NICE ME/CFS draft guideline - publication dates and delays 2020

You covered much of the ground I was going to. But it goes further than this, too.

PwME are not the only stakeholders here, as you rightly point out. If the guideline is rushed or the protocol deviated from, then anyone who didn't like the new guideline could challenge it by judicial review and they very well might win on a technicality.

The process is so laborious precisely because they don't want things like that to happen.

Let's say I set up my own treatment. It's a bunch of diet tips, coaching, arts and crafts techniques to help you unlock your inner suffering, and the restorative properties of the primal scream. But let's say NICE decides it's mumbo-jumbo in their guideline and had previously put out a warning without public consultation.

I see that NICE preempted their own guideline, so I jump on it as an excuse to challenge the validity of the guideline. It goes to judicial review. I win, and so a new, totally different committee has to come together, including, it just so happens, some of my mates.

The result is that I get my treatment in and we have an awful guideline instead of a fairly decent one--all because NICE broke its own rules.

Do you see my point? It gets difficult when exceptions get made for any reason.

 

Okay, I'll put it even more simply: how can NICE decide there's no evidence without looking at the evidence first? Therein lies the rub.

To make a decision, it needs to look at the evidence. If it looks at the evidence, it needs needs a committee to consider that evidence. If it forms a committee, then we repeat the two-year process all over again so the committee can reach a decision.

If someone has never seen the sky, you can't ask them to decide what colour it is without first letting them look out the window.

 

yes, I was thinking about this. Like the CBT program for IBS I've been writing about. Now they can say, and this is even better given the coronavirus era. It is a bit worrisome.

 

I didn’t say evidence should never be looked at, evidence is looked at. But my post wasn’t about that, it was about the balance of formal processes, what evidence means and different ways things are done. Take for example the processes the UK feels the need to use, how they develop guidelines and what it takes as evidence. Not every country goes through a formal long process similar to NICE, with committees which cannot even issue interim measures, and which explicitly looks at “cost benefit” analysis.

The other point though, more importantly for me, is CBT & GET is continuing to harm patients still, possibly even now, through online programmes. Long term harm, maybe permanent harm. And because of the way the UK follows processes, people will be harmed. I get what you’re saying. I get the arguments. I understand them. It doesn’t mean it’s not happening though. And I don’t feel ok with it.

(Again, I am grateful for what you and others are doing on the committee.. I also know a lot of this is not in your control, but this is just my opinion on this).

 

This is a special case, though. There never was evidence for it in the first place and it was blatantly so. Which they can't admit to, of course, the process that created the current guidelines was corrupt and flawed but acknowledging that would require serious changes to the entire system and that would be bad for many people's career and reputation, which here is the highest of concerns, if not the only one.

There is no need for a process to remove recommendations that people should lather themselves in beef tallow to guard against the flu, unless somehow a flawed process actually made that recommendation in the first place. Which is sort of our situation here. An empty gas bag was turned into "evidence" somehow but since it happened and people who like the gas bag would be angry, evidence has to be provided that the gas bag is in fact empty, complete with the all-predictable thought-terminating cliché that the gas bag can't be empty if there's ambient air in it, which while technically true is completely besides the point and serves entirely to derail the reality that facts were entirely irrelevant in the elevation of the empty gas bag into a set of clinical guidelines. It's a scenario that should not happen but it clearly did and so the normal process can't work here.

In the end this is all because of face-saving, nothing to do with being a valid process and even less so about patient outcomes, welfare, quality of life or even basic survival. It's more of a ritual than a serious process, frankly. Which absolutely does not remove what you are doing on the committee, it remains vital to keep the worst at bay, but there is simply no legitimate reason for the current guidelines to hold, science is not supposed to be subject to the asymmetry of bullshit and yet here we are.

Anyway the reasons this happened at all are all political and ideological and we know this, everyone knows this, it's just damn pathetic that this is how some people play with millions of lives, indifferent to suffering they impose on others because they just darn love magical thinking or want to avoid angering some well-connected jerks who can make their lives miserable. Rotten system disconnected from reality, frankly.

 

I recall Jonas Bergquist, in a presentation at the Invest in ME Conference, quoting Lord Kelvin:
“To measure is to know.”
“If you cannot measure it, you cannot improve it.”
[https://physicsworld.com/a/in-praise-of-lord-kelvin/]

The problem with this study (and these studies generally) is that they didn't use objective measures. E.g. Fluge, and Mella's, rituximab study used activity monitors to assess activity levels before/after treatment.

The PACE study (which I didn't study) used self reported questionnaire's i.e. no objective measurement. Nowadays you could just use your mobile phone to measure activity levels -- it doesn't appear to be that difficult. There are a lot of other problems with this study and thereby the use of the study to formulate Government policy. It took 5 million pounds of public money to fund this c--p.

I don't see why the Government doesn't abandon it --- it can't be doing their image/credibility and good.

 

And if Covid-19 patients are at risk of developing ME that risk increases if recovering patients are pushed into GET...
So yes, the update of the guidelines - removing GET recommendations - would be a relevant response to Covid19.

 

But the problem, again, is what published evidence is there and how strong is that evidence? Yet again I don't disagree, but without having the evidence that NICE will take notice of I sadly don't see it happening.

 

There are a number of issues which I'd be happy to discuss in more detail once I'm out of NDA. I have a lot of opinions about everything, obviously.

I certainly think there are some crucial steps we need to take to improve the evidence base going forward. This won't be a surprise to anyone.

But there may need to be a shift in priorities to make evidence more suitable for NICE's purposes in particular, and that shift may be different to the way things have been done before.

In the scheme of things, though, a delay now isn't the worst outcome.

In the long-term, it'll be better to get this right. The guideline could stand for 10 years or more. A few more months till consultation may be painful now, but a decade of bad guidance would be a nightmare.

I know groups have tried to get NICE to issue an interim warning, but I think once you understand how NICE works then you realise that's never going to happen.

That doesn't mean people shouldn't complain or do what they feel they have to--everyone has that right. It probably does mean we should be realistic, though, and be aware of the spoons involved in fighting this.

Does it make more sense to fight this now, during coronavirus, when it's most likely to be ignored and easiest to do so; or does it make more sense to save energies for the consultation period, where that energy will be needed most?

 

Can you give us any clues as to what this might be?
Would say, putting together a database of research papers/ articles relevent for the Cochrane Exercise review (if that ever happens) be a worthwhile project?

 

Probably not. The problem isn't highlighting papers that are already there--NICE (or Cochrane) see those papers and know they're there.

It's just that if those papers don't meet certain thresholds or requirements, they aren't included in the literature reviews so that limits what can be done with them.

Literature reviews have a pre-defined protocol based on the initial scope. Things that don't fall under the scope are ignored. If it doesn't fit the protocol, likewise. They have to do this, or they'd have too many studies to analyse.

Read through the scope and you'll get a better idea of which answers NICE was looking for. Then ask yourself, do we actually have papers that unequivocally answer this, and directly?

It's no use if it maybe refers to it three-quarters of the way through a paper.

There's also an inequality in research. Some groups publish lots of the type of study likely to be included in literature reviews, while others do not.

 

Like everyone else I would love to see the guidelines changed, or at least have a warning slapped on them ASAP. However I also see the reasons outlined y @adambeyoncelowe and @Andy why this isn't likely and could cause further problems if due process isn't followed.

Years back physicians had a lot more leeway in treating patients and many patients benefited greatly. However, some were also harmed. Then we had the likes of Harold Shipman & it became clear there was little effective oversight. So more due processes were put in place. More central control. In correcting that issue, I think they've gone to far.

I don't know if we can prove the process in developing the guidelines was corrupt. Biased & ineffective, cedtainly. However, once the process is in place, you have to use the process to change the process. Otherwise we go back to the days of no oversight and the likes of Shipman, who may have killed as many as 260 people, being left to do as they please.

It may be that in developing the new ME/CFS guideline, some of the shortcomings of the system will highlighted and could, ultimately, lead to a change in the process itself.

 

@Invisible Woman I understand what the reasoning was for NICE and central control. But like you I think that in correcting the issue, I think they’ve gone too far. I don’t think it has to be an “either NICE or Harold Shipman” type issue really. I don’t have the answers but I wish I was better versed in the different systems that other institutions / countries use so I could discuss it more. Probably a good thing actually as I’d use up my energy discussing it..

There are other issues with NICE in regards to their cost benefits analysis. Their Wikipedia page for example has lots of the issues other charities / people with other conditions have as well, in terms of how they work out their “cost benefit” analysis and what they count as the “evidence” that they take into account. I remember an uproar recently about serious change in their guidelines for back pain.

I’ve been affected by one of their latest cost benefit analysis changes for a pain medication and am now paying £300 a month for a pain med that isn’t available on the NHS any more even though it’s one of the two main things that helps. Without it, my pain gets unbearable within 2-3 days.

It’s people with severe ME and very severe ME who are going to get more affected by this delay though. We don’t even have a date when this will resume. Dr Weir is constantly having to help patients like this - severe patients who are forced into doing exercise as inpatients at hospitals because of these very guidelines, and people in care homes where providers will use this as an excuse for maltreatment. The longer this goes on, more people are getting hurt.

I’m scared every day this guideline remains in place as I’m scared what could happen to me in a care/hospital setting in the future as well as how social services treat me. As well as those newer people being pushed into it. This is where my thoughts come from. I know this is the current process but even the fact an interim measure is unable to be introduced because of how these actual processes work, it is very frustrating and also upsetting. It is very hard living with severe ME with these guidelines in place.

 

Definitely @Sly Saint

 

I get this. I'm afraid there may not be an easy solution, though. Perhaps the best we can hope for right now is that what is endured this time isn't endured again next time.

 

I do understand @lunarainbows. I too have been denied a medication that made a huge improvement on my life quality. Even though I had letter from a number of different highly qualified consultants on my records saying I should have it, a new GP used the guidelines and a single letter from some unknown specialist to deny me the treatment.

Luckily for me I found a workaround. An expensive one, but there we are.

I also agree that the cost vs benefit analysis is woeful. We know from our own experience that many (most?) CFS clinics either do not properly record harm caused, if they record it at all. Let alone recording outcomes. If they don't record long term outcomes then they cannot know if the treatment was effective, let alone cost effective. Ironically, other patients with other conditions are denied treatment purely based on cost of treatment- even though the treatment may be very effective.

We are where we are now though and can only move forward from here. Maybe one day our case will be instrumental in bringing in changes that reach beyond the cause of ME/CFS patients?

 

I do hope so, @Invisible Woman.

 

I’m around long enough to remember when some people and groups pushed for NICE guidelines for ME/CFS. It didn’t seem a wise move to me: it looked almost certainly that CBT and GET would be recommended and as a rationing body, NICE would recommend against many other treatments and tests.

It’s one of a number of times over the years I thought not pushing for things at that time would be better than pushing for something.