The Science Media Centre and MECFS: Best Scientific Evidence or Biased Opinion?

The Science Media Centre describes itself as: “an independent press office helping to ensure that the public have access to the best scientific evidence and expertise through the news media when science hits the headlines.” (https://www.sciencemediacentre.org/)

Here I examine the SMC’s reports on MECFS-related publications relating to the PACE trial, from 2011 when the trial was published until 2017 when the Journal of Health Psychology published a Special Issue critiquing the trial. What the SMC describes as ‘best scientific evidence’ consists of biased opinions from people with strong vested interests.

My personal take on the experts’ opinions is placed [inside square brackets throughout the text].

The recently published revised guidance on MECFS by NICE (2021) recommends that GET should be dropped and CBT only used in a supportive role in the treatment of people with MECFS. How well does the SMC ‘expert opinion’ stand up to scrutiny in light of that new NICE guidance?

I leave this for readers to decide.

JULY 31, 2017

expert reaction to Journal of Health Psychology’s Special Issue on The PACE Trial

The Journal of Healthy Psychology has published a special issue focusing on the PACE trial – originally published in The Lancet (2011). ‘Special Issue on The PACE Trial’ edited by David Marks published in Journal of Health Psychology on Monday 31st July 2017.

Prof. Malcolm Macleod, Professor of Neurology and Translational Neuroscience, University of Edinburgh, said:

“The PACE trial, while not perfect, provides far and away the best evidence for the effectiveness of any intervention for chronic fatigue; and certainly is more robust than any of the other research cited. Reading the criticisms, I was struck by how little actual meat there is in them; and wondered where some of the authors came from. [Ad hominem]. In fact, one of them [a reputable and well-published family doctor in Amsterdam] lists as an institution a research centre (Soerabaja Research Center) which only seems to exist as an affiliation on papers he wrote criticising the PACE trial. [It is normal practice to consider the quality of a critic’s argument not their institution. For the record, affiliations and the alma mater of other PACE trial critics include University College London, City, University of London, Northwestern University, DePaul University, the University of Hertfordshire, Victoria University of Wellington New Zealand, UC Berkeley, and the ME Association.]

“Their main criticisms seem to revolve around the primary outcome was changed halfway through the trial: there are lots of reasons this can happen, some justifiable and others not; the main think is whether it was done without knowledge of the outcomes already accumulated in the trial and before data lock – which is what was done here. [Evidence on this point remains uncertain.]

“So I don’t think there is really a story here, apart from a group of authors, some of doubtful provenance [a family doctor does not have doubtful provenance]  kicking up dust about a study which has a few minor wrinkles (as all do) but still provides information reliable enough to shape practice. If you substitute ‘CFS’ for ‘autism’ and ‘PACE trial’ for ‘vaccination’ you see a familiar pattern…” [This statement is a shameful ad hominem argument that is unbecoming of any reputable academic.] 

A spokesperson for University of Oxford [where a PACE trial investigator is employed, no conflicts of interest declared] said:

“The PACE trial of Chronic Fatigue Syndrome treatments was conducted to the highest scientific standards and scrutiny. This included extensive peer review from the Medical Research Council, ethical approval from a Research Ethics Committee, independent oversight by a Trial Steering Committee and further peer review before publication in high-impact journals such as The Lancet. 

“The allegation that criteria for patient improvement and recovery were changed to increase the reported benefit of some treatments is completely unfounded. As the study authors have repeatedly made clear, the criteria were changed on expert advice and with oversight committee approvals before any of the outcome data was analysed.

“Oxford University considers Professor Sharpe and his colleagues to be highly reputable scientists whose sole aim has been to improve quality of life for patients with ME/CFS. While scientific research should always be open to challenge and debate, this does not justify the unwarranted attacks on professionalism and personal integrity which the PACE trial team have been subjected to.” [It does not justify vilification of patients, citizen scientists and scholars who have criticized very poorly done trials such as the PACE trial.]

OCTOBER 28, 2015

expert reaction to long-term follow-up study from the PACE trial on rehabilitative treatments for CFS/ME, and accompanying comment piece

A paper published in The Lancet Psychiatry reports results of a long-term follow-up study to the PACE trial for CFS/ME. The study has assessed the original trial participants’ health in the long-term, and asks whether their current state of health, two and a half years after entering the trial, has been affected by which treatment they received in the trial.

‘Rehabilitative treatments for chronic fatigue syndrome: long-term follow-up from the PACE trial’ by Michael Sharpe et al. published in the Lancet Psychiatry on Wednesday 28 October 2015.

‘Chronic fatigue syndrome: what is it and how to treat?’ by Steven Moylan et al. published in the Lancet Psychiatry on Wednesday 28 October 2015.

Prof. Rona Moss-Morris, Professor of Psychology as Applied to Medicine, King’s College London, said:

“I think this is a robust study with some limitations that the authors have been clear about. [The authors have not been ‘clear about’ the limitations and refuse to acknowledge the many methodological flaws in the PACE trial. ] The original PACE trial published in 2011 showed that at one year people with CFS/ME who received either graded exercise therapy (GET) or cognitive behavioural therapy (CBT) in addition to standard medical care were significantly less fatigued than those who received standard care alone or those who received adapted pacing therapy. The authors concluded GET and CBT were moderately effective treatments for CFS. Now, moderately effective may not sound all that impressive until you consider that many of our commonly used pharmaceuticals for medical conditions have similar moderate treatment effects. When using pharmaceuticals as treatment, maintaining these effects may mean taking ongoing medicines. This study shows that even two years or more after treatment has completed, patients receiving GET and CBT sustain their clinical benefits. A small percentage of these patients accessed some further treatment, but even so, these sustained effects are impressive. [In light of re-analyses, the effects practically disappear and are fully consistent with a placebo effect].

“Despite these impressive results [hype], this isn’t time for complacency. Some patients do not benefit from the treatment. [The majority of patients do not benefit from the treatment.] We need to do more to understand why. [A critical review of the underlying theory would be a good place to start.]  We also need to develop and tailor existing treatment to get larger effects. It is also important to note that the CBT and GET protocols used in PACE were developed specifically for CFS. They are not the same as CBT for depression and anxiety or the exercise training you may receive at a local gym. The therapies are based on a [non-scientific] biopsychosocial understanding of CFS and the health care professionals in PACE received specific training and supervision in these approaches. This is an important note for commissioners as not all CBT and exercise therapies are equal. Specialist knowledge and competence [and a failure to control for placebo effects] in these therapies is needed to obtain these sustained [contentious and unrecommended by NICE, 2020] treatment effects.”

 Declared interests

Prof. Rona Moss-Morris: “Two authors of this study, Trudie Chalder and Kimberley Goldsmith, are colleagues of mine at King’s College London. I work with Trudie on other CFS work and with Kimberley on different work. I published a small study on GET in 2005. I am a National Advisor for NHS England for improving access to psychological therapies for long-term conditions and medically unexplained symptoms. Peter White (another author of the present study) is Chair of trial steering committee for an HTA NIHR-funded RCT I am working on with people with irritable bowel syndrome.” [Multiple conflicts of interest declared.]

FEBRUARY 17, 2011

expert reaction to Lancet study looking at treatments for Chronic Fatigue Syndrome/ME.

Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial, by Peter White et al, published in the Lancet at 00.01hr UK time Friday 18 February 2011.

The study made the first definitive comparison of various treatments for CFS/ME to deduce the most effective treatments.

Dr Alastair Miller, Consultant Physician at Royal Liverpool University Hospital, Clinical lead for CFS services in Liverpool, Independent assessor of trial safety data for PACE trial and Principal Medical Advisor, Action for ME, [Action for ME was one of the PACE trial sponsors and Dr Miller has an undeclared conflict of interest] said:

“Although NICE have previously recommended graded exercise and CBT as treatments for ME/CFS, this was on the basis of somewhat limited evidence in the form of fairly small clinical trials. This trial represents the highest grade of clinical evidence – a large randomized [uncontrolled] clinical trial, carefully designed, rigorously conducted and scrupulously analysed and reported [A totally false description of the PACE trial which contained 14 design and ethical flaws.] It provides convincing evidence that GET and CBT are safe and effective and should be widely available for our patients with CFS/ME.

“It is clearly vital to continue our research into biological mechanisms for ME/CFS but recent ‘false dawns’ for example, over the role of retroviruses (XMRV) have shown how difficult this can be. In the current absence of a biomedical model for the causation and the absence of any pharmacological intervention, we have a pragmatic approach to therapy that works and we should use it.” [even if it is only a small placebo effect?]

Dr Derick Wade, Consultant and Professor in Neurological Rehabilitation and Clinical Director, Enablement Directorate, Oxford Centre for Enablement, said:

“CFS is common, and it is vital to know whether treatments proposed and/or used are safe and are effective. Randomised controlled trials provide the best and only reliable evidence on safety and effectiveness of any intervention in any condition. The trial design in this study was very good, [but it was not a controlled trial and there are more than a dozen objective flaws] and means that the conclusions drawn can be drawn with confidence. [A patently untrue statement.]

“This is a very significant finding. It identifies that one commonly used intervention is not effective (and therefore should not be used), and it confirms the effectiveness of two treatments, and their safety. The study suggests that everyone with the condition should be offered the treatment, and every patient who wishes to be helped should be willing to try one or both of the treatments. It also means that we can allocate resources to treatments that will benefit patients and, more importantly, stop allocating treatments that do not have proven efficiency. Further research should identify ways that treatments derived from these may deliver greater benefits. [All of this paragraph is spin.]

“Research needs to investigate both treatments and factors that increase the risk of developing CFS. However, it is probably more effective to research treatments, and proving a treatment is effective starts to give clues about causative factors.”

Dr Fergus Macbeth, Director of the Centre for Clinical Practice at NICE, said:

“We welcome the findings of the PACE trial, which further support cognitive behavioural therapy and graded exercise therapy as safe and effective treatment options for people who have mild or moderate CFS/ME. These findings are in line with our current recommendations on the management of this condition.

“We will now analyse the results of this important trial in more detail before making a final decision on whether there is a clinical need to update our guideline. Until then, healthcare professionals should continue to follow our existing recommendations, especially as this latest research appears to endorse them as best practice for the NHS.”

[NICE, 2021, reported its revised guidance that GET should be dropped and CBT only used in a supportive role.]

Dr Esther Crawley, Consultant Paediatrician and Clinical Lead for the Bath Specialist Paediatrics Chronic Fatigue Syndrome/ME Service, [research associate with no conflicts of interest declared] said:

“All children with chronic fatigue syndrome and their parents are desperate for new research to understand how to treat this condition. The next step is to do a study like this for children to find out if these treatments work.” [Promoting her SMILE trial grant application.]

Prof Willie Hamilton, GP in Exeter and Professor of Primary Care Diagnostics, Peninsula College of Medicine and Dentistry, said:

“At least half of patients improved with CBT or GET. The study also allays fears that CBT or GET may be harmful. [Not among patients who are at the receiving end.] There are a minority of patients who didn’t see improvement so the next step must try and find treatments to help them.

“This study matters: it matters a lot. CFS/ME is common, and causes a lot of suffering. Up until now we have known only that CBT and GET work for some people. We didn’t know if pacing worked. This caused a real dilemma – especially for those in primary care. We didn’t know whether to recommend pacing, or to refer for CBT or GET. Worse still, not all GPs have access to CBT or GET, so ended up suggesting pacing almost by default. This study should solve that dilemma.

“At a patient level, I now know what to suggest to my patients. Almost as important, it sends a powerful message to PCTs – and the soon-to-be-formed GP consortia – that they must fund CBT or GET. NICE proposed that before this study came out – the evidence is even stronger now.”

[With the exception of AfME who sponsored the trial, and later apologised, patient advocacy organisations have not accepted the PACE trial evidence. CBT and GET continue to fail to meet patients’ needs. The NICE (2021) guidance changed recommendations on both GET and CBT and neither therapy is recommended as a treatment for MUS/MECFS.]          

Published by David F Marks

Author, editor, psychologist.

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