UK NICE guideline consultation open 10 July 2017 until Friday, 21 July 2017.

[Barry53]

They are also likely to use the line that something is better that nothing and that withdrawing the current recommendations of CBT and GET would leave patients with nothing and NICE exists to provide everyone with something . If they have some words on a peace of paper they will sign it off...job done!!

The 'best evidence' GET works is much weaker than the best evidence (verifiable case histories maybe) that it actively harms some people, possibly many to some degree. And because more research is necessary, at present *no-one* can know who is who, so no way to tell who will be harmed ... but a number most definitely will.

And saying patients are given a choice by NICE regarding acceptance of treatments, the crucial point is it's an UNINFORMED choice but (mis-)guided by BPS-ingrained clinicians.

 

[MEMum]

Just looked thro the list of stakeholders, counted maybe 14 that would definitely want a change to the NICE guidelines.
A lot more that would not.

Very oddly (or not, depending on how you look at it), Action for ME do not appear to be on the list?

I noticed that, but AYME are, so they will get info via their contact, as they have "merged".

 

[Large Donner]

The 'best evidence' GET works is much weaker than the best evidence (verifiable case histories maybe) that it actively harms some people, possibly many to some degree. And because more research is necessary, at present *no-one* can know who is who, so no way to tell who will be harmed ... but a number most definitely will.

And saying patients are given a choice by NICE regarding acceptance of treatments, the crucial point is it's an UNINFORMED choice but (mis-)guided by BPS-ingrained clinicians.

Correct but dont forget this is the British establishment we are dealing with here whereby, as great as free at the point of entry is in health care, we are dealing with an organisation (NICE) who is set up to say what treatments patients should get is government controlled. At the same time the insurer who pays for the "free health care" is the government purse and to round all that off its the government purse which pays for disability benefits using evidence from government paid GPS etc, who refuse tests, and often refuse to support your claim against the other, privately appointed by the government, contracted doctors appointed to assess you when you make a claim.

 

[Mark]

Is there any chance that PR could be included as a stakeholder? PR certainly represents loads of UK patients and European and worldwide ones whose health has suffered due to the adoption of PACE recommendations.
We could collate a summary of real science-based evidence of abnormalities in the physiology and biochemistry of people with ME.
I am sure many members would be happy to help and maybe @Janet Dafoe (Rose49) could add a quote from Ron!

What do members think? Anyone up for this @Tom Kindlon , @Mark , @JaimeS , @AndyPR ...@anyone else who's interested. Even if we are not registered stakeholders, I think it would be good to submit our views.

Last time I looked at this (when the same question was asked on the forums, I think), my rough impression (IIRC) was that as a US non-profit we probably wouldn't qualify, due to the list mentioning 'national' organisations (which I took to mean UK). However as Jo's post and subsequent discussion has clarified, as an organisation with an international remit we might perhaps qualify under 'Overseas agencies with a remit covering England'.

The question is moot in any case unless somebody has the time to organise our registration and any subsequent discussion and submission, because I certainly don't.

For what it's worth, my personal view (as I've said before) is that pressing for a review of the guidelines before mid-2018 (when Fluge and Mella's Rituximab trial should be available) looks to me like a catastrophic error, because that trial is the only potential game-changer as far as I can see and it's crucial for it to be considered in the assessed evidence base as soon as possible. If we do get a review just before RituxME is published, and then go back and ask for another review, well, good luck with that...we may be waiting many years...

PACE may be somewhat devalued currency these days (though there are still dinosaurs around that will dispute that of course), but the NICE guidelines pre-date PACE anyway and I don't see what aspect of those guidelines is realistically going to change due to the recent pressure on PACE (much though I think they should). NICE being obliged to take into consideration a successful Phase 3 treatment trial which carries the strong implication of an autoimmune etiology, however, would change everything - including the context in which the NICE reviewers will look at the PACE controversy and CBT/GET. They likely still wouldn't make a treatment recommendation for Rituximab at this stage, but at the very least I would expect that they would make some mention of it which would point readers in the right direction (e.g. "evidence for treatment with Rituximab or cyclophosphamide is promising but not yet solid enough for recommendation; there's only been one Phase 3 trial and more research is needed to understand who will benefit from this"...which many GPs who missed that news will read and say "wow, what?! so it's a real disease after all?!!"), and after having studied RituxME I think the reviewers would be far more likely to water down the wording of their comments about CBT/GET.

So just before RituxME comes out is the worst possible time to review the guidelines IMO...but that's just my personal view. I'm more than happy for members to organise a submission from PR on this (the board would have to approve it, of course), if there are people out there willing and able to do the necessary work.

 

[Barry53]

Correct but dont forget this is the British establishment we are dealing with here whereby, as great as free at the point of entry is in health care, we are dealing with an organisation (NICE) who is set up to say what treatments patients should get is government controlled. At the same time the insurer who pays for the "free health care" is the government purse and to round all that off its the government purse which pays for disability benefits using evidence from government paid GPS etc, who refuse tests, and often refuse to support your claim against the other, privately appointed by the government, contracted doctors appointed to assess you when you make a claim.

Precisely. I'm British and my wife has ME, so a real personal perspective here. Without the NICE guidelines being reviewed and then sensibly altered we are not going to get anywhere.

I'm hoping that next week's File on Four on BBC R4 might help reinforce the potential dangers of GET. If it's a decent piece of journalism then the timing would be excellent.

 

[slysaint]

I noticed that, but AYME are, so they will get info via their contact, as they have "merged".

Yes I spotted that..........but I still would have thought that at some stage AfME the biggest (?) ME charity would have signed up(??)

 

[Keela Too]

The timing of the submission window is VERY short for ME peeps to respond. We don't even know what format the response is to be made in? Will they ask questions we need to answer? Or do we just write our own thoughts on the issues?

How long are the windows usually for this sort of thing? Anyone know?

 

[Jo Best]

For what it's worth, my personal view (as I've said before) is that pressing for a review of the guidelines before mid-2018 (when Fluge and Mella's Rituximab trial should be available) looks to me like a catastrophic error, because that trial is the only potential game-changer as far as I can see and it's crucial for it to be considered in the assessed evidence base as soon as possible. If we do get a review just before RituxME is published, and then go back and ask for another review, well, good luck with that...we may be waiting many years...

I did wonder if this was behind the decision by NICE to consider whether a review is necessary at this time, i.e. get in quick before the results of the Phase III rituximab trial, and I wondered if we might see Esther Crawley's SMILE trial published just in time to provide evidence before critics would have a chance to submit an alternative conclusion.

That said, this initial stage is just to decide whether to review, and I don't know how long it will be between the decision and starting the review, but the review process may take between 12 and 27 months, according to the NICE manual, so this would allow time for publication of the Phase III rituximab trial, and it may be that NICE would consider the pre-publication results (from unblinding in autumn 2017) as 'colloquial evidence' or along those lines.

 

[Barry53]

The timing of the submission window is VERY short for ME peeps to respond. We don't even know what format the response is to be made in? Will they ask questions we need to answer? Or do we just write our own thoughts on the issues?

How long are the windows usually for this sort of thing? Anyone know?

@charles shepherd I imagine / hope the MEA is working in the wings on this for us. Are you able to enlighten us about what is happening?

 

[Jo Best]

The timing of the submission window is VERY short for ME peeps to respond. We don't even know what format the response is to be made in? Will they ask questions we need to answer? Or do we just write our own thoughts on the issues?

How long are the windows usually for this sort of thing? Anyone know?

Sally, bearing in mind this is just to decide whether to review and that they have posed this question in view of new information they had received, e.g. publications from USA and new evidence from the 2011 PACE trial.

That said, IiMER replied to NICE (see quote below).

If NICE decides to review, the review process could take 12 to 27 months.

“Thank you for the notification.

However, the two week consultation is only 10 working days and you state that we will be contacted once the consultation has opened.

Would it not be advisable to give advanced warning of what the consultation process will consist of in order that we may prepare the appropriate information?

You will be aware, perhaps, that a charity such as Invest in ME Research has many other tasks it is performing at this time and we would wish for NICE to have the fullest possible information available in order to make the very necessary decision that a revision is necessary.

We would suggest distributing relevant documents already before the consultation opens in order to give more time to those submitting information.”

 

[Jo Best]

I imagine / hope the MEA is working in the wings on this for us.

Barry, yes, all the ME charities will be working on this, it's been known for some time that NICE planned to decide this summer whether to review the guideline, and all the registered stakeholders will have received that letter that I copied here in the original post. Sorry, I should have considered it would be news to some PR members.
I've just tried to find previous threads on the subject (e.g. previous correspondence with NICE) to link to here.

 

[Barry53]

Only got access to my trusty iPhone4 at the moment so cannot easily check this. But I'm pretty sure the justification for reviewing the guidelines includes something along the lines of - if there is reasonable cause to believe the existing guidelines might cause harm. Only a rough recall of it, but the crucial bit was reasonable concern or suchlike, not hard evidence.

 

[Barry53]

Barry, yes, all the ME charities will be working on this, it's been known for some time that NICE planned to decide this summer whether to review the guideline, and all the registered stakeholders will have received that letter that I copied here in the original post. Sorry, I should have considered it would be news to some PR members.
I've just tried to find previous threads on the subject (e.g. previous correspondence with NICE) to link to here.

Thanks Jo. No, it's just me. Not so easy to check things before I post at the moment. The links would be great.

 

[Keela Too]

Thanks @Jo Best - Glad IiMER replied and asked about timing. Weeks around 12th July are also general holiday time in N.Ireland, so that's frustrating too.

 

[BurnA]

and it may be that NICE would consider the pre-publication results (from unblinding in autumn 2017) as 'colloquial evidence' or along those lines.

Just to point out,
this is not an option simply because there will be no pre-publication results.
Mella was clear about that.

 

[Binkie4]

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)32589-2/abstract#.WUytTm-ARM4.facebook

What a convenient publication date.

What an august journal.

EDIT:http://forums.phoenixrising.me/index.php?threads/getset-white-in-lancet-22-06-17.52402/

Just seen thread discussing this

 

[Jo Best]

Thanks @Jo Best - Glad IiMER replied and asked about timing. Weeks around 12th July are also general holiday time in N.Ireland, so that's frustrating too.

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)32589-2/abstract#.WUytTm-ARM4.facebook

What a convenient publication date.

What an august journal.

EDIT:http://forums.phoenixrising.me/index.php?threads/getset-white-in-lancet-22-06-17.52402/

Just seen thread discussing this

Yep! All 'perfect' timing!

Just to point out,
this is not an option simply because there will be no pre-publication results.
Mella was clear about that.

Thanks for that reminder, I was stretching the hope a bit there!

The 12 to 27 month time frame for a review allows for the published results to be taken heed of, so it will be interesting to see if NICE wants to hurry up the review process, and although NICE won't recommend rituximab on the basis of the Norwegian Phase III trial, it will be known that the IiMER UK trial is planned to start by the end of 2018, so it should at least be mentioned in the revised guideline and the fact that there is a UK clinical drug trial in the pipeline should be enough to ensure the guideline isn't put back on the static list (there I go hoping again!)

I'm quite sure we'll be stuck with the psychobehavioural 'options should be available to patients' as that's gone much wider than ME now, as we know, with the BPS, MUPS, Improving Access to Psychological Therapies, essentially 'no healtcare without psychobehavioural therapies' gravy train.

 

[Keela Too]

I wonder do we need to start using the phrase "psychiatric abuse" on a regular basis? Often the psych approach is just another means of patient blaming for issues over which the patient has no control... which is effectively abuse.

 

[Barry53]

I wonder do we need to start using the phrase "psychiatric abuse" on a regular basis? Often the psych approach is just another means of patient blaming for issues over which the patient has no control... which is effectively abuse.

Trouble is to me they are abusing their own profession by their unprofessional conduct, and thereby abusing their genuine colleagues. We know there are many good ones, and the BJPsyc for example seems to be trying to help set the record straight, by providing free access to papers; I think the BPS crew are proving to be an embarrassment to them all frankly. So no, I would just saying it is rogue psychiatrists engaging in psychological abuse, same as so many low life's the world over engage in.

 

[Keela Too]

Trouble is to me they are abusing their own profession........

Yes.. I think I agree. But if that's the case we need more psychiatrists speaking out against them, and loudly refusing to deliver GET and CBT programmes to ME patients. So far we are not getting that - or not getting it enough to make a real difference....