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PACE trial re-analysis and the 2007 NICE guideline on ME/CFS

eafw

Senior Member
Messages
936
Location
UK
If a widely prescribed drug had been shown to be useless (and was additionally known to cause harm) then it would be withdrawn overnight. This does, and has happened. If, in addition the marketing of said drug was given a boost by a corrupt and fraudulent study then the perpetrators would be called to account by the authorities.

What is the reason for the dragging of feet on throwing out the PACE/GET/CBT/BPS/MAGENTA alphabet soup of lies, stupidity and vested interests ? No reason if we're going on facts, patient experience and proper data analysis. But we're dealing with the politics of the thing, and what is most worrying is that those in authority (NICE, government, NHS etc) already know damn well that CBT/GET is no good, and that the PACE trail was rigged. And yet they kept pushing it, and still will as long as they can get away with it.
 
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charles shepherd

Senior Member
Messages
2,239
The simple answer to your very sensible question is that the mindset at NICE regards evidence from randomised controlled trials to be the dominating factor when it comes to preparing guidance on the management of a specific condition like ME/CFS

Patient evidence and clinician evidence comes right down at the bottom of their evidence ladder

What we have at the moment is robust and repeated patient evidence on the lack of effectiveness of CBT and the harmful effects of GET and an unpublished (in a peer reviewed scientific journal) paper that has identified serious flaws in the PACE trial

That is not enough to force a straightforward change of mind at NICE or NHS England

I will be discussing future action with MEA trustees when they meet on Monday 26th September

The Forward ME Group of charities will also be meeting in a few weeks time at the House of Lords with the Countess of Mar

And I'm sure we will be discussing how we should make use of the results from the PACE trial re-analysis in our discussions with both NICE and NHS England regarding revision of the NICE guideline

We will also need to consider what sort of political action may now be appropriate

Forward ME Group:http://www.forward-me.org.uk
 

medfeb

Senior Member
Messages
491
The simple answer to your very sensible question is that the mindset at NICE regards evidence from randomised controlled trials to be the dominating factor when it comes to preparing guidance on the management of a specific condition like ME/CFS

Can you help me understand how NICE will deal with the conclusions drawn in NIH's Pathways to Prevention and the AHRQ Addendum - e.g. :
  • The Oxford definition "results in a high risk of including patients who may have an alternate fatiguing illness or whose illness resolves spontaneously with time.”
  • Oxford should be retired because it can "impair progress and cause harm"
  • Once Oxford studies were excluded from analysis, the AHRQ evidence review addendum found was no evidence of efficacy for GET and barely any for CBT
Are they apt to just ignore those conclusions, especially the AHRQ evidence review addendum?
 

worldbackwards

Senior Member
Messages
2,051
Can you help me understand how NICE will deal with the conclusions drawn in NIH's Pathways to Prevention and the AHRQ Addendum - e.g. :
  • The Oxford definition "results in a high risk of including patients who may have an alternate fatiguing illness or whose illness resolves spontaneously with time.”
  • Oxford should be retired because it can "impair progress and cause harm"
  • Once Oxford studies were excluded from analysis, the AHRQ evidence review addendum found was no evidence of efficacy for GET and barely any for CBT
Are they apt to just ignore those conclusions, especially the AHRQ evidence review addendum?
NICE have never played any attention to international stuff before, I can't see them starting now.
 

Aurator

Senior Member
Messages
625
That is not enough to force a straightforward change of mind at NICE or NHS England

I will be discussing future action with MEA trustees when they meet on Monday 26th September

The Forward ME Group of charities will also be meeting in a few weeks time at the House of Lords with the Countess of Mar

And I'm sure we will be discussing how we should make use of the results from the PACE trial re-analysis in our discussions with both NICE and NHS England regarding revision of the NICE guideline.
I can already see the outcome of all our efforts to demolish PACE and make NICE and NHS England acknowledge there are grounds for change: they will drop GET (think of the cost savings!) and keep CBT - end of.
 

charles shepherd

Senior Member
Messages
2,239
NICE have never played any attention to international stuff before, I can't see them starting now.

Professor Mark Baker at NICE is aware of the conclusions in the NIH report

They add to the pressure on NICE

But as already noted, NICE has a massive workload

So when they do not feel there is compelling evidence to revise an existing guideline, this does not become one of their priorities…….
 
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adreno

PR activist
Messages
4,841
The simple answer to your very sensible question is that the mindset at NICE regards evidence from randomised controlled trials to be the dominating factor when it comes to preparing guidance on the management of a specific condition like ME/CFS

Patient evidence and clinician evidence comes right down at the bottom of their evidence ladder

What we have at the moment is robust and repeated patient evidence on the lack of effectiveness of CBT and the harmful effects of GET and an unpublished (in a peer reviewed scientific journal) paper that has identified serious flaws in the PACE trial

That is not enough to force a straightforward change of mind at NICE or NHS England
This is our main problem ATM. And this is why we need independent, peer-reviewed re-analysis of the PACE trial data.
 
Messages
2,087
But as already noted, NICE has a massive workload and revising existing guidelines, when they do not feel there is compelling evidence to do so, is not one of their priorities…….

I don't understand how they can "feel" there is no compelling evidence without actually looking at the evidence.

What does it take - mass protests or lawsuits from people harmed by GET. I think that would get their attention - why should it come to that, the evidence ( or lack of it in this case ) is there if they look now.

If this was a drug it would have been pulled immediately pending a review. This is pseduoscience we are talking about here, if ever we had compelling evidence for a review it is now.

The largest ( randomised ?!) clinical trial ever lookng at GET and CBT shows they have no significant treatment effect for ME.

That isn't ringing alarm bells ?
 

charles shepherd

Senior Member
Messages
2,239
Hopefully, one of the next steps following publication of this re-appraisal of data will be for The Lancet to accept that there is real cause for concern here and arrange (what they would regard as being) an independent review of the now conflicting findings from the PACE trial data

If this happens then NICE and NHS England will obviously have to take note of what is found

But if The Lancet decides that everything is still OK, and the PACE trial papers are fine, we are going to face a real uphill struggle when it comes to persuading NICE and NHS England that there is now a case to revise the 2007 NICE guideline on ME/CFS on the basis of this re-appraisal

Remember - the recommendations on CBT and GET in the 2007 NICE guideline are NOT based on the PACE trial findings. They are based on the York University systematic review of evidence from RCTs relating to CBT and GET at the time
 
Messages
2,087
But if The Lancet decides that everything is still OK, and the PACE trial papers are fine, we are going to face a real uphill struggle when it comes to persuading NICE and NHS England that there is now a case to revise the 2007 NICE guideline on ME/CFS on the basis of this re-appraisal

Remember - the recommendations on CBT and GET in the 2007 NICE guideline are NOT based on the PACE trial findings. They are based on the York University systematic review of evidence from RCTs relating to CBT and GET at the time

I don't see why the Lancet should play a role in this - they are responsible for this mess in the first place. Science is science, data is data regardless of whether the Lancet gives it the ok or not.

If a drug was shown to be harmful would everybody sit patiently until the Lancet got the finger out ? Are NICE claiming there is/was a link between autism and vaccines because the Lancet said so.

Second point is moot for reasons already discussed.
 

charles shepherd

Senior Member
Messages
2,239
I hope you appreciate that I'm just pointing out what might or might not happen next out in the real world!

If The Lancet maintains that there is nothing wrong with the papers they have published and it's time to 'move along - nothing to worry about' then this is the position that NICE and NHS England may also take as well

So I think it is important what action (or non action) The Lancet decides to take following publication of this re-analysis
 

adreno

PR activist
Messages
4,841
I don't see why the Lancet should play a role in this - they are responsible for this mess in the first place. Science is science, data is data regardless of whether the Lancet gives it the ok or not.
But isn't it the Lancet who ultimately decides whether to retract PACE or not?
 
Messages
2,087
I hope you appreciate that I'm just pointing out what might or might not happen next out in the real world!

Of course I do Charles.
I realise your answers are based on previous experience however that doesnt mean we the patient community have to accept that.

Every situation is different and warrants a new look. They cannot or should not continue to do what they previously did just becasue that's what they always did in the past. That is what we should be arguing.

ME patients are only too familiar with the real world despite it feeling very surreal at times.

Any campaign strategy should not be based on what you or anyone may think or expect might happen, it should be based on the principles of human rights, ethics, science etc.

If they chose to ignore these principles that is their decision but we should not temper our expectations or demands based on their flawed thinking.
 
Messages
2,087
But isn't it the Lancet who ultimately decides whether to retract PACE or not?
Yes, however the world doesn't stand still waiting for the Lancet to decide if something is statistically significant or not.

Retraction is obviously the end goal but we shouldn't have to wait around twiddling our thumbs while the Lancet waits another decade to decide what to do.
 

worldbackwards

Senior Member
Messages
2,051
Hopefully, one of the next steps following publication of this re-appraisal of data will be for The Lancet to accept that there is real cause for concern here and arrange (what they would regard as being) an independent review of the now conflicting findings from the PACE trial data
Does Richard Horton's behaviour imply that he is likely to do anything of the sort unless he is absolutely forced to?
 
Messages
2,158
My gut feeling is that this re-analysis will now lead to questions being asked at NICE and NHS England - but no immediate action as far as a revision of the NICE guideline. Part of the problem here is that NICE is overloaded with new guideline work and there is big reluctance to start fiddling with existing guidelines as well…….

Does NICE have a mechanism to fast track changes if, for example, a recommended drug treatment is withdrawn because of safety concerns?

Surely, however busy the NICE decision makers are, they would be able to amend or put an expression of caution on an existing guideline immediately, so doctors don't go on prescribing proven incorrect treatment.
 

aimossy

Senior Member
Messages
1,106
The NICE guidelines are not in the best interests of patients and therefore keeping the pressure on about them is important in my view. It is up there with one of the biggest problems we have.

I personally feel that when it comes to advocacy, organisations have their own inherent constraints in some elements of advocacy, so having patients doing their own independent advocacy and taking action themselves helps. I think this separate factions working on the same problem using different avenues is good and this means they can also (sometimes) compliment each other, whether they agree with each others actions or not.

Good examples are of Alem Matthees and Mary Dimock's independent work as well as MEAction protests and petitions. Patients themselves may be able to get something "opened up" with respect to NICE in some way which hasn't been thought of yet.

It is obvious there is major value in formal published papers of the PACE trial data showing that there is no clinically significant benefit of these treatments. Would that not possibly have some affect or bearing on previous findings that the NICE guidelines are based on? I haven't looked at the papers they are basing the guidelines on but would the new PACE findings possibly trump them in the value of the weight they have been given?
 
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