting in touch.

The following day I wrote another short blog post. [ETA: This post is entitled “A debt of gratitude“. In this post, I explained about the email I had received, acknowledged the work of the guideline committee and thanked them for their service.] Later that day, I received this response from Mr AB [ETA: Mr AB was not a member of the guideline committee]:

Hi Valerie

My response was not ‘frank’. It was extremely diplomatic.

When I do ‘frank’, you will know about it.

I did read carefully the parenthesis that you gave to the ‘rubbish’ comment but that did not. I feel, ameliorate the whole strident tone of your blog. Still, that is what blogs that seek readers seem to favour.

You might care to read that very old book “How to win friends and influence people“. That phrase has, regrettably, come into disrepute. But the book shows a deep understanding of  people and how you can influence them. Shouting at them rarely works.

I like the fable about the wind and the sun in their attempts to divest a man of his coat. Bluster from the wind, failed. But the warmth of the sun, worked.

I think the future for ME patients…..lies in research and the development of  medical education as to how we can be best treated. The new Guideline contains some positive advances in that area. We need to make sure they are brought into general practice.

I think we do that by using our expert knowledge of the illness coupled with our diplomatic skills.

AB

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

The substance of the complaint

This is the relevant extract from my Statement of Complaint to the charity:

  1. At no time, have I ever had any contact with AB, other than during these exchanges.
  2. The two emails he sent are offensive per se. In other circumstances such as random or anonymous comments on social media, I would have ignored them. However, in the context of an email conversation between a group of professionals, this is unacceptable behaviour.
  3. AB’s conduct renders him unfit to continue as X of YZ [charity]………

ACTION REQUIRED IN RESPONSE TO THIS COMPLAINT

  1. A full, transparent and independent investigation should be carried out into AB’s fitness to continue in his current office as X at YZ [charity].

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

The outcome

Two months later, I received a decision from the charity. An internal (not independent) investigation had been carried out and no further action would be taken in response to my complaint.

I appealed this decision to the Charity Commission (a rather cumbersome process). On 2 December, I received a response saying that the Commission would take no further action.

Where do I go from here?

Both decisions were as I had expected – a sad indictment in itself. However, given the nature of the emails I received, combined with the high-level position of trust held by the sender and his abuse of that position, I decided that the complaint should be made so that it stands as a matter of record.

The next stage in the process would be an application for judicial review of the Charity Commission’s refusal to take any action. However, I can say with some confidence that my complaint would be unlikely to meet the threshold of seriousness required for such an application to succeed.

Conclusion

Whilst this was very far from being amongst the worst examples of offensive online behaviour, nevertheless it will remain as a stain on the reputation of both a major ME charity and the sender of the emails. It also contains one of the most absurd instances of “mansplaining” that I’ve ever come across.

In failing to take any action, both the charity and the Charity Commission have tacitly condoned inappropriate conduct by an officeholder of an ME charity towards an ME patient-advocate.

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

Complaint dismissed: a charitable error or failure of due process?

January 10, 2022

This blog deals with issues relating to law and health, due process and civil society, as stated in the sub-heading above. 

I have lived with the discrete illness myalgic encephalomyelitis/ME (sometimes referred to, confusingly, as “ME/CFS”) since 1981. I work independently and I am not affiliated to any organisation or group in the ME community. I am a barrister. For more information see About.

This post is concerned primarily with due process, in relation to the handling of a complaint that I made to a major ME charity in the UK and my subsequent appeal to the Charity Commission.

Storm over City

Lightning strikes the city in 2014

It’s hard to believe how difficult it is to call out the conduct of some organisations in a supposedly democratic state which purports to have a strong civil society and robust civic institutions – but somehow that seems to be the case. I’m not giving up trying to find ways of doing it but I’m a bit stumped at the moment.

~ From an email I sent to a friend and ME advocate in December 2021.

The background

In August 2021, the international ME community was thrown into a state of consternation and confusion by an unprecedented “pause” in final publication of the new NICE guideline for “ME/CFS“. After a stressful and chaotic few months, the guideline was eventually published on 29 October 2021 with some ex post facto amendments.

The complaint

During the initial period of chaos immediately after the publication was “paused” by NICE (the English National Institute for Health and Care Excellence), I was in contact with various organisations and individuals. I was invited to contribute a group email discussion which was started by a senior member of an ME collaboration.

Arising from this group thread, I received two emails which were sent to me as the sole recipient. These are the emails which gave rise to my complaint. The sender was – and still is – a senior and longstanding official in his organisation, a major ME charity.

In September 2021, I made a formal complaint to the charity, summarised as follows:

“During the course of a group email exchange, Mr AB sent two emails which were inappropriate, threatening, intimidating and sexist. They were also intended to shut down legitimate discussion about the current situation regarding the “paused” publication of the NICE guideline for “ME/CFS” [contrary to a stated aim of the charity]. These actions call into question Mr AB’s fitness to continue in the role of X.” 

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

The emails which are the subject of my complaint

The first email was sent in response to a blog post I had written about the current situation with, and contents of, the “paused” publication. The email read as follows:

So, three years of long days in committee for our ME/CFS experts and patients on the Guideline Group. Giving up their time and energy for people with ME
They change the use of CBT, stop CBT [sic] and improve the previous Guideline hugely………….and you dismiss their achievement as “rubbish”!
Clearly that makes a good blog grabber but I would have expected a more measured and thoughtful approach from a public commentator.

I replied, in an email which I sent separately from the group thread:

Thank you for your frank response, AB. 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 desperate 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. So far, as you know, I am only hearing from xxxxx in the group email. I am therefore unable to gauge reactions to my contributions or answer questions and address the very real concerns that group members will have. 

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.”

Please feel free to share the contents of this email with any other members of the group.

Thank you again for getting in touch.

The following day I wrote another short blog post. [ETA: This post is entitled “A debt of gratitude“. In this post, I explained about the email I had received, acknowledged the work of the guideline committee and thanked them for their service.] Later that day, I received this response from Mr AB [ETA: Mr AB was not a member of the guideline committee]:

Hi Valerie

My response was not ‘frank’. It was extremely diplomatic.

When I do ‘frank’, you will know about it.

I did read carefully the parenthesis that you gave to the ‘rubbish’ comment but that did not. I feel, ameliorate the whole strident tone of your blog. Still, that is what blogs that seek readers seem to favour.

You might care to read that very old book “How to win friends and influence people“. That phrase has, regrettably, come into disrepute. But the book shows a deep understanding of  people and how you can influence them. Shouting at them rarely works.

I like the fable about the wind and the sun in their attempts to divest a man of his coat. Bluster from the wind, failed. But the warmth of the sun, worked.

I think the future for ME patients…..lies in research and the development of  medical education as to how we can be best treated. The new Guideline contains some positive advances in that area. We need to make sure they are brought into general practice.

I think we do that by using our expert knowledge of the illness coupled with our diplomatic skills.

AB

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

The substance of the complaint

This is the relevant extract from my Statement of Complaint to the charity:

  1. At no time, have I ever had any contact with AB, other than during these exchanges.
  2. The two emails he sent are offensive per se. In other circumstances such as random or anonymous comments on social media, I would have ignored them. However, in the context of an email conversation between a group of professionals, this is unacceptable behaviour.
  3. AB’s conduct renders him unfit to continue as X of YZ [charity]………

ACTION REQUIRED IN RESPONSE TO THIS COMPLAINT

  1. A full, transparent and independent investigation should be carried out into AB’s fitness to continue in his current office as X at YZ [charity].

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

The outcome

Two months later, I received a decision from the charity. An internal (not independent) investigation had been carried out and no further action would be taken in response to my complaint.

I appealed this decision to the Charity Commission (a rather cumbersome process). On 2 December, I received a response saying that the Commission would take no further action.

Where do I go from here?

Both decisions were as I had expected – a sad indictment in itself. However, given the nature of the emails I received, combined with the high-level position of trust held by the sender and his abuse of that position, I decided that the complaint should be made so that it stands as a matter of record.

The next stage in the process would be an application for judicial review of the Charity Commission’s refusal to take any action. However, I can say with some confidence that my complaint would be unlikely to meet the threshold of seriousness required for such an application to succeed.

Conclusion

Whilst this was very far from being amongst the worst examples of offensive online behaviour, nevertheless it will remain as a stain on the reputation of both a major ME charity and the sender of the emails. It also contains one of the most absurd instances of “mansplaining” that I’ve ever come across.

In failing to take any action, both the charity and the Charity Commission have tacitly condoned inappropriate conduct by an officeholder of an ME charity towards an ME patient-advocate.

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

Photo credit ~ Valerie Eliot Smith 2014

FOI requests reveal that NICE caved in response to threats from psychiatric lobby in “ME/CFS” debacle

December 13, 2021

Disclosure: I have lived with the discrete illness myalgic encephalomyelitis (ME, referred to here as “ME/CFS”) since 1981. I have written extensively about the 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. 

NOTE: there is a full summary of events relating to the English National Institute for Health and Care Excellence (NICE)’s updated guideline for “ME/CFS” at the end of this post. Please scroll down to access it.

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

2021-12-10 (2)Background to this post

In 2017, NICE took the decision to update the guideline for the illness it terms “ME/CFS”. After some delays, the draft was completed and submitted for comment in November 2020. The final version was circulated to specific stakeholders on 4 August 2021 with general publication due on 18 August.

In the afternoon of 17 August, NICE circulated an email informing stakeholders that publication was being paused. Shortly afterwards, it transpired that this pause was the result of external interference from a lobby group of representatives from some of the Royal Colleges and NHS England.

This powerful group disagreed with the new guideline and was threatening to refuse to cooperate with implementation of the new version, despite it having been finalised and signed off by NICE’s guidance executive. In giving effect to this pause in publication, NICE sacrificed its independence and allowed the subversion of its own prescribed process. 

A series of unprecedented events followed, ending in publication of an amended version of the guideline on 29 October 2021, a delay of nearly three months. This delay caused considerable unwarranted consternation and distress to millions of members of the international ME patient community.

As a result of this bizarre series of events, members of the ME community submitted Freedom of Information (FOI) requests to NICE. Dom Salisbury is a scientist who lives with ME. On 6 December, he published a blog post detailing and analysing some of the responses to those requests. 

On 7 December I composed a 10-tweet Twitter thread about that blog post:

Thread begins/
17 Aug 2021: in a highly controversial move @NICEComms paused the final publication of the new guideline for the illness “ME/CFS”
@domsalisbury has now collated the results of FOI requests showing the insidious lobbying behind NICE’s actions

 

It has become clear that this external interference was led by the psychiatric lobby. This vociferous lobby group has long controlled the narrative of “ME/CFS” causing unimaginable distress and damage to the patient community. 
At this point, NICE should have refused to engage with this powerful lobby group, stuck with its own prescribed process and published as planned on 18 August 2021. It didn’t. Instead, it capitulated, tore up its own manual and allowed this lobby group to manipulate the process. 
NICE surrendered to threats of non-cooperation from a dangerous lobby group. This invalidated the process & rendered it potentially unlawful. NICE sacrificed its independence as an executive non-departmental public body of the Dept of Health in England thereby losing public trust 
NICE should have remained firm and stuck to its own manual. It should have published the guideline as planned and addressed the problem of implementation afterwards (precedent exists for this course of action). 
The ME orgs also capitulated, thereby validating NICE’s shameful actions & undermining any future investigation. This capitulation facilitated the grubby events which followed, including the “roundtable meeting”. By this point the psych lobby had retreated to plan their comeback. 
As a result of this lobbying, NICE finally published an amended version of the guideline on 29 October. During the intervening period, I wrote a series of posts condemning NICE’s actions

 

So why does this matter? This fiasco calls into question two matters of great importance:
1) How much influence the psychiatric lobby has had over the fate of the international ME patient community during the last 40 years
2) NICE’s trustworthiness & independence as a public body 
/End of thread. Thanks for reading. 

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

SUMMARY OF PREVIOUS EVENTS 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.

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.) 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.

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.

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.

On 18 October the roundtable took place, [firstly with seemingly positive reports of broad agreement but then with what has transpired to be a deceptively positive outcome].

An amended version of the new guideline was then published on 29 October 2021.

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

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

 

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

NICE publishes new guideline for “ME/CFS”: cracks in the table emerge [updated]

October 29, 2021

THIS POST WAS UPDATED ON 1 NOVEMBER 2021 TO REFLECT DEVELOPMENTS SINCE 29 0CTOBER. EDITS ARE SHOWN IN SQUARE BRACKETS [like this].

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

Note: there is a summary of the background to this story at the end of this post. Please scroll down to access it.

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

The English National Institute for Health and Care Excellence (NICE) has today, 29 October 2021, published the new guideline for diagnosis and management of the illness which it terms “myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome” or “ME/CFS”. This replaces the dangerously flawed “CFS/ME” guideline from 2007.

2021-10-29 (2)The publication of the new guideline follows an abject failure of due process by NICE. The new document was due for final publication on 18 August 2021 but this was “paused” at the last minute as a direct result of external interference by representatives of the Royal Colleges and NHS England.

This unprecedented “pause” in publication has caused completely unwarranted distress to millions of members of the international ME community* as the newly published document is broadly similar to the previous unpublished version (available to download from this blog in an earlier post here).

[A roundtable event on 18 October (minutes here) purported to address concerns over implementation of the new guideline. This meeting appeared to secure general consensus on the new document. However, subsequent developments indicate that this may not have been as successful as was first thought (see statement below).

The results of NICE’s capitulation to a flawed process are beginning to show. Inevitably, this gives rise to cause for concern regarding its long term outcomes and potential for detrimental effects on the international ME community.]

There was extensive media coverage of the new publication, for example, by the BBC and The Guardian. Both highlighted the [apparent] rejection of harmful and long disputed Graded Exercise Therapy (GET) as a treatment for “ME/CFS”.

* NICE guidance generally is used as a template by many other countries

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

My response to the new guideline is as follows:

STATEMENT ON THE UPDATED NICE GUIDELINE

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 [attempt at] 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.

[However, it remains to be seen how implementation of the new guideline will work. Even before the release of the new version, evidence emerged about how GET will be repurposed in treating patients at a “chronic fatigue” clinic. The new phrase appears to be “graded activity management/GAM”.

Even more worrying (though not entirely unexpected) is the response by the Royal Colleges issued later on 29 October, which indicated that they do not agree with the new guideline and will continue to promote their own brand of exercise and CBT treatments.

It seems that there were some cracks in NICE’s round table which are now becoming apparent. The optimism expressed in NICE’s news release may have been premature.]

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

[In any event,] the current situation for “ME/CFS” patients is still dire.

  • The new guideline acknowledges that there is currently no diagnostic test and no cure for “ME/CFS”. There is no recommended treatment, only management of energy and symptoms.
  • The guideline recognises: “that people with ME/CFS may have experienced prejudice and disbelief and could feel stigmatised by people (including family, friends, health and social care professionals, and teachers) who do not understand their illness.” (para 1.1.2)

These are shocking admissions to be making about a devastating illness which was first documented nearly a hundred years ago.

[However,] 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 [has the potential to] open 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.

~ 29 October 2021

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

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

SUMMARY OF PREVIOUS EVENTS 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.

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.) 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.

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.

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.

On 18 October the roundtable took place, [firstly with seemingly positive reports of broad agreement but then with what has transpired to be a deceptively positive outcome].

The new guideline was then published on 29 October 2021.

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

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

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

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

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

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 (image file): 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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