Comment: A Continuing Saga of Ineptitude - 2021

If the welfare of patients was a prime consideration for NICE when discussing the plans to issue new guidelines for ME then their performance would be considered monumentally negligent by any independent observer.

The anxiety that NICE continues to cause in its non-transparent and unprofessional actions directly affects the health of those patients and carers who still hold on to some semblance of hope that new guidelines might deliver a better future.

Firstly, it has to be remembered that NICE had to be forced into considering a review of the flawed 2007 guidelines.

After initiating the review of existing guidelines with the botched creation of a “balanced” working group that included behind the scenes machinations [1], they spend years and many hundreds of thousands (millions?) of pounds in creating a draft set of guidelines for stakeholders to comment [2].

Then they analyse the comments, decide on what changes they will make to the guidelines and then set a date for a set of final guidelines to be published [3].

Then they alter that date, without consultation, to another date some four months into the future [4].

Then, a matter of hours before the publication of the final guidelines, they issue a statement that they intend to pause the guidelines publication – due to “……issues raised during the pre-publication period with the final guideline, we need to take time to consider next steps. We will hold conversations with professional and patient stakeholder groups to do this.” {Note: we were not consulted} [5].

They do not respond to IiMER’s letters [6] demanding their immediate publication.

Then, ten days after pausing the guidelines publication, they unilaterally decide to set up a roundtable of stakeholders (selected by them) to discuss the guidelines [7].

We do not know how many of their own guidelines development rules they have breached in their actions.

We can surmise that they are influenced by external forces that do not have the welfare of patients primarily in mind.

Now, when many stakeholders (not to mention the wider community of patients and carers) are left in the dark about intent, NICE are planning between themselves and their chosen partners what course of action is to be taken.

As we wrote when the guidelines working group was set up in 2018 [1]

So what will happen now with the NICE “balance” of working group members?
There are three ways this may likely go.
Those who finally make up the working group and seen to have an affinity to ME and to patients and with no vested interests of their own will argue for CBT and GET to be removed. And the BPS-side will either argue against or walk away.

Or the BPS-dominated influences in the establishment will protect their previous work by ensuring CBT is kept (with an attempt to retain GET) – and then anyone with any loyalty to people with ME and their families will have a duty to walk away.

Or thirdly, an almighty fudge is made with everyone looking to protect their own reputations and a muddle of guidelines is produced which will be ineffective for another five years and continue to pit patient against doctor - a lamentable achievement of the existing NICE guidelines.

We ended the article with this -

Two years will go by where dangerous recommendations of CBT and GET are kept, causing untold havoc.
And at the end? A lost opportunity?
What a mess!

A prescient comment.

Meanwhile, during all of these years of this review, damaging guidelines have been left in place.

IiMER were the first and only organisation to call for a health warning to be added as an addendum to the existing guidelines if they were to be retained (though some later seem to have followed our request).

In our letters to NICE Guidelines Director Professor Mark Baker in 2018 we called for CBT and GET to be removed immediately before the review was to take place – or for this addendum to be added immediately.

To ignore completely the evidence that is in front of you makes you directly responsible for any harmful effects administered by practitioners of CBT and/or GET following referral by any doctor who follows NICE guidance.

Whilst you may be providing cover for establishment organisations and individuals, you are not protecting patients – surely that should be your overarching concern.

What you must do, at the minimum we feel, is to issue an addendum to the existing NICE guidelines which states that not only are patients wanting to remove the recommendations for use of CBT and GET for ME but also that the USA agencies have removed CBT and GET from their recommendations. This will not only give some protection for your own liability but you could actually be saving lives.

This request was declined - for reasons that bore no logic but had all the hallmarks of appeasing the establishment entities who have controlled the way ME is treated in the UK for decades.

We await for what will transpire. Already we see some saying that they have already discussed with NICE directly – so much for transparency and fairness.

It seems ironic that the only certain recommendation to come out of a review of guidelines would be the call for a review of NICE’s operations and impartiality.

UPDATE: 4 September 2021

We have stated before that the NICE guidelines development process should be transparent.

There should not be a different approach being exhibited toward stakeholders - with some favoured entities apparently being provided with a direct route for behind the scenes discussions with NICE and preset inclusion in their planned roundtable, without other stakeholders being informed or patients being made aware.
Neither should the prioritisation of responses to letters to NICE (from stakeholders and others) on this topic be based on anything other than a fair and proper policy used in answering these requests and with due process followed.

There should be no favoured parties.

Over two weeks after writing to NICE [6] Invest in ME Research was, until yesterday, still awaiting a response to our letter to their CEO.
We were forced to contact Professor Gillian Leng (CEO of NICE) again as it seemed that our email had been left in some long queue whilst other letters had experienced a much shorter response turn-around.

This time we asked why there was such disdain for a UK charity, that is also a stakeholder in the NICE guidelines development, while more attention and priority was applied to requests received later than ours.
Only then did we receive a short response.

This reply did not answer our questions but did state -
"Bringing interested parties together will provide an opportunity to talk everyone through the approach that has been taken, with the aim of ensuring support for its implementation. We will progress this as quickly as possible."

There is still no clarity or justification for NICE's pause in publishing their guidelines after the development process had been completed.

Still no detail on what their "clear the air" roundtable is meant to achieve - let alone whether it follows due process or not.
All stakeholders received responses to their comments in the due process already.

Neither was there any official news of which stakeholders they had chosen to attend their roundtable - have any been nominated and notified? Without this information being known it leads to unnecessary and unhelpful speculation.

The phrase in the reply from Professor Leng - "We will progress this as quickly as possible." - belies the fact that the date has seemingly already been set for this roundtable meeting - though again, only the informed few seem to have been made aware.

So much for openness!

One is left to speculate what is really going on behind the scenes - from both sides of the artificial "balance" that NICE created when they set up this fiasco.

Was it part of another tactic that some resigned or were "dismissed" from the guidelines working group before the decision to pause publication was made?
Will those who resigned or were "dismissed" from the guidelines working group be allowed any role in future discussions of these guidelines, let alone participation in the proposed round table?
Surely not!

What discussions have been going on behind the scenes and between which parties since the embargoed guidelines were distributed to stakeholders, through the period when the decision was made to pause the publication, and up to the present day - and with which individuals or groups?

Do we need a FOI request to determine all of this?

Will all stakeholders eventually be invited to this roundtable, or just those self-chosen few who may have been involved in the behind the scenes "discussion" already?

If this is so then who is deciding which stakeholders are present, what criteria are used to select them, how can they be sure of representing all interests if all existing stakeholders are not contacted for their views beforehand?

What is the full intent of the roundtable, what is the agenda?

If the intent of the roundtable is merely to provide an opportunity to talk everyone through the approach that has been taken, with the aim of ensuring support for the implementation of the already-developed and approved guidelines, then why can this not be performed after the final guidelines are published?
No such opportunity was given to patients following the final review of the CG53 guidelines prior to their publication in 2007.
Instead, patients were forced to find the resources in order to take NICE to a judicial review to remove the harmful recommendations.

If the fear from NICE (due to threats made by others) is that NICE will be taken to a judicial review by some stakeholders who object to the new guideline evidence review findings then we say - let them do it!

Far better to have this out in the open for the whole world to see, and for the harm that has been inflicted on people with ME for fourteen years [8] to be seen for all to comprehend.
Let us have an airing of the tragedy that has been imposed on a large section of the population, with little proper analysis by media and appalling mendacity by establishment institutes and research councils and health services.

For once NICE may have a willing ally in patients - surely a unique occurrence in its history regarding ME.

The damage already done to people with ME would not so easily be inflicted on the ever-growing population of people with long covid.

We state this, not because we believe the final NICE guidelines to be published are good enough or sufficient, but because we believe at least that they will demonstrate how poorly served people with ME have been over the last fourteen years and there will be a chance for a fresh beginning [8].

If NICE are afraid of being challenged by Royal colleges in a judicial review because these colleges do not want to let go of their favoured panaceas for all disease then we say ignore them.
A judicial review will not be about the content of the guidelines but about due process.
If NICE are confident that they have followed accepted due process then they should not be afraid of such a manufactured and pernicious challenge.

And when the Royal colleges have lost that judicial review, as they surely will, then attention can be turned on their role and on their relevance and on the people within influencing their policies and all, including the media, can begin an investigation as to why we need these Royal colleges who would seem not have the welfare of patients as their main interest.

Whichever "side" one takes on this "balance" of opinions (that was falsely created to maintain and protect careers, businesses, egos) it is a false premise to think that it can be resolved by a lack of transparency.

It is patients and their families that matter and it is the interests of patients that should be at the heart of all guidelines development.

Though patients can be certain of one thing with all of the current events - they will be the last to know.

And meanwhile the old guidelines remain in place with no addendum or warning as requested by IiMER since 2018 [9] - just a slightly nuanced addition to satisfy our request to the previous NICE Guidelines Director -
NICE is aware of concerns about graded exercise therapy (GET) and is updating the current recommendations.
Please see the guideline in development page for information on our update (including draft recommendations on GET).
We are also developing guidance on the management of the long-term effects of COVID-19.

What a mess!


Last Update 28/08/2021