2005-2007 NICE CFS/ME GUIDELINE DEVELOPMENT GROUP meeting minutes

I got asked to put these online. Not had a chance to read them yet myself, but apparently there may be some final minutes missing, as apparently they could not be found.

They are numbered from 1-16, but I had difficulty getting them to attach in the right order. Sorry for any confusion.

 

And here are the final 8. Comments are anonymised, but at the very least they should give us more insight into how the process worked, and how we can more effectively engage with it this time around.

Apparently there are mentions of PACE within too.

Also - thanks a lot to whomever first got these. They look like they came via an FOI.

 

edit: I think I may have just replied to a deleted post!

That was published in 2007 and stated "Review Date: 2011"

It is still on-line without being updated, despite the fact that they were eagerly awaiting the employment outcomes from PACE (which turned out to show no improvement with CBT and GET).

"A large multi-centre RCT is currently under way, comparing these three treatments as supplements to medical care with medical care alone. The trial, “Pacing, activity and cognitive behaviour therapy: a randomised evaluation (PACE) will include work outcomes [43]."

Very odd.

 

This bit from the 250705 file is interesting:

So it would suggest that patient representatives cannot look at the studies, and are entirely reliant upon the interpretations by those with institutional or other access. I think this is a very big problem, as it effectively excludes all patient representatives from having meaningful involvement in the evidence review.

 

Thanks - that sounds terrible.

That is GDG02. For people wanting to read them in order, it is that numbers after GDG that go up from 01 to 16.

 

Another big problem is that they're assessing the evidence before defining the disease. Someone kept bringing that problem up, and apparently kept getting ignored. So Oxford studies are happily being applied, even though the NICE criteria ended up being vastly different from Oxford criteria.

Hopefully this time around there will be a definition of ME/CFS used, and studies can be excluded from consideration if they do not use similar recruitment criteria. The NICE criteria themselves aren't a bad starting point, since they sort of require PEM.

 

I disagree. I think Nice criteria were an attempt too keep CFS vague once Oxford was being discredited. It's the criteria of choice for Crawley. The last thing we need is Crawley type studies forming the basis of a NICE guide - bearing in mind as far as NICE are concerned the biggest exciting research on the horizon is FITNET. The PEF of NICE IMO is too vague and can be vaguely applied and basing studies on tiredness, poor sleep and extra tiredness on exertion IMO lets in dangerous exercise/CBT studies.

 

She blatantly omits PEM while calling it NICE. Should we omit CCC studies too, if she claims to use those criteria while not actually doing so?

 

Crawley makes it up as she goes along, including her various 'proxy' versions. How she gets away with it is beyond me........she seems to think that by 'asking the children' that makes it all ok.

 

I only very quickly skimmed one of the files, but I did get the impression that one of the patient members was being steamrollered.

Thanks to everyone who has started looking through these files.

 

Issues that have popped out to me:

1. Harm from GET

There are reports of the harm that GET can do throughout the minutes and the need to frame the advise to take this into consideration:


From minutes #4:

Discussion of GET article - This article doesn’t include that it isn’t suitable for everyone and that some people may get worse.
​

minutes #5

XXX cited figures of 95% of patients finding GET unhelpful. We need to address the issues of sub-groups of patients who this treatment may not be appropriate for. Patients should not be forced into this therapy.
​

minutes #13

Discussion based around various concerns regarding GET, its outcomes and associated harms. While it was pointed out that there is no evidence to suggest that GET causes harm, the group agreed that harm must be acknowledged because by not doing this, there is the potential to disregard some patient experiences.
Action
 Graded Exercise Therapy – To be re-drafted to include a number of issues including:
 Patient control.
 Anecdotal evidence of harms, benefits and risks.
 Positive self management.
​

minutes #14

GDG members Issues
 GET causes no harm – this is not true. Patient evidence says it does. But we do not have objective, published data on how often, how harmful GET is GDG member remarked. So suggest that this is added to the discursive section.

Commented that one of the things that is obvious, is that the language around CBT/GET is inappropriate
​

minutes #16:​

A member said that their only concern is with the GET section in the paper as it doesn’t say what the exclusions are. The NCC PC project team confirmed that the inclusion and exclusion criteria are included in the York review which is an Appendix to the guideline.
The member of the group also added that the statements should state that the trials were done on mild and mild to moderate ambulant patients. Another member said that it should not be underplayed that the trials included CFS patients​

A member said that the guideline must acknowledge that some people will be made worse following a GET programme. Another member said that if the guideline gives a message that it has significant risk, patients won’t be offered GET. In addition, there are already a number of caveats in the guideline. It was agreed that something should be included in the guideline that says that the GET is not appropriate for someone who does not want to partake in GET (after appropriate explanation).

Another member said that they are concerned about aerobic activity and people need to be made aware of the concern. Another member said that it is overly optimistic and does not give an explanation that it can be harmful. They added that the guideline should give the pro’s and con’s. A different member of the group said that the group has to be careful to put recommendation like that, when there is good evidence for the recommendation. Recommendations are not made like that for other conditions and pro’s and con’s have to be qualified with the strength of evidence.

A member confirmed that the RCT’s show no evidence of people getting worse. A member of the NCC PC project team asked if there are documented alarm bells for GET. The member confirmed that they had not had any problems with the programme.

A member asked what the dropout rates are. Another member responded saying that there are dropout rates in the RCT trials but there is not follow up information on why they left the trials, whilst 3 of the RCT’s used the Oxford criteria. A group member added that the drop out rates are documented in the trials and the RCT evidence suggests that people with CFS/ME are likely to get better rather than worse. A member said that there is evidence suggesting harm.
It was agreed that the NCC PC project team should redraft the section.
​

​

The purple text is relevant to a number of other threads on the forum where people taking part in the PACE trial said they had reported they were getting worse to the team running it. Although PACE was not published at this time it looks like they were using information from it. So this must be that no harms were reported from other trials - is this the case? ​

​

2. They are using data from the PACE trial even though it has not been published.

I'm sure I have read somewhere that for a particular type of research to be considered there needs to be two publications giving the same results and that they have to use published research.

from minutes #10

Envelope theory is about being constantly below maximum capacity. Pending the publication of the PACE trial, we ought to make a recommendation which can be amended in future.​

 

http://www.brame.org/contact2.html

Patient representative to NICE 2007, Tanya Harrison. Her statement about the NICE process and her resignation,

edit. Tanya made all the vital points a full 10 years ago. NICE ignored all of them. Do we really have more years/decades to waste trying to get a decent non damaging Guideline out of NICE? NICE comes across as a grubby dodgy little org which cannot be trusted to organise a car boot sale, imo.

 

"Just one example of this is GET; the question posed by the York team looked for papers on ‘GET and ME/CFS’, it did not however search for papers on ‘Exercise and ME/CFS’, and this meant that the many papers showing the potential harm of exercise on the bodies of people with ME/CFS, and that people with ME/CFS react adversely to exercise were not picked up, and no matter how many times I brought them up in the meetings, I was told that the scope of the guideline meant that they could not be discussed, creating a slanted view on exercise and ME/CFS, with only the papers on GET being able to be discussed."

"

• That any recommendation of CBT is based on flawed research, and goes against patient, and research, evidence:
  • That the MRC neuroethics committee has expressed concern about CBT, and states that harm has already been caused.
  • That the majority of patients find CBT unhelpful/harmful, and that person-centred counselling, is the more acceptable form of help in coming to terms and coping with this life changing condition.
  • That ‘illness beliefs’ have no place with this condition. ME/CFS is a debilitating and chronic organic condition – you cannot ‘believe’ yourself better.

• That any recommendation of GET is based on flawed research, and goes against patient, and research, evidence:
  • There are multiple research papers showing that people with ME react adversely to exercise, and that increasing the cardiac rate, in particular, is extremely dangerous.
  • That patient evidence has shown that the majority of patients find GET unhelpful/harmful, with more than one patient survey showing over half of patients undertaking GET are made worse.
  • That patients find pacing activities to be the more helpful approach to managing their condition."
  
  "I fear that when this guideline comes out, I, and hundreds of thousands of other patients, will be worse off. I have already heard that the few bio-medical clinics in this country, run by the NHS, will probably become psycho-social therapy centres following this document, with no follow-up care or monitoring for the severely affected."

 

In 2005 to 2007 NICE released a series of Guideline drafts, I cant remember how many, 3, I think. After each draft there was opportunity for patients and advocates to make online responses to each draft. Charities and some informed advocates and patient groups made extensive and detailed responses to the drafts.

It was during that process that Peter White and Barts made the now notorious recommendations that patients should not have mobility aids, and other monstrous recommendations.

So although there were only 3 patients on the GDG, NICE was provided with a massive amount of informed patient and advocate feedback to the draft Guidelines, but chose to ignore the bulk of it and recommend cbt/get.

 

This time it may be different - there is more exposure of how things are discussed and more public sway - they wouldn't have even gone ahead with the update if it wasn't for public opinion.

 

I think the difference now is that patients are ready to riot if NICE keeps playing games with our lives.

There's also been a lot more evidence disproving the efficacy of CBT and GET, and some (additional?) large patient surveys of their harms. A lot of work has been published regarding the flaws of PACE, and that's taken a big chunk out of CBT/GET's reputation in the process.

The 2-day CPET has also come along in the mean time, as well as a lot of other biomedical findings, meaning it's going to be really damned hard for anyone to pretend they have a good reason to treat ME as being psychosomatic.

 

Crucially, some very well known and respected scientists have become aware and spoken out. It's not just patients anymore.

The scientists, doctors and institutions who continue to back CBT/GET for ME/CFS will have to face the criticism of their international peers. The old school tie club won't be able to protect them anymore.

 

I think it's possible NICE, or the committee, will try it on. But I agree with the comments that we are in stronger position for the reasons mentioned. I hope it's strong enough, I'm guardedly optimistic. I think it's also possible that we might see an improvement in the guidelines but that the BPS players may be protected to some degree as they serve a useful function.

 

It would be good if someone (!) wrote an article on how the guideline was conducted last time and include all of the stand out bits including patients resigning etc.