Proposed Letter to NICE

Good letter. Just a couple of minor points:

Graham said:
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.
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I would re-write the above sentence to make it easier to read. Something like: “Not only did it seem unusual for NICE to state that, in its view, the results confirmed its recommendations as appropriate, but the speed at which the statement followed publication appeared unwise.”

The trial was an attempt to give a definitive answer to the efficacy or not of CBT and GET.
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I don’t accept that this is necessarily true. I would say it was a purported attempt. In my view it was actually an attempt to prove that CBT and GET are effective treatments for ME/CFS.

Thanks to all who have worked on this.
 
Keela Too said:
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.
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Keela Too said:
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.
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I can recognise the difference in the two points, but perhaps they could be combined?
So that transparency is described as applying to both the process and the choices made?
 
Thanks for all your suggestions, and I agree that they are valid points, but I have decided to stop tweaking and let the letter stand as it is. It's only the start of a conversation, so it doesn't need to be perfect. Otherwise I'll be tweaking all through Christmas, and that's not a pretty sight. It's the overall tone and message that are important.

And of course, there is no reason why any of you shouldn't also write to him expressing your concerns.

I'll transfer the letter to a new, locked thread soon, then if you want to inform others about it, you can link them to that one. I'll not actually send it until early January - there's little point in sending it over the Christmas break.

If you would like me to add your signatures, you can do so until early January, but they won't appear on the version on the locked thread unless you tell me tonight.
 
Graham said:
If you would like me to add your signatures, you can do so until early January
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Once you have produced your final version and we've got it in it's separate thread, we could start a petition to more easily collect signatures? My personal opinion would be that the petition be left open to continue collecting signatures but you could refer to it at the point that you send the letter in, i.e at that point in time the petition had collected so many signatures of people agreeing with the content of the letter. And I'd assume that, due to the impact of NICE guidelines worldwide that we'd accept non-UK signatures?
 
@Sasha The bolded bit could be a bit tricky, because no matter how much you try to identify roles with potential COI there will always be others - friends, family, classmates, etc. Does it need to be less specific but try to eliminate any conflict of interest. Require to declare potential COI.

Struggling with iPhone at minute.
 
@Graham a comment from our Facebook page that I promised to copy over to this discussion.
Good points and suggestions from all the forum commenters. I see Graham has concluded it's not worth getting 'bogged down' with alterations at this point, on the basis of it's just being the beginning of a dialogue - but - if I had anything to add, it would be that I'd rather a stronger emphasis was made re harm potentials in the ref to sufferers being forced to chose between complying with benefits/insurance requirements, and making their illness worse. (Actually, I think someone did say something about that, but have forgotten exactly what they said now).

I just think it might be worth using a word/phrase indicating that 'getting worse' may not just involve a transient symptom worsening - there are some (even if relatively a smallish minority) for whom this can be a cause of very long-term/permanent devastation to their illness and life quality.

I appreciate this, otherwise excellent letter, is probably geared at being encouragingly 'moderate' in tone, but feel this aspect perhaps warrants a more serious mention from the beginning, to draw some attention to the gravity of the issues at stake for sufferers - otherwise 'getting worse' could just wash over in reading as not that big a deal.
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Graham said:
@Trish , I'm happy for it to be public - putting it here was a conscious decision. I just wanted a pause before touting it on Facebook etc to give folk here a chance to point out anything that needed rephrasing etc.
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Should the drafting of a letter be public before it is finalised?
 
Robert 1973 said:
Good letter. Just a couple of minor points:



I would re-write the above sentence to make it easier to read. Something like: “Not only did it seem unusual for NICE to state that, in its view, the results confirmed its recommendations as appropriate, but the speed at which the statement followed publication appeared unwise.”



I don’t accept that this is necessarily true. I would say it was a purported attempt. In my view it was actually an attempt to prove that CBT and GET are effective treatments for ME/CFS.

Thanks to all who have worked on this.
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I agree with this. It is a strong possibility the authors already had built in bias to prove their favoured treatments worked, rather than a truly objective (that word again!) assessment of efficacy.
 
Graham said:
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 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 associated with 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
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Iain McGinn
 
Should the drafting of a letter be public before it is finalised?
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We had discussed it and finalized it elsewhere, but nobody is perfect, and on a forum like this, nothing is ever "finalized". I value the input, the comments, the advice: it's what makes this forum zing. But equally, I have to decide when to stop. This is only going to be one of a large number of arguments and presentations put forward to NICE: feel free to write yourself with a different slant - they need to know how strongly we feel about this and how clearly we see why it is wrong.

I don't have a problem with letting people see that we are fallible, nor that we help each other out to improve things: that is one of our greatest strengths, and something that I am proud to be a part of. Equally, the good-natured way in which we make suggestions, but accept that they won't always be acted on: that too is a very strong plus for this forum. Greatly appreciated!
 
Well done @Graham. You've put together a good letter.

I would, however, like to make a couple of points:

1. I would like to see highlighted, the fact that the particular brand of CBT advocated by the PACE trial crowd, is directive (hand in hand with GET) and therefore not of the supportive kind, which CBT is conventionally thought to be.

2. On the back of the robust arguments you have made against the use of CBT and GET, I would reiterate the call for them to be suspended / removed from the current guideline as a matter of urgency in order to protect patients from potential harm.

Thank you for your efforts.
 
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