Proposed Letter to NICE

We intend to send this letter to Sir Andrew Dillon (NICE) early in January. I don't know whether any of you would like to add your (real) names to it or not: although a clear and logical explanation should not need the added weight of extra names, I'm not convinced that many medical professionals are suitably analytical in their thinking. Please get in touch with me if you would like me to add your name, and I will also add it beneath the letter here.​

Dear Sir Andrew,

We welcome the decision by NICE to review the guidelines on ME/CFS.

As you are probably aware, many patients have always questioned the NICE advice that CBT and GET are effective treatments for the illness. It is widely accepted that the decision in 2007 to recommend these interventions was based on small studies and unreliable evidence, a consequence of the neglect of ME/CFS by the MRC in this country and the NIH in the USA. Indeed, one of the justifications for the large amount of public money spent on the PACE and FINE trials was the 'somewhat limited evidence in the form of fairly small clinical trials' previously available.

Patients were surprised by NICE's quick and unquestioning welcome of the PACE trial findings as published in The Lancet in 2011. Not only did the statement that in NICE's view the results confirmed its recommendations as appropriate seem unusual in itself, but the speed at which it followed publication appeared unwise. The suggestion that NICE had somehow been vindicated by the trial only strengthened the perception by patients that the organization had taken sides in the debate and had an interest in finding evidence to support the interventions. The alacrity of the reaction, before the trial as published could properly be scrutinized, equally gave the impression that NICE was not disinterested.

These feelings among patients were strengthened by the contrast between the fast and warm reaction to PACE and the silence of NICE (and many others) to the publication of the sister FINE trial. Not only is FINE important in itself, but it casts doubt on the model on which the interventions trialled in PACE are based. FINE found CBT and GET made no difference to those most severely ill with ME/CFS. NICE made no comment on its results.

You probably know of some of the controversy surrounding PACE. The trial was an attempt to give a definitive answer to the efficacy or not of CBT and GET. What is clear from PACE and cannot be disputed is that there is no evidence the vast majority of patients benefit at all from CBT or GET, whichever the measurements of recovery and improvement used. Any slight, subjective, self-reported benefit that there may have been for a small number of patients was only temporary. The lack of evidence for objective and lasting improvement is glaring.

Over the last couple of years, criticism of PACE has been extensive, and a good review of the major issues can be found in volume 22 of the Journal of Health Psychology. The trial's major flaws are a repeat of those consistently found in studies on ME/CFS in recent decades: the use of the Oxford criteria to select patients and the use of subjective outcomes in unblinded trials. Patients find it hard to understand how NICE's recommendation of CBT and GET on the back of this work fits its aim to improve "health and social care through evidence-based guidance".

Despite this lack of evidence, NICE guidelines not only recommend CBT and GET but seem to do so enthusiastically. While for multiple sclerosis, for example, there is a single sentence on CBT, and for anxiety and anorexia there are a couple of small paragraphs on CBT, the guidelines for ME/CFS include 120 lines on the benefits of CBT and GET.

Patients' doubts about NICE's position on ME/CFS were only strengthened by the obvious conflicts of interest of so many on the guideline committee. Of a committee of twenty-one members, five had a financial interest and another ten were known supporters of the model and the interventions. This is not to suggest any lack of integrity on the part of the committee members, but to recognize the growing awareness in science of the need to guard against not just financial interests but researcher allegiance.

The contrast in findings when neutral parties examine the evidence on ME/CFS and possible treatments is stark. Separate reports for the US NIH and the US IOM (now National Academy) rejected both the illness model favoured in this country and the claim that CBT and GET were effective. None of the US CDC, FDA and AHRQ any longer recommends CBT or GET. All have rejected evidence from trials, including PACE, that use the Oxford criteria, which are now considered as impairing progress and causing harm.

It is, of course, important in itself for NICE guidelines to be valid. The consequences, though, should these guidelines be wrong can be severe. The omission from recommended treatments of CBT and GET would not prevent patients from using CBT to help them manage the effects of the symptoms or from obtaining help with psychological problems that may develop as a result of suffering this awful illness. Those so minded would still be able to use any elements of GET that they may find helpful, such as establishing a daily routine or using one activity to measure any possible improvement over time. Everyone agrees that doing everything that symptoms allow, to maintain mental and physical health, is crucial.

However, a recommendation of treatment for which there is no evidence risks causing considerable pain: patients may be obliged to follow these interventions or face losing benefits or insurance payments. Although few harms are reported in closely monitored trials, where GET as practised may in fact be no more than a form of maximized pacing, patient surveys consistently report damage caused by GET, in particular, and CBT. Patients would find themselves faced with the choice of losing their only means of survival or making themselves more ill, possibly considerably worse.

Given the importance of getting the guidelines right and the clear difference allegiance to one model of ME/CFS makes, we would therefore ask the following of NICE:

First, the process to determine who decides the membership of the guideline committee should be open and involve stakeholders.

Second, whoever appoints the members of the guideline committee should not have any involvement in research into CBT-GET or be currently using these interventions to try to treat ME/CFS or be a colleague of anyone associated with the CBT-GET model.

Third, the selection of members of the guideline committee should also be an open process and involve stakeholders.

Fourth, no one who has previously sat on an ME/CFS guideline committee should be eligible to sit on the new guideline committee.

Fifth, no one with a conflict of interest should be allowed to be a member of the guideline committee, and that conflict of interest should include any financial interest or researcher allegiance (such as involvement in research of CBT-GET for ME/CFS or attempting to treat with these interventions) or close working association with someone linked to the CBT-GET model.

Sixth, stakeholders should have a right of appeal with cause against members selected.

There cannot be a repeat of a process in which many patients have no confidence. There cannot be a guideline committee which includes, for example, someone who makes money by offering CBT-GET privately, who has a clear allegiance to one particular model and who took part in the major piece of evidence to be considered by the committee, a guideline committee which then recommends a treatment that is rejected as without evidence by all the major US institutions.

Despite the somewhat wild claims that have been made, patients do not have any desire other than to find effective treatment for an illness which devastates their lives. There is no prejudice against any particular approach. We simply want NICE to take an unbiased look at the available evidence.

We realize that some of this request may not be standard practice, but there can be little doubt of the controversy surrounding ME/CFS and there is a clear need for members of the guidance committee to be one step removed from the debate. The investigations by the NIH and IOM/NA show how it is possible for independent scientists to consider the evidence.

You are aware no doubt of the great interest many ME patients have in this subject, so we shall be posting this email online for others to see. We shall also post your reply, unless you advise you would rather we do not.

Thank you for your time and consideration of this matter.

Yours sincerely,

Graham McPhee
John Peters
Sally Burch
Patricia Davis
Dr Elisabeth Blank
Kate Milford
Justine Railton
Vivien Pomfrey
Maggie Wallace
Peter Trewhitt
Carly Mayhew
Wendy Boutilier
Jan Johnson
Lyn Gillam
Lizzie Corran
Kate Behrend
John Wallace
Veronica Jones
Amanda Silver
Penelope Jane McMilan
Diane Ogilvy
Debbie Smith
Ann West
Linda Hending
Sean Kirby
Andy Hugh
Jan Sussex
Elisabeth Aveling
Scott Simpson
Gill Bigglestone

 

Can I ask how the 1st and 3rd points differ here. I'm reading it again and again... but I must be missing something, because these two points seem to be the same to me??

Edit to say - letter looks good. I particularly like that previous committee should be excluded.

 

Excellent letter. May I suggest clearly saying that this is an opportunity for NICE to resolve some of the controversy surrounding ME/CFS.

 

Ah, one of the first reasons for putting up a proposed letter is to wait for eagle-eyed @Keela Too to spot any repetitions. Another reason is so that if we say the same thing twice, @Keela Too will point it out.

Thanks!

 

Nicely measured letter Graham.

I would be very happy to add my name but think it may be good for me to voice my opinions independently.

 

LOL That gave me a giggle.

Add my name too.
Sally Burch

 

@Graham - do you think it would be helpful for there to be more names on the letter or not?
There is no way my foggy brain would be able to write a letter like this, but I’d be delighted to add my name! However, the most important thing is to maximize the impact of your efforts.

 

We genuinely do not know, which is why we passed the buck and left it with all of you to decide!

I'm not claiming any credit for the quality of writing - that was John. I kicked it off as a topic, and did a first draft. I'd have been alright if it had been in rhyme, but prose gives me headaches.

 

Excellent letter Graham - just one nitpicking issue which is probably something which the current NICE guidelines would welcome.

"Those so minded would still be able to use any elements of GET that they may find helpful, such as establishing a daily routine or using one activity to measure the body's recovery over time. Everyone agrees that doing everything symptoms allow to maintain mental and physical health is crucial."

As you're no doubt aware (and I appreciate that you're accommodating the possibility of relapse/recovery and the variable nature of the illness) that as worded it does suggest that 'recovery over time' is likely which isn't the experience of many. I'm sure that's not how you intended it to be understood.

 

Good point, "fluctuations" might be better than "recovery," @Graham.

 

Great letter, might be worth putting it on www.change.org as a petition to help share it, allow people to show their support and comment.

 

Thanks @Adam pwme . I suppose the mathematician in me wants it to be a solid, logical argument, in which case it isn't really a petition. The realist in me knows that more signatures carry more weight. But once we have sorted out the glitches (and we haven't finished the editing yet, so thanks for the comments and suggestions: we're processing!) and once we have added the signatures of folk on here who want to sign, we'll probably decide that is enough. Then we will send it off, but also spread the word elsewhere.

It might be worth taking a simpler part of it though and creating something that could act as a petition. We'd be happy for anyone to give that a go.

 

Very good. Glad to see the point brought out of treatment recommended has potential to cause harm. Happy for you to add my name, Barry Chamley.

 

Thanks Graham and John! I don't know much about how NICE works, and it's been a long time since I read the NICE guidelines, so my comments might be worthless, but I thought I'd say some things that came to mind as I read through.

This probably doesn't matter, but I don't think that there's a sub-group analysis for FINE on the most severely affected, so we can only comment on the overall results, and also maybe they'd quibble on whether pragmatic rehabilitation was CBT and GET? Possible edit:

"FINE was designed to ensure severely affected patients were included as participants, and found that rehabilitation based on CBT and GET made no difference"

I found the punctuation there a little confusing. It was as if the MS guidelines included a single sentence for anxiety and anorexia.

This could be a risky point to raise, as the judicial review on NICE's CFS/ME guidelines led to a judgement that was dismissive of concerns about COI. That seemed to at least partly be because the case put before the judge by the complainant was misguided, with out of context quote which were then picked apart, but there may still be reason for caution here. I don't know, but just thought I'd raise that concern for consideration. You could just weaken this introductory sentence? "There were also concerns about potential conflicts of interest amongst a number of those serving on the guideline committee"? I think I'd avoid 'obvious' on this one.

What about if someone has been critical of the CBT-GET model? Does your approach risk excluding anyone who might already know the details of the debate? Given how thoughtless and deferential people in UK medicine can be, I fear that starting with an entirely indifferent and unbiased committee could be bad for us, and mean that they just give us whatever Larun's Cochrane review tells them to. Would we be better off with a few CBT-GET proponents, and a few critics, who are then left to argue things out within the review process?

If arguing for the exclusion of people associated with the CBT-GET model, or providing CBT-GET, should you be arguing for the exclusion of people associated with any model, or making money from any treatment?

Is this right? Didn't those investigations include those who were already part of the debate? Lily Chu was involved with the IOM one. You cited those reports earlier in the letter with more confidence than I would too, but I get the impression I'm in a minority on that (I don't trust any reports!).

It would be good to get some advice from someone who has a good understanding of how NICE works, and how they'd be likely to respond to something like this. I'm afraid that I'm completely ignorant on that front. Good luck with it.

 

I know what you mean, they do host open letters on there but it may be better to put it somewhere on this site, like in a blog/pages section for open letters.

Does anyone know if there are plans to add this functionality in the future? Apologies if I’m creating work for people, I know it’s not a small job.

 

Sorry if I wasn’t clear, I meant a web page rather than a forum thread, just wondering what the plans are for the future but im probably getting ahead of myself

 

I think it's safe to say that the committee has no plans to expand beyond the forum format in this context for a long while yet, if ever. Curious as to the benefits that you see for it being on a web page as opposed to in a forum thread like this?