The draft scope for the NICE guideline on ME/CFS is now out for consultation, June 2018

Dear All, here is a draft of the VIRAS response to the NICE draft scope. I would be glad to hear if patients/advocates have any objections as I am not entirely up to speed with the M.E. situation, though I note that in recent news that in some other European countries there is a disturbing drive for GET and CBT and they are not going away.
http://counsellingme.com/VIRAS/VIRAS_NICE_ME_Draft_Scope_comments.html

 

Thanks, Peter, and welcome to the forum.

I wasn't familiar with VIRAS, but it's 'Vector-borne Infection - Research, Analysis, Strategy' and on its home page it says:

VIRAS is a non-profit group comprised of patients and professionals with knowledge and experience in Lyme borreliosis and coinfections, Myalgic Encephalomyelitis (M.E.) and Chronic Fatigue Syndrome (CFS).

Our members are qualified and experienced in science and research, ethics, biology, psychology, psychotherapy, teaching, business and media.

VIRAS group objectives are:

> Improved testing and diagnosis of Lyme borreliosis in the UK

> Campaigning for testing, diagnosis and treatment of other vector borne infections, e.g., bartonella, babesiosis

> Campaigning for the identification and proper diagnosis of some of the tens of thousands of undiagnosed cases of Lyme borreliosis - particularly among misdiagnosed M.E. and 'CFS' patients where there is significant symptom overlap

> Analysis and comment on published research

> Analysis of public health policies and campaigning for changes which help patients and physicians​

 

There's a huge issue with the outcomes in the scope: they're all subjective. I think you noted that this section is satisfactory, so you may wish to amend that. Including subjective outcomes solely will result in more GET and CBT.

 

Dear @Peter Kemp,
Everyone is entitled to submit comments to NICE on this but are you sure that your comments will be in the interests of people with ME?

You say:
Sources indicate that the NICE scoping meetings were encouraging, that NICE staff were keen and motivated towards producing a good guideline. All very positive and heart-warming. However, the draft scope shows that either the NICE staff are ignorant of the vested-interests and stratagems used on M.E. and CFS patients, or are accomplices in a subterfuge. Either way, the end result is the same. Patients and doctors are being bamboozled into believing that with a new NICE guideline, things will change for the better. The reality is that the only change that might happen, is greater restriction on the prescribing of GET and CBT. Other than this, NICE are planning a guideline for an heterogeneous collection of 'fatigue' patients, which at best, will leave M.E. patients exactly where they are now - victims of social and medical neglect and discrimination.

Yes, those of us who went to the meetings were moderately encouraged and achieved some rapport with Peter Barry, the guideline committee chair, and other NICE staff. It sounds as if nobody from 'VIRAS' was there? So everyone who was there is likely to take the above comments as fairly ill-informed - including the committee. I agree that the only likely positive outcome is removal of CBT and GET from the guideline but I do not see much justification for anything else to be honest.

I strongly suspect that your comments will simply annoy the members of the committee and to that extent may well weaken the case that has been painstaking put forward by ME advocacy groups like this one. Is that a good thing?

If the idea is to restrict the guideline to ME and abandon other illnesses that involve fatigue then I am not clear why Lyme disease is relevant, since it is presumably 'just another disease that involves fatigue'?

It would be good to know who VIRAS really consists of. I am afraid that as something of a cynic it sounds like either a commercial pressure group for selling Lyme tests or a single blogger.

 

I've been corrected by my better half:

When done well, it should be a description of what is best practice worldwide. They should be taking into account what is done elsewhere in the world.

But not necessarily in the UK. It can be used to push for things not currently available in the UK to be made available.

Apart from TAGs (technical appraisal guidelines - usually applies to drugs mostly). Although that may change, after an orbiter in Rose v Thanet CCG, which argued that it was wrong not to follow non-statutory NICE guidance.

 

I don't quite follow this @Lucibee. What is not currently available in the UK is pretty much defined by what is not in NICE guidelines. It could also be something not licensed in the UK but I am not aware of NICE ever being used to exert pressure on the Medicines Control Agency to get something licensed. NICE is basically about 1. saving money and 2. standardising the use of what is licensed.

 

By "things", I wasn't necessarily referring to drugs (medicines). NICE guidance is about more than drugs.

 

Thank you Jonathan and others who replied. It is for the very reason that I want to be sure that the VIRAS response is in the interests of PWME that I made our comments public before submitting them, so that I could get some feedback. Thus far cautionary feedback is far outweighed by supportive comments but all feedback will be taken into account before we go ahead with our submission.

I (with my own name) have been writing about M.E. on various groups, including probably around 100 posts on CoCure over the past 20 years (they are still there). The only other member of VIRAS who is publicly named the co-founder member, Denise Longman MSc, who like myself, is a long time M.E. and Lyme campaigner. The other 9 current members include medical professionals who for reasons that I hope that I do not have to explain, are wise to remain beneath the radar.

VIRAS do not sell anything, on the contrary, over the past 12 year I personally have spent thousands of pounds (which I might have spent on other things and which one day I might sorely miss) and countless hours on research into Lyme disease: http://counsellingme.com/microscopy/introduction.html

As mentioned in our feeback, VIRAS were stakeholders for the NICE guideline and we know fairly well how it works. NICE staff certainly seem well meaning, but IMO they are also ignorant and incompetent. The guideline committee for Lyme disease was easily manipulated by one 'expert' and a chairman who ate out of his hand, the product was a disaster for doctors and patients.

Annoying NICE staff or anybody else for that matter is of no moment to me. I would not go out of my way to do it but neither would avoid it from fear of annoying people, people get over being annoyed, they do not usually get over M.E. Unless I hear a credible argument about why a single set of stakeholder comments annoying NICE officers, will weaken the case of others, I do not think we should change our stance. Personally, I like to see a range of opinion, including those that are challenging, passionate or cool. Do you think that the VIRAS comments were not written 'painstakingly' as your remark suggests to me?

The pending stakeholder comments are the last chance that patients and groups have before the structure of the guideline is set. That is how it works. Once the final scope is written the only opportunity that anyone will have to comment will be in the stakeholder consultation for the draft guideline. At that point, NICE will acknowledge all comments, but will respond only to those which they choose to and ignore the rest. That is the extent of peer-review as utilised by NICE.

Re Lyme disease. It is not just another disease that involves fatigue. It is another disease with a virtually identical symptom list, including PEM, and is therefore easily misdiagnosed as M.E. Differentiating Lyme from M.E. is so difficult that the RCGP asked NICE to provide advice on this but NICE did not respond.

I look forward to reading any reasoned arguments (they don't have to be painstaking) to withhold the VIRAS stakeholder submission.

Thank You,
Peter

 

Dear Adam, I think you have a good point and I will add: return to employment or studying, (or increase in work/study hours per week), transferred off sickness benefits, resumption of pre-illness activities and sports. If anyone can think of others, please let me know.

 

The big one is steps via actimeter. Lots of people where Fitbits now, so it's very easy to track.

 

I agree but things that are not drugs are by and large just as 'available' in the UK as anywhere else, other than to the extent that NICE does not recommend them. There may be hi-tech things like robot-controlled surgery or proton beam therapy not available in the UK but mostly it is just a matter of the penny pinching making provision slow and miserly. I guess in theory there might be something for which there is evidence of efficacy but where NHS service providers were not up to speed on that and needed it pointing out that they should be providing it but that is pretty rare in my experience. It is pretty much always NICE that drags its feet in those situations.

 

I think there is also the problem of displacement or normal physical and cognitive activities to do the steps even in the long term. I would like to see something like crash severity and frequency measured alongside steps and heart rate activity used to give context.

Being mild, I can do steps at 5000 per day if I have the time to do this in small slow bursts during the day with no other challenges (like working on a desk job that drains me cognitively)

However if those same steps are split in 3 walks then I will crash, have a low period then can resume so I could be in a push crash cycle and say average steps down to around 3500-4000. The severity of that crash would be dependent upon briskness of walking pace, whether it was cool or hot outside or whether I had just done something physical (like a shower) just before and my heart rate was raised before I went out on the walk. There are many other factors.

If I work full time in a cognitively demanding job, deskbound apart from a couple of trips to the loo, and in a cool air conditioned office, then I can manage this with a low frequency of crashes and my steps would be 1800-2200

So my steps could vary from 1800 - 5000 per day depending upon how I was managing things.

Looking at steps alone wouldn’t give a very precise picture at all because there are many different contexts to those steps...it has to have some other measure.

The problem with crash self reporting is it will be subject to bias. If this is completed every day though for a long period of time (like a year) with a simple linear scale then I suspect that bias would be less important since its being used as a comparative measure. It also has a non subjective primary measure alongside.

What is apparent for me though is that heart rate zone activity is a far superior measure than steps since it encompasses a fuller picture of physical activity.

You then have of course the knotty issue of cognitive exertion to deal with, but I’m not sure how that could be captured as data to analyse.

I think we have to tread with caution with a 2 day CPET due to it being a snapshot measure in time that won’t have the context as mentioned. So you would need to do a lot of these to get a trend.

It’s also a test that will crash the patient on purpose ...I have a problem with doctors doing this from an ethical point of view, particularly in the context of harm...but I recognise that we do need something biological (perhaps that where a marker comes in?)

 

Dear @Peter Kemp,

Thanks for the detailed response.

Let me take your points in order, for simplicity. I do not understand why medical professionals advocating for patient groups should want to be anonymous. There are lots of us, including myself, Charles Shepherd, Nigel Speight, Luis Nacul, Chris Ponting, Stephen Holgate, William Weir, etc. very happy to say who we are. I agree that there is an issue for junior professionals who are also ill but those who have chosen to make themselves known, like Keith Geraghty, have actually done well out of it.

I agree that NICE staff appear well meaning and in some cases ill-informed and maybe not up to the task. NICE has certainly made a lot of mistakes in the past. But I think annoying those involved in the guideline committee may be a serious mistake. We have had lengthy discussions about this but a lot of it may have been on a private thread set up for people attending the meetings.

The current guideline re-assessment was set up specifically because people like Charles Shepherd had convinced NICE that the recommendations for CBT and GET needed reviewing. As far as I can see removal of these is the only thing that will make a material difference. NICE guidelines are not about defining diseases or 'disease recognition'. They are instructions for doctors about practical management of ill people. Since there are no specific treatments other than CBT and GET for which there is useful evidence of efficacy there is nothing else of relevance to ask for. (The service is collapsing because the NHS is collapsing but that is not going to be dealt with in this guideline.) Moreover, since the evidence for CBT and GET is no better for people without PEM there is no need to focus on PEM as a determinant of treatment other than the obvious point that it makes sense not to push exercise if you have PEM.

So, the committee is a group of people brought together with the purpose of deciding whether or not to remove CBT and GET recommendations, which most people with ME seem to want to happen. If a group of people have it in their power to do something you want you do not annoy them. It is as simple as that.

More specifically, last time I made a guess at this I reckoned that there is a 40% chance that the committee will have the guts to remove CBT and GET and 60% they will not. The crucial issue here is that if they do not the situation is much worse than not convening the committee because the decision will likely stand for ten years. We know that the committee chair Peter barry has read all the papers criticising PACE etc. and that he takes them seriously. We now that Ilona Findlay, the vice chair, is keen to keep people with vested interest out and is broadly sympathetic. But the problem is that by inertia the committee is almost certain to fill up with professionals for whom making a decision to withdraw recommendation would be very difficult personally. They might even lose their jobs, judging by the phone calls and emails that have occurred in the past.

Basically people with ME desperately need these people to be on side. They will not be NICE staff. They will be professionals and lay people elected to the committee. To annoy them seems to me to be very foolish. I realise that comments at this stage are being fed back to NICE administration and may not get anywhere near some of the committee. However, I doubt it is as black and white as that. The person who is most needed to be on side is Peter Barry and he is already very much involved. If Barry sees the patient stakeholders as intelligent people with all the detailed arguments at their fingertips, prepared to treat him with respect and argue entirely reasonably he may well be swayed into saying to his committee that they should bite the bullet and do the right thing. If he sees a muddle of arguments about one disease being more important than another and wanting to have all sorts of unproven treatments available then the path of least resistance may appear attractive.

I have sat on committees like this - particularly ethics committees. I can picture the body language as people take positions on a sensitive point. I had considered applying to be on it but have reasons not to. Somebody will have to pipe up and say 'let's face it, the patients have got this exactly right, their arguments are cool, rational, detailed, but focused, the evidence is not there and we should stick to the principle that where there is no reliable evidence there is no recommendation'. And when someone else pipes up with 'but what are we going to have for treatment if we do not have CBT and GET' there have to be enough people who are not annoyed with the patients to swing the vote.

 

It's more about what they *could* be recommending - access to services, ie, specialist nurses for severe ME in every area.

I don't think they are as obsessed with cost as you make them out to be. I'm reliably informed that if every health professional followed NICE guidance to the letter, the NHS would be bankrupt very very quickly.

But while we're on the subject of drugs, I found this interesting: https://www.nice.org.uk/donotdo/ant...tigue-syndromemyalgic-encephalomyelitis-cfsme

 

Not sure if this is within the remit, but isn't there now good evidence that many PWME also have OI? Should NICE therefore be recommending that all patients who get diagnosed with ME get tested for OI (since it is somewhat treatable and a very disabling symptom in its own right)?

Should this be in S4ME's response to NICE? (Sorry if this has already been tackled - these threads are too long for me to follow.)

 

What a cruel list. They could also say "do not treat people with ME/CFS with the exception of CBT/GET".

 

Many thanks to Adam. The Outcomes section now looks like this:

“‘Main Outcomes”

The list omits the following objective measures:

· Return to employment or study, (or increase in work/study hours per week)
· Change in sickness and disability benefits
· Change in social services provision
· Change to pre-illness activities (i.e., resumption of hobbies and sports)
· 2, 6, or 12 minute walk tests
· Step test
· Actometer recording
· Peak O2 exercise challenge (with day 2 repetition)
· Blood lactic acid (mitochondrial function)
· ADP, ATP recycling (mitochondrial function)
· Tilt-table test (POTS)
· Nerve conduction studies

 

Hi Sasha, what is 'OI' please?