IiME have just received this letter from NICE

[worldbackwards]

Interesting - is that the recovey and improvers data from Alem Matthees's FOI request (and subsequent analysis)?

Given that it hasn't been published as yet and seems unlikely to make the timescale, it seems more likely that it will be the LTFU. I wonder if NICE will be as happy to whitewash the null result as the authors were.

 

[Sasha]

In 2015 we were advised of 3 US reports that indicated there are likely to be changes in the diagnostic criteria in this field that will have implications for the guideline in the future, but not until after the proposed 2 year validation of the diagnostic criteria is completed. In view of these reports we have decided to commence a formal check of the need to update the guideline earlier than the 5 year interval. We have since been made aware of new information about the 2011 PACE trial, and we will also consider that in the review.

@charles shepherd, is it known what new information about PACE this refers to? If not, would you be willing to ask?

 

[BurnA]

Well that's terrible news. This review is coming too soon to include any of the gamechanging information which will appear in the peer reviewed literature at a later date such as the Matthees et al reanalysis of PACE, the Phase III rituximab trial and the cyclophosphamide trial.

I

Is this an actual review or a decision whether to review? If it is the latter, how long will it take to do a review which could affect the guideline?

I read this as a decision to review, not an actual review, would be completed by summer 2017.

But it's not easy to read.

I'd be hoping for a PACE reanalyses to be published before then but obviously rituximab results probably won't be published till 2018.

 

[Simon]

We have since been made aware of new information about the 2011 PACE trial, and we will also consider that in the review.

Interesting - is that the recovey and improvers data from Alem Matthees's FOI request (and subsequent analysis)?

Given that it hasn't been published as yet and seems unlikely to make the timescale, it seems more likely that it will be the LTFU. I wonder if NICE will be as happy to whitewash the null result as the authors were.

It could be LTFU, but as they said information, not research or a paper, they might still be referring to the FOI data release. The problem is that relates to recovery, and I don't think NICE based its recommendations on recovery rates.

(And though the improver rates were not those defined in the protocol, the mean gains for fatigue and function were exactly as published, and that was the basis for NICE recommendations, as I understand it. The bigger issue was relying on self-reports in an unblinded trial, and that was a flagged problem when NICE made its original recommendations).

 

[Mark]

I wonder if Phoenix Rising should apply @Mark ?

MEAction UK? Anyone/everyone else?

We briefly considered this a couple of years ago and I think the conclusion was that as a US non-profit we aren't eligible. MEAction UK might need to be a UK charity similarly, I don't know if they are. If anyone can confirm that PR is eligible we can consider it, although as always it would require that someone step up to be our representative on this and co-ordinate the work of members on the forums; we don't have the staff resources to take on any more work otherwise.

 

[Mark]

Yes, this is how I feel about it too. It concerns me that they could be concluding this a bit too soon, before we have more information. Will the phase III Rituximab trial results be known at all by closing? What about other developments? It could be that this leads in the longer term to more delay if they close on this too soon. It's felt recently that the British medical establishment, at least those who have been involved in or supportive of those hijacking this illness, have been circling the wagons.

Me three. It really seems to me that the time we want the guidelines reviewed is after the publication of the Rituximab Phase 3 trial. Immediately before that seems like the worst possible time. In theory, yes, Sasha's right that the guidelines can be scheduled for review whenever significant new information comes in. In practice I suspect that Rituximab Phase 3 may be seen as insufficient by itself to warrant a change of treatment recommendation because of the need for independent replication, and therefore insufficient to prompt another review of the guidelines when one has just taken place, whereas if it were included as evidence within the upcoming review the trial results would be likely to change attitudes and get a mention in the guidelines which could have a significant impact and force people to think more seriously. Very disappointing to me that our charities don't seem to have been advocating for the review to take place mid-2018. A major tactical error, I suspect.