By David Tuller, DrPH
Action For ME is the largest charity for this disease in the UK. It is also the charity responsible for enabling the PACE trial through its unfortunate decision to work with the investigators to develop â€œadaptive pacing therapy.â€ This was a terrible idea from the start, for multiple reasons.
First, the PACE investigators had already demonstrated their true colors with their sub-par research and unwarranted claims going back at least a decade. Moreover, it should have been obvious to any reasonably intelligent researcher that the PACE operationalization of â€œpacingâ€ transformed this intervention into something other than the self-help strategy that patients use. PACE did not investigate â€œpacing.â€ It only investigated APTâ€”a very different animal that required patients to create diaries and schedules of activities and on and on. Yet the PACE results have routinely been used to claim that â€œpacingâ€ doesnâ€™t work. This is nonsense–and Action For ME bears much of the blame.
Action For MEâ€™s current leadership has, thankfully, taken some major steps to repair its often-tense relationship with many in the patient community. The organization has distanced itself from Professor Esther Crawleyâ€”a good move given that her work is rife with ethical and methodological flaws. It has acknowledged the problematic nature of its involvement in PACE, and has updated the information about the illness on its site to better conform to reality. While these actions were welcome, they should have happened years earlier.
The organization also signed last summerâ€™s open letter to The Lancetâ€”a first. Some advised me to refuse to let Action For ME add its name, given the history. That was an interesting and provocative proposition. But I felt that the groupâ€™s public endorsement of the letterâ€™s argument outweighed the political point that would be made by excluding it.
Despite these changes, criticisms continue. For many patients, the groupâ€™s PACE mea culpa and the revised website information, while welcome, did not adequately address all concerns. And the Science For ME forum has recently been discussing an Action For ME â€œtool-kitâ€ designed for professionals advising ME patients on work-related issues. This document was based on a program called â€œSupport, empower and employ people with ME,â€ which Action For ME piloted at Bristolâ€™s NHS CFS/ME specialist service in 2015-2016.
Hereâ€™s what the tool-kit states: â€œThe information and advice presented in this toolkit is based upon the evidence, experiences and outcomes of the SEE M.E. service, and aims to improve employment outcomes for people with M.E. by informing the practice of those professionals working with them.â€
Unfortunately, it is hard to trust much of the information coming out of clinical services that generally adhere to the notions promoted by the GET/CBT ideological brigades. Whatever the possible value of the SEE ME program, conducting a test-run at a clinic strongly advocating the now-discredited treatment paradigm was a short-sighted move–that is, if Action For ME hoped to foster credibility for this endeavor among patients. That clinic environment could also explain the overall impression created by the tool-kit, which appears to be suggesting that the main thing many or even most ME patients need to have a fulfilling work life is some encouragement that they can do it.
To be frank, this document comes across largely as a light form of biopsychosocial mumbo-jumbo. Patients are generally desperate to work. The idea that they need â€œencouragementâ€ to do so parallels the insulting and debunked claim that they have â€œdysfunctional cognitionsâ€ about the illness and an irrational fear of activity. That is likely not the intent of the tool-kitâ€”but thatâ€™s certainly how it reads to me. It is therefore troubling that this document has apparently been widely distributed to bureaucrats at the Department of Work and Pensions as authoritative professional advice.
As usual, the smart patients on the Science For ME have been all over this. One of them, Trish Davis, sent the following open letter to Action For ME:
To the trustees and staff of Action for ME.
A personal plea from a long standing ME sufferer and carer.Â
â€˜Toolkit for professionalsâ€™ – A critique and request for withdrawal
I understand the SEE ME project was set up to test whether a specialist employment and benefit support and advice service, based in an ME/CFS clinic, focused on the particular needs of people with ME (pwME) would be useful both in covering perceived deficiencies in existing services and to address the particular challenges faced by pwME, and to save time and therefore money for ME clinicians to focus on their clinical care of the patient.
I can see that, having tried out such a service at one clinic, it seemed logical to pass on lessons learned from this project that are specific for pwME to the organisations that normally deal with these clients. Giving occupational health assessors, CAB advisers, and DWP job coaches and benefits assessors accurate and helpful information about ME and the particular needs and difficulties faced by pwME could be useful.
BUT the following conditions would need to be met:
1. TheÂ definition and descriptionÂ of ME/CFSÂ should be based on recognised criteria, include post exertional malaise, and include accurate descriptions of both the symptoms and the severity and disabling effect of those symptoms. And it should not confuse the picture by implicitly or explicitly including other fatiguing conditions such as idiopathic chronic fatigue, anxiety, depression or stress related problems such as burn out.
2. The description ofÂ Post Exertional MalaiseÂ should be accurate and not downplay the severity and risk of prolonged worsening from seemingly slight levels of over-activity. PEM is not just feeling a bit sicker or more tired for a few days after significantly increased activity. It can be completely disabling and last significantly longer than a few days and be triggered by quite minor increases in activity and can lead to long term deterioration.
3. Any descriptions of what is known at present aboutÂ causes, underlying pathology and perpetuating factorsÂ of ME must be accurate and evidence based. The biopsychosocial, central sensitisation and stress-HPA-axis models of ME are not evidence based. Treatments based these models that include changing mind set, ignoring or re-interpreting symptoms, or ‘desensitisation’ or overcoming deconditioning by building up activity, do not work and may cause harm. Therefore suggestions that pwME need to be encouraged to do more, or are reluctant to try, or can gradually build up their activity to beyond their current energy envelope, have no place in evidence based employment support or advice.
4. Any description ofÂ severity levelsÂ and consequent levels of disability, duration of relapses and unpredictability of these needs to be accurate and not downplay the seriousness of the disease and the likelihood that the majority of pwME are too sick to work. The current document barely mentions the majority of pwME who are moderate or severe and unable to work at all.Â
5. PacingÂ needs to be accurately described, including the importance of staying within the energy envelope and listening to the body. Pacing, as most experienced patients understand it, is not a structured or hour by hour planned process, and does not involve increasing activity outside the energy envelope – whether by 10% or any other amount. The key is finding the baseline, or â€˜energy envelopeâ€™ and sticking within it, listening to the body and reducing activity when symptoms begin to worsen, and resting as much as needed to prevent short or long term relapses.
6. The impossibility of planning aheadÂ should be emphasised, and therefore the complete inappropriateness of terms like â€˜rehabilitationâ€™, â€˜goalsâ€™, â€˜gradually increasing activityâ€™ etc. The harms likely from such approaches for the majority of pwME need to be spelled out. Setting goals and any planning which involves any increases in activity are incompatible with pacing. A proper risk assessment of any rehabilitation plan for a pwME that involves increasing activity planned ahead of time would be likely to find too great a risk of long term harm and no evidence of benefit to the pwME either in health or in employment prospects. (Even the flawed PACE trial did not manage to find any improvement in employment or objective health measures for the active therapy groups).
7. Advice servicesÂ for pwME on employment and benefits should focus solely on providing information about employment rights, help with achieving these with employers, and assistance with accessing benefits to which they are entitled. They should not involve goal setting or making rehabilitation plans. Such forward planning for activity levels different from what the patient is currently able to sustain is effectively medical advice and has no evidence supporting its use.Â Â
8. Objective scientific evidence:
Any written or spoken advice from AfME to professionals on how to deal with pwME with respect to employment or benefits should not be based on the subjective impressions of the workers and subjective feedback from clients on a single short term project that was not studied scientifically. Experiences on a project based in a clinic and provided while the pwME are also getting clinical support from the clinic should not be extrapolated to pwME who are not being seen in that context (eg hospital clinic versus job centre). Documents and information provided to professionals must be based on rigorously carried out, scientific trials of the strategies included in the advice, with a meaningful control group, objective outcome measures and long term follow up, and specific to the type of context in which the strategy is being tested.
The â€˜Toolkit for Professionalsâ€™ fails on all 8 counts.
Action for M.E.’s commitment to scientific evidence
The ME charities in the UK, including Action for ME, have been fighting hard to get the NICE guidelines changed on the basis that the evidence for the directive CBT and GET approach has been shown to be scientifically unsound, and the treatments can cause harm. The charities have insisted in their submissions to NICE that clinical guidelines should be based on sound and objective scientific evidence.
Given that, I find it shocking to see Action for ME undermining so dramatically and drastically all that good work by producing a document for professionals that is not evidence based, not scientific, full of false or unfounded claims and assumptions and is likely to do immeasurable harm to pwME. I find it equally shocking that an employee of Action for ME is not only be unable to provide me with any evidence, but appears puzzled at a request for research evidence supporting the approach taken in the document. Does AfME not have a commitment to provide information based on sound evidence?
The way forward
I therefore ask that AfME take responsibility for this major error of judgement in producing and disseminating this unevidenced document, and withdraw the â€˜Toolkit for Professionalsâ€™ immediately, and inform the DWP, and anyone else it has been given to, that this has been done and why.
A short replacement document spelling out the seriousness of ME as a disabling illness made worse by activity and for which setting employment goals, forward planning and rehabilitation are not appropriate strategies should be provided to counteract the damage done by the Toolkit. I suggest such a document, which need not be more than a page or two, be written in consultation with expert patients who understand the importance of science and evidence (such as those on the Science for ME forum).
It should be emphasised to the DWP that pwME who are currently too sick to work should be automatically placed in the ESA support group, on the grounds that there is no evidence that making pwME set goals, or undergo any planning or rehabilitation activities leads to improved health or employment, and that expecting pwME who are currently too sick to work to participate in such processes is cruel and harmful and likely to cause worsening symptoms long term.
The current Toolkit document, with its emphasis on goal setting and rehabilitation, provides a real and present danger that more pwME will be wrongly placed in the Work Related Activity Group (WRAG) by the DWP, and expected to do inappropriate preparation for work activities and to return to work when they are too sick to sustain it, endangering their long term future health.
I urge Action for ME to act swiftly before the misinformation and unevidenced advice in the Toolkit document are disseminated any further and to counter the harm already done.
I could, when I have recovered sufficiently from writing this letter, provide a detailed critique of the inaccurate and inappropriate material in the Toolkit. However, I see no point in doing this when I am urging that the whole document be withdrawn.
To get a flavour of the specific points of contention, and the level of anger at the harm this document will cause, I suggest you read carefully the responses on the Science for ME forum thread.
I am the member called Trish on that forum. I emphasise that this is a personal letter. I am not writing on behalf of the forum or its members.
Link to thread.
I think Action for ME needs to reconsider its apparently high dependence for materials for training doctors and other professionals on the North Bristol clinic run by Hazel Oâ€™Dowd. It is not appropriate that medical advice and clinical training for a physical illness like ME/CFS is devised or presented by a clinical psychologist with no medical training.
Thank you. I look forward to your considered response.
Please note: This letter will be made public on the Science for ME forum and I intend to post any reply I receive there too.
Trish received the following response from Clare Ogden, Action For MEâ€™s head of communications:
Many thanks for your email, which I asked my colleague Imogen to pass to me so I could respond on behalf of the charity.
I am hugely grateful to you for taking the time and energy to share your feedback with us, and I understand this would have been a considerable undertaking for you.
The advice we give in the toolkit, published in September 2016, is based on learning from our independently evaluated project which delivered an employment support service to people with M.E. It is designed to provide information, good practice advice, real case examples and practical resources, with the aim of improving the support specialist M.E. clinicians, employment advisers, work coaches and careers guidance practitioners give to people with M.E.
You have very clearly set out your concerns about its content and how this may contribute to misunderstanding about its causes, pathology, perpetuating factors, severity and impact of M.E., and the consequences of these for employment.
You have also asked for the toolkit to be withdrawn, and replaced with a document that spells out the seriousness of M.E. as a disabling illness made worse by activity, and for which setting employment goals, forward planning and rehabilitation are not appropriate strategies.
My team and I have reviewed the toolkit and I do not agree that it should be withdrawn. However, itâ€™s clear that is needs to be updated to ensure it gives clear, accurate, evidence-based information on the severity and impact of M.E., including post-exertional malaise; and the risks associated with ignoring or re-interpreting symptoms, or ‘desensitisation’ or overcoming deconditioning by building up activity.
This update will be included as a priority in our current ongoing content review, which is focusing on the website and also our range of publications.
Your letter will be very useful in feeding into this update, and I would like to thank you again for getting in touch. I understand that this response will be shared on the Science4ME forum.
Many thanks and best wishes
Head of Communications and Engagement
Action for M.E.