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!
Severe ME Awareness Day, 8th August 2014 - ME Cover up!
If you want to raise awareness of the cover up of our serious neurological disease, please share a photo with us.
If you can, get a photo taken of yourself with a sheet over, in whatever way can be tolerated or managed, whether it is a photo in bed, a wheelchair, sitting, standing, it does not matter.
If you are not able to tolerate a sheet over you, get someone else to represent you, if possible.
The important thing is to capture the image of being covered up.
We want to create a powerful visual impact to shock and shame and show for August 8th, Severe Myalgic Encephalomyelitis Day!
We suggest that you also include a short caption to go along with the photo (this might be to illustrate your invisibility as a sufferer or to illustrate a political point or both). All photos must be submitted by email to email@example.com by no later than 30th June. These photos will then be placed on the website for Severe Myalgic Encephalomyelitis Day 2014 and campaign documents (such as an MP Letter, Press Release) will be enclosed with your summer Quarterly.
A meta-analysis including 530,525 people, partly funded by the British Heart Foundation, and published in the Annals of Internal Medicine has just come to this conclusion:
Conclusion: Current evidence does not clearly support cardiovascular guidelines that encourage high consumption of polyunsaturated fatty acids and low consumption of total saturated fats 1.
Or to put it another way, there is no evidence that saturated fat consumption has anything, whatsoever, to do with causing heart disease, or strokes. Once again I get to say ‘I told you so.’ Ah, the four most satisfying words in the English language. That is, when arranged in that particular order.
So, eat butter, drink milk, and throw away the horrible sugar-loaded low fat yoghurt. Go to France and enjoy the highest saturated fat diet in Europe and you, too, can enjoy the French rate of heart disease. Yes, of course, the lowest in Europe.
But now what happens? You see, the entire edifice of the cholesterol hypothesis is held together by two links in a chain. Link one is that saturated fat consumption raises cholesterol levels. Link two is that raised cholesterol levels then cause heart disease.
Various ‘experts’ have simplified this to the very simple equation:
A (saturated fat in the diet) > B (high cholesterol levels) > C (heart disease)
This is the cholesterol hypothesis, or the lipid hypothesis, and it has driven medical thinking for the last sixty years.
I have had it painstakingly explained to me, by very clever people, exactly how saturated fat raises cholesterol levels. Indeed, you will find ‘evidence’ for this almost universally accepted fact in literally thousands of clinical studies. Here is what Wikipedia has to say on the matter
‘There are strong, consistent, and graded relationships between saturated fat intake, blood cholesterol levels, and the mass occurrence of cardiovascular disease. The relationships are accepted as causal 2.’
Okay, let us accept that eating saturated fat does raise cholesterol levels. However, if consumption of saturated fat does not increase the rate of heart disease then….. Then raised cholesterol levels can have nothing whatsoever to do with causing heart disease. Just keep chasing the implications of that statement around in your head for a while.
So what happens now? We now have a cholesterol/lipid hypothesis that just had its head blown off. Yet, it still continues to wander about, unaware that it is actually dead.
As everyone knows you can chop the head off a chicken and it can wander about for years. I was also informed, when I was an open-mouthed child, that you could shoot a dinosaur through the head and it would continue to blunder about for some time, the rest of its body blissfully unaware that it was actually dead.
Well, the cholesterol hypothesis has just been shot dead, but I suspect it will continue to rampage about, stomping on puny humans for many years, before it finally keels over and admits that it is dead.
But I say, farewell Cholsterolosaurus. You are now a deceased hypothesis. Gone to meet your maker. You just don’t know it yet. Because the people that believe in you do not understand logic.
With healthcare where better to learn than from patients?
As with much of the research that is and has been funded, under the subterfuge of research into Myalgic Encephalomyelitis (ME), it seems a persistent theme of those entrusted with the future of people with ME and their families that they do not listen to patients.
Dr Clare Gerada, former chair of the Royal College of GPs, said at the last IiME international conference in 2013 that GPs know very little about ME.
She also said that patients know their illness better than doctors.
Common sense - something that is obvious one would think.
It would seem obvious that the UK Medical Research Council should not spend more on psychological research after the farcical and flawed PACE trial squandered £5 million and showed no objective improvements in patient outcomes and is clouded in controversy about methods used and claims being made . Yet it goes on.
It would seem obvious and self-evident that children should not be coerced into graded exercise when they are ill and unable to attend school. Yet the SMILE study is funded -funding given to the vice-chair of the MRC/SMC collaborative of charities and organisations. in our opinion an appalling and dangerous waste of funding to flawed theories. 
It would seem obvious that after being taken to a Judicial Review, by patients, that an organisation such as the UK National Institute for Health and Care Excellence (NICE) would show some humility toward a patient community that for a generation has been denied proper treatment, proper research or any form of respect. Yet NICE have again not listened and ignored calls for a review of their previously unacceptable guidelines for ME. 
Karina Hansen is 24 years old who has been seriously ill for some years and was cared for by her parents in Jylland, Denmark. On 12 February 2013 she was removed by force, under police supervision, by doctors and the local authority who seemingly gained access to Karina's residence without prior notice. Later, the parents informed that Karina had been admitted to Hammel Neuro Centre for assessment, treatment and rehabilitation. Karina's lawyer has now taken over the case. 
It would seem obvious that locking up a young adult, stopping her family from regularly seeing her, forcing psychiatric theories and practices on her would all qualify for an investigation into human rights.
Yet one year on from this situation Karina Hansen is still locked up, with sparse information about her condition, with rumours that a UK psychiatrist is "advising" the Danish psychiatrists on treatment, and uncertainty about her condition or her prognosis.
We cannot be sure what is the current status of Karina Hansen's health.
Despite Danish national ME organisations attempting to assist no help seems to have been accepted by those currently treating Karina and no information seems to be forthcoming - either from the Hammel Neurocenter or from the Danish Health Ministry.
Yet one thing is clear - patients are not being listened to.
And lessons are not learnt from past misfortunes.
This must change.
In an attempt to break this impasse IiME last year invited the physicians at the Hammel Neurocenter to the 8th Invest in ME International ME Conference. We followed up this invitation by contacting the Danish health minister Ms Astrid Krag and inviting her. 
We received no reply.
"He who is afraid of asking is ashamed of learning"
In order to support a fresh attempt at helping Karina Hansen the charity has offered the new minister of health, Nick Hækkerup, an invitation to meet with clinicians and researchers at the BRMEC4 research colloquium  and IIMEC9  events in London in May.
We have sent the invitation also to the physicians at the Hammel Neurocenter, again. IiME have offered to arrange confidential meetings with ME experts with a view to helping get the best attention for Karina Hansen. And we have offered a place at the research colloquium and at the conference.
We await a reply.
We know from too many stories of how severely affected ME patients suffer in silence and are often misunderstood by social workers, by doctors and by the healthcare system. 
We have written in the past that we feel it is impossible to marry the views of those who believe in the deconditioning/behavioural and wrong illness belief model of ME with those from the biomedical side.
Yet what we can agree on is that we need to exhaust all possibilities when a patient such as Karina is in such an awful situation.
This charity has never bothered with egos or status - what matters is progress.
But we recognise that to accept this invitation will be difficult for anyone whose professional authority is questioned. We understand this.
Yet it takes a greater degree of courage to accept an invitation such as this - to accept that learning never stops.
This invitation will cost everyone very little - yet it might help save a life.
As someone currently receiving hospice care due solely to the effects of ME, it irks me when people claim ME is not a fatal disease. Many, many ME-related deaths have shown that, at the very least, this disease can be fatal. I’ve seen people throw around a statistic which claims the death rate for this disease is 3%. What they don’t realize is most ME experts agree this number is grossly underestimated. Let me explain why.
ME is most similar in nature to another neurological illness, Multiple Sclerosis. Like MS, most ME experts agree there are certain subtypes which exist within the same illness name. The most commonly suggested categories (and those I personally see) are stable (illness remains the same or improves slightly with careful energy planning), relapsing/remitting (illness cycles through better and worse phases), and progressive/deteriorating (illness consistently deteriorates over time, regardless of planning and treatment). Of these three, the second category, relapsing/remitting, seems most common, while the last, progressive/deteriorating, is least frequently seen. Short of a miracle, no one ever fully recovers from ME.If you hear someone who claims to have had ME and is now functioning at 100% normal again, chances are extremely high they never had ME to begin with. Unfortunately, due to the high level of mis-education about this disease, thousands and thousands of people diagnosed with CFS believe they have ME when what they truly have is something completely different. Read my post on ME vs CFS for more on that.
That said, anyone who spends any significant amount of time studying the true nature of this illness will see the tremendous amount of damage it does to multiple body systems. It makes sense that this damage would have a shortening effect on most ME patients’ lives. For example, Dr. Elizabeth Dowsett says of ME patients, “20% have progressive and frequently undiagnosed degeneration of cardiac muscle which has led to sudden death following exercise.” Dr. Dowsett goes on to explain that the vast majority of these deaths are recorded as general heart failure rather than being officially linked to ME.
Herein lies the problem. Education and general knowledge of ME are so uncommon that for most of us, cause of death will be recorded as a secondary condition, even if that condition wouldn’t have developed without ME. This brings to mind another illness where sufferers nearly always die of secondary conditions: AIDS. People with AIDS generally die of secondary infections which their bodies are unable to fight off due to the effect of the AIDS virus on their system. Yet everyone knows AIDS is a terminal condition. We don’t deny its severity or its life-ending effect just because the final straw is nearly always a secondary condition. The same should be understood about ME.
ME is extremely hard on the body. One survey found people with ME most often die of heart failure, but we die from it on average over 20 years earlier than people without ME who die of heart failure. Cancer is another frequent killer of ME patients, but again, we tend to die from it decades earlier than non-ME cancer patients. Again, this makes sense, taking into account the strain ME places on nearly every body system, including our organs. It’s time for the world to wake up and realize the seriousness of this disease, but how can we expect others to recognize these facts if we ourselves refuse to face up to them?
Not everyone with this disease will die as a direct result of it. Other things can happen. But it is unrealistic and goes against what information we do have to believe that the tremendous strain placed on our bodies by this level of ongoing illness will have no effect whatsoever on the length of life we are allowed. Smoking shortens life. Overeating shortens life. Cancer and AIDS and kidney failure shorten life, despite allowing a much higher overall quality of life than ME. It only makes sense that ME shortens life as well, for some more than others. As someone whom doctors agree is currently dying from this disease, I beg you, don’t minimize its effects when speaking to the public. Don’t ignore people like me. Don’t let our deaths be in vain. Spread the word – ME does kill.
MEA chairman Neil Riley unpicks a central thread in the PACE Trial
MEA chairman Neil Riley unpicks a central thread in the PACE Trial
26 February 2014
‘Recovered’ – or do you only feel better?
“I feel so much better today, I’ll go back to work”. Ah, those halcyon days before you had ME. You were ill, you rested, you got better. Put simply, you had recovered.
So when a trial of treatments for people with ME/CFS reports that many of them had “recovered” you would imagine shouts of joy throughout the ME community. But joy there was none and for good reason. “Recovery” as defined in the PACE Trial, involving the use of Cognitive Behaviour therapy (CBT) and Graded Exercise Therapy (GET), is not what you think it is.
In medical trials there are ways of measuring your physical abilities and the SF-36 Function Scale is one that’s often used. It’s useful in comparing the burden of different diseases, differentiating the health benefits produced by different treatments, and in screening individual patients.
A score of 85 or above on that scale indicates that an adult, even one who was previously ill, is able to carry out most everyday tasks. The Pace Trial took as patients, adults with CFS/ME who had a point score of 65 or less, so they were clearly ill. They were given CBT and GET.
Now common sense suggests to me that if the treatments had worked well, those patients would have recovered. Their SF36 score would be 85 or over and off to work they would go. Singing merrily as they went. Well, I was wrong.
Originally PACE said that a score of 85 would indicate their patients had recovered their function but later decided achieving a score of 60 was sufficient. So patients could enter the trial “severely disabled” with a score of 65 or less and exit the trial “recovered” with a score of 60. Yes, you read that correctly.
Some could be as ill at the end of their treatments as they were when they started, yet, says PACE, they had “recovered” their physical function.
PACE does a wonderful sleight of hand here by claiming that as the fatigue score for patients showed improvement then that constituted recovery. Imagine you have just finished treatment for an illness and you’re asked: “How do you feel?” You might say: “I feel much better today thanks”. Feeling “much better thanks” is, as we know, not the same as “recovered”.
If I still can’t go back to work, play football or score my 85 points, then I’m not sure I’d feel “recovered” even if I didn’t feel as knackered as before.
Did PACE check their recovery measures by asking patients scoring 60 if they had recovered? Well, blow me down with a feather, they did not. Here’s a suggestion, dear researchers. Why not go back and ask those patients if they can now do what they did before they were ill.
Why is this important to you? Because the treatment you get from your GP is often based on trials. If those trial results are not founded on common sense but on inappropriate formula on the wrong set of data, what use are they? We live in a world where common sense rules, not in the world of PACE where “recovery” is not what it seems.”
This article first appeared in ME Essential, the quarterly magazine of The ME Association, in February 2014.
British Doctor Wants to Rescue ME Patient Held at Danish Hospital
A British doctor who specializes in the devastating disease myalgic encephalomyelitis (ME) has joined an international bid to free a young ME patient who was incarcerated in a Danish hospital a year ago. Dr. Nigel Speight wants to examine Karina Hansen, a sane but sick woman aged 25 who was forcibly removed from her home in Denmark on February 12 last year, and provide a second opinion as soon as her state-appointed guardian gives the go-ahead. If he gains access Dr. Speight believes he will be able to rescue the young woman from the hospital’s mental ward, where she is being held against her will and the will of her parents.
A group known as Justice for Karina Hansen (J4KH) has been petitioning for the young woman’s release from Hammel Neuro Center since May last year. Their most recent campaign was launched last Thursday, in the form of an open letter from her parents, Per and Ketty Hansen, to the man appointed by the Danish health authorities as Hansen’s guardian. In terms of the World Health Organization’s (WHO) A Declaration on the Promotion of Patients Rights in Europe (March 1994), that states patients “should have the possibility of obtaining a second opinion,” they have asked that Dr. Speight be allowed to see her and give a second opinion. The ME Association in Denmark has undertaken to pay his travel costs. J4KH reported on their Facebook page that the guardian had acknowledged receipt of the letter and undertaken to discuss the matter with “those in charge of her care.” The group has also launched a new change.org petition that already has more than 1,665 supporters.
The bedridden Hansen was taken from her home in Holstebro County last February, by five policemen who forced their way into the house; they were accompanied by two doctors, two social workers and a locksmith. Hansen called for help, but none of the family members could get past the police. She also phoned her sister, Janni asking for help, saying she did not know where she was being taken. The following day she phoned her mother from her cell phone asking how she could “get out of here.” She said she could not “take this.” They later discovered that she made a total of 43 calls and sent seven text messages before her phone battery went flat. The last call was to the police. The Hansens have asked for transcripts of the calls, but have received nothing. They have asked that her phone be recharged, but she has to do it herself and cannot get out of bed.
The Hansens said they were not given any reasons for the action and received no official paperwork relating to it. All they found was a note on the floor with a telephone number and message to say they would be contacted daily by a doctor. This did not happen, and they have not been permitted to visit their daughter because they do not support her treatment. Her sister, Janni has seen her briefly and is very concerned about her condition. The Hansens have taken legal action, but the court system is slow and drawn out.
Treatment for a Functional Disorder
Several days after Hansen’s removal, her parents received a letter from Nils Baile Christensen, a psychiatrist who said he was in charge of the treatment she would be given. Christensen is from The Research Clinic for Functional Disorders and Psychosomatics in Aarhus that is headed by Prof. Per Fink. Fink is the man who in 2010 introduced a new medical definition known as “bodily distress syndrome” (BDS) that categorizes all the “functional” syndromes that have physical symptoms that cannot be “explained by well-recognized medical illness.” Typical symptoms include headache; back, muscle and joint pain; stomach problems; shortage of breath; and fatigue. Illnesses that are lumped together under BDS include fibromyalgia, irritable bowel syndrome, chronic fatigue syndrome (CFS) and ME.
In Denmark functional disorders are labeled “psychosomatic,” and this particular clinic treats patients with cognitive behavioral therapy (CBT), graded exercise therapy (GET), and anti-depressant drugs. It has been reported that the clinic does not have experience treating ME patients that are severely ill, and there is widespread concern because it is known that any form of physical exertion can harm ME patients.
“All the other symptoms can be made worse by physical exertion, and mental effort can make the physical fatigue worse.”
Dr. Nigel Speight
Hansen has been sick since she was 16-years-old, and has been diagnosed with ME, an illness that the WHO has coded “neurological” since 1969. Over the years she has been hospitalized several times, undergoing treatments that did not help her condition, which had made her extremely light and sound sensitive. ME was confirmed the correct diagnosis by several doctors, at least one of whom expressly noted that she “had no depressive or psychotic tendencies.” By 2009 the young ME patient was completely bed-bound, in a great deal of pain, and constantly exhausted.
In 2012 Hansen’s general practitioner and another doctor visited her without an appointment, stating they had been told by the government’s Board of Health to “evaluate her mental state.” While they found she her to be “mentally competent,” they said she would have to see a psychiatrist. This is when her story first broke, Hansen choosing pictures that could be used for publicity. She also hired a lawyer and went through the legal procedure to give her parents power of attorney to make all decisions for her when she got too sick to be able to make her own decisions.
Even though Hansen’s health care category stated that she could opt to see any doctor she wishes to see, and that the Danish government cannot assign doctors to her, she was assigned a psychiatrist by the Board of Health. At that stage she had her own physician, a dietician, and a dedicated health care giver, and was living at home with her parents and family.
Even though Hansen has been diagnosed with ME on numerous occasions, the research clinic doctors have now changed the diagnosis to pervasive arousal withdrawal syndrome (PAWS). According to research published by the National Institutes of Health (NIH), PAWS (which was previously known as pervasive refusal syndrome) is a very rare “child psychiatric disorder” about which little is known or been written about. Symptoms include resisting help and withdrawing socially.
Dr. Nigel Speight
The British doctor Speight believes that the emphasis put on the efficacy of CBT has “most unfortunately” resulted in the disease being viewed from a psychiatric standpoint rather than as “a ‘genuine’ disease.” He is convinced that ME is “primarily an organic illness” with no psychological factors causing it. There may though be “secondary psychological consequences.” This is clearly a reason he wants to rescue the young Danish ME patient who has been held at the hospital in Hammel for a year.
Medical advisor to the British ME Association, and reputedly the most experienced and knowledgeable ME consultant pediatrician in the United Kingdom, Dr. Speight has played a major role in the rescue of many children with ME from “care proceedings” by social services. In a recent interview he said it was “a very painful area” and one of the most unpleasant things he has witnessed in his entire medical career. A lot of it comes from “a simple failure of doctors to protect patients by diagnosing them with ME/CFS“ which “leaves them at risk of being persecuted for alternative explanations.”
He said he had been involved in over 30 cases, all of which resulted in child protection proceedings. However, most had been averted by the “second opinion” process. He described cases that are very similar to Hansen’s, where children were removed from their homes. For instance, he described how a Scottish teenager who had been diagnosed with ME that became very severe, and how she was sent to a psychiatrist who diagnosed pervasive refusal syndrome. By the time he was called in to intervene she was in a psychiatric ward, curled up in a fetal position, being tube fed – and like Hansen, was highly sensitive to light and sound. The story ended happily with her being transferred to “a gentle nursing home” where she had a slow but steady recovery. However, “how you can change from having ME to having a purely psychiatric illness just because you have been handed from a pediatrician to a psychiatrist, I do not really understand,” he said.
“It is the medical profession’s duty to be able to make a confident, clear diagnosis of ME/CFS and if they do that, there should be protection. But many of the cases I have seen have not even been diagnosed.”
Dr Nigel Speight
Currently involved with about three cases in Britain, this British doctor is the best hope Hansen’s parents have had in the past year. His willingness to help rescue the young ME patient being held in a mental ward at the Danish Hammel Neuro Center Hospital has resulted in excitement on the part of the J4KH group which is headed by people who themselves suffer from ME and CFS. All the family wants is their little girl back.
Invest in ME’s Submission to the APPG for ME on 3rd February 2014
Questions from Invest in ME to Mike Penning, Minister of State for Disabled People Mike Penning
It is clear from many of our supporters that GPs are often known to refuse referrals for their ME patients on the grounds that there is little point in doing so as they believe there are no treatments.
This illustrates an ignorance of ME and of research into the disease (RCGP Chair Dr Clare Gerada stated at the IIMEC8 Invest in ME International ME Conference, in London in 2013, that GPs know little about ME).
This impacts the patient as well as compromises their entitlement to benefits.
Some of the clinics set up for ME and CFS specifically state:
“Please note that we do not accept referrals where the sole purpose is for second opinion for pending benefits claims.”
(- King’s College CFS Unit)
How are patients supposed to obtain medical evidence for their benefits applications if they are refused referrals and the few clinics set up to see these patients cannot provide appropriate support?
How are they supposed to get better if their personal physician is ignorant of the disease and refuses to facilitate the possibility of improved treatment?
This adds further stress for patients and their families and enforces again the view that ME patients are subject to systemic bias in the healthcare system and ignored by disabilities agencies.
Effectively ME patients are discriminated against.
The failure of government policy on ME for a generation means that few patients have decent healthcare or prognosis once they have the diagnosis of ME.
This makes the impact of ATOS and welfare reforms even harder than usual for ME patients as no one seems to take responsibility for this group of patients even though many acknowledge the shameful treatment these patients have received (in Norway the government officially apologised for their treatment of ME patients).
How is it possible then for Atos medical assessors to be able to give prognoses of ME patients' ability to return to work based on one interview and with no knowledge of the disease and no understanding of the effects of the disease and especially the consequences from post-exertional malaise?
It is obvious from patient experiences that ATOS are acting purely to enforce DWP policy to deny benefits - seemingly influenced by the outdated establishment bias which has been allowed to be built up by vested interests.
The role of the ministry is to improve the health and safety system, simplifying the welfare system and making sure work pays. Helping people to find and stay in work.
It is plainly obvious that these objectives are completely failing in being materialised for ME patients.
We would respectfully suggest that the minister consider the following in relation to the ministry’s objectives -
· The health and safety of patients has not been improved and continues to be so poor that severe deterioration and even deaths from ME are becoming more frequent.
· The welfare system for ME patients is a scandal - with little understanding of the disease being exhibited by DWP, or their contracted third-party organisations such as ATOS, and not even healthcare practitioners.
· Making sure work pays is a meaningless concept if people are denied any hope of development of treatments or cures for this disease due to lack of proper research being funded by those charged with that responsibility (such as the MRC).
The minister, we feel, should consider the deplorable state in which successive governments have left ME patients.
An entire section of the population is discriminated against on a regular basis - something a Minister for Disability Issues really ought to consider a major priority.
Welcome to IIMEC9 - the 9th Invest in ME International ME Conference 2014 in Westminster, London, UK, on 30th May 2014.
Today Invest in ME announce some of the speakers at the 2014 conference.
The key to resolving, treating and curing ME lies in biomedical research.
Healthcare staff need to be aware of the latest biomedical research into ME as well as the multiple symptoms exhibited by ME patients and of the possible treatments available and future research directions.
Benefits of attending Invest in ME 2014 Conference
o Increase your understanding of diagnosis, treatment and management of ME
o Explore current and future biomedical research into ME
o Assess the role of immunological markers in ME
o Learn about ongoing clinical trials using Rituximab to treat ME patients
o Learn about inflammation in the CNS and its contribution to neurological disease
o Learn about the function of the immune response in the gut
o Share and exchange ideas with the leading practitioners in the field
Who should attend?
IIMEC9 will be of interest to:
o Specialists in ME (CFS)
o GPs with an interest in ME (CFS)
o Palliative care nurses
o Occupational Therapists
o Specialists in pain management
o Specialists in care of the chronically ill
o Community nurses
o All trainees in these disciplines
o ME Support groups and charities
Conference fee includes:
Entrance to the conference, lunch & refreshments, full conference documentation and certificate of accreditation (for professionals).
Invest in ME are pleased to announce the following speakers at the conference -
Professor Jonathan Edwards
Emeritus Professor of Connective Tissue Medicine University College London (UCL), UK
Associate Professor Mady Hornig
Center for Infection and Immunity (CII), Columbia University Mailman School of Public Health New York, USA
Professor Sonya Marshall-Gradisnik
Associate Professor, Biochemistry, Griffith University, Australia
Professor Julia Newton
Clinical Professor of Ageing and Medicine, Institute for Ageing and Health, Newcastle University and Honorary Consultant Physician, Royal Victoria Infirmary, UK
Dr James Baraniuk
Professor of Medicine at Georgetown University Medical Centre, USA
Dr Ian Gibson
Former Dean of Biological Sciences, University of East Anglia
Additional speakers are expected to be announced shortly
As the Invest in ME initiated and funded research becomes underway at UEA (gut microbiome) and UCL (rituximab clinical trial) the conference will reflect the research being performed and focus on synergizing the research elements from around the world to find cause and provide treatments for this disease.
Also present at the conference will be representatives of the European ME Alliance (EMEA) as the EMEA AGM takes place after the conference.
CPD Accreditation from the Royal colleges has been applied for and we hope to obtain the maximum credits for the conference, as in previous years.
How can we ensure ME research and patient care benefit from the latest thinking in ME/CFS and related areas of research? What is the best way forward?
The Invest in ME conferences have attracted presenters and delegates from fifteen countries and our DVDs of the conferences have been distributed to over 20 countries in Europe, USA, Canada, Australia and New Zealand.
Full details of the conference can be found at this address - click here.
IiME are again offering a discounted rate for healthcare staff who attend in connection with a local ME Support Group. IiME welcome all professionals who are working with, or have an interest in, ME/CFS.
We look forward to welcoming you to the conference,
Invest in ME
Bristol ME Event - “Exercise and ME/CFS – the evidence”
I received the following from Natalie Boulton of “Voices from the Shadows”; the flyer mentioned in the text can be found here and a programme for the event here.
From Natalie -
I would like to let people know about an evening event in Bristol “Exercise and ME/CFS - the evidence" on Feb 5th which I am organising with the Bristol North Fibro & ME/CFS Support Group. Since some charities only wish to publicise their own events it is proving rather difficult to let relevant people know about this event. However, since people from far, far away have made bookings, I realise that many people do very much appreciate the opportunity this event provides, if they know about it.
The evening will include a short 30 min version of the film - the young ME patients' stories - backed up by a presentation by Prof Mark VanNess about the research from the Workwell Foundation with Staci Stevens and Chris Snell, previously at the Pacific Fatigue Lab California. This work is very significant in that it objectively demonstrates the reality of the cardinal symptom of ME - post exertional malaise, or the post exertional exacerbation of symptoms which can prove so damaging to patients. Their work counters assertions made by proponents of graded exercise and the PACE Trial that the fatigue and disability of CFS and ME is merely caused by deconditioning and that GET and CBT are the most effective treatment options for patients.
Dr Nigel Speight who speaks in the film will also explain some of the problems encountered by families and medical professionals when trying to help young patients.
I hope the event may be of interest to you and would be very glad of your help with letting other ME sufferers know about it. It is not only of relevance to patients, but will also be of use to relatives, carers and medical professionals. If you have any questions about it do please ask me.
With best wishes,
ME on TV
On the 4th December 2013, on “The People’s Voice” online TV channel, journalist Sonia Poulton interviewed Jane Colby (of the TYMES Trust) and Rebecca Hansen (of the ME Association in Denmark) about ME and, in particular, about the abuse of people with ME both in the UK and abroad. It centres on the case of a young lady in Denmark who has been removed from her home and is being held in hospital against her will and that of her family. It also includes details of why ME is not just “chronic fatigue”. The interview lasted around 20 minutes and is well worth listening to; it’s quite an eye-opener as to what is going on.
The interview is available to watch on YouTube – click here
Out of Hours
Chronic fatigue syndrome:
a patient’s perspective
In 1999 I contracted a throat infection that receded after many weeks, but I was still unbelievably exhausted with the most intense flu-like malaise. Two years later I was diagnosed with chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) and joined the 240,000-plus people in the UK with this Illness. I assumed that a diagnosis would lead to effective treatment, but I was in for a shock.
Initially my GP suggested I see a psychotherapist. It seemed a strange recommendation, but I trusted his judgement and decided to see if this would help. Unfortunately it had no impact at all on the illness. My GP then referred me to an endocrinologist who boldly announced that, as the test results were all normal, everything was fine and offered to prescribe antidepressants. I was deeply frustrated by the suggestion that clear test panels meant I should be treated as a depressed patient. I was not inclined to agree that antidepressants were the best treatment when my experience of the symptoms was closer to that of an infection than a mood disorder. In fact, I have been told a number of times that I’m simply depressed, or that I am de-conditioned and just need to exercise. I wouldn’t mind if either diagnosis were true, as there are effective treatments available, but they are inadequate explanations.
CFS/ME waxes and wanes but also causes post-exertional malaise: when patients go beyond their usual (restricted) activity level they suffer a worsening of symptoms which can be severe. Patients often refer to this as a crash. For me this can mean being bedridden for weeks with muscle weakness, dizziness, loss of appetite, and indescribable physical and mental exhaustion. It’s worth noting that my GP has only ever seen me when the symptoms are at the lesser end of the scale. During a crash I am too ill to leave my bed, let alone travel to the surgery.
When I first got sick, CFS/ME seemed to be largely treated as a mysterious psychological condition, with doctors encouraged to limit the number of tests done, and with patients left to self-manage. Since then things have improved a little in that there are fatigue clinics in some areas, but the overall treatment situation remains poor, with most patients receiving little or no effective treatment through the NHS.
The PACE trial is the largest study performed into CFS/ME treatments, primarily cognitive behavioural therapy (CBT) and graded exercise therapy (GET). I think the £5 million cost would have been better spent on immunological studies, exercise physiology testing, and understanding the disease mechanisms. A recently published PACE trial paper reported on ‘recovery’ rates.(1) However, the letters published in response to the paper show that the study’s post-hoc definition of ‘recovery’ was seriously flawed, and so much looser than the recovery criteria outlined in the trial’s protocol that the ‘recovery’ outcomes bear no relation to what an average person, or clinician, would define as recovery of health. PACE was an un-blinded study and the primary outcomes were all subjective self-report measures at risk of response bias. Changes from the trial protocol (2) also meant that it was easier for patients to be classed as improved, yet even then the addition of CBT and GET to specialist medical care led to only an extra 11-15% of patients reporting improvement.(3) This simply underscores the need for more research across all areas to find effective treatments.
CFS/ME presents difficulties for both patients and doctors, reinforcing the need for them to work together in partnership. A recent BMJ editorial (4) entitled Let the Patient Resolution Begin could not have said it better:
“… health care won’t get better until patients play a leading role in fixing it.”
Software engineer, London.
1. White PD. Goldsmth K. Johnson AL. et al. Recovery from chronic fatigue syndrome after treatments given in the PACE trial Psychol Med 2013 40»10»: 2Z27-223S.
2. White PD. Sharpe MC. Chalder. et al Protocol for the PACE trial: a randomised controlled trial of adaptive pacing. cognitive behaviour therapy, and graded exercise, as supplements to standardised specialist medical care versus standardised specialist medical care alone for patents with the chronic fatigue syndrome / myalgic encephalomyelitis or encephalopathy BMC Neurol 2007; 7: 6
3. White PD. Goldsmith KA Johnson AL, et al. Comparison of adaptive: pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medcal care for chronic fatigue syndrome (PACE): a randomised trial Lancet 2011 377197681:823-836.
4. Richards T, Montori VM, Godlee F.et al Let the patent revolution begin BMJ 2013 346: f2614.
INCORRECT GOVERNMENT INFORMATION COULD BE HURTING CHRONIC FATIGUE SYNDROME PATIENTS, NEW RESEARCH FINDS
PRESS RELEASE: NEW YORK, NY (11/20/2013) – An untold number of New Yorkers, perhaps well over 100,000, who have been diagnosed with Myalgic Encephalomyelitis and Chronic Fatigue Syndrome (ME/CFS) could be at risk of relapsing and exacerbating their condition due to a course of a treatment suggested to them by the federal government, according to groundbreaking new research.
At a medical conference today sponsored by the New York ME and CFS Center at Mt. Sinai and held at the New York Academy of Medicine, researchers showed that a form of treatment called Graded Exercise Therapy (GET) which has been lauded by the UK’s National Institute of Clinical Excellence (NICE) and recommended by the U.S. Centers for Disease Control and Prevention (CDC) may not help ME/CFS, but actually can make it worse. Unfortunately, the CDC has long been touting that certain exercise regimens can help manage the disease, even offering guidance on their website.
Dr. Derek Enlander, Dr. Eric Schadt, Dr. Miriam Merad, Dr. Christian Becker and a team of researchers at Mt. Sinai Medical Center have discovered new research on ME/CFS that could change the way the disease is treated. Their research shows that the disease is tied to the immune system much more than originally thought. A recent study showed patients can actually relapse when they partake in excessive exercise, and other therapies maybe more effective.
“We want to raise awareness about this disease, how it affects the body and the best way to treat it,” Dr. Enlander said. “For too long, this disease has been misunderstood, leading to a poor quality of life for far too many patients. We hope to change all that.”
Myalgic Encephalomyelitis was first identified in the mid-1950s, by Dr. Melvin Ramsay of London’s Royal Free Hospital, after being suspected of outbreaks dating back at least two decades’ prior. What is thought to have been an outbreak in Nevada’s Incline Village in the mid-1980s, mirroring one in rural upstate New York’s Lyndonville, led to the CDC officially recognizing a condition reduced Chronic Fatigue Syndrome in 1988 following the elimination of the Epsten-Barr virus as a potential culprit. The CDC has displayed an inconsistent track record ever since, diverting millions of dollars earmarked for research in the disease to other causes in a scandal uncovered some 15 years ago. Recent estimates suggest that hundreds of thousands of people in the U.S. suffer from CFS, although the CDC is thought to have both underestimated the severity of the disease, while overestimating the numbers, as they have reported a disease prevalence of 2.54% in the U.S. This figure is not accepted by experts in the field. Using the more-accepted figure of 0.4% would estimate the number of sufferers in the New York City Metropolitan area alone at over a half million patients, the majority of whom are likely undiagnosed.
The illness which afflicts women to a greater degree than men, causes severe immunologic dysfunction, profound loss of energy (sometimes referred to as fatigue, though in many cases patients would report that this term is inadequate as a descriptor), sleep disorders, neurological disturbances, pain, and other symptoms. Underlying causes and treatments for CFS have been elusive, but new research is shedding light on how the disease works.
This document was produced by The Grace Charity for ME and is reproduced here with their kind permission. It can be found online as Word and PDF documents.
SAYING NO CAN BE POSITIVE Spring 2006 (updated 2013)
The following has been designed to support M.E. sufferers who choose to not attend the current NHS Chronic Fatigue Syndrome/Myalgic Encephalomyelitis clinics, set up across the country. These clinics have been based upon the Chief Medical Officer’s report from 2002 and consist mainly of psychological therapies such as Cognitive Behavioural Therapy and Graded Exercise Therapy. This document may also support M.E. patients who refuse to receive the treatments of CBT and GET recently recommended by NICE for CFS/M.E. and also by the PACE trials (Prof. Peter White et al.) Bedbound/housebound sufferers who are advised to have these therapies on domiciliary visits may also find this document helpful. It may also help those pressurised to undertake CBT and Graded Exercise Therapy by Private Health Insurers.
Those who wish to refuse psychological therapies for M.E. can be supported by the following facts:
1) The law protects patients from unwanted treatments if the patient is deemed to be mentally competent. Medical practitioners cannot give a treatment to a patient without the patient’s consent. 1 Scientifically, M.E. is NOT in Mental Health, see below.
2) An M.E. patient doesn’t have to comply with the recent NICE guidelines on CFS/M.E., supported by the above law, because M.E. is not scientifically in mental health.
3) The NICE guidelines, which support CBT and Graded Exercise Therapy for M.E., are not mandatory. In practice, GPs and all doctors do follow the NICE Guidelines: this is because all NHS organisations have a legal requirement to implement NICE guidance. However, the treatment aspect is not enforceable.
‘I can clarify that NHS organisations are indeed expected (and in some cases, such as a type of guidance called Technology Appraisal guidance, legally obliged) to implement NICE’s recommendations. This is not the same as saying that the NHS has the power to force a patient to undergo a treatment which they do not want.’ 2
‘NICE clinical guidelines such as CG53 are not legally enforceable.’ 3
4) M.E. patients have a right, under the NICE guidelines, to refuse the recommended treatments from NICE.
The following could be used to help M.E. sufferers who wish to refuse NICE’s recommendations of treatment:
‘Healthcare professionals should be aware that – like all people receiving care in the NHS – people with CFS/ME have the right to refuse or withdraw from any component of their care plan without this affecting other aspects of their care, or future choices about care.’ 4
A patient’s care plan can include state benefits and social services care, which are now also linked with the NICE guidelines.
The NICE guidelines do not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of each patient. Healthcare professionals should record their reasons for not following clinical guideline recommendations.
In other words, every patient case is individual and a doctor does have the right to express clinical freedom, along with consulting the patient, as to what is best. This may mean refusing Graded Exercise Therapy and CBT.
5) An M.E. patient who is in a comatose/semi comatose state cannot by law be forced into psychological treatment just because they have M.E. 5
6) Private Health Insurers cannot force an M.E. client to undergo unwanted treatment before making a payment, unless those treatments are specified in the contract. Unless the contract of a company states clearly that M.E. clients must undergo CBT and/or Graded Exercise Therapy before a payment is made, the company could well be in breach of contract. Also, every individual has freedom to express views as stated by The Human Rights Act 1998. If an insurance company ignores a client’s reasons for refusing CBT and/or Graded Exercise Therapy, a client could claim their ‘freedom of expression’ has been violated. 6 The following organisation may offer help, including a free telephone appointment for legal advice:
Disability Law Service
39-45 Cavell Street
Tel: 020 7791 9800
7) An M.E. patient cannot have their state benefits withdrawn for refusing CBT and Graded Exercise Therapy.
Unfortunately, the NICE guidelines are now linked with the awarding of state benefits and Social Services care.
U.K. law says that if a patient refuses suitable treatment without good cause, benefits can be withdrawn. 7
However, CBT and Graded Exercise Therapy could be argued as unsuitable treatments for M.E. sufferers (see facts below). Scientific opinion which is against CBT and GET for M.E. can be used to obtain state benefits for sufferers.
In addition, NICE has written the following in its CFS/ME Guidelines:
‘Healthcare professionals should be aware that – like all people receiving care in the NHS – people with CFS/ME have the right to refuse or withdraw from any component of their care plan without this affecting other aspects of their care, or future choices about care.’ (This is also quoted in section number 4 of this paper. See Footnote 4 for reference.)
Although NICE Guidelines are now linked in with the awarding of Social Services care and State Benefits, the above quote can be used in favour of an M.E. sufferer’s refusal to undergo CBT and Graded Exercise Therapy.
If sufferers find themselves in a legal battle with their benefits, those who qualify for legal aid may find the following organisation helpful:
Civil Legal Advice (formerly Community Legal Advice) Tel: 0845 3454345
8) M.E. is a neurological disorder. It has been classified as such by the World Health Organisation in the International Classification of Diseases since 1969. 8 Therefore psychological therapies could well be inappropriate.
9) M.E. has a strong medical history of being an organic disease. Dr. Gordon Parish is the curator of the Ramsey Archive, which is possibly the world’s largest collection of medical papers on M.E. 9 It includes detailed world-wide epidemics of M.E. since 1934 and the viruses which triggered the disease.
10) There are over 2,000 papers showing that M.E. is an organic disorder, according to Prof. Anthony Komaroff (Professor of Medicine at Harvard). 10
11) In November 2010, M.E. sufferers were banned from giving blood. NHS Blood and Transplant has said that the ban is a precaution to protect the donor’s safety by ensuring the condition of M.E. is not made worse by donating blood. They say that the move brings M.E. in line with other relapsing conditions such as Multiple Sclerosis and Parkinson’s Disease. 11 However, many people in the M.E. community feel that the ban is over the possibility of contamination from the virus XMRV, which has been shown in studies to be high in M.E. patients. (See research by The Whittemore Peterson Institute team, published in the journal Science 2009.)
12) Many tests exist in aiding a diagnosis for M.E. Therefore, using psychological therapies for ‘unexplained fatigue’ is inappropriate. Although diagnostic tests for M.E. are still being worked upon with promise, nevertheless many tests and procedures can be administered in aiding a diagnosis of M.E. These include the use of SPECT, MRI and PET scans, test for NK cell activity and endocrine abnormalities, Tilt Table Test, viral tests and many more. 12 Although these tests are rarely offered by the NHS for M.E., they have nevertheless shown evidence of physical abnormalities.
13) “Patients who improve after physical exercise programmes do not have M.E./CFS.,” says Dr. Byron Hyde, M.D. of the Nightingale Research Foundation for M.E. in Canada, who has studied M.E. since 1984. 13 Dr. Hyde stresses that M.E. is primarily a disease of the Central Nervous System. 14
14) Patients who respond well to CBT and Graded Exercise Therapy might not have M.E. due to the diverse criteria used. Some criteria focus on unexplained chronic fatigue only, omitting symptoms showing central nervous system involvement. There are at least twelve definitions of Chronic Fatigue Syndrome and/or M.E., all of them different. 15 In the U.K., a frequently used case definition is the Oxford Criteria which includes patients with no physical signs and selects subgroups of patients with high levels of psychiatric diagnoses . 16 The PACE and FINE trials (funded by the Medical Research Council) use the Oxford Criteria. 17
15) The assumption that an M.E. patient can always do more is an erroneous one. There are overwhelming international research findings on M.E., which support multi-system involvement particularly of the immune, endocrine, cardiovascular and neurological systems. 18 Also, there is evidence indicating pathology of the central nervous system and immune system 19 and evidence of metabolic dysfunction in the exercising muscle. 20 Also, Dr. Jay Goldstein has demonstrated through SPECT scans the severely decreased brain perfusion of an M.E. patient 24 hours after physical exercise. 21 The Canadian Criteria (2003) states that the worsening of symptoms after exertion is a principal symptom of M.E. 22 Raised levels of noxious by-products of abnormal cell membrane metabolism, associated with exercise and correlating with patients’ symptoms have been demonstrated. 23
16) CBT and Graded Exercise Therapy can worsen M.E. symptoms. In a survey of 3074 M.E./CFS patients conducted between 1998 – 2001, 55% of patients said that CBT had made no difference to their illness, whilst 22% said CBT had made their illness worse. 16% of patients said that graded exercise had made no difference to their illness whilst 48% said it had made their illness worse. 24 A survey by the 25% ME Group (for severe sufferers) of 437 patients, demonstrated that of the 39% of group members who had used graded exercise, 95% had found this therapy unhelpful, whilst 82% reported their condition had been made worse by graded exercise. Some patients were not severely ill with M.E. until after graded exercise. In the same survey 93% of those who had undergone Cognitive Behavioural Therapy had found it unhelpful. 25
17) The CMO’s Report recommended CBT and Graded Exercise Therapy despite the objection of two patient support groups. The patient support groups of BRAME (Blue Ribbon for the Awareness of ME) and the 25% ME Group refused to endorse the CMO’s Report of 2002 based on its recommended treatments of CBT and graded exercise. These support groups mainly represent the needs of severe M.E. sufferers and were part of the CMO’s Working Group.
18) Medical Concerns have been raised about the CMO’s Report. The Journal of Chronic Fatigue Syndrome, mentions criticism by health professionals and the public of both the British and the Australian M.E./CFS guidelines. “These criticisms included claims of bias in the recommendations toward a psychiatric outcome and failure to understand the limitations of patients to perform exercise programs as well as many others.” 26
19) The NICE guidelines have received widespread condemnation. The recent NICE guidelines were NOT supported by the following registered U.K. M.E. charities: The M.E. Association, the 25%M.E. Group, Invest in M.E., and the Grace Charity for M.E. Also, the organisation BRAME did not support the guidelines outcome, despite the latter serving on the panel. There are many other M.E. groups who also condemn these guidelines. The NICE guidelines received so much criticism that NICE were taken to court by two M.E. sufferers in February 2009. Views from international researchers (e.g. Carruthers, Peterson, Lerner, Hooper and Drs involved with M.E. Research UK) regarding the potential negative effects of Graded Exercise Therapy and CBT, were not acknowledged in the Judge’s decision.
Also, the NICE guidelines group had no-one offering a biomedical aetiology (cause) of M.E: therefore, the disease M.E. was never properly addressed by NICE because researchers offering a biomedical cause were not allowed to serve on the guideline group.
‘’Most Independent M.E. charities and patient organisations have rejected the NICE guidelines...” 27
20) The PACE trials results in February 2011, promoting CBT, Graded Exercise Therapy and APT (Adaptive Pacing Therapy, a form of Graded Exercise) have also received widespread condemnation from M.E. patient groups and medical researchers. 28
21) The International Consensus Primer for Medical Practitioners 2012, states that PENE is a required symptom for a diagnosis of M.E. (Post-Exertional Neuroimmune Exhaustion).
‘PENE is characterised by a pathological low threshold of physical and mental fatigability, exhaustion, pain and an abnormal exacerbation of symptoms in response to exertion. It is followed by a prolonged recovery period. Fatigue and pain are part of the body’s global protection response and are indispensable bioalarms that alert patients to modify their activities in order to prevent further damage.’
The authors of the panel consist of twelve countries. 29
1 See the case of St.George’s Healthcare NHS Trust v S (1998) 3 All ER 673 (Court of Appeal), p.758 of Hepple, Howarth and Matthews Tort, Cases and Materials, 5th Edition by DR Howarth and JA O’Sullivan, ISBN 0 406 063265 (Butterworths, 2000)
2 Quote from Kathleen Jackson-Heppell, Communications Co-ordinator (Enquiry Handling and Internal Communications for NICE), in an email to the Grace Charity for M.E. dated 15/02/2011
3 Quote from Natalie Whelan, Communications Executive (Enquiry Handling) for NICE, in a letter to the Grace Charity for M.E. dated 23rd September 2009.
5 See above publication in endnote 1 (Hepple, Howarth and Matthews Tort) regarding section attributed to Lord Brandon of Oakbrook, pp.744, 745
6 The Human Rights Act 1998, European Convention for the Protection of Human Rights and Fundamental Freedoms, Section 1, Article 10, no.1
7 U.K. law on state benefits, Regulation 18 Social Security (Incapacity For Work) Regulations. A similar law applies to other state benefits for sickness and disability.
8 World Health Organisation - International Classification of Diseases 10-G93.3
9 What is ME? What is CFS? Information For Clinicians and Lawyers, Dec. 2001, Marshall, Williams, Hooper, page 11. Available from Prof. Malcolm Hooper, Dept.of Life Sciences, University of Sunderland SR2 7EE. Also, see www.meactionuk.org.uk
10 See the paper ‘Illustrations of Clinical Observations and International Research Findings from 1955 – 2005 that demonstrate the organic aetiology of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome’ by Hooper, Marshall, Williams, 2005, page 6. See also www.meactionuk.org.uk
11 See report from BBC NEWS HEALTH, October 8 2010, ME patients face UK ban on donating blood by Michelle Roberts. www.bbc.co.uk/news/health
12 Leaflet A Physician’s Guide to Myalgic Encephalomyelitis Chronic Fatigue Syndrome, The Nightingale Research Foundation, Vol.1, Issue 7, revised, 1992, page 17. Also, Journal of Chronic Fatigue Syndrome Vol . II, No.1, 2003, Canadian Criteria, page 25, The Haworth Press Inc.
13 Ibid., A Physician’s Guide to Myalgic Encephalomyelitis Chronic Fatigue Syndrome, page 25
14 Clinical Observations of Central Nervous System Dysfunction in Post-Infectious, Acute Onset M.E/CFS, page 38, The Clinical and Scientific Basis of Myalgic Encephalomyelitis Chronic Fatigue Syndrome 1992, Byron Marshall Hyde, M.D., The Nightingale Research Foundation.
15 Report from the National Task Force on Chronic Fatigue Syndrome, Westcare, Bristol 1994. This states nine definitions: the recent Canadian definition in 2003 makes ten; the Reeves definition (2005) makes eleven and the International Consensus Primer (2012) makes twelve.
16 Katon & Russo, 1992; Freiberg, 1999, Unhelpful Counsel? MERGE’s response to the CMO report on CFS/ME, 2002, p15.
17 See the website of the Medical Research Council at www.mrc.ac.uk
18 ME and/or CFS paper, September 2001, page 1, V.A. Spence PhD, Chairman of MERGE (ME Research Group for Education and Support). MERGE has become MERUK since this publication (ME Research UK.) This paper quotes from several published findings. Available from MERUK, The Gateway, North Methven Street, Perth PH1 5PP. Also, see www.meresearch.org.uk
19 The Biology of the Chronic Fatigue Syndrome, Prof. Anthony Komaroff, The American Journal of Medicine 2000: 108: 99-105.
20 Mitochrondrial abnormalities in the postviral fatigue syndrome, Behan, W.M.H. et al., Acta Neuropathologica 83, 1991, pages 61-65.
21 The Negative Effects of Exercise on an M.E./CFS Dysfunctional Brain, page vii, The Clinical and Scientific Basis of Myalgic Encephalomyelitis Chronic Fatigue Syndrome 1992, Byron Marshall Hyde, M.D., The Nightingale Research Foundation.
22 Journal of Chronic Fatigue Syndrome Vol. 11, No.1, 2003, Canadian Criteria, page 22, The Haworth Press Inc.
23 Oxidative stress levels are raised in Chronic Fatigue Syndrome and are associated with clinical symptoms, Kennedy, Spence, Belch, Free Radical Biology & Medicine 2005:39:584-589
24 Directly from the Horses’ Mouths, Doris M. Jones MSc, Reference Group Member, CMO’s Working Group. This survey was part of the Working Group on ME/CFS set up by the Chief Medical Officer Sir Kenneth Calman in 1998.
Much maligned and misunderstood, ME gets a radical makeover in this exclusive editorial for nhsManagers.network. But is this pathway really so radical? Perhaps only if you are a healthcare professional!
Based on the premise that if an illness is defined by the fact that exercise makes it worse, maybe that should be a starting point for dealing with it!
Immediate diagnosis by careful initial interview: If patient reports an extraordinary level of debility following a viral illness, which has persisted – has other symptoms which seem random and variable but can be understood as problems of muscle metabolism, cognitive function (short-term memory problems, difficulty in following lines of reasoning), endocrine function (disturbances of appetite, sleep rhythms, temperature regulation) and immune system activity (sore lymph glands, persistent low fever, sore throats), this whole constellation points to ME/CFS.
This should be regarded as a medical emergency, because the patient’s behaviour in the early stages determines either a path towards recovery or a path towards extreme and long lasting states of incapacity. (1)
The basic prescription should be to go home and go to bed; just doing the minimum exercise necessary to prevent DVT (getting up to go to the loo might be enough!). Families need an explanation that for the patient, minimising muscular exertion is essential. A home visit from a Physiotherapy/OT team can provide advice about how to do everyday tasks using a minimum of muscular exertion, like the advice given to MS sufferers for the management of their exhaustion. The OT should assess the home and recommend/ provide aids as appropriate for any physical illness which causes extreme weakness. The patient will need psychological support to accept that the (unwelcome!) adoption of a ‘disabled’ lifestyle is the way to ‘fight’ this illness and facilitate a gradual return to as normal a life as possible. After that, a regular visit from a key worker backed up by online support may be all the patient needs while he is conserving energy towards getting better.
What should absolutely not happen is a referral to hospital, unless to provide a period of complete bed rest. Tests to eliminate other potential diagnoses should be done at home as far as possible. The expensive centres which have been set up, requiring patients to attend in order to engage in extra exertion (just getting to a hospital appointment is enough to wipe out an ME/CFS patient for days) should be replaced by these less expensive domiciliary services. Apart from encouragement to keep on resting, and encouragement to family members to appreciate that this is needed, the patient should be left alone, allowed plenty of time to get better. Under this regime, gradual improvement is to be expected (school-age children should be provided with home education until a gradual return to school becomes a possibility).
When the patient is ready, there should be interventions at the patient’s educational institution/place of work aimed at eliminating all avoidable exertion. Along with facilities for rest breaks and perhaps being able to do some work from home, this gives the patient the best chance of returning to their education, job, or professional activities. Which, contrary to the ‘false illness beliefs’ of some psychiatrists, is what patients are desperate to do. It needs to be respected that this illness is not one of motivation: ‘I can’t’ does not mean ‘I don’t want to’, it means that there is a physical limit to what the patient can do without serious subsequent repercussions.
Doctors brave enough to use this ‘light touch’ approach would be rewarded by positive relations with their patients, and the prospect of seeing them getting better instead of getting worse. But it would take real courage to challenge the cultural myths that ‘fighting’ illness is the only way to go, that exercise is good for absolutely everything, and that people who have ME/CFS don’t want to get better, and must be persuaded or coerced into activity. Counter-intuitively, treating ME/CFS patients like invalids initially is the process most likely to maximise ‘return to function’.
The current psychiatric model has no way of acknowledging treatment failure – failure can always be blamed on the patient. No wonder there is so much hostility. It is time to step across the divide, accept that patients are telling the truth, and start giving them a chance to get better.
Nancy Blake is author of ‘A Beginner’s Guide to CFS/ME’, and co-author, with Les Simpson, Ph.D. of ‘Ramsay’s Disease – ME’. She is currently undertaking a Ph.D. project at Lancaster University on the conflicting paradigms of ME/CFS
1. www.name-us. Melvin Ramsay. name-us.org. [Online] [Cited: 3 October 2013.] “The degree of physical incapacity varies greatly, but the dominant clinical feature of profound fatigue is directly related to the length of time the patient persists in physical effort after its onset; put in another way, those patients who are given a period of enforced rest from the onset have the best prognosis.”
“…in those patients whose dynamic or conscientious temperament urge them to continue effort despite profound malaise or in those who, on the false assumption of ‘neurosis’, have been exhorted to ‘snap out of it’ and ‘ take plenty of exercise’ the condition finally results in a state of constant exhaustion.”
Dr Jayne Donegan’s career was almost ruined when she did her own research into vaccinations and discovered that doctors are being misled by the government about their safety and effectiveness
Anti-vaccine groups are variously dismissed as hysterics, conspiracy theorists and antisocial alarmists—but what happens when a doctor starts out as pro-vaccine, reads the evidence for herself and decides that the MMR and other vaccinations for our children probably do more harm than good?
Dr Jayne Donegan is a GP who believes her profession is being deliberately misled by the UK’s Department of Health (DoH) which, in its ‘Green Book’ on vaccinations issued to all doctors, is deliberately massaging the data to make vaccines seem more effective and safe than they actually are.
For her troubles, Dr Donegan was charged by her own governing body, the General Medical Council (GMC), of serious professional misconduct and of bringing the profession into disrepute. The hearing, which ran over three weeks in 2007, was the result of the GMC charging her directly although, in the vast majority of cases, it acts only after receiving complaints from the public.
Remarkably, the GMC panel found her not guilty and agreed in their findings that she had been objective, independent and unbiased in her research and conclusions—which, by implication, suggests that the UK’s leading medical authority happens to agree that vaccines are not as safe or effective as government agencies state.
To find out the truth about vaccinations, Dr Donegan spent many days at the Office for National Statistics (ONS) studying health records going all the way back to 1837. There she discovered something that shook her world: deaths from whooping cough had fallen dramatically from the mid-1850s onwards and death rates had dropped by 99 per cent before the pertussis (whooping cough) vaccine was partially introduced in the 1950s.
And yet the graph in the DoH’s Green Book only showed data from 1940 and so suggested that the vaccine had a more dramatic effect than it really had.
She found the same thing with measles. Again, the Green Book graph starts in 1940 and appears to show an enormous drop in cases from 1968, when the vaccine was introduced. But when Dr Donegan took the data back to the early 1900s, she uncovered a similar picture to pertussis: there had been around a 99 per cent drop off in death rates in the 60 years before the vaccine was brought out. “There was a virtual 100 per cent decline in deaths from measles between 1905 and 1965—three years before the measles vaccine was introduced in the UK,” she says.
Public sanitation, personal hygiene and better nutrition had played a far more significant role in controlling childhood diseases—making them benign rather than killers—than vaccines ever did.
Dr Donegan’s journey from vaccine believer to vaccine sceptic was a courageous one because she had so much to lose. After qualifying as a doctor in 1983, she had been very pro-vaccination and had urged worried parents to vaccinate their children. “I used to think that parents who didn’t want to vaccinate their children were either ignorant or sociopathic. I believe that view is not uncommon among doctors today,” she says. When her own two children were born—in 1991 and 1993—she had them vaccinated, even though one had suffered worrying reactions to the BCG (bacillus Calmette–Guérin) tuberculosis jab.
Then in 1994 the government launched a major measles vaccination drive after an epidemic had been forecast; only years later was it revealed that the forecast had been based on a faulty mathematical model. Even children who had already been vaccinated were to have a second dose, the DoH announced, as one dose might not provide maximum protection. Dr Donegan accepted this, but she was concerned by a further announcement that even children who had received two doses before should still have a third shot.
This started raising alarm bells especially as the vaccine had been heralded as a ‘one-shot’ jab that on its own would provide life-long immunity. The second worry was the need to vaccinate tiny babies to achieve herd immunity and “break the chain of transmission”, as the DoH described it. Dr Donegan wondered why they couldn’t just vaccinate children aged three or so and so break the chain among those whose immune systems might at least be strong enough to withstand any adverse reactions to the jab.
“Some things just didn’t seem to quite add up,” Dr Donegan recalls, “but it’s very hard to start seriously questioning whether or not vaccination is anything other than safe and effective, especially when it is something that you have been taught to believe in so strongly.
The more medically qualified you are, the more difficult it is, as in some ways the more brainwashed you are.”
She started to read anti-vaccination books, but the evidence in them was so contrary to what she had been taught that she decided to do her own research.
That research, which included her visits to the ONS, culminated in the research paper ‘Vaccinatable Diseases and Their Vaccines’. The report includes data from the mid-1850s that she gleaned from the ONS, and a review of the small number of studies into vaccine safety and effectiveness.
Astonishingly, there haven’t been any “clear, open, objective and well-designed studies on vaccination safety”, she states in the report’s introduction. And the studies that have been done invariably conclude that vaccines are safe—even though the data don’t support such a conclusion.
Dr Donegan antidoted all the vaccines given to her children with homeopathic nosodes—she had qualified as a homeopath in 1990—and she also appeared as an expert witness in a high-profile vaccine case where a mother was refusing to have her child vaccinated even though it was against the wishes of her estranged husband.
Because she had spoken out against vaccines in a court case, the GMC decided to take action against her. The GMC expert witness was Dr David Elliman, consultant in community child health at Great Ormond Street Hospital, who spent four months reviewing the evidence Dr Donegan had given in the case before he attended the GMC hearing.
Under cross-examination, Dr Elliman admitted that, as Dr Donegan had stated, there had been no proper randomized, placebo-controlled trials into any childhood vaccines in the past 30 years, and his 62 criticisms of her evidence were reduced to just two.
Despite this significant victory, the media failed to report on the result—although it had written up the first day of the hearing with headlines such as “GP accused of misleading court over MMR danger”.
Afterwards she reflected: “If a parent says ‘I’m worried about the safety of the vaccination’, they are told ‘You don’t understand, you’re not a doctor’. But if a doctor says the same thing, he or she is charged with serious professional misconduct.”
Dr Donegan is speaking on vaccinations at the College of Naturopathic Medicine, 41 Riding House Street, London W1, on November 11, starting at 6.30 pm. The talk is entitled ‘Vaccination—The Question’. The entrance fee is £10. To purchase tickets or find out more, telephone 01342 410 505 or book online at www.naturopathy-uk.com
Donegan on the DPT (diphtheria–pertussis–tetanus) jab
Diphtheria: The likelihood of contracting diphtheria in the UK is so low that I do not think any benefit is to be gained by vaccinating against it, and any detrimental effects are therefore unacceptable.
Pertussis (whooping cough): Children develop natural immunity against whooping cough from breast milk, but parents who want their child vaccinated should choose the acellular vaccine. It is currently not available without the mercury additive thiomersal (thimerosal in the US), and the whole-cell version has such a high incidence of side-effects that I think it should never be used.
Tetanus: Wounds should be cleaned immediately, and 3 per cent hydrogen peroxide is an excellent cleanser. As the tetanus vaccine is available only with thiomersal, aluminium hydroxide and formaldehyde, it is safer to build up a child’s immune system and clean any wounds carefully.
Donegan on the MMR (measles–mumps–rubella) jab
Measles: This is a benign childhood illness in the child with a strong immune system. In the Steiner alternative school community, during a measles outbreak not one severe case was reported. There is plenty of evidence about adverse reactions to the vaccine that should convince parents not to have it. Don’t give in to the fear about measles generated by doctors and governments.
Mumps: This is generally a mild illness. I do not recommend mumps vaccination, as any benefit is minimal and any side-effects unacceptable.
Rubella (German measles): The effects of rubella are minor and the vaccination cannot be recommended. And the vaccine doesn’t seem to work very well, as it often fails to protect the unborn child of women who are not immune.
When Invest in ME announced in June that we were planning a UK trial of rituximab for ME there was a great deal of interest raised.
The rituximab trial follows the exciting work which has been, and is being performed in Norway by the Haukeland University hospital researchers Professor Olav Mella and Dr Oystein Fluge.
Since these excellent Norwegian researchers came to present at the Invest in ME conferences in 2011 we have followed their progress, and invited them back every year for our BRMEC researchers meetings and IIMEC conferences.
The research work has been backed up by impressive and dedicated patient advocacy by the Norwegian ME Forening which has raised the profile of ME in Norway and throughout the world. Their tireless work has encouraged IiME. The more recent success of the ME and You campaign to raise funds for the Norwegian research has created real hope amongst patients.
At the IIMEC7 conference IiME announced our intention to work toward establishing a clinical trial of rituximab in UK (click here).
In updates published through July and August IiME has stated that all that is required for the trial to proceed is the funding. In the spirit of cooperation we have stated that support for the trial was welcome and that IiME would acknowledge all such support.
Our supporters have risen to the occasion and valiantly supported the IiME/UCL trial with wonderful enthusiasm. The imaginative Let’s Do It For ME campaign has continued to produce ideas to raise funds and awareness and The MATRIX is an example of a unique method of achieving both.
We have had donations from around the world, ranging from £1 to £3,000. We have had a very generous donation of £25,000 from a foundation and this has allowed the funds raised to grow to £59,000 in a very short space of time. We have also had fantastic moral support from a great many.
As such, IiME and our supporters have managed to initiate and organise something which many thought was not possible.
IiME made it clear from the beginning that we welcomed support for the IiME/UCL clinical trial from other organisations. Our objective is to ensure that a clinical trial of rituximab is allowed to be performed by the best researchers possible and to ensure that this trial makes a valuable contribution to the collective research pool. This is why we have been keen from the beginning, and since our inception as a charity, to initiate collaboration with other like-minded international charities and organisations, and build collaborations between ME researchers across continents.
We believe in achieving results by the most direct method, where possible. For IiME the issue of making rapid progress in ME research is important, it is personal. The need is here - the need is now.
We arranged a specific web site which has been set up to inform on all aspects of the UK rituximab trial. This is at -
We have the means of fundraising for this trial available (see The MATRIX) and we have a campaign to raise funds
We have emphasised that the only remaining element required was funding
We have reached this position thanks to the vision, efforts and help from Professor Edwards, Dr Cambridge, UCL and our supporters.
Thanks to the amazing efforts of our supporters we have been able to agree already to initiate a preliminary study on B-cells at UCL.
Professor Edwards will shortly visit Bergen – a trip arranged by IiME as part of our collaborative attempts to unite researchers and build on experience.
We can now announce that IiME have been given a pledge of £200,000 from a foundation to supplement the amount we have raised already.
This would bring our rituximab fund to almost £260,000 – that is over two-thirds of the requirement for the clinical trial to proceed.
The foundation has two conditions to this pledge
That IiME continue to be the lead patient organisation steering this trial
That IiME continue to raise funds for the remaining £90,000 that is required for the full trial to proceed
The trustees of IiME have accepted these conditions willingly.
We are thankful and grateful for this extraordinarily generous offer from the donating foundation. It is an amazing gesture from compassionate and caring people who want to make a difference. It allows the hopes of many patients to become a reality – allows a vision to be maintained that there is a future for ME patients and that we, patients and families, can make a difference.
We have communicated this to the UCL team with whom we are working to make this trial a reality.
We are now distributing this information to our supporters.
There were many who doubted that IiME and our supporters could achieve this. Though we knew this would be a daunting task we have never doubted it was possible.
We continue our efforts to raise the remaining funds.
To our supporters who have been with us since the beginning and everyone who has contributed in so many ways to this trial we want you to know this is your result. It is what you have achieved. It is what we have achieved together.
We thank all those who are supporting this trial and we will continue to provide information on the status of the trial as we progress.
We continue to welcome support. Please contact IiME directly if you or your organisation would like to assist or contribute.
If anyone would like to ask any questions about the UK rituximab trial then please use the Contact form on the rituximab web site.
On 16 September 2013 Bristol University issued a press release (click here) which announced a grant of £1.2 million for Chronic Fatigue Syndrome research.
The grant to two researchers included one to Dr Esther Crawley - for research that seems to be effectively performing a PACE trial on children.
“The five-year study entitled ‘Investigating the treatment of paediatric chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME) has been awarded NIHR funding of over £864,000.”
“Dr Simon Collin, Research Fellow also in the School of Social and Community Medicine, will lead the first study of its kind to investigate CFS/ME in primary and secondary care in England. He will use data from the Clinical Practice Research Datalink (CPRD) to obtain an up-to-date estimate of the number of adults diagnosed with CFS/ME by GPs in England. Dr Collin will collect data from NHS specialist services for adults with CFS/ME, document the different approaches to treatment and investigate long-term outcomes.”
“The three-year study entitled ‘CFS in the NHS: diagnosis of Chronic Fatigue Syndrome in primary care and outcomes after treatment by specialist services’ has been awarded NIHR funding of £321,861.”
After the IIMEC8 conference and the Biomedical Research into ME Collaborative research meeting in London in May there was a real sense of ME entering into mainstream research with new interest from new researchers and focus on collaboration.
To hear of this massive amount of funding to one area, graded exercise - this time on children - is disappointing to say the least and indicates that nothing has been learned from the flawed and non-productive debacle of the PACE trial.
Bristol University still uses the prevalence figures of 600 000 in the press release - an issue that was debated at the MRC/SMC collaborative grouping, of which Dr Crawley is vice chairman. The minutes of that group from 19 July 2013 state that “Charities have met to discuss the information in future press releases re prevalence. This is still being progressed." (click here)
There seems to be no shortage of public funding for GET related studies despite £5 million being spent on the PACE trial which showed no objective improvements in patient outcomes and is clouded in controversy about methods used and claims being made (see PACE Trial Observations).
By now it ought to be self-evident that children should not be coerced into graded exercise when they are ill and unable to attend school. This approach can lead to a great deal of harm - not just for the child but for the whole family.
Even though Invest in ME is not a children’s charity we are contacted by families in distress due to pressures being put on their children to attend school or to perform activities beyond their capabilities due to the effects of ME.
This often leads to very difficult family situations and instead of listening to and believing the child parents are wrongly led to believe that they are doing the right thing by following a set programme. By the time families realise this is the wrong approach it may be too late and the child’s condition has deteriorated and the families may even break up as a result.
Epidemiological studies are welcomed but one has to be careful as GPs are known to be very poor at diagnosing ME patients. Any data coming out of Dr Collin’s research is likely not going to be accurate without considerable effort being put into trying to find out how patients were diagnosed.
In fact, Dr Clare Gerada, chair of RCGPs, stated at the IiMEC8 conference in June 2013 that GPs know very little about ME.
The adult services in the UK can only offer CBT and/or GET as set out in NICE so Dr Collin's research to document different approaches to treatment is likely to be a simple task. Long term outcomes might be difficult to determine as patients are usually seen by the specialist clinics only for a certain number of times before being sent back to their GPs.
These awards indicate that the understanding of this disease is still poor in those establishment organisations which control funding.
It is a wonder to patients how key funding agencies can get it so wrong.
It seems that in reality there is no shortage of funds available for studies which fit government policy. And this shames those who issue statements talking of funding being available for high-quality studies.
It would indeed be a sad indictment of the society that we ourselves subsidise if what matters is who one knows rather than what one does when it comes to research funding granted for ME - and the devil take the consequences.
Funding more GET-related research into ME, is a fatuous approach. It is monstrously wasteful to throw funding at poor science, based on false views of this disease.
So what of the real research required - the right stuff?
Funding is scarce and the efforts of our supporters to make up what has been lacking from government agencies and research funding organisations have been awe-inspiring.
Patients have worked tirelessly and imaginatively to raise funds for the research proposed by IiME. Currently Invest in ME and our supporters are actually initiating, organising and funding possibly the two most important ME research studies currently in the UK - the gut microbiome project at UEA and the IiME/UCL rituximab clinical trial.
As mentioned in our article which was published at the beginning of April (A Tale of Two Collaboratives) research into ME needs a strategic approach - but it may be destined to fail completely by attempting to establish the way forward on foundations which include so much of what has been wrong in the past.
We have written in the past that we feel it is impossible to marry the views of those who believe in the deconditioning/behavioural and wrong illness belief model of ME with those from the biomedical side. The failed PACE Trial has demonstrably proven that the behavioural view of ME cannot deliver and should not continue to command more funding.
There is another way - perhaps a better way forward for ME research - a clear case to be made for segregating the biomedical from the psychosocial here and now. This could then force a separation of fatigue research from ME research.
A strategy of biomedical research into ME with a biomedical research collaborative into ME being formed consisting of biomedical researchers, using resources and facilities across continents - hooked up to share research and data and crowd fund new research?
Such is the meaning behind our Biomedical Research into ME Collaborative meetings (click here) which have been organised by Invest in ME in cooperation with the Alison Hunter Memorial Foundation. These aim to interest other biomedical researchers to the field of biomedical research into ME, assist those who are undertaking research or planning research into ME, and look for future collaborative projects and funding which could be generated by new ideas. We repeat them in 2014.
Future research into ME must be based on collaboration. But not collaboration at any cost. But it would seem quite meaningless to base the strategy on those failed policies and directions of the past - which have served patients so poorly and caused such suffering (Diane's story - Lili).
There is the wrong way and the right way to progress research into ME.
Cholesterol-lowering statin drugs are doing more harm than good, and should be abandoned as the primary therapy for heart disease prevention, a major review has concluded.
Instead, coenzyme Q10 antioxidants are more effective and with fewer—or no—side effects, say researchers at University College Hospital in Galway.
Statins dramatically increase the risk of diabetes and cataracts in younger patients, and cancer and neuro-degenerative diseases in the elderly. And the benefits don’t outweigh the risks, say the researchers. Even for patients with advanced heart disease, the drugs may extend life by a further nine months at best if the drug is taken for 30 years.
Analysing previous studies on statins, the researchers discovered that some had never been published because the results were so alarming, while others had obscured the real risks. One study, the Illuminate trial, was shelved after researchers discovered the statin drug increased the risk of cancer and sudden death. But it’s unlikely the researchers will be heard: the statin market is worth £20bn a year and rising.
(Source: Journal of Endocrine and Metabolic Diseases, 2013; 3: doi: 10.4236 / ojemd.2013.33025).
Another update on the UK Rituximab Trial - I imagine there may be many more in the coming weeks and months!
On 6th June Invest in ME announced that we were in discussions to set up a UK trial of rituximab for ME patients and since that announcement things have been progressing well. The charity had been working on trying to get such a trial started since the IIMEC7 conference - click here.
In updates published through June/July, we have stated that all that is required for the trial to proceed is the funding.
As such, IiME began fundraising for this trial and invited everyone to support us in this project.
Recently we arranged a specific web site which has been set up to inform on all aspects of the UK rituximab trial. This is at - www.ukrituximabtrial.org
and we reiterated the current status - (click here)
We have the facilities available.
We have the researchers available.
We have the best expertise possible available.
We have the means of fundraising for this trial available (see The MATRIX - click here) and we have a campaign to raise funds
As we have agreed with our advisor, Professor Jonathan Edwards, the proposed clinical trial will undergo a rigorous peer review process.
We have reached this position thanks to the vision, efforts and help from Professor Edwards, Dr Cambridge, UCL and our supporters.
We have emphasised from when we announced the trial that the only element required is funding.
IiME will continue organising and raising funds for this trial. The IiME BRF Rituximab fund is specifically ring-fenced in a separate account for the UK rituximab trial.
The first part of the trial will be a preliminary study which will be designed to confirm and extend the earlier work of Dr Amolak Bansal (click here) on B-cells but using a different cohort of ME patients.
Professor Edwards believes this is a useful study in its own right and a pre-requisite for the clinical trial. Meanwhile work is continuing on the design of a protocol which will be finalised after the trip to Bergen that IiME and Professor Edwards have arranged.
Good progress is being made and IiME are committed to expedite this trial as best we can. To achieve this IiME has recently been in discussions with a charitable foundation with a view to help in funding this work.
We are enormously pleased to announce that, thanks to the extraordinary generosity and support of the foundation's representative, our biomedical research fund for the UK rituximab trial has now reached £50,000. This is due to a donation from the charitable foundation which will match our existing BRF rituximab total of £25,000 - click here. The charitable foundation currently wishes to remain anonymous but they have asked us to keep them informed of the progress of plans for the trial and we are sure that the ME community will join us in thanking them for this wonderful support
This now means that the first part of this project can be initiated by the UCL team without delay.
We thank all those who are supporting this trial and we will continue to provide information on the status of the trial as we progress.
We now resolve to increase our efforts to raise the remaining funds for the trial and ask for your continued support in this project in the knowledge that it will benefit all people with ME and their families.
The fundraising for this trial is being organised and coordinated by IiME so please contact IiME directly if you or your organisation would like to assist or contribute.
If anyone would like to ask any questions about the UK rituximab trial then please use the Contact form on the rituximab web site (click here).
In summary we feel that the best research team possible to undertake this trial is now able to begin the work - taking a huge leap forward in ME research in the UK.
The charity Invest in ME has provided a truly remarkable opportunity to address one of the biggest medical scandals in history and to remove what in 2007 Alex Fergusson, Presiding Officer (Speaker) of the Scottish Parliament, referred to as “the cold grip of psychiatry” on myalgic encephalomyelitis (ME), which he said was “still far too deeply rooted in the world of ME”
Now, however, despite the power and control of the psychiatric lobby, thanks to Invest in ME and the invaluable support of Jonathan Edwards, Emeritus Professor of Connective Tissue Medicine at University College, London, (world-renowned for his work in B cell immunology and as lead researcher in the clinical trials of rituximab for rheumatoid arthritis), the neuro-immune disease ME is at last about to enter the realm of mainstream medicine in the UK under the guidance of Professor Edwards himself.
Invest in ME are at the forefront of international biomedical research and have by sheer determination and effort managed to put things in place for a trial of rituximab to begin on ME patients in the UK. They recognise the urgency of the situation and know that many ME patients do not have the luxury of time. The charity already has the facilities in place, including suitably experienced researchers (Professor Jo Cambridge is now principal researcher at UCL, and the ME trial will involve the same team working under her that carried out the rituximab research in RA).
The Clinical Trials Unit at UCL is already working on the protocol, and Invest in ME have agreed with Professor Edwards that the protocol will be externally reviewed even though the UCL team will make sure it is cast-iron by their own internal reviewers.
Invest in ME have been told this trial could start relatively quickly if the charity had funds available. Such an opportunity must not be lost. However, this will not happen without substantial funding.
We therefore ask everyone who is able to do so to donate whatever they can afford, in order that the UK rituximab trial can get under way as quickly as possible whilst the excellent facilities and committed staff at UCL and the active support of Professor Edwards remain available, so that ME can finally be recognised as the devastating multi-system neuro-immune disease that it is and – most importantly -- so that sufferers may at last have some hope of alleviation of their suffering.
Invest in ME have assured us that all donations to the rituximab fund will sit in a separate account which is totally ring-fenced, and should the trial not proceed, the following statement on the IiME website will be honoured –
What Happens With These Funds If The Project Does Not Go Ahead:
If the rituximab project does not go ahead for some reason then the funds raised will be transferred to the IiME Biomedical Research Fund to fund other biomedical research projects which are attached to our proposal for an examination and research facility based in Norwich Research park in Norfolk, UK. These funds will only be used for biomedical research into ME.
A UK trial of rituximab is essential to move ME out of the realm of psychiatric dogma and into the realm of medical reality.
In order to make it easier for ME patients, ME support Groups, charities, organisations, researchers and the media to find more easily and bookmark the central point for the UK Rituximab Trial, Invest in ME have set up a special micro-site to collate all of the relevant information - www.ukrituximabtrial.org
On a separate issue – but still ME related – the following is a new document that gives a detailed analysis of the “6 Minute Walking Test” which was used in the PACE Trial -
For further info about the PACE Trial, please see –
Magical Medicine: How to make a disease disappear (February 2010)
Background to, consideration of, and quotations from the Manuals for the Medical Research Council’s PACE Trial of behavioural interventions for Chronic Fatigue Syndrome / Myalgic Encephalomyelitis, together with evidence that such interventions are unlikely to be effective and may even be contraindicated
Professor Malcolm Hooper http://www.meactionuk.org.uk/magical-medicine.pdf (6 Mb)
Statements By Professor Jonathan Edwards and Invest in ME - July 2013
Professor Jo Edwards
My interest in ME/CFS was sparked when I was invited, unexpectedly, by IiME to the IiMEC8 Conference in May.
The meeting was impressive: not just professional science, but at a high level. I was particularly impressed that negative findings were given adequate weight.
It became clear to me that there was a community committed to identifying and encouraging the very best research in a difficult and neglected field.
I was aware of the study by Fluge and Mella, using rituximab. I had not been surprised to see some patients respond, but the type of response, which was similar to what we had found in rheumatoid arthritis fifteen years ago, caught my attention. In fact, the situation seemed very reminiscent of the time when we first started to get results with targeted therapy in rheumatoid arthritis. We had the benefit of more immunological clues then, but on the other hand, the experience we have gained over the last decade now makes things easier in other ways.
My limited understanding of ME/CFS is that, like arthritis, it is probably several diseases with similar symptoms. Most colleagues who specialise in ME/CFS seem to agree. What the Fluge/Mella study suggests is that perhaps half of those suffering from these symptoms may have a B cell-dependent autoimmune disease.
A recent study by Dr Amolak Bansal and colleagues also suggests that B cells may be functioning abnormally in a significant proportion of people with ME/CFS.
To me, a key feature of this approach, unlike chasing one particular virus or gene, is that, if confirmed, it will provide a broad base for understanding disease mechanisms.
Even if rituximab is a cumbersome treatment in the short term its use may not only help a good proportion of patients directly but also begin to show us how to divide ME/CFS into different groups. So it may be useful even for those whose disease does not respond because once separated out from B cell-dependent disease the role of other factors such as NK cell function or cerebral blood flow may become clear.
Looking at the research directions currently being pursued in ME/CFS, I am in no doubt that the usage of rituximab is one of the most promising. There is clearly enthusiasm for further trials. However, rituximab is not an easy drug to use and many doctors do not feel confident with using it. This may explain why studies have been slow to gain momentum outside Norway.
Safe and effective usage requires understanding of B cell life history and function. Each condition has to be considered differently, especially in terms of when treatment is repeated. But with experience its use is very effective and probably as safe as most drugs.
After the IiME Conference I began thinking about my personal experience of patients and friends with ME/CFS. I was sent a copy of ‘Lost Voices ‘ by IiME, which made me think more. It struck me that, whether or not results are positive, further trials of rituximab for ME/CFS should be encouraged not only because impact on life for those affected can be so severe but also because further trials could give clues to disease mechanism. I am retired and would not be personally involved but have suggested to IiME that I would be happy to advise and to encourage others to set up a trial.
My feeling is that a trial should be carried out somewhere with detailed experience in use of rituximab in autoimmune conditions.
The UCL service set up when we started treating rheumatoid arthritis, lupus and a range of other conditions has the most extensive experience.
There is laboratory expertise in B cell immunology under Dr Jo Cambridge.
UCL also has a new Clinical Trials Research Facility with staff appointed to manage trials of this sort.
Importantly, there is enthusiasm amongst local teams for a rituximab ME/CFS trial.
I have suggested to IiME that this would be the ideal centre for such a trial, to be set up in collaboration with clinicians with expertise in ME/CFS from around London, and in particular Dr Bansal.
IiME have accepted this and this is the planned and preferred research base for this trial.
Clinical trials are costly. The trial planned in Norway to confirm the results from Fluge and Mella’s initial trial will cost something like £1-2M pounds. I think it would be most sensible to set up a smaller scale trial initially in the UK with a focus on trying to identify which patients are most likely to benefit. A trial treating about 30 patients, giving useful scientific information should hopefully be feasible for around £3-400,000. Trial design will require careful thought and some further preliminary laboratory work is likely to be needed before it is clear what design would be optimal.
Nevertheless, I am optimistic that a trial could be set up without major delay if funds can be raised. If the role of B cells in at least some ME/CFS, suggested by Fluge and Mella’s study, can be confirmed I think there is a genuine chance of getting to grips with the mechanism of the disease.
From there on things can only get easier.
Statement from Invest in ME:
The statement above from Professor Edwards is an astonishing opportunity for those patients with ME and their families.
To have somebody of Professor Edwards' standing produce such a statement, after agreeing to advise the charity following the IIMEC8 conference, justifies completely the conference theme of Mainstreaming ME Research.
This is a potential breakthrough for state-of-the-art biomedical research into ME.
We believe this study would add great value to other similar research being performed elsewhere.
It would also put the UK into the forefront of ME research.
There is no greater expert able to advise on a trial of rituximab than Professor Edwards who formally established the validity of B cell depletion in autoimmune disorders via his groundbreaking rituximab trials.
At the Biomedical Research into ME Collaborative meeting (BRMEC) organised by Invest in ME and the Alison Hunter Memorial Foundation Dr Jo Cambridge from UCL was invited by the charity to attend and present to the 40 researchers from nine countries gathered in London for the meeting. We felt it important to get the best advice possible to help with this area of ME research. Dr Cambridge added an enormous amount to the meeting – followed by a sincere and positive approach to progressing research.
UCL, as Professor Edwards has explained, has first-class facilities and we believe this opportunity is unique in the UK.
If the UK patient community wish to have a rituximab study then this is as good as it gets.
With the clinical team and Dr Cambridge at UCL performing this work, and with Professor Edwards as advisor, we are sure that a huge leap in understanding ME will be possible.
IiME have managed to work with the experts to set up this possibility. As Professor Edwards states “a trial could be set up without major delay if funds can be raised”.
Our fundraising campaign now must begin in earnest.
We invite everyone to get behind this UK rituximab study and support us.
We welcome contributions from other organisations and companies and individuals. The quality of the researchers and the facilities is beyond doubt.
IiME will contact other organisations to invite them to donate to this cause. One organisation has already indicated it will support a rituximab trial – in fact the MEA chairman has publicly stated on 29th July to an IiME supporter - “Let us know when you find some good quality researchers with a peer reviewed proposal. We have £60,000 in a ring fenced pot awaiting such a development.”.
We now have the researchers willing to perform this trial in the UK.
The quality of the researchers and the facilities at their disposal place the capability of the UCL team to perform this trial beyond doubt.
There is enthusiasm for setting up a study at UCL.
UCL can take this forward in collaboration with Dr Bansal and with close liaison, including visits, with Bergen. This has been agreed.
A meeting has been arranged for Professor Edwards to visit Bergen to discuss with Dr Fluge.
Further trips by the UCL team would be a possibility and will be arranged by the charity.
We welcome this as this will undoubtedly help both the Norwegian and the UK studies.
We need to raise funding for this study so we urge all our supporters, and others who wish to have a UK rituximab trial or wish to advance biomedical research into ME, to raise awareness and interest from as many sources as possible and support us in this venture.
This UK rituximab study has been initiated by IiME and the UCL staff who were at our conference and BRMEC research meeting.
The best research team possible to undertake this trial is able to perform this.
8th August - Severe Myalgic Encephalomyelitis Understanding and Remembrance Day
'I am a ghost in the land of the living – forgotten, ignored and drifting on the edges of life, whispering my message in the ears of the lucky ones who can participate in life. I have Myalgic Encephalomyelitis. I call it paralysis, muscle and cardiac failure, brain injury, a living plague that kills only slowly, but does kill...
Aylwin (Jennifer) Catchpole, who died in August 2010
Why have an awareness day just for the severely affected?
The severity of this illness often makes it impossible for people to have contact with loved ones, doctors, or the outside world. This is a group of thousands of people in the UK who are generally invisible. People with the severe forms of this disease can no longer pursue their careers, hobbies, or everyday lives.
In helping us to make visible the stories of people living with severe M.E., and of those who have died as a result of the illness, you can help end years of misrepresentation about M.E. and increase the understanding of the general public, who often underestimate the seriousness of the disease. This ignorance causes much suffering to those with M.E., who have a double battle, not only with the disease itself, but also to get the illness taken seriously by those around them. There is an urgent need to raise awareness.
What's the significance of 8th August?
This is the birth date of Sophia Mirza. Sophia was bed-bound with severe Myalgic Encephalomyelitis and was a victim of medical abuse. Her doctors did not believe that Myalgic Encephalomyelitis was a physical disease and so she was forcibly taken from her bed/home by social workers, police officers and doctors, and kept in a psychiatric facility where she received inappropriate treatment and care. Sophia subsequently died of M.E. at the age of 32. Her post-mortem revealed widespread inflammation in the spinal cord. This same inexcusable abuse still goes on.
Emily Collingridge - 17th April 1981 - 18th March 2012
“When our daughter, Emily, died in 2012, my husband and I were overwhelmed by the hundreds of messages of sympathy we received, even from people we did not know. They came from friends, from those expressing gratitude for her endless campaigning to spread awareness of ME and from readers of her guide to living with severe M.E., many of whom said it had changed their lives.”
The inquest into Emily’s death took place on 24th May 2013. In her summary the Coroner referred to ME as a condition which is not understood, and expressed the need for more research. She was echoing an appeal made by Emily in 2011 highlighting what she described as “the scandalous lack of research into the most severe form of M.E. and the lack of appropriate support for those suffering from it.”
A final plea in Emily’s own words.
“Please put an end to the abandonment of people with severe ME and give us all real reason to hope”. Emily may have lost her personal battle, but her battle on behalf of all those still suffering from severe ME should not be ignored.
What is Myalgic Encephalomyelitis?
Myalgic Encephalomyelitis literally means muscle pain (myalgia) with brain and spinal cord inflammation (encephalomyelitis). It is a complex neurological illness. The most characteristic feature is that symptoms are exacerbated by activity and sensory stimuli beyond the patient's limitations. Activities that trigger flare-ups can be tiny by healthy standards, depending on the severity of the illness. Simple things like talking, watching a TV programme, or eating a meal, can cause an exacerbation.
Dysfunction has been found in all the major systems - neurological, immune, endocrine, cardiovascular, musculoskeletal, gastrointestinal, respiratory, and genito-urinary, which is why people with Myalgic Encephalomyelitis can have such a wide range of symptoms. Common symptoms include widespread pain, cognitive dysfunctions (e.g. problems with concentration and memory), disabling sensitivities to everyday stimuli (such as light and noise), difficulty being upright (including sitting up in bed), sleep disorders and gastrointestinal problems.
The parents of those mentioned in this Press Release are happy to be contacted by members of the Media. This can be arranged through contacting the 25% ME Group, (the national support group for severely affected ME Sufferers). Contact details below.
GOD’S SPECIAL TENT: The Story of the Tabernacle and What Came After. Jean Stapleton. Christian Focus Publications, 52 pages, paperback, £5.99.
This A4 size book, as the subtitle suggests, seeks to open up for young people the mysteries of the tabernacle. The book begins with the Old Testament people of God at the foot of Mount Sinai, reviewing their history from the Exodus to that point, before moving on to the LORD’s giving of the 10 Commandments and His directions for worship. This smoothly leads into the main subject of the tabernacle.
Mrs. Stapleton then covers aspects such as dimensions, furnishings, sacrifices, as well as priests and Levites, and the High Priest’s office. The latter part of the book goes on to speak of the building of Solomon’s temple, it’s destruction at the Exile and the subsequent rebuilding and extension, ending with the final destruction in AD 70. Very helpfully, this all leads to the author speaking about the true temple – made up of living stones – the church.
This book would be most useful in the context of church work – for children’s work or children’s talks in services; it could also be profitably used by Christian parents, as well, of course, by children themselves, who would have edifying fun constructing the card model of the tabernacle included in this book as they learn biblical truths from “God’s Special Tent”.
There are two Christian conferences coming up in July that I would recommend – dates and speakers given below. I believe that the Met Tab will be showing the Wednesday evening sessions by Dr Masters live online; Tabernacle Cardiff aim to broadcast all sessions live. Both will have the talks available to download or purchase on disks afterwards.
“Recovery From Spiritual Decline – Proving the Methods of Scripture”
2 – 4 July 2013
Speakers – Ibrahim Ag Mohamed (London), Roger Brazier (Edmonton), Roland Burrows (Cradley Heath), Chris Buss (Battersea), Richard Clarke (Plymouth), Chris Hand (Crich), Dewi Higham (Cardiff), Peter Masters (London), Jonathan Northern (Baldock), Jack Seaton (Inverness) John Thackway (Holywell), Ted Williams, James Zenker (Blackheath)
A report on the 8th Invest in ME International Conference 2013, “Infection, Immunity and Myalgic Encephalomyelitis – Mainstreaming ME Research, Clinical and Research Updates”, written by Dr Ros Vallings, who is medical adviser to the Associated New Zealand ME Society (ANZMES) and secretary of the IACFS/ME, can now be found on the IiME website at -
At the recent Invest in ME (IiME) conference, the Norwegian ME Association presented Professor Malcolm Hooper with a prize, consisting of a framed citation and beautiful hand-made glass vase in recognition of his "untiring and exceptional contribution to the ME cause".
The award states -
Professor Malcolm Hooper has stood on the barricades for years and fought for ME from many angles. He is described as a real "warrior", which is very true. It is noteworthy that he is fighting for a disease with which he has no personal involvement.
He has written informative documents, published articles in international journals and fought politically. He gives lectures and has often spoken out against opponents such as Professor Simon Wessely, and other key individuals and institutions in the psychosocial environment. In addition, he has been an active part of the work of Invest in ME, has chaired their conferences several times, and has been their professional supporter.
The Norwegian ME Association has, on many occasions, approached him for advice in specific situations, and has benefited from the advice he has given in our struggle for recognition in Norway.
On behalf of the Norwegian ME Association it gives me great pleasure to present this ME Award to Professor Malcolm Hooper for his untiring and exceptional contribution to the ME cause.
STATEMENT FROM THE 25% ME GROUP REGARDING THE CFS/ME RESEARCH COLLABORATIVE CHARTER (CMRC)
The 25% ME Group is the only UK charity representing those who are severely affected with Myalgic Encephalomyelitis, a World Health Organization ( ICD10.9.3) classified disease, recognised by the UK Government as neurological. We subscribe to the use of the International Consensus Criteria (ICC) to clearly identify and separate ME from CFS, in order to ensure that ME is respected, treated and researched as a serious neurological disease impacting upon multiple systems of the body.
Therefore we cannot support nor validate the recently created CFS/ME Research Collaborative charter (CMRC) since, in our opinion it is an unacceptable waste of precious research funds, accommodating a range of research across a wide and vague criteria range not specific to ME. The CMRC, in our opinion, is more likely to prolong the current state of confusion rather than bring about much needed medical research or clarity.
Under the umbrella term “CFS/ME”, so often used to mean Chronic Fatigue (CF), leading to the mistreatment of people with ME; the CMRC does not and cannot represent or safeguard the needs of people with Severe ME.
It is wholly unacceptable for people with chronic fatigue and mental health issues to be included in research for Myalgic Encephalomyelitis and for people with Myalgic Encephalomyelitis to be used for CF research.
Without the separation of ME from CFS and particularly Chronic Fatigue, the 25% ME Group fears there will continue to be misdiagnosis, misrepresentation and negation of Myalgic Encephalomyelitis alongside the inappropriate perpetuation of psychological therapies charading as treatment, that, as our research has shown, does great harm to our members.
The 25% ME Group supports the need for medical research, using specific criteria to safely identify Myalgic Encephalomyelitis, so that ME can be studied and identified accurately in research; this will not come about through, non ICC-based research into vague “CFS/ME”.
For these reasons, the 25% ME Group, along with other concerned ME charities (ie, Tymes Trust, IiME and Grace Charity for ME) wholeheartedly cannot support the CFS/ME Research Collaborative charter.