In previous posts here, here and here I describe how patients diagnosed with Myalgic Encephalomylitis (ME) are continuously misrepresented, smeared and gaslighted by a propoganda machine at the Science Media Centre. In a relentless barrage of distorted messaging, the propoganda never stops flowing.
From there, it is fed by mainstream media to the general public.
I reproduce here further examples.
APRIL 29, 2019
expert reaction to study investigating a potential biomarker for chronic fatigue syndrome / ME
Prof Sir Simon Wessely, Regius Chair of Psychiatry, Insti- tute of Psychiatry Psychology & Neuroscience, King’s Col- lege London (IoPPN), and President, Royal Society of Medicine, said:
“There have been many previous attempts to find a specific bio- marker for CFS. The problem is not differentiating patients with CFS from healthy controls. The issue is can any biomarker distinguish CFS patients from those with other fatiguing illnesses? And second, is it measuring the cause, and not the consequence, of illness? This study does not provide any evidence that either has finally been achieved. [Excellent point. The same issue ap- plies to the entire research programme of the PS but is rarely mentioned. Instead, multiple occurrences of inappropriate causal language are employed in PS papers.] It is also regrettable that it is claimed that such a test would give “scientific proof” of the existence of the condition, and prove it is “not imaginary”. You don’t need a blood test to prove that an illness exists, and nor does the absence of such a test mean that it is “all in the mind”. Any sub who runs a headline that says ‘new test proves CFS is real and not psychiatric’ should be ashamed of themselves.” [Any sub or Psychiatrist who says CFS is psychiatric and not organic should be ashamed of themselves because this has never been scientifically demonstrated.]
MARCH 22, 2018
reanalysis of the PACE trial
Comment from three authors of the original PACE trial Prof Michael Sharpe, Professor of Psychological Medicine, University of Oxford, Prof Trudie Chalder, Professor of Cognitive Behavioural Psychotherapy, Institute of Psychiatry Psychology & Neuroscience (IoPPN), King’s College Lon- don, & Dr Kimberley Goldsmith Senior Lecturer in Medical Statistics, Institute of Psychiatry Psychology & Neuroscience (IoPPN), King’s College London, said:
“Wilshire et al have written a critique of several papers reporting on the PACE trial of treatments for CFS/ME, of which we are authors. They also report a reanalysis of the PACE trial data. We note that most of the analyses they report have already been published, either in peer re- viewed journals or by ourselves on the PACE trial website (https://www.qmul.ac.uk/wolfson/research-projects-a-z/cur- rent-projects/pace-trial/). [Where exactly? I could not find this, only the message: Sorry, the page you requested could not be found]
“They report different results from the original trial. However this is not surprising as their analyses used only part of the trial dataset and followed a preliminary PACE analysis plan, rather than the final approved and published one. Furthermore they do not refer to the many other trials and meta-analyses that have replicated the findings of the PACE trial.[Why should they? Wilshire et al. conducted a reanalysis of the PACE trial not the entire literature. NICE (2020] did that.]
“In conclusion we find little of substance in this critique and stand by our original reports. [These are all available through the trial website (see above). [Sorry, the page you requested could not be found.] The PACE trial found that CBT and graded exercise therapy are safe and moderately effective treatments; a positive message for people who suffer from this otherwise long-term debilitating illness.”
SEPTEMBER 20, 2017
The Lightning Process – a controversial treatment for chil- dren with chronic fatigue
The Lightning Process is a controversial treatment that is some- times used for children with chronic fatigue syndrome (CFS)/ myalgic encephalomyelitis (ME), a disabling illness that means 1% of UK secondary school children miss a day a week or more of school. Describing itself as “a training course that focuses on the science behind how the brain and body interact”. The Lightning Process has been met with scepticism in the scientific community. [Because it is a pseudoscientific cult based on Neurolinguistic Programming, rituals and osteopathy.]
Researchers decided to test the robustness of this treatment so, despite activists trying to stop them, [Denigration of critics and protesters like those inconvenient people who protest about GM foods?] they ran its first [and, almost definitely, the last] ever trial – an RCT that looked at the effectiveness and cost-effec- tiveness in children with CFS/ME. The results are published in the Journal of Archives of Disease in Childhood [twice – the second time with major corrections – after revelations by ‘activ- ist’ David Tuller about the trial’s changed endpoints and ethical shortcomings.]
SEPTEMBER 20, 2017
expert reaction to controversial treatment for CFS/M
* ‘Clinical and cost-effectiveness of the Lightning Process in addition to specialist medical care for paediatric chronic fa- tigue syndrome: randomised controlled trial’ by Crawley et al. published in Journal of Archives of Disease in Childhood on Wednesday 20th September.
Prof. Alastair Sutcliffe, Professor of General Paediatrics, UCL, said:
“A recent systematic review of neurolinguistic programming (NLP) stated “There is little evidence that NLP interventions im- prove health-related outcomes. This conclusion reflects the lim- ited quantity and quality of NLP research, rather than robust evidence of no effect. [An interesting distinction. There is currently insufficient evidence to support the allocation of NHS resources to NLP activities outside of research purposes.” [Br J Gen Pract. 2012 Nov; 62(604): e757–e764. Published online 2012 Oct 29. doi: 10.3399/bjgp12X658287, PMCID: PMC3481516]. But now we have this interesting study by Crawley, a well-conducted single blind clinical trial that suggests NLP, in combination with other therapies and described as the ‘Lightning Process’, is effective for some children with the very hard to treat condition of chronic fatigue syndrome (CFS).
“Although in my view the effects described show some benefit and are therefore to be welcomed, this could be due to placebo which would still be GOOD news. Costs are modest [Really? They range between £775 and £2500 per patient] and therefore this study is to be welcomed.
“These press releases are accurate, [hype] however, there is no reference to the fact that the effect may be due to placebo as this is a single-blind trial. But in a sense this is not so important [illogical spin] and as the trial shows convincing evidence of benefit [convincing to whom?] and as placebo is impossible to quantify [especially in any trial that does not include a placebo control group] we are left with the alternative possibility that these children benefited from the package of care per se, rather than the nebulous placebo effect.[Hype and spin.]
“CFS is a difficult to treat and common disorder, so overall I welcome this step in the direction of evidence-based care as, at present in the UK, there is little agreement about what is the best way to treat this illness.” [Translates as: “ It’s perfectly OK and welcomed to treat children with a quacky set of techniques that may only consist of a nebulous placebo effect because we hav- en’t really got a clue about else to give them.]
Prof. Dorothy Bishop, Professor of Developmental Neuro- psychology, University of Oxford, said:
“The gains for patients in this study do seem solid, however, I am still rather uneasy because while the patient allocation and statistical analysis of the trial appear to be done to a high standard, the intervention that was assessed is commercial and associated with a number of warning signs. The Lightning Process appears based on neurolinguistic programming, which, despite its scientific-sounding name, has long been recognised as pseu-doscience. [How did this get past the SMC editors?]
“I am sympathetic to the authors’ decision to evaluate the Light- ning Process (LP), given that they had patients who had used it and reported favourably on it, and it could be argued that to fail to do so would indicate a degree of closed-mindedness [This is absurd. Then, must everything any patients anywhere have tried, no matter what, be evaluated in a clinical trial including hyperbaric oxygen therapy, “chi deficiency”, acupuncture, naturopathy and chiropractic (invented by D. D. Palmer, who took his instructions from a talking ghost!) to avoid a ‘degree of closed-mindedness’? What about potential harms and wastage of research resources investigating all these quack practices?] But the commercial nature of LP really creates problems. We cannot tell which aspect of LP is responsible for the gains in patients who took part.
“I noticed, for instance, that LP involves group sessions, where- as the comparison group undergoing standard medical care were treated individually. So it may be that the benefits derive from interacting with other children with chronic fatigue syndrome/ ME, rather than the specific exercises and training. This is, of course, something that could be investigated in future research [!] but meanwhile the concern is that this report will in effect act as positive publicity for a programme that is being proposed for a wide range of physical conditions (including chronic pain, low self-esteem, multiple sclerosis, and depression, to name just a few) and has to date been promoted largely through celebrity en- dorsements.” [You already said, the technique is based on pseudoscience, yet you are really suggesting further research with improved controls? Bizarre!]
Dr James Thompson, Honorary Senior Lecturer in Psychology, UCL, said:
“The treatment in this study looks like it had an effect, at least by the standard of most clinical trials. To be extra robust I would have liked to see more objective measures, but unfortunately chronic fatigue syndrome is not an objective diagnosis, it is a leftover category and fatigue is subjective.[ Not having an objective diagnosis does not prevent objective measurements of improvement, e.g. activity measures.]
“One limitation is that self-report scales can be subject to place- bo effects, however if the patients feel better in the experimental condition in which they receive extra help, even if everyone knows it, then that is something and the pupils miss less school, which is an objective measure. In this case it may not have been the CBT element of the treatment [?], but it looks like it.” [How can you possibly tell?]
Prof. Michael Sharpe, Professor of Psychological Medicine, University of Oxford, said:
“Chronic fatigue syndrome (CFS) is a name for an illness with symptoms of long lasting and disabling fatigue. It affects many young people and can interfere with their education. Whilst some people call it myalgic encephalomyelitis (ME) it is not clear if this is the same or a different condition.
“This trial tests the effectiveness of a commercially available brief intensive talking therapy for CFS called the Lightning Pro- cess. The treatment has similarities to cognitive behaviour ther- apy (CBT) and is given in groups. [Except CBT does not require participants to: Tell everyone that you have been healed; Per- form magical rituals such as standing in circles drawn on paper with positive keywords inscribed; etc etc]. The treatment was found to be better than usual care in fatigue, physical function and school attendance, with benefit seen as long as a year later. It was also safe. The study does not tell us how it works however. “This is a robust study because patient was allocated to one of the two treatments at random ensuring that any difference seen in outcome between these treatments, is not due to pre-existing differences in the patients. The main limitation is that, as it is not possible to hide which treatment they received from the patients, their self-ratings of fatigue and functioning could potentially be biased by their views on the treatment they received. [These criticisms are true of all trials run by the PS including the PACE trial but you have never acknowledged these.] However, differences in the school attendance a year later were also noted; it seems [un?] likely that these could be due to such a bias.
“Commercially available treatments like this one that are being used by patients should be rigorously tested. This is especially important for an illness like this one about which much misin- formation is spread using social media. [And by using medical journals that pass defective trials though peer review and refus- ing to retract them.] We need more studies and less polemic.”
JULY 31, 2017
expert reaction to Journal of Health Psychology’s Special Is- sue 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 Trans- lational 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 chron- ic 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 repu- table 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 criticis- ing the PACE trial. [It is normal practice to consider the quality of a critic’s argument not their institution. For the record, other affiliations of PACE critics include University College 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 out- come 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 has 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 hominen argument.]
A Spokesperson for University of Oxford 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 re- covery 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 ad- vice and with oversight committee approvals before any of the outcome data was analysed.
“Oxford University considers Professor Sharpe and his col- leagues to be highly reputable scientists whose sole aim has been to improve quality of life for patients with ME/CFS. [For he’s a jolly good fellow.] While scientific research should always be open to challenge and debate, this does not justify the unwar- ranted attacks on professionalism and personal integrity which the PACE trial team have been subjected to.” [Nor does it justi- fy vilification of patients who have criticized 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 accom- panying 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 au- thors have been clear about. [The authors have not been at all clear about the limitations and they refuse to accept that 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 stan- dard 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 com- monly 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. [Hype].
“Despite these impressive results [repeated hype], this isn’t time for complacency. Some patients do not benefit from the treat- ment. [Many patients do not benefit from the treatment.] We need to do more to understand why. [Examine the underlying theory?] 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 import- ant note for commissioners as not all CBT and exercise therapies are equal. Specialist knowledge and competence [and a failure to take account of placebo effects] in these therapies is needed to obtain these sustained [questionable] treatment effects.”
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.” [Totally conflicted and biased, but that’s the reason the SMC selected you.]
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 treat- ments 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 Liver- pool, Independent assessor of trial safety data for PACE trial and Principal Medical Advisor, Action for ME, 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 de- signed, rigorously conducted and scrupulously analysed and re- ported [but full of well-recognised flaws, nevertheless.] It pro- vides [un]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 mech- anisms 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 is a placebo effect.]
Dr Derick Wade, Consultant and Professor in Neurological Rehabilitation and Clinical Director, Enablement Director- ate, 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 means that the conclusions drawn can be drawn with confidence. [An untrue statement.]
“This is a very significant finding. It identifies that one common- ly 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 treat- ments. 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 de- liver greater benefits.
[All of the above 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 Prac- tice at NICE, said:
“We welcome the findings of the PACE trial, which further sup- port 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 clin- ical need to update our guideline. Until then, healthcare profes- sionals should continue to follow our existing recommendations, especially as this latest research appears to endorse them as best practice for the NHS.”
[NICE, 2020, 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, 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.” [Promotes her forthcoming SMILE trial grant application.]
Prof Willie Hamilton, GP in Exeter and Professor of Primary Care Diagnostics, Peninsula College of Medicine and Den- tistry, 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 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.”
[For good reasons, patient organisations did not accept the PACE trial evidence. CBT and GET continue to fail patients’ health care needs.]
Copyright: ©2022 David F Marks. This post is reproduced from an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. The original source is:
David F Marks. (2022). The Rise and Fall of the Psychosomatic Approach to Medically Unexplained Symptoms, Myalgic Encephalomyelitis and Chronic Fatigue Syndrome. Arch Epidemiol Pub Health Res, 1(2), 97-143.