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Crimeless victims – living with a chronic illness

Originally written by Esther Mills, and available here: http://www.helium.com/items/1660416-chronic-illness

There are victimless crimes, and then there are crimeless victims. That is one of the most hateful aspects of chronic illness, that it is a crime with no criminal. A family may be torn apart by a cruel illness but there is no one to lash back at; it is the hit-and-run that keeps on giving.

When they do think of chronic illness, those on the outside may think mainly of the ill person himself, but the genius of illness is how thin it can spread itself and how many people it can devastate beyond just the person it touches. The man with multiple sclerosis suffers a great deal, and so does his wife: in mourning the loss of what their marriage used to be, in his daily care, in worry about the future, in having no one to talk with who understands. The children of the woman with fibromyalgia adju st to the “new normal” way of life, learning to care more for themselves or need less from their mother, learning to walk under skies that are never completely bright.

Like a predator, chronic illness isolates its prey and attacks. Few friends are able to understand, nor do they find it comfortable to imagine it for too long, and so they call less, visit less…or else the ill person himself finds it hard to reach out. He sinks into the depths and leaves phone calls unreturned. He turns his face from the window and embraces the lethargy of depression.

Chronic illness is the slow, insidious death of dreams. The once wide-open future has been reduced to only one or two possibilities, and neither of them is particularly exciting. Those who are ill shut themselves off, as well as they can, from what might have been, while those who care for them try to forget what else they had hoped to do. This is the new reality, and thinking of anything else is now an exercise in masochism.

Of course they tried fighting at first, tried flinging their fists at the invisible assailant, but inevitably they wore down. Now the world still revolves freely outside, but inside, here where illness lives, those taken hostage by it follow its rules and submit to its demands with a sort of glassy-eyed resignation. There is nothing else to do, after all, with no one to fight, and no one on the receiving end of an anger which rises, always, despite its futility.~jimmy~

CBT and GET: do they help ME/CFS?

Various media outlets have recently reported on the cost-effectiveness of receiving Cognitive Behavioural Therapy and Graded Exercise Therapy as treatment for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome.  The paper referred to is McCrone et al 2012[1] and can be found on the PLOS One website.

Amongst ME/CFS sufferers and related charities there is a lot of reticence regarding the efficacy of CBT and GET.  For those with severe symptoms, CBT at best is able to help cope with the illness and GET is often found to make it worse.  These are anecdotal conclusions, so it is important for randomised controlled trials to be conducted to find out what treatments are effective.

The trial citied above relied on the Oxford Criteria (1990) for CFS.  These are:

  • there is a definite onset (ie it is not lifelong)
  • fatigue is the main symptom
  • the fatigue is severe, disabling and affects both physical and mental functioning
  • the fatigue has been present for at least six months, during which time it has been present more than 50 per cent of the time
  • other symptoms may be present, particularly myalgia, mood and sleep disturbance.

This is markedly different from the criteria that are most widely used, from the Centre for Disease Control (1994) in the USA, which importantly includes post-exertional malaise and gives more weight to non-fatigue symptoms:

  • Fatigue of definite or new onset that is not the result of exertion, is not significantly improved by sleep or rest and which results in substantial reduction in overall performance for a consecutive period of six months or longer.

Plus at least four from the following list:

  • self-reported significant impairment of short term memory or concentration
  • sore throat
  • tender lymph glands (small swellings under the skin which are part of the immune system) in the neck region or under the armpits
  • muscle pain
  • headaches of a new type, pattern or severity
  • unrefreshing sleep
  • malaise following effort that lasts more than 24 hours
  • pains in several joints occurring without joint swelling or redness.

A previous paper[2] by the same people found that CBT and GET were more effective than ‘specialist medical advice’ or ‘adaptive pacing training’, and the size of this effect is moderate.  GET was effective in reducing post-exertional malaise and CBT was effective in improving mood.

The trial has met with significant criticism.  As the White et al 2011 paper and McCrone et al 2012 people use the same data, criticisms apply to both papers.

A report by Professor Malcolm Hooper provides information of the flaws in the above papers.[3]  These include:

  • “Significant and serious mis-reporting and non-reporting of the PACE trial results.”
    • Outcomes were measured as the distance walked in six minutes.  Completion figure for this test was 20% lower than the secondary outcome measures.  The Principal Investigators do not explain this.  If this is because participants dropped out due to poor health, then the results are biased in favour of the best-scoring participants.
    • Participants receiving GET were unable at the end of the trial to walk as far as patients with chronic obstructive pulmonary disorder, chronic heart failure or heart failure classes II or III, or those awaiting lung transplantation.  GET recipients on average improved their walking distance by 67 metres, to 379m.
    • The “clinically useful” differences used to assess improvement are “so small as to be imperceptible in daily living.”  60% of those receiving GET and 58% of those receiving CBT reported negative or minimal change.
    • Around 87% of patients did not benefit to a clinically useful degree from CBT/GET.
    • No data on recovery has been provided.
    • No data on rate of deterioration has been provided.
    • No data on return to gainful employment has been provided.  The trial was funded partly because it was hoped that it would find a therapy that brings sufficient improvement to ME/CFS sufferers to get them off benefits and into work.
    • No data relating to Investigator bias has been provided.
    • “The Investigators already knew, as did Professor Simon Wessely, that: “These interventions are not the answer to CFS”[4] and that “many CFS patients, in specialised treatment centres and the wider world, do not benefit from these interventions”[5]
  • Poor quality of research:
    • Professor White simultaneously claimed there was sufficient evidence for CBT and GET to be the recommended treatment for ME/CFS, and that there was insufficient evidence on CBT and GET efficacy such that he received a £5 million grant to study these interventions.
    • Members of this RAG ignored elementary rules of procedure that require awareness of already established knowledge of the disorder under consideration.   This is in contravention of the Declaration of Helsinki that, “Medical research involving human subjects must conform to generally accepted scientific principles (and) be based on a thorough knowledge of the scientific literature.”
    • Recruitment difficulties led to some patients feeling they were coerced into the trial, by being told they would be discharged (and thus lose consultant support for claiming State Benefits) if they did not agree to undergo CBT and GET.  This contravenes the Declaration of Helsinki.
    • It is inadvisable, misleading and unethical to advise participants that CBT is a cure.  Giving participants such a bias can create a placebo effect.
    • Patients were unable to report a deterioration.
    • The Chalder Fatigue Questionnaire cannot record post-exertional malaise.  This is unscientific when studying a disorder for which the primary symptom is post-exertional malaise.
    •  “The trial therapists were trained to provide participants with misinformation; they were also trained to advise participants to ignore symptoms arising from the interventions, a situation that may in some cases result in death.”
    • The Investigators used a six minute walking test as “an objective outcome measure of physical capacity.”  It is difficult to get reproducible results with this test and it is not truly objective.  No objective measures were obtained, because measuring post-treatment actigraphy was abandoned “on the spurious grounds that wearing such a monitor for one week would be too great a burden at the end of the trial.”  Participants’ subjective responses to questionnaires do not relate well to actual activity. “This is of particular concern when two of the interventions being tested (CBT and GET) specifically encouraged participants to re-interpret their symptoms as not resulting from disease but as normal responses to exercise in deconditioned people.”
    • The trial was not a controlled trial.
    • The MRC Research Activity Group (authored by one of the PACE trials Investigators) for ME/CFS said that it is not necessary to identify causal pathways for ME/CFS, in conflict with the duty of the Medical Research Council (MRC) to identify causal pathways.
  • Numerous changes were made to the trial after the trial began:
    • The entry criteria to the trial were diluted after the commencement of the trial. “This undermines the reliability of all conclusions to be drawn from the data, not least because the first tranche of participants met different entry criteria from those who were recruited later.”
    • Recovery statistics were redefined so that a participant could decline on both primary outcomes (fatigue and physical function) yet still fall within “normal range.” A patient could enter the trial as below normal, deteriorate and then leave the trial as “normal,” because the normal range was reset to be lower than the entry criteria.  “Normal range” thus did not mean “normal” health at the end of the trial.  Patients with Hep C, osteoarthritis of the hip or those with stable congestive heart failure would by this standard be considered “normal.” The figure of 30% of CBT and GET recipients recovering was based on this redefinition of “normal.”
    • Scoring methodology was changed, leading again to a patient deteriorating yet leaving the trial in the (new) “normal range.”  This may have been because a paper published a year previously had reported no reductions in fatigue or physical function after 70 weeks.   There was thus an incentive to change methodology in order to find a ‘significant’ effect.
    • The article cited the comparison group as the UK working age population.  In fact it was the English adult population, which includes the elderly and thus allows a lower threshold of the “normal” range.
    • The Chief Principal Investigator said, in writing, that, “The PACE trial paper …. does not purport to be studying CFS/ME but CFS defined simply as a principal complaint of fatigue that is disabling, having lasted six months, with no alternative medical explanation (Oxford criteria).” Yet ethical approval and funding were granted for studying ME/CFS, not fatigue.
  • The trial was reported in an inaccurate manner:
    • It was not correctly registered, and thus could be manipulated at a later date to appear more successful than was the case.  “Numerous changes were made between the publication of the Trial Protocol and the publication of selective results in the Lancet.”
    • It failed to comply with the Trial Protocol that primary outcome measures are reported; did not conform to Good Clinical Practice guidance, the Data Protection Act (1998), CONSORT or the ISRCTN Register for transparency and completeness; and the Chief Principal Investigator did not keep his promise to the West Midlands Multicentre Research Ethics Committee.[6]
    • Baroness Wilcox said “that the MRC does not have a position on how the outcome of MRC-funded studies are interpreted and used by regulators or policy makers.”[7]  This “essentially means that investigators can mis-report their findings and withhold their data at will because the MRC takes no responsibility for checking, and such misrepresentation of the data can then be relied upon and used with impunity by Government bodies.”[8]  Yet the MRC requires that data is presented accurately for safe use by clinicians and policy makers.
    • The data was presented in such a way that “it may be construed as their attempt to hide the fact that the PACE Trial results were disappointing. One can only conclude that Professor White endeavoured to disguise the poor results in the wealth of data presented, because the detail in the published figures serves to obscure the fact that the reported “improvements” are miniscule, and for those results to have been widely proclaimed as even “moderately successful” must border on impropriety.”
  • The researchers involved in the trial are all psychiatrists from the Wessely School, who deliberately ignore scientific consensus regarding ME/CFS:
    • They knowingly and deliberately conflate ME/CFS with chronic fatigue (burn-out).  Whilst they consider ME/CFS to be chronic fatigue, and that both are mental or behavioural disorders, current scientific consensus is leaning towards true ME/CFS as being an immunological disorder.  WHO classify ME/CFS as a neurological disease, and have done so since 1969.  The UK Read Codes, National Service Framework of long-term neurological syndromes and Department for Work and Pensions all treat ME/CFS as neurological.  It is not possible for dual classification under WHO; therefore ME/CFS cannot be classified as a mental health condition.  Chronic fatigue is a distinct condition that is separate from and unrelated to ME/CFS.  Portrayal of ME/CFS as a “dysfunctional belief” is “both scientifically invalid and also unethical.”
    • the Wessely School wrote the Oxford Criteria, which by definition excludes people with neurological conditions.  The results therefore do not apply to those with ME/CFS, contrary to the Investigator’s claims.  Regarding the Oxford Criteria, “there is no consensus about them; they are used only in Britain and only by the Wessely School; they lack diagnostic specificity, have been shown to have no predictive validity, and select a widely heterogeneous patient population.”
    • Professor Hooper lists 27 “proven and published organic abnormalities in ME/CFS”; these include cardiac failure, reduced lung function, dysfunction of energy metabolism.  There is no evidence of deconditioning or that ME/CFS is a psychiatric or behavioural disorder.
    • “From the Chief PI’s perspective, the existence of biomarkers was indeed irrelevant to the application of CBT and GET to correct what he and his colleagues assert are reversible wrong illness beliefs and deconditioning. However, they were not irrelevant to what should be the primary aim of any clinical trial, namely scientific integrity: to base research on a falsehood and to disregard the existing biomedical evidence to suit a desired outcome and personal beliefs is scientifically and morally inexcusable… The PIs portrayed their own assumptions as established facts, thereby deliberately misleading participants, which is deceitful and unethical.”
  • There were conflicts of interest:
    •  Funding for the research changed partway through, probably because of conflicts of interest.
    • The Wessely School work as consultants in the health insurance industry and thus have a vested interest in having ME/CFS classified as a mental disorder, as mental disorders are excluded from insurance benefits.
    • The Wessely School has described ME/CFS as ‘a belief’ and sufferers as ‘the underserving sick.’

Conclusion:  The trial was conducted in contravention of the Declaration of Helsinki B11.  The authors hold to a view of ME/CFS which is in conflict with the scientific consensus[9] and the World Health Organisation.   They also have numerous conflicts of interest.

The study has major methodological flaws.  It presents results that are contrary to the findings of the international scientific community and ignores knowledge and data available from previous studies.  The results it presents are “irrefutably poor.”  To present CBT and GET as effective treatments for ME/CFS will at best lead to a waste of time and resources and at worst cause a worsening in conditions of many ME/CFS sufferers.

“There is irrefutable evidence that ME/CFS is not “medically unexplained fatigue” that is perpetuated by aberrant illness beliefs, pervasive inactivity, membership of a self-help group, hypervigilance to normal bodily sensations or being in receipt of disability benefits, as claimed by the Wessely School.”


[3] Prof Malcom Hooper, June 2012, Briefing Notes re: MRC-funded PACE trial and ME/CFS http://www.investinme.org/Documents/PACE%20Trial/Notes%20for%20meeting%20with%20BIS%20officials.pdf

[4] Editorial: Simon Wessely; JAMA 19th September 2001:286:11

[5] Huibers and Wessely; Psychological Medicine 2006:36:(7):895-900

[6] “Magical Medicine: How to Make a Disease Disappear” http://www.meactionuk.org.uk/magical-medicine.htm; “Professor Malcolm Hooper’s Further Concerns about the PACE Trial, The Lancet http://www.meactionuk.org.uk/Normal-fatigue.htm; “Statistics and ME,” The Royal Statistical Society http://www.investinme.org/Article435%20Statistics%20and%20ME.htm

[7] Prof Malcom Hooper, June 2012, Briefing Notes re: MRC-funded PACE trial and ME/CFS http://www.investinme.org/Documents/PACE%20Trial/Notes%20for%20meeting%20with%20BIS%20officials.pdf

[8] ibid.

[9] Statements of Concern about CBT/GET Provided for the High Court Judicial Review of February 2009: www.meactionuk.org.uk; “at the 7th Invest in ME Conference on 1st June 2012, Professor Dan Peterson from the US said over 6,000 articles have been published.”