2021: Communications between NICE and the S4ME management committee about the paused NICE ME/CFS guideline

The following letter was sent by email by the S4ME management committee to NICE to express our concerns and ask for clarifications about the 'pause' they announced to publication of the final version of the ME/CFS guideline.

* a few words have been removed from this copy which refer to sections in the final version of the guideline, to avoid breaking the embargo.

For more information and discussion about the pause and the upcoming roundtable meeting NICE has announced, go to this thread:
NICE pauses publication of updated ME/CFS guideline hours before publication was due - 17th August 2021
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To NICE
re NICE's pause in publication of the ME/CFS guideline and the roundtable meeting
from Science for ME (stakeholder)

We were concerned to receive the notification that the publication of the ME/CFS Guideline has been paused. We urge NICE to reconsider this decision and publish the guideline without further delay.

Science for ME wish to have a representative present at the roundtable meeting. Please provide clear instructions on the procedure for this.

Many stakeholders, both patient organisations and Royal Colleges, are membership organisations. Science for ME's submission to the draft consultation process was the result of extensive discussion among our members. In order for membership organisations to properly represent their members at the proposed roundtable, they should have the opportunity to consult their members on the basis of the final version of the guideline. This is not possible while it remains embargoed.

There are areas of the final guideline * that fall far short of being evidence-based, as we raised in our submissions. It seems reasonable to us that if patient organisations are invited to a roundtable they should be able to raise these issues, and ask NICE to provide the scientific evidence base for them, just as the Royal Colleges will, we understand from the media, be asking for evidence for the removal of GET.

If the aim is solely for NICE to respond to the objections of the Royal Colleges, it is difficult to see what role other stakeholders are expected to play in that process. It is not reasonable to expect patient organisations to argue NICE's case for it with so little time to prepare, nor is it reasonable to expect them to hold back their own reservations about the unevidenced parts of the guideline. There is also a real risk that such a meeting will be portrayed in the media as 'patients versus doctors', whereas it is in fact a disagreement between some doctors holding on to outdated and unevidenced treatments, and NICE.

If the meeting is to go ahead, we consider it essential that people with suitable expertise are present to put the case to the Royal Colleges. We urge NICE to include Professor Jonathan Edwards on this expert team at the meeting, and to enable him to present his expert witness evidence to the roundtable as he did to the guideline committee. He is in the unique position as a fellow of the Royal College of Physicians and an expert on clinical trials with detailed knowledge of ME/CFS research and patients' experiences, but without any personal or professional conflicts of interest.

Would you please inform Science for ME as soon as possible:
A. whether we will be invited to send a representative;
B. whether the final guideline documents will be published well in advance of the roundtable;
C. what the agenda of the roundtable will be;
D. whether attendance can be virtual.

Would you please answer the following questions, with reasons to justify the responses. We also think it incumbent on NICE to provide the answers to the following questions to all stakeholders at the earliest possible time, and that such information be made public in the interests of transparency.

1. What are the intended purpose and potential outcomes of the roundtable?

2. Will the final guideline, the final evidence reviews and the stakeholder comments tables be published in sufficient time for stakeholder representatives to consult their membership before the meeting?

3. Will all stakeholders be invited to send representatives? If not, on what basis will they be selected? Will a list of invitees be published in advance of the meeting?

4. Will the roundtable be held virtually? What accommodations will be made to make it accessible to people with ME/CFS? Will the meeting be recorded or, ideally, live streamed to those who are interested? Will written submissions be accepted from stakeholders for whom it is not possible for a representative to attend, and be read out at the roundtable?

5. Will an agenda for the roundtable be published in advance of the meeting so that attendees, and especially representatives of patient stakeholders who may not have the resources of the Royal Colleges, have time to prepare?

6. Will stakeholders be invited to suggest additional items for the agenda?

7. What is the intended role of the 'neutral' chair? Does the requirement for neutrality stem from the possibility they may be fulfilling a mediatory function? Who has been appointed to this role?

8. Is it a possible outcome of the roundtable that further changes will be made to guideline content? If yes, what is the basis in NICE's guideline procedure documentation for making alterations to the guideline at this stage? What further procedure would then apply before publication, i.e., would the guideline committee have to sign off any proposed changes?

9. Will NICE still publish the guideline if the Royal Colleges don't offer their support?

10. How does NICE intend to address the delay in publication of the guideline in their communications with the public and the media so that the media coverage does not wrongly place the blame for the delay on people with ME/CFS?

11. In which part of NICE's documentation on its guideline development and publication procedures is the 'pause' in publication of the ME/CFS guideline authorised?

12. Will NICE publish in advance of the roundtable a list of stakeholder organisations or other parties with whom correspondence has taken place leading to the pause in publication? In keeping with publication of the minutes for all guideline committee meetings, will NICE publish the minutes for all meetings relating to the decision to pause publication?

13. Given this delay in publication, for which the length is unknown, will NICE now place a clear warning on guideline CG53 that graded exercise therapy may cause deterioration in order to reduce the risk of further harms being incurred by ME/CFS patients in the interim?

14. What reassurances can NICE provide to the patient community to allay concerns about the implications of this pause in publication?

The announcement first of the pause and then of the roundtable, and the lack of clear explanations of the purpose, agenda and next steps has caused considerable concern to our members who are relying on the new guideline to enable them to access appropriate compassionate care. Given key medical professional groups have stated that they are willing to work with the final guideline, is it really worth putting so many very sick people through more months of lack of care and uncertainty?

We look forward to your swift response.

Science for ME Management Committee.
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An excellent letter. Thanks to all involved.

 

Well done!

 

Great letter, thanks to everyone for their hard work on this.

 

I am not well enough to be around the forum consistently and would like to thank you all very very much for this and everything that you do for the ME community.

Thank you.

 

A very well considered letter, many thanks for the time and effort that have clearly gone into producing it.

Hopefully you will be able to share NICE's response in full in due course.

 

Thank you all – that reads very well and the arguments are really clearly stated. Let's hope we get some answers.

 

Thank-you xx

 

Thank you so much for all your hard work! Brilliant!

 

Excellent letter. Well done and thanks to everyone who worked on putting this together.

 

This is an excellent letter - very clear and focused - thank you for the hard work that went into it.

Is there a signed PDF or scanned copy of the original letter available? I have secured an in-person meeting with my MP next week and if a copy of the letter is available, I will print it out and take it along with me.

Thanks again

 

Thank you. However I don't want to create more work - I can always just print out the text if a more 'formal looking' version under letter template doesn't exist.

 

Excellent letter, well done to all and many thanks for your continued hard work.

 

I second that.

 

Thanks to everyone for all the extraordinary work ye do on behalf of all of us. It is really hugely appreciated.

 

Thank you to our guidelines group for all your hard work, it must seem feel it is becoming endless, and thank you also for continuing to participate in the general activity of S4ME with the additional stress of monitoring what is said to whom and ensuring it does not breach the lurking embargo.

NICE really should clarify the current status of the embargo/confidentiality agreement, as said in the letter this is happering the ability of many in various groups to fulfil their roles and to act in the interests of their memberships/constituents (in the non political sense).

 

Much appreciated. Thanks all those involved for their work and determination.

 

Thank you for your dedication and hard work in producing such a well thought out letter.