NICE ME/CFS guideline - draft published for consultation - 10th November 2020

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Jonathan Edwards said:
No, nothing overlooked. I have spent some time searching into this as people know and there is no reliable evidence for ME/CFS being associated either with EDS or mast cell disorders. This is where the level playing field comes in. If it is hope that the guidelines will change in recognition of poor quality of evidence it would not help to raise issues based on even poorer quality evidence.

Moreover, I am quite sure that these issues haven't been 'overlooked' because Willy Weir inbound to have raised them at the committee.He certainly did at the scoping meeting. Everyone its aware of the claimed association. I think it is important that it has not made its way into the guidelines.

I would personally prefer to see focus on orthostatic intolerance rather than 'POTS', which is a very ambiguous concept and not necessarily relevant to the OI of ME/CFS.
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Agreed. The whole point is for NICE to not be influenced by low grade evidence, no matter what its source and no matter what in relation to. I imagine NICE must by now appreciate that even back in 2007 they fell foul of this big-time, so hopefully all the more determined not to repeat the same mistake again.
 
Kalliope said:
Per Fink states that the Department of Functional Disorders at Aarhus University Hospital will object to the proposal from NICE.
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Is it common for non-British treatment centres to seek to involve themselves in NICE reviews? Looking at the CG53 table of comments and the stakeholder consultation comments from the 2017 10-year guideline update proposal - I see British charities and support groups, the Royal Colleges, PCTs/CCGs, NHS CFS services - but nothing from outside of the UK.
 
Nightsong said:
Is it common for non-British treatment centres to seek to involve themselves in NICE reviews? Looking at the CG53 table of comments and the stakeholder consultation comments from the 2017 10-year guideline update proposal - I see British charities and support groups, the Royal Colleges, PCTs/CCGs, NHS CFS services - but nothing from outside of the UK.
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I think anybody can send in a comment but unless they are stakeholders, and stakeholders need to be either in the UK or have a strong and relevant connection to the UK, their comments won't be published. And unless their objection somehow manages to provide an argument to counter the fact that all the BPS research was found to be low or very low quality evidence, all it will be is the academic version of a temper tantrum, as a lot of Fink's toys are taken away from him.
 
Nightsong said:
Is it common for non-British treatment centres to seek to involve themselves in NICE reviews? Looking at the CG53 table of comments and the stakeholder consultation comments from the 2017 10-year guideline update proposal - I see British charities and support groups, the Royal Colleges, PCTs/CCGs, NHS CFS services - but nothing from outside of the UK.
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I think that, the standard Government line is that, all responses (to the consultation) are considered on there merits. E.g. Bupesh Prusty contribute to the NIH Conference a few years ago so "outside" input is fine. However, the "concept" is that if 1 million people support a crap idea and 1 person suggests something positive/useful then you go with the 1 useful idea and summarise the million (politely - yes not a strength I have) as crap and therefore discounted. Inevitably politicians want to be on the right side and in some cases that can lead to decisions not purely based on the available data (swayed by the numbers).In this case my feeling is that the Government will want to disassociate themselves from this toxic mess (CBT/GET) - Government policy based on flawed publicly funded research -- ill people being ill treated (CBT/GET) --- would you want to be knocking doors looking for votes with that on your CV?

@Andy I gather there's been progress in Germany re centres of excellence (Charite + another) - if that's in the public realm then it might be useful to include in the response to the consultation. For me the obvious UK (centre of excellence - patient referral) choice would Julia Newton/Cara Tomas - Newcastle University --- other options are of course possible!
@Michiel Tack
 
Andy said:
I think anybody can send in a comment
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If that's the case I hope that people like those who signed @dave30th letter to the Lancet re the PACE trial retraction, who are not in the UK, have voiced their support for removal of GET/CBT and for the downgrading of all the 'evidence'.

Just to show that it's not just the 'vocal minority' of patients/patient organisations behind it as Fink and the most of the 'experts' at the SMC would have people believe.
 
Kalliope said:
Here's a google translation of the article in a journal for neurologists on Fink's reaction:
Professor shocked by NICE: Exercise helps ME patients

"I believe that the working group with the draft compromises the whole of NICE's credibility. It is a reputable and respected organization that works scientifically. But here there is no scientific evidence to reverse the guidelines to be the exact opposite of what has been recommended so far. There are large and thorough studies that document that graduated physical exercise and cognitive therapy have an effect on patients with ME or chronic fatigue syndrome. However, those studies disregard the NICE working group, as well as disregard two Cochrane studies, which clearly document an effect of graduated training and cognitive therapy , and that there are no significant side effects to treatment. ”

...

“I believe that there are some enduring perceptions that predominantly run in the rather closed ME / CFS environment, which consists of a few professionals and dominant patient associations. Here it is difficult to gain a hearing for scientific facts. It is therefore also deeply shocking to experience that an otherwise scientifically sound organization such as NICE is under such a strong influence from the ME / CFS environment, which represents only a small sample of the patient group - and typically those who do not is in treatment. The many patients we have helped have a hard time getting wording. The consequences of the recommendations to support patients in being passive are frightening, especially among children. The way in which the draft guidelines deal with the research results is on the verge of manipulation, and I completely do not understand why NICE will agree to this. ”

Per Fink states that the Department of Functional Disorders at Aarhus University Hospital will object to the proposal from NICE.
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The purpose on the review is guess what - to review the evidence. If there were well conducted reviews, e.g. with objective measures of improvement (activity monitors rather than questionnaires), then Per Fink should bring them to the review committee's attention.

The second paragraph, you quote, is worrying. OK there will be differences in opinion within the patient community/their families but to quote Jaime Seltzer (EDIT - MEAction) we know that this approach (Per Fink's - BPS) approach doesn't work so why fund it? That's the only thing that seems to have come out of the PACE study i.e. people did not return to their normal lives - the intervention failed.
 
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FMMM1 said:
I think that, the standard Government line is that, all responses (to the consultation) are considered on there merits. E.g. Bupesh Prusty contribute to the NIH Conference a few years ago so "outside" input is fine. However, the "concept" is that if 1 million people support a crap idea and 1 person suggests something positive/useful then you go with the 1 useful idea and summarise the million (politely - yes not a strength I have) as crap and therefore discounted. Inevitably politicians want to be on the right side and in some cases that can lead to decisions not purely based on the available data (swayed by the numbers).In this case my feeling is that the Government will want to disassociate themselves from this toxic mess (CBT/GET) - Government policy based on flawed publicly funded research -- ill people being ill treated (CBT/GET) --- would you want to be knocking doors looking for votes with that on your CV?

@Andy I gather there's been progress in Germany re centres of excellence (Charite + another) - if that's in the public realm then it might be useful to include in the response to the consultation. For me the obvious UK (centre of excellence - patient referral) choice would Julia Newton/Cara Tomas - Newcastle University --- other options are of course possible!
@Michiel Tack
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I'm a bit confused by this. NICE isn't the government. And what the US NIH does with non US researchers is irrelevant to the UK. As I understand it, NICE is a government funded independent advisory body set up to provide guidelines on cost effective treatment and care for the NHS.

As to suggesting a model diagnostic and treatment centre in the UK, I'm not aware of any I would recommend. From the little I have seen of papers on treatment Julia Newton has put her name to, if I remember correctly, they seemed very poor, involved exercise classes, and used Fukuda criteria. Cara Thomas is, as far as I know a lab scientist, not a clinician.
 
Trish said:
I'm a bit confused by this. NICE isn't the government. And what the US NIH does with non US researchers is irrelevant to the UK. As I understand it, NICE is a government funded independent advisory body set up to provide guidelines on cost effective treatment and care for the NHS.

As to suggesting a model diagnostic and treatment centre in the UK, I'm not aware of any I would recommend. From the little I have seen of papers on treatment Julia Newton has put her name to, if I remember correctly, they seemed very poor, involved exercise classes, and used Fukuda criteria. Cara Thomas is, as far as I know a lab scientist, not a clinician.
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Government policy is supposed to be "evidence based"; the review panel will be required to operate on that basis. I'm not involved in health policy (I work at a junior level in planning policy - devolved UK administration); but it's really beyond a stretch to say that the (NICE) guidance, which applies to the NHS, is not "Government" guidance.

I wondered if I should use the example of Prusty but it illustrates that Government entities (NIH) will, quite rightly, look internationally for options.

As for Julia Newton, I'm a bit disappointed to hear that i.e. exercise classes; however, I'm struggling to see a better example in the UK. Yes agreed that Cara is not a clinician but clinicians with good biomedical research teams seems to be promising - again, I'm struggling to see a better example in the UK.
 
rvallee said:
Well, GET is basically CBT + exercise. Same foundational idea of just ignore symptoms.
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Yeah, they're both focused on changing perceptions of the ability to engage in activity. CBT approaches that cognitively, with behavioral experiments to test out going further. GET approaches it by setting up activity experiments and using those as the basis for encouraging changes in cognition. Same overall process and concept of change but approached from different perspectives
 
Just seen that this has been added to the current guidelines, which can be found here, https://www.nice.org.uk/guidance/cg53
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) which we expect to publish in April 2021. We are also developing guidance on the management of the long-term effects of COVID-19.
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ETA: MEAction have an article on the change, https://www.meaction.net/2020/12/11/new-graded-exercise-warning-on-current-me-cfs-guideline/
 
Thanks for posting Andy. Super proud to have worked alongside a fab bunch of people at #MEAction UK to make this change happen, and for the many many people who sent us their stories along the way - I believe the 6-metre-long care we sent earlier this year genuinely had an impact on Helen.

Here's the whole email I received from NICE earlier today:

Hello Sian

I’m so sorry for the delay in replying to your email below, this was an oversight on my part so thank you for your follow up email.

Thank you for your positive feedback on the draft guideline.

I’ve discussed your email with colleagues in the Centre for Guidelines.

As part of the guideline development process, the committee still needs to consider comments submitted during consultation. Those comments, and the committee’s response, inform the final guideline and it is not finalised until this consideration has happened.

So, our position is that the published guideline remains in place until the new one is published. However, although it remains the case that the current guideline is clear that any course of treatment or management should be as a result of a shared decision after discussion of the potential benefits and risks, clinicians might want to consider whether, in light of the draft recommendations around the use of GET and pending publication of the final guidance, it would be appropriate to initiate patients on this treatment.

As a result of your email, we have amended the note on the overview page of the current guideline to highlight that the draft recommendations are now available, including those on GET.

With best wishes for a lovely Christmas,

Helen

Helen Finn
Senior communications manager (enquiries)
National Institute for Health and Care Excellence
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Andy said:
Just seen that this has been added to the current guidelines, which can be found here, https://www.nice.org.uk/guidance/cg53


ETA: MEAction have an article on the change, https://www.meaction.net/2020/12/11/new-graded-exercise-warning-on-current-me-cfs-guideline/
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Well now we know what two quarter-steps add up to: a half-step, unsurprisingly. For something that is a complete reversal of, well, everything, it's a very muted mumbling-don't-ask-me-I-just-work-here. Kinda like the CDC, just "clarifying" some confusion, I guess.

It's a meek mumbling in the right direction but there is no such thing as a smooth transition to full reversal. This is the exact opposite and the scam has been revealed for having been based on no credible evidence, as was pointed out endlessly, now that they were forced to go through a review. They screwed up and will have to admit it sooner or later. Might as well get on with it, it will happen regardless.

They really do not place patient safety or outcomes at any level in their decision-making, now do they? Egos and politics before lives.

Given that however I don't see how Cochrane can keep their reviews up. It's beyond indefensible at this point.
 
Statement from Invest in ME
NICE- DENY, DELAY and ACQUIESCE

So, a success for Invest in ME Research's persistence - but rather a ridiculous half-way measure by NICE - demonstrating what IiMER has been stating for years - that NICE really do not listen to patients or have the welfare of patients at heart.

This is not really sufficient.
It still leaves the recommendation for CBT in place - which we will not accept.
 
"Just seen that this has been added to the current guidelines, which can be found here, https://www.nice.org.uk/guidance/cg53.."


Good news with NICE now waving a clearly visible white flag. Well done to all who petitioned them!

LocalME and the 25% Group, (like MEAction, Invest in ME and Forward ME, together no doubt with may others) have been pilling on the pressure.

LocalME, as Stake holders, have been in dialogue with the Senior guideline commissioning manager - Centre for Guidelines (CfG) with a number of specific concerns and requests.

We were advised by email on the 9th of the decision to add the 'note', (which was on the website from the 9th.)

Senior guideline commissioning manager told us, 'There is a note on the webpage for the current guideline and we will shortly be updating this to include a reference to the draft guideline.'

Regarding our longstanding concerns about another arm of the NHS, NHS Health at Work, and their promotional literature for Occupational Health of GET CBT etc, the email stated,

'With respect to your concerns about the guidance from the Faculty of Occupational Medicine, ultimately their guidance is their responsibility and we are unable to comment further about it.'

Regarding our written concerns that NICE have in effect chosen to ignore Government long standing guidance on consultation arrangements and 'do their own thing', well, that will be a spat for another time.


It is a firm belief amongst our groups that NICE may have felt they were in danger of possibly being regarded as a 'rogue organisation' , shambolic at least and in danger of losing all credibility at worst.

They just keep on being caught out by poor process errors, disregard of proper practice and guidance.

1. In 2017 they were challenged on failure to review - a huge mistake as they had never assessed the 2007 guidelines against ensuing legislation, 5 notable Acts thereby breaching their own protocols.
2. They gave insufficient time for us to respond to the consultation in 2017 to which we made formal complaint and they had to reschedule and extend the deadline.


3. Most relevant and important, on November 25th 2020, they posted the following' https://www.nice.org.uk/news/blog/how-nice-is-improving-patient-safety

"How NICE is improving patient safety
Annual patient safety update covers the period from September 2019 to September 2020
Professor Kevin Harris, NICE's senior responsible officer for patient safety

The role of the senior responsible officer for patient safety was established to bring together strands of patient safety across NICE, providing a source of advice and oversight accessible throughout the organisation. Last week, the NICE public board meeting considered the my first annual patient safety update.
The board paper proposed NICE develops a unified approach to patient safety, integrating the excellent work already occurring in different parts of the organisation. It will build on existing structures and draw on the expertise of the Science, Evidence and Analytics Directorate to consider how new technology such as artificial intelligence could help detect patient safety signals more quickly in the future.

The work will also explore how patient safety at NICE can evolve and integrate with NICE Connect, our multiyear project which will transform the way we produce and present our guidance and the lives of people receiving care.
In view of NICE’s key role in supporting quality health and social care, a clear and accessible patient safety structure across the organisation will help improve not only our own patient safety activity, but also support learning and action in the wider health system. Patient safety is a shared value that reflects a central tenet of care: first do no harm….." (my emphasis)

Maybe the possibility of class actions for harms may have been in mind?
Maybe they are feeling the heat and do not wish the continued light to be shone on them?

At the end of the day, what will the NICE guidance bring?

What will it translate to if it's more powerful partners who hold the purse strings, NHS England and NHS Improvements fail to cough up for ME and CFS as a special case like Long Covid?
Will it provide any means to challenge the culture of wilful disregard and disinterest in ME and CFS at Local CCG/ Strategic Commissioning level? WHO knows!?
If Local Area Strategic Alliances and Commissioning have refused to put ME as a priority in their 5 year plans, I believe very little is likely to happen at all, as they will continue to prevaricate and stall as they have done for the last 16 years. ...... since the 2004 roll out of service, many of which have disappeared or changed for the worse.
Sorry if this sounds gloomy and pessimistic. David Tuller's conference for the Sheffield Group was excellent and essentially made many similar observations.
 
Further history/evuidene that NICE have form! - 2017 example

Consultation dates: 10 July 2017 (9am) to 24 July 2017 (9am)
* The Consultation breach has been resolved; NICE Enquiry (our ref EH82669) 11/07/17


I have had to challenge the NICE Consultation period 10th-21st July* and secure an extension; and have issued an FOI- to secure material information to inform my response. (which will not be made available within the necessary timeframe).
The provisional decision issued and now under consideration by NICE: may endanger compliance with the following NICE Terms of Reference (5 in the footnote below).
Having looked at the NICE website, I can see no evidence that the NICE process of review is in the public interest and complies with the transparency and openness required by the public who have a right to interrogate the NICE decision making and question any NICE guidance fitness for purpose.


5 https://www.nice.org.uk/Media/Default/About/Who-we-are/20140910-smt-tors-final.pdf
NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE

Senior Management Team
Standing Orders and Terms of Reference

Terms of Reference
Overview
1. constructing effective relationships with partner organisations and maintaining good communications with the public , the NHS, social care and local government and with the life sciences industries
identifying and mitigating the risks faced by the Institute.

and perhaps just as relevant today for the new guideline;


Furthermore, recent case law6 will require that NICE show due diligence to assess the need to review their decision making against any new legal benchmarking.

We request that either the guideline be revised to include the vital information now excluded, or that NICE develops a new surveillance report that directly addresses these ethical considerations in a way that reflects the organisation’s commitments to the ethical practices described in the NICE Social Value Judgments document.

6 The Montgomery case has changed the way in which guidance now needs to be given. NICE can no longer rely on only the best available evidence in their opinion, they have a duty to identify all risks and benefits.

https://www.supremecourt.uk/decided-cases/d/UKSC_2013_0136_Judgment.pdf
https://mdujournal.themdu.com/issue-archive/issue-4/informed-consent-a-year-on-from-montgomery
http://www.meassociation.org.uk/2014/07/forward-me-group-minutes-of-meeting-at-house-of-lords-25-june-2014/
 
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I think a lot of us realise a change to the NICE guidelines isn’t going to of itself result in some kind of root and branch overhaul of how people with ME are dealt with or not dealt with by the NHS @Suffolkres. It is about removing that particular excuse for not changing the status quo. Other roadblocks do exist and will need to be addressed through more advocacy. But if the guidelines had remained as they were the brick wall was extremely solid.

ps is there a link to a LocalME website?
 
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