IiME letter to Mark Baker (NICE) re: CBT & GET as recommended treatments

Andy

Andy

Retired committee member
In short they are asking for GET and CBT to be removed as treatments before the review concludes in 2020.

Core of first letter
By removing the recommendations for CBT and GET from the existing guidelines now, with an addendum or correction of some sort, it could go a long way to establishing some trust in NICE from patients that was forfeited when the previous guidelines were published and the views of patients were ignored.

It would publicise the fact that NICE are responsible and would avoid future possible litigation from those adversely affected by CBT and GET in the intervening period before a new set of guidelines have been published.

The full review of the guidelines for ME will take time. There would be no excuse not to remove what is already known to be faulty recommendations.
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Core of Mark Baker's reply
As you are, I’m sure, aware the NICE guideline on ME/CFS was published before the PACE trial was seriously under way. Our recommendations were based on a body of research which preceded the PACE study. In our most recent review of the guideline, and cognisant of the controversies regarding the interpretation of the PACE results and methods, we assessed the evidence with, and without, the PACE results and the trial made no difference to the conclusions. Therefore, I cannot accept at this stage that reports of flaws in one study invalidate the results of all the studies in this area.
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And core of IiME response
t seems very strange that you can state categorically that NICE found no evidence to change the conclusions and, therefore, did not alter the recommendations of using CBT and GET for ME.

However, you are now aware that the NIH, CDC, AHRQ and IOM in USA are not only downgrading CBT and GET but have removed them from as recommendations.

Finland’s Valvira has also now removed the suggestion that CBT and GET be used for ME.

We have to state that we are somewhat shocked by your lack of action.

It is unfathomable why you continue to allow these recommendations for CBT and GET to stand.
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Link leads to, at time of posting, all three letters - http://www.investinme.org/IIMER-Newslet-1801-01.shtml
 
"What you must do, at the minimum we feel, is to issue an addendum to the existing NICE guidelines which states that not only are patients wanting to remove the recommendations for use of CBT and GET for ME but also that the USA agencies have removed CBT and GET from their recommendations. This will not only give some protection for your own liability but you could actually be saving lives."
 
A lot of the CFS GET CBT research outside PACE used Oxford or Fukuda criteria didn't it? neither require PEM and Oxford is awful. Unfortunately because the thinking behind NICE CFS is to keep things broad (hence their own broad criteria), they can then refer to broad fatigue studies as evidence. The whole approach is flawed. They have to start refusing to accept Oxford fatigue studies and, like IOM, recognise ME or SEID in a more specific and serious way.

Given that even their own research (was it Crawley ) is showing poor results for 'treatment ' with the more sick, complex cases it's pretty clear the loosing of ME in UK CFS has been disastrous for pwME who still have nothing beyond pacing (pathetic) and yet it's still going on.
 
Cinders66 said:
A lot of the CFS GET CBT research outside PACE used Oxford or Fukuda criteria didn't it? neither require PEM and Oxford is awful. Unfortunately because the thinking behind NICE CFS is to keep things broad (hence their own broad criteria), they can then refer to broad fatigue studies as evidence. The whole approach is flawed. They have to start refusing to accept Oxford fatigue studies and, like IOM, recognise ME or SEID in a more specific and serious way.
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I don't think that is the issue. PACE and the other preceding trials used subjective outcomes when the trials were open label and the chosen interventions aimed at changing how patients thought about symptoms. Thus the results they are relying on for NICE are unreliable. This is demonstrated by looking at the more objective outcomes which don't support the PACE results.
 
Same circular bullsh**.

CBT & GET were the treatments they wanted to inflict. There were some not great & rather subjective trials.

NICE were recommending CBT (PACE style) & GET, but the only evidence they had were rather poor trials. The PACE trial was supposed to shore up the previous body of work - it being such a great thing of beauty & all that.

Now PACE has come crashing down they are relying on the previous trials that weren't good enough in the first place.

Question: if the body of work previously provided sufficient, high quality, objective evidence then why spend £5 million (plus 250k on hiding the data) on the PACE trial?

So, forgive me, I'm brainfogged: you're now saying you spent nearly 6 million of public funds unnecessarily????

ETA I know NICE themselves didn't spend it, but they didn't object or in any way try to stop the expenditure
 
'As you are, I’m sure, aware the NICE guideline on ME/CFS was published before the PACE trial was seriously under way. Our recommendations were based on a body of research which preceded the PACE study. In our most recent review of the guideline, and cognisant of the controversies regarding the interpretation of the PACE results and methods, we assessed the evidence with, and without, the PACE results and the trial made no difference to the conclusions. Therefore, I cannot accept at this stage that reports of flaws in one study invalidate the results of all the studies in this area.'

This is disappointing to read after an encouraging meeting today. It is effectively doublespeak, as @Invisible Woman indicates. I appreciate that baker may feel he has to protect himself from everyone calling for this and that but i did hope we were a bit further along the path of constructive debate.

Who assessed the evidence and how come they came up with a positive recommendation if PACE adds nothing? The evidence is no better than homeopaths claiming that their treatment must work because they see it working so often - at least as far as I am aware.
 
'Therefore, I cannot accept at this stage that reports of flaws in one study invalidate the results of all the studies in this area.'

Point 1: PACE invalidates the results of all the previous studies because it has brought to the attention of people who know something about trial design that all the other studies have been carried out with methodology so poor that they are meaningless.

Point 2: Whereas previous studies may have given weak evidence for a positive effect of CBT and GET, as Kindlon (and others) has cogently pointed out, PACE actually gives strong evidence for no effect. Objective measures did not change. Recovery was minimal. Extended follow up at two and a half years showed NO BENEFIT AT ALL over the null comparator (not to be confused with a control).
 
Actually, now I think about this a bit more ......

There are controversies around PACE but I think everyone has gotten to the stage where they can see that PACE does add to the debate. It contradicts the previous studies because It pretty effectively shows there is no real benefit to CBT (PACE style) and GET.

So NICE are endorsing a treatment that, at best, does nothing. Now, surely NICE were set up to try to ensure that treatments were effective both in terms of cost and patient outcomes. NICE have been known to stop even relatively effective treatments on grounds of cost alone. So why endorse expensive treatments that are proven not to work ?

ETA crossed with JE's post and he put it much better anyway...
 
I thought I had fairies at the bottom of my garden. Then I paid a team to carry out a proper, definitive survey and they discovered that there weren't any. But that doesn't invalidate my first suspicions, so clearly there are still fairies at the bottom of my garden.
 
This is confusing and disappointing.
NICE stated today that:
  • They have made the decision to replace the Guideline in full, ie not try and update the old one
  • They recognise the need to start again as the current guideline does not resonate with people with ME
  • They are increasing the number of patient/carer members to 4.
 
Invisible Woman said:
Actually, now I think about this a bit more ......

There are controversies around PACE but I think everyone has gotten to the stage where they can see that PACE does add to the debate. It contradicts the previous studies because It pretty effectively shows there is no real benefit to CBT (PACE style) and GET.

So NICE are endorsing a treatment that, at best, does nothing. Now, surely NICE were set up to try to ensure that treatments were effective both in terms of cost and patient outcomes. NICE have been known to stop even relatively effective treatments on grounds of cost alone. So why endorse expensive treatments that are proven not to work ?

ETA crossed with JE's post and he put it much better anyway...
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And the real killer (perhaps even literally :() is it is about more than just treatments being ineffective, but in some cases harmful. I appreciate that the studies do not themselves provide solid evidence of harm ... but I would love to have more detailed information, including follow-up details, of those who dropped out, in case there was evidence in there.
 
Barry said:
And the real killer (perhaps even literally :() is it is about more than just treatments being ineffective, but in some cases harmful. I appreciate that the studies do not themselves provide solid evidence of harm ... but I would love to have more detailed information, including follow-up details, of those who dropped out, in case there was evidence in there.
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I remember @Tom Kindlon put a huge amounting of time and effort into going through the MEA survey about PACE and the people whose conditioned became worse because of it. I know he posted about it on other forums.

Also there is Tom's paper on the under reporting of harms in PACE. When I had a consultant mention GET to me I gave him a copy.That was the end of that.

Thank you Tom:thumbup:
 
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Allele said:
There is plenty of clear evidence of exertion harm from the Lights and I-forget-their-names-right-now who do the 2-day CPET/V02max test in California.
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Not sure it was available at the time or if it was I was unaware of it.

Tom's paper worked nicely ,thank you.

ETA - Unrealized that sounded a bit st after I hit the post button. Not intended that way. The thank you was,again, to Tom.

Also I needed to answer in relation to PACE 'cause that's what was being cited.
 
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Barry said:
I've been trying to find this out for myself but not having much luck. What is a null comparator please? And how does it differ from controls?
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Null comparator is my do-it-yourself term, for which I apologise. However, I am not sure that there is an official term and there should be. It is an indication of how much one learns from these discussions that I only really got the idea of the difference myself while thinking about the PACE problems.

As an example: I used to stain tissues with fluorescence-tagged antibodies to tissue proteins that under a fluorescence microscope showed exactly where the protein was with a beautiful green line or red blob (technically known as immunohistochemistry). A null comparator would be to look at a section without adding any antibody. And that was important because it turns out that some parts of tissues fluoresce without even putting any stain on. But if we were not sure that our fluorescent antibody was reliably specific for what we were looking for we would compare it with using other fluorescent antibodies that should give other patterns or no pattern because they were directed against other proteins or nothing relevant (often called an 'isotype control'; you used an antibody of the same isotype family to make sure that if there was non-specific binding you would get it with both).

So a control in science is a comparator (comparison with something else) that allows you to exclude the possibility that your test result is due to a non-specific aspect of the experiment. A null comparator is the simplest comparator where you are comparing with doing nothing. So the standard medical care in PACE is a null comparator. An adequate control would be a 'fake' therapy delivered by an enthusiastic fake therapy therapist with all the extra messages that went with CBT or GET. In simple terms a 'placebo' is by implication a control, whereas waiting list is a null comparator. There is a world of difference, which is why we have placebo controlled trials.
 
Invisible Woman said:
Not sure it was available at the time or if it was I was unaware of it.

Tom's paper worked nicely ,thank you.

ETA - Unrealized that sounded a bit st after I hit the post button. Not intended that way. The thank you was,again, to Tom.

Also I needed to answer in relation to PACE 'cause that's what was being cited.
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I sometimes forget to quote the bit I'm referring to, sorry; and I wasn't snarking either :)
(Except at the institutions that are supposed to be paying attention! :devilish:)
So when I said there was plenty of evidence above, I was responding to what Barry said:

And the real killer (perhaps even literally :() is it is about more than just treatments being ineffective, but in some cases harmful. I appreciate that the studies do not themselves provide solid evidence of harm
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I feel strongly that entities tasked with informing on important subjects ought themselves to be informed (and by this I mean the NICE people):bag:

I appreciate so much everyone here who is doing their job for them!
 
In our most recent review of the guideline, and cognisant of the controversies regarding the interpretation of the PACE results and methods, we assessed the evidence with, and without, the PACE results and the trial made no difference to the conclusions. Therefore, I cannot accept at this stage that reports of flaws in one study invalidate the results of all the studies in this area.
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Keith Geraghty's twitter posts today (c.4- 5 hours or so ago) are pertinent to this criticising some of the research supporting GET prior to PACE

eg



 
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