Following suggestions from visitors to the website, this page has been set up to allow me to give details of items about M.E. and related issues, as well as other subjects, that will hopefully be of interest to those who visit the site. Do let me know what you think!
Out of Hours
Chronic fatigue syndrome:
a patient’s perspective
In 1999 I contracted a throat infection that receded after many weeks, but I was still unbelievably exhausted with the most intense flu-like malaise. Two years later I was diagnosed with chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) and joined the 240,000-plus people in the UK with this Illness. I assumed that a diagnosis would lead to effective treatment, but I was in for a shock.
Initially my GP suggested I see a psychotherapist. It seemed a strange recommendation, but I trusted his judgement and decided to see if this would help. Unfortunately it had no impact at all on the illness. My GP then referred me to an endocrinologist who boldly announced that, as the test results were all normal, everything was fine and offered to prescribe antidepressants. I was deeply frustrated by the suggestion that clear test panels meant I should be treated as a depressed patient. I was not inclined to agree that antidepressants were the best treatment when my experience of the symptoms was closer to that of an infection than a mood disorder. In fact, I have been told a number of times that I’m simply depressed, or that I am de-conditioned and just need to exercise. I wouldn’t mind if either diagnosis were true, as there are effective treatments available, but they are inadequate explanations.
CFS/ME waxes and wanes but also causes post-exertional malaise: when patients go beyond their usual (restricted) activity level they suffer a worsening of symptoms which can be severe. Patients often refer to this as a crash. For me this can mean being bedridden for weeks with muscle weakness, dizziness, loss of appetite, and indescribable physical and mental exhaustion. It’s worth noting that my GP has only ever seen me when the symptoms are at the lesser end of the scale. During a crash I am too ill to leave my bed, let alone travel to the surgery.
When I first got sick, CFS/ME seemed to be largely treated as a mysterious psychological condition, with doctors encouraged to limit the number of tests done, and with patients left to self-manage. Since then things have improved a little in that there are fatigue clinics in some areas, but the overall treatment situation remains poor, with most patients receiving little or no effective treatment through the NHS.
The PACE trial is the largest study performed into CFS/ME treatments, primarily cognitive behavioural therapy (CBT) and graded exercise therapy (GET). I think the £5 million cost would have been better spent on immunological studies, exercise physiology testing, and understanding the disease mechanisms. A recently published PACE trial paper reported on ‘recovery’ rates.(1) However, the letters published in response to the paper show that the study’s post-hoc definition of ‘recovery’ was seriously flawed, and so much looser than the recovery criteria outlined in the trial’s protocol that the ‘recovery’ outcomes bear no relation to what an average person, or clinician, would define as recovery of health. PACE was an un-blinded study and the primary outcomes were all subjective self-report measures at risk of response bias. Changes from the trial protocol (2) also meant that it was easier for patients to be classed as improved, yet even then the addition of CBT and GET to specialist medical care led to only an extra 11-15% of patients reporting improvement.(3) This simply underscores the need for more research across all areas to find effective treatments.
CFS/ME presents difficulties for both patients and doctors, reinforcing the need for them to work together in partnership. A recent BMJ editorial (4) entitled Let the Patient Resolution Begin could not have said it better:
“… health care won’t get better until patients play a leading role in fixing it.”
Software engineer, London.
1. White PD. Goldsmth K. Johnson AL. et al. Recovery from chronic fatigue syndrome after treatments given in the PACE trial Psychol Med 2013 40»10»: 2Z27-223S.
2. White PD. Sharpe MC. Chalder. et al Protocol for the PACE trial: a randomised controlled trial of adaptive pacing. cognitive behaviour therapy, and graded exercise, as supplements to standardised specialist medical care versus standardised specialist medical care alone for patents with the chronic fatigue syndrome / myalgic encephalomyelitis or encephalopathy BMC Neurol 2007; 7: 6
3. White PD. Goldsmith KA Johnson AL, et al. Comparison of adaptive: pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medcal care for chronic fatigue syndrome (PACE): a randomised trial Lancet 2011 377197681:823-836.
4. Richards T, Montori VM, Godlee F.et al Let the patent revolution begin BMJ 2013 346: f2614.
O Little Town Of Bethlehem
A favourite Christmas Carol for the start of December –
O little town of Bethlehem,
How still we see thee lie!
Above thy deep and dreamless sleep
The silent stars go by:
Yet in thy dark street shineth
The everlasting Light;
The hopes and fears of all the years
Are met in thee tonight.
O morning stars, together
Proclaim the holy birth,
And praises sing to God the King,
And peace to men on earth;
For Christ is born of Mary;
And, gathered all above,
While mortals sleep, the angels keep
Their watch of wondering love.
How silently, how silently,
The wondrous gift is given!
So God imparts to human hearts
The blessings of His heaven.
No ear may hear His coming;
But in this world of sin,
Where meek souls will receive Him, still
The dear Christ enters in.
O holy Child of Bethlehem,
Descend to us, we pray;
Cast out our sin, and enter in;
Be born in us today.
We hear the Christmas angels
The great glad tidings tell;
O come to us, abide with us,
Our Lord Immanuel.
Phillips Brooks, 1835-1893
INCORRECT GOVERNMENT INFORMATION COULD BE HURTING CHRONIC FATIGUE SYNDROME PATIENTS, NEW RESEARCH FINDS
PRESS RELEASE: NEW YORK, NY (11/20/2013) – An untold number of New Yorkers, perhaps well over 100,000, who have been diagnosed with Myalgic Encephalomyelitis and Chronic Fatigue Syndrome (ME/CFS) could be at risk of relapsing and exacerbating their condition due to a course of a treatment suggested to them by the federal government, according to groundbreaking new research.
At a medical conference today sponsored by the New York ME and CFS Center at Mt. Sinai and held at the New York Academy of Medicine, researchers showed that a form of treatment called Graded Exercise Therapy (GET) which has been lauded by the UK’s National Institute of Clinical Excellence (NICE) and recommended by the U.S. Centers for Disease Control and Prevention (CDC) may not help ME/CFS, but actually can make it worse. Unfortunately, the CDC has long been touting that certain exercise regimens can help manage the disease, even offering guidance on their website.
Dr. Derek Enlander, Dr. Eric Schadt, Dr. Miriam Merad, Dr. Christian Becker and a team of researchers at Mt. Sinai Medical Center have discovered new research on ME/CFS that could change the way the disease is treated. Their research shows that the disease is tied to the immune system much more than originally thought. A recent study showed patients can actually relapse when they partake in excessive exercise, and other therapies maybe more effective.
“We want to raise awareness about this disease, how it affects the body and the best way to treat it,” Dr. Enlander said. “For too long, this disease has been misunderstood, leading to a poor quality of life for far too many patients. We hope to change all that.”
Myalgic Encephalomyelitis was first identified in the mid-1950s, by Dr. Melvin Ramsay of London’s Royal Free Hospital, after being suspected of outbreaks dating back at least two decades’ prior. What is thought to have been an outbreak in Nevada’s Incline Village in the mid-1980s, mirroring one in rural upstate New York’s Lyndonville, led to the CDC officially recognizing a condition reduced Chronic Fatigue Syndrome in 1988 following the elimination of the Epsten-Barr virus as a potential culprit. The CDC has displayed an inconsistent track record ever since, diverting millions of dollars earmarked for research in the disease to other causes in a scandal uncovered some 15 years ago. Recent estimates suggest that hundreds of thousands of people in the U.S. suffer from CFS, although the CDC is thought to have both underestimated the severity of the disease, while overestimating the numbers, as they have reported a disease prevalence of 2.54% in the U.S. This figure is not accepted by experts in the field. Using the more-accepted figure of 0.4% would estimate the number of sufferers in the New York City Metropolitan area alone at over a half million patients, the majority of whom are likely undiagnosed.
The illness which afflicts women to a greater degree than men, causes severe immunologic dysfunction, profound loss of energy (sometimes referred to as fatigue, though in many cases patients would report that this term is inadequate as a descriptor), sleep disorders, neurological disturbances, pain, and other symptoms. Underlying causes and treatments for CFS have been elusive, but new research is shedding light on how the disease works.
This document was produced by The Grace Charity for ME and is reproduced here with their kind permission. It can be found online as Word and PDF documents.
SAYING NO CAN BE POSITIVE Spring 2006 (updated 2013)
The following has been designed to support M.E. sufferers who choose to not attend the current NHS Chronic Fatigue Syndrome/Myalgic Encephalomyelitis clinics, set up across the country. These clinics have been based upon the Chief Medical Officer’s report from 2002 and consist mainly of psychological therapies such as Cognitive Behavioural Therapy and Graded Exercise Therapy. This document may also support M.E. patients who refuse to receive the treatments of CBT and GET recently recommended by NICE for CFS/M.E. and also by the PACE trials (Prof. Peter White et al.) Bedbound/housebound sufferers who are advised to have these therapies on domiciliary visits may also find this document helpful. It may also help those pressurised to undertake CBT and Graded Exercise Therapy by Private Health Insurers.
Those who wish to refuse psychological therapies for M.E. can be supported by the following facts:
1) The law protects patients from unwanted treatments if the patient is deemed to be mentally competent. Medical practitioners cannot give a treatment to a patient without the patient’s consent. 1 Scientifically, M.E. is NOT in Mental Health, see below.
2) An M.E. patient doesn’t have to comply with the recent NICE guidelines on CFS/M.E., supported by the above law, because M.E. is not scientifically in mental health.
3) The NICE guidelines, which support CBT and Graded Exercise Therapy for M.E., are not mandatory. In practice, GPs and all doctors do follow the NICE Guidelines: this is because all NHS organisations have a legal requirement to implement NICE guidance. However, the treatment aspect is not enforceable.
‘I can clarify that NHS organisations are indeed expected (and in some cases, such as a type of guidance called Technology Appraisal guidance, legally obliged) to implement NICE’s recommendations. This is not the same as saying that the NHS has the power to force a patient to undergo a treatment which they do not want.’ 2
‘NICE clinical guidelines such as CG53 are not legally enforceable.’ 3
4) M.E. patients have a right, under the NICE guidelines, to refuse the recommended treatments from NICE.
The following could be used to help M.E. sufferers who wish to refuse NICE’s recommendations of treatment:
‘Healthcare professionals should be aware that – like all people receiving care in the NHS – people with CFS/ME have the right to refuse or withdraw from any component of their care plan without this affecting other aspects of their care, or future choices about care.’ 4
A patient’s care plan can include state benefits and social services care, which are now also linked with the NICE guidelines.
The NICE guidelines do not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of each patient. Healthcare professionals should record their reasons for not following clinical guideline recommendations.
In other words, every patient case is individual and a doctor does have the right to express clinical freedom, along with consulting the patient, as to what is best. This may mean refusing Graded Exercise Therapy and CBT.
5) An M.E. patient who is in a comatose/semi comatose state cannot by law be forced into psychological treatment just because they have M.E. 5
6) Private Health Insurers cannot force an M.E. client to undergo unwanted treatment before making a payment, unless those treatments are specified in the contract. Unless the contract of a company states clearly that M.E. clients must undergo CBT and/or Graded Exercise Therapy before a payment is made, the company could well be in breach of contract. Also, every individual has freedom to express views as stated by The Human Rights Act 1998. If an insurance company ignores a client’s reasons for refusing CBT and/or Graded Exercise Therapy, a client could claim their ‘freedom of expression’ has been violated. 6 The following organisation may offer help, including a free telephone appointment for legal advice:
Disability Law Service
39-45 Cavell Street
Tel: 020 7791 9800
7) An M.E. patient cannot have their state benefits withdrawn for refusing CBT and Graded Exercise Therapy.
Unfortunately, the NICE guidelines are now linked with the awarding of state benefits and Social Services care.
U.K. law says that if a patient refuses suitable treatment without good cause, benefits can be withdrawn. 7
However, CBT and Graded Exercise Therapy could be argued as unsuitable treatments for M.E. sufferers (see facts below). Scientific opinion which is against CBT and GET for M.E. can be used to obtain state benefits for sufferers.
In addition, NICE has written the following in its CFS/ME Guidelines:
‘Healthcare professionals should be aware that – like all people receiving care in the NHS – people with CFS/ME have the right to refuse or withdraw from any component of their care plan without this affecting other aspects of their care, or future choices about care.’ (This is also quoted in section number 4 of this paper. See Footnote 4 for reference.)
Although NICE Guidelines are now linked in with the awarding of Social Services care and State Benefits, the above quote can be used in favour of an M.E. sufferer’s refusal to undergo CBT and Graded Exercise Therapy.
If sufferers find themselves in a legal battle with their benefits, those who qualify for legal aid may find the following organisation helpful:
Civil Legal Advice (formerly Community Legal Advice) Tel: 0845 3454345
8) M.E. is a neurological disorder. It has been classified as such by the World Health Organisation in the International Classification of Diseases since 1969. 8 Therefore psychological therapies could well be inappropriate.
9) M.E. has a strong medical history of being an organic disease. Dr. Gordon Parish is the curator of the Ramsey Archive, which is possibly the world’s largest collection of medical papers on M.E. 9 It includes detailed world-wide epidemics of M.E. since 1934 and the viruses which triggered the disease.
10) There are over 2,000 papers showing that M.E. is an organic disorder, according to Prof. Anthony Komaroff (Professor of Medicine at Harvard). 10
11) In November 2010, M.E. sufferers were banned from giving blood. NHS Blood and Transplant has said that the ban is a precaution to protect the donor’s safety by ensuring the condition of M.E. is not made worse by donating blood. They say that the move brings M.E. in line with other relapsing conditions such as Multiple Sclerosis and Parkinson’s Disease. 11 However, many people in the M.E. community feel that the ban is over the possibility of contamination from the virus XMRV, which has been shown in studies to be high in M.E. patients. (See research by The Whittemore Peterson Institute team, published in the journal Science 2009.)
12) Many tests exist in aiding a diagnosis for M.E. Therefore, using psychological therapies for ‘unexplained fatigue’ is inappropriate. Although diagnostic tests for M.E. are still being worked upon with promise, nevertheless many tests and procedures can be administered in aiding a diagnosis of M.E. These include the use of SPECT, MRI and PET scans, test for NK cell activity and endocrine abnormalities, Tilt Table Test, viral tests and many more. 12 Although these tests are rarely offered by the NHS for M.E., they have nevertheless shown evidence of physical abnormalities.
13) “Patients who improve after physical exercise programmes do not have M.E./CFS.,” says Dr. Byron Hyde, M.D. of the Nightingale Research Foundation for M.E. in Canada, who has studied M.E. since 1984. 13 Dr. Hyde stresses that M.E. is primarily a disease of the Central Nervous System. 14
14) Patients who respond well to CBT and Graded Exercise Therapy might not have M.E. due to the diverse criteria used. Some criteria focus on unexplained chronic fatigue only, omitting symptoms showing central nervous system involvement. There are at least twelve definitions of Chronic Fatigue Syndrome and/or M.E., all of them different. 15 In the U.K., a frequently used case definition is the Oxford Criteria which includes patients with no physical signs and selects subgroups of patients with high levels of psychiatric diagnoses . 16 The PACE and FINE trials (funded by the Medical Research Council) use the Oxford Criteria. 17
15) The assumption that an M.E. patient can always do more is an erroneous one. There are overwhelming international research findings on M.E., which support multi-system involvement particularly of the immune, endocrine, cardiovascular and neurological systems. 18 Also, there is evidence indicating pathology of the central nervous system and immune system 19 and evidence of metabolic dysfunction in the exercising muscle. 20 Also, Dr. Jay Goldstein has demonstrated through SPECT scans the severely decreased brain perfusion of an M.E. patient 24 hours after physical exercise. 21 The Canadian Criteria (2003) states that the worsening of symptoms after exertion is a principal symptom of M.E. 22 Raised levels of noxious by-products of abnormal cell membrane metabolism, associated with exercise and correlating with patients’ symptoms have been demonstrated. 23
16) CBT and Graded Exercise Therapy can worsen M.E. symptoms. In a survey of 3074 M.E./CFS patients conducted between 1998 – 2001, 55% of patients said that CBT had made no difference to their illness, whilst 22% said CBT had made their illness worse. 16% of patients said that graded exercise had made no difference to their illness whilst 48% said it had made their illness worse. 24 A survey by the 25% ME Group (for severe sufferers) of 437 patients, demonstrated that of the 39% of group members who had used graded exercise, 95% had found this therapy unhelpful, whilst 82% reported their condition had been made worse by graded exercise. Some patients were not severely ill with M.E. until after graded exercise. In the same survey 93% of those who had undergone Cognitive Behavioural Therapy had found it unhelpful. 25
17) The CMO’s Report recommended CBT and Graded Exercise Therapy despite the objection of two patient support groups. The patient support groups of BRAME (Blue Ribbon for the Awareness of ME) and the 25% ME Group refused to endorse the CMO’s Report of 2002 based on its recommended treatments of CBT and graded exercise. These support groups mainly represent the needs of severe M.E. sufferers and were part of the CMO’s Working Group.
18) Medical Concerns have been raised about the CMO’s Report. The Journal of Chronic Fatigue Syndrome, mentions criticism by health professionals and the public of both the British and the Australian M.E./CFS guidelines. “These criticisms included claims of bias in the recommendations toward a psychiatric outcome and failure to understand the limitations of patients to perform exercise programs as well as many others.” 26
19) The NICE guidelines have received widespread condemnation. The recent NICE guidelines were NOT supported by the following registered U.K. M.E. charities: The M.E. Association, the 25%M.E. Group, Invest in M.E., and the Grace Charity for M.E. Also, the organisation BRAME did not support the guidelines outcome, despite the latter serving on the panel. There are many other M.E. groups who also condemn these guidelines. The NICE guidelines received so much criticism that NICE were taken to court by two M.E. sufferers in February 2009. Views from international researchers (e.g. Carruthers, Peterson, Lerner, Hooper and Drs involved with M.E. Research UK) regarding the potential negative effects of Graded Exercise Therapy and CBT, were not acknowledged in the Judge’s decision.
Also, the NICE guidelines group had no-one offering a biomedical aetiology (cause) of M.E: therefore, the disease M.E. was never properly addressed by NICE because researchers offering a biomedical cause were not allowed to serve on the guideline group.
‘’Most Independent M.E. charities and patient organisations have rejected the NICE guidelines...” 27
20) The PACE trials results in February 2011, promoting CBT, Graded Exercise Therapy and APT (Adaptive Pacing Therapy, a form of Graded Exercise) have also received widespread condemnation from M.E. patient groups and medical researchers. 28
21) The International Consensus Primer for Medical Practitioners 2012, states that PENE is a required symptom for a diagnosis of M.E. (Post-Exertional Neuroimmune Exhaustion).
‘PENE is characterised by a pathological low threshold of physical and mental fatigability, exhaustion, pain and an abnormal exacerbation of symptoms in response to exertion. It is followed by a prolonged recovery period. Fatigue and pain are part of the body’s global protection response and are indispensable bioalarms that alert patients to modify their activities in order to prevent further damage.’
The authors of the panel consist of twelve countries. 29
1 See the case of St.George’s Healthcare NHS Trust v S (1998) 3 All ER 673 (Court of Appeal), p.758 of Hepple, Howarth and Matthews Tort, Cases and Materials, 5th Edition by DR Howarth and JA O’Sullivan, ISBN 0 406 063265 (Butterworths, 2000)
2 Quote from Kathleen Jackson-Heppell, Communications Co-ordinator (Enquiry Handling and Internal Communications for NICE), in an email to the Grace Charity for M.E. dated 15/02/2011
3 Quote from Natalie Whelan, Communications Executive (Enquiry Handling) for NICE, in a letter to the Grace Charity for M.E. dated 23rd September 2009.
5 See above publication in endnote 1 (Hepple, Howarth and Matthews Tort) regarding section attributed to Lord Brandon of Oakbrook, pp.744, 745
6 The Human Rights Act 1998, European Convention for the Protection of Human Rights and Fundamental Freedoms, Section 1, Article 10, no.1
7 U.K. law on state benefits, Regulation 18 Social Security (Incapacity For Work) Regulations. A similar law applies to other state benefits for sickness and disability.
8 World Health Organisation - International Classification of Diseases 10-G93.3
9 What is ME? What is CFS? Information For Clinicians and Lawyers, Dec. 2001, Marshall, Williams, Hooper, page 11. Available from Prof. Malcolm Hooper, Dept.of Life Sciences, University of Sunderland SR2 7EE. Also, see www.meactionuk.org.uk
10 See the paper ‘Illustrations of Clinical Observations and International Research Findings from 1955 – 2005 that demonstrate the organic aetiology of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome’ by Hooper, Marshall, Williams, 2005, page 6. See also www.meactionuk.org.uk
11 See report from BBC NEWS HEALTH, October 8 2010, ME patients face UK ban on donating blood by Michelle Roberts. www.bbc.co.uk/news/health
12 Leaflet A Physician’s Guide to Myalgic Encephalomyelitis Chronic Fatigue Syndrome, The Nightingale Research Foundation, Vol.1, Issue 7, revised, 1992, page 17. Also, Journal of Chronic Fatigue Syndrome Vol . II, No.1, 2003, Canadian Criteria, page 25, The Haworth Press Inc.
13 Ibid., A Physician’s Guide to Myalgic Encephalomyelitis Chronic Fatigue Syndrome, page 25
14 Clinical Observations of Central Nervous System Dysfunction in Post-Infectious, Acute Onset M.E/CFS, page 38, The Clinical and Scientific Basis of Myalgic Encephalomyelitis Chronic Fatigue Syndrome 1992, Byron Marshall Hyde, M.D., The Nightingale Research Foundation.
15 Report from the National Task Force on Chronic Fatigue Syndrome, Westcare, Bristol 1994. This states nine definitions: the recent Canadian definition in 2003 makes ten; the Reeves definition (2005) makes eleven and the International Consensus Primer (2012) makes twelve.
16 Katon & Russo, 1992; Freiberg, 1999, Unhelpful Counsel? MERGE’s response to the CMO report on CFS/ME, 2002, p15.
17 See the website of the Medical Research Council at www.mrc.ac.uk
18 ME and/or CFS paper, September 2001, page 1, V.A. Spence PhD, Chairman of MERGE (ME Research Group for Education and Support). MERGE has become MERUK since this publication (ME Research UK.) This paper quotes from several published findings. Available from MERUK, The Gateway, North Methven Street, Perth PH1 5PP. Also, see www.meresearch.org.uk
19 The Biology of the Chronic Fatigue Syndrome, Prof. Anthony Komaroff, The American Journal of Medicine 2000: 108: 99-105.
20 Mitochrondrial abnormalities in the postviral fatigue syndrome, Behan, W.M.H. et al., Acta Neuropathologica 83, 1991, pages 61-65.
21 The Negative Effects of Exercise on an M.E./CFS Dysfunctional Brain, page vii, The Clinical and Scientific Basis of Myalgic Encephalomyelitis Chronic Fatigue Syndrome 1992, Byron Marshall Hyde, M.D., The Nightingale Research Foundation.
22 Journal of Chronic Fatigue Syndrome Vol. 11, No.1, 2003, Canadian Criteria, page 22, The Haworth Press Inc.
23 Oxidative stress levels are raised in Chronic Fatigue Syndrome and are associated with clinical symptoms, Kennedy, Spence, Belch, Free Radical Biology & Medicine 2005:39:584-589
24 Directly from the Horses’ Mouths, Doris M. Jones MSc, Reference Group Member, CMO’s Working Group. This survey was part of the Working Group on ME/CFS set up by the Chief Medical Officer Sir Kenneth Calman in 1998.
Much maligned and misunderstood, ME gets a radical makeover in this exclusive editorial for nhsManagers.network. But is this pathway really so radical? Perhaps only if you are a healthcare professional!
Based on the premise that if an illness is defined by the fact that exercise makes it worse, maybe that should be a starting point for dealing with it!
Immediate diagnosis by careful initial interview: If patient reports an extraordinary level of debility following a viral illness, which has persisted – has other symptoms which seem random and variable but can be understood as problems of muscle metabolism, cognitive function (short-term memory problems, difficulty in following lines of reasoning), endocrine function (disturbances of appetite, sleep rhythms, temperature regulation) and immune system activity (sore lymph glands, persistent low fever, sore throats), this whole constellation points to ME/CFS.
This should be regarded as a medical emergency, because the patient’s behaviour in the early stages determines either a path towards recovery or a path towards extreme and long lasting states of incapacity. (1)
The basic prescription should be to go home and go to bed; just doing the minimum exercise necessary to prevent DVT (getting up to go to the loo might be enough!). Families need an explanation that for the patient, minimising muscular exertion is essential. A home visit from a Physiotherapy/OT team can provide advice about how to do everyday tasks using a minimum of muscular exertion, like the advice given to MS sufferers for the management of their exhaustion. The OT should assess the home and recommend/ provide aids as appropriate for any physical illness which causes extreme weakness. The patient will need psychological support to accept that the (unwelcome!) adoption of a ‘disabled’ lifestyle is the way to ‘fight’ this illness and facilitate a gradual return to as normal a life as possible. After that, a regular visit from a key worker backed up by online support may be all the patient needs while he is conserving energy towards getting better.
What should absolutely not happen is a referral to hospital, unless to provide a period of complete bed rest. Tests to eliminate other potential diagnoses should be done at home as far as possible. The expensive centres which have been set up, requiring patients to attend in order to engage in extra exertion (just getting to a hospital appointment is enough to wipe out an ME/CFS patient for days) should be replaced by these less expensive domiciliary services. Apart from encouragement to keep on resting, and encouragement to family members to appreciate that this is needed, the patient should be left alone, allowed plenty of time to get better. Under this regime, gradual improvement is to be expected (school-age children should be provided with home education until a gradual return to school becomes a possibility).
When the patient is ready, there should be interventions at the patient’s educational institution/place of work aimed at eliminating all avoidable exertion. Along with facilities for rest breaks and perhaps being able to do some work from home, this gives the patient the best chance of returning to their education, job, or professional activities. Which, contrary to the ‘false illness beliefs’ of some psychiatrists, is what patients are desperate to do. It needs to be respected that this illness is not one of motivation: ‘I can’t’ does not mean ‘I don’t want to’, it means that there is a physical limit to what the patient can do without serious subsequent repercussions.
Doctors brave enough to use this ‘light touch’ approach would be rewarded by positive relations with their patients, and the prospect of seeing them getting better instead of getting worse. But it would take real courage to challenge the cultural myths that ‘fighting’ illness is the only way to go, that exercise is good for absolutely everything, and that people who have ME/CFS don’t want to get better, and must be persuaded or coerced into activity. Counter-intuitively, treating ME/CFS patients like invalids initially is the process most likely to maximise ‘return to function’.
The current psychiatric model has no way of acknowledging treatment failure – failure can always be blamed on the patient. No wonder there is so much hostility. It is time to step across the divide, accept that patients are telling the truth, and start giving them a chance to get better.
Nancy Blake is author of ‘A Beginner’s Guide to CFS/ME’, and co-author, with Les Simpson, Ph.D. of ‘Ramsay’s Disease – ME’. She is currently undertaking a Ph.D. project at Lancaster University on the conflicting paradigms of ME/CFS
1. www.name-us. Melvin Ramsay. name-us.org. [Online] [Cited: 3 October 2013.] “The degree of physical incapacity varies greatly, but the dominant clinical feature of profound fatigue is directly related to the length of time the patient persists in physical effort after its onset; put in another way, those patients who are given a period of enforced rest from the onset have the best prognosis.”
“…in those patients whose dynamic or conscientious temperament urge them to continue effort despite profound malaise or in those who, on the false assumption of ‘neurosis’, have been exhorted to ‘snap out of it’ and ‘ take plenty of exercise’ the condition finally results in a state of constant exhaustion.”
Dr Jayne Donegan’s career was almost ruined when she did her own research into vaccinations and discovered that doctors are being misled by the government about their safety and effectiveness
Anti-vaccine groups are variously dismissed as hysterics, conspiracy theorists and antisocial alarmists—but what happens when a doctor starts out as pro-vaccine, reads the evidence for herself and decides that the MMR and other vaccinations for our children probably do more harm than good?
Dr Jayne Donegan is a GP who believes her profession is being deliberately misled by the UK’s Department of Health (DoH) which, in its ‘Green Book’ on vaccinations issued to all doctors, is deliberately massaging the data to make vaccines seem more effective and safe than they actually are.
For her troubles, Dr Donegan was charged by her own governing body, the General Medical Council (GMC), of serious professional misconduct and of bringing the profession into disrepute. The hearing, which ran over three weeks in 2007, was the result of the GMC charging her directly although, in the vast majority of cases, it acts only after receiving complaints from the public.
Remarkably, the GMC panel found her not guilty and agreed in their findings that she had been objective, independent and unbiased in her research and conclusions—which, by implication, suggests that the UK’s leading medical authority happens to agree that vaccines are not as safe or effective as government agencies state.
To find out the truth about vaccinations, Dr Donegan spent many days at the Office for National Statistics (ONS) studying health records going all the way back to 1837. There she discovered something that shook her world: deaths from whooping cough had fallen dramatically from the mid-1850s onwards and death rates had dropped by 99 per cent before the pertussis (whooping cough) vaccine was partially introduced in the 1950s.
And yet the graph in the DoH’s Green Book only showed data from 1940 and so suggested that the vaccine had a more dramatic effect than it really had.
She found the same thing with measles. Again, the Green Book graph starts in 1940 and appears to show an enormous drop in cases from 1968, when the vaccine was introduced. But when Dr Donegan took the data back to the early 1900s, she uncovered a similar picture to pertussis: there had been around a 99 per cent drop off in death rates in the 60 years before the vaccine was brought out. “There was a virtual 100 per cent decline in deaths from measles between 1905 and 1965—three years before the measles vaccine was introduced in the UK,” she says.
Public sanitation, personal hygiene and better nutrition had played a far more significant role in controlling childhood diseases—making them benign rather than killers—than vaccines ever did.
Dr Donegan’s journey from vaccine believer to vaccine sceptic was a courageous one because she had so much to lose. After qualifying as a doctor in 1983, she had been very pro-vaccination and had urged worried parents to vaccinate their children. “I used to think that parents who didn’t want to vaccinate their children were either ignorant or sociopathic. I believe that view is not uncommon among doctors today,” she says. When her own two children were born—in 1991 and 1993—she had them vaccinated, even though one had suffered worrying reactions to the BCG (bacillus Calmette–Guérin) tuberculosis jab.
Then in 1994 the government launched a major measles vaccination drive after an epidemic had been forecast; only years later was it revealed that the forecast had been based on a faulty mathematical model. Even children who had already been vaccinated were to have a second dose, the DoH announced, as one dose might not provide maximum protection. Dr Donegan accepted this, but she was concerned by a further announcement that even children who had received two doses before should still have a third shot.
This started raising alarm bells especially as the vaccine had been heralded as a ‘one-shot’ jab that on its own would provide life-long immunity. The second worry was the need to vaccinate tiny babies to achieve herd immunity and “break the chain of transmission”, as the DoH described it. Dr Donegan wondered why they couldn’t just vaccinate children aged three or so and so break the chain among those whose immune systems might at least be strong enough to withstand any adverse reactions to the jab.
“Some things just didn’t seem to quite add up,” Dr Donegan recalls, “but it’s very hard to start seriously questioning whether or not vaccination is anything other than safe and effective, especially when it is something that you have been taught to believe in so strongly.
The more medically qualified you are, the more difficult it is, as in some ways the more brainwashed you are.”
She started to read anti-vaccination books, but the evidence in them was so contrary to what she had been taught that she decided to do her own research.
That research, which included her visits to the ONS, culminated in the research paper ‘Vaccinatable Diseases and Their Vaccines’. The report includes data from the mid-1850s that she gleaned from the ONS, and a review of the small number of studies into vaccine safety and effectiveness.
Astonishingly, there haven’t been any “clear, open, objective and well-designed studies on vaccination safety”, she states in the report’s introduction. And the studies that have been done invariably conclude that vaccines are safe—even though the data don’t support such a conclusion.
Dr Donegan antidoted all the vaccines given to her children with homeopathic nosodes—she had qualified as a homeopath in 1990—and she also appeared as an expert witness in a high-profile vaccine case where a mother was refusing to have her child vaccinated even though it was against the wishes of her estranged husband.
Because she had spoken out against vaccines in a court case, the GMC decided to take action against her. The GMC expert witness was Dr David Elliman, consultant in community child health at Great Ormond Street Hospital, who spent four months reviewing the evidence Dr Donegan had given in the case before he attended the GMC hearing.
Under cross-examination, Dr Elliman admitted that, as Dr Donegan had stated, there had been no proper randomized, placebo-controlled trials into any childhood vaccines in the past 30 years, and his 62 criticisms of her evidence were reduced to just two.
Despite this significant victory, the media failed to report on the result—although it had written up the first day of the hearing with headlines such as “GP accused of misleading court over MMR danger”.
Afterwards she reflected: “If a parent says ‘I’m worried about the safety of the vaccination’, they are told ‘You don’t understand, you’re not a doctor’. But if a doctor says the same thing, he or she is charged with serious professional misconduct.”
Dr Donegan is speaking on vaccinations at the College of Naturopathic Medicine, 41 Riding House Street, London W1, on November 11, starting at 6.30 pm. The talk is entitled ‘Vaccination—The Question’. The entrance fee is £10. To purchase tickets or find out more, telephone 01342 410 505 or book online at www.naturopathy-uk.com
Donegan on the DPT (diphtheria–pertussis–tetanus) jab
Diphtheria: The likelihood of contracting diphtheria in the UK is so low that I do not think any benefit is to be gained by vaccinating against it, and any detrimental effects are therefore unacceptable.
Pertussis (whooping cough): Children develop natural immunity against whooping cough from breast milk, but parents who want their child vaccinated should choose the acellular vaccine. It is currently not available without the mercury additive thiomersal (thimerosal in the US), and the whole-cell version has such a high incidence of side-effects that I think it should never be used.
Tetanus: Wounds should be cleaned immediately, and 3 per cent hydrogen peroxide is an excellent cleanser. As the tetanus vaccine is available only with thiomersal, aluminium hydroxide and formaldehyde, it is safer to build up a child’s immune system and clean any wounds carefully.
Donegan on the MMR (measles–mumps–rubella) jab
Measles: This is a benign childhood illness in the child with a strong immune system. In the Steiner alternative school community, during a measles outbreak not one severe case was reported. There is plenty of evidence about adverse reactions to the vaccine that should convince parents not to have it. Don’t give in to the fear about measles generated by doctors and governments.
Mumps: This is generally a mild illness. I do not recommend mumps vaccination, as any benefit is minimal and any side-effects unacceptable.
Rubella (German measles): The effects of rubella are minor and the vaccination cannot be recommended. And the vaccine doesn’t seem to work very well, as it often fails to protect the unborn child of women who are not immune.
When Invest in ME announced in June that we were planning a UK trial of rituximab for ME there was a great deal of interest raised.
The rituximab trial follows the exciting work which has been, and is being performed in Norway by the Haukeland University hospital researchers Professor Olav Mella and Dr Oystein Fluge.
Since these excellent Norwegian researchers came to present at the Invest in ME conferences in 2011 we have followed their progress, and invited them back every year for our BRMEC researchers meetings and IIMEC conferences.
The research work has been backed up by impressive and dedicated patient advocacy by the Norwegian ME Forening which has raised the profile of ME in Norway and throughout the world. Their tireless work has encouraged IiME. The more recent success of the ME and You campaign to raise funds for the Norwegian research has created real hope amongst patients.
At the IIMEC7 conference IiME announced our intention to work toward establishing a clinical trial of rituximab in UK (click here).
In updates published through July and August IiME has stated that all that is required for the trial to proceed is the funding. In the spirit of cooperation we have stated that support for the trial was welcome and that IiME would acknowledge all such support.
Our supporters have risen to the occasion and valiantly supported the IiME/UCL trial with wonderful enthusiasm. The imaginative Let’s Do It For ME campaign has continued to produce ideas to raise funds and awareness and The MATRIX is an example of a unique method of achieving both.
We have had donations from around the world, ranging from £1 to £3,000. We have had a very generous donation of £25,000 from a foundation and this has allowed the funds raised to grow to £59,000 in a very short space of time. We have also had fantastic moral support from a great many.
As such, IiME and our supporters have managed to initiate and organise something which many thought was not possible.
IiME made it clear from the beginning that we welcomed support for the IiME/UCL clinical trial from other organisations. Our objective is to ensure that a clinical trial of rituximab is allowed to be performed by the best researchers possible and to ensure that this trial makes a valuable contribution to the collective research pool. This is why we have been keen from the beginning, and since our inception as a charity, to initiate collaboration with other like-minded international charities and organisations, and build collaborations between ME researchers across continents.
We believe in achieving results by the most direct method, where possible. For IiME the issue of making rapid progress in ME research is important, it is personal. The need is here - the need is now.
We arranged a specific web site which has been set up to inform on all aspects of the UK rituximab trial. This is at -
We have the means of fundraising for this trial available (see The MATRIX) and we have a campaign to raise funds
We have emphasised that the only remaining element required was funding
We have reached this position thanks to the vision, efforts and help from Professor Edwards, Dr Cambridge, UCL and our supporters.
Thanks to the amazing efforts of our supporters we have been able to agree already to initiate a preliminary study on B-cells at UCL.
Professor Edwards will shortly visit Bergen – a trip arranged by IiME as part of our collaborative attempts to unite researchers and build on experience.
We can now announce that IiME have been given a pledge of £200,000 from a foundation to supplement the amount we have raised already.
This would bring our rituximab fund to almost £260,000 – that is over two-thirds of the requirement for the clinical trial to proceed.
The foundation has two conditions to this pledge
That IiME continue to be the lead patient organisation steering this trial
That IiME continue to raise funds for the remaining £90,000 that is required for the full trial to proceed
The trustees of IiME have accepted these conditions willingly.
We are thankful and grateful for this extraordinarily generous offer from the donating foundation. It is an amazing gesture from compassionate and caring people who want to make a difference. It allows the hopes of many patients to become a reality – allows a vision to be maintained that there is a future for ME patients and that we, patients and families, can make a difference.
We have communicated this to the UCL team with whom we are working to make this trial a reality.
We are now distributing this information to our supporters.
There were many who doubted that IiME and our supporters could achieve this. Though we knew this would be a daunting task we have never doubted it was possible.
We continue our efforts to raise the remaining funds.
To our supporters who have been with us since the beginning and everyone who has contributed in so many ways to this trial we want you to know this is your result. It is what you have achieved. It is what we have achieved together.
We thank all those who are supporting this trial and we will continue to provide information on the status of the trial as we progress.
We continue to welcome support. Please contact IiME directly if you or your organisation would like to assist or contribute.
If anyone would like to ask any questions about the UK rituximab trial then please use the Contact form on the rituximab web site.
On 16 September 2013 Bristol University issued a press release (click here) which announced a grant of £1.2 million for Chronic Fatigue Syndrome research.
The grant to two researchers included one to Dr Esther Crawley - for research that seems to be effectively performing a PACE trial on children.
“The five-year study entitled ‘Investigating the treatment of paediatric chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME) has been awarded NIHR funding of over £864,000.”
“Dr Simon Collin, Research Fellow also in the School of Social and Community Medicine, will lead the first study of its kind to investigate CFS/ME in primary and secondary care in England. He will use data from the Clinical Practice Research Datalink (CPRD) to obtain an up-to-date estimate of the number of adults diagnosed with CFS/ME by GPs in England. Dr Collin will collect data from NHS specialist services for adults with CFS/ME, document the different approaches to treatment and investigate long-term outcomes.”
“The three-year study entitled ‘CFS in the NHS: diagnosis of Chronic Fatigue Syndrome in primary care and outcomes after treatment by specialist services’ has been awarded NIHR funding of £321,861.”
After the IIMEC8 conference and the Biomedical Research into ME Collaborative research meeting in London in May there was a real sense of ME entering into mainstream research with new interest from new researchers and focus on collaboration.
To hear of this massive amount of funding to one area, graded exercise - this time on children - is disappointing to say the least and indicates that nothing has been learned from the flawed and non-productive debacle of the PACE trial.
Bristol University still uses the prevalence figures of 600 000 in the press release - an issue that was debated at the MRC/SMC collaborative grouping, of which Dr Crawley is vice chairman. The minutes of that group from 19 July 2013 state that “Charities have met to discuss the information in future press releases re prevalence. This is still being progressed." (click here)
There seems to be no shortage of public funding for GET related studies despite £5 million being spent on the PACE trial which showed no objective improvements in patient outcomes and is clouded in controversy about methods used and claims being made (see PACE Trial Observations).
By now it ought to be self-evident that children should not be coerced into graded exercise when they are ill and unable to attend school. This approach can lead to a great deal of harm - not just for the child but for the whole family.
Even though Invest in ME is not a children’s charity we are contacted by families in distress due to pressures being put on their children to attend school or to perform activities beyond their capabilities due to the effects of ME.
This often leads to very difficult family situations and instead of listening to and believing the child parents are wrongly led to believe that they are doing the right thing by following a set programme. By the time families realise this is the wrong approach it may be too late and the child’s condition has deteriorated and the families may even break up as a result.
Epidemiological studies are welcomed but one has to be careful as GPs are known to be very poor at diagnosing ME patients. Any data coming out of Dr Collin’s research is likely not going to be accurate without considerable effort being put into trying to find out how patients were diagnosed.
In fact, Dr Clare Gerada, chair of RCGPs, stated at the IiMEC8 conference in June 2013 that GPs know very little about ME.
The adult services in the UK can only offer CBT and/or GET as set out in NICE so Dr Collin's research to document different approaches to treatment is likely to be a simple task. Long term outcomes might be difficult to determine as patients are usually seen by the specialist clinics only for a certain number of times before being sent back to their GPs.
These awards indicate that the understanding of this disease is still poor in those establishment organisations which control funding.
It is a wonder to patients how key funding agencies can get it so wrong.
It seems that in reality there is no shortage of funds available for studies which fit government policy. And this shames those who issue statements talking of funding being available for high-quality studies.
It would indeed be a sad indictment of the society that we ourselves subsidise if what matters is who one knows rather than what one does when it comes to research funding granted for ME - and the devil take the consequences.
Funding more GET-related research into ME, is a fatuous approach. It is monstrously wasteful to throw funding at poor science, based on false views of this disease.
So what of the real research required - the right stuff?
Funding is scarce and the efforts of our supporters to make up what has been lacking from government agencies and research funding organisations have been awe-inspiring.
Patients have worked tirelessly and imaginatively to raise funds for the research proposed by IiME. Currently Invest in ME and our supporters are actually initiating, organising and funding possibly the two most important ME research studies currently in the UK - the gut microbiome project at UEA and the IiME/UCL rituximab clinical trial.
As mentioned in our article which was published at the beginning of April (A Tale of Two Collaboratives) research into ME needs a strategic approach - but it may be destined to fail completely by attempting to establish the way forward on foundations which include so much of what has been wrong in the past.
We have written in the past that we feel it is impossible to marry the views of those who believe in the deconditioning/behavioural and wrong illness belief model of ME with those from the biomedical side. The failed PACE Trial has demonstrably proven that the behavioural view of ME cannot deliver and should not continue to command more funding.
There is another way - perhaps a better way forward for ME research - a clear case to be made for segregating the biomedical from the psychosocial here and now. This could then force a separation of fatigue research from ME research.
A strategy of biomedical research into ME with a biomedical research collaborative into ME being formed consisting of biomedical researchers, using resources and facilities across continents - hooked up to share research and data and crowd fund new research?
Such is the meaning behind our Biomedical Research into ME Collaborative meetings (click here) which have been organised by Invest in ME in cooperation with the Alison Hunter Memorial Foundation. These aim to interest other biomedical researchers to the field of biomedical research into ME, assist those who are undertaking research or planning research into ME, and look for future collaborative projects and funding which could be generated by new ideas. We repeat them in 2014.
Future research into ME must be based on collaboration. But not collaboration at any cost. But it would seem quite meaningless to base the strategy on those failed policies and directions of the past - which have served patients so poorly and caused such suffering (Diane's story - Lili).
There is the wrong way and the right way to progress research into ME.
Cholesterol-lowering statin drugs are doing more harm than good, and should be abandoned as the primary therapy for heart disease prevention, a major review has concluded.
Instead, coenzyme Q10 antioxidants are more effective and with fewer—or no—side effects, say researchers at University College Hospital in Galway.
Statins dramatically increase the risk of diabetes and cataracts in younger patients, and cancer and neuro-degenerative diseases in the elderly. And the benefits don’t outweigh the risks, say the researchers. Even for patients with advanced heart disease, the drugs may extend life by a further nine months at best if the drug is taken for 30 years.
Analysing previous studies on statins, the researchers discovered that some had never been published because the results were so alarming, while others had obscured the real risks. One study, the Illuminate trial, was shelved after researchers discovered the statin drug increased the risk of cancer and sudden death. But it’s unlikely the researchers will be heard: the statin market is worth £20bn a year and rising.
(Source: Journal of Endocrine and Metabolic Diseases, 2013; 3: doi: 10.4236 / ojemd.2013.33025).
Another update on the UK Rituximab Trial - I imagine there may be many more in the coming weeks and months!
On 6th June Invest in ME announced that we were in discussions to set up a UK trial of rituximab for ME patients and since that announcement things have been progressing well. The charity had been working on trying to get such a trial started since the IIMEC7 conference - click here.
In updates published through June/July, we have stated that all that is required for the trial to proceed is the funding.
As such, IiME began fundraising for this trial and invited everyone to support us in this project.
Recently we arranged a specific web site which has been set up to inform on all aspects of the UK rituximab trial. This is at - www.ukrituximabtrial.org
and we reiterated the current status - (click here)
We have the facilities available.
We have the researchers available.
We have the best expertise possible available.
We have the means of fundraising for this trial available (see The MATRIX - click here) and we have a campaign to raise funds
As we have agreed with our advisor, Professor Jonathan Edwards, the proposed clinical trial will undergo a rigorous peer review process.
We have reached this position thanks to the vision, efforts and help from Professor Edwards, Dr Cambridge, UCL and our supporters.
We have emphasised from when we announced the trial that the only element required is funding.
IiME will continue organising and raising funds for this trial. The IiME BRF Rituximab fund is specifically ring-fenced in a separate account for the UK rituximab trial.
The first part of the trial will be a preliminary study which will be designed to confirm and extend the earlier work of Dr Amolak Bansal (click here) on B-cells but using a different cohort of ME patients.
Professor Edwards believes this is a useful study in its own right and a pre-requisite for the clinical trial. Meanwhile work is continuing on the design of a protocol which will be finalised after the trip to Bergen that IiME and Professor Edwards have arranged.
Good progress is being made and IiME are committed to expedite this trial as best we can. To achieve this IiME has recently been in discussions with a charitable foundation with a view to help in funding this work.
We are enormously pleased to announce that, thanks to the extraordinary generosity and support of the foundation's representative, our biomedical research fund for the UK rituximab trial has now reached £50,000. This is due to a donation from the charitable foundation which will match our existing BRF rituximab total of £25,000 - click here. The charitable foundation currently wishes to remain anonymous but they have asked us to keep them informed of the progress of plans for the trial and we are sure that the ME community will join us in thanking them for this wonderful support
This now means that the first part of this project can be initiated by the UCL team without delay.
We thank all those who are supporting this trial and we will continue to provide information on the status of the trial as we progress.
We now resolve to increase our efforts to raise the remaining funds for the trial and ask for your continued support in this project in the knowledge that it will benefit all people with ME and their families.
The fundraising for this trial is being organised and coordinated by IiME so please contact IiME directly if you or your organisation would like to assist or contribute.
If anyone would like to ask any questions about the UK rituximab trial then please use the Contact form on the rituximab web site (click here).
In summary we feel that the best research team possible to undertake this trial is now able to begin the work - taking a huge leap forward in ME research in the UK.
The charity Invest in ME has provided a truly remarkable opportunity to address one of the biggest medical scandals in history and to remove what in 2007 Alex Fergusson, Presiding Officer (Speaker) of the Scottish Parliament, referred to as “the cold grip of psychiatry” on myalgic encephalomyelitis (ME), which he said was “still far too deeply rooted in the world of ME”
Now, however, despite the power and control of the psychiatric lobby, thanks to Invest in ME and the invaluable support of Jonathan Edwards, Emeritus Professor of Connective Tissue Medicine at University College, London, (world-renowned for his work in B cell immunology and as lead researcher in the clinical trials of rituximab for rheumatoid arthritis), the neuro-immune disease ME is at last about to enter the realm of mainstream medicine in the UK under the guidance of Professor Edwards himself.
Invest in ME are at the forefront of international biomedical research and have by sheer determination and effort managed to put things in place for a trial of rituximab to begin on ME patients in the UK. They recognise the urgency of the situation and know that many ME patients do not have the luxury of time. The charity already has the facilities in place, including suitably experienced researchers (Professor Jo Cambridge is now principal researcher at UCL, and the ME trial will involve the same team working under her that carried out the rituximab research in RA).
The Clinical Trials Unit at UCL is already working on the protocol, and Invest in ME have agreed with Professor Edwards that the protocol will be externally reviewed even though the UCL team will make sure it is cast-iron by their own internal reviewers.
Invest in ME have been told this trial could start relatively quickly if the charity had funds available. Such an opportunity must not be lost. However, this will not happen without substantial funding.
We therefore ask everyone who is able to do so to donate whatever they can afford, in order that the UK rituximab trial can get under way as quickly as possible whilst the excellent facilities and committed staff at UCL and the active support of Professor Edwards remain available, so that ME can finally be recognised as the devastating multi-system neuro-immune disease that it is and – most importantly -- so that sufferers may at last have some hope of alleviation of their suffering.
Invest in ME have assured us that all donations to the rituximab fund will sit in a separate account which is totally ring-fenced, and should the trial not proceed, the following statement on the IiME website will be honoured –
What Happens With These Funds If The Project Does Not Go Ahead:
If the rituximab project does not go ahead for some reason then the funds raised will be transferred to the IiME Biomedical Research Fund to fund other biomedical research projects which are attached to our proposal for an examination and research facility based in Norwich Research park in Norfolk, UK. These funds will only be used for biomedical research into ME.
A UK trial of rituximab is essential to move ME out of the realm of psychiatric dogma and into the realm of medical reality.
In order to make it easier for ME patients, ME support Groups, charities, organisations, researchers and the media to find more easily and bookmark the central point for the UK Rituximab Trial, Invest in ME have set up a special micro-site to collate all of the relevant information - www.ukrituximabtrial.org
On a separate issue – but still ME related – the following is a new document that gives a detailed analysis of the “6 Minute Walking Test” which was used in the PACE Trial -
For further info about the PACE Trial, please see –
Magical Medicine: How to make a disease disappear (February 2010)
Background to, consideration of, and quotations from the Manuals for the Medical Research Council’s PACE Trial of behavioural interventions for Chronic Fatigue Syndrome / Myalgic Encephalomyelitis, together with evidence that such interventions are unlikely to be effective and may even be contraindicated
Professor Malcolm Hooper http://www.meactionuk.org.uk/magical-medicine.pdf (6 Mb)
Statements By Professor Jonathan Edwards and Invest in ME - July 2013
Professor Jo Edwards
My interest in ME/CFS was sparked when I was invited, unexpectedly, by IiME to the IiMEC8 Conference in May.
The meeting was impressive: not just professional science, but at a high level. I was particularly impressed that negative findings were given adequate weight.
It became clear to me that there was a community committed to identifying and encouraging the very best research in a difficult and neglected field.
I was aware of the study by Fluge and Mella, using rituximab. I had not been surprised to see some patients respond, but the type of response, which was similar to what we had found in rheumatoid arthritis fifteen years ago, caught my attention. In fact, the situation seemed very reminiscent of the time when we first started to get results with targeted therapy in rheumatoid arthritis. We had the benefit of more immunological clues then, but on the other hand, the experience we have gained over the last decade now makes things easier in other ways.
My limited understanding of ME/CFS is that, like arthritis, it is probably several diseases with similar symptoms. Most colleagues who specialise in ME/CFS seem to agree. What the Fluge/Mella study suggests is that perhaps half of those suffering from these symptoms may have a B cell-dependent autoimmune disease.
A recent study by Dr Amolak Bansal and colleagues also suggests that B cells may be functioning abnormally in a significant proportion of people with ME/CFS.
To me, a key feature of this approach, unlike chasing one particular virus or gene, is that, if confirmed, it will provide a broad base for understanding disease mechanisms.
Even if rituximab is a cumbersome treatment in the short term its use may not only help a good proportion of patients directly but also begin to show us how to divide ME/CFS into different groups. So it may be useful even for those whose disease does not respond because once separated out from B cell-dependent disease the role of other factors such as NK cell function or cerebral blood flow may become clear.
Looking at the research directions currently being pursued in ME/CFS, I am in no doubt that the usage of rituximab is one of the most promising. There is clearly enthusiasm for further trials. However, rituximab is not an easy drug to use and many doctors do not feel confident with using it. This may explain why studies have been slow to gain momentum outside Norway.
Safe and effective usage requires understanding of B cell life history and function. Each condition has to be considered differently, especially in terms of when treatment is repeated. But with experience its use is very effective and probably as safe as most drugs.
After the IiME Conference I began thinking about my personal experience of patients and friends with ME/CFS. I was sent a copy of ‘Lost Voices ‘ by IiME, which made me think more. It struck me that, whether or not results are positive, further trials of rituximab for ME/CFS should be encouraged not only because impact on life for those affected can be so severe but also because further trials could give clues to disease mechanism. I am retired and would not be personally involved but have suggested to IiME that I would be happy to advise and to encourage others to set up a trial.
My feeling is that a trial should be carried out somewhere with detailed experience in use of rituximab in autoimmune conditions.
The UCL service set up when we started treating rheumatoid arthritis, lupus and a range of other conditions has the most extensive experience.
There is laboratory expertise in B cell immunology under Dr Jo Cambridge.
UCL also has a new Clinical Trials Research Facility with staff appointed to manage trials of this sort.
Importantly, there is enthusiasm amongst local teams for a rituximab ME/CFS trial.
I have suggested to IiME that this would be the ideal centre for such a trial, to be set up in collaboration with clinicians with expertise in ME/CFS from around London, and in particular Dr Bansal.
IiME have accepted this and this is the planned and preferred research base for this trial.
Clinical trials are costly. The trial planned in Norway to confirm the results from Fluge and Mella’s initial trial will cost something like £1-2M pounds. I think it would be most sensible to set up a smaller scale trial initially in the UK with a focus on trying to identify which patients are most likely to benefit. A trial treating about 30 patients, giving useful scientific information should hopefully be feasible for around £3-400,000. Trial design will require careful thought and some further preliminary laboratory work is likely to be needed before it is clear what design would be optimal.
Nevertheless, I am optimistic that a trial could be set up without major delay if funds can be raised. If the role of B cells in at least some ME/CFS, suggested by Fluge and Mella’s study, can be confirmed I think there is a genuine chance of getting to grips with the mechanism of the disease.
From there on things can only get easier.
Statement from Invest in ME:
The statement above from Professor Edwards is an astonishing opportunity for those patients with ME and their families.
To have somebody of Professor Edwards' standing produce such a statement, after agreeing to advise the charity following the IIMEC8 conference, justifies completely the conference theme of Mainstreaming ME Research.
This is a potential breakthrough for state-of-the-art biomedical research into ME.
We believe this study would add great value to other similar research being performed elsewhere.
It would also put the UK into the forefront of ME research.
There is no greater expert able to advise on a trial of rituximab than Professor Edwards who formally established the validity of B cell depletion in autoimmune disorders via his groundbreaking rituximab trials.
At the Biomedical Research into ME Collaborative meeting (BRMEC) organised by Invest in ME and the Alison Hunter Memorial Foundation Dr Jo Cambridge from UCL was invited by the charity to attend and present to the 40 researchers from nine countries gathered in London for the meeting. We felt it important to get the best advice possible to help with this area of ME research. Dr Cambridge added an enormous amount to the meeting – followed by a sincere and positive approach to progressing research.
UCL, as Professor Edwards has explained, has first-class facilities and we believe this opportunity is unique in the UK.
If the UK patient community wish to have a rituximab study then this is as good as it gets.
With the clinical team and Dr Cambridge at UCL performing this work, and with Professor Edwards as advisor, we are sure that a huge leap in understanding ME will be possible.
IiME have managed to work with the experts to set up this possibility. As Professor Edwards states “a trial could be set up without major delay if funds can be raised”.
Our fundraising campaign now must begin in earnest.
We invite everyone to get behind this UK rituximab study and support us.
We welcome contributions from other organisations and companies and individuals. The quality of the researchers and the facilities is beyond doubt.
IiME will contact other organisations to invite them to donate to this cause. One organisation has already indicated it will support a rituximab trial – in fact the MEA chairman has publicly stated on 29th July to an IiME supporter - “Let us know when you find some good quality researchers with a peer reviewed proposal. We have £60,000 in a ring fenced pot awaiting such a development.”.
We now have the researchers willing to perform this trial in the UK.
The quality of the researchers and the facilities at their disposal place the capability of the UCL team to perform this trial beyond doubt.
There is enthusiasm for setting up a study at UCL.
UCL can take this forward in collaboration with Dr Bansal and with close liaison, including visits, with Bergen. This has been agreed.
A meeting has been arranged for Professor Edwards to visit Bergen to discuss with Dr Fluge.
Further trips by the UCL team would be a possibility and will be arranged by the charity.
We welcome this as this will undoubtedly help both the Norwegian and the UK studies.
We need to raise funding for this study so we urge all our supporters, and others who wish to have a UK rituximab trial or wish to advance biomedical research into ME, to raise awareness and interest from as many sources as possible and support us in this venture.
This UK rituximab study has been initiated by IiME and the UCL staff who were at our conference and BRMEC research meeting.
The best research team possible to undertake this trial is able to perform this.
8th August - Severe Myalgic Encephalomyelitis Understanding and Remembrance Day
'I am a ghost in the land of the living – forgotten, ignored and drifting on the edges of life, whispering my message in the ears of the lucky ones who can participate in life. I have Myalgic Encephalomyelitis. I call it paralysis, muscle and cardiac failure, brain injury, a living plague that kills only slowly, but does kill...
Aylwin (Jennifer) Catchpole, who died in August 2010
Why have an awareness day just for the severely affected?
The severity of this illness often makes it impossible for people to have contact with loved ones, doctors, or the outside world. This is a group of thousands of people in the UK who are generally invisible. People with the severe forms of this disease can no longer pursue their careers, hobbies, or everyday lives.
In helping us to make visible the stories of people living with severe M.E., and of those who have died as a result of the illness, you can help end years of misrepresentation about M.E. and increase the understanding of the general public, who often underestimate the seriousness of the disease. This ignorance causes much suffering to those with M.E., who have a double battle, not only with the disease itself, but also to get the illness taken seriously by those around them. There is an urgent need to raise awareness.
What's the significance of 8th August?
This is the birth date of Sophia Mirza. Sophia was bed-bound with severe Myalgic Encephalomyelitis and was a victim of medical abuse. Her doctors did not believe that Myalgic Encephalomyelitis was a physical disease and so she was forcibly taken from her bed/home by social workers, police officers and doctors, and kept in a psychiatric facility where she received inappropriate treatment and care. Sophia subsequently died of M.E. at the age of 32. Her post-mortem revealed widespread inflammation in the spinal cord. This same inexcusable abuse still goes on.
Emily Collingridge - 17th April 1981 - 18th March 2012
“When our daughter, Emily, died in 2012, my husband and I were overwhelmed by the hundreds of messages of sympathy we received, even from people we did not know. They came from friends, from those expressing gratitude for her endless campaigning to spread awareness of ME and from readers of her guide to living with severe M.E., many of whom said it had changed their lives.”
The inquest into Emily’s death took place on 24th May 2013. In her summary the Coroner referred to ME as a condition which is not understood, and expressed the need for more research. She was echoing an appeal made by Emily in 2011 highlighting what she described as “the scandalous lack of research into the most severe form of M.E. and the lack of appropriate support for those suffering from it.”
A final plea in Emily’s own words.
“Please put an end to the abandonment of people with severe ME and give us all real reason to hope”. Emily may have lost her personal battle, but her battle on behalf of all those still suffering from severe ME should not be ignored.
What is Myalgic Encephalomyelitis?
Myalgic Encephalomyelitis literally means muscle pain (myalgia) with brain and spinal cord inflammation (encephalomyelitis). It is a complex neurological illness. The most characteristic feature is that symptoms are exacerbated by activity and sensory stimuli beyond the patient's limitations. Activities that trigger flare-ups can be tiny by healthy standards, depending on the severity of the illness. Simple things like talking, watching a TV programme, or eating a meal, can cause an exacerbation.
Dysfunction has been found in all the major systems - neurological, immune, endocrine, cardiovascular, musculoskeletal, gastrointestinal, respiratory, and genito-urinary, which is why people with Myalgic Encephalomyelitis can have such a wide range of symptoms. Common symptoms include widespread pain, cognitive dysfunctions (e.g. problems with concentration and memory), disabling sensitivities to everyday stimuli (such as light and noise), difficulty being upright (including sitting up in bed), sleep disorders and gastrointestinal problems.
The parents of those mentioned in this Press Release are happy to be contacted by members of the Media. This can be arranged through contacting the 25% ME Group, (the national support group for severely affected ME Sufferers). Contact details below.
GOD’S SPECIAL TENT: The Story of the Tabernacle and What Came After. Jean Stapleton. Christian Focus Publications, 52 pages, paperback, £5.99.
This A4 size book, as the subtitle suggests, seeks to open up for young people the mysteries of the tabernacle. The book begins with the Old Testament people of God at the foot of Mount Sinai, reviewing their history from the Exodus to that point, before moving on to the LORD’s giving of the 10 Commandments and His directions for worship. This smoothly leads into the main subject of the tabernacle.
Mrs. Stapleton then covers aspects such as dimensions, furnishings, sacrifices, as well as priests and Levites, and the High Priest’s office. The latter part of the book goes on to speak of the building of Solomon’s temple, it’s destruction at the Exile and the subsequent rebuilding and extension, ending with the final destruction in AD 70. Very helpfully, this all leads to the author speaking about the true temple – made up of living stones – the church.
This book would be most useful in the context of church work – for children’s work or children’s talks in services; it could also be profitably used by Christian parents, as well, of course, by children themselves, who would have edifying fun constructing the card model of the tabernacle included in this book as they learn biblical truths from “God’s Special Tent”.
There are two Christian conferences coming up in July that I would recommend – dates and speakers given below. I believe that the Met Tab will be showing the Wednesday evening sessions by Dr Masters live online; Tabernacle Cardiff aim to broadcast all sessions live. Both will have the talks available to download or purchase on disks afterwards.
“Recovery From Spiritual Decline – Proving the Methods of Scripture”
2 – 4 July 2013
Speakers – Ibrahim Ag Mohamed (London), Roger Brazier (Edmonton), Roland Burrows (Cradley Heath), Chris Buss (Battersea), Richard Clarke (Plymouth), Chris Hand (Crich), Dewi Higham (Cardiff), Peter Masters (London), Jonathan Northern (Baldock), Jack Seaton (Inverness) John Thackway (Holywell), Ted Williams, James Zenker (Blackheath)
A report on the 8th Invest in ME International Conference 2013, “Infection, Immunity and Myalgic Encephalomyelitis – Mainstreaming ME Research, Clinical and Research Updates”, written by Dr Ros Vallings, who is medical adviser to the Associated New Zealand ME Society (ANZMES) and secretary of the IACFS/ME, can now be found on the IiME website at -
At the recent Invest in ME (IiME) conference, the Norwegian ME Association presented Professor Malcolm Hooper with a prize, consisting of a framed citation and beautiful hand-made glass vase in recognition of his "untiring and exceptional contribution to the ME cause".
The award states -
Professor Malcolm Hooper has stood on the barricades for years and fought for ME from many angles. He is described as a real "warrior", which is very true. It is noteworthy that he is fighting for a disease with which he has no personal involvement.
He has written informative documents, published articles in international journals and fought politically. He gives lectures and has often spoken out against opponents such as Professor Simon Wessely, and other key individuals and institutions in the psychosocial environment. In addition, he has been an active part of the work of Invest in ME, has chaired their conferences several times, and has been their professional supporter.
The Norwegian ME Association has, on many occasions, approached him for advice in specific situations, and has benefited from the advice he has given in our struggle for recognition in Norway.
On behalf of the Norwegian ME Association it gives me great pleasure to present this ME Award to Professor Malcolm Hooper for his untiring and exceptional contribution to the ME cause.
STATEMENT FROM THE 25% ME GROUP REGARDING THE CFS/ME RESEARCH COLLABORATIVE CHARTER (CMRC)
The 25% ME Group is the only UK charity representing those who are severely affected with Myalgic Encephalomyelitis, a World Health Organization ( ICD10.9.3) classified disease, recognised by the UK Government as neurological. We subscribe to the use of the International Consensus Criteria (ICC) to clearly identify and separate ME from CFS, in order to ensure that ME is respected, treated and researched as a serious neurological disease impacting upon multiple systems of the body.
Therefore we cannot support nor validate the recently created CFS/ME Research Collaborative charter (CMRC) since, in our opinion it is an unacceptable waste of precious research funds, accommodating a range of research across a wide and vague criteria range not specific to ME. The CMRC, in our opinion, is more likely to prolong the current state of confusion rather than bring about much needed medical research or clarity.
Under the umbrella term “CFS/ME”, so often used to mean Chronic Fatigue (CF), leading to the mistreatment of people with ME; the CMRC does not and cannot represent or safeguard the needs of people with Severe ME.
It is wholly unacceptable for people with chronic fatigue and mental health issues to be included in research for Myalgic Encephalomyelitis and for people with Myalgic Encephalomyelitis to be used for CF research.
Without the separation of ME from CFS and particularly Chronic Fatigue, the 25% ME Group fears there will continue to be misdiagnosis, misrepresentation and negation of Myalgic Encephalomyelitis alongside the inappropriate perpetuation of psychological therapies charading as treatment, that, as our research has shown, does great harm to our members.
The 25% ME Group supports the need for medical research, using specific criteria to safely identify Myalgic Encephalomyelitis, so that ME can be studied and identified accurately in research; this will not come about through, non ICC-based research into vague “CFS/ME”.
For these reasons, the 25% ME Group, along with other concerned ME charities (ie, Tymes Trust, IiME and Grace Charity for ME) wholeheartedly cannot support the CFS/ME Research Collaborative charter.
Hannah Devlin Science Editor
Last updated at 12:01AM, April 23 2013
Scientists have found compelling new evidence for an underlying biological cause for the constant fatigue suffered by ME patients.
The study revealed abnormalities in the muscle cells people suffering from ME which are likely to contribute to feelings of tiredness and the inability to cope with sustained physical activity that many experience.
An analysis of muscle biopsies suggested that the cells had undergone substantial changes making them less able to cope with exertion.
The finding shows that whatever the initial trigger for ME, the condition leads to a cascade of physical changes right down to the cellular level.
Some patients still report facing stigma due to popular misconceptions that the condition is “all in the mind”, despite growing evidence that ME has real physical symptoms.
Julia Newton, Dean for Clinical Medicine at Newcastle University who led the study, said that the latest science was “changing people's perception of this terrible symptom”.
Professor Newton presented the findings at a meeting in London yesterday marking the launch of a collaboration aimed at generating more research into the disease.
In the study, scientists took muscle biopsies from 10 patients and ten healthy but sedentary volunteers.
The muscle cells were grown into small pieces of muscle and then subjected to “exercise” in the form of electrical impulses.
The cells from ME patients produced on average 20 times as much acid when exercised, suggesting an underlying cause for aching muscles that patients often experience as soon as they begin to exercise.
The cells also showed other abnormalities such as reproducing more slowly.
“We have found very real abnormalities” said Professor Newton.
PUBLISHED: 23:43, 11 April 2013 | UPDATED: 07:35, 12 April 2013
Another week, another humiliating blow for the healthy eating lobby. Yet again, their advice on nutrition, delivered in those familiar authoritative, disapproving tones, has proved to be completely misleading.
For years, these self-styled experts have warned us against eating too many eggs. Despite the fact our ancestors happily consumed this natural food for centuries, not so long ago the finger-wagging professionals suddenly decided that they were public enemy number one.
Eggs promoted heart attacks, clogged arteries, caused high blood pressure and weight gain, they declared, adding that we should eat a maximum of no more than two or three a week.
Now, though, it turns out that their advice is not only false, but even counter-productive. Just as these experts have been shown to be wrong about the dangers of red meat, cheese, milk and butter, so they have been hopelessly wrong about eggs.
Contrary to their grim admonitions, this week, scientists have declared that eggs are, in fact, a health food, packed with nutrients and proteins. The more eggs we eat, the healthier we should feel.
This new research has comprehensively demolished the claims that eggs are bad for the heart and the circulatory system. Just the opposite is true. Scientists at the Jilin University in China have found that one of the key components of egg whites can be just as powerful as specialised medication in reducing blood pressure.
This component is a peptide — one of the building blocks of protein — which appears to have the ability to inhibit the action of substances in the body that raise blood pressure.
‘Our research suggests that there may be another reason to call it the incredible, edible egg,’ said Dr Zhipeng Yu, the scientist in charge of this project.
His findings back up a recent study from the University of Alberta in Canada, which revealed that proteins in eggs can prevent the narrowing of blood vessels in the body, while researchers at the University of Missouri discovered that eggs are the best way to control appetite.
The health promotion lobby has long maintained that eggs are dangerous because they contain cholesterol, and high levels of cholesterol in the blood are supposed to be damaging to the heart.
But this argument now seems as dodgy as the rest of the theories they have inflicted on us.
For cholesterol, far from being a threatening substance, is an enriching natural product, vital for the healthy functioning of our bodies. Cholesterol is essential for making hormones, building cell membranes and digesting fats; that is why it is found in large amounts in mothers’ breast milk.
If cholesterol was really bad for us, then why would nature have made it an integral part of our biological composition in the first place?
This question goes to the heart of what is so wrong with the health promotion brigade. The frankly unscientific campaign against eggs reflects the wider propaganda effort that constantly pumps out misleading information about what we should eat.
So we have been led to believe that we should cut down on meat and dairy produce at the same time as increasing our intake of carbohydrates. On the NHS’s ‘Eatwell Plate’ — a plate which shows the proportions of food groups we should have and is a key tool of the food lobbyists’ campaigning — by far the largest portion is given over to ‘bread, rice, pasta and other starchy foods’.
Meanwhile, the portion on the Eatwell Plate given to ‘meat, fish, eggs and beans’ is less than half this size. Just as disturbingly, the Eatwell campaign also urges us to buy low-fat products, like skimmed milk, rather than more natural, full-fat ones.
Such advice could hardly be more wrong-headed. It is no wonder we are facing an obesity epidemic in this country. In their demonisation of meat and dairy products, along with their enthusiasm for carbohydrates and so-called ‘low-fat’ items, health campaigners are actually encouraging us to consume far more processed, unhealthy, high-sugar foods, with the disastrous consequences visible all around us.
Healthy eating is not complicated. The basic message is that natural foods, including free-range eggs, full-fat milk and organic meat, are good for us.
In contrast, foods that have been through the industrialised, high-tech, factory-farmed process have had all the goodness taken out, with their nourishing ingredients replaced by chemicals.
But, of course, this message not does suit big producers and retailers, who make their money from processing. Driven by this vested financial interest, they pretend that natural foods are full of dangerous timebombs, like heart-threatening fats and cholesterol, which they will defuse for us. So we end up in the absurd position where we are encouraged to eat more refined bread, which has few real health benefits, and to ditch eggs, which are perhaps the most nutritious of all foods.
Even more than meat, eggs are packed with the amino acids, minerals and high-quality proteins that are essential to our bodies’ continual process of regeneration. It is no exaggeration to say that every egg is an Aladdin’s cave of nutrients.
Indeed, except for Vitamin C, they contain every single vitamin that we need. They are especially useful as a source of Vitamin D, of which British people are often deficient because of the lack of sunshine in our climate.
Vitamin D can be consumed through oily fish such as herrings and sardines, but many people are not keen on such pungent dishes, so eggs are an attractive alternative.
Moreover, eggs also contain several vital antioxidants, which are essential for the prevention of disease, as well as the important nutrient choline, which helps with the development of the brain.
One of the many fallacies of the health promotion lobby is that the yolk is particularly unhealthy, a dogma that gave rise to the fashion for eating only egg whites.
The egg-white omelette, for instance, became a faddish statement of healthy eating in Hollywood circles. But it is just more nonsense. The yolk is the best part of the egg, not only delicious but full of all the right, health-giving ingredients.
In truth, there is no food that can match the egg in its nourishment, value and variety of uses. It is tremendously cheap. A box of half-a-dozen free-range eggs usually costs less than £2, much less than a sugar-packed, microwavable ready meal.
The purveyors of junk fast foods like to proclaim that they are providing convenience in our busy lives, but there has never been a better instant meal than a couple of eggs.
Indeed, the variety of dishes with eggs at their centre is almost infinite, from the sophistication of Eggs Benedict to that great Caledonian favourite of my homeland, the Scotch egg, which is a far healthier snack than any bag of crisps.
The only thing you need to worry about when buying your eggs is that they are free-range. Just as meat from organic and grass-fed livestock is far better than the produce of factory-farmed animals, so eggs from caged battery hens are nothing like free-range eggs.
If only the health lobby was not so blinded by dogma and commercial influences, they would recognise that eggs could be a vital weapon in the fight against obesity.
As I know from my own experience, an egg at breakfast wards off hunger pains right through until lunchtime, something that is never achieved by a couple of slices of toast or a bowl of muesli.
Any food agency that really cared about the nation’s health would be embracing egg consumption rather than frowning upon it. For, as we all knew before the arrival of the lobbyists and their commercial allies, we should all be going to work on an egg.
Entitled “Ensuring a good education for children who cannot attend school because of health needs," the guidance clarifies what must be done by local authorities for children who cannot attend mainstream or special schools due to illness.
In order to help you understand the implications of the new DfE Guidance on Sick Children, we invited Jane Colby, Executive Director of the TYMES Trust, to be our guest speaker at a webinar. Jane reviewed the guidance, and shared her thoughts including potential solutions in implementing it. After her many years as a head teacher, and now at the helm of the TYMES Trust, she has worked tirelessly to get the right support for medically ill children. Her advice is invaluable.
On Monday 18th February an ME meeting was held in The Long Gallery, Stormont, Parliament Buildings, in Northern Ireland. The meeting was organised by ME Support Northern Ireland in conjunction with the Chair of the Assembly’s Health Committee, and the purpose was to give a screening of the excellent film about severe ME called “Voices from the Shadows”. All 108 Members of the Legislative Assembly (MLAs) were invited and, although only a few stayed right through, quite a few popped in and out during the meeting. However, the organisers seemed very encouraged by the meeting – simply having the opportunity to show Voices from the Shadows at Stormont was quite something – I certainly can’t imagine such a thing happening in the Houses of Parliament at Westminster! To see a newsletter produced by ME Support Northern Ireland about the event, please click here – Mum and Dad are in one of the photos. NB The file is 5 Mb.
The DVD of Voices from the Shadows has actually just been re-released. It has the option of being watched with or without subtitles, with the subtitles being available in nine different languages. I would still definitely recommend it for giving an idea of what severe ME is like – many of those featured having very severe ME – although I would say that it is not suitable for children or anyone newly diagnosed with ME.
Newswise — FT. LAUDERDALE-DAVIE Fla. — Nova Southeastern University’s College of Osteopathic Medicine (NSU-COM) will hold a grand opening for America’s first Institute for Neuro Immune Medicine on Feb. 12.
Located at NSU’s main campus in Davie, the Institute will be the only one of its kind in the nation that will treat patients with conditions such as chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) and Gulf War Illness (GWI), as well as conduct basic and clinical research under one roof in this field.
The Institute will also be the first in the nation to study neuroinflammatory and neurodegenerative disorders such as CFS/ME, GWI, Parkinson’s Disease and multiple sclerosis using the newest genomic techniques.
By studying individual genes and what they code for, the Institute’s scientists will better understand the cause and point to new ways to treat these complex disorders. The idea is to challenge the patient with something like exercise and measure which genes turn on or off and to better understand the cause of relapse and illness persistence and find points of intervention. This important basic research will provide answers that will help scientists develop new pharmaceutical medications to treat these illnesses.
The Institute will have research laboratories, a patient clinic, a clinical research unit, faculty offices and conference facilities. It’s designed to put together multiple core medical and scientific disciplines in one place: clinicians, educators and researchers in the areas of genomics, virology, immunology, cellular biology, computational biology and therapeutic modeling.
“We have created a one-of-a-kind think tank that will become the leading neuro immune medicine institute of its kind in the United States,” said the Institute’s director Nancy Klimas, M.D., who is one of the world’s leading researchers and clinicians in chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). “It will be a place to coordinate cutting edge thinking and research, train new practitioners, and offer the highest quality clinical care for a hugely underserved population. We are thrilled to take this giant step forward in the field of CFS/ME and Gulf War Illness care and research.”
The Institute partners with the Miami VA Medical Center in the Gulf War Illness research program. It will compliment an existing NSU-COM clinic Klimas oversees in Kendall, which treats CFS/ME, GWI and other patients suffering from neuro immune disorders. When the Institute begins seeing patients on March 1, both facilities will accommodate around 1,300 patients from South Florida, throughout the nation and around the world.
By bringing together some of the best scientific minds in the world, the facility will act as both a working institute for research, train new clinicians, and provide diagnostic and therapeutic clinical care.
In addition to seeing patients and conducting research, Klimas and her team are conducting clinical trials for the drug Ampligen, which would be the first-ever medication to treat CFS/ME if approved by the Food and Drug Administration (FDA).
CFS/ME is a debilitating immune disorder that affects more than one million Americans. A majority of CFS/ME sufferers are women, who remain mostly untreated. The disease damages the patient’s immune system and causes symptoms such as extreme fatigue unabated by sleep, faintness, widespread muscle and joint pain, sore throat, severe headaches, cognitive difficulties, and severe mental and physical exhaustion. CFS/ME symptoms typically last for more than six months, often decades. Those suffering from the disease find their lives dramatically altered to the extent that working and completing simple tasks become difficult or impossible.
Gulf War Illness is a medical condition that affects veterans and civilians who were exposed to a number of triggers, including chemical weapons during the 1991 Gulf War. Symptoms include musculoskeletal pain, fatigue, skin rashes, cognitive problems, and diarrhea.
The Institute is part of NSU’s initiative to bring world renowned researchers to campus. The Schemel Family Foundation has generously donated $2 million to establish an additional endowed professorship, the Schemel Professor for Neuro Immune Medicine in neuroimmunology, at the Institute to work directly with Klimas. In addition, a beautiful patient waiting area was generously contributed by the Maroone Family.
The grand opening ceremony, which starts at 6 p.m., will be by invitation only. The event is not open to the public.
Members of the news media are invited to attend without an invitation. Please call Ken Ma, M.B.A., associate director of NSU Public Affairs, only if you are a news media member who would like to attend. He can be reached at 954-621-7961 or firstname.lastname@example.org
About NSU’s College of Osteopathic Medicine: The mission of the College of Osteopathic Medicine is to provide learner-centered education, both nationally and internationally, for osteopathic medical students, postgraduate trainees, and other professionals. Through its interprofessional programs, the college prepares competent and compassionate lifelong learners; supports research, scholarly activity, and community service; and advocates for the health and welfare of diverse populations, including the medically underserved. NSU-COM. http://medicine.nova.edu/
About Nova Southeastern University: Situated on 300 beautiful acres in Davie, Florida, Nova Southeastern University is a dynamic fully accredited research institution dedicated to providing high-quality educational programs at all levels. NSU is the eighth largest not-for-profit independent institution nationally with more than 28,000 students. NSU awards associate’s, bachelor’s, master’s, specialist, doctoral and first-professional degrees in a wide range of fields. Classified as a research university with “high research activity” by the Carnegie Foundation for the Advancement of Teaching, NSU is one of only 37 universities nationwide to also be awarded Carnegie’s Community Engagement Classification. www.nova.edu
(It seems to me that they are not even going to attempt to answer the points raised by the Countess of Mar.)
Here is the response to the Countess of Mar's letter from Professor White and Professor Sir Simon Wessely:
Dear Lady Mar,
Thank you for your recent email and letter.
We are disappointed that your response quotes sentences from various papers and presentations without context to seek to confirm conclusions already arrived at; conclusions we do not share. We cannot even agree the meaning of terms, let alone a more detailed analysis of the literature. As one example, perpetuating or maintaining factors of a medical condition are not the same as the causes of the condition. So, treatments tested and shown to be effective in the PACE trial do not address the infection that may have started CFS, but do help patients address particular barriers to their recovery, which are often nothing to do with an original infection.
With regret, we believe that continuing a correspondence will not bring our views closer together.
Professor Peter White and Professor Sir Simon Wessely
Professor Peter White has responded to the Countess of Mar’s letter published in the “Independent on Sunday” of 13th January 2013 :
From: "Peter White"
To: "MAR, Countess"
Subject: RE: Letter to the Independent on Sunday
Dear Lady Mar,
As a matter of courtesy and for your information, I attach the link to an IoS wesbite posting from Sir Simon and myself, which was uploaded on Saturday.
Also for your information, I attach two of my most relevant papers that speak to the important role of infection as an immediate cause of CFS.
“John Maddox Prize: We would like to correct several errors of fact in the letter published on this website by the Countess of Mar and others. These authors state that we "..have promoted an hypothesis that ME/CFS is due to an abnormal illness beliefs,.. " We have not; beliefs about an illness determine the ways people cope with it, but this has little to do with how the illness develops in the first place (its immediate cause), which our own research has shown can follow certain infections.
The correspondents also mention the PACE trial and state that "No data on recovery rates and positive outcomes have been released.." The results of positive (and negative) outcomes were published in the Lancet medical journal early in 2011. The results of recovery rates are due to be published in the medical journal Psychological Medicine within the next three weeks.
The authors state that "There has been no attempt by Professor White to correct the misapprehension in respected journals as well as the popular press that the PACE trial demonstrated recovery rates of between 30% and 40%." Again this is not the case; Prof White and colleagues published the following in the Lancet in May 2011: "It is important to clarify that our paper did not report on recovery; we will address this in a future publication."
The PACE trial has added to the now overwhelming scientific literature showing that two rehabilitative approaches of cognitive behaviour therapy and graded exercise therapy are moderately effective treatments of what is otherwise a chronic, debilitating and untreatable illness that blights patient's lives. This is good news that needs sharing. Professor Peter White Professor Sir Simon Wessely Queen Mary University London and King's College London”
Professor PD White
Professor of Psychological Medicine,
Centre for Psychiatry, Wolfson Institute of Preventive Medicine,
Barts and The London School of Medicine and Dentistry,
Queen Mary University of London.
Address: Psychological Medicine, St Bartholomew's Hospital, London, EC1A 7BE, UK.
And the following is the Countess of Mar’s response, sent on 25th January 2013:
From: "MAR, Countess"
To: "Peter White"
Subject: RE: Letter to the Independent on Sunday
Dear Professor White
Thank you for sending me a copy of the reply which you and Professor Sir Simon Wessely tells me was uploaded to the Independent on Sunday website on 19th January. I concede that I do not understand much of it, as semantics is no substitute for science.
We do not even know what disorder you are talking about because, whilst ethical approval and funding were granted on the basis that you would study CFS/ME and whilst the PACE trial documentation refers to CFS/ME (about which you stated in the PACE trial patient leaflet: “Chronic fatigue syndrome” is “also known as post-viral fatigue syndrome, myalgic encephalomyelitis (ME) or myalgic encephalomyelopathy (ME)….Medical authorities are not certain that CFS is exactly the same illness as ME, but until scientific evidence shows that they are different they have decided to treat CFS and ME as if they are one illness”), in March 2011 you confirmed to the editor of The Lancet: “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”.
I will address the points in your reply one by one: (1) that you have not promoted ME/CFS as abnormal illness behaviour; (2) that the PACE trial outcomes were published in The Lancet early in 2011; (3) that you did correct the mis-reporting in respected journals and the popular press that PACE demonstrated recovery rates of between 30% and 40% and (4) that the PACE trial has added to the overwhelming scientific literature showing that CBT and GET are moderately effective treatments, and that this is good news which needs sharing.
Your first point (that you have never claimed ME/CFS is an “abnormal illness belief”)
You and Sir Simon state categorically that you have not promoted an hypothesis that ME/CFS is due to “abnormal illness beliefs”.
Why, then, was CBT in the PACE trial (of which you were Chief Principal Investigator, with whom all responsibility ultimately rests) provided on the basis that "the symptoms and disability of CFS/ME are perpetuated predominantly by unhelpful illness beliefs (fears) and coping behaviours (avoidance)", whilst “GET was done on the basis of deconditioning and exercise intolerance theories of chronic fatigue syndrome. These theories assume that the syndrome is perpetuated by reversible physiological changes of deconditioning and avoidance of activity”?
Moreover, in your 2007 paper co-authored with Professors Bleijenberg and Knoop, you state: “The attitude of the therapist towards the treatment goals will affect the expectations and perceptions of the patient…If the therapist suggests that recovery is possible, the patient expectations are raised, which in turn may lead to a change in the perception of symptoms….For complete recovery, the perception of the patient also has to change. The patient has to perceive his fatigue and functioning as both normal and comparable to healthy people….A therapist delivering CBT can tell the patient that…full recovery is possible” (Psychother Psychosom 2007:76:171-176).
What else can this mean but that you regard ME/CFS, not as a pathological process resulting in chronic multi-system disease, but as a condition maintained by patients’ abnormal illness beliefs which trap them in “self-perpetuating vicious circles of fatigue and disability”?
If it is the case that you both now accept this theory to be wrong (as your comment on the IoS website implies), this would be remarkable, because you have promoted and championed it for more than twenty years and the PACE trial interventions were based on that hypothesis. Therapists were trained to instruct participants that their symptoms do not result from physical disease, with the inescapable conclusion that ME/CFS is considered a non-disease. Indeed, the Therapists’ Manual on CBT taught therapists how to manage participants who believe they have a physical disease, how to persuade them that this is not the case, and how to dissuade them from seeking further medical attention.
Exactly what do you understand the nature of ME/CFS to be? Clearly, as you consistently disregard the biomedical evidence, including the fact that the MRC now states: “There is now preliminary evidence supporting the view that inflammatory mechanisms in the brain and spinal cord may underlie the pathophysiology of some severe disease CFS/ME phenotypes”, you do not agree that it is a multi-system organic disorder and instead ascribe the protean symptomatology to psychiatric illness.
Because the issue of what kind of disorder you believe ME/CFS to be is so important, I remind you of the published views of all the PACE trial Principal Investigators (including your own) and of Sir Simon’s views, since he directed and oversaw the PACE Clinical Trial Unit that was responsible for randomisation and database design.
Sir Simon wrote to me on 21st December 2012 and confirmed: “CFS is not classified as a somatisation disorder. Nor do I believe it should be”. However, his published beliefs about the nature of ME/CFS do not accord with what he wrote to me, for example, his views are that “Functional somatic syndromes…include chronic fatigue syndrome” (Rev Bras Psiquiatr 2005:27:3) and that ME/CFS is “somatisation par excellence” (J Psychosom Res 1994:38:2:89-98).
You and your colleagues have flooded the literature with terms that you claim categorise ME/CFS, some of these being functional somatic syndrome; somatisation disorder; functional disorder; medically unexplained symptoms (MUS) and medically unexplained physical symptoms (MUPS).
The profusion of these terms to signify psychiatric conditions whose existence can neither be proven nor disproven illustrates a profound conceptual problem at the heart of liaison psychiatry.
There is no objective way to prove that a person has a functional somatic syndrome or somatisation disorder; it can only be claimed that no physical cause has so far been found, not that there is no physical cause (ie. one cannot prove a negative).
Using terms that are deliberately ambiguous, sometimes with the intention of concealing the clinician’s belief that the patient has a mental illness, can only be damaging to the doctor-patient relationship.
In his 2012 JNNP paper (for which he designed the study and edited the manuscript -- The function of ‘functional’: a mixed methods investigation. JNNP: 16th January 2012) Sir Simon says that: “The term ‘functional’ …has increasingly come to mean ‘hysterical’…(and) its ambiguity was seen as useful when engaging with patients…. ‘Functional’ is a common term for medically unexplained symptoms…It has retained popularity among neurologists as a medical term for conversion disorder….It can, for example, be used to mean a disturbance of bodily function or it can be used to denote conversion disorder, and by telling a patient they have a ‘functional disorder’ they may encourage them to contemplate the former meaning without being aware of the latter…allowing neurologists to use the same term to mean one thing to colleagues and another to patients”.
Sir Simon explains that the forthcoming DSM V proposes to use the term “functional” as the official diagnostic term for medically unexplained neurological symptoms and that these are currently known as “conversion disorder”, which is a somatisation disorder.
Sir Simon is known for his view that ME/CFS is now best described as MUS or MUPS and that MUPS is synonymous with somatisation disorder, where the cause of symptoms is mental in origin. MUPS is now used interchangeably with somatisation and functional somatic symptoms (Rosendal M, Fink P et al. Scandinavian Journal of Primary Health Care 2005: 21 (1): 3–10.)
On the one hand, Sir Simon states that he does not believe that CFS/ME should be classified as a somatisation disorder, however he has also written that it is a somatisation disorder.
You are on record as disagreeing with Sir Simon and Professor Michael Sharpe (one of your PACE trial Principal Investigators) that there is only one functional somatic syndrome which incorporates ME/CFS together with irritable bowel syndrome, fibromyalgia and pre-menstrual syndrome (by including pre-menstrual syndrome, Wessely and Sharpe ignore the incidence of ME/CFS in males) (Lancet 1999:354:936-939); your view was that ME/CFS is an individual functional somatic syndrome (Brit J Psychiat 2004:185:95-96).
In 2009 you commented that Sharpe and Wessely believed: “functional disorders…include irritable bowel syndrome (and) CFS/ME. I have argued against this idea, suggesting that the commonality is abnormal illness behaviour, as seen in the process of somatisation” (Psychol Med 2009: 15 April: 1-9:PMID:19366500). Clearly you do promote the view that ME/CFS is abnormal illness behaviour.
You also contributed the chapter in Clinical Medicine (Kumar & Clark: 2005: pp1281 ff) where the entry for ME directs readers to the entry for CFS, which in turn directs readers to Section 21 (Psychological Medicine) where CFS/ME is listed under “Functional or Psychosomatic Disorders: Medically Unexplained Symptoms”, in which you asserted that the psychiatric classification of these disorders is “somatoform disorder”, which you state were previously known as “ ‘all in the mind’, imaginary and malingering”. In this chapter, you stated: “ ‘Functional’ disorders are illnesses in which there is no obvious pathology or anatomical change in an organ…The psychiatric classification of these disorders would be somatoform disorders. Examples of functional disorders (include) fibromyalgia (and) chronic or post-viral fatigue syndrome…aetiological factors include physical inactivity…. Perpetuating (maintaining) factors include avoidant behaviours (and) maladaptive illness beliefs”.
In your presentation to The Royal College of Psychiatrists’ Liaison Psychiatry Conference in March 2012 you asserted that ME/CFS is perpetuated by behavioural and psychological factors (ME or CFS: Belief or Science? slide 14). The irony of this is that the ME/CFS battleground represents your beliefs versus medical science.
In his presentation at the Foundation for Science and Technology event “The future strategy for the management of mental health in the UK” held at The Royal Society on 11th September 2012 Sir Simon repeated your own assertion in his presentation “Health in mind and body” (“CFS: what do we know?”) that ME/CFS is “perpetuated by behavioural and psychological factors” and that there is “no evidence for chronic infection”.
Your other PACE Principal Investigator, Professor Trudie Chalder, asserts that “Anorexia nervosa and chronic fatigue syndrome are classical psychosomatic disorders” (Advertisement for Research Worker, Institute of Psychiatry, 2007; Ref No: 07/R68).
What other neuroimmune disease is subjected to such relentless and unjustified dismissal by one particular group of mental health professionals? It is unsurprising therefore that you are seen to be attributing ME/CFS merely to wrong coping ability, in other words, you assume the person had a viral infection from which s/he would have recovered if s/he did not harbour aberrant illness beliefs, ie. no wrong illness beliefs, no ME/CFS.
You attached two of your own papers (1998 and 2001) that you say “speak to the important role of infection as an immediate cause of CFS” yet in your Lancet report you make no mention of the role of infection.
Why do you refuse to accept the evidence that it is the physical disease which limits activity? The evidence is convincing that ME/CFS is characterised by an inability to produce sufficient energy on demand (Canadian International Consensus Primer for Medical Practitioners, Carruthers B et al, 2012). Your own studies have not overturned that evidence, nor have they demonstrated that the well-recognised dysfunction of the central and autonomic nervous systems, the cardiovascular system, the musculature and the immune system are, as you propose in Kumar and Clark, merely secondary to inactivity (“Immune and endocrine abnormalities noted in CFS may be secondary to the inactivity”).
From your own 2004 study on the effect of exercise on pro- and anti-inflammatory cytokines (JCFS 2004:12 (2):51-66) you know that the pro-inflammatory cytokine TNFa remains elevated three days after exercise in ME/CFS patients and that it can have deleterious effects on the central nervous system, TNF being a cytokine that is involved in systemic inflammation. In your article you said: “TNF-a is known to be a cause of acute sickness behaviour, characterised by reduced activity related to ‘weakness, malaise, listlessness and inability to concentrate’, symptoms also notable in CFS”, yet you made no mention of it in the PACE trial literature or in your Lancet report.
Although your own previous studies have shown a link with one particular precipitating infection (EBV) and post-viral fatigue, the interventions you promote do not equate with management of a chronic infectious disease with a dysfunctional immune system and you treat ME/CFS as primarily a mental health problem.
With regard to Professor Sharpe’s views about ME/CFS, they are very clear: he believes that ME is a “pseudo-diagnosis” (Occup Med 1997:47:217-227); he believes that people with ME who “refuse to be placed into and accept the stigma of mental illness remain the undeserving sick of our society and our health service” (ME. What do we know: real illness or all in the mind? Lecture given in October 1999 at University of Strathclyde; transcript available); his view is “that the issues around CFS/ME are the same as those surrounding the acceptance and management of (patients) who suffer conditions that are not dignified by the presence of what we call disease” (J Psychsom Res 2002:52:6:437-438) and that: “Factors such as immunological abnormalities are not of clinical value” (BMJ 2002:325:480-483); he believes that classifying ME/CFS as a somatisation disorder has “the most clinical utility” (Trends in Disability: UNUMProvident Report 2002) and he believes that: “Every medical specialty has its own syndrome of… ’functional’ somatic symptoms….Fibromyalgia (and) chronic fatigue syndrome…are just some examples….Patients are assumed to have ‘mental disease’ ” (Editorial: Somatoform Disorders: J Psychosom Res 2004:56:387-390).
In their chapter in “Somatoform Disorders”, Volume 9, ed: Mario Maj et al 2005 (Chapter 5), Sharpe and Wessely assert: “The majority of patients with CFS…will fit the…criteria for…somatoform disorder”.
In view of the above, what we said in our letter in the IoS (ie. that you promote the hypothesis that ME/CFS is due to abnormal illness beliefs) is justified and your denial is not supported by the published evidence.
Your second point (on “recovery” versus “positive outcomes”)
You say that the PACE recovery rates are due to be published in Psychological Medicine within the next three weeks. Why, when these are the most important issue, has it taken two years over and above the published “positive outcomes” to provide the recovery figures? Such an exceptional delay gives rise to speculation that you are having difficulty in achieving the desired outcome.
Your Lancet report did not mention “recovery” but assumed that “reversal” of symptoms was possible; however, according to the PACE results, the condition is not reversible with your interventions and the only effect of CBT and GET was to change how participants filled in subjective questionnaires whilst offering no objective improvement in health.
I look forward to your forthcoming paper on recovery rates with considerable interest, given that in response to an FOIA request to Queen Mary University of London, Paul Smallcombe stated as recently as 1st November 2012: “The requested data relating to recovery rates and positive outcomes do not exist. That is to say that such analyses have not been done and there is no intention to do so. The reason for this is that the analysis strategy has changed from the original protocol”. He went on to explain: “With regards to the recovery rates: the criteria threshold for measuring recovery in the Trial were changed in the light of more detailed consideration of previous published studies…and in the light of newly published work”. This has been interpreted as meaning that you changed the threshold for recovery in light of the very poor results of the PACE trial’s sibling trial (FINE), which used the same threshold that you had intended to use.
In your letter of March 2011 to the editor of The Lancet responding to Professor Hooper’s formal complaint (which was sent to Margaret Williams by The Lancet), you wrote: “Future papers…are in preparation including reports of economic outcomes (and) different definitions of recovery and remission”. Once again, your position is based on equivocal language. “Recovery” means recovery to full health, nothing less, but you obviously continue to believe that: “The percentage of recovered patients depended on the criteria used for recovery” (Psychother Psychosom 2007:76:171-176). You go into the meaning of standard deviations in relation to an alleged return to “normal” (universally interpreted as “recovery”) whilst then admitting that your version of “normal” is not the same as normal health as interpreted by the average doctor. If a clinician treats a patient with CBT/GET, s/he will not be using standard deviations to measure a patient’s recovery.
Reporting on “positive outcomes” is not the same as reporting on recovery rates: you and your co-authors Professors Bleijenberg and Knoop acknowledge that: “Improvement and not meeting research criteria for an illness are different from recovering” (ibid).
If the PACE trial is to be used as a guide for treatment, you need to explain in unambiguous terms what “recovery” mean -- ie. what percentage (and how many) of the 641 participants recovered as per the original protocol, which would be in line with the generally accepted meaning of recovery; what percentage (and how many) returned to gainful employment or study, as well as what percentage (and how many) no longer claimed sickness or insurance benefits as a direct result of the PACE interventions. Such outcomes were the intended purpose of the trial.
It is disturbing that you have re-defined your own definition of “recovery”. According to your original protocol, “recovery” meant that a participant met all four of the following criteria: (i) a Chalder Fatigue scale score of 3 or less (ii) an SF-36 physical function score of 85 or above (iii) a CGI (Clinical Global Impression) score of 1 and (iv) the participant no longer met the Oxford criteria for CFS, the CDC criteria or your own version of the London criteria (which bore little resemblance to the original London (Ramsay) criteria, since there is no requirement for the presence of the cardinal feature of ME -- post-exertional exhaustion -- or of any neurological disturbance, thus lessening the distinction between true ME and “medically unexplained” fatigue, which is a somatisation disorder).
Ben Goldacre, writing about the Enhance trial of the cholesterol-lowering drug Simvastatin, stated: "in a trial, you might measure many things but you have to say which is the "primary outcome" before you start: you can't change your mind about what you're counting as your main outcome after you've finished and the results are in. It's not just dodgy, it also messes with the statistics….But the people running the Enhance trial altered their chosen endpoint when the trial was over. They say they did so before they knew the results. That may be so, but it doesn't look good, and they've now had a very serious letter from a US congressional committee demanding to know why it was done….You cannot change the rules after the game has started. You cannot even be seen to do that" (The data belong to the people who gave it to you: The Guardian: 5th January 2008).
It can be surmised that few if any PACE participants met the requirement for “recovery” as originally specified, which is why you lowered the SF-36 physical function score by 25 points from 85 to 60.
To date, there has been considerable deviation from the normal scientific process, including the failure of the peer-review process to fulfil its duty as guardian of accuracy in the reporting of the results.
Your third point (that you did correct the mis-reporting of the PACE trial results)
You claim that your letter to The Lancet of 17th May 2011 was sufficient to correct the widespread misrepresentation of the success of the PACE trial interventions (“It is important to clarify that our paper did not report on recovery”).
A number of things can be said about this. First, your Principal Investigators themselves contributed to the misrepresentation, including Professor Chalder's comment at the press conference on 17th February 2011 that: "twice as many people on graded exercise therapy and cognitive behaviour therapy got back to normal", which a reasonable person would understand to signify recovery, but "normal" as defined in the PACE Trial was in fact a level of health so low that a participant could be made worse by CBT and GET and still be classified as having "got back to normal".
Secondly, when other authors, such as Professors Bleijenberg and Knoop, and then Dr Esther Crawley, claimed (erroneously) in medical journals including The Lancet itself that CBT and GET had resulted in “recovery” rates of 30% - 40%, no action was taken to correct the record.
By contrast, when David Tuller, writing in The New York Times, criticised the case definition applied in the trial, within days you and Professors Chalder and Sharpe wrote directly to the paper to mount a defence.
Thus it is the case that when the misrepresentation was in your own favour, it was not corrected, but when comments that were factually correct but were not in your favour were reported, you immediately objected to them.
That you made no attempt at correcting the misinformation in The Lancet Comment by Bleijenberg and Knoop is not surprising, given that the Deputy Editor of The Lancet has confirmed that you approved it before publication: “The Comment in question was reviewed, as is our standard practice, by the authors of the accompanying PACE trial” (letter dated 22nd January 2013 from Dr Astrid James to the Press Complaints Commission).
The Deputy Editor goes on to state about my complaint to the Press Complaints Commission concerning the Comment: “We would like to reject this complaint in the strongest possible terms. We believe there are no inaccuracies….We have shared the complaint with Dr Bleijenberg and Dr Knoop and they stand by the content of their published Comment….They stand by their use of the term ‘recovery’….We stand by our publication of the Comment by Dr Bleijemberg and Dr Knoop, and have found no inaccuracy that warrants a correction. We hope that our response is clear”.
This is in stark contradiction to the email sent on 8th June 2011 by Zoe Mullan, Senior Editor at The Lancet, who confirmed about the Bleijenberg and Knoop Comment that it should be withdrawn: “Yes, I do think we should correct the Bleijenberg and Knoop Comment, since White et al explicitly state that recovery will be reported in a separate report. I will let you know when we have done this”. Despite Zoe Mullan’s assurance, it has not been corrected.
Such contradiction by The Lancet reflects badly on the editorial staff.
What you reported in The Lancet article was not “recovery” statistics but the number of participants who fell within your own (artificially low) definition of the “normal range” for fatigue and physical function.
In your letter published in The Lancet on 17th May 2011 you clarified that no recovery results had been published.
Why, then, did you approve publication of the Comment? That Comment said: “Both graded exercise therapy and cognitive behavioural therapy assume that recovery from chronic fatigue syndrome is possible and convey this hope more or less explicitly to patients….Have patients recovered after treatment? The answer depends on one’s definition of recovery (quoting the paper you co-authored with Bleijenberg and Knoop: Psychother Psychosom 2007:76:171-176). PACE used a strict criterion for recovery: a score on both fatigue and physical function within the range of the mean plus (or minus) one standard deviation of a healthy person’s score. In accordance with this criterion, the recovery rate of cognitive behavioural therapy and graded exercise therapy was about 30%....the PACE trial shows that recovery from chronic fatigue syndrome is possible”.
Bleijenberg himself regards an SF-36 score of 65 as representing severe impairment (BMJ: 2005 January 1; 330: (7481):14), yet in the Comment he implicitly accepts a score of 60 (five points worse) to equate with “recovery”.
As you approved the Comment before publication, was it not an omission on your part not to inform Bleijenberg and Knoop (and The Lancet) of their error?
The whole point is that PACE participants did not fulfil your “strict definition for recovery” (which you abandoned) and the SF-36 measure was not plus or minus one standard deviation of a healthy person’s score; you yourself conceded in your letter to The Lancet that you used the mean of an English adult population (not a working age population as you claimed in your Lancet report). This distinction is important because an English adult population includes elderly people and individuals with chronic illness so your comparison for recovery was not, as Bleijenberg and Knoop state, relative to a healthy person’s score. By not comparing with a healthy person’s score (but with the average that included elderly and the chronically sick), you increased the likelihood that PACE participants’ scores would reach your re-defined “normal range” on conclusion of the trial.
When your Lancet report mentioned one standard deviation, it was in relation to a marker by which improvement could be assessed. As mentioned, you accept that improvement is not the same as recovery and patients could have improved yet be far from “recovered”. On what evidence, then, did Bleijenberg and Knoop claim “recovery” of “about 30%”?
This, according to the University of St Andrews, is false citation which may be construed as academic misconduct (University of St Andrews. 2013. Policy and governance. 6.1.2 Categories of academic misconduct. False Citation). False citation is the citing of a source for information when the source does not contain that information.
As one of the UK’s most respected medical statisticians, Professor Martin Bland, makes clear: “Potentially incorrect conclusions, based on faulty analysis, should not be allowed to remain in the literature to be cited uncritically by others” (BMJ: 19th February 2000:320:515-516).
No-one from the PACE trial team published a single thing that corrected the greatly exaggerated spin that flooded the media. Merely publishing a letter in The Lancet three months after the media frenzy of misreporting the results of the PACE trial is not sufficient. You, as Chief Principal Investigator, have a duty to at least try to ensure the accurate reporting of the trial results so that patients, clinicians and policy makers will not be influenced by misleading information.
Your fourth point (your claim that the PACE trial has added to the now overwhelming scientific literature about the efficacy of CBT and GET)
There is no body of “overwhelming scientific literature” that patients with ME/CFS benefit even moderately from CBT and/or GET. The only objective results of the PACE trial (ie. the six minute walking test) do not support such a claim. Indeed, Sir Simon is on record:
“It should be kept in mind that evidence from randomised controlled trials bears no guarantee for treatment success in routine practice. In fact, many CFS patients, in specialised treatment centres and the wider world, do not benefit from these interventions” (Huibers and Wessely. Psychological Medicine 2006:36:(7):895-900).
The very modest benefit in only some patients has been shown to last for only 6 -8 months: “the observed gains may be transient” (Long-term Outcome of Cognitive Behavioural Therapy versus Relaxation Therapy for Chronic Fatigue Syndrome: A 5-Year Follow-Up Study. Alicia Deale, Trudie Chalder, Simon Wessely et al. Am J Psychiat 2001:158:2038-2042).
This was confirmed by others: in 2003 it was reported at the 6th AACFS International Conference that Dr Daniel Clauw (who had studied 1,092 patients) found that at 3 months there were modest gains from CBT, but at follow-up at 6 and 12 months those modest gains were lost.
A Dutch report in February 2008 came to unambiguous conclusions about CBT for ME/CFS: the study “does not confirm the high success rates regularly claimed by research into the effectiveness of CBT for ME/CFS”. It found no increase in employment rates, in educational training, engaging in sports, maintaining social contacts and doing household tasks. The majority reported substantial deterioration. Moreover, the length of the therapy did not affect the results. The authors’ conclusion was: “Overall, CBT for ME/CFS does not improve patients’ well-being. More patients report deterioration of their condition rather than improvement. Our conclusion is that the claims in scientific publications about the effectiveness of this therapy, based on trials in strictly controlled settings within universities, have been overstated and are therefore misleading” (Source: Medisch Contact, February 2008, ISBN: 978-90-812658-1-2, by Koolhaas MP, de Boorder H, van Hoof E. The Netherlands).
In January 2011, the result of a randomised controlled trial (and the PACE trial was not controlled) of the same interventions as those used in the PACE Trial came to very different conclusions at one year of follow-up: M Nunez et al. Clin Rheumatol doi 10.1007/s10067-010-1677-y). At 12 months, the interventions did not improve health-related quality of life scores, with worse SF-36 physical function and bodily pain scores in the intervention group.
In the six minute walking test at the end of the PACE trial, for those who had undergone GET the mean distance managed was 379 metres, representing a 67 metre increase from baseline after one year of therapy. The results were worse than results for those awaiting lung transplant (400 metres) or those in chronic heart failure (682 metres), and PACE participants were able to walk less distance during the 6 minute walking test than people with traumatic brain injury. After CBT or GET, PACE participants (average age 38 years) did not even achieve a six minute walking distance of 518 metres that is considered abnormally low for healthy people aged 50-85 years.
In the PACE trial report, you concede that only about 30% were helped “moderately”. However, this figure taken in isolation is misleading as 15% of participants who received standard medical care also achieved the same outcome, meaning that only 15% of participants gained benefit from the addition of CBT or GET. This means that 85% of participants gained no additional benefits from CBT/GET over and above standard medical care, even though you re-defined a “positive outcome” and set the bar at an exceptionally low level.
On the participant-rated CGI (clinical global impression) of change in overall health, 60% of the GET group reported negative or minimal change after 52 weeks and 58% of the CBT group reported negative or minimal change after 52 weeks. By any standards, that is not a successful outcome.
In his broadcast on 18th April 2011 on Australian radio, Professor Sharpe said: “We have a number needed to treat; I think it’s about seven to get a clinically important treatment benefit with CBT and GET” (ie. seven patients had to be treated to find one who benefitted). Your results show that only one in seven of those who were only “moderately” affected gained only a “moderate” benefit. That is a woeful result.
However, the real world efficacy is lower even than this because severely affected and housebound patients were excluded from your trial.
Professor Sharpe further stated about the PACE trial: “What this trial isn’t able to answer is how much better are these treatments than really not having very much treatment at all”.
This is very different from the exaggerated spin of “recovery” that was fed to the international media, including the figure of about 30% recovery in The Lancet Comment by Bleijenberg & Knoop, not forgetting the even more inflated but insupportable figure of 40% recovery claimed by Dr Esther Crawley (Esther Crawley et al, BMC Health Services Research 2011, 15th September: 11:217 doi:10.1186/1472-6963-11-217), one of your 26 co-signatories to the IoS letter supporting the award of the John Maddox prize to Sir Simon.
In the light of this evidence, for you and Sir Simon to claim that the PACE trial adds to the “overwhelming scientific literature” of the efficacy of CBT and GET appears at best misguided.
I find your position not only incomprehensible, but also inconsistent with what you have written elsewhere, and very much at odds with the reality of the disease.
I look forward to receiving your considered response.
On Sunday 25th November the UK newspaper, the Independent on Sunday, published an article, "ME: bitterest row yet in a long saga" (1) which led to the publication of a letter signed by 27 signatories, which was published on the 2nd December (2).
On Sunday 13th January, in response to this, the following letter has been published in the Independent on Sunday, in both the hard copy and on-line:
Scientific understanding always depends upon sound evidence. According to Sir Paul Nurse FRS: "The John Maddox Prize is an exciting new initiative to recognise bold scientists who battle to ensure that sense, reason and evidence base play a role in the most contentious debates." For scientific understanding to prevail, the extensive biomedical evidence base of ME/CFS [myalgic encephalomyelitis/chronic fatigue syndrome] must now be recognised by all researchers in the field.
The idea that ME/CFS is due to a dysfunctional psyche is a hypothesis without an evidence base. The Maddox Prize was thereby awarded to the defender of a hypothesis with no evidence base rather than to someone who was upholding true scientific inquiry. Personal attacks against Professor Sir Simon Wessely do not advance the cause, but it is scientifically legitimate to direct criticism at the hypothesis both he and Professor White continue to espouse.
The Countess of Mar
Professor Malcolm Hooper
Dr William Weir
House of Lords, London SW1
A longer version, too long for the printed edition, is expected to appear on the IoS website:
Professor Peter White, on behalf of himself and his 26 co-signatories, has apologized to the three of us following the publication of their letter on 2 December 2012. He made it clear that he did not intend to imply that we were harassing Professor (now Sir) Simon Wessely. We were not harassing him. None of us believes that harassment is a means of advancing scientific debate, and certainly not in promoting a greater understanding of the causes of ME/CFS.
In the IoS article of 25 November 2012 we were criticizing the award of the Maddox Prize to Professor Wessely because it is axiomatic that the progress of scientific understanding depends upon sound evidence. Sir Paul Nurse, President of the Royal Society, has said: “The John Maddox Prize is an exciting new initiative to recognize bold scientists who battle to ensure that sense, reason and evidence baseplay a role in the most contentious debates.”
We are in complete agreement with Sir Paul. We would wish the scientific process to prevail, whereby the extensive peer reviewed biomedical evidence base on ME/CFS is acknowledged and used by all researchers in the field to advance the understanding of the disorder, and we have been calling for this for many years.
There can be no doubt that the cause of ME/CFS is a contentious issue and that there remain many unanswered questions. Both Professor White and Sir Simon Wessely have promoted an hypothesis that ME/CFS is due to an abnormal illness belief; that it is perpetuated by dysfunctional beliefs and coping behaviours, and that cognitive behavior therapy (CBT) and graded exercise therapy (GET) are effective treatments for the condition. In an attempt to prove this hypothesis Professor White, principal investigator, and colleagues, including Sir Simon, conducted what has become known as the PACE trial, published in February 2011 in The Lancet, at a cost of some £5m to the taxpayer. No data on recovery rates and positive outcomes have been released and a FOI request to Queen Mary University of London revealed that: “The requested data relating to recovery rates and positive outcomes do not exist. That is to say that such analyses have not been done and there is no intention to do so. The reason for this is that the analysis strategy has changed from the original protocol.”
There has been no attempt by Professor White to correct the misapprehension in respected journals as well as the popular press that the PACE trial demonstrated recovery rates of between 30% and 40%. The release of all the data relating to the PACE trial would be the most telling indication of the efficacy of CBT and GET and would contribute very effectively to the evidence base that precise scientific enquiry demands.
In our view, the idea that ME/CFS owes its origins to a dysfunctional psyche is an hypothesis that lacks any scientific evidence base. We are therefore at a loss to understand why the Maddox Prize was awarded to the defender of that hypothesis rather than to someone who was upholding the spirit of true scientific enquiry.
Our main interest is in advancing the scientific understanding of the cause of a frequently devastating and debilitating condition which blights the lives of many thousands of people. We do not believe that personal attacks directed against Professor Sir Simon Wessely will advance the cause, but reserve the right to direct criticism at the hypothesis both he and Professor White continue to espouse. We believe that a proper scientific understanding of the cause(s) of ME/CFS will emerge in the fullness of time.
The Countess of Mar
Professor Malcolm Hooper
Dr William Weir
House of Lords