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

Yep, Dr Fink has admitted to being a complete phoney.

 

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.

 

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.

 

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.

 

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

 

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.

 

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.

 

#MEAction

 

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.

 

Thanks!

 

Just talking to a doctor who was looking for CBT and GET services here like there are in the UK: was able to say they are no longer recommended in the draft NICE guidelines.

 

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

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:

https://twitter.com/user/status/1337464292644368385

 

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/