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!
May 2013
STATEMENT FROM THE 25% ME GROUP REGARDING THE CFS/ME RESEARCH COLLABORATIVE CHARTER (CMRC)
MAY 2013
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.
The 11th of January DfE statutory guidance to local authorities on educating children with health needs has taken account of the advice of the TYMES Trust (The Young ME Sufferers Trust) in many aspects.
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.
She knows what works and what doesn’t.
You can watch a video of her presentation by clicking here.
March 2013
Comments on the PACE debate held in House of Lords (Grand Committee) on 6th February 2013
An analysis of the comments made by the various Lords at the PACE Debate as a result of a question posed by the Countess of Mar.
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 ken.ma@nova.edu
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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.
Yours sincerely,
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.
Yours sincerely,
Professor White
“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.
(http://www.st-andrews.ac.uk/staff/policy/tlac/academicmisconduct/academicmisconduct/).
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:
Sir,
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
London SW1
On 6th November 2012 the charity Sense about Science, a sibling of the Science Media Centre, announced that Professor Simon Wessely had been awarded the inaugural John Maddox Prize “for his ambition and courage in the field of ME (chronic fatigue syndrome) and Gulf War syndrome, and the way he has dealt bravely with intimidation and harassment when speaking about his work and that of colleagues” (http://www.senseaboutscience.org/pages/2012-maddox-prize.html).
Wessely’s plentiful published and spoken views on the psychosomatic nature of ME are well-known, and people will recall that in 2000, Anthony Komaroff, Professor of Medicine at Harvard, said: “There is now considerable evidence of an underlying biological process which is inconsistent with the hypothesis that (ME/CFS) involves symptoms that are only imagined or amplified because of underlying psychiatric distress. It is time to put that hypothesis to rest” (The Biology of the Chronic Fatigue Syndrome. Anthony Komaroff. Am J Med 2000:108:99-105).
Indeed, in the above letter that is on the website of the Independent on Sunday, Professor Peter White and his 26 co-signatories confirmed that the “accusations” against Professor Wessely are “false” and that “it was because of accusations like this that Professor Wessely received the award in the first place”.
Now we see that Professor Wessely has been awarded a knighthood in the New Year Honours for his work on Gulf War Syndrome.
It can hardly be forgotten that Wessely has denied the very existence of a Gulf War Syndrome: in their official report published in The Lancet (Health of UK servicemen who served in Persian Gulf War; Catherine Unwin, Anthony David, Simon Wessely et al; Lancet 16 January 1999:353:169-178), the authors claimed they found an association with the “belief” of exposure to a chemical attack, but they failed to identify a specific illness among Gulf War veterans and concluded that there is no such thing as Gulf War Syndrome. In an accompanying supportive article, the late Stephen Straus was categoric: “The cumulative studies now confirm that there is no unique Gulf War syndrome”.
Thirteen years later, acknowledging his honour, Wessely says: “There may not be a distinct illness -- Gulf War Syndrome is a misnomer—Rather it’s an illness or health effect” (Military health expert knighted: 28thDecember 2012: http://www.bbc.co.uk/news/health-20850694). Wessely’s comment must be seen in the light of the fact that “illness” is now deemed by some to be a “behaviour” and in order to be afforded legitimacy, one must have a “disease” (The Scientific and Conceptual Basis of Incapacity Benefits (TSO, 2005) written by Gordon Waddell and Mansel Aylward; published by the Department for Work and Pensions).
Nine months after Wessely et al published their negative findings in The Lancet, a two-year study carried out by Dr Beatrice Golomb for the US Defense Department did not support their conclusions. On 20th October 1999 at 2.20am it was announced on the BBC World Service that, as a result of the Golomb study, the Pentagon had released a statement confirming that it had changed its policy and now admitted that there could be a link with Gulf War Syndrome and the use of pyridostigmine bromide (PB) anti-nerve gas tablets (which UK troops were forced to take during the conflict in the Gulf). This cast significant doubt on the reliability of Wessely’s findings.
Subsequently the 2008 report of the Research Advisory Committee on Gulf War Veterans’ Illness categorically identified concomitant exposure to PB and organophosphate pesticides as causative agents in GWS (see below).
Evidence presented at the Second World Congress on CFS and Related Disorders (including GWS) on 9-12th September 1999 in Brussels included findings in GWS of inadequate cardiovascular support (Professor Ben Natelson); the possible role of environmental factors (Professor Paul Levine); reports of 600 cases of anaphylaxis in US Marines (Professor Garth Nicholson), and evidence that the Gulf War conflict had been the most toxic war in military history (Professor Malcolm Hooper), who told of the injection of vaccines which included biological warfare agents and of exposure to chemical warfare agents including mustard gas and sarin. When they were ordered to take the NAPS (Nerve Agent Protection Sets) tablets, some troops experienced classic autonomic effects such as sweating and uncontrollable diarrhoea, which resulted in their protection suits being soiled with their own excrement. In addition there was exposure to depleted uranium (DU) and to toxic smoke from oil-well fires and exposure to solvents and biohazards such as malaria, Leishmaniasis, fleas, scabies, sand flies and mosquitos.
It was easy to design studies which gave the desired result, said Hooper, but there was little doubt that the troops had received a cholinergic triple whammy, and he pointed out that almost the entire cholinergic system would be damaged and/or rendered dysfunctional. Could a person still function? The answer was No – the central nervous system was affected, as were the autonomic and peripheral nervous systems. Hooper discussed various diagnostic tests which ought to have been carried out on the Gulf War veterans, including neurological, immunological, cardiovascular, renal and liver function tests, as well as tests for genetic markers, for assessment of oxidative status, for bone density, for pancreatic and gut function and permeability, and for levels of micro-nutrients (Denigration by Design? Update November 1999: http://www.meactionuk.org.uk/Denigrationbydesign.htm).
On his own admission, in his official study of Gulf War veterans, Wessely performed no clinical examination or laboratory investigations. He worked only from a self-report questionnaire sent only to selected veterans, yet he confidently concluded that there is no such thing as Gulf War Syndrome and the MOD accepted his findings.
In 1999, statistics showed that in the US, 9,000 Gulf War deployed personnel were dead (and these were previously fit and healthy young men) and that there were 230,000 medical cases. From the UK alone, 53,000 troops were involved in the Gulf War but it was not known how many were ill or dead because the only epidemiological study on UK veterans was the one done by Wessely et al which failed to identify a specific Gulf War Syndrome.
A review of all the epidemiological data by Lea Steele for the Research Advisory Committee on Gulf War Veterans’ illness in Washington DC published on 17th November 2008 found between 25 – 30% of deployed and prepared-for-deployment veterans were sick. In the UK this equates to 13,000 to 16,000 veterans. Many of these have died and the remainder live with unacknowledged chronic multi-system conditions with deleterious health and social effects on wives and children.
This 2008 report runs to over 450 pages and contains more than 1,800 references. Its most important findings are that PB and NAPS tablets were causally linked to GWS and that pesticides, especially organophosphates, were causally linked to GWS.
The report states that GWS has the following features:
it is a complex, chronic, organic illness
many veterans show evidence of physical brain injury
it is not a stress-related condition or due to PTSD
features that have been demonstrated by extensive investigations including advanced brain imaging include abnormalities of brain structure (including cancer); impaired function of the autonomic nervous system; cardiovascular and respiratory dysfunction and disease; neuroendocrine abnormalities resulting in serious physical impairment, Parkinson’s Disease, multiple sclerosis and motor neurone disease; altered control of cerebral blood flow; alterations in immune system and function; genetic variation in enzymes responsible for protection against neurotoxins; damage to the skeletal system at tissue and cellular level; increased cancer risk, especially brain, bowel, blood, bone, bladder and lung (associated with the principle toxins and DU)
Notwithstanding this evidence, it seems that nothing has changed the belief of Simon Wessely, the “leading researcher into the health of military personnel” whose work has “dramatically improved mental health services for the Armed Forces” that there is no Gulf War Syndrome.
Perhaps Sir Simon and those who nominated him are unaware of two reports in the journal Neuro-epidemiology that once again seem to prove him to be entirely wrong about Gulf War Syndrome.
A study of meteorological and intelligence evidence tracking the fall-out of chemical weapons and the bombing of chemical weapons stores shows that what the troops reported was correct (though denied by the authorities at the time) and provides direct confirmation of repetitive exposure to low level sarin nerve agent resulting from that fall-out (James J Tuite and Robert W Haley; Neuro-epidemiology 2013:40:160-177).
A companion study shows that exposure to low level sarin nerve agent in fall-out from the bombing by coalition forces in the initial air war contributed to chronic illness which is “manifested by fatigue, fever and night sweats, memory and concentration problems, pathogen-free diarrhoea, sexual dysfunction, chronic body pain and other symptoms compatible with autonomic nervous system dysfunction and damage to the brain’s cholinergic system, referred to as Gulf War illness” (Robert W Haley and James J Tuite; Neuro-epidemiology 2013:40:178-189).
Is it not curious -- disturbing even – that such honours should be bestowed upon a psychiatrist whose beliefs and doctrine do not accord with the published science and whose beliefs have been so compellingly disproven?
December 2012
The Countess of Mar writes to Simon Wessely
The following is an open letter from The Countess of Mar to Professor Simon Wessely. It can be found online at -
I note from recent correspondence arising from the report in the Independent on Sunday on 25 November 2012, that you believe me as guilty of harassing you. Perhaps it is not surprising that I regard this belief with something less than amusement.
I wonder whether you recall the time when you were just getting your initial research into Gulf War Illnesses off the ground in mid-1998? I had given evidence to the Royal College of Physicians and Royal College of Psychiatrists Inquiry on Low Level Exposure to Organophosphate Sheep Dip which was published in November 1998. Your colleague, Professor Anthony David, was a member of the inquiry. I recall receiving a letter from you both to the effect that you were sorry that I had had reason to criticise your Gulf War research in the course of my evidence when, in fact I had not mentioned Gulf War research. You also asked to meet me. I recall correcting you on the facts and stated that I had no desire to meet you. I then received a number of telephone calls and letters, both to my office and my home, demanding that I meet you. I have to say that I regarded this as harassment at the time, though I did not see the need to contact the police. Eventually I agreed to accept your invitation to lunch at Gordon’s Wine Bar behind Charing Cross Station.
I brought with me Ms Emily Green, an eminent scientific journalist, with your agreement. I shall never forget being astounded to find that, when we arrived at the appointed time, 12.30 pm, you had arrived early; bought your own lunch, and presented us with a bottle of water. Prior to the meeting you were very firm about the time, as you had patients to see at 2.00 pm. We discussed a number of topics, including whether you knew Elaine Showalter and whether you had ever advised the Department of Social Security on subjects such as ME. Some of your responses we found were economical with the truth to put it mildly. It was very shortly before 3.00 pm that you finally got to the point – you wanted me to help persuade the Gulf War Veterans to complete your questionnaire!
I think you need to understand that this encounter left a rather enduring and nasty taste in my mouth, not least because I had to buy my own lunch when you had invited me to lunch. Neither was I impressed by your deviousness in response to straightforward questions. This caused me to look more deeply into what you were doing and into your associations, most of which are now public knowledge. This, in part, helps to explain why I have reason to criticise some of your work.
I have also attended some of your lectures and have read reports of others. I have heard and read the extraordinary way in which you and some of your colleagues have denigrated people with ME and have tried (and to some extent succeeded) to persuade others that people with ME are not really ill at all; they merely have ‘aberrant illness beliefs’. You have deliberately obfuscated the terminology surrounding ME by linking it with chronic fatigue and attempting surreptitiously to reclassify it as a psychological condition under the WHO ICD classifications. In doing this you appear to have totally ignored the first exhortation to doctors – “First do no harm”. Yet when this beleaguered population has reason to look at your work critically you deny what you have said and written and plead persecution and harassment from the very people you purport to be helping. I would have thought that any thinking person would ask themselves why this is happening; would ask the individuals who are clearly angry what is angering them, and try to put things right. You are in an exalted position – a Professor of Psychiatry with all sorts of awards. Why on earth do you need to play the victim?
My personal experience with organophosphate poisoning taught me that there are members of the medical profession who are not prepared to “listen to the patient for they will probably tell you the diagnosis”. I am fortunate in that I am articulate and determined and I have been put into a position where I can speak for others less fortunate than I am. If that means offering honest criticism of individuals who, I believe, are hurting others who are not in a position to speak for themselves I am prepared to take any brickbats that come my way.
So much of the friction comes from people not knowing what you think because you are so inconsistent. For example, in your presentation to the full Board Meeting of the DLAAB on 2 November 1993 which was considering those with ME/CFS you said: “Benefits can often make people worse”, yet in your letter to Dr Mansell Aylward at the DSS you wrote: “CFS sufferers should be entitled to the full range of benefits”. Given that, in 1990 you had written: “A number of patients diagnosed as having myalgic encephalomyelitis ……… were examined ……..in many of them, the usual findings of simulated muscle weakness were present” (Recent advances in Clinical Neurology, 1990, pp 85 – 131), I am wondering how a genuine condition can also be simulated and am curious to know what your position is regarding benefits for people with ME.
I note that you do not hesitate to condemn statements from your critics as “the same old stuff that they have been saying about me for years”. People with ME could be equally justified in their belief that you perpetuate the beliefs that you have long held that ME is a psychosocial behavioural problem and that you have totally failed to embrace the vast body of peer reviewed scientific literature that demonstrates damage to neurological, cardiac, endocrine and other systems in people with ME. I believe it was you who recommended that GPs should not indulge patients with too many investigations. This has meant that people with conditions that could have been treated have been misdiagnosed and neglected.
I have spoken strongly in defence of people with ME who have been traduced by you and your colleagues who have embraced the psychosocial behavioural model. I am not ashamed of having done so for they have few who will defend them publicly. The scientific evidence is heavily weighted against ME being ‘all in the mind’ so, by deduction it must be the economic argument that prevails, to the disadvantage of the estimated 250,000 people who have ME. have you ever considered the savings to the exchequer and to the insurance industry if people with ME were properly investigated and treated so that they could return to work or education?
I take no pleasure in asking “bogus” questions and making speeches in the Lords. I would very much sooner your profession got its act together and spent some time studying the real effects of ME on patients and looking for solutions. We all recognise that chronic illness, whatever it may be, presents with psychological aspects. CBT can only be a management tool and GET reportedly does more harm than good for patients with ME/CFS as opposed to chronic fatigue.
Patients must be able to trust doctors and scientists. You have betrayed this trust. A scientist should be able to accept honest criticism. You have misconstrued criticism and turned it into harassment. You have much to answer for, so it ill behoves you to employ diversionary tactics in an attempt to portray yourself as the injured party.
I have written this as an open letter because so much of this debate has been in the open. It would be helpful if you would make your position with regard to people with ME/CFS utterly clear. Do you still believe the ME/CFS is “perpetuated by dysfunctional beliefs and coping behaviours” as you wrote in your 2002 CBT Manual for Therapists? If you do, please will you explain why no one got better with your model. If you do not, would it not be sensible for you to withdraw it instead of continuing to make the facts fit your theories as they appear to have been in the PACE statistics where you were in charge of the Clinical Trial Unit.
Today’s Independent on Sunday publishes a letter signed by 27 medical professionals - who may be described as supporters of the psychosocial model of ME/CFS - in which they refer to the harassment of some researchers working in the field.
It is regrettable that the wholly unacceptable actions of a few people have not only undermined the efforts of those who, for many years, have sought to engage scientifically with proponents of the psychosocial model but have tarnished the reputation of all ME/CFS sufferers. Further, it has allowed a narrative to develop, namely that ME/CFS patients are prejudiced against psychiatry and are resistant to the possible role of psychological factors in their illness. A siege-like mentality has developed between patients and doctors and it is essential, if progress is to be made, to move beyond this impasse towards a constructive dialogue based on evidence, so that if the psychosocial model is found wanting, a commitment can be made to look for alternative causal mechanisms.
Much of the recent frustration has stemmed from the presentation of PACE Trial data in The Lancet (published online February 18 2011) and other journals. For example, in their accompanying editorial in The Lancet, Bleijenberg and Knoop wrote: "PACE used a strict criterion for recovery...In accordance with this criterion, the recovery rate of cognitive behaviour therapy and graded exercise therapy was about 30%", with another journal reporting "a recovery rate of 30-40%" (BMC Health Serv Res. 2011; 11: 217, three of the authors being signatories to the letter to the Independent on Sunday).
Both these reports are wrong, because no recovery data from the trial have been published, and although The Lancet's senior editor, Zoe Mullan, acknowledged this error and promised to publish a correction, to date (22 months after publication) no correction has been issued, allowing this misrepresentation to continue.
The above are but two of many well documented discrepancies surrounding the publication of selective results of the PACE Trial.
In their letter, the signatories say that the harassment: “risks undermining research, preventing the development of new treatments and discouraging specialist clinicians from entering the field. We fear that this may have resulted in patients not receiving the best treatments or care”.
Quite apart from the fact that the signatories’ favoured treatment may not be the best for people with ME/CFS, the signatories make no distinction between “extremists” and those who continue to present reasoned, evidence-based critiques of the psychosocial model. Moreover, they appear to have conflated criticism of a particular psychiatric theory with the wholesale rejection of psychiatry per se: being critical of certain psychiatrists’ beliefs about the causation of ME/CFS is not the same as being anti-psychiatry.
The psychosocial model has been subject to challenge because when its predictions were tested empirically, such as in the FINE and PACE Trials, objective data from these trials show clearly that ME/CFS is not perpetuated by dysfunctional thinking and deconditioning as the model posits.
People are angry, but that's because a small group of psychiatrists who have consumed such a large share of research funding for twenty years have acted in a way that is perceived to be wholly unscientific ie. when the evidence (even from their own studies) shows their ideas to be wrong, they either ignore the evidence (eg. FINE), or appear to misrepresent it (eg. PACE), and the system which is meant to protect against this - academic peer review - has completely failed to prevent the dissemination of papers which contain egregious errors.
It is also the case that many patients and clinicians alike feel let down by the wider scientific community for not speaking out against apparent abuses of process such as the post hoc revision of primary outcome measures in the PACE Trial which made it possible for a participant to deteriorate after treatment but still be described as “recovered”. Had such a situation applied in a drug trial there would, rightly, have been an outcry.
For the proponents of the psychosocial model to continue to ignore the biomedical evidence from world-class experts such as Drs Nancy Klimas, Mary Ann Fletcher, Anthony Komaroff, Kathy and Alan Light and Dan Peterson must surely conflict with a clinician’s first duty to patients, as rejection of that evidence may carry the risk of iatrogenic harm.
As Professor Komaroff wrote in Nature Reviews Neuroscience, September 2011: “Many of the documented abnormalities involve the central and autonomic nervous systems. In my experience, most sceptics are unaware of the extensive literature citing such abnormalities and become less sceptical upon reading it”.
Professor Klimas was equally clear about those who dismiss the biomedical evidence, saying at the IACFSME Conference in September 2011: “Look at the studies of many patients – and they tell you the same. It is not difficult. I mean immune findings in ME / CFS is proved. It is not controversial, and it is not just a hypothesis. There is immune activation, it is dysfunctional cells and a significant degree of malfunction of the immune system….I have no difficulty (saying) with great certainty that the immune system in ME/CFS is not working as it should”.
Given the well-established body of biomedical evidence and the failure of CBT and GET to produce objective benefits, people diagnosed with ME/CFS (and the clinicians who support them) struggle to comprehend the continued propagation of the doctrine that they can be cured and be returned to employment by psychotherapy, when the evidence from the psychosocial studies shows this is not the case.
It is time for a more productive dialectic so that patients can receive treatment and support based on sound evidence and researchers can work without fear.
November 2012
Help ME!
I first wrote a little leaflet called “Help ME!”, giving some basic information about ME, a few years ago and I have recently revised and updated it. It can be downloaded as a PDF file and it prints onto both sides of a single piece of A4 paper which is then folded into three. I am happy for it to be downloaded, saved, printed out and used as required – as long as it is not altered in any way. To download the leaflet, please click here.
November 2012
Mum’s New Book
I am pleased to say that Christian Focus has published a second book written by Mum. A4 size and 52 pages long, “God’s Special Tent – The Story of the Tabernacle and What Came After” is part of the Christian Focus for Kids Activity Series. It centres on the Tabernacle of Old Testament times and includes a cut-out model of the Tabernacle which children can make for themselves.
Do you like tents? Perhaps you've gone camping, staying in one place and then moving to another. God's people the Israelites lived in tents in the wilderness as they moved from Egypt to the Promised Land. God gave them instructions about how to make a special tent - where He could be present among His people. Find out about how they made this tent and what special furniture and curtains were placed inside it. How did they build the tent and how did they carry it from one place to another? The priests made sacrifices to atone for the sin of the people, but the tabernacle or tent of meeting was a place that taught the people about the One Who was going to save them from their sin for good - Jesus Christ, the promised Messiah. His sacrifice would mean that no other sacrifices were needed and that people could worship God all around the world.
Just in case you missed Mum’s previous book, “Read with Me”, which was first published in 2006 and is still available, you can find a review of it on the Tabernacle Bookshop website – click here.
The members of the European ME Alliance have put forward a petition to the European Parliament in Brussels. EMEA feel there is an urgent requirement to address the perception, treatment and research into myalgic encephalomyelitis.
Letters have been sent to all of the Alliance's members of the European Parliament –
Dear Members of the European Parliament,
The European ME Alliance (EMEA) is a grouping of European organisations that are involved in supporting patients suffering from myalgic encephalomyelitis (ME) - (in some countries ME is embraced in the term ME/CFS or even CFS) and the Alliance campaigns for a strategy of biomedical research into ME in order to provide treatments and cures for this neurological disease.
The Alliance consists of member organisations from Belgium, Germany, Holland, Ireland, Italy, Norway, Spain, Sweden, Switzerland, Denmark and UK.
The representatives of the European ME Alliance wish to ask for your support of the attached petition. The petition seeks to ensure that member states of the EU abide by, enforce and respect the following: -
- that myalgic encephalomyelitis is treated as a neurological disease
- the medical and civil rights of people suffering from ME are respected
- the most recent criteria for diagnosis of ME are used by member states
- biomedical research on ME is fostered and funded by the EU
- discrimination against people with ME is stopped
EMEA Belgium will represent the Alliance in any discussions with the EU that are held in Brussels.
We hope we can count on your support for this petition.
Yours Sincerely,
The Chairman, Board and Members of the European ME Alliance
Belgium - ME/CFS Association
Denmark - Dansk ME Forening
Ireland - Irish ME Trust
Italy - Associazione Malati di CFS
Germany - Fatigatio e.V.
Netherlands - Het Alternatief
Norway - Norges M.E. Forening
Spain - Liga SFC
Sweden - Riksföreningen för ME-patienter
Switzerland - Verein CFS Schweiz
UK - Invest in ME
PETITION
The legal and medical situation of ME (Myalgic Encephalomyelitis) and CFS (Chronic Fatigue Syndrome) patients
Myalgic Encephalomyelitis (ME) was accepted by the WHO as a neurological disease in 1969.
In some countries ME is referred to as Chronic Fatigue Syndrome (CFS). In 1993 CFS was added as an addendum to ICD-10 but the “fatigue”-based definition of CFS still causes confusion and problems for patients, as was stated by Mrs. Androulla Vassiliou, former European Health Commissioner.
ME can occur in outbreaks: one was described for the first time in 1934.
Experts have placed ME in the same category as cancer and late stage AIDS regarding quality of life and suffering.
We therefore request the following:
- to respect the WHO ICD-10-Code G93.3 for ME as a neurological disease and ensure that the Member States implement this in their Health Care System;
- to respect the rights of ME patients – including children - in all Member States;
- to endorse as diagnostic criteria for ME the Canadian Consensus Criteria and the developing International Consensus Criteria;
- to encourage the development of biomedical research.
An estimated 1,200,000 very sick ME patients in Europe are waiting for parliament to recognise the WHO ICD-10-Code G93.3.
References
1. www.who.int/classifications/icf
G93.3 Postviral fatigue syndrome
Benign myalgic encephalomyelitis (ME)
2. Carruthers B, Jain AK, De Meirleir KL, Peterson DL, Klimas NG, Lerner AM, Bested AC, Flor-Henry P, Joshi P, Powles AP, et al.: Myalgic encephalomyelitis/chronic fatigue syndrome: clinical working case definition, diagnostic and treatment protocols. Journal of chronic fatigue syndrome 2003, 11(1):7-115.
3. Carruthers BM, van de Sande MI, De Meirleir KL, Klimas NG, Broderick G, Mitchell T et al. Myalgic encephalomyelitis: International Consensus Criteria. J Intern Med 2011;270:327–38.
4. Nacul LC, Lacerda EM, Campion P, Pheby D, Drachler MD, Leite JC, Poland F, Howe A, Fayyaz S, Molokhia M: The functional status and well being of people with myalgic encephalomyelitis/chronic fatigue syndrome and their carers. BMC Public Health 2011, 11(1):402.
5. J. Mark Van Ness, Staci R. Stevens, Kylie T. Kumasaka, Harnoor Singh, Betsy Keller, Daniel L. Peterson, Jose Montoya and Christopher R. Snell: A diagnostic test for the identification of metabolic dysfunction. Conference abstract 9th IACFS/ME clinical and research conference, Reno, March 7, 2009.
6. Brown, M. M., Bell, D. S., Jason, L. A., Christos, C. and Bell, D. E. (2012), Understanding Long-Term Outcomes of Chronic Fatigue Syndrome. J. Clin. Psychol., 68: 1028–1035. doi: 10.1002/jclp.21880
7. Twisk, F.N., Maes, M., 2009. A review on cognitive behavioral therapy (CBT) and graded exercise therapy (GET) in myalgic encephalomyelitis (ME)/ chronic fatigue syndrome (CFS): CBT/GET is not only ineffective and not evidence-based, but also potentially harmful for many patients with ME/CFS. Neuro Endocrinology Letters 30 (3), 284–299.
8. KCE report: Evaluation of CBT/GET therapy. https://kce.fgov.be/nl?SGREF=5268&CREF=11648
9. Fluge Ø, Bruland O, Risa K, Storstein A, Kristoffersen EK, et al. (2011) Benefit from B-Lymphocyte Depletion Using the Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome. A Double-Blind and Placebo-Controlled Study. PLoS ONE 6(10): e26358. doi:10.1371/journal.pone.0026358
10. Maes M, Twisk FN: Chronic fatigue syndrome: Harvey and Wessely's (bio)psychosocial model versus a bio(psychosocial) model based on inflammatory and oxidative and nitrosative stress pathways. BMC Med 8:35.
11. Broderick G, Fuite J, Kreitz A, Vernon SD, Klimas N, Fletcher MA. A formal analysis of cytokine networks in chronic fatigue syndrome. Brain Behav Immun. 2010 Oct;24(7):1209-17.
12. Komaroff AL, Cho TA: Role of infection and neurologic dysfunction in chronic fatigue syndrome. Seminars in Neurology 2011, in press.
For further information
1. Klimas NG, Salvato FR, Morgan R, Fletcher MA. Immunologic abnormalities in chronic fatigue syndrome. J Clin Microbiol 1990; 28: 1403-10. [PMID: 2166084]
2. Myhill S, Booth NE, McLaren-Howard J. Chronic fatigue syndrome and mitochondrial dysfunction. Int J Clin Exp Med 2009; 2: 1-16. [PMID: 19436827]
3. Peckerman, A., LaManca, J.J., Dahl, K.A., Chemitiganti, R., Qureishi, B., Natelson, B.H., 2003. Abnormal impedance cardiography predicts symptom severity in chronic fatigue syndrome. American Journal of Medical Sciences 326 (2), 55–60.
4. Streeten DH, Thomas D, Bell DS. The roles of orthostatic hypotension, orthostatic tachycardia and subnormal erythrocyte volume in the pathogenesis of the chronic fatigue syndrome. Am J Med 2000; 320: 1-8. [PMID: 10910366]
5. Kerr JR, Burke B, Petty R, et al. Seven genomic subtypes of chronic fatigue syndrome/myalgic encephalomyelitis; a detailed analysis of gene network and clinical phenotypes. J Clin Pathol 2008; 61: 730-739. [PMID: 18057078]
6. Tirelli U, Chierichetti F, Tavio M, Simonelli C, Bianchin G, Zanco P, Ferlin G. Brain positron emission tomography (PET) in chronic fatigue syndrome: preliminary data. Amer J Med 1998; 105: 54S-8S. [PMID: 9790483]
7. Goldstein JA. Chronic Fatigue Syndrome: The Limbic Hypothesis. Binghamptom, New York: Haworth Medical Press; 1993:19, 116.
8. Chia J, Chia A, Voeller M, Lee T, Chang R. Acute enterovirus infection followed by myalgic encephalomyelitis/chronic fatigue syndrome and viral persistence. J Clin Pathol 2010; 63: 163-8. [PMID: 19828908]
9. Pall ML. Explaining “Unexplained Illnesses”: Disease Paradigm for Chronic Fatigue Syndrome, Multiple Chemical Sensitivity, Fibromyalgia, Post-Traumatic Stress Disorder, Gulf War Syndrome and Others. Bighamton, NY: Harrington Park (Haworth) Press, 2007.
10. Meeus M, Nijs J, McGregor N, Meeusen R, De Schutter G, Truijen S, Frémont M, Van Hoof E, De Meirleir K.: Unravelling intracellular immune dysfunctions in chronic fatigue syndrome: interactions between protein kinase R activity, RNase L cleavage and elastase activity, and their clinical relevance. In Vivo. 2008 Jan-Feb;22(1):115-21.PMID:18396793 [PubMed - indexed for MEDLINE]
For an objective view of the establishment intrigue surrounding ME we recommend:
Magical Medicine: How to Make a Disease Disappear by Professor Malcolm Hooper [click here]
Professor Hooper has made a formal complaint to the Minister of State responsible for the Medical Research Council.
October 2012
All The Bible!
Terry J Blackman
I read the Bible little, and so little did I read:
Much of the precious Scripture was unknown to me indeed.
I liked the shepherd Psalm and loved Isaiah fifty-three,
And the fifteenth of Corinthians, though long, it seemed to me;
But often made excuses: much too busy, or, too tired,
And thus despised the Holy Book by God Himself inspired.
But then a thought occurred to me, a thought divine I’m sure:
To read the whole of God’s good Word, and not think this a chore.
And as I read it more and more, what joy did it afford,
To read and feed on every word as spoken by the Lord.
The Bible! all the Bible! Yes, each jot and tittle there:
By grace I’ll read and learn it all, with reverence and prayer.
Oh Book of heavenly wisdom, full of power and majesty!
An endless source of treasure, and a lens by which I see
The glory of the Saviour, all the vileness of sin,
The meaning of affliction, and the joy of truth within.
When reading of the saints and godly patriarchs of old;
The holy Tent, the Temple, full of glory, rich in gold;
Of God’s ways with the people of the chosen Hebrew line,
Of visions so amazing, of great mysteries divine:
In every part I find the Spirit’s message is all one -
Revealing the Messiah, our Redeemer, God’s dear Son.
The Bible! all the Bible! Yes, each jot and tittle there:
By grace I’ll read it, every word, with reverence and prayer.
Now first the books of Moses open up their plenteous stores,
And show to us our origin, with types and righteous laws.
In Joshua comes the conquest of the promised land of rest,
The war and strife of Judges, and then Ruth - how sweet and blessed!
The books of Samuel give the reigns of Saul and Jesse’s son;
The First of Kings: the peaceful times of prudent Solomon.
Then reading on in Kings we find that some kings were quite just,
While others did no good, for molten idols were their trust.
The Chronicles begin anew with Adam, the first man,
And trace the sacred history till captivity began.
The Bible! all the Bible! Yes, each jot and tittle there:
By grace I’ll read it, day by day, with reverence and prayer.
In Ezra and Nehemiah the holy city is reclaimed,
While Esther shows God’s ceaseless care, although He is not named.
In Job we see God’s will is best e’en in the darkest days,
The Psalms are full of heartfelt prayer and joyful songs of praise.
Then Proverbs and Ecclesiastes godly fear impart,
And Song of Songs reveals the love which fills our Bridegroom’s heart.
Isaiah, Jeremiah and Ezekiel, Daniel too,
And twelve more “Minor Prophets”, show the great things God will do,
And speak of the Messiah divine, of Whom we’ll read much more
In those New Covenant Scriptures which await us on before:
The Bible! all the Bible! Yes, each jot and tittle there:
By grace I’ll read it carefully, with reverence and prayer.
Four Gospels tell our hearts about our Saviour Jesus Christ,
One Who was perfect, and in love for us was sacrificed;
How, risen and ascended now, He still is just the same,
And says to all His followers, “Go forth: My word proclaim”!
In Acts the apostolic band their Master’s Word make known,
And meet with love the hatred which so oft to them is shown.
The Epistles then so richly God’s most precious thoughts display,
To expound the Christian teaching, and to guide the Christian’s way.
The Revelation then concludes the wondrous Book of God:
Christ, glorified in heaven and earth, rules nations with a rod.
The Bible! all the Bible! Yes, each jot and tittle there:
By grace I’ll read it o’er again, with reverence and prayer.
Oh my dear fellow-Christian, please allow me to say this,
With earnestness, entreaties, and with holy emphasis:
Don’t just read favourite portions, for it is the Word of God,
And we’re His much loved children, all redeemed with precious blood.
This Book is from our Father, God, its theme is His dear Son,
And by the Spirit every word’s inspired, yes, every one.
Oh you, who know and love the truth, God’s words do not neglect:
From every part, yes every part, a blessing true expect.
So give much time to God’s dear Book, (your mind for this was made),
Your life will be more holy, and your heart no more afraid.
The Bible! all the Bible! Yes, each jot and tittle there:
Oh let us read it, through and through, with reverence and prayer!
Taken from the Bible League Quarterly Magazine, October - December 2012, Issue 451.
The over-riding message I have received has been one of gratitude. I can tell you that this is something of an unusual experience for a journalist writing for national newspapers.
These people have Facebook-ed and Tweeted me. I have received calls and e-mails. There have been forums addressing the article and pictures and cards received which outlined a sense of relief for millions of people.
Many of these voices – including some of the greatest scientific, legal and academic minds in the ME world – have echoed a collective sigh to see their illness validated in the media.
The very notion that the media, and the press in particular, can actually serve a positive purpose in society may come as a surprise. But sometimes it does. And my piece, according to the phenomenal response that greeted it, was just one of those times.
Here's why. For decades, people who have suffered the debilitating – and sometimes fatal – condition of ME have been forced into a type of denial.
They have been told that their illness doesn't really exist on the scale that they claim to experience it (due, in part, to it being labelled a 'chronic fatigue syndrome'. A highly controversial description because it creates an image of something substantially less than what ME actually is).
They have been told, repeatedly, to 'pull themselves together' and to 'G.E.T. A G.R.I.P.' (a vile acronym actually used to describe the graded exercise prescribed, wrongly, to ME patients).
In short, it is not enough for people to have to endure serious multi-system issues that can leave them bed-bound for months at a time, but they are also made to feel bad for, well, feeling bad.
What an injustice.
From the insight I have gained into the ME world, I cannot overstate the consequences of such a twilight-type existence. One in which your body responds a specific way but you are told that it isn't actually possible. That it's not really happening. That you are imagining it.
And that myth, of it 'being in the mind' has been perpetuated worldwide.
Millions of sufferers have been left in the dark to deal with their illness. Sometimes, if they are fortunate, they will be supported by their loved ones - who are also in need of support, too – but often they are left to deal with it alone.
For those reasons, certainly, many ME patients may suffer depression but it is not the other way around - and it is deplorable to suggest it is.
It may surprise you to learn that I have detractors or, as modern parlance would have it, haters. These people troll me on the internet as if their lives depended on it.
Around about now they will be making comments like 'get the violins out - here comes a sob story'. Well, ME is a sob story. And the way patients have been portrayed is grossly wrong and that injustice must be recognised as such.
In my experience, they are anything but cranks or victims but people who have simply waited too long to have the truth of their experience recognised.
And that, partly, arrived yesterday with the launch of the Lipkin Study, a significant multi-centre study into ME.
Chances are you may think otherwise for, as is common with any major ME announcements, there were a number of misleading reports prior to the press conference.
Subsequently, representatives from the ME society have announced their intention to pursue media outlets and seek rectification of some articles that have emerged.
In short, much of the media misunderstood the Lipkin study findings. Partly because some reports jumped-the-gun and took information from rumours and speculation rather than wait for the official announcement. But, it also occurred because the mis-information fed into already-established prejudices.
Many people, and for whatever reason, want to believe that ME is nothing more than feeling a little world-weary and tired.
It is nothing of the sort. It is a neurological condition that savages the body. People die from ME and millions across the world are being mistreated and misdiagnosed as a consequence of poor and hostile reporting.
Yesterday's announcement – that ME was not a result of the XMRV virus – seemed to herald, to some, the idea that ME is not the result of any virus but is, infact, a psychological condition.
Wrong. Wrong. Oh, and for good measure, wrong again.
Many highly-respected and learned people have compared the overall devastation of ME to illnesses including Multiple Sclerosis and even AIDS - and with good reason.
Dr. Charles Shepherd of the ME Association responded to the misleading idea that ME cannot be contracted by any virus by saying:
“There is, in fact, a great deal of robust anecdotal and research evidence to demonstrate that a number of specific infections - examples include enteroviruses, dengue fever, glandular fever, hepatitis, parvovirus, Q fever, Ross River virus - trigger ME/CFS.”
Many ME sufferers like Dr. Shepherd have little doubt that their illness was triggered by one of these viruses. The problem has been getting it recognised and appropriately treated.
This is poor response, certainly, and even more so when you factor in that the World Health Organisation acknowledged it as a neurological condition over 30 years ago, then it becomes more than a little alarming.
But there have been powerful forces at play that have served to maintain the status quo on ME thinking, and they have proven more than a challenge to be reckoned with.
For the past 60 years, the illness has been hijacked by the psychiatric community as one of 'theirs'. They have clutched ME to their collective bosom and have refused to release the iron-grasp on it.
This wholesale insistence of it being something that can be overcome with the right attitude has been highly detrimental to those who actually matter in this debate: the people who are suffering with it.
As a consequence, ME patients have been failed in terms of adequate treatment and significant funds are dove-tailed into Cognitive Behavioural Therapy and, even worse, Graded Exercise – which has been shown to have a detrimental impact on the health of ME patients.
The problems about treating a physical illness in a psychological manner are brilliantly explored in Angela Kennedy's 'Authors Of Our Own Misfortune?' which tackles the topic with some considerable aplomb.
What we are dealing with here is a systematic neglect of ME patients - and we should be under no illusion about that.
Equally, we must be sure to tackle it - medically and in the media - without hysteria or bile.
One of the reasons that ME patients are so vocal is because the mis-information of their illness has resulted in a dangerous delay of appropriate research and treatment. If that were you, would you be quiet about it? I certainly would not!
So yes, ME is a modern-day scandal. The way it has been portrayed is shocking. The Lipkin study, despite its detractors, will enable a deeper exploration of the illness and how it impacts and ravages bodies and lives.
And, to the relief of ME sufferers worldwide, that understanding cannot come a moment too soon.
Statin drugs – designed to protect against heart disease by lowering cholesterol – are killers, and accelerate cardiovascular problems, a damning new report has discovered.
The drugs harden the main arteries, they are a main cause of type 2 diabetes in healthy people, and they accelerate the major health problems in diabetics, say researchers from the Phoenix Veterans Affairs’ Healthcare System. In short, the drugs help cause heart disease and death.
They monitored the health of 197 patients with type 2 diabetes and their use of statins. Coronary artery hardening, or calcification, was far more accelerated in the patients who were regular statin users compared to those who took the drugs only occasionally.
Patients who weren’t initially taking a statin quickly developed aortic artery hardening once they started taking the drug regularly.
The researchers fear their latest discoveries are but the tip of an iceberg of statin-associated adverse effects. Their database lists 300 adverse effects, including the weakening of the heart and increasing the risk of type 2 diabetes by 48 per cent in post-menopausal women.
(Source: Diabetes Care, 2012; epublished ahead of print: PMID: 22875226).
For further information on this subject, please see the following (there are many more books and websites available) -
There were reports in the media announcing the results of the PACE trial, with ecstatic claims about treating a widespread and deadly disease. And then, there were more reports – this time confused, not ecstatic – reporting the outrage of patients with this disease at those claims of being able to treat them.
I can fully understand why people are confused. I mean, what it looks like, is they found a cure but we all want to stay sick. Let me assure you, things are not at all the way the media make them to appear.
The whole area of Myalgic Encephalomyelitis and Chronic Fatigue is a dank and dangerous politico-medical mire. I won’t go into the politics/medical side of it (if you’re interested, see HFME and the rest of that site), or the myriad of scientific reasons that the PACE trial was a fraudulent, unethical waste of money and effort (again, if interested, see Invest in ME: Magical Medicine, A Review on CBT/GET, A Reporting of Harms). Oh, and the fact that the PACE trial actually dis-proved the theories it was based on (Pace Results Undermine)
Instead, I want to paint a picture of what’s going on in a way that regular people might understand – by comparing it to an illness that most people actually know about: Diabetes. You do know about it right? Good. Now, diabetes is nasty when it’s not treated. It can cause people to go blind, need amputations, have organs fail, and even die. So, if you’ve got it, treating it is pretty important. In the same way that diabetes can be thought of as the body being unable to handle sugar properly, ME can be thought of as the body being unable to handle activity properly, in every and any form.
So, instead of ME, lets think diabetes – here’s what the PACE trial would be if it was dealing with diabetes instead:
There’s a group of doctors, mostly psychiatrists, who’ve noticed that diabetes is a pretty dangerous and nasty disease. So they’ve taken a look at diabetes patients to see if they can work out a treatment to help them (so far so good).
Now, one of the characteristics they notice about your average severe diabetes patient is this: they avoid sugary foods. They go so far as to specifically purchase food that would usually contain sugar, but has been manufactured in a way to leave as much as possible out. Their whole eating lifestyles revolve around keeping sugar out of their food.
“Gosh!” says one of the doctors “I think I understand the cause of their illness! These people are ill because they are major sugar avoiders.
“You’re right!” chips in another: “Sugar is an important part of the diet, in the right quantities. We should see if a steady increase of their sugar intake improves their symptoms”.
“Yes” adds a third, “but we need to deal with the root of the problem too. I suggest that we try cognitive behavioural treatments, to free them of their pathological sugar avoidance. If they can learn that sugar is safe, they’ll not need any further treatment at all.”
“We should also use this opportunity to see if dietary management actually helps the diabetes patients” returns #2 “after all, it’s what they’re all doing already. But since we know sugar-avoidance is a no-no, we’ll add sugar, instead of taking it away!”
So, they come up with a trial to test these out. Except, it turns out that diabetics aren’t allowed to eat sugar in large quantities, and there are some serious ethical problems with forcing them to.
“That’s alright” says doctor #1, “we can use patients who are diabetic-like. As long as they don’t actually have diabetes, we have no barriers to the trial.”
Thus they petition their friends in government for £5million to carry out the trial. Here’s the details of it:
They take a group of patients who are at risk of diabetes, but don’t actually have it.
1/4 of them receive care from a doctor, then go about life as usual
1/4 receive care from a doctor, then CBT to get rid of their sugar-avoidance
1/4 receive care from a doctor, then steadily replace the sugar-free foods in their diet with ones that contain sugar
1/4 receive care from a doctor, then are prescribed regular spoonfuls of sugar in steadily increasing amounts.
Originally, they were going to take lots of measures of insulin levels etc. throughout the trial, but they soon discovered that the results didn’t reflect their original idea, so they dropped that. Instead, they got patients to rate whether they thought sugar was good for them, and how they felt. They also did a single test of blood-sugar levels at the end of the trial.
The trial results were as follows:
The patients just receiving care from their doctors had high blood sugar levels, but below the level of diabetes. However, their attitudes towards sugar and their general sugar-avoidance did not improve at all! These were the control group, to compare other groups to.
The patients who received CBT had very high blood sugar levels, but they were below the level of diabetes. Hurrah! Their attitudes towards sugar were slightly improved; they were willing to, on their own initiative, increase the sugar in their diet. Conclusion: CBT is an effective method of treating diabetes.
The patients who increased the sugar-containing foods had very high blood sugar levels, but they were below the level of diabetes. Hurrah! Their attitudes towards sugar were not very good, they were willing to incorporate a little more sugar into their diets but not enough to have much effect on them. Conclusion: Dietary management is not an effective method of handling diabetes.
The patients who took increasingly large quantities of sugar had very high blood sugar levels, but they were below the level of diabetes! Hurrah! Their attitudes towards sugar were much better, they were comfortable incorporating a lot more sugar into their diets. Conclusion: Increasing amounts of sugar is an effective method of treating diabetes.
Looking at the costs for each treatment, it was clear that spoonfulls of sugar were the cheapest to finance, followed by a short course of CBT to counter sugar-avoidance behaviour.
Thus they released the trials conclusions to the press: We can cure diabetes through giving patients large amounts of sugar on a regular basis, and by giving them CBT to counter their sugar-avoidance behaviour! Both of these treatments are cost-effective and can be offered on the NHS!
I hope now, you can understand why we’re angry about PACE.
August 2012
The PACE Trial in the media
Sadly there is further publicity for the PACE Trial in the media at the moment, promoting psychological based treatments for ME, a serious, debilitating illness which has been classed as a neurological condition by the World Health Organisation for over 40 years and is in reality a multi-system failure. The “treatments” being promoted are Cognitive Behavioural Therapy (CBT) and Graded Exercise Therapy (GET), both of which have been repeatedly found over many years to be at best unhelpful to those with ME and, in the case of GET, at worst positively harmful. Just to cite one example, in a survey carried out in 2004 by the 25% M.E. Group, 93% of sufferers who tried CBT found it to be unhelpful, with 95% finding GET unhelpful. Worryingly, of those who tried GET, 82% reported that they were worse afterwards.
Would “treatments” such as these be offered (to put it kindly) as first-line – or indeed as the only – treatment options to those with other neurological conditions such as multiple sclerosis and motor neurone disease? Of course not! Doing so would be seen as an insult, and rightly so. Yet, interestingly, when the Chief Medical Officer’s Report on ME was released in January 2002, the then CMO, Professor Sir Liam Donaldson, said that ME “should be classed as a chronic condition with long term effects on health, alongside other illnesses such as multiple sclerosis and motor neurone disease”.
The PIs [Principal Investigators] themselves concede that:
“Our trial had limitations. We excluded patients unable to attend hospital”;
that
“Results cannot be extrapolated to those who are severely affected”;
that
“primary outcomes were subjective”
and that
“What this trial isn’t able to answer is how much better are these treatments than really not having very much treatment at all”.
What the PIs failed to acknowledge was that their ignoring of the biomedical evidence about the disorder they were supposedly studying (breaching the Declaration of Helsinki B11) invalidated the entire trial in that it was not grounded on the existing evidence-base and thus contravened the most basic principle of scientific research.
After a trial lasting nine years and costing £5 million, the PACE Trial has not taken us forward: not only have the results been misrepresented, but safe guidance on management options must address the needs of all patients with ME/CFS and it is not the case that the PACE Trial results are generalisable to all people with the disorder as claimed by the PIs.
The problematic analysis and selective presentation of data means that the PACE Trial has failed to provide “high quality evidence”, which is an unacceptable outcome: patients, clinicians and tax-payers have a right to expect higher scientific standards from the MRC.
The PACE Trial failed on a fundamental aspect of clinical research in that the benchmarks used to judge suitability for entry to the trial and successful outcomes are patently contradictory.
The need for independent statistical re-evaluation of the raw data is overwhelming as, without such an independent assessment, doubts over the veracity of the claims made by Professor White et al cannot be resolved.
Furthermore, the post-publication admission by the Chief Principal Investigator that the study was ‘not purporting to be studying CFS/ME’ invalidates the whole study which claimed to be addressing CFS/ME.
Given (i) the inability of the recruitment criteria to distinguish between ME/CFS and psychogenic fatigue, (ii) the illogical overlap of the entry criteria with “the normal range”, (iii) the failure of CBT to achieve a clinically useful difference for one of the primary outcomes and the trivial improvement produced by GET, (iv) the failure to recognise that an “averaged” improvement often masks very different responses to an intervention, and (v) the fact that around two thirds of participants who received CBT/GET remained in the lowest functioning 10% of the general population, the international ME community wonders why the PACE Trial is being hailed as a “gold standard” study which demonstrated the efficacy of CBT and GET for ME/CFS patients (as noted above, although the Protocol refers to it as an RCT [randomised controlled trial], The Lancet paper at no point describes PACE as a controlled trial, yet it was described in the press release as “the highest grade of clinical evidence” and as “extremely rigorous (and) carefully conducted”), which by any standards is risible.
Despite the irrefutably poor results of the trial, CBT and GET are being actively and inappropriately applied to people with ME/CFS; the PACE press release stated that the results suggest: “everyone with the condition should be offered the treatment” and that every patient “who wishes to be helped” should be willing to take part in such regimes. Non-compliance (for example, if a person has already found that exercise exacerbates their condition) is deemed to demonstrate lack of desire to recover, which in some instances has already led to the withdrawal of state and/or insurance benefits.
The PACE Trial was not a scientific study and defies reason but, given the considerable investment (Governmental, financial and professional) in its success, it could not be allowed to fail.
Magical Medicine!
No competing interests declared.
(Magical Medicine can be found here, pdf file, 6mb file size)
Many people have submitted formal complaints about the flawed methodology of the £5 million publicly-funded PACE Trial; these include complaints about the with-holding of the recovery statistics, the mis-reporting of the results by Principal Investigators themselves and by the media through the auspices of the Science Media Centre, and the apparent manipulation of the raw data, widely believed to be an attempt by the Investigators to salvage a trial that could not be allowed to fail.
Those complaints have been made to the Medical Research Council (MRC), whose Head of Corporate Governance and Policy, Dr Frances Rawle, chose not to address the issues raised and then to mock the complaint (BMJ 22nd June 2011); to The Lancet, whose editors admitted in writing that its erroneous reporting of the trial results must be corrected but almost 18 months later have still not done so and who – against the Elsevier complaints protocol -- dismissed a formal complaint entirely; to the Secretary of State (who referred it back to the MRC); to the editors of numerous newspapers who mis-reported the trial results (the way in which ME/CFS patients have been vilified in the press has just been put before Lord Leveson’s Inquiry by the Neuroimmune Alliance), and to the Royal Statistical Society, who enthusiastically requested an analysis of the statistics but then refused to publish it but provided no reason.
All complaints and concerns were ignored or dismissed and met with determined refusal to address the issues raised.
The redoubtable Countess of Mar therefore tabled a number of questions on 9th May 2012 and replies to her questions were provided by Baroness Wilcox, Parliamentary Under-Secretary of State in the Department for Business, Innovation and Skills (the Department responsible for the MRC).
Those replies were widely regarded as being unsatisfactory and Lady Wilcox was clearly anxious about the situation; following discussions between Lady Mar and Lady Wilcox, the latter offered Lady Mar a meeting with BIS officials to discuss the concerns, which Lady Mar accepted. It was anticipated that four prominent people from the ME community would accompany Lady Mar to that meeting with officials from the MRC and BIS.
Consequently, the attached document “Briefing Notes for meeting with BIS officials about incorrect answers to Parliamentary Questions re: the MRC-funded PACE Trial and ME/CFS” was compiled.
Given that it was accepted that BIS officials would have little knowledge of the situation, the document was written in plain English and was in five easy-to-understand sections: (i) Objectives of meeting with officials from the Department for Business, Innovation and Skills (BIS); (ii) Essential background information about ME/CFS (iii) Problems with the replies to Parliamentary Questions (PQs) of the Parliamentary Under Secretary of State in the Department for Business, Innovation and Skills (Baroness Wilcox); (iv) Problems with the Medical Research Council’s role in the PACE Trial and its repeated denial of accountability and (v) Failure of the PACE Trial Principal Investigators (PIs) to report primary outcome measures as set out in the Trial Protocol; evidence of misrepresentation of the data and evidence of unacceptable selectivity in the results of the trial published in The Lancet.
However, on 21st June 2012, Lady Wilcox informed Lady Mar that the BIS officials were “concerned” about Lady Mar’s “associations” and suggested that she and Lady Mar should have tea together to enable her to get a handle on the problem before the full meeting with BIS officials.
Before any such discussions could take place, on 25th June 2012 Jamie Ballantyre, Assistant Private Secretary to Baroness Wilcox, wrote to the Countess of Mar asking if she would be available to meet Baroness Wilcox, Officials from the MRC and Officials from BIS at 16.30 on 12th July 2012. The letter was specific: “This meeting would be to discuss MRC funding opportunities for CFS/ME and the actions the MRC has taken to try to build capacity in this area…It will not be possible for the technical details of the trial or interpretation of the data to be discussed”. The reasons given were (i) “The research itself has been conducted independently of government and results of the trial, following peer review, have been published (ii) Although funding for the trial was provided by the MRC, this decision to fund would have been made based on peer review. In line with the Haldane Principle of scientific independence, the department would not and should not have any influence on this process (iii) None of the officials who will be present have the relevant technical expertise and knowledge”. The letter continued: “It is important to note that there are channels for challenging scientific results through journals and other publications, speaking at conferences, further research work etc”.
Not only was the DWP a co-funder of the PACE Trial (so it cannot be argued that the trial was independent of government, which has a strong vested interest in getting people with ME/CFS off state benefits and back to work, this being the non-clinical rationale for the “clinical” trial), it has been acknowledged that the PACE Trial protocol that was published in BMC Neurology on 8th March 2007 (BMC Neurology 2007, 7:6 doi:10.1186/1471-2377-7-6) was not peer-reviewed by the journal before publication (“This study protocol was not peer reviewed by the journal because it had already received ‘ethical’ and funding approval by the time it was submitted….We strongly advise readers to contact the authors or compare with any published results article(s) to ensure that no deviations from the protocol occurred during the study” -- Editor’s comment 31st January 2007: http://www.biomedcentral.com/imedia/2095594212130588_comment.pdf ).
In the case of the PACE Trial, The Lancet’s peer review process has patently failed, since no non-biased peer-reviewer would have approved such a significant deviation from the published Protocol including the highly selective publication of results, the abandonment of primary end-points and the shifting of goal posts such that the post-hoc “normal range” overlapped with the entry criteria.
It seems remarkable that officials from the MRC would not have the relevant knowledge to discuss very basic concerns about the methodology of one of its own clinical trials or its own role in that trial.
Moreover, the Haldane Principle (ie. that decisions about how research funds should be spent should be made by researchers and not by politicians) has nothing to do with the issues raised: the key issue is that BIS is responsible for the MRC’s failure to adhere to elementary rules of scientific procedure that occurred in the PACE Trial and as a result of the MRC’s failure, sick people continue to be put at risk of iatrogenic harm.
What is at stake here is the fact that the PACE Trial is scientifically flawed and the results have been misrepresented so NICE, insurance companies, the DWP and private companies contracted by the government (including Atos) are relying on false interpretation of the data to the serious detriment of very sick people.
Lady Mar’s response was that such a meeting would “get us nowhere” and that she would meet Baroness Wilcox privately and explain the situation to her.
A private meeting between the Countess of Mar and Baroness Wilcox took place on 11th July 2012, at which Lady Wilcox agreed that the best way to deal with the situation would be a debate in the House of Lords; this will be arranged for October when the House returns after the recess.
At the conclusion of that meeting, Lady Mar gave Lady Wilcox a copy of the attached Briefing Notes, so there can be no argument that she did not receive a copy.
These facts are being made publicly known in accordance with the government’s keenness for transparency and accountability.
For further information about the PACE Trial, please read Magical Medicine: How To Make A Disease Disappear by Prof Malcolm Hooper. A PDF file is available here (442 pages, 6Mb file size).
Int J Clin Exp Med 2012;5(3):208-220 www.ijcem.com ISSN:1940-5901/IJCEM1204005 Full text available HERE.
Mitochondrial dysfunction and the pathophysiology of Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME)
Norman E Booth (1), Sarah Myhill (2), John McLaren-Howard (3)
(1) Department of Physics and Mansfield College, University of Oxford,Oxford UK;
(2) Sarah Myhill Ltd, Llangunllo, Powys UK;
(3) Acumen, Tiverton, Devon UK
Abstract
The objectives of this study are to test the hypothesis that the fatigue and accompanying symptoms of Chronic Fatigue Syndrome/Myalgic Encephalomyelitis are in part due to defects in energy provision at the cellular level, and to understand the pathophysiology of the defects so that effective medical intervention can be implemented.
We performed an audit of 139 patients (ages 18-65) diagnosed with CFS/ME and attending a private practice.
The patients and 53 normal, healthy controls had the ATP Profile test carried out on neutrophils from a 3-ml venous blood sample. This test yields 6 numerical factors that describe the availability of ATP and the efficiency of oxidative phosphorylation in mitochondria. Other biomedical measurements, including the concentration of cell-free DNA in plasma, were made.
The results of the audit are compared with the controls and a previous cohort of 61 patients. We find that all patients tested have measureable mitochondrial dysfunction which correlates with the severity of the illness. The patients divide into two main groups differentiated by how cellular metabolism attempts to compensate for the dysfunction.
Comparisons with exercise studies suggest that the dysfunction in neutrophils also occurs in other cells. This is confirmed by the cell-free DNA measurements which indicate levels of tissue damage up to 3.5 times the normal reference range.
The major immediate causes of the dysfunction are lack of essential substrates and partial blocking of the translocator protein sites in mitochondria. The ATP Profile is a valuable diagnostic tool for the clinical management of CFS/ME.
June 2012
Dr Elizabeth Dowsett
I remember meeting Dr Dowsett just once, many years ago, at an ME conference. Some items written by her are available online – click here for further details. The following is by Simon Lawrence of the 25% ME Group -
Dr Elizabeth Dowsett
19th September 1920 - 14th June 2012
A True Hero
By Simon Lawrence, 25% ME Group
We hear every day of people who do amazing things and who are portrayed as heroes for their actions. We also hear of heroic characters in films, novels, comic books and the like.
However, I feel certain that many of you within the ME community, when hearing the sad news of Dr Elizabeth (Betty) Dowsett’s death, will no doubt remember her as someone who truly deserved the title of hero.
She was someone who was relentlessly courageous in fighting the establishment on their stance of ME. She was sympathetic and empathetic to all who contacted her for help and support. She was someone who did not seek glory or try to make a name for herself in all that she did for others but simply did it because, as a doctor and, more importantly, as a human being, she felt it was her duty to help and, indeed, took great pleasure in helping people with this disease.
Over the decades she has helped in countless different ways, many thousands of people throughout the world. Many knew and thought of her as a personal friend because she was so warm and caring in all her dealings and treatment of people. She cared, showed empathy and loved people and she fought tirelessly to try to put an end to the injustice and mistreatment of people with ME.
She was one of the last remaining of the group of doctors from the Ramsay era who believed in ME as it really is, unlike today where we have all sorts of theories and scandalous activities that are truly harming people with ME. People are dying of ME and people are left paralysed by ME. Dr Betty Dowsett was someone who was truly upset about this and who worked day and night to help change the situation and even fought in the face of the establishment and other ME organisations that she felt were “dumping down” ME.
In a world where we are so often left to suffer and be denigrated as ME sufferers, it was refreshing to meet someone who really did care and, at the same time, who never sought monetary gain from her services or some selfish recognition for doing what she felt was right.
Betty you were not just a personal friend, and someone who was passionate about what you believed was right, but you were also a true hero and angel sent by God.
Thank you for all you did for me and for many people throughout the world.
You will be greatly missed and will forever remain in our hearts and minds.
The 7th Invest in ME International ME/CFS Conference took place on Friday 1st June. The Conference looked at “Building a Future for Research into ME” with “Clinical and Research Updates in Myalgic Encephalomyelitis”. Presenters and delegates from 16 countries and 4 continents were present. The Conference showed the urgent need for more funding for biomedical research and the sure progress being made by those committed professionals with a clear strategy for scientific advancement.
Invest in ME published it’s Journal of IiME at the Conference and abstracts of the Conference presenters’ presentations are included in it. For further details click here.
A report of the Conference by Rosamund Vallings of the Associated New Zealand ME Society can be found by clicking here and DVDs showing the talks and plenary sessions can be ordered here.
June 2012
It's like being switched off
Funny how the BBC can do a serious report about “chronic fatigue” when it isn’t about ME!
Chronic fatigue dominates the lives of people with multiple sclerosis - and other long-term conditions. Here Alison Potts, who has had MS for 20 years, tells how it affects her life.
Earlier this month MS in Focus magazine published the results of a global survey on MS fatigue.
"My family and friends just think I'm tired and lazy," one person said - and another: "Fatigue prevents me from being the wife and mother I want to be."
Chronic fatigue is the most common symptom of MS, the hardest to treat and the most misunderstood.
In the MS Focus poll, 89% of the 100,000 people from 101 countries who were surveyed said fatigue had a high impact on their life.
But more than half felt those around them do not accept its effects.
Unless you have endured it yourself, there isn't anyone who can imagine what this experience is like, yet for we who live our lives with this illness, other peoples' understanding is crucial and other peoples' misunderstandings add further damage to an already devastating condition.
'Bewildering'
I have lived with MS fatigue for more than 20 years.
I sometimes feel like I have spent half my adult life in a cave.
I woke up one morning with the equivalent of a blanket on my head which I stumbled around with for years and which was finally explained with my diagnosis of MS.
Even I didn't understand why I found the simplest activities so hard. Even I questioned my own sanity. So it's hardly surprising that it's so bewildering for those looking on.
Part of the problem is that people equate fatigue with ordinary tiredness - which it is nothing like.
Even the word "fatigue" really just doesn't cut it.
It sounds rather soft or quaint, like something that could be fixed with a good lie down or a nice cup of tea.
We are easily misunderstood because we look fine and we are often perfectionists by nature so we can get a lot done in spite of what we are dealing with.
'Can you drop everything?'
In fact, chronic fatigue (in MS and other illnesses) is nothing like every day tiredness.
Fatigue is a debilitating state of physical and mental exhaustion that comes crashing down suddenly and without warning attacking - among other things - eyesight, balance, muscular strength, and threatening everything in one's immediate focus.
"I am lifeless. At times it is like someone has switched me off," says someone in the survey.
In an acute episode I have to cancel many or most activities. I have to do as little as possible - which goes against my nature and I hate it - but I don't have any choice.
Conversely when an episode is over, I am in danger of bouncing around like tigger, playing catch-up and trying to get anything and every done while I feel well enough.
Fatigue doesn't announce itself in advance. It can happen at any time, anywhere.
It can bring anxiety - "What will happen if I don't get this done?", and panic, even terror - "Will I get home in time before the complete collapse? Am I safe to drive? What if I am not?"
It brings with it this terrifying conundrum. Can you drop everything at once, not knowing for how long?
What will happen to your life if you drop everything at once? What will happen to your life if you don't?
We often feel under pressure to do things we know will be bad for us.
Saying 'no'
My friend and fellow chronic fatigue sufferer Sarah reports one experience where she felt under pressure to comply with others' plans when she felt unable to.
"For my birthday in 2005 friends insisted meeting me for a BBQ. I resisted as I knew I had been overdoing it. They would not take no for an answer."
It had such an effect on her that she says: "It took me three months to recover from that event. It was like falling sick all over again."
And she adds: "It's unhelpful of friends or family to beg me to come or to modify the nature of my attendance, or worse still, be hurt. Don't they realise it breaks my heart to cancel?
"It's not like I wanted to spend my entire 30s missing out on shared, fun times. Don't make it any harder than it is. This is simply what I have to do."
These days everyone is too busy, overloaded, driven by tyrannical deadlines.
"I know there are probably people who look at me and think, how is my life any different from theirs?
"But In my case I have to do all this while accommodating an illness which presses the stop button indiscriminately.
Those of us with chronic fatigue have to say "no" a lot.
As the survey states: "People with fatigue need time to rest, but most of all they need understanding from others."
