S4ME letter to NICE and Replies, re: "three members of the ME/CFS Guideline Committee have a conflict of interest"

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This is a letter we sent from S4ME to NICE as discussed in a voting thread for those members who have posted enough to have voting rights.

We are posting here so that it and the responses are available publicly.



To: Dr Peter Barry
Chair, NICE ME/CFS Guideline committee
cc: CFSME@nice.org.uk'; 'complaints@nice.org.uk'

Dear Dr Barry,

Science for ME is an online forum with over 1000 members internationally, including people with ME, their carers and supporters including scientists. We are a stakeholder for the NICE ME/CFS guideline.

We would like to express our concern that three members of the ME/CFS Guideline Committee have a conflict of interest.

Reviewing the evidence for GET and CBT
Professor Mark Baker, director of the NICE centre for guidelines, declared that the main rationale for reviewing the NICE guideline on ME/CFS is to address and resolve "the continuing debate about the best approach to treating people with this condition." [1] The current NICE guideline (CG53) recommended the use of cognitive behavioural therapy (CBT) and graded exercise therapy (GET), two treatments that are increasingly controversial. According to the final version of the guideline scope:

"concerns have since been raised about these interventions, including challenges to the evidence supporting them and reports that people with ME/CFS have been pressured to participate in exercise programmes, leading to a worsening of symptoms. There is a need to review the evidence for these and other interventions."

The 2017 surveillance report noticed that "patient surveys appear to contradict findings from randomised controlled trials and systematic reviews regarding the safety and efficacy of CBT, GET and pacing." Several stakeholders have requested an immediate retraction of GET and CBT, arguing that "these interventions are ineffective, harmful and scientifically untenable." Abroad, prestigious institutions such as the US Centers for Disease control and Prevention (CDC), the Agency for Healthcare Research and Quality (AHRQ) and the Dutch Health Council, have recently downgraded their recommendations for GET and CBT. It thus seems safe to conclude that a reassessment of the efficacy and safety of these interventions will form the core of the new ME/CFS guideline committee's assignment.

Conflict of interest
Three members of the Guideline Committee have apparent conflicts of interest regarding GET and CBT. Physiotherapist Joanne Bond-Kendall has provided these treatments at the paediatric CFS/ME service in Bath to participants of the ongoing MAGENTA and FITNET studies. Jo Daniels, psychologist at the University of Bath, published a clinical study that investigated the effectiveness of CBT for ME/CFS. The paper claimed positive results and called for further research in this area. [2] This indicates that both Bond-Kendall and Daniels have a professional interest in maintaining the NICE recommendation for GET and CBT. A conflict of interest is even more apparent for another member on the committee. Gabrielle Murphy, a specialist physician at the Royal Free Hospital, has written a book to promote GET and CBT and was one of the authors of the PACE trial. Serious methodological errors have been detected in this study. According to the 10 year surveillance of the ME/CFS guideline:

"the PACE trial has been criticised in several publications. Criticisms include: patient selection criteria; changes to criteria set out in the original protocol for effectiveness and recovery; and using subjective primary outcomes."

A special issue of the Journal of Health Psychology was devoted to criticism of the PACE trial and more than 100 scientists and other experts have signed an open letter urging The Lancet to address the study's "unacceptable methodological lapses". [3] As the largest randomised trial of GET and CBT, the PACE trial is a major part of the available evidence for these treatments. Dr Murphy has consistently defended the conclusions of the PACE trial as one of its original authors, and is unsuited to objectively assess the evidence for GET and CBT.

Partial exclusion
The position of Bond-Kendall, Daniels and Murphy correspond to what NICE policy calls a non-financial professional conflict of interest:

"When a person has a non-financial professional or personal benefit, such as increasing or maintaining their professional reputation. This can include situations where the person: […] Is actively involved in an ongoing or scheduled trial or research project aimed at determining the effectiveness of a matter under review."

NICE's recommendation in such circumstances is a partial exclusion where the person is allowed to engage in committee discussion but is excluded from decision-making or recommendations on the matter relating to the interest. The policy on declaring and managing interests for NICE advisory committees is very clear on this and provides a case example:

"Example of interests: Publications in which a member expresses a clear opinion about the intervention being considered.

"Action and rationale: Potential exclusion – this is non-financial professional interest and the response will depend on the nature of the view expressed and the risk to perceived objectivity. In determining the level of involvement the chair should consider the balance between this risk and the benefit of the member’s input to the committee. It may be decided to allow a member to remain in the room to answer questions but not take part in decision-making."

According to the NICE conflict of interest policy, a decision on participation should balance the conflict of interest with the benefit of the committee’s access to the person’s expertise. However CBT and GET are common treatments and according to the NICE guideline manual, the committee can demand expert testimony if further clarification is necessary. The sole appropriate action therefore is an exclusion of committee members Bond-Kendall, Daniels and Murphy from the assessment of GET and CBT.

Formal confirmation
The influence of non-financial conflicts of interest should not be underestimated. According to a recent publication on the influence of the team in conducting a systematic review:

"Consumers of systematic reviews cannot rely solely on declarations of competing interests, which may relate to recent pecuniary funding (within the last 3 years), as opposed to more long-term affiliations to health interventions, to know whether those conducting the review have an interest in the results of the research (researcher allegiance). For example, for some, their very employment is reliant on a given intervention’s reputation such as […] psychotherapists and they are unsurprisingly unlikely to publish a rigorous review with neutral or negative conclusions underpinning the basis of their profession." [4]

As you may be aware, there is great concern among the ME/CFS community about recent committee appointments and their lack of impartiality regarding GET and CBT. We therefore request formal confirmation that committee members Bond-Kendall, Daniels and Murphy will be excluded from the assessment of GET and CBT as the NICE guideline prescribes.

Yours faithfully,

...


References:

[1] NICE announces next steps in updating its guideline on ME/CFS, 5 February 2018. https://www.nice.org.uk/news/article/nice-announces-next-steps-in-updating-its-guideline-on-me-cfs

[2] Daniels J, Loades ME. A Novel Approach to Treating CFS and Co-morbid Health Anxiety: A Case Study. Clin Psychol Psychother. 2017 May;24(3):727-736.

[3] Tuller D. (2018, August 18). Trial By Error: Open Letter to The Lancet, version 3.0. Virology blog. http://www.virology.ws/2018/08/13/trial-by-error-open-letter-to-the-lancet-version-3-0/

[4] Uttley L, Montgomery P. The influence of the team in conducting a systematic review. Syst Rev. 2017 Aug 1;6(1):149
 
Response from Peter Barry

Dear Members of Science for ME,


Thank you for your email. I appreciate your concerns and am grateful to you for bringing them to my attention.


All members of the Guideline Committee have conflicts of interest, and these will be declared and dealt with in line with the NICE 'Policy on declaring and managing interests for NICE advisory committees'. I assume from your email that you have already seen this, but if not it is available on the NICE website.


So I am happy to confirm that all conflicts will be dealt with in the way that the NICE policy prescribes.


With best wishes


Peter Barry
 
Response from NICE

Dear Sir/Madam


Thank you for your recent email to the National Institute for Health and Care Excellence (NICE), in which you express concern about the membership of our ME/CFS guideline committee.


It is important that our guideline committees have the experience and expertise to consider the published evidence and to take account of the views of people who receive and who provide care for this condition. Our arrangements for appointing the chair, vice chair and the members of guideline committees are designed to ensure that the opportunity to take part is advertised and that appointments are made on merit.


We are very aware that the causes of ME/CFS and the treatments that should be made available are the subject of debate and many people living with the condition hold strong views on both questions. Because of this, we have worked carefully to ensure that the membership of the committee contains a balance of those who have expressed clear views, together with members who have not so far taken a position on the currently available evidence.


Because of the concerns you and others have expressed, we have reviewed the appointments made so far and we consider that they are appropriate and that the interests the members have declared can be managed using our conflicts of interest policy. We will ensure that the small number of final appointments yet to be made retain the balance referred to earlier.


I hope that you will allow the guideline committee to begin its work and judge it not on the basis of your views of those who sit on it, but by how it interprets the evidence and the way in which it takes account of your perspectives and experience, when you have the opportunity to comment on the draft recommendations.


Kind regards


Helen




Helen Finn

Communications Manager (Enquiries)

National Institute for Health and Care Excellence
 
Science For ME said:
Because of this, we have worked carefully to ensure that the membership of the committee contains a balance of those who have expressed clear views
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This is stupidity, you don't need a balanced view to develop treatments, in a science based system you should look to find the truth not a way to support unscientific discredited data.
Of course if you don't want to be scientific then claiming to be is a sham.
 
Sean said:
Truth is not determined by compromise, by 'balancing' competing interpretations and claims.

The only options are true, not true, or we can't tell.
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But the true/not true has nothing to do with the selection but is rather a question for discussion afterward.
I am not as pessimistic this time round as I have been in the past.

The cabal will continue to resist but I don't see them getting away with no change. The only issue then is how much is conceded. I expect they will be very crafty about trying to only give the minimum they can get away with.

My thought is they will see some concession as necessary in order to try and avoid giving away the farm because their present stance is completely untenable.

I know the issue is clear to us, the true/not true but I expect their are nuances to wording and details that can be blurred.
 
We took this to a stage 2 review and received a response which basically says they followed due process which I think is all their complaints procedure looks at.

Dear Science for ME,

We are sorry that you were dissatisfied with the response you received to your emails regarding appointments to the guideline committee for the update of the ME/CFS guideline. David Coombs advised you that because Andrew Dillon, NICE’s Chief Executive has already been involved in investigating your complaint, the matter had been referred to us as non-executive directors on NICE’s Board.

In stage 2 of the complaints process we are required to review the substance of your complaint and the response you received, and to consider whether the matters have been handled appropriately. We have had the opportunity to review all the relevant documents and to speak to the NICE staff who were involved in managing your complaint.

Before setting out our conclusions, we want to acknowledge that we are aware that the diagnosis and treatment of ME/CFS is a contentious topic on which there are strongly-held views.

We noted that NICE’s initial response to concerns raised about the membership of the guideline committee was prepared in the context of a large number of emails containing standard text, with some also supplying details of the correspondent’s personal experience of the condition. We consider this to have been an appropriate way of handling a large volume of correspondence and that a careful explanation of the approach taken to the recruitment of members to the committee had been provided.

In considering the make-up of the committee, we noted that neither the chair nor the vice chair have any conflicts of interest. We were told that in appointing to the committee, the guideline developers wanted to ensure that they had an appropriate range of expertise and experience and that neither of the two principal views, about the causes and best approaches to care in ME/CFS should dominate in the committee. We were shown an analysis of the membership of the committee,prepared by the chair, which we consider demonstrates that this objective, with which we agree, has been achieved and indeed, that the majority of members have not publicly expressed a view or published articles on the condition. We saw evidence that the guideline developers had carefully reviewed the declared interests of the committee members, including those relating to clinical trials and arrived at the reasonable conclusion that they can be managed effectively in line with NICE’s policy on declaring and managing interests.

In addressing your complaint, we were concerned to ensure that adequate consideration had been given to the importance of the committee having access to specific clinical experts. We were assured that the chair has the facility to call on any expertise, clinical or otherwise, to ensure that the committee has access to all the evidence it requires.

We noted that for this guideline, NICE has gone beyond its usual arrangements to ensure lay people, patients and their carers are able to be involved in the committee’s work. For most guidelines, two places on a committee are allocated for lay members, patients and their carers. This guideline committee has five lay members, and the venue for the meetings will be a hotel to provide patients with somewhere to rest and stay at the hotel on the evenings prior to, during and after the meetings.

It is important to note here, that in considering the concerns expressed about recruitment to the committee, NICE took the additional step of requesting its conflicts of interest reference panel to consider the membership of the ME/CFS guideline committee. This panel consists of two non-executive directors (Rima Makarem and Tim Irish in this case), Andrew Dillon, Chief Executive and Alexia Tonnel, Evidence Resources Director. We consider that this additional level of scrutiny demonstrates NICE’s commitment to achieving a balanced committee that is capable of considering all the evidence objectively and taking account of the differing individual perspectives.

In summary we conclude that NICE and the guideline developers have followed due process in appointing to the committee and in doing so, have recognised appropriately the particular sensitivities of this guideline topic. We are not, therefore, proposing to recommend that any further action be taken in response to your complaint.

This is the final stage of the internal complaint procedure. If you remain dissatisfied with the outcome, NICE has a duty to inform you of your right to apply for a review by the Parliamentary and Health Service Ombudsman if you are still dissatisfied. This can be done by contacting the Ombudsman via www.ombudsman.org.uk.


Yours sincerely
Professor Martin Cowie, Non-Executive Director
Tom Wright, Non-Executive Director
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So they take the view that all sides positions have equal merit, no matter how batshit crazy and potentially harmful one side is, no matter how ineffective it has been shown to be?

Just as long as everything is 'equal', as in numbers on the panel, not in terms of representation, fairness or sanity, everything's fine and above board.

Possibly they take the view that organised crime deserves, and must have, equal representation and consultation before laws that might affect them are made?

Their position is, in my opinion, totally absurd.

But what do I know, according to half the panel I'm a malingering hate monger.
 
Wonko said:
So they take the view that all sides positions have equal merit, no matter how batshit crazy and potentially harmful one side is, no matter how ineffective it has been shown to be?

Just as long as everything is 'equal', as in numbers on the panel, not in terms of representation, fairness or sanity, everything's fine and above board.

Possibly they take the view that organised crime deserves, and must have, equal representation and consultation before laws that might affect them are made?

Their position is, in my opinion, totally absurd.

But what do I know, according to half the panel I'm a malingering hate monger.
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Strongly-held opinions are just one side of objective reality, apparently.

I don't know if this is final but this response is unsatisfying because of the context, which is that a review of the guidelines was forced on NICE by overwhelming complaints after they rubber-stamped the previous ones without showing any evidence of measurable usefulness.

Those complaints were raised during and after the 2007 guidelines, showing they are not a knee-jerk reaction. A full decade has passed since and the concerns are still raised. The response completely ignores this context, treats it as an inconsequential formality.

The review is not happening in some vacuum, where past events have no significance. Pretending otherwise only shows how badly they misunderstand the situation. They still frame our objections as mere whinings, of no particular weight. Cowards.
 
Wonko said:
So they take the view that all sides positions have equal merit, no matter how batshit crazy and potentially harmful one side is, no matter how ineffective it has been shown to be?
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I think the problem is a Catch22. If the panel is selected on the basis of the merit of the views it is, by definition, being gerrymandered by someone who has prejudged the value of those views. The whole point of the committee is that it judges those views.

That said, the approach has been disingenuous because there was no justification for including people whose expertise lay in the provision of treatments that might be decided not to be recommendable. The underlying problem here is that NICE, along with a lot of other organisations, has taken the politically correct view of including all professions allied to medicine in addition to medicine itself in all decision-making bodies.
 
Jonathan Edwards said:
That said, the approach has been disingenuous because there was no justification for including people whose expertise lay in the provision of treatments that might be decided not to be recommendable. The underlying problem here is that NICE, along with a lot of other organisations, has taken the politically correct view of including all professions allied to medicine in addition to medicine itself in all decision-making bodies.
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I do wonder if the process is somewhat broken in that it may be better to have a committee of people able to assess evidence rather than being knowledgeable about the subject and then have experts giving opinions. Instead of mixing experts into the judgement process so that they can choose their own views.
 
Surely one side, the BPS side, has had the time, power and resources to prove their case already. Millions of pounds, total control over the way the health system over significant parts of the world, near total control over the way the world views ME.

If they couldn't prove their case in over 20 years why isn't that being taken into account? Why aren't they now being seen for the fakiers they are? Why are they getting another chance to keep their merry go round spinning?

Why do the opinions of these people who their own activities and lack of medical success have proved to be, at best, wrong, why are they even there?

It's like asking a mechanical, who has been given every resource they asked for, about the best way to fix your car. A car they have failed to fix, indeed made considerably less fixed, for 3 decades, despite millions of pounds, and the involvement of thousands of people.

Surely at some point, when it comes to meetings on how best to fix the car, someone's got to realise that asking said mechanic for his opinion is.........
 
Adrian said:
it may be better to have a committee of people able to assess evidence rather than being knowledgeable about the subject
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It would be great if we lived in an ideal world where such people would exist. But 'people able to assess evidence' could easily be the MRC advisers who happily approved the PACE trial in the first place. NICE has a group of evidence-assessors who are not knowledgeable and I suspect that is half the problem.
 
Jonathan Edwards said:
It would be great if we lived in an ideal world where such people would exist. But 'people able to assess evidence' could easily be the MRC advisers who happily approved the PACE trial in the first place. NICE has a group of evidence-assessors who are not knowledgeable and I suspect that is half the problem.
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Yes that's probably why they don't do it that way. These days I get very worried about the lack of analytical skills exhibited by people and it make me think we are not teaching people how to assess evidence and think about problems, ask the right questions of experts and assess proposed solutions.
 
Trish said:
And less following recipes and memorising facts in science and more discussion of how to weigh up evidence and interpret data and understand bias.
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When GCSEs came in (80’s) the science subjects encorporated experimental design into the curriculum. However those educated before this time had much less training on the scientific method, and many teachers had to be trained up in order to teach it.

I have hope that the next generation might be more switched on to designing a fair test.:thumbsup:
 
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