This petition calls for the Association of Young People with ME (AYME) to take the necessary action to address the serious concerns outlined below, or cease operating as a charity for children and young people with ME. Specifically:
- We call upon AYME to retract its statements about the PACE trial.
- We call upon AYME to withdraw its support for the pilot study known as SMILE.
SUMMARY OF CONCERNS
AYME stands alone in its welcome of the results of the study known as PACE, and in its support of a pilot study known as SMILE, led by its medical advisor, Dr. Esther Crawley.
- The statements issued on 18th February 2011 by AYME clearly show its support for the conclusions of the PACE trial, despite a raft of scientific and patient evidence to the contrary.
- AYME’s call for studies of CBT and GET with children and young people with ME, in the face of all the contradictory evidence, is irresponsible and is counter-productive to the ME patient community’s call for biomedical research into causes and treatments for both adults and children with ME/CFS.
- AYME is giving support to another trial (SMILE) that its medical adviser is currently involved in – one in which children are test subjects for a commercial training programme that is based on an unproven hypothesis of the cause of ME/CFS, and which relies on the same biopsychosocial model of ME/CFS as CBT and GET.
- In its statements about PACE, AYME gives inaccurate and misleading information which is potentially harmful to children and young people with ME/CFS – see examples listed below under supporting information. We believe this to be a very serious breach of trust and duty of care.
We believe that the statements made by AYME show it to be an organisation that can no longer be trusted to serve the best interests of children and young people with Myalgic Encephalomyelitis or Chronic Fatigue Syndrome, or their families and carers.
THE PACE STUDY
AYME stands alone in its welcome of the results of the study known as PACE.
- PACE compared 3 therapies (described as treatments) for the neurological disease, myalgic encephalomyelitis – also confusingly referred to chronic fatigue syndrome – that aim to affect patients’ thoughts and behaviour, rather than addressing the underlying disease process. They are: cognitive behaviour therapy (CBT), graded exercise therapy (GET) adaptive pacing therapy (APT) – note that APT is a form of graded activity, different from the pacing approach to illness management reported as helpful by most patients and patient groups.
- The PACE trial has been denounced by every other significant patient group around the world (see links below). PACE has been robustly discredited and widely criticised, both for its study methods, and for the presentation of results, which significantly overstated the success of CBT and GET in a way that cannot be substantiated by the figures, and in the face of numerous published studies and patient surveys that come to very different conclusions.
- PACE does not demonstrate that either CBT or GET are either safe or substantially effective therapies for patients with ME/CFS, nor even cost-effective – yet the results will be used to strengthen existing NICE guidelines that recommend CBT and GET as “evidence-based treatments” for ME/CFS.
- ME/CFS is a neurological disease with a viral basis. While talking and exercise therapies can potentially help as palliatives for many illnesses, they cannot treat a neurological disease or chronic infection. It is therefore not acceptable to present CBT and GET as ‘treatments’ for ME/CFS, any more than it would be acceptable to present them as primary treatments for cancer or heart disease. GET has been harmful to a majority of patients with ME.
MISLEADING AND INACCURATE INFORMATION IN AYME STATEMENT ON PACE
1. AYME: “Two effective treatments benefit up to 60 per cent of patients with Chronic Fatigue Syndrome or Myalgic Encephalomyelitis (CFS/ME), according to a collaborative trial funded by the Medical Research Council (MRC) and UK government departments.”
- This high percentage is not supported by the PACE results.
2. AYME: “The findings suggest these two treatments should be offered to all patients who are able to attend hospital if they are suffering from fatigue caused by CFS/ME.”
- The results of PACE do not suggest this.
3. In the notes to editors, AYME states: “The MRC uses the term CFS/ME when referring to CFS and/or ME, in accordance with the World Health Organisation (WHO)’s description of the illness.”
- This is incorrect and an unacceptable error for a charity for children and young people with ME/CFS to publish. Correction of the same mistake made by Health Minister, Paul Burstow, was published on the government website following a recent short debate on ME/CFS research. The World Health Organisation classification of the disease at ICD-10 G.93.3, is Post-Viral Fatigue Syndrome: Benign Myalgic Encephalomyelitis.
- Chronic Fatigue Syndrome (a term invented in the 1980s) is listed in the index where it points the reader to G.93.3 – it has no separate definition at WHO and is, therefore, also classified as neurological. AYME should know that post-mortem examination shows the damage to the brain in ME/CFS that warrants its correct name of Myalgic Encephalomyelitis (not Encephalopathy).
4. AYME: “CFS/ME is a long-term, complex and debilitating condition which causes fatigue and other symptoms such as poor concentration and memory, disturbed sleep and muscle and joint pain. The cause is not known. CFS/ME affects around 250,000 people in the UK.”
- AYME should state that the disease is neurological with multi-systemic effects.
- AYME should state that one of the defining symptoms of ME/CFS is post-exertional malaise – which is not the same as fatigue.
- AYME should state clearly that poor concentration and memory problems are features of broader cognitive dysfunction – this disease is neurological and affects the brain of the child/young patient.
- AYME should not state that the cause of this disease is unknown – it should state accurately that is is usually of clear viral onset and that it is the chronic and often variable nature of the disease that is of unknown cause – as a charity purporting to represent the interests of children and young people with serious and possibly life-long neurological disease, it should state clearly that the reason that the cause remains unknown is that the MRC has consistently failed to fund biomedical research into the biophysical cause – instead, wasting millions of pounds of tax-payers’ money on trials into so-called “treatments” – such as the £5m wasted on PACE – that are based on a behavioural model of “CFS/ME” which its medical advisor Esther Crawley espouses, to the detriment of thousands of children and young people in Britain.
5.AYME: “The PACE trial included 640 patients with CFS from England and Scotland who were able to attend hospital clinics for treatment.”
- AYME should be demanding biomedical research and treatment to help the thousands of children and young people who are too ill to attend clinics for treatment – NOT calling for them to be included in trials of CBT and GET.
6..AYME: “All patients in the trial received specialist medical care which included general advice about managing the illness and prescribed medicines for symptoms such as insomnia and pain.”
- AYME should decry the fact that drugs for symptoms such insomnia and pain constitutes the extent of “specialist medical care” for children and young people with neurological disease.
7.AYME: “CBT and GET are used for a wide range of conditions including rheumatoid arthritis, heart disease, diabetes and chronic pain.”
- AYME should make it clear that CBT and GET are offered as adjunctive therapies for other chronic diseases – there would be an outcry if CBT and GET were a) even described as treatments for these diseases and b) offered as the ONLY treatments for these diseases.
- AYME should reject the advocating of behavioural therapies such as CBT and GET as “treatments” for ME/CFS.
8.AYME: “Professor Michael Sharpe, from the University of Edinburgh and co-author on the PACE trial, said:
“Patients can suffer for years with debilitating symptoms which affect their ability to lead a normal life. Although previous small trials had suggested that CBT and GET help some patients, concerns had been raised about the safety of these treatments. An alternative approach called pacing was widely advocated but had not been scientifically tested. The PACE trial was designed to find out the relative benefits and harms of all of these treatments when combined with specialist medical care.”
- AYME should point out in its statement, that the pacing reported by patients as helpful is not the same as the adaptive pacing therapy used in the PACE trial. Adaptive pacing should not be described as a “treatment”. Pacing is simply a common-sense way for patients to manage their activities in such a way that least aggravates their symptoms and to avoid relapse. PACE was not, therefore, studying the effectiveness of pacing and cannot be used to state that pacing is ineffective in managing symptoms and aiding optimal functioning and possible recovery.
9.In notes to editors, AYME states: “The PACE trial classified patients using the diagnostic criteria for both CFS and ME to test whether the results applied to both groups of patients.”
- AYME should point out that criteria for patient selection for PACE excluded patients with neurological signs or symptoms and by definition, excluded patients with ME/CFS; classified by WHO at ICD-10 G.93.3.
- AYME should point out that, also excluded, were patients with evidence of active chronic infection – a hallmark of ME/CFS patients, as shown in research published in September 2010, which corroborated US research findings in research carried out on adults in 2005. Persistent viral infection would contra-indicate the effectiveness and safety of the approaches used in CBT, GET and The Lightning Process – AYME should publicise the results of this important research and demand that the MRC fund further research on the underlying chronic viral infection in children and young people with ME/CFS, that may lead to treatment that is both appropriate and effective.
Biochemical and Vascular Aspects of Paediatric Chronic Fatigue Syndrome:
STATEMENTS ON PACE BY AYME
“AYME welcomes the findings of the PACE trial, the largest ever study of ME/CFS treatments”. http://www.ayme.org.uk/article.php?sid=7
AYME’s full statement issued 18th February:
AYME‘s comments, as quoted in The Guardian on 18th February:
“The Association of Young People with ME welcomed the findings and said it hoped it would begin to lay to rest fears about graded exercise therapy and CBT being harmful. It called for the study to be replicated in children. Mary-Jane Willows, AYME’s chief executive, said: “These treatments should be made available to all patients by those who are trained and experienced in dealing with CFS/ME.” She added that there was “an urgent need” to find a way to include house-bound patients in a trial. Participants in the study had to be able to get to hospital.”
STATEMENTS ON PACE BY OTHER ORGANISATIONS
The Young ME Sufferers Trust letter to The Guardian:http://www.guardian.co.uk/society/2011/feb/24/truth-about-exercise-and-therapy/print
Invest in ME:
The 25% ME group:
Action for ME:
The ME Association :
European Society for ME:
International Association for CFS / ME:
Professor Malcolm Hooper’s statement on the scientific quality of the PACE Trial:
THE SMILE PILOT STUDY
- AYME’s Medical Adviser, Dr. Esther Crawley, is currently leading a pilot study (SMILE) of a non-medical TRAINING PROGRAMME (The Lightning Process) based on an unproven scientific hypothesis about the cause of ME/CFS, on children recruited at the point of diagnosis at her “CFS/ME” clinic at the Hospital for Rheumatic Diseases in Bath, UK. The Lightning Process is based on the same biopsychosocial (behavioural) model as CBT and GET; therapies that Dr. Crawley has previously recommended for use with ME/CFS patients. In her study proposal, Esther Crawley stated there were no risks to the patients from participating in SMILE. She was required to correct that statement – to include that there are risks – by the National Research Ethics Service, as a result of a review carried out in response to a number of ethical concerns raised about SMILE, most of which remain, and which are currently under further consideration by the NRES.
- Research guidance states that research should only be done on children if it cannot feasibly be done on adults first. Dr. Crawley claimed that, if LP research were done on adults first, the results could not be applied to children, as the course and outcomes of ME/CFS are different in adults and children – in spite of claims by LP traders that it is equally effective in both adults and children. This raises questions over why AYME have not tempered their enthusiastic welcome of the results of PACE, with caution that CBT and GET cannot be presumed to be safe or effective for children with ME until the research has been replicated in children – as they are calling for – with positive results for safety and effectiveness.
- AYME’s President, Esther Rantzen, has also endorsed CBT and GET in the media over a number years, claiming that her daughter Emily was cured by this approach. It was later reported that she had been cured again by The Lightning Process. Recently, Emily admitted in the media that she had been “faking” her recoveries and that she now feels “infinitely better” since eliminating gluten from her diet, claiming that she has coeliac disease and not ME after all. In a piece headed, “No more “fake it til I feel it”, Emily wrote:
“In the years since my recovery in 2006, I’ve been used to secretly feeling I have to drag myself through life, forcing my body to be active and using mind over matter to “fake it til I feel it”.
Having publicly endorsed CBT, GET and The Lightning Process as curative treatments for ME, it would appear that Esther Rantzen has a vested interest in claims that CBT and GET are both safe and effective for ME.
Details of SMILE:
“At last I have discovered the secret of Emily’s lost 14 years”.
STATEMENTS ON SMILE BY OTHER ORGANISATIONS
Joint statement by The MEA and TYMES: http://www.meassociation.org.uk/?page_id=1341
Church Times article on the study, “Children should not be used as guinea pigs”:
CALL FOR ACTION
We, the undersigned, call for the Association of Young People with ME (AYME) to take the necessary action to address the serious concerns outlined above, or cease operating as a charity for children and young people with ME.
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