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UK academics view ME differently to US says NICE spokesman

Mark

Senior Member
Messages
5,238
Location
Sofa, UK
In some ways a review not until later in 2017 might almost be a positive.
We absolutely don't want a (hopefully soon to be published) peer reviewed paper on the PACE trial reanalysis to be left out.
Plus, if the rituximab trial comes out in the mean time, and is significantly positive, ...
In some ways more interesting than the patient results of a rituximab trial might be pre/post trial omics testing of responders and non-responders.
Thank you Roger, I've been wanting to make a similar point for a long time. It's a horrible gamble we have to take here, because as we all know here, lives are being lost and suffering and iatrogenic harm continues while the current guidelines remain in place. However, after the next review, whether it's in 2017 or later, how long after that will it be until the next review? And regardless of the real strength of the evidence, given what we know about NICE's values, how do we think they will assess the existing evidence if they reassess the guidelines some time in 2017?

My instinct on that calculation is perhaps a bit conservative, but I would personally want to wait until the Rituximab Phase 3 trial has been published in early 2018, and have NICE look at everything soon after that, because I think that will be a total game-changer. I also want to wait until there is as much peer-reviewed publication as possible re-analysing PACE based on the recently released data, because they can and will ignore the existing re-analysis because it's not on their radar as far as 'publication' is concerned (however brainless their 'evidence-based' approach may be).

I think the timing is key here. We have some really strong evidence on our side right now, but that evidence is set to reach standards that even NICE will find impossible to ignore within the next year or so. I'd hate to see them get away with ignoring it based on stuff like 'only one phase 2 trial' and 'not peer-reviewed' for the want of another 6 months of waiting - especially if we then have to wait another 5 or 10 years for the next re-assessment.

It's disgusting to be in this situation, because we know the kind of suffering that continues while we wait for a change in the status quo. But my feeling is that around about mid-to-late 2018 is going to be a much better time to require NICE to examine the evidence: with everything we have to present to them by then, I think the case will be so strong that I don't see how they'll be able to ignore it, whereas right now, I can see all too easily how they could brush it all under the carpet again.
 

RogerBlack

Senior Member
Messages
902
Thank you Roger, I've been wanting to make a similar
point for a long time. It's a horrible gamble we have to take here, because as we all know here, lives are being lost and suffering and iatrogenic harm continues while the current guidelines remain in place.
Has anyone come up with some numbers for the total number of people referred to various secondary services in the UK, and some idea of how they are actually attempting to treat CFS patients?
 

charles shepherd

Senior Member
Messages
2,239
The rituximab papers won't be published until 2018 I don't think, and knowing the politics, that could be a prompt for NICE bringing forward the date when they consider whether to remove ME/CFS from the static list. It's also possible NICE will be guided to keep the guideline on the static list pending the MEGA study, in the same way they previously delayed review to await publication of the PACE trial. The MEGA study would take years to yield evidence to warrant updating the NICE guideline so that would do nicely. These are just thoughts based on what's gone before.

Jo

As I've pointed out elsewhere on PR, NICE is not going to pay any significant attention to research studies and clinical trials such as the MEGA study or the proposal to carry out a small clinica trial of rituximab here in the UK where/when:

1 funding is not yet in place
2 protocols have not been prepared and agreed
3 PIs, locations etc have not yet been agreed and confirmed

To quote from a three page letter from Sir Andrew Dillon, Chief Executive at NICE, dated 26 September 2016, sitting here on my desk:

"CG53 (the NICE guideline on ME/CFS) is due for a 10 year review in 2017.

Yes, I can confirm that CG53 will undergo a full guidance surveillance review (in 2017).

The exact timescale for review has not yet been confirmed."

From the MEA patient evidence report:


heart-rate-monitoring-and-nice-guideline-for-me-3-638.jpg

http://image.slidesharecdn.com/hear...nice-guideline-for-me-3-638.jpg?cb=1447723929