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!
A Response to Professor Fred Friedberg’s Editorial about CBT
Professor Fred Friedberg asks why cognitive behavioural therapy (CBT) is so vilified in the chronic fatigue syndrome community.
He opens his Editorial by stating: “Cognitive behaviour therapy (CBT) is a well-established psychosocial intervention for psychiatric disorders, pain management and stress related to medical conditions” (Editorial: Cognitive-behavior therapy: why is it so vilified in the chronic fatigue syndrome community? Fatigue, Biomedicine, Health & Behavior 2016:vol 4: no:3:127-131) but ME/CFS is not, and never has been, a psychiatric disorder and CBT has no more role in its management than in the management of multiple sclerosis, MND, Parkinson’s Disease, malignancies or other autoimmune disorders such as lupus or RA.
CBT is not mandated as the primary management approach in those other disorders, so why in ME/CFS?
Patients with ME/CFS do not summarily reject any intervention that would help them: what they reject is a psychosocial intervention that is used with the intention of changing their correct perception that they are very sick with an organic disease, not with a behavioural disorder that is curable by “cognitive re-structuring” if they would only co-operate.
Friedberg appears to assume that, where there is stress related to a medical disorder, CBT supports patients to help them cope better with their disease.
However, a key consideration which he fails to mention is the significant difference between supportive CBT and directive CBT.
In relation to ME/CFS, in the UK PACE trial CBT was not supportive but directive: Professor Sir Simon Wessely, currently President of the Royal College of Psychiatrists, has publicly stated: “CBT is directive – it is not enough to be kind or supportive” (New Statesman, 1st May 2008).
No amount of directive “cognitive re-structuring” can result in “recovery” from such a multi-system inflammatory disease process as has been demonstrated in ME/CFS.
The Centres for Disease Control (CDC) has archived its toolkit that recommended CBT and GET as interventions for ME/CFS (http://www.cdc.gov/cfs/toolkit/archived.html) and the National Institutes for Health (NIH) has produced a report which acknowledges the harm done to patients (http://annals.org/article.aspx?articleid=2322804); their conclusions were based on comprehensive reviews of over 9000 peer-reviewed research papers and testimony from expert researchers and clinicians.
Does this not provide the answer to Friedberg’s question as to why CBT is so vilified in the ME/CFS community?
Diverting scarce resources from biomedical research by funding psychosocial interventions that have been conclusively proven to be ineffective can only harm patients further.
Money must now urgently be made available by institutions such as the MRC for research that is relevant to the disorder; for example, Professor Faisal Khan (recently appointed to the Chair of Cardiovascular Sciences, Division of Molecular and Clinical Medicine at the University of Dundee) is working on NRF2 (nuclear receptor factor 2) in ME/CFS patients and his work ties in with the study by Japanese researchers who looked at index markers in ME/CFS patients with dysfunction of TCA (the tricarboxylic acid cycle, also known as the Krebs cycle, which is the biochemical pathway used to generate energy) and urea cycles (http://www.nature.com/articles/srep34990).
Behavioural researchers who for over 30 years have shown disregard for the scientific process should have no influence on future research.
Patients with ME/CFS do not need “behavioural” guidance from a profession which has visited such harm upon them.
To spell it out: directive CBT does not work for patients with ME/CFS and it is time that those psychologists and psychiatrists who insist that it does returned to reality.
Professor Malcolm Hooper
15th October 2016
The serious trust deficiency afflicting medical advice and what to do about it
Trust me I’m a doctor has become a knowing, cynical catch-phrase but the underlying truth is that we do need to trust our doctors, not only because trusted doctors exert a beneficial healing effect but also because we are entrusting them with something precious – our health.
Several recent events however suggest that we would do well to keep our cynical streak on high alert when visiting. Unquestioning trust can have dangerous consequences, as some patients taking statins have found along with those with ME/CFS.
A reasonable summary of a recent HIUK post about statins would be: ‘You can’t trust claims about statins because they are based on secret data’. While a summary of last week’s post might be: ‘You can’t trust claims about the benefits of psychological treatment for ME/CFS because they have been wildly exaggerated’. Not only that but the authorities involved fought hard and expensively to prevent the facts emerging.
I do think there may be a way out of this long-running conflict between patients and authorities which I will come to later but what happened initially in the wake of these two posts caused my trustometer to plunge even lower.
Impenetrable mathematical wizardry
First was a post on another blog which explained that a trial of the great and good Mediterranean diet had arrived at its impressive conclusion with the aid of the sort of impenetrable statistical workings that has given a shine to statins. I knew that a similar form of mathematical wizardry had created things called ‘collateralised debt obligations’ that set off the banking crash but I’d never actually seen one at work.
Now I have and this is what it looks like:
We calculated PAF [Population Attributable Fraction] based on the formula of rate difference: PAF = (I0 − Ii)/I0, equivalent to I0 − HR × dMDS/I0, where HR was estimated continuously with adjustment for potential confounders as aforementioned, I0 is observed incidence per 10,000 person-years, and Ii represents a hypothetical, ideal incidence if the population achieved high MDS (95th percentile) (dMDS=MDSideal – MDSobserved). The CI of the PAF was derived from bootstrapping to estimate HR and PAF iteratively (n resampling = 100, after confirming no difference in results between n = 100 and 1000).”
Remarkable isn’t it? This one was found in a large nutrition trial published last week extolling the benefits of the Mediterranean diet (the comment originates from the blog). I’m prepared to bet that no more than a handful of BMJ or Lancet readers could assess whether the answer it produced was right or wrong or how the conclusion was arrived at. You just have to take it on trust.
It might be described as a “statistical McGuffin” (A McGuffin is a term used in movie circles to describe something that propels the plot without having any further function.) Its purpose in the trial was to produce a result that would generate the impressive headline: ‘Mediterranean Diet could prevent 20,000 heart disease deaths per year.’
What you need to know about McGufIins
I’m grateful to the indefatigable Dr Zoe Harcombe, a hugely well-informed nutritionist with a clear grip on bio-medical statistics, for this explanation. She cheerfully admitted she didn’t understand the workings of this particular McGuffin, but that didn’t matter. She knew what its underlying assumptions were and what it was designed to do.
Its purpose was to translate the key finding of the research –that following the diet closely made you less likely to die from a heart attack – into the number of lives that would save in the UK as a whole.
The problem isn’t with the mathematical processes but, as with the financial statistical McGuffins, with the assumptions it was set to work on. Firstly, that the result of a study of a 24,000 people with an average age of 59 would be directly applicable to people of the average age in the UK which is 40. Secondly that 12.5% of the total number of heart attack deaths could be prevented with the diet. As Dr Harcombe explains there are good reasons why both are unfounded.
Without independent and informed experts like her, national dietary policy and drug guidelines can presented as objective and scientific when they are actually based on questionable assumptions.
Patients take unusual steps
But there is no need to reach for a McGuffin to give statistics a highly misleading spin. A quick change to the criteria for success can also do it effectively. This move was central to last week’s blog about the remarkable events in the world of ME/CFS where the issue of how best to treat patients is bitterly contested.
For those starting here the story centred round a standard clinical trial that, five years ago, had found that the official treatment –psychotherapy and graded exercise – was effective in improving many patients’ lives and helping a significant number to recover.
When it was published something unusual happened. Not only did a considerable number of patients not believe the results but they wrote letters and compiled reports setting out their reasons and demanding to see the original data. Last month five years of campaigning produced two totally unexpected results. The psychologists who ran the trial were forced to release the data and when it was analysed the patients concerns appeared justified.
What triggered a further drop in my trustometer was the response to this bombshell. Serious questions had been raised about the accuracy of the data underpinning a NICE approved treatment which affects around 200,000 patients. And nothing happened. No TV coverage, no headlines just an uneasy silence like a car crash in slow motion.
The curve ball here was that the re-analysis had been driven by the patients rather than the regulator. That’s unheard of, although there is no reason why the results shouldn’t be correct. In fact there is obviously a case for involving patients in any such re-assessment. They are certainly stakeholders in the business here and I describe a way it might happen below.
Nothing to do with me guv.
The BMJ covered this dramatic story in a misleadingly low-key way. It didn’t spell out the long campaign to get the data or convey how damning was the dismissal of the reasons given for not releasing the data. This was especially curious because the journal has been campaigning for the release of hidden statin data for at least two years. Surely a patient’s successful use of Freedom of Information could have been hailed as a significant victory and maybe a strategy to try?
The Guardian was the only national paper to cover it but it didn’t even attempt to set out the details or provide any context. Instead of dishing out the forensic treatment given to wealthy tax dodgers or regulation busting banks, it handed over half a page to the lead author of the disputed trial to explain how hard he worked to help patients – most likely true –but which he followed with a curious use of the passive tense:
‘There are claims of foul play,’ he wrote ‘with issues over freedom of information and sharing of trial data.’ The fact that he is one of the central figures in these issues doesn’t really come across. It would certainly leave the casual reader no wiser as to what had been happening.
What this limited and downbeat response highlighted was that once a treatment is out there approved and being used, it is virtually impossible to get any kind of reassessment until people start dying as with Vioxx. And that even evidence based critiques are unwelcome.
Cholesterol data fiddling goes back a long way
Resisting any kind of challenge and dismissing critics is also the way the current statin debate has been handled. What I hadn’t appreciated until I started reading a remarkable new book this week, was just how far back the fiddling of statin data and refusal to engage with critics goes.
It has one of those does-what-it-says-on-the-tin titles: ‘Fat And Cholesterol Don’t Cause Heart Attacks And Statins Are Not The Solution’ and contains contributions from 22 leading clinical and academic critics of the widespread use of these drugs.
It builds a detailed case for the way evidence has long been ignored or twisted, detailing, for example, the early shenanigans around the long running Framingham study investigating the links between diet and heart disease. One influential paper claimed that for every 1% reduction in cholesterol there was a 2% reduction in the risk of heart disease. This was seriously misleading. Years later when the study was re-examined it emerged that the study had actually found that for every 1% drop in cholesterol there was an 11% increase in coronary and other causes of death.
The book details other long, large scale trials such as MRFIT (Multiple Risk Factor Intervention Trial) and WHI (Women’s Health Initiative) both of which found that a drop in cholesterol had no effect on CHD. There’s a description of a randomised controlled trial of a cholesterol lowering drug called Cholestryramine, which claimed to have found the same 1% reduction leading to a 2% reduction in CHD events. Again, a subsequent review found no difference between the placebo and drug groups.
Critics warned off having a meeting
But the failed trials were not enough to counter the major PR offensives against cholesterol and the facts about the unreliable ones came out later. Persistent and informed critics were ruthlessly treated. One of these was George Mann, a professor of Medicine and Biochemistry who had done research in 1960 which failed to find a link between lower cholesterol and heart disease rates, which was never published at the time.
When he attempted to organise a conference to discuss flaws in the cholesterol hypothesis only 12 delegates turned up. The rest had been either fooled by false announcements saying it had been cancelled or warned their funding would be cancelled if they attended.
A big difference between then and now is the internet, which makes it far harder to stifle criticism as both ‘Statins Are Not The Solution’ and the ME/CFS re-analysis shows. The opportunities it throws up are leading to more formal involvement by cancer patients, for example, in their treatment under the mantra: ‘Nothing about us without us’. This could be expanded to other diseases.
Patient representatives have long had a place on committees run by companies and organisations but the latest idea, dubbed ‘evidence based advocacy’, is that they should be more involved, informed and proactive. The sorts of things being suggested include ‘conducting online surveys though software such as Survey Monkey, gathering opinions at conferences and conducting Facebook polls.’ Might some such formal feedback system have made action on the demands of ME/CFS patient less of a frustrating battle for both sides?
One organisation called Europa Donna, which involves breast cancer patients, is now being asked to serve on the committees that run clinical trials. Since these can involve highly technical decisions, Europa Donna is providing training, particularly in the research field. ‘The result,’ a spokesperson is quoted as saying ‘is they can do an effective job and not just rubber-stamp what is handed to them by the scientific investigators.’
Is it wildly optimistic to imagine patients sitting across a table from researchers discussing the release of the full data on statins- maybe some had been in the original trials – or making informed critiques of the trial of a new treatment for ME/CFS. Certainly something needs to change.
Key points from the analysis of the PACE trial raw data for “recovery”
by Alem Matthees (1), Tom Kindlon (2), Carly Maryhew (3), Philip Stark (4), Bruce Levin (5)
1. Perth, Australia. firstname.lastname@example.org
2. Information Officer, Irish ME/CFS Association, Dublin, Ireland.
3. Amersfoort, Netherlands.
4. Associate Dean, Mathematical and Physical Sciences; Professor, Department of Statistics; University of California, Berkeley, California, USA.
5. Professor of Biostatistics and Past Chair, Department of Biostatistics, Mailman School of Public Health, Columbia University, New York, USA.
1. There was no committee approval for the re-definition of “recovery”.
2. “Recovery” rates for CBT and GET were not statistically significant.
3. The PACE PIs originally reported “recovery” rates of 22% for CBT and GET.
4. The published “recovery” rates were based on thresholds that deviated substantially from the published protocol and were inflated by an average of four-fold.
5. In contrast to the published paper by the PIs, the recovery rates in the CBT and GET groups are not significantly higher than in the SMC (standard medical care) group alone.
6. APT (adaptive pacing therapy) was a highly modified version of “pacing” (preferred by patients).
7. 13% of participants at baseline simultaneously met the trial entry criteria for “significant disability” and the revised “recovery” criteria.
8. The Investigators excluded drop-outs, which is not recommended practice in clinical trials.
9. Logistic regression (used by the PIs) has been shown to be an inappropriate method of analysis in randomised trials.
10. The figures originally given by the PIs for the four groups were:
SMC 7% (but according to the protocol are 3%)
APT 8% (but according to the protocol are 2%)
CBT 22% (but according to the protocol are 7%)
GET 22% (but according to the protocol are 4%)
11. “Our findings therefore contradict the conclusion of White et al (2013) that CBT and GET were significantly more likely than the SMC group to be associated with ‘recovery’ at 52 weeks”.
12. “The multiple changes to the recovery criteria had inflated the estimates of recovery by approximately 2.3 to 5.1-fold, depending on the group, with an average inflation of 3.8-fold”.
13. When using the revised recovery criteria, 8% of the “recovered” participants still met trial eligibility criteria for “significant disability”.
14. “The changes made by the PACE investigators after the trial was well under way resulted in the recovery criteria becoming too lax to allow conclusions about the efficacy of CBT and GET as rehabilitative treatments for CFS”.
15. “This analysis, based on the published trial protocol, demonstrates that the major changes to the thresholds for recovery had inflated the estimates of recovery by an average of approximately four-fold”.
16. “It is clear from these results that the changes made to the protocol were not minor or insignificant, as they have produced major differences that warrant further consideration”.
17. “The PACE trial provides a good example of the problems that can occur when investigators are allowed to substantially deviate from the trial protocol without adequate justification or scrutiny”.
18. “It seems prudent that the published trial results should be treated as potentially unsound, as well as the medical texts, review articles, and public policies based on those results”.
The PACE trial was instigated and carried out mostly by a group of psychiatrists well-known for teaching that ME/CFS does not exist other than as an aberrant belief: their assumption was that ME/CFS is a behavioural disorder that is amenable to behavioural interventions. The Investigators had no evidence for their assumption and despite abundant scientific evidence to the contrary, it remained their firmly-held belief. They favoured two interventions in particular: cognitive behavioural therapy (CBT), which was to “change the behavioural and cognitive factors assumed to be responsible for perpetuation of the participant’s symptoms and disability” and graded exercise therapy (GET), which was to correct the assumed deconditioning resulting from avoidance of activity.
The original (selective) results on the PACE trial were published in The Lancet in early 2011; they were accompanied by press releases from The Medical Research Council, King’s College London and Queen Mary University of London, all of which proclaimed: “Two effective treatments benefit up to 60 per cent of patients with CFS/ME”. Importantly, this figure was achievable only because the Investigators used a much less demanding definition of improvement than they had stated in their published protocol.
Following lengthy Freedom of Information (FOIA) requests, all of which were refused until the final one, the raw data from the PACE trial had to be released, following which the Investigators re-analysed their data according to their own published protocol.
Those results were different from what had been published in The Lancet to such loud acclaim (orchestrated by the Science Media Centre, of which Professor Sir Simon Wessely, one of the PACE team, was a founder member).
It revealed that the improvement figure was only 21% for the GET group and 20% for the CBT group versus 10% for those who received usual medical care alone, meaning that for every ten people treated with CBT or GET, only one person would show protocol-defined improvement. All participants received what was described as standardised “specialist” medical care (SSMC), but those receiving SSMC alone may have seen the Fatigue clinic doctor only three times for 30 minutes each time during their participation in the trial, a total of 90 minutes throughout the trial.
Hence the protocol-specified figures are that CBT and GET helped only an additional 10% of participants over usual medical care and not the widely reported 60%.
Findings of research facilitated by the Open Medicine Foundation could be set to rock the world of medicine, writes Action for M.E. Volunteer Pharmacist Emily Beardall.
Published online in Proceedings of the National Academy of Sciences of the United States of America, and reported in UK press including the Telegraph and the Economist, the study looked closely at the blood chemistry in people with M.E. with a research technique called “metabolomics.” This involves measuring the chemicals in our blood created by the different steps and by-products of metabolising, or breaking down, the energy and nutrients from our food into the chemicals that can be used for energy, hormones and building blocks of new cells.
The research found 20 abnormal metabolic processes in people with M.E.; nine in both men and women with the illness, and a further eleven which varied between gender. This means normal metabolites found in healthy people were found to be low in M.E., so the illness could be described as a “hypometabolic” disease and the body is effectively in hibernation.
The researchers suggest that many of these abnormalities might be part of the body’s own response to try to limit the spread and effect of viral or bacterial infection because cells are using alternative pathways to create the substances it needs. This is normally only seen in acute infection but this state is ongoing in M.E. patients.
What abnormalities did the researchers find?
The disrupted processes that the researchers have found affect:
- cell building blocks sphingolipids and glycosphingolipids which are used by the body to form cell membranes in brain and nerve tissue
- cholesterol, which is needed for the production of cell membranes and steroid hormones such as cortisol and aldosterone
- bile acid, which is important for normal fat digestion; not enough bile acid secreted into the bowel can lead to a “leaky gut” where nutrients aren’t absorbed as efficiently
- mitochondria, the powerhouses of cells, leading to a lower reserve of energy and an inability to replenish high-energy stores after exertion
- the body’s ability to convert vitamins from food into the form needed by cells; those affected are vitamin A and the B vitamins riboflavin (B2), niacin (B3), pyridoxine (B6), folic acid (B9), and - cobalamin (B12). These vitamins are essential for energy production, new cell development such as red blood cells, and for normal nervous system function.
- a substance normally produced by the body as an antifungal and antibacterial, called HICA
A quarter of the abnormalities found were common to all the M.E. patients but the rest varied between individuals, giving each person their own characteristic pattern of abnormalities. The authors suggest that instead of focusing on the common disrupted processes in M.E. for developing a treatment, a personalised medicine approach, ie. giving each person a treatment for their own specific metabolic abnormalities, would be more successful.
The study also uncovered five different types of triggers for the illness:
- biological infections (viral, bacterial, fungal, and parasitic infections)
- exposure to toxic chemicals
- physical trauma
- psychological trauma
- and a category of unknown triggers.
Regardless of what triggered someone’s M.E., the underlying disease process was found to be exactly the same, contributing to the distinct chemical signature found for the condition.
Such a huge amount of biological processes in people with M.E. being affected could be the game-changer so desperately needed to move research forward to find treatments and change attitudes towards M.E.
Are Myalgic Encephalomyelitis and chronic fatigue syndrome different illnesses? A preliminary analysis.
(It seems that some of them are just starting to catch up with what we, the patients, have been saying for years!)
Considerable discussion has transpired regarding whether chronic fatigue syndrome is a distinct illness from Myalgic Encephalomyelitis. A prior study contrasted the Myalgic Encephalomyelitis International Consensus Criteria with the Fukuda and colleagues' chronic fatigue syndrome criteria and found that the Myalgic Encephalomyelitis International Consensus Criteria identified a subset of patients with greater functional impairment and physical, mental, and cognitive problems than the larger group who met Fukuda and colleagues' criteria. The current study analyzed two discrete data sets and found that the Myalgic Encephalomyelitis International Consensus Criteria identified more impaired individuals with more severe symptomatology.
Prof Malcolm Hooper, Margaret Williams, and the PACE Trial
From an email I received - and I am sure this will be a valuable resource for anyone interested in ME -
We are pleased to announce the launch of a website containing a catalogue of all the articles on ME written by Margaret Williams and Professor Malcolm Hooper:
The articles in this catalogue have been available on the internet or elsewhere for many years but now for the first time have been brought together in one place. The intention is to provide a valuable historical resource for researchers, advocates, patients and anyone interested in the illness Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. These articles illustrate how the "Wessely School" have ignored the biomedical science on ME/CFS for almost 30 years.
Margaret Williams is the pen-name used by someone who spent her professional life in the British National Health Service (NHS), latterly in a senior clinical capacity for many years until severe ME put an end to her career. For professional and personal reasons she does not wish her own name to be in the public domain.
Malcolm Hooper is Professor Emeritus of Medicinal Chemistry at the University of Sunderland in the UK, and is an advocate for ME/CFS patients. He chaired the International Invest in ME Conference in 2008, 2010, and 2011. He is also the Chief Scientific Adviser to the British Gulf War Veterans Association.
With contributions from Eileen Marshall (1994-2007) and others.
The First-Tier Tribunal judgment in this case (click on that link to read full judgment) has just been published. QMUL’s appeal has been roundly dismissed and therefore the Tribunal has decided that the requested data from the PACE trial should be released.
I have just skimmed the 48 pages of the judgment and so have only taken in a small amount so far. However, it appears that this is a defining moment for the international ME community and the PACE Trial. Alem Matthees (the original requestor of the data) has done an extraordinary job.
However, it is important to remember that, in theory, QMUL could still seek leave to appeal against this judgment to the Upper Tribunal so it will be a bit longer before we can be absolutely certain that this judgment will stand.
I will write a longer post with a more detailed analysis in due course (health permitting).
Some further encouraging news -
AHRQ Evidence Review Changes Its Conclusions
In response to requests by U.S. patient organizations and advocates, the U.S. Agency for Healthcare Research and Quality (AHRQ) has issued an Addendum to its 2014 ME/CFS evidence review. This Addendum downgrades the conclusions on the effectiveness of cognitive behavioral therapy (CBT) and graded exercise therapy (GET), and this has tremendous implications for medical education and treatment recommendations.
The final paragraph reads -
There is no evidence that CBT and GET are effective treatments for us, and therefore, these treatments can no longer be recommended. If CDC and others persist in recommending treatments for which there is no evidence of effectiveness in ME/CFS patients, it will not only perpetuate confusion but also put patients at risk. Such an unscientific recommendation goes against the principles of evidence-based medicine and is not accepted in other diseases. It will not be tolerated here.
The NHS offers treatment for chronic fatigue syndrome (CFS) and tells us that CFS is "also known as" Myalgic Encephalomyelitis (ME) in order to justify treating ME the same as CFS. It is unethical to treat one condition as another; it makes patients more ill and is a waste of time and money.
Myalgic Encephalomyelitis means "muscle pain + inflammation of the brain and spinal cord", in other words it is a neurological illness. It is accepted as such by the World Health Organization (WHO). The term CFS was coined in the USA and seized upon by psychiatrists in the UK, and today the psychiatric view of ME (that ME does not exist but is really a "fatigue syndrome") now dictates the Department of Health, Nice, and NHS policy. While this policy remains in place, ME patients are untreated.
Introduction: Well I'm now pretty exhausted! Never mind - I'm also over the moon at the tremendous success and attendance at the Afternoon Tea and Awards, held in the House of Lords for members and guests of Tymes Trust and the Nisai Virtual Academy. Our host was the Lord Clement-Jones, who welcomed everyone with his usual great good humour and aplomb.
We were also pleased to have journalist David Tuller with us, who was presented with a Tymes Trust Press Award.
I launched a new leaflet on ME for families and GPs. This will be online soon, along with my introductory speech, on the Tymes Trust website.
However, I thought you'd like to read the speech as soon as possible, so here is the text. It's called:
THE TYRANNOSAURUS REX IN THE ROOM
Because I was a GP's wife, I know that GPs need practical ways to help patients where there is no curative treatment. And they also need knowledge of what treatments, or types of management, might be actively unhelpful.
Because I was a headteacher, I know how education can be modified for sick children so they can achieve whilst protecting their health and recovery.
And because I got ME (diagnosed by that name) from a coxsackie B virus, I have personal experience. But of course I have also learned a huge amount through working with medical professionals who understand ME. And when I say ME, I do mean, ME. More of that later.
The late Dr Alan Franklin was one of the foremost experts in paediatric ME, and it was a real privilege to work with him on the Chief Medical Officer's Working Group on CFS/ME. This leaflet I'm holding, which we're launching today, has been produced in commemoration of him and his wonderful, compassionate work for children. Everyone respected Alan and he still is sorely missed. Now some of that personal information is in the leaflet. There's a reason for that.
OK, so here was the challenge. One sheet of paper. Why? And what's it all about?
First, the Why. Over my years dealing with – and suffering from – ME, I've worked with some pretty eminent doctors. Dr Elizabeth Dowsett was my first. She was a renowned microbiologist who probably knew more about ME than anyone in the medical establishment at that time. She diagnosed me, she demonstrated the cause, through tests – a virus related to polio. She told me that mine was almost the severest case she had ever seen. And she asked me to help her, long before I was really well enough (and she got told off for it by my mum, who was my main carer!) She asked me to help spread knowledge of ME in children, and that was how our schools research began. We discovered that no other illness causes such long term sickness absence from school. It really is that disabling and Lord Clement-Jones has explained to you one of the reasons for that.
Among the doctors I've worked with, including our guest Dr Charles Shepherd, there was a GP with whom I wrote articles. He called me in to advise the local education authority in a very severe paediatric case of his. He said to me: “Hmm. GPs. Keep it to one sheet!” We've taken his advice.
What's it all about? Well, we thought it was high time to tackle the Tyrannosaurus Rex in the room – the thorny issue of how ME and CFS are actually not the same thing, and why the present emphasis on fatigue is potentially unsafe for people who would once have been diagnosed with ME – myalgic encephalomyelitis – as originally described by Ramsay – but who now either go undiagnosed or more likely end up under another illness name such as postviral fatigue or CFS – Chronic Fatigue Syndrome.
That's important because it affects treatment and for children, it affects the type of education recommended too.
I made a typing mistake when I first typed Tyrannosaurus Rex. I put a y in the middle. Tyranny saurus Rex. I thought that was spookily accurate. The fatigue label and the recommendations that have followed from it have become a tyranny. I don't need to tell you how oppressive it is to have your children forced to school when they are not yet well enough, and when there is an excellent replacement in virtual education. The Establishment can be a bit of a dinosaur when it comes to this type of revolution. There are those who seem to believe that there is some kind of moral virtue in just getting to the school building, never mind the educational results. And then I suppose there is the fear: we surely can't buy in a virtual education course for this child – suppose they all want one! But the bottom line is - a child's needs must be catered for. That's the law.
Tymes Trust, whenever it can, sticks to talking about ME. But this is an occasion when it is important to give you one sheet that your GP can see is fully medically referenced, explains how ME, CFS and SEID (systemic exertion intolerance disease - a name suggested by the American Institute of Medicine) relate to each other, and carries medical authority for the information within it.
Of course, doctors, patients, me - author of the leaflet – we're all human. Connecting personally with other people is what it's all about. In the final analysis, GPs want solutions for their patients. We hope this will help.
The ‘all in the mind’ myth of myalgic encephalomyelitis/chronic fatigue syndrome | Nursing in Practice | 27 June 2016
Article written by Dr Keith Geraghty
The ‘all in the mind’ myth of myalgic encephalomyelitis/chronic fatigue syndrome
Health professionals should be made aware that ME/CFS is not a psychological illness and in order to improve patient care, nurses need to better understand this illness and its impact on patients.
Nurses often witness close-up the impact of acute and chronic illness on patients. Myalgic encephalomyelitis (ME)/chronic fatigue syndrome (CFS) is one illness that nurses may encounter that causes profound life changes for many sufferers. This controversial illness is sometimes presented as a psychosomatic disorder that requires psychological treatment. However, there is no compelling evidence that ME/CFS is a mental health condition and increasing evidence shows it is a biological disease with a range of complex symptoms. This article discusses how the ‘all in the mind’ myth of ME/CFS has permeated both medical discourse and popular culture, with negative consequences for patients living with this poorly understood condition.
1. Is ME/CFS really a mental illness?
In a recent Nursing in Practice article, Roberts (2016)1 suggests that ME/CFS is a psychosomatic disorder, best treated with psychotherapy and mindfulness. The erroneous idea that mindfulness is an optimum treatment masks a hidden and more important story; that very little is understood about ME/CFS and many health professionals are skeptical about whether ME/CFS is even a real illness. For example, NICE guidelines do not mention mindfulness.2 A GP once exclaimed to me that ‘all these patients need is anti-depressants and a good pair of running shoes’. While discussing my ME/CFS research at a hospital in Leicester a nurse offered me a similar opinion by suggesting that ‘ME/CFS patients would get out of bed if you paid them £5000 per day’. Such negative views among doctors and nurses are not uncommon and are perhaps fueled by misinformation about the illness being psychological.
In a recent book, All in Your Head: True Stories of Imaginary Illness,3 Dr Suzanne O’Sullivan, a London-based consultant neurologist, includes a chapter on ME/CFS. O’Sullivan argues ME/CFS is strongly associated with psychological complaints and illness beliefs. In contrast, a growing body of scientific evidence suggests that ME/CFS is not an imagined illness, nor is it a psychological condition, but a complex biological disease that is often triggered by an infection that causes observable neuro-immune dysfunction. Far from being ‘all in the mind’, sufferers often experience life-changing and disabling physical symptoms and physiological abnormalities (see Table 1).
Table 1: Biological abnormalities observed in ME/CFS
· Alterations in grey and white brain matter.
· Muscle cell dysfunction.
· Immune cell abnormalities.
· Raised inflammatory markers.
· Cellular and oxidative stress.
· Autonomic irregularities.
· Cardiovascular deficiencies.
· Orthostatic intolerance.
The World Health Organization (WHO) classifies ME as a neurological disorder in the International Classification of Diseases (ICD-10: G 93.3; WHO, 1992).4
The US Institute of Medicine (2015) conducted an extensive review of the evidence and concluded that ME/CFS is ‘a serious, chronic, complex, systemic disease’.5
The US National Institutes for Health confirmed ME/CFS as a disabling physical illness and stated that the medical profession has been responsible for causing distress to patients with ME/CFS by ignoring patients’ calls for medical help and failing to adequately research the disease.6
2. So why is ME/CFS treated with psychotherapy?
Psychiatrists have long been interested in attempting to explain the medically unexplained. Sigmund Freud, the father of modern psychiatry, explored the connection between the mind and health. The famous French neurologist J. Charcot believed traumatic life events may bring about a form of hysteria or paralysis in patients; while George Beard put forward the theory of neurasthenia (exhaustion of energy within the nervous system).7 These theories continue to influence how doctors perceive medically unexplained illnesses, particularly ME/CFS.
A brief time-line of how ME (nuero-immune disease) became CFS (a psychosomatic fatigue syndrome)
· 1955: Melvin Ramsay describes a viral outbreak illness among staff at the Royal Free Hospital in London as a post-infectious disease affecting brain, nerves and muscle tissue (Myalgic Encephalomyelitis).
· 1970s: UK psychiatrists McEvedy and Beard state that ME is nothing more than a case of ‘mass hysteria’.
· 1980s: A London newspaper runs a story about ME being ‘Yuppie Flu’. Since then, ME has been indelibly linked with stressed-out professionals complaining about exhaustion.
· 1988: The US Centers for Disease Control recommend replacing ME with a new syndrome (Chronic Fatigue Syndrome).
· 1990s: UK psychiatrist Simon Wessely argues ME (now CFS) is a biopsychosocial syndrome, partly created by social trends and maintained by patients’ illness beliefs and behaviours.
· 2000s: Colleagues of Wessely, including nurse/researcher Professor Trudie Chalder, conduct clinical trials of psychotherapy to treat CFS, including the £5 million PACE trial testing cognitive behavioural therapy and graded exercise therapy.8
· 2007: The UK National Institute for Health and Care Excellence (NICE) conducts a review and recommends CBT and GET for the treatment of ME/CFS.2 This decision is criticised by ME/CFS patient groups who deem CBT and GET inappropriate treatments. In particular, GET attracts much criticism.
· 2015: A large patient survey finds CBT has little impact on the condition: 74% of patients report that GET makes their symptoms worse, while simple pacing is preferred by patients.9 Such concerns are echoed in scientific studies that suggest exercise therapy may be harmful, given biological abnormalities found in ME/CFS.10
3. So, does cognitive therapy or exercise therapy help anyone with ME/CFS?
The answer to this question is rather complex. ME/CFS is an umbrella term often used for patients with ongoing unexplained fatigue. Hooper (2006) points out that ‘Amorphous definitions and diagnostic symptom criteria have contaminated study cohorts and corrupted research data’.11 Essentially, it may be difficult to differentiate patients with ME/CFS from patients with fatigue or depression, given the generality of the diagnostic criteria for CFS: patients are often lumped together in studies, with depressed patients responding better to CBT compared with ME/CFS patients.12 In addition, CBT may help with the secondary depression or anxiety that occurs in most illness states. Clinical trials of CBT and GET tend to recruit mild to moderately unwell CFS patients, as more severe cases are too unwell to take part. Yet, even if we accept these research biases, the evidence for the success of psychological or exercise therapies in ME/CFS is unconvincing:
· Cochrane review:A meta-analysis found that while CBT and/or GET may benefit some patients with ME/CFS in the short term, the benefits are short-lived and have little impact on restoring physical function over the long term.13
· PACE trial:The largest clinical trial of CBT and GET for CFS reported that 22% of patients recovered following CBT/GET added to standard care, while only 7% did after standard care alone.14 However, ‘recovery’ here did not mean a return to normal physical function. A patient could be deemed recovered with a SF-36 (quality of life) score of 60/100 or higher,8 even though a score of 65/100 indicates severe disability with 57/100 being a score of patients with Class II congestive heart failure.15 At follow-up, two years after treatment, there was no clear benefit of adding CBT or GET to standard medical care.8
· FINE trial:A study of nurse-provided community-based CBT and GET for 296 CFS patients failed to find any evidence for the long-term effectiveness of these therapies.16FINE stood for ‘Fatigue Intervention by Nurses Evaluation’. CBT-GET was compared against a supportive listening treatment. The FINE investigators found no statistically significant benefits to either pragmatic rehabilitation (CBT-GET) or supportive listening at 70 weeks. The authors concluded that the community setting was inappropriate, rather than the psychotherapy treatment.
4. Why is it important to know the facts?
In a recent Centers for Disease Control ‘Grand Rounds’ event (2016) discussing ME/CFS research, Professor Anthony Komaroff of Harvard University stated that the medical profession were wrong to adopt the name Chronic Fatigue Syndrome in 1988, as this term led to inaccurate perceptions of the illness. Komaroff points out that that there are thousands of published articles on biological dysfunction in ME/CFS, with no compelling evidence to suggest the illness is psychogenic (an illness of the mind).16
Many ME/CFS sufferers and advocacy groups are deeply concerned about the portrayal of the disorder as a psychological illness in medical publications and the wider media. Misinformation may negatively impact patients. Patient surveys consistently reveal that many ME/CFS patients experience medical scepticism, difficult interactions with health professionals and poor care quality (AfME, 2001).17 Sufferers report finding it difficult accessing benefits and social care and often have to fend off accusations of laziness and hypochondria – perhaps a consequence of the perception that the illness is a self-generated psychological illness.
The 25% ME Group, a charity that supports the most severely ill sufferers, state that the medical establishment has largely ignored these ME/CFS patients.18 Many are housebound or bedbound, with family members as full-time care-givers.
We must consider the harrowing case of Miss Sophia Mirza, a young ME sufferer forcibly removed from her home and sectioned under the Mental Health Act to impose psychiatric treatment on her. Miss Mirza died in 2005 and is one of the first patients in the UK to have ME as the official cause of death. The reality that ME/CFS kills some patients and dramatically shortens life expectancy is rarely reported in the media. In addition, ME/CFS sufferers are six times more likely to commit suicide compared to the general population;19 most likely as the result of having to deal with debilitating symptoms, such as chronic pain and sleep deprivation, but perhaps also having to deal with feelings of social isolation and poor medical treatment.
5. What can nurses do to support ME/CFS patients?
Many nurses will encounter ME/CFS patients, particularly in primary care. Nurses often have the capacity to form close therapeutic relationships with patients. Offering empathy and understanding to patients experiencing distressing symptoms is a central part of the nursing role. In the absence of a cure for ME/CFS, nurses are well placed to provide supportive care. By understanding the symptoms generated by the illness, nurses may be able to offer patients better care. ME/CFS severity varies from mild to severe and patients experience the illness in different ways. Some sufferers may be able to continue work on a limited basis, while others may be bed-bound, reliant on family and carers. Retired nurse Greg Crowhurst, a care-giver to a wife with severe ME/CFS, writes eloquently about how nurses may support patients with the illness.19
Practical tips for nursing practice are as follows:
· Sufferers experience profound fatigue – nurses may be able to ensure patients are not left in waiting areas for long periods of time.
· Sufferers experience cognitive problems – nurses may assist patients in medical consultations, perhaps asking whether the patient understands the information provided.
· Sufferers experience sensory overload – nurses may ask patients if they require a quiet area or darkened room, or on home visits, nurses may avoid causing sensory distress by speaking quietly and ensuring mobile phones are turned off.
· Sufferers symptoms vary and fluctuate – nurses should liaise with family members or care-givers to get a personalised account of the patient’s health status and care needs.
· Sufferers often feel disbelieved and anxious – nurses may reassure patients, particularly if they convey empathy and knowledge of the illness to the patient.
Nurses also have an another important role as advocates for ME/CFS patients, helping to liaise between the patient and doctor and also helping to promote the patient voice in the public domain. However, to fulfill this important role, nurses need to better understand the illness and to understand that ME/CFS is by no means ‘all-in-then-mind’.
Conclusion: The key message for nurses
Most people feel fatigued following illness, stressful events, or after working long hours. This is quite different from the severe fatigue and the range of symptoms that patients with ME/CFS endure, including: unrelenting painful joints and muscles; cognitive dysfunction, including memory problems; gastrointestinal complaints; transient paralysis; hypersensitivity to light, noise and touch; unrefreshing sleep; post-exertional malaise after minimal effort; and the inability to maintain an upright posture for any significant period. Overwhelming evidence shows that these symptoms are not psychosomatic. Nurses have a valuable role to play in assisting and supporting patients with ME/CFS. Nurses should not underestimate the power and importance of the nursing position to relieve suffering, prevent harm and promote better care for ME/CFS patients.
1. Roberts D. Diagnosing and managing chronic fatigue syndrome. Nursing in Practice 2016, 89.
3. O’Sullivan S. All in Your Head: True Stories of Imaginary Illness, 2016.
4. WHO. International Classification of Diseases, Tenth Revision (ICD-10). WHO 1992; G93.3.
5. IOM (Institute of Medicine). Beyond myalgic encephalomyelitis/chronic fatigue syndrome: redefining an illness. Washington, DC; 2015. ISBN: 978-0-309-31689-7.
6. Green CR, Cowan P, Elk R, O’Neil KM, Rasmussen AL. National Institutes of Health pathways to prevention workshop: Advancing the research on Myalgic Encephalomyelitis/chronic fatigue syndrome. Annals of Internal Medicine 2015;16;162(12):860-865.
7. Beard G. Neurasthenia, or nervous exhaustion. The Boston Medical and Surgical Journal 1869;217-221.
8. White PD, Goldsmith KA, Johnson AL et al. Recovery from chronic fatigue syndrome after treatments given in the PACE trial. Psychological Medicine 2013;43(10):2227-2235.
12. Jason LA, Torres-Harding S, Brown M et al. Predictors of change following participation in non-pharmacologic interventions for CFS. Tropical Medicine and Health 2008;36(1):23-32. DOI: 10.2149/tmh.36.23.
13. Price JR, Mitchel E, Tidy E, Hunot V. Cognitive behaviour therapy for chronic fatigue syndrome in adults. Cochrane Database of Systematic Reviews 2008, Issue 3.
14. Sharpe M, Goldsmith KA, Johnson AL, Chalder T, Walker J, White PD. Rehabilitative treatments for chronic fatigue syndrome: long-term follow-up from the PACE trial. The Lancet Psychiatry 2015a;2(12):1067-1074.
15. Juenger J, Schellberg D, Kraemer S, Haunstetter A, Zugck C, Herzog W, Haass M. Health related quality of life in patients with congestive heart failure: comparison with other chronic diseases and relation to functional variables. Heart 2002;87(3):235-241. http://dx.doi.org/10.1136/heart.87.3.235
16. Wearden A, Dowrick C, Chew-Graham C et al. Nurse led, home based self help treatment for patients in primary care with chronic fatigue syndrome: randomised controlled trial. British Medical Journal 2010;340:c1777.
16. Komaroff AL. Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: A Real Illness. Annals of Internal Medicine 2015;162:871-872.
17. Action for ME. ‘Severely neglected’. Patient Survey, 2001.
19. Roberts E, Wessely S, Chalder T et al. Mortality of people with chronic fatigue syndrome: a retrospective cohort study in England and Wales from the South London and Maudsley NHS Foundation Trust Biomedical Research Centre (SLaM BRC) Clinical Record Interactive Search (CRIS) Register, Lancet, (published online Feb 9.), 2016.
20. Crowhurst G. Supporting people with severe myalgic encephalomyelitis. Nursing Standard 2005;19(21):38-43
About the Author Dr Keith Geraghty
Honorary Research Fellow, Centre for Primary Care, University of Manchester
Wise Words from Prof Malcolm Hooper
The following picture of Prof Hooper speaking was taken (I don’t know who by) at the recent Chasing Competent Care conference in Belfast – and I couldn’t agree more!
It started with a bout of mononucleosis. Two college roommates and I got it at the same time. They felt better after a month. I didn’t. Decades later, I’m still living with bone-penetrating exhaustion and brain fog as thick as pea soup. I spent much of my 30s and 40s tethered to my bed, too weak to function. I’ve had to abandon both my career in international relations and my social life.
My mono had morphed into something more permanent, a neuroimmune disease the World Health Organization calls myalgic encephalomyelitis (ME). It affects between 1 million and 2.5 million Americans and 17 million people worldwide.
It’s a disease that can force you to put your life on hold. According to the Institute of Medicine, it can reduce an individual’s ability to function more than heart failure, multiple sclerosis, or end-stage kidney disease. There’s no generally accepted diagnosis for ME. It can take up to five years to be accurately diagnosed, and up to 90 percent of people with it are never accurately diagnosed. Worse still, the FDA hasn’t given the green light to any treatments for it.
Those of us with ME have long hoped the government would come to our aid. Instead, in 1988 it gave the disease a new name, chronic fatigue syndrome, that stigmatizes people with this condition. And the National Institutes of Health has generally looked the other way. Year after year, the NIH has set aside a paltry $5 million to $7 million of its $30 billion annual budget for ME research. Compare that with the $100 million set aside for research on multiple sclerosis, which affects about 400,000 Americans.
Labelling ME as chronic fatigue syndrome gives doctors, the media, the public, and even family members permission to assume individuals are exaggerating, that we’re simply refusing to pull it together. With such a name, who could fault folks for thinking we just need to take a nap, some fish oil, and a vigorous walk? This type of thinking has led to individuals with ME, some too sick to care for themselves, being abandoned by both disbelieving families and physicians.
Last October, two things seemed poised to break the logjam of government neglect and stigmatizing research. First, investigative journalist and public health expert David Tuller successfully debunked the PACE study, a randomized trial that had cemented the widely held but erroneous belief that ME is a psychological disorder rather than a physical illness. Tuller’s work showed that the many flaws in the trial’s methodology seriously undermined the credibility of the treatments it supported — cognitive behavior therapy and graded exercise therapy. The investigation prompted 42 scientists and experts from Columbia, Harvard, Stanford, Berkeley, and elsewhere to release an open letter to the Lancet supporting Tuller’s analysis and demanding an independent analysis of the trial.
As any ME patient can tell you, behavior or talk therapy and pushing yourself physically won’t make you well. In fact, exercise often causes me to relapse, requiring weeks or months of home-bound bedrest. Telling an ME patient to exercise is dangerous, tantamount to prescribing sugar to a diabetic.
Also last October, the federal government promised to bolster research on what it now calls ME/CFS. Many of us thought this condition would finally get the type of government attention and funding offered to multiple sclerosis and Parkinson’s disease, two other neurological diseases also without a known cause or cure. Unfortunately, half a year later, the government falls short in making a serious commitment to ME. The NIH’s offering in the last six months includes one study of just 40 ME/CFS patients that will take at least two years to complete and some supplemental research money to expand grants already awarded.
In an effort to get on the US Department of Health and Human Services’s radar, ME patients and their caregivers will stage a protest, #MillionsMissing, at various cities around the country on May 25. What’s missing are millions of dollars of federal research funds into ME and millions of patients missing out on their own lives, from attending school to climbing the career ladder to simply spending time with family and friends.
Of course, many of us are too sick to attend the protests in person. We’ll be there in spirit — with empty pairs of our shoes symbolically standing in for us — as we advocate for our lives from our beds.
Rivka Solomon is a Massachusetts advocate for myalgic encephalomyelitis who is helping coordinate the #MillionsMissing protest. She is working on a book about her quarter century with the disease.
PACE Trial: Prof Malcom Hooper’s response to Dr Stuart Spencer of The Lancet
In your acknowledgement of my letter of 15th April 2016 to Dr Richard Horton, you write: “We have received, considered and discussed your letter. We recognise that scientific findings can be a matter for debate, but disagreement, however intense, is not grounds for retraction of an article”.
In the light of the extensive international criticism of the PACE trial, I regard this as an unsatisfactory reply and ask you to reconsider.
My letter calling once again for a retraction of the PACE article is not about a “disagreement”: it is a critique alerting editors of The Lancet to basic errors of fact and to misuse of statistics by the PACE PIs.
The article you published in The Lancet in 2011 promotes the use of a non-effective intervention. You will recall that one of the PACE PIs, Professor Michael Sharpe, conceded this on 18th April 2011 when he said on air: “What this trial wasn't able to answer is how much better are these treatments than really not having very much treatment at all”.
There can be no doubt that the PACE trial did not fulfil its objective, which was to demonstrate the effectiveness of CBT/GET in “curing” ME, and that (as confirmed on 26th March 2016 by Rebecca Goldin, Director of STATS.org and Professor of Mathematical Sciences at George Mason University in Fairfax, Virginia): “flaws in this design were enough to doom its results from the start” (http://www.stats.org/pace-research-sparked-patient-rebellion-challenged-medicine/).
The many flaws were pointed out to you in my formal complaint of 28th March 2011: some of these were that the entry requirements and the primary outcome thresholds were changed after the trial had begun; it failed to report on its primary outcome measures as set out in the protocol; PIs relied upon the subjective reports of participants because the use of actometers was dropped and the few remaining objective measures of function failed to demonstrate any benefit from the PIs’ favoured interventions; there was an absence of blinding; it was not, as advertised, a randomised controlled trial -- there was no control group, and participants were not made aware of the conflicting interests of the investigators; astonishingly, it was possible for a participant to leave the trial with a lower physical function score and a higher fatigue score than their entry score, but still be classed as “recovered”.
That is a travesty of science, a tragedy for patients and is tantamount to fraud.
The accompanying Comment by Bleijenberg and Knoop (approved before publication by the Chief PI Professor Peter White) erroneously claimed a 30% recovery rate but, even though one of your senior editors promised it would be removed, the error remains uncorrected.
For the last five years the PACE study has been totally discredited by the international community of scientists: for the selective results you published to remain in the literature to be quoted uncritically by others continues to risk more iatrogenic harm.
Monday 6th June at the Stormont Hotel, Belfast, BT4 3LP
6pm registration for 6.30pm start
Admission £6 at door (if funding is secured then it will be FREE)
Hope 4 ME & Fibro Northern Ireland are organizing this conference "Chasing Competent Care" as part of a campaign to improve medical care for thousands of ME and fibromyalgia patients in Northern Ireland.
Professor Mady Hornig, from Columbia University USA -The search for biomarkers in ME/CFS: accelerating diagnosis, predicting treatment response
Dr Joe McVeigh, Researcher at University of Ulster - The Exercise Dilemma with Fibromyalgia
Natalie Boulton, A Parent’s Perspective: ‘Lost Voices’ as the years pass.
Dr Pamela Bell, Pain Alliance - The Problem with Pain
Professor Malcolm Hooper - A Review of the PACE Trial
Louise Skelly, Patient & Client Council - Amplifying the Voice of the Patient
Jane Colby at the Named Person Supreme Court Appeal Hearing
JANE COLBY: SUPREME COURT APPEAL HEARING, NAMED PERSON, 2016
The Chair of Trustees and Executive Director Jane Colby of Tymes Trust attended the Supreme Court Appeal hearing in Westminster, 8-9 March 2016
I wanted to speak. I hadn’t anticipated that. I wanted to speak out, but as you know, it wasn’t that kind of hearing. And yet, an unexpected moment arrived when I really wanted to give evidence. Impossible of course. This was an Appeal to the Supreme Court, a war where the weapons are points of law, wielded by lawyers, before five Supreme Court Judges with minds (as was said of Miss Marple) like a bacon slicer.
It was forensic, a relentless examination of legal arguments put forward by QCs, on the one side for the Appellants (against the Named Person/state guardian Law) and on the other, representing the Scottish Government (determined to impose it). And the arguments piled up, one on another, by little and little, till they made a great mountain.
The compulsory Named Person state guardian scheme. What it was, how it came to be what it was, and why it was illegal.
Why it was not illegal.
Why it was “mission creep”, a “service” morphed out of all recognition into a monstrous Jabberwock, gobbling up family rights and shredding their liberty to raise children in freedom.
Why it was not. And why sharing data without permission, without telling parents, was quite permissable.
Why it was not.
And that was where I wanted to speak. Data sharing? Information sharing? What data? What information?
“So often,” I wanted to say, “it’s not data and it’s not information. Not in the true sense of those words and all that they imply. Through being recorded, through being written, through being shared and passed on, it becomes data, it mutates into facts, irrefutable, immutable information about a family, any family. Your family.
“And how did some of this data start out?” I wanted to ask. And I wanted to answer: “As a rumour. Nothing more than over the fence, back of the cab, tittle tattle. Eventually, no-one remembers the fence. Or the chat between neighbours. Or the cab, or the gossip the driver overheard. What do they remember? They remember the documents.”
The Supreme Court building is in every sense, awesome. A Gothic beauty designed, ironically, by a Scot, transformed inside into a glass and leather palace. Each nation of the United Kingdom is symbolised in national emblems formed in illuminated glass and coloured like jewels. Hanging high above us, high above the judges.
Why would we not? This was an occasion of wonder, demanding of full respect and a supreme test of these lawyers’ skills, but it was also a battle for freedom.
This is why Tymes Trust – The Young ME Sufferers Trust – agreed to join this genuine modern day struggle.
However, the iatrogenic disaster that is the PACE trial did not go unchallenged for five years.
It is important that there should be an accurate record of the many challenges which were submitted by numerous people, including Professor Malcolm Hooper, but which were either ignored, dismissed, publicly ridiculed, denied outright or denigrated, for example, as in Nigel Hawkes’ feature article in the British Medical Journal: “Dangers of research into chronic fatigue syndrome -- Nigel Hawkes reports how threats to researchers from activists in the CFS/ME community are stifling research into the condition” (BMJ 2011;342:d3780 doi: 10.1136/bmj.d3780 Page 1).
Hawkes wrote that publication of the PACE results prompted a: “response to the Medical Research Council (MRC), which part funded the trial, and a shorter 43 page rebuttal to the Lancet. Both were written by Malcolm Hooper, emeritus professor of medicinal chemistry at the University of Sunderland, who branded the trial “unethical and unscientific.” He wrote: “Entry criteria were used that have no credibility; definitions and outcome measures were changed repeatedly; data appears to have been manipulated, obfuscated, or not presented at all (so it cannot be checked) and the authors interpretation of their published data as ‘moderate’ success is unsustainable.” Both the MRC and the Lancet have considered the submission and rejected it, the Lancet commenting that the volume of critical letters it received about the PACE trial smacked of an active campaign to discredit the research.
‘It is a relentless, vicious, vile campaign designed to hurt and intimidate’, Professor Wessely says….’These people are sulphurous, vicious, horrible’.
“Professor Wessely is not alone. All of those who approach CFS/ME from a psychiatric perspective are the targets of critics who believe the disease has a physical cause that would have been discovered by now if the debate, and the research money, had not been cornered by what they see as a conspiracy of psychiatrists, characterised by them as ‘the Wessely school’.
“As for Professor Wessely, he gave up active research on CFS/ME 10 years ago. He now specialises in the problems of war veterans. ‘I now go to Iraq and Afghanistan, where I feel a lot safer’, he says”.
Such public disparagement is characteristic of how genuine and legitimate complaints about the PACE trial have been treated. All challenges from within the UK were simply buried without trace, even by Ministers of State.
Indeed, on 6th February 2013 there was a “debate” on the PACE trial in the House of Lords for which, on his own admission, Professor Peter White (Chief Principal Investigator of the trial) briefed all those who spoke in support of it, with the intended result that the study was enshrined in Hansard as an officially-recorded success story.
It was not until David Tuller from America took up the cause that the whole matter was subjected to world-wide scrutiny by academics, medical scientists and statisticians whose views could not be dismissed or silenced.
It is worth noting that currently there are calls for the involvement of UK’s Royal Statistical Society: the RSS has already been involved but was conflicted, so declined to assist (see below).
Welcome to London for the IIMEC11 International ME Conference for 2016.
Invest in ME Research is a UK charity facilitating and funding a strategy of biomedical research into Myalgic Encephalomyelitis (ME or ME/CFS) and promoting better education about ME.
IIMEC11 is the eleventh annual CPD-accredited biomedical research conference organised and hosted by the charity and now attracts presenters, researchers, physicians, patient groups and journalists from twenty countries around the world.
This allows unique networking opportunities and increase the potential for one of the charity's main objectives - international collaboration between researchers.
Below one will find a description of the conference, how to register, the venue and details of the presenters.
Research into Myalgic Encephalomyelitis has emerged into the mainstream of research and is receiving increasingly more attention from both major research institutes in several countries as well as national health organisations.
The IIMEC11 conference will show some of the major initiatives and research taking place to set up a collaborative strategy for biomedical research into ME to make progress in understanding and treating this complex but exciting area of research.
Private M.E. medical practitioner Dr Sarah Myhill will be the guest speaker at the OMEGA Annual General Meeting in Oxford on Saturday, March 5.
OMEGA – otherwise known as there Oxfordshire M.E. Group for Action – have invited Dr Myhill, from Knighton in Powys close to the Welsh borders, to speak on the diagnosis and management of ME/CFS at their meeting in the Oxford Spires Four Pillars Hotel, Abingdon Road, Oxford OX1 4PS.
The meeting in the hotel’s ground-floor Cranmer Room will be held between 2 and 4pm.
There will be a break for refreshment and a chance to ask the speaker questions.
There are plenty of parking spaces, and there are bus stops near to the hotel and it is a five minute taxi ride from the train station. (The bus stops are New Hinksey, Lake Street).
The hotel is about 1.5 miles south of Oxford on the Abingdon Road A4144 – about one mile from the ring road at the Kennington roundabout.
(NaturalNews) In 1971, the MMR vaccine against measles, mumps and rubella was licensed in the United States. Since then, it has been marketed in more than 60 countries around the world under various names such as M-M-R II, Priorix, Tresivac and Trimovax. As recommended by its developers, the first dose of the vaccine is administered to children around age one, while the second dose is administered between ages four and five.
Doubts about the MMR vaccine first became public in 1998, due to a paper published by the world-renowned gastrointestinal surgeon and researcher Andrew Wakefield. In his research, Dr. Wakefield observed that there is a link between the MMR vaccine and gastrointestinal conditions related to autism. He did not recommend that parents should reject the vaccine, but rather that a single vaccine rather than a combo should be implemented.
Now, a new documentary from critically acclaimed journalist Ben Swann exposes the CDC's dirty secrets for the whole world to see. Click here to watch the revealing video, "CDC, Vaccines & Autism."
Dr. William Thompson and the 2004 CDC study
In 2010, Dr. Wakefield's research was found "dishonest" by the UK's General Medical Council. His career was ruined and his name discredited, as the Council barred him and the co-author of the study from practicing medicine. Although he issued challenges to his accusers to debate him in the media, he was of course ignored. Until now.
On August 27, 2014, Dr. William Thompson, who was and remains a scientist at the CDC, hired a whistleblower attorney to make a major statement about the 2004 CDC studyregarding vaccines and autism. As expected, the mainstream media paid little attention to the claim.
Nevertheless, after being secretly recorded by a Dr. Brian Hooker, Dr. Thompson declaredthat he regrets omitting "statistically significant information" in the 2004 article published by the journal Pediatrics. He continued by adding that this data suggested an "increased risk for autism" in African American males who received the vaccine before the age of three. As it was later discovered in the official documents that Dr. Thompson handed over to Congress, evidence about the link between the MMR vaccine and autism was not only omitted but also destroyed by the participating scientists.
When journalist Ben Swann finally managed to get a hold of these documents from congressman Bill Posey, he was joined by other journalists, doctors and CDC specialists in creating a comprehensive documentary on Dr. Thompson's claim, which you can watch here.
The CDC response and interpretation of the study
According to the official statement published by the CDC in response to Dr. Thompson's claims, the 2004 CDC study revealed that vaccination between 24 and 36 months of age was slightly more common among children with autism. This association was most relevant among children aged three to five. However, the authors of the report claimed it was not evidence of a link between the MMR vaccine and a higher risk of autism.
Instead, they assumed that the statistics reflected "immunization requirements for preschool special education program attendance in children with autism." In other words, the CDC claimed that an increased rate of autism among children who received the MMR vaccine before age three was not a case of vaccine injury. According to them, the statistics just appeared this way because children with autism were more likely to be vaccinated before entering a special education program.
Doubt persists among protesters in Atlanta
All of a sudden, it seems that the career of Dr. Andrew Wakefield was buried into the ground for no other reason than scientific curiosity and honesty, as new evidence suggests that he might have had serious reasons for concern regarding the MMR vaccine. Is the CDC, the media or the public going to apologize? No. On the contrary, more studies claiming the absolute safety of vaccines will flourish to cover up previous leaks.
On October 23, 2015, more than 100 protesters gathered in front of the CDC headquarters in Atlanta to demand answers about vaccines. But with all these controversies covered up by the CDC in the past, how much honesty can the people really expect?
The Scandal Of The £5M PACE Trial For ME: What Can Be Done?
'The PACE study is claimed to have negative impact on the way patients are perceived by society'
Over 11,000 ME/CFS patients have signed a petition calling for an independent review of the PACE Trial.
The PACE Trial is a £5 million study promoting the view that ME/CFS patients can recover if they increase their physical activity, claiming that “fear of activity” has fierce negative impact on patients. However, there’s plenty of evidence suggesting otherwise.
Dr Ronald Davis of Stanford University said: “I’m shocked that the Lancet published it… The PACE study has so many flaws and there are so many questions you’d want to ask that I don’t understand how it got through any kind of peer review.”
Even worse, the PACE study is claimed to have negative impact on the way patients are perceived by society and treated in medical practice.
Jo-Anne Dobson MLA is set to join Hope 4 Me & Fibro Northern Ireland in an event titled: The Scandal Of The £5M PACE Trial For ME: What Can Be Done? This exciting presentation, delivered by James C. Coyne PhD, will discuss opposition towards the trial and involve a question and answer session.
James C. Coyne is a professor of psychology at the University of Pennsylvania whose main principle of research has been the coping process in cancer patients and the testing of interventions aimed at affecting these individuals’ wellbeing. He is known for delivering lively lectures that combine science with insight and tenacity.
James has previously criticised positive psychology research that claims a correlation between positive thinking and the progression of cancer and advocates good science and ethical conduct towards patients.
He described himself as: “Irreverent socially concious Clinical Health Psychologist sceptical about hype and hokum in science and medicine and their media representations.”
James and Hope 4 ME & Fibro Northern Ireland are hoping to advocate the importance of science and scientific accuracy when it comes to patient care at this moving and enlightening event.
The professional event is taking place at Stormont Buildings Room 115 on Tuesday 9 February 2016 at 6:30pm.
The open event is taking place at Belfast Castle on Saturday 7 February 2016 3 – 5pm
Jean Martin Charcot was a pathfinding 19th century neurologist with a particular genius for anatomical dissection and postmortem diagnosis, but he may be best known today for his work on ‘hysteria’. In his book Freud, Richard Webster describes Charcot’s ‘classic case of neurotic hysteria’, in which a man named Le Log—– who suffered memory loss, paralysis and seizures after being knocked to the ground by a speeding carriage, was deemed by Charcot to be suffering psychological trauma from the accident. As Webster suggests in his book, such a patient today would be recognized as having ‘a case of closed head injury complicated by late epilepsy and raised intracranial pressure’. But the concept of internal head injuries was not understood at the time, so because Le Log—– had no visible signs of injury, Charcot assumed that the symptoms must be psychological. The poor man was misdiagnosed with ‘neurotic hysteria’ and subjected to psychological therapy, which won’t have done very much to cure his concussion.
Charcot did not invent the concept of ‘hysteria’ but his interest popularized its use and over the years it was applied to epilepsy, multiple sclerosis, Parkinsons disease, cerebral tumours, and a great many other conditions which were not at the time recognized as the physical problems they were later acknowledged to be.
The diagnosis ‘hysteria’ is not in use today but the medical profession’s habit of labeling any patient with symptoms that don’t fit the pattern of a currently recognized pathology as ‘psychologically ill’ remains as prevalent as ever. These days, they use terms like ‘somatization’, ‘conversion disorder’, and ‘medically unexplained symptoms’ but the concept remains the same. Any set of symptoms which aren’t in the medical textbooks is assumed to be ‘all in the head’.
In the 21st century there is really no excuse for this. A quick glance back through history will reveal that time after time this practice has led to misdiagnosis, as medical science has gradually identified more and more genuine physical conditions which were previously dismissed as ‘psychological’. Yesterday’s ‘hysteria’ is today’s epilepsy, today’s MS…
Ironically, while the physical conditions are required to meet precise and stringent criteria for diagnosis, the psychological labels seem to be largely defined by exclusion. ‘If you don’t meet the physical criteria,’ you are told, ‘you must have this other condition we’ve dreamed up…’ No further evidence seems to be needed. The health professional’s opinion is all powerful.
As far as I can deduce, there is no proof that conditions such as somatization actually exist, any more than hysteria did, but even if they may sometimes have some validity, the practice of allocating them to patients by default, just because medical science has not yet defined a specific template for their symptoms, is clearly mistaken.
So why does it continue?
I can only assume it is because it is convenient for the medical profession. Doctors are able to refer patients on for psychological therapy instead of having to admit that the patient’s problem is outside their knowledge, and at the same time it brings in extra work for psychiatrists and psychologists. So everybody wins – except for the misdiagnosed patients of course.
In this environment, is it really surprising that people with ME (myalgic encephalomyelitis) are so often misdiagnosed as having a psychological condition? It’s only the same thing the doctors have been doing for years: assuming that the state of medical knowledge is so advanced that anything not in the textbooks can’t be physically real and must be down to some sort of aberrant thinking on the part of the patient. When you look at it from this perspective, you could argue that the doctors aren’t really picking on people with ME after all. This is just what they do with conditions they don’t understand. They’re done it for hundreds of years. It’s nothing personal to us…
I’m sure doctors think they’re helping their patients by referring them on for psychological therapies – and in some cases they are, of course. Such therapies can be helpful, even where a physical condition exists. CBT (cognitive behavioural therapy) can be of assistance in ME, for instance, if it’s used to address obstacles to pacing such as guilt and ‘people pleasing’. But where it is used – as it predominantly is – hand in glove with GET (graded exercise therapy) to convince the patient there is nothing physically wrong with them and all they have to do to get better is to ignore their symptoms and push themselves regardless, then it can lead to a serious and long term deterioration in the condition, as evidenced by the recent ME Association patient survey.
One of the frequently repeated misapprehensions about people with ME is that we object to a psychological diagnosis because of the stigma it brings. This was most recently voiced by the former BMJ editor Richard Smith (in an otherwise helpful piece which called on the PACE Trial researchers to release their data). He wrote:
“The emotion stems from sufferers from the condition (ME) resenting greatly the idea that it may have psychological causes with the stigma that implies. The resentment seems to be that psychological problems are not seen “real” in the way that physical ones are and that they may result from “moral weakness” rather than a morally neutral virus.”
Goodness knows where Richard Smith got these weird ideas but they’re not something I’ve ever heard from people with ME. The main reason we object to a psychological diagnosis is straightforward enough: because it isn’t accurate. There is now substantial evidence that ME is (as the recent IOM Report describes it) a ‘serious chronic complex systemic disease’ with a growing body of biomedical research studies to support this view. A handy A4 sheet with details of ten such important findings was recently produced by Prof Anthony Komaroff, and the IOM Pathways to Prevention Report makes clear: ‘this is not a primary psychological disease in etiology’.
Furthermore, the psychological misinterpretation of the condition leads to inappropriate therapies which, as mentioned above, can have seriously damaging consequences for patients; it diverts interest and investment away from the biomedical research which is desperately needed; and it provides ammunition for misinformed media coverage like the Telegraph article we saw a few weeks ago, which can seriously damage relationships between people with ME and their friends & family and society in general.
These are the reasons why we want our condition to be recognized for what it is. It has nothing to do with the potential stigma of psychiatric illness. We have no reason to fear such stigma, as the truth is that we already have more than enough of our own. Sir Simon Wessely quite rightly speaks out against the stigma of mental illness, pointing out that such conditions are as ‘real’ and unpleasant as physical ones, but the truth is that this stigmatization seems to be just as prevalent among the medical profession as it is in society at large, and the medics who buy into it seem to reserve special disdain for those they perceive to be mentally ill yet who refuse to accept their diagnosis. It is true that if you’re mentally ill, you tend to be at a disadvantage in dealing with doctors. But if you don’t accept this label and – worse still – don’t respond well to the treatments they give you, then you’re really in trouble.
Welcome to life with ME.
Never mind that there is substantial evidence of biophysical abnormalities and none of an underlying psychological cause, the psychosocial model of ME so beloved of mainstream medicine, especially here in the UK, requires us to forget all that and believe we’re not physically ill – or else risk being seen as a difficult patient. We are asked to believe that the day to day reality of our illness is other than what it is.
In her excellent recent blog post, ‘The Politics of Stigma with ME/CFS’, Catherine Hale quotes the Buddhist author and ME patient Toni Bernhard on this subject: “we have been branded not credible witnesses to our own condition”. Catherine goes on to suggest that ME has been represented as ‘an illness of misperception of reality’.
Yet whose misperception of reality is really the problem here?
We patients with ME are sometimes described as having ‘medically unexplained symptoms’, yet what exactly is ‘unexplained’?
We don’t yet understand the exact mechanism by which our symptoms are produced but if, as the evidence suggests, we have a neuro-immune multi-systemic condition, that is surely explanation enough for why we are suffering.
What is less easy to explain are the many misperceptions of the medical profession:
why any set of symptoms not in the medical textbooks is automatically assumed to be ‘psychological’, even though history shows this has consistently proved to be a mistake
why people with ME are assumed not to be physically ill when there is plenty of credible evidence to show that we are
why we are treated with therapies such as CBT and GET for which there is little evidence of efficacy and which patient experience suggests can be very damaging
why PACE, the largest study in support of these therapies, is assumed to be ‘excellent research’ in spite of innumerable fatal flaws
It seems to me we are the victims not of ‘medically unexplained symptoms’ but of ‘medically unexplained assumptions’.
It is not us, people with ME, who are making these assumptions. But day after day, year after year, we have had to suffer their consequences.
Now, as a new year dawns, perhaps the medical profession will finally start to open its eyes to reality.
2015 brought many encouraging developments:
The US IOM and P2P Reports have reported on the true nature of our condition
New research funding has been announced by the US National Institutes of Health
Prominent researchers such as Ian Lipkin and Ron Davis have spoken of a new urgency to ‘solve the puzzle’ of ME
Even here in the UK, thanks to David Tuller, James Coyne and the work of the many patients and professionals who have chipped away to expose the flaws of the study over many years, pressure is growing on the PACE trial researchers to surrender their data.
Let’s hope that 2016 brings us closer to the day when the mists finally part to reveal the truth, and the mistaken assumptions of decades (and centuries) past are consigned to history.
While the clocks tick by on our lives, we wait to see…
Happy New Year and My Blog Top 10 2015
A Very Happy New Year to readers of my website, your families and friends.
C H Spurgeon’s morning devotional for 1st January –
"They did eat of the fruit of the land of Canaan that year."
Israel's weary wanderings were all over, and the promised rest was attained. No more moving tents, fiery serpents, fierce Amalekites, and howling wildernesses: they came to the land which flowed with milk and honey, and they ate the old corn of the land. Perhaps this year, beloved Christian reader, this may be thy case or mine. Joyful is the prospect, and if faith be in active exercise, it will yield unalloyed delight. To be with Jesus in the rest which remaineth for the people of God, is a cheering hope indeed, and to expect this glory so soon is a double bliss. Unbelief shudders at the Jordan which still rolls between us and the goodly land, but let us rest assured that we have already experienced more ills than death at its worst can cause us. Let us banish every fearful thought, and rejoice with exceeding great joy, in the prospect that this year we shall begin to be "forever with the Lord."
A part of the host will this year tarry on earth, to do service for their Lord. If this should fall to our lot, there is no reason why the New Year's text should not still be true. "We who have believed do enter into rest." The Holy Spirit is the earnest of our inheritance; he gives us "glory begun below." In heaven they are secure, and so are we preserved in Christ Jesus; there they triumph over their enemies, and we have victories too. Celestial spirits enjoy communion with their Lord, and this is not denied to us; they rest in his love, and we have perfect peace in him: they hymn his praise, and it is our privilege to bless him too. We will this year gather celestial fruits on earthly ground, where faith and hope have made the desert like the garden of the Lord. Man did eat angels' food of old, and why not now? O for grace to feed on Jesus, and so to eat of the fruit of the land of Canaan this year!
My Blog Top 10 2015
The Top 10 most popular items of all the things I posted on my blog during 2015 were as follows –
For too long the medical community has dismissed 'Chronic Fatigue Syndrome' as a mental illness which can be cured with therapy and exercise
By Dr Charles Shepherd
9:35AM GMT 07 Dec 2015
Back in 1955, a mysterious polio-like illness affected 262 doctors and nurses at London’s Royal Free Hospital. The hospital had to close for just over three months.
The outbreak was written up in The Lancet and a new neurological disease entered medical language: myalgic encephalomyelitis, or ME, as it still remains in the WHO Classification of Diseases. "Myalgic" referred to the muscle symptoms; "encephalomyelitis" referred to the various neurological symptoms.
Others were not convinced that ME was a neurological disease, and two decades later two psychiatrists, without interviewing any of the patients, wrote a paper for the British Medical Journal where they concluded that the Royal Free outbreak was due to mass hysteria.
The mud from the BMJ stuck. Like most doctors at the time, I left medical school believing that ME was not a real disease and I would probably never see a case. I was wrong.
Ignored or dismissed by doctors, people with ME went undiagnosed or misdiagnosed for long periods of time, often combined with harmful management advice – as is still the case. I can confirm this after developing classic ME following chickenpox, caught from one of my hospital patients. Some developed severe ME, becoming housebound or bed-bound with no medical help. Some never recovered.
During the 1980s, ME was redefined and given a dreadful new name: chronic fatigue syndrome (CFS). The term CFS trivialised a serious medical condition – the equivalent of trivialising dementia by calling it a chronic forgetfulness syndrome – and shifted the focus from a "disease" to a single symptom, "chronic fatigue".
CFS also brought in a much wider group of people suffering from chronic undiagnosed fatigue. A powerful body of psychiatric opinion convinced the medical profession that CFS was basically a mental health problem whereby people became trapped in a vicious circle of abnormal illness beliefs and behaviours, inactivity and deconditioning. In other words, there was no "disease" present.
The CFS model of causation resulted in two controversial forms of behavioural management – cognitive behaviour therapy (CBT) and graded exercise therapy (GET) – being recommended by NICE as the main form of treatment.
Now we have the PACE trial – the largest and most recent assessment of CBT and GET, which has cost the taxpayer almost £5 million. At long term follow-up, and contrary to what was reported in the press, the PACE trial found no significant difference between CBT, GET, adaptive pacing and specialised medical care.
Public reaction to the spin that has been put on the PACE trial results for CBT and GET has resulted in over 10,000 people signing a petition calling for claims relating to so-called recovery to be retracted and six academic researchers calling for an independent review of the study.
By contrast, in evidence collected from 1,428 people with ME by the ME Association, for which I am medical adviser, 73 per cent reported that CBT had no effect on symptoms while 74 per cent said reported that GET had made their condition worse. The MEA has therefore recommended that NICE withdraws their advice relating to GET.
On the progressive side of this medical divide are physicians and researchers who, like the patient community, believe that ME is a serious multi-system disease, often triggered by infection, but maintained by abnormalities involving, neurology, muscle, and the immune system.
In the UK, a research collaborative with a strong emphasis on the biomedical research has been established. And a major report from the prestigious US Institute of Medicine has recently concluded that ME is a "serious, chronic, complex, systemic disease that can profoundly affect the lives of patients". ME is not a psychological problem.
Biomedical research into ME is revealing abnormalities in the way that muscle creates energy, along with evidence of an ongoing overactive immune system response. New types of brain imaging are demonstrating low-level inflammation in several specific parts of the brain.
At the same time, a large multi-centre clinical trial is taking place to assess the use of Rituximab – a drug that depletes immune system B cells and which is normally used to treat a form of cancer called lymphoma.
The argument here is not with mental illness, which is just as real and horrible as physical illness. As with any long-term illness, some people will develop mental health problems where talking therapies can clearly be of help.
The argument is with a simplistic and seriously flawed model of causation that patients know is wrong and which has seriously delayed progress in understanding the underlying cause of ME and developing effective forms of treatment.
Opening the 2015 research collaborative section of neuropathology, Jose Montoya, professor of medicine at the University of Stanford, said: “I have a wish and a dream that medical and scientific societies will apologise to their ME patients.
I agree – the time has come for doctors and scientists to apologise for the very neglectful way in which ME has been researched and treated over the past 60 years. Doctors need to start listening to their patients and there must now be increased investment in biomedical research to gain a better understanding of the disease process and to develop treatments that these patients desperately need.
Dr Charles Shepherd is medical adviser to the ME Association
Huddersfield woman Nathalie Wright talks about the misery of living with ME
In this thought provoking first person feature Huddersfield 22-year-old Nathalie Wright reveals how her life has been devastated by the crippling illness ME. Nathalie grew up in Pole Moor above Slaithwaite, went to Wilberlee Primary School, Crossley Heath School in Halifax and then Greenhead College. Day and night became indistinguishable
I lost my life as I knew it on November 1, 2013.
For many ME sufferers there is a date etched onto their deepest memory, the traumatic day they became ill with an often life-long disease. At my worst I suffered months of being completely bed-bound and was too weak to even clean up my own sick from the floor beside me. I only had the strength to shower every few weeks (sitting down.) I was 22.
Day and night were indistinguishable because most of the time I was not fully conscious in the way a healthy person is. I could simply pass out at any point.
When the crushing fog around my brain cleared even a little it only allowed me to be more aware of the relentless pain in my thighs and chest accompanied by a constant vice-like grip on my skull. A myriad of other symptoms danced round my body to a rhythm I couldn’t understand. Take away from this piece one fact about ME – it severely limits the patient’s capacity to function as a human being. I was reduced to a body on a bed in the prime of my life (yet in the grand scheme of ME suffering, I consider myself to have got off relatively lightly.)
My ME story began, as is very common, with a fever. I was a final year student studying English at Oxford University and was happy and fulfilled, looking forward to the future. When the fever hit I was working on some coursework and so asked for an extension as I just did not seem to be getting better. My request was denied.
The subsequent weeks were a blurred mix of confusion and helplessness as I felt myself slip further and further into the nadir of the disease. Why couldn’t I move? Why couldn’t I eat? Why could no doctors help me? You may think that with such a serious disease I would have been offered extensive medical support, but the opposite was true. Several GPs brushed me aside as being ‘a little stressed.’ When I asked another how long I could expect to be so severely ill she simply replied: “How long’s a piece of string?” Not only was I condemned to this tortuous illness, but my sentence was indefinite. I was forced to suspend my studies.
Months later when I finally got a referral to hospital (all the while languishing in a house I shared with strangers where I could barely cope to look after myself at all), I was finally officially diagnosed. “You’ll be back up and running in no time” grinned the specialist. I wanted badly to believe him but his words did not reflect reality.
As so often happens with poorly understood illnesses, attempts were made to psychologise my ME. I reluctantly saw a hospital psychologist who seemed determined to find a cause in my immediate environment. After 40 minutes of desperate floundering it seemed he’d hit the jackpot.
“Where did you go to school?” he asked. I told him, Huddersfield. Nodding sagely and narrowing his eyes he asked: “Are you having a hard time with the posh boys at Oxford?”
That was all the NHS had to offer me.
The relentless avalanche of ME symptoms completely took away my life and such a profoundly disturbing change in physical health is enough to drive anyone to despair.
I remember thinking, often, ‘I both feel like I’m dying and want to die so that I can stop feeling like I’m dying.’
Yet I think the worst consequence of such a disease is the sheer loneliness of it. I saved and treasured my scarce grains of energy to be able to have human interaction, often spending more energy on masking my symptoms and trying to appear as well as possible – I was so ashamed of my ME.
It seemed impossible to make friends and family understand exactly what was happening. Common responses included: “You’re just depressed” or even “this is just an ‘illness behaviour’ and not a real disease.”
However, often complete silence is the most hurtful response. As is common when a young women is in any kind of distress I felt I was dismissed and disbelieved while at the same time I was also blamed for it. It must have been that I was working too hard; it must have been that I only did four hours of exercise a week instead of six; it must have been that I was doing too much exercise. This added up to me eventually doubting every aspect of my being and sense of self – something I’m still trying to recover from.
Oxford University is often a terrible place to be sick. Determined to finish my degree I struggled on a year later under what is an enormous workload for anyone. As is usually the case at Oxford, even though I had suspended purely on medical grounds I was asked to sit nine hours of exams (including my extra time) to be ‘allowed’ back on my course. My protestations that that would make me extremely ill were all but ignored, although I managed to battle my way to just one penal exam with my tutor’s admonishment to ‘toughen up’ ringing in my ears.
I want to end this piece by saying that my ME is currently extremely life limiting, but nevertheless, I have improved a lot and am much better than thousands of severe sufferers around the world who literally can’t speak and are often ignored even when they break their backs to utter a cry of pain.
There are in-person ME support groups but it is a recurring joke in my head that people with ME are always too ill to attend them anyway – sometimes black humour gets you through a bad day. I stumbled across one such voice online which is where the ME community thrives and is an incredibly supportive environment. This voice was so ill and in such pain that it was simply asking others how best it could kill itself.
ME was my gateway to the world of the sick and often the barrier between the two worlds seems unsurmountable. How can you verbalise your body? How can the healthy understand sensations that no body should feel? This is why, when sick people speak it is of utmost importance that we are listened to, and listened to without judgement.
For ME, more biomedical research is needed urgently. In the meantime, the skills of listening and empathy are free.
I, along with millions of other sufferers around the world, want help and we want answers. Oxford University recently published follow-up data to its 2011 trial undertaken in partnership with Queen Mary and Kings College universities. The trial aimed to prove that the best treatment for ME (which they call ‘CFS/ME’) is cognitive behavioural therapy (CBT) and graded exercise therapy (GET).
However, the trial, known as the PACE trial, has been highly criticised internationally and in the UK. Dr Ronald Davis of Stanford University commented: “I’m shocked that the Lancet published it. The PACE study has so many flaws and there are so many questions you’d want to ask about it that I don’t understand how it got through any kind of peer review.”
Indeed, according to the trial’s definitions, ME patients were deemed ‘recovered’ even if they had physical function similar to someone with congestive heart failure. For me, the impact of such misleading claims not only increase the stigma I experience but is actively dangerous. GET was found to make over 70% of patients worse, according to a study conducted by the ME association.
The reason why this is so makes complete sense to any ME sufferer. The defining feature of ME is something called PEM or post exertional malaise (if one thing, ME has honed my acronym skills). This means if I exert myself physically or even mentally I will experience a worsening of all my symptoms, possibly for days or even weeks. If I walk too far at once (say 100m rather than 50m) I will feel sick and faint. Several times I have passed out in public or had to sit of the floor if a queue in a shop is too long. It’s humiliating, but I have thick skin now. I used to be a cross country runner.
The UK trial is contradicted by a landmark report made by the American Institute of Medicine this year which examined all the current evidence and came to the conclusion that ‘ME/CFS is an acquired, chronic multi-systemic disease characterised by significant relapse after physical, cognitive, or emotional exertion of any sort.’ In contrast to the PACE trial which selected patients solely on the basis that they experienced ‘fatigue’ for at least six months, the IOM report states that: ‘The disease includes immune, neurological and cognitive impairment, sleep abnormalities and autonomic dysfunction, resulting in significant functional impairment accompanied by a pathological level of fatigue.’
The report found that ME patients are more functionally impaired than those with type 2 diabetes mellitus, congestive heart failure, hypertension, depression, multiple sclerosis and end-stage renal disease.
Further responses to the article in The Telegraph about the PACE Trial
An open letter to Dr Richard Horton and The Lancet
Dr. Richard Horton
125 London Wall
London, EC2Y 5AS, UK
Dear Dr Horton:
In February, 2011, The Lancet published an article called “Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomized trial.” The article reported that two “rehabilitative” approaches, cognitive behavior therapy and graded exercise therapy, were effective in treating chronic fatigue syndrome, also known as myalgic encephalomyelitis, ME/CFS and CFS/ME. The study received international attention and has had widespread influence on research, treatment options and public attitudes.
The PACE study was an unblinded clinical trial with subjective primary outcomes, a design that requires strict vigilance in order to prevent the possibility of bias. Yet the study suffered from major flaws that have raised serious concerns about the validity, reliability and integrity of the findings. The patient and advocacy communities have known this for years, but a recent in-depth report on this site, which included statements from five of us, has brought the extent of the problems to the attention of a broader public. The PACE investigators have replied to many of the criticisms, but their responses have not addressed or answered key concerns.
The major flaws documented at length in the recent report include, but are not limited to, the following:
*The Lancet paper included an analysis in which the outcome thresholds for being “within the normal range” on the two primary measures of fatigue and physical function demonstrated worse health than the criteria for entry, which already indicated serious disability. In fact, 13 percent of the study participants were already “within the normal range” on one or both outcome measures at baseline, but the investigators did not disclose this salient fact in the Lancet paper. In an accompanying Lancet commentary, colleagues of the PACE team defined participants who met these expansive “normal ranges” as having achieved a “strict criterion for recovery.” The PACE authors reviewed this commentary before publication.
*During the trial, the authors published a newsletter for participants that included positive testimonials from earlier participants about the benefits of the “therapy” and “treatment.” The same newsletter included an article that cited the two rehabilitative interventions pioneered by the researchers and being tested in the PACE trial as having been recommended by a U.K. clinical guidelines committee “based on the best available evidence.” The newsletter did not mention that a key PACE investigator also served on the clinical guidelines committee. At the time of the newsletter, two hundred or more participants—about a third of the total sample–were still undergoing assessments.
*Mid-trial, the PACE investigators changed their protocol methods of assessing their primary outcome measures of fatigue and physical function. This is of particular concern in an unblinded trial like PACE, in which outcome trends are often apparent long before outcome data are seen. The investigators provided no sensitivity analyses to assess the impact of the changes and have refused requests to provide the results per the methods outlined in their protocol.
*The PACE investigators based their claims of treatment success solely on their subjective outcomes. In the Lancet paper, the results of a six-minute walking test—described in the protocol as “an objective measure of physical capacity”–did not support such claims, notwithstanding the minimal gains in one arm. In subsequent comments in another journal, the investigators dismissed the walking-test results as irrelevant, non-objective and fraught with limitations. All the other objective measures in PACE, presented in other journals, also failed. The results of one objective measure, the fitness step-test, were provided in a 2015 paper in The Lancet Psychiatry, but only in the form of a tiny graph. A request for the step-test data used to create the graph was rejected as “vexatious.”
*The investigators violated their promise in the PACE protocol to adhere to the Declaration of Helsinki, which mandates that prospective participants be “adequately informed” about researchers’ “possible conflicts of interest.” The main investigators have had financial and consulting relationships with disability insurance companies, advising them that rehabilitative therapies like those tested in PACE could help ME/CFS claimants get off benefits and back to work. They disclosed these insurance industry links in The Lancet but did not inform trial participants, contrary to their protocol commitment. This serious ethical breach raises concerns about whether the consent obtained from the 641 trial participants is legitimate.
Such flaws have no place in published research. This is of particular concern in the case of the PACE trial because of its significant impact on government policy, public health practice, clinical care, and decisions about disability insurance and other social benefits. Under the circumstances, it is incumbent upon The Lancet to address this matter as soon as possible.
We therefore urge The Lancet to seek an independent re-analysis of the individual-level PACE trial data, with appropriate sensitivity analyses, from highly respected reviewers with extensive expertise in statistics and study design. The reviewers should be from outside the U.K. and outside the domains of psychiatry and psychological medicine. They should also be completely independent of, and have no conflicts of interests involving, the PACE investigators and the funders of the trial.
Thank you very much for your quick attention to this matter.
Ronald W. Davis, PhD
Professor of Biochemistry and Genetics
Jonathan C.W. Edwards, MD
Emeritus Professor of Medicine
University College London
Leonard A. Jason, PhD
Professor of Psychology
Bruce Levin, PhD
Professor of Biostatistics
Vincent R. Racaniello, PhD
Professor of Microbiology and Immunology
Arthur L. Reingold, MD
Professor of Epidemiology
University of California, Berkeley
ME isn’t just ‘exercise phobia’: it’s a physical illness
Imagine you’re diagnosed with epilepsy: what would you think if you weren’t referred to a specialist but taken to a psychiatrist to treat you for your ‘false illness beliefs’?
This is what happens to Myalgic Encephalomyelitis (ME) patients in the UK. They are told to ignore their symptoms, view themselves as healthy, and increase their exercise. The NHS guidelines amalgamate ME and Chronic Fatigue Syndrome, assuming symptoms are caused by deconditioning and ‘exercise phobia’. Sufferers are offered Graded Exercise to increase fitness, and Cognitive Behavioural Therapy (CBT) to rid them of their ‘false illness beliefs’.
Enter Spectator writer Rod Liddle, who’s baffled by ME patients wanting better treatment than this. The culprit, he claims, is not the therapy, but society’s stigma of mental illness. With a strange logic, he asserts that because ME patients deny that they have a psychiatric disorder, this proves they have a psychiatric disorder.
Meanwhile, people are quietly dying of ME. ME sufferer Emily Collingridge died, aged 30; Victoria Webster died at just 18. People don’t die from ‘exercise phobia’. ME is not ‘lethargy’ and ‘aches and pains’, as Liddle claims. Severe ME is lying in a darkened room, alone, in agonising pain, tube-fed, catheterised, too weak to move or speak.
Sophia Mirza was such a person. Her doctors believed ME to be psychiatric, so police broke into her home, carrying her by force to a psychiatric institution to pursue Graded Exercise Therapy. She never recovered, and died soon afterwards of ME, aged 32. The cause of death was officially recorded as ‘Chronic Fatigue Syndrome’. Her autopsy revealed indisputable, pathological proof of the disease.
Though Graded Exercise helps some, the ME Association reports 74 per cent of ME patients are harmed by the therapy, with some made permanently disabled. Dr Julia Newton ran electrical pulses through muscle biopsies; Dr Van Ness tested anaerobic thresholds of ME patients – both studies demonstrated ME patients are damaged by exercise.
What about the claim, by the PACE trial, that Graded Exercise Therapy and CBT can treat ME? This is a trial where you could enter moderately ill, get worse in the trial, and be declared ‘recovered’ at the end. Even the recent follow-up study conceded that, long-term, Graded Exercise and CBT are no better for ME than doing nothing. Investigative journalists and academics alike have dismissed the PACE trial as ‘clinical trial amateurism’.
Like MS or epilepsy, which were also once wrongly believed to be psychiatric disorders, ME is a neurological disease, and the World Health Organisation lists it as such. I am too weak to walk more than a few metres, needing to lie in bed 21 hours a day. With the little energy I have, I am an ME patient activist.
Patients are releasing awareness documentaries, petitioning the NHS to reform their guidelines so that fewer patients are harmed, and asking for medical journals to retract misleading claims of recovery from the PACE trial. Liddle may see this as ‘blind fury’; I think our eyes are wide open.
When I first heard The Telegraph had featured an article concerning a follow-up study of the notorious PACE trial I was inclined to ignore it1. I’ve long become used to the appalling coverage of ME by the British media2 and felt I didn’t need to read any more disinformation disseminated via the Science Media Centre. However, I cracked and had the misfortune to read an article written by Sarah Knapton that is the worst I have seen in the thirty years I have been ill with this disease, which considering the competition is an impressive achievement1.
The article clearly implies ME is a non-illness, the suggestion in the headline that a bit of positivity and exercise could cure sufferers merits no other interpretation. One wonders what spin was put on the latest study by the SMC, as the results of this research bear no similarity to its reporting in the press. Indeed, flawed as the PACE trial is, at no point do the researchers suggest GET or CBT cure ME, as claimed by Ms Knapton in her inaccurate and mendacious article1.
Most in the ME community are aware of the substantial problems with the PACE study, including the selection criteria, the self-reporting and lack of objective measures, a flawed methodology, which have been outlined in detail by various authors including Angela Kennedy, Professor Malcolm Hooper, Tom Kindlon, Jane Colby, the late Dr Elizabeth Dowsett and, most recently, David Tuller in the US. Unfortunately the UK media continues its obsession with treating ME as a non-illness affecting lazy people whose only problem is their inability to pull themselves together and push through their fatigue, which seems to be the only symptom the media acknowledge.
To start Knapton states:
‘Chronic Fatigue Syndrome is not actually a chronic illness and sufferers can overcome symptoms by increasing exercise and thinking positively, Oxford University has found’1.
Not a single word in that opening paragraph is accurate. The study included a large number of participants who probably did not have ME as the primary criteria for participating was fatigue. Despite this the PACE trial was only able to establish that some participants showed mild improvement while undergoing GET and CBT (though these were self-reported, subjective results). Participants remained ill and severely limited in their ability to perform normal daily activities. To repeat, any positive results revealed by the trial were barely notable yet according to Knapton,
‘The new study found that graded exercise therapy (GET), in which sufferers gradually increase activity levels, as well as cognitive behavioural therapy (CBT), which encourages positive thinking and behaviour, had a dramatic impact’1.
A definition of dramatic: sudden and striking, impressive3
The PACE trial in no way justifies such an adjective, a more accurate description would be, ‘a negligible impact’ though this would not have supported the slant of Knapton’s piece.
Her next paragraph aggravates matters,
‘The finding is important because many CFS sufferers believe that exercise will make their condition worse.’1
Sufferers do not believe, ME is not a religion (the proponents of the psychosocial model and their media acolytes exhibit cult-like behaviour but that’s a separate issue). ME sufferers know exercise can make their condition worse through first hand experience of the damage it can cause, something supported by scientific studies illustrating physiological damage(4,5).
Two more paragraphs in the article were particularly disturbing:
‘But gradually increasing exercise and therapy to remove patients’ negative thoughts that they would never get better seemed to work. Prof Sharpe said the study was likely to prove controversial because a “minority” believe that CFS is either caused by a virus or is chronic and cannot be alleviated.’1
In what other chronic illness would sufferers be accused of contributing to their illness due to their ‘negative thoughts’? A more clear case of blaming the patient is hard to imagine and to make such a statement with zero evidence to support it, is unworthy of an academic. Suggesting that only a minority believe a virus triggers the disease and that it is chronic is not only untrue, there has never been any suggestion that ME is an acute condition, but a use of language designed to offend ME sufferers. The following paragraph continues in the same vein,
Prof Sharpe added: “It’s wrong to say people don’t want to get better, but they get locked into a pattern and their life constricts around what they can do. If you live within your limits that becomes a self-fulfilling prophesy.”1
There is no science to substantiate anything the professor states in this sentence and I can think of no other illness in which a researcher would speak of sufferers in such a fashion, it is immoral, breaches the Hippocratic Oath and constitutes abuse of a vulnerable group of patients.
Another point to make, highlighted by John Cohen in Science6, is that the basis of the original trial’s supposed success has been undermined by this latest study. The PACE trial claim that GET and CBT were the best treatments for ME is demolished by the finding in this latest study, which revealed that all therapy options produced the same results. To quote John Cohen,
‘After analyzing the responses, the researchers concluded that the benefits reported in the original study, which assessed participants at 1 year, were maintained for at least another 1.5 years. But the participants randomized to receive the two interventions that initially did nothing also improved, and there “was little evidence of differences in outcomes” when compared with the people in the other treatment groups’5.
Sharpe et al try to explain this by claiming that participants undergoing other therapies switched to GET and CBT in the intervening period but there is no evidence to support this conclusion. I’d also like to query what condition participants are in now, as the suggestion that any improvement was maintained for ‘at least another 1.5 years’ implies their health could have declined after this period of time.
Knapton’s article provides a list of ME symptoms, which exclude post-exertional malaise (PEM) arguably the defining symptom of the illness. It also includes a link to a video featuring Martine McCutcheon talking about the lightning process, telling you all you need to know about the malicious intent behind this article.
‘These are not magic cures’ says Sharpe. Apparently Sarah Knapton disagrees.
A final comment from Professor Sharpe:
‘It’s sometimes quite hard to understand what motivates the very vocal minority that gets upset by this apparently benign bit of moderately helpful treatment’1.
Perhaps some of the headlines in the British media this morning will enlighten the good professor as to why so many in the ME community are upset by his ‘treatment’.