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

I think they vaguely reported that outcomes were the same for the subgroups meeting the different criteria. Not sure I believe them though, and they didn't show any numbers for it

 

They did, and I thought that they meant what they implied, but then, after the PACE data was released, when they reassessed the improvement figures and found that they were much, much less, they remarked that the result was still the same (i.e. that CBT did better than no CBT). That made me wonder whether, in the light of no actual information, there was a very distinct difference between the London ME group and the rest, but as long as the CBT group still did a bit better on the subjective assessments, they could remark that the effect was the same.

 

This would be ideal, but probably not possible because Oxford includes ME patients in its fatigue catch-all.

Yes, I think perhaps the strongest argument we can make against Oxford-based evidence relies on PEM being fundamental in identifying patients correctly.

To that end, there is a possibly helpful meta-analysis of the relevant literature by Abigail Brown, part of Leonard Jason's group, from last July, assessing whether PEM should be regarded as a core symptom. My current brain is not up to checking the analysis, but Brown concludes that

It is a thesis, so may or may not have been published in a peer reviewed journal, which is probably relevant for NICE to consider it, but the info is perhaps useful, and we could probably find out if necessary.

Good idea. The chances of getting any (reliable) information about the PEM status of those who opted in and out are probably approximately nil, though. Some of the authors of the relevant work are not exactly forthcoming with data...

 

I don't doubt there are patients who could be in both Oxford and PEM groups, but it's probably a small enough number than mean scores for the groups would still be different. It happens with symptoms and severity (from what I recall), so why not with biochemistry?

 

@Valentijn Yes, well I guess it would prove the point of how useless Oxford is, if that were to be the case.

 

Mark Baker said:
The existing recommendations are carefully nuanced and crafted to give power and choice to patients. The problem is, I believe, in the unthinking and ill-informed manner in which the recommendations are imposed on people for whom they are not intended and/or not suitable. To this extent, some clarification may be required prior to the completion of the new guideline.

I was struck by some of the stories at the workshop about the misuse of the current recommendations and the disturbing extent to which they are imposed on people who are unlikely to benefit from them and for whom alternative approaches would be sensible. However, scrapping the entire guideline now would be massively counter-productive as it would almost certainly result in the withdrawal of the already dwindling number of services available to people with ME. Therefore, a rather more limited approach would be required to protect what is good whilst modifying what may be harmful.

This looks seriously worrying to me. I wonder if Charles has seen it. There is nothing nuanced or crafted in the guidelines that is being imposed on people for whom the recommendations were not intended. They were intended. 'Some clarification' is not what is needed. Removal of recommendations based on valueless evidence is needed.

What alternative approaches are sensible for those unlikely to benefit, and which are they, if we don't think anyone benefits from these treatments?

Scrapping the reference to CBT and GET is not scrapping the guideline. Except that if it is thought that these are the meat of the guidelines then yes, that is what is needed. There is absolutely no implication of scrapping services since everyone has pointed out that we need more regular follow up and review for intercurrent or missed problems. As I understand it IiME is asking for a limited approach in which pretty much everything except CBT and GET is kept - i.e. the good bits.

This letter certainly gives the impression that Baker really has not understood that the old guidelines included seriously inappropriate material. There is a lot more work to do I think.

 

The idea that services would need to be scrapped sans CBT and GET pretty much illustrates the paucity of what is on offer for PwME. I suspect this is the stumbling block politically, in that if CBT and GET are removed, then there is not much left for the staff to do in most of the ME clinics, as it stands.*

Perhaps instead they need to actually do the sort of exclusionary investigations recommended by the MEA?

In terms of approaches, teaching good pacing would be useful.

Also, not an approach as such, but domicilliary services for the severely affected would be very helpful. Especially if it included OTs who understand ME and PEM, and so help rather than hinder (it's been surprising to me how much power OTs have over things like social care, in addition to their power to give or withhold useful equipment).

*ETA Meaning not so much that there is nothing that the clinics could do, but nothing much that they do do currently, other than CBT and GET.

 

If they were serious then they can link patients to services that may be available in their area, create legitimate guidelines for mild/moderate patients to hopefully prevent them overdoing and becoming severe, redirect money to legitimate researchers and even reconfirm the diagnosis and refer patients who are atypical (or improperly assessed) to other specialists to rule out other more treatable conditions.

I can't see anyone accepting treating terminal cancer patients with therapies that will cause unnecessary suffering just because there is no other treatment...

 

Yes, my post wasn't clear enough, I've added an edit, thanks. I don't think we're disagreeing. I meant that the current clinics don't actually do much except CBT and GET, as it stands now, so take that away, and they're out of jobs, and the NHS can't say they have services for PwME.

So the clinics need to pick up the slack on all the useful stuff they could be doing for us instead, as you say.

ETA Erm, just re-read your post and might have misunderstood you slightly...anyway, I think we agree. My brain is fried

 

Cool

One could easily argue what they do now is worse then doing nothing. Perhaps thats an article worth writing if someone can get it published.

 

I very much got the impression that the health professionals attending the stakeholder meeting are still stuck in this thought-warp. 'If we don't have CBT and GET we would have no treatment.' My suspicion is that the great majority of health professionals dealing with ME have not actually woken up to what the patients are saying. Certainly when I talked to my old department about a year ago nobody had even heard of PACE, let alone any patient discontent.

 

How would they react if you asked them why is a patient harming treatment superior to no treatment? I assume they would just deny it?

 

I'm not even sure I would want to see clinics "teaching" pacing. They will just call it CBT and we will be back to square one because the BPS crowd will run them claiming only they know how we should "behave".

 

Do we have any figures for how many OTs, physios, specialist nurses and psychotherapists are employed in the current NHS chronic fatigue clinics?

It seems to me that withdrawing CBT and GET as is necessary, and using those resources for useful services for ME, would require an major interim reorganisation prior to the 2020 new guidelines ( when drawn up) implementation.

Perhaps Mark Baker is starting to realise the size of the problem.

 

Presumably needing to study something that is strongly suspected to harm people is not unknown to science. It is obviously unethical to run a trial that deliberately puts people into harm's way, and as you say people would not volunteer anyway.

But is there not another approach? To study in more depth those harmful incidents that are suspected to have been caused by GET anyway? Maybe with a sort of forensic approach. It's presumably not unethical (provided the proper safeguards are put in place) to forensically analyse harmful incidents that have already occurred anyway. I fully appreciate it cannot be done under tightly controlled laboratory conditions, but if the will and the money is there, could not something like this be viable?

Edit: I do appreciate that animal experiments have probably been science's way round this dilemma to date, but probably not such a good idea now. Hmm SW, PW et al encouraging rats to run faster ... that sounds like a cartoon in the making.

 

Ah - but there is always MUPS and a plethora of other conditions for which CBT is being positioned as a treatment. No doubt an exercise arm can be added...

 

If GET and CBT are to be abolished for pwme, as they should, it will still require significant reorganisation as an interim measure.

It may just be simpler for Nice not to remove them.

Arguments about them being "nuanced and crafted to give power and choice to patients" are such rubbish that they have to have been 'crafted' to hide something.


EDIT: sp

 

I've not been able to keep up with all this thread, so sorry if I missed some comments.

I'm not sure how well judged some of IiME's comments were, and have some sympathy for Baker being in a difficult position, but I do find his new reply worrying: http://www.investinme.org/IIMER-Newslet-1801-01.shtml#IiMER-reply18-1

The problems with consent and CBT/GET rest very largely on the misleading claims made to patients about the evidence for the efficacy of CBT and GET. Being providing with misleading information, and then consenting to a treatment on the basis of that information, is not meaningful consent.

 

I suspect that these are most of the people employed in these services. Physicians or paediatricians will run assessment clinics in at least some cases but it may be that even this is done by therapists in some areas. Otherwise therapists are the entire staff.

In a way what PWME are asking for is a bit like asking the Roman Catholic Church to stop doing prayers or communion. It goes tot he heart of the ethos of the set up. ME services will be based on a 'multidisciplinary approach'. This involves the belief that by definition you need therapists of various sorts to deliver care. The advantage of the approach for health care professionals is that no one person takes any responsibility for what happens to patients and so it has become very popular.

So if CBT and GET are removed from recommendations the people providing services will just be bewildered and have no idea what to do. The logical outcome is that psychotherapists and physiotherapists become redundant. Instead you need someone who actually understands what is known and what is not known about the illness - and at present there seem to be precious few people of that sort.

So Baker is entitled to be cautious about making several hundred and maybe a few thousand people redundant overnight. But I think we need the debate to be transparent and based on a clear understanding of the real issues. Baker should perhaps have pointed out that such a major change in the service needs planning and proper consideration by an elected committee. He should not have suggested that making so many people redundant was actually a problem in itself.

It is very strange that when dealing with a drug treatment NICE is all for being strict about recommendations and seems keen to find opportunities to withdraw recommendations on the grounds of saving money, but when dealing with therapists it is frightened of making them redundant. This makes some sort of sense if it is perceived that these therapists are 'in house' and therefore the NHS takes responsibility for their security. But the NHS now runs pretty much on divided commercial lines. Service providers within the NHS bid for contracts just like pharmaceutical companies. So why would NICE preferentially want to protect therapists? My impression is that they have swallowed the story given them by the health professionals. I have a strong feeling that the penny's still not dropped that they are supporting a commercial scam, just as they did for homeopathy for so long.

 

Another thought. If an existing service is abandoned - it no longer exists. (Stay with me.)

Perhaps he is worried if he removes the CBT/GET clinics, then the funding for those clinics will disappear and it will be more difficult to re-instate the funding for a new ME service in 2020?