PACE re-analysis and NICE guidelines

[Daisymay]

Where do the NICE guidelines stand if re-analysis of the PACE trial data show the benefits of CBT/GET are not as we've been told?

I think the correspondence between Professor Hooper and Frances Rawle in 2011 sheds some light on this. Professor Hooper had been corresponding with Frances Rawle about PACE. Frances Rawle was, and still is, Head of Corporate Governance and Policy at the MRC. She was also a witness at the tribunal for QMUL.

The excerpt below is taken from the article "Prof Hooper's Reply to MRC, Rawle 26 Jan 2011" which can be found in the catalogue of articles by Margaret Williams and Malcolm Hooper:

http://margaretwilliams.me/2011/hooper-reply-to-mrc-rawle_26jan2011.pdf


"You attempt to justify the MRC’s funding of the PACE Trial by stating:

"there was a lack of high quality evidence to inform treatment of CFS/ME and in particular on the need to evaluate treatments that were already in use and for which there was insufficiently strong evidence from random controlled trials of their effectiveness”.

That is a remarkable admission, since the NICE Clinical Guideline 53 of August 2007 relies upon the pre-PACE Trial “evidence -base” to recommend the use of CBT and GET nationally as the intervention of choice for ME/CFS, yet you state in your letter that there was insufficient evidence for the implementation of this nationwide programme of CBT and GET recommended by NICE in its Clinical Guideline 53.

In other words, on the one hand Professor Peter White was strongly promoting CBT/GET in his submissions to NICE because he asserted that there was sufficient evidence of their efficacy for their implementation across the nation, yet on the other hand he has received millions of pounds of tax payers’ money to carry out the PACE Trial because there was NOT sufficient evidence of the efficacy of the same interventions.

This can only mean that since August 2007 NICE has been promoting interventions and subjecting sick people throughout the nation to a regime for which insufficient evidence exists, a situation that raises yet more legal issues and ramifications, since the correct option for NICE pending the outcome of the PACE Trial was to have recommended the use of CBT and GET “only in research”, not to have issued recommendations for widespread clinical use when evidence of efficacy for those interventions was insufficient at the time the Guideline was published.

This raises the issue of exactly why the Guideline Development Group was so determined to implement nationwide CBT and GET on an insufficient evidence-base."

.........

So, if the PACE data re-analysis does not support the use of CBT/GET then there is clearly insufficient evidence for the NICE guidelines and they should be withdrawn immediately pending an expert review.

 

[Jenny TipsforME]

Well aren't the NICE guidelines up for review 2017? Could be good timing.

https://www.nice.org.uk/guidance/cg53?unlid=78446220201623143418

 

[Daisymay]

Well aren't the NICE guidelines up for review 2017? Could be good timing.

https://www.nice.org.uk/guidance/cg53?unlid=78446220201623143418

If, if the re-analysis were to show CBT/GET were n't beneficial then surely NICE would have to deal with this as soon as possibile for patient safety and legally.

 

[TiredSam]

Where do the NICE guidelines stand if re-analysis of the PACE trial data show the benefits of CBT/GET are not as we've been told?

I think the correspondence between Professor Hooper and Frances Rawle in 2011 sheds some light on this. Professor Hooper had been corresponding with Frances Rawle about PACE. Frances Rawle was, and still is, Head of Corporate Governance and Policy at the MRC. She was also a witness at the tribunal for QMUL.

If only logic and evidence was given more weight than policy, dogma and cost-saving, we'd have won the battle long ago. At least things are starting to move in the right direction now, but there will still be struggles, foot dragging and having to deal with mind-bendingly annoying entrenched positions ahead, whilst patients continue to suffer.

 

[Skippa]

So... Who does NICE have to answer to...?

 

[Invisible Woman]

So... Who does NICE have to answer to...?

NHS England I think.

At least when Prof. Baker of NICE agreed that there were issues with the NICE guidelines, he also said that he could do nothing about this as NICE now comes under NHS England. So all the work done by the Forward ME Group and Dr Charles Shepherd had to start again with new contacts with NHS England.

Earlier this year there was a meeting in which representatives from NHS England and NICE agreed they were aware of issues but seemed reluctant to do anything about it.

Sorry brain is struggling today, otherwise I would try to find some links. There's probably something on the ME Assoc website.

 

[TiredSam]

whilst patients continue to suffer

Sorry to quote myself, but I just realised that I inadvertently used the word "patients", which has been bothering me, because as I've said before, we can be called patients once we have access to medical care or treatments. What I meant to say was "whilst ME sufferers continue to be patient".

 

[user9876]

If, if the re-analysis were to show CBT/GET were n't beneficial then surely NICE would have to deal with this as soon as possibile for patient safety and legally.

PACE claim

Description : NICE affirmed guideline on management of CFS/ME
Geographic Reach: National
Policy Influence Type: Citation in other policy documents
Impact: NICE publically affirmed that the results of the PACE trial strengthened the evidence base for cognitive behaviour therapy and graded exercise therapy in its current (2007) guideline. Original guideline - http://publications.nice.org.uk/chr...lgic-encephalomyelitis-or-encephalopathy-cg53.
URL http://publications.nice.org.uk/chronic-fatigue-syndromemyalgic-encephalomyelitis-or-encephalopathy-...

I think it is worth noting that improvements were better with CBT/GET just much less than was claimed. This is to be expected given they are subjective measurements and CBT/GET try to change patients views on symptoms and the level of there illness. So the PACE team will claim there is effectiveness. The big thing will be 6mwt data and the fitness test data. I think the fitness test data will still be kept secret.

 

[Chrisb]

I wonder whether we have any members resident in Totnes. There seem to be a few from that sort of area. That is the constituency of Dr Sarah Wollaston MP. Dr Wollaston is Chair of the Health Committee of the House of Commons.

It could be no bad thing for a constituent to raise the matter with her.

 

[Amused]

PACE claim



I think it is worth noting that improvements were better with CBT/GET just much less than was claimed. This is to be expected given they are subjective measurements and CBT/GET try to change patients views on symptoms and the level of there illness. So the PACE team will claim there is effectiveness. The big thing will be 6mwt data and the fitness test data. I think the fitness test data will still be kept secret.

What's '6mwt' data.
Why would fitness data be kept secret? the Tribunal ordered data be released, so presumably if it was included in the FOI request, it would be released?

For me personally on the CBT arm - I do remember my number of steps walked and also number of up downs on the mini stairs both decreased during the Trial. I ended up giving up pretty much my entire life outside part time work and surviving, but that did ease some symptoms. So I can't remember, but I imagine on the questionnaires etc my physical function had got worse, my mood had got worse (grief from giving stuff up) but my symptoms had 'improved' though such improvement is relative. For me it was the lead carapace of exhaustion and other symptoms that descended a second or so after waking (giving me a second or so of feeling like a normal human being that was snatched away by teh carapace) eased a lot. Never got a baseline though.

 

[Amused]

I thought NICE was a political initiative that's been pulled somewhat. There's new Guidelines being created (some having waiting for almost decades for them) but there's not the money/ staffing to amend old ones? I have gathered that from MEA news in their magazine & online. But then again, I'm increasingly conscious I get muddled between actual reality and 'hallucinations' so I might be totes wrong on that....

 

[Daisymay]

If only logic and evidence was given more weight than policy, dogma and cost-saving, we'd have won the battle long ago. At least things are starting to move in the right direction now, but there will still be struggles, foot dragging and having to deal with mind-bendingly annoying entrenched positions ahead, whilst patients continue to suffer.

I agree it's still a real struggle but we need to use all the tools open to us to make those in power finally sit up and take action to protect PWME.

And I just think this was a significant admission from Frances Rawle which the ME community needs to remember and if possible use to help to speed up a review of the NICE guidelines or their withdrawal if the PACE re-analysis brings the original PACE findings into question.

If NICE were dealing with a drug for a disease, they simply wouldn't get away with recommending it as a treatment if there was a "lack of high quality evidence to inform treatment" yet that's precisely what they've done with ME and CBT/GET.

 

[user9876]

What's '6mwt' data.
Why would fitness data be kept secret? the Tribunal ordered data be released, so presumably if it was included in the FOI request, it would be released?

For me personally on the CBT arm - I do remember my number of steps walked and also number of up downs on the mini stairs both decreased during the Trial. I ended up giving up pretty much my entire life outside part time work and surviving, but that did ease some symptoms. So I can't remember, but I imagine on the questionnaires etc my physical function had got worse, my mood had got worse (grief from giving stuff up) but my symptoms had 'improved' though such improvement is relative. For me it was the lead carapace of exhaustion and other symptoms that descended a second or so after waking (giving me a second or so of feeling like a normal human being that was snatched away by teh carapace) eased a lot. Never got a baseline though.

6mwt - is the 6 minute walking test. That is how far someone can walk in 6 mins

The FoI request was for enough data to look at the main outcomes along with the 6 mwt data. The fitness data was not mentioned until a subsequent paper (although specified in the protocol) it was based on the up and downs that you describe as the mini stairs along with BMI to normalise it. The requested data was a minimal set and if I understood the judgement properly the 6mwt data was the most contentious from a privacy angle.

 

[Daisymay]

User9876 posted:

"PACE claim

Description : NICE affirmed guideline on management of CFS/ME
Geographic Reach: National
Policy Influence Type: Citation in other policy documents
Impact: NICE publically affirmed that the results of the PACE trial strengthened the evidence base for cognitive behaviour therapy and graded exercise therapy in its current (2007) guideline. Original guideline - http://publications.nice.org.uk/chr...lgic-encephalomyelitis-or-encephalopathy-cg53.
URL http://publications.nice.org.uk/chronic-fatigue-syndromemyalgic-encephalomyelitis-or-encephalopathy-..."

"Impact: NICE publically affirmed that the results of the PACE trial strengthened the evidence base for cognitive behaviour therapy and graded exercise therapy in its current (2007) guideline."

Yes it did strengthened the evidence base, but from what level, that's the critical issue.

Rawle admitted that the NICE guidelines evidence base prior to PACE was n't adequate to inform treatment so if PACE were to be removed from the equation on re-analysis, you are left with guidelines based on inadequate high quality scientific evidence as admitted by Frances Rawle, Head of Corporate Governance and Policy at the MRC .

"there was a lack of high quality evidence to inform treatment of CFS/ME and in particular on the need to evaluate treatments that were already in use and for which there was insufficiently strong evidence from random controlled trials of their effectiveness”.

 

[user9876]

I thought NICE was a political initiative that's been pulled somewhat. There's new Guidelines being created (some having waiting for almost decades for them) but there's not the money/ staffing to amend old ones? I have gathered that from MEA news in their magazine & online. But then again, I'm increasingly conscious I get muddled between actual reality and 'hallucinations' so I might be totes wrong on that....

I think NICE was a labour initiative to standardise treatments across the country because there had been a lot of complaints that treatment was a 'post code lottery' as in the treatment you got depending on where you lived. The idea of NICE was to take an evidence based approach to looking at what was cost effective and hence should be funded by all authorities.

Issues seem to come where treatments are proposed by acedemics who are also on the committees. i.e. things like CBT with ME but also things like psychosis.

 

[worldbackwards]

My recollection is that NICE published the guidelines citing that there wasn't good evidence at the time for CBT/GET, but that a major trial (PACE) was in the works which would clarify the situation. It seems to me that the intervention from Sharpe earlier in the week was designed to say "no, the results may not be so great but the treatments are still shown to be effective, more or less".

As such, it may be that, as long as they can show any effect, NICE will be prepared to back them, largely because PACE is the basket in which they've placed all their eggs and, with it's withdrawal, they would simply have to admit that they had no treatment and hadn't the faintest idea what they were doing with ME.

Much of the progression of CBT/GET has pretty much been to do with that fact that, as Sharpe says, it is "the only game in town". It may be a rubbish game where no one wins except the people who make the rules, where the players often leave the field severely injured, but the fact that they have suppressed the opposition for so long means that there is no competition. Health bodies simply take the path of least resistance. As such, CBT/GET is embedded in the institutional mindset of how ME is treated in the UK. This makes it very difficult to dislodge without proof of harms (very difficult to come by, however much we have experienced it to be the case) or a better treatment.

ME isn't treated in the same way as other illnesses, it never has been: expert opinion counts for far more than trifling matters like evidence or patient feedback. I suspect that the old boys club will continue to exert it's influence unless this blows up into a major scandal elsewhere (we can only hope). This, of course, is now more likely than it ever has been, though I'm still not holding my breath.

 

[Invisible Woman]

I think it's also worth remembering that there is a bigger picture in the UK.

The BPS ideology underpins the government's entire attitude to the benefits and welfare system. The idea being that work is beneficial and people should do what they can has been distorted and taken way too far. The reality has become that those who are ill should be continually pushed, regardless of how ill they are, into some sort of work.

PACE, in my opinion, was a flagship for this and hence the funding from the DWP. In the UK, there is so much more at stake than treatment of ME/CFS.

 

[Chrisb]

As I recall, but I often recall wrongly, NICE was always, or rapidly became, a sham. It was sold to the public as an organisation to ensure that no-one would be given outdated or ineffective treatment. It became the means for restricting unaffordable treatments.

Hence CBT and GET is all we can have. With no expensive tests.

 

[Amused]

6mwt - is the 6 minute walking test. That is how far someone can walk in 6 mins

The FoI request was for enough data to look at the main outcomes along with the 6 mwt data. The fitness data was not mentioned until a subsequent paper (although specified in the protocol) it was based on the up and downs that you describe as the mini stairs along with BMI to normalise it. The requested data was a minimal set and if I understood the judgement properly the 6mwt data was the most contentious from a privacy angle.

Oh I'm an idiot LOL. Overnight I thought oh 6mins walking test. Considering I actually DID them, I should have remembered it was for 6 mins. but I didn't sorry! and thanks!

 

[Amused]

As to the 6mwt data being the most contentious from a privacy angle - those CBT sessions I did were recorded. I NEVER want to hear them myself, never mind anyone else hearing them. It would be like re-reading some dreadful teen angst filled ancient forgotten diaries I'd come across in my loft *shudders* I don't remember much about them, but I do remember wailing a LOT about having to give stuff up! and I do remember getting through LOTS of boxes of tissues....