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!
Science, Politics, .......and ME: A health scandal in our generation
by Dr Ian Gibson (Author), Ms Elaine Sherriffs (Contributor)
The Dedication –
To all patients suffering from ME and their families and carers. You have been let down by governments, healthcare departments, the media and by those in positions of influence who could have made a difference but have totally failed you.
From the back cover –
Few diseases can have been so maligned by false information, so manipulated by an insidious establishment-controlled ideology, or so poorly dealt with by those holding the purse-strings for research into the disease, than Myalgic Encephalomyelitis (ME).
This book examines a scandal in our generation – a scandal still being played out by corrupt, apathetic, inept or ignorant attitudes in governments and Medical Research Councils and health services.
One of the authors (Dr Ian Gibson) in his ‘ Retirement’ has written this book with a political friend (Elaine Sherriffs). Ian Gibson has a passing interest in the current political scene across the world and regularly speaks on these issues. When it comes to universal health, he has pointed out on many occasions that governments often ignore scientific evidence. ME, as described in the book, is a major problem where evidence is relegated to psychiatric explanations. It is a desperate need for scientists as far as health issues are concerned to look for biomedical evidence and ME is a major example. This book describes the political manoeuvring which features just like those in the TV programme The House of Cards in the USA & the UK which described the games that are played in both parliaments. He has previously addressed these problems in an early book in 1981 – called ‘Class, Health & Profit’.
Ian and Elaine have penetrated the murky world of politics which features in the world of ME. It is long past the time to treat this as a serious illness and the need for serious biomedical research. This will only come about when politicians and the media stop trivialising the illness.
Science, Politics …… and ME is a book which will serve as a reference for the dark times, when patients were ill-served by the clash of interests between truths and untruths. It is also a book which comes at a time where a brighter future may be in the making for people with ME and their families.
Two ME Films
There are two short films about ME that have recently been produced and I would recommend them to you.
A 10 minute film on ME was shown on Carte Blanche, South Africa’s longest-running TV investigation show, on 20 February 2017. It has won plaudits from around the world for its straight talking about this illness, and choice of interview subjects – particularly Dr Ron Davis and David Tuller. The UK ME Association has made the film available on it’s website and you can watch it by clicking here.
In the other film, which lasts for 18 minutes, Dr Ron Davis presents an ME/CFS research update from his lab at the Stanford Genome Technology Centre in California, USA. The Centre has made significant breakthroughs towards understanding the molecular mechanisms of the disease and is now in a position to test chemical compounds for treatment.
The film is available to watch on YouTube, thanks to the Open Medicine Foundation – click here – and you can read a transcript of all that was said on the ME Association website by clicking here.
Three New Items On The Margaret Williams website -
The OMEGA petition organisers wish to thank all supporters who have added their names to the OMEGA Petition as well as heartfelt comments about the way in which they as the service recipients of ‘ME’ research wish to see that research being carried out in their name. We would like to think the OMEGA Petition can stand as a documented challenge to ‘MEGA’ illustrating that those who support ‘MEGA’ do not have the mandate they claim. The following letter has been sent to many researchers and interested parties so that they cannot claim to be ignorant of this challenge. We will only update if or when a significant change occurs which relates to this petition. The petition therefore remains open for the time being. We invite everyone to continue to share and sign the petition in support – https://www.change.org/p/opposing-mega-a-vote-of-no-confidence-in-mega-research-for-me-cfs
Letter to Mainstream Research Funders
FAO: All persons with responsibility for research grant applications
CC: Any persons with an interest in the above
NB: This is a serious matter of public interest so please acknowledge receipt of this letter and note that correspondence will be in the public domain
To whom it may concern,
This letter is to inform you that a majority of people reject calls by the M.E./CFS Epidemiology and Genomics Alliance (a project of the UK CFS/ME Research Collaborative) to support their forthcoming submissions for funding for their research proposals.
MEGA created a petition addressed to ‘mainstream research funders’ on a public petition site and this petition was publicised on internet sites of CMRC member charities representing ME patients, from 28th September 2016.
A number of valid concerns about this call for funding were not allayed by subsequent correspondence with members of the board of CMRC. Thus a counter-petition was posted on 19th October on the same petition site as used by MEGA to provide an option to register rejection of calls for mainstream funding of their study proposals.
Supporters of the counter-petition were described by a charity representative member of the CMRC Board as ‘a vocal minority’ and the Chairman of the board wrote that they were ‘baffled’ by opposition to the MEGA proposals, in spite of having read carefully considered and in some cases, quite detailed explanations of the various concerns.
The ‘MEGA’ petition was open for 35 days. It closed on the evening of 2nd November and has 2,542 signatures. The counter-petition ‘Opposing MEGA’ had 2,912 signatures at 35 days (currently over 3,000). This shows that more people rejected the call by MEGA for mainstream research funding than supported it within the same amount of time.
It is understood that the MEGA petition was a means to demonstrate the weight of support from patients for forthcoming grant applications. In that respect it has not succeeded as it is now a matter of public record that the majority of patients have cast a vote of no confidence in MEGA and reject calls for mainstream research funding applications by an alliance formed by the CMRC.
It will not suffice for MEGA or CMRC to reassure research funders that patients are represented on their steering and monitoring committees and advisory groups or that patient concerns will be taken on board. Such measures have not served the best interests of ME/CFS patients over decades past and there is no reason to suppose there will be any change in this position going forward. Indeed great harm has been caused to many ME/CFS patients with the same establishment charities involved as are currently represented in the CMRC.
In addition we are informed that the children and young persons representation will be taken from an existing group working within the University of Bristol. We must assume that this group of young people will already be involved in other trials being conducted by MEGA applicant, Professor Esther Crawley – MAGENTA and FITNET-NHS – both of which are already embroiled in controversy. These young people will, therefore, be already subjected to bias and influence.
Dr. David Tuller, academic coordinator of the concurrent masters degree program in public health and journalism at the University of California, Berkeley, explained:
“Dr. Crawley is a professor of child health at the University of Bristol. She is also currently recruiting for the MAGENTA study of graded exercise therapy for children with the illness. She is a lead player in the U.K. CFS/ME Research Collaborative, an umbrella organization that is sponsoring an ambitious Big Data effort called MEGA, now in the planning stages. While patients and advocates are desperate for the kind of top-notch biomedical and genetic research being proposed, many oppose MEGA precisely because of the involvement of Dr. Crawley and Peter White, the lead PACE investigator. (Dr. White is reportedly no longer involved in MEGA; Dr. Crawley still definitely is.)”
The PACE trial has been debunked internationally by leading clinicians and scientists, and 42 experts signed an open letter to The Lancet, condemning its egregious flaws and noting that they “have no place in published research.” The PACE trial has even been presented as a case study of bad science in graduate epidemiology seminars and at major scientific gatherings. MAGENTA relies on the PACE trial as evidence of efficacy of graded exercise therapy in adults. The PACE trial results have been shown to have been grossly exaggerated to claim positive effects of psycho-behavioural therapies, and in any case, had shown null effect at long-term follow-up. FITNET-NHS relies on a Dutch study, with methodologcal flaws, and which showed null effect of the treatment trial at long-term follow-up. As the MEGA team have consistently refused to answer all questions about PACE, and are even relying on it for funding of current treatment trials, we submit that the MEGA applicants are attempting to build a research project on crumbling foundations and should receive no further funding under any guise.
We would draw your attention to a number of parliamentary questions raised by Kelvin Hopkins MP regarding matters of conduct, policy, and funding, as these relate to individuals and organisations, including patient charities, involved in the MEGA proposal and on the board of the CMRC, and reflect the central concerns raised in the Opposing MEGA petition and the conclusion that we have no confidence in MEGA.
It is imperative that research funders are aware of the majority view in response to the request by MEGA for support of their proposals and the legitimate concerns behind this majority view. This is, of course, particularly important where those funds are from the public purse and when better value for money can be gleaned by using existing resources.
As Prof Jonathan Edwards, Emeritus Professor of Connective Tissue Medicine, stated on the Phoenix Rising Forum:
“Of course it would be nice to have a big study of lots of things in lots of patients but it needs to be done carefully and it will cost a vast amount of money to do that. I think it likely that the money would be better spent in other ways. We already have a Biobank resource and a method for recruiting cohorts – which could be improved but is a good start. I strongly suspect that several metabolomic and genetic and other projects are already being set up with reasonable sized samples elsewhere in the UK”.
The international scientific and clinical community is on the verge of establishing biomarkers for accurate diagnosis of this complex disease, known for research purposes as ME/CFS, and it would be foolhardy to fund a fishing expedition at this stage. However, we must emphasise that our petition is not primarily concerned with the details of the protocol, but rather with the insurmountable and serious matters of research conduct and integrity.
Patients and professionals alike were misled over the PACE trial from its inception to the present day. Children are among the patients suffering daily from the consequences. We cannot afford as a civilised society to repeat nor perpetuate this mistake.
Thus, we submit this letter and Opposing MEGA petition, along with its comments, as an outright rejection of calls by CMRC/MEGA for mainstream research funding and request that you ensure this letter and content is brought to the attention of all personnel in your organisation with responsibility for research funding applications.
We are willing to provide you with further information upon request. We would strongly recommend that you take note of the comments on the petition, the various updates posted and the Opposing Mega website https://opposingmega.wordpress.com/
A Travesty Of Science And A Tragedy For Patients: Quotable Quotes Continued 2006 – 2016
This document is in 4 sections: Professors Wessely, White, Sharpe and the PACE Trial
Compiled by Margaret Williams
17th December 2016
To assist the reader, as this document is quite lengthy, notable sentences have been highlighted in yellow.
In his power-point presentation on 29th June 2011 about the PACE Trial for the “Forward ME” meeting at The House of Lords, Professor Malcolm Hooper referred to the ME situation in the UK as: “The 3 Ts – Travesty of Science; Tragedy for Patients and Tantamount to Fraud”.
The tragedy for ME patients in the UK existed long before the PACE Trial: it has existed for the last three decades. Can it be attributed to the zealous proselytizing by certain psychiatrists – all of whom are involved with the medical insurance industry and who deem themselves “experts” on ME/CFS - to convert non-believers to their own beliefs about the nature of it?
As in “Quotable Quotes Updated” (which provided examples of unhelpful comments about people with ME/CFS from 1988 to 2005 emanating from psychiatrists Professors Simon Wessely, Peter Denton White and Michael Sharpe and can be accessed at www.margaretwilliams.me), this continuation provides more illustrations of their published views on ME/CFS from 2006 to 2016. It is not comprehensive but merely representative.
In order to understand the effect on patients with ME of the Wessely School’s beliefs and their total disregard of the mainstream biomedical evidence-base that has been shown to underpin the disorder (evidence which vitiates their beliefs), it is essential to be aware of that evidence-base, particularly of the widespread inflammation and the proven immunological, cardiovascular, endocrine, gastrointestinal and musculoskeletal dysfunction, summaries of which can be accessed at www.margaretwilliams.me
One would have expected that these psychiatrists would have kept up-to-date (which doctors are required to do) but their views have remained intransigent (ie. They continue to insist that ME/CFS is a behavioural disorder and that patients who believe they suffer from a physical disease perpetuate their own “perceived” ill-health).
Although some of these quotations are from ten years ago, they were published during the planning/execution of the PACE trial, whose interventions of CBT and GET were predicated on these psychiatrists’ beliefs.
For the last six years, I have fought to legitimize an illness widely—and erroneously—believed to be “all in your head.”
I have myalgic encephalomyelitis, a debilitating multi-system disease that the Centers for Disease Control and Prevention conservatively estimates afflicts more than one million Americans. It is commonly known as chronic fatigue syndrome, a truly trivializing name that belittles what I and other sufferers live with. (Though it is preferable to the condescending term “yuppie flu.”) Doctors have told many people with the disease—including myself—that there is no treatment, and more often, that what we are experiencing is merely a manifestation of the mind.
The latter is the basis for psychosomatic theory, which is the idea that the mind can produce diseases. Diseases commonly thought to be psychosomatic—such as irritable bowel syndrome and Crohn’s disease—can pummel a healthy, thriving member of society without any indication of how. This theory became popular in the US in the early 20th century; Sigmund Freud is the most well-known name associated with it, who maintained that “hysteria” could cause any number of physical illnesses.
Similar theoretical concepts like somatoform disorder suggest that the body can only cope with a finite amount of mental factors before physical symptoms, like headaches, begin to show. But there is a substantial difference between an acute problem like a stress-related headache and claiming that a serious chronic illness is psychosomatic. With the exception of chronic migraines, a headache is generally considered to be an acute symptom, not a chronic illness.
Dr. Dale Peterson, former president of the Oklahoma Academy of Family Physicians, is even more adamant that physiological disease cannot be caused by mental factors. “Psychological and sociological dynamics may predispose an individual to illness or cause an illness to be much more severe, but other factors must be present to trigger the condition,” he says.
The idea that a disease can be generated from the mind not only lacks scientific evidence—it is belittling to those who suffer from physical illnesses. As Dr. Peterson explains, for someone in the medical field to say a physiological illness is psychosomatic is merely “a professional way of saying I don’t have a clue!”
I contracted myalgic encephalomyelitis after a bad case of mononucleosis in 2010 (an illness often jokingly referred to as the “kissing bug”). Within the first year, my condition had deteriorated to the point where I could no longer take care of myself; I had become bedridden, and eventually lost my ability to speak, eat, tolerate light, or lift my head off the pillow. Through a daily regimen of oral anti-viral medication and IV treatments, my health eventually started to improve. I can now speak polysyllabic words, chew soft food, and sit up in bed to see the sunlight streaming across my room.
But these improvements have had nothing to do with changes in my mental state; I did not will them to happen. Instead, my body was given the proper medicine to improve its physiological impairment.
Regardless, many doctors still disregard my ailments as some form of psychosomatic illness. But sometimes technology just isn’t advanced enough in order to reveal the true underlying physical symptoms behind a disease. For example, until the invention of the MRI in the 1970s, multiple sclerosis was believed to be a form of “hysterical paralysis.” Likewise, some forms of autism, particularly in children, were once thought by some psychologists to be due to a lack of maternal nurturing. Similarly, until inflammation could be measured, asthma was also commonly blamed on overbearing mothers. We all now know that these three diseases have true, physiological causes—not mental ones.
While these illnesses have largely overcome psychogenic theories, other physiological illnesses still face similar stigmas: Inflammatory conditions like Crohn’s disease, stomach ulcers, and irritable bowel syndrome (IBS) still carry psychosomatic overtones—usually stress-related—even though they have been proven to have physiological origins. Researchers at the University of Edinburgh, for instance, have compiled an overview of studies that link Crohn’s disease to factors such as genetics, immune function, and gut bacteria, not psychogenesis.
A lot of this misinformation has spread widely throughout popular culture despite being proven scientifically unsound. For example, a study published in 2011 in the Lancet, a prestigious UK medical journal, used psychosomatic theory to claim that cognitive behavioral therapy (CBT) substantially benefited people with myalgic encephalomyelitis. The study, known as the PACE trial, was eventually debunked and proved to be the product of bad science—but not before it had influenced public-health services to adopt treatment models, many of which actively harmed patients by prescribing exercise to severely ill patients based on psychogenic models.
There is hope, however. After all, multiple sclerosis and autism have managed to transcend the stigma of outmoded psychosomatic theory. But until the government and medical establishment realizes that psychosomatic theory has no place in modern medicine, diseases like mine will continue to be stigmatized, trivialized, and dismissed.
By Catherine Mackenzie, Christian Focus Publications, 7 December 2016
Christian Focus Publications would like to extend its sincerest condolences to the family and friends of our dear Helen Roseveare, who passed away this morning. She dedicated her life to serving others even in the deep trials of life. She pioneered vital medical work in the rainforests of what is now the Democratic Republic of Congo and was an internationally respected speaker with WEC ministries. We are thankful at Christian Focus for Helen’s ministry through the books we have been blessed to publish. She spent her life in service for the Lord and today she is with Him, worshipping Him, in heaven.
Catherine Mackenzie, Children’s Editor at Christian Focus, shares the impact Helen Roseveare had on her life.
This morning a good friend and encourager Helen Roseveare passed away, she had been longing to go home to be with Christ. Now this has happened we who remain look back at her life and rejoice in the work that the Lord gave her and in the witness she gave to his worthiness.
It was eleven years ago that I met Helen Roseveare for the first time. She had not long celebrated her eightieth birthday. I’d read her books and knew her story and somehow or other I had been invited to stay with her in Belfast. It was great to actually meet one of my heroines. She was not only encouraging, she was challenging. It was an environment – all be it just for a weekend – where I felt safe to be honest with her and Pat, her friend, about the challenges and struggles of my own little life. Even though she had been through so much herself (if you don’t know what I mean then read her books) my problems didn’t feel too insignificant to share. And the words she gave me before I left on the flight from Belfast to Inverness were straight forward – just telling me to keep on going. And I’m thankful to her and to God that I have through His strength.
After that she came over to my congregation to do a conference. It was there that she gave, as part of her message, four little words that I believe were the backbone to her life and reinforced, for me, the message of her books, the message she gave me before I left Belfast and the message her Lord and Saviour, Jesus Christ, gives all believers.
“Jesus is Worth it”.
Towards the end of that conference I had the pleasure of taking her and Pat for a tour of the Black Isle – a Scottish peninsula near Inverness. What took place at lunch that day is one of several distinct ‘Helen and Pat’ memories that will stay with me for the rest of my life. If you’ve not met either of them – let me describe these two women of God… in two words (believe me I could pick another 100 words to describe them and I wouldn’t do them justice.)
Smart. They both graduated in medicine at a time when to be a female graduate in any discipline like this was rare.
Cosmopolitan. Both travelled extensively – before the easy days of online booking and satnav.
But if you had been the couple sitting beside us in the restaurant that day you wouldn’t have looked twice. You would have presumed ‘they’re just two little old ladies’. But that’s one point where the church and the world differs – God’s kingdom never puts the word ‘just’ before any category of believer – particularly little old ladies.
Our neighbouring diners were given a visual and audible lesson in this when, after lunch, Pat and Helen’s conversation went as follows:
“I don’t think we’ll ever be able to get back to Afghanistan but it is a beautiful country, and the Lord is at work there…” – or words to that effect.
As my chin dropped I could see the looks on the people at the table beside us as they turned and stared. Two women they had just spent the last hour ignoring were talking about a trip they had made to what was now one of the most notoriously violent countries in the world.
Helen and Pat started reminiscing about people who had lived and worked in that region and about the brief time they had spent in a nation that was now in the thick of a conflict that threw up words like Taliban and Terrorist.
I drove them back to my parent’s house and before too long they were on their way back to Belfast discussing, no doubt, their plans for the development of the girl’s clubs they were involved in and the future fundraising for their local church.
So don’t make assumptions about little old ladies… especially when you hear the word church and missionary in the same sentence … they may very well have been where we will never go, have done what we wouldn’t dream of, and have given up what we just aren’t willing to.
Helen Roseveare was a little old lady, during the time I knew her, but really age didn’t come into it. She was a woman after God’s own heart and Jesus was the one that her heart longed after. She’s with him this morning – still part of the church as she worships more fully in heaven. We who remain, continue as she did once to long for home.
Parliamentary Questions asked by MP Kelvin Hopkins
Kelvin Hopkins, Member of Parliament for Luton North, has addressed some written parliamentary questions about ME/CFS research and treatment recommendations to the Department of Health and Department for Business, Energy and Industrial Strategy.
He asked if the Secretary of State for Business, Energy and Industrial Strategy will request that the Medical Research Council conducts an inquiry into the management of the PACE trial to ascertain whether any fraudulent activity has occurred; and if he will prevent the PACE trial researchers from being given further public research funding until an inquiry into possible fraudulent activity into the PACE trial has been conducted. The Department for Business, Energy and Industrial Strategy indicated on 25th November that it will not be possible to answer these questions within the usual time period and that answers are being prepared and will be provided as soon as they are available.
Two further questions by Kelvin Hopkins, which are currently awaiting answers, ask the Secretary of State for Business, Energy and Industrial Strategy, if he will take steps to identify those responsible for the Medical Research Council’s policies towards ME research over the last decade; and if he will seek those people’s removal from positions of influence over future of ME research; and if he will review the policy of the Medical Research Council (MRC) in so far as it relates to addressing the dissatisfaction of ME patients with MRC’s approach in this area.
Kelvin Hopkins also asked questions of the Secretary of State for Health regarding review of the NICE guideline and treatment recommendations. The answer was –
The National Institute for Health and Care Excellence (NICE) is an independent body and is responsible for ensuring that its guidance remains up to date. NICE has advised that it has brought forward the next review date for its guidance on the diagnosis and management of chronic fatigue syndrome/myalgic encephalomyelitis from 2019 to 2017 to coincide with the expected publication of relevant new evidence.
NICE’s aim is to make a decision on whether an update of the guideline is required by the end of 2017.
The Opposing MEGA petition organisers have not been in contact with Kelvin Hopkins, but these parliamentary questions are relevant to our rejection of the call by MEGA for ‘mainstream research funding’ which stands to amount to at least £9m.
MEGA (M.E./CFS Epidemiology and Genomics Alliance) is a project of the CFS/ME Research Collaborative (CMRC). The CMRC formed in 2013 following on from the last CFS/ME ‘Expert Group’ of the Medical Research Council (MRC).
The MRC co-funded the £5m+ PACE trial, designed to provide evidence that the psycho-behavioural and graded exercise therapies recommended by the National Institute for Health and Care Excellence (NICE) are effective and cost effective treatments for ME/CFS, along with the Department for Work and Pensions and other co-funders.
The PACE trial was led by Professor Peter White of Queen Mary University London (QMUL). The university spent some £200k of public funds appealing a decision by the Information Commissioners Office for release of raw data from the trial for analysis by independent researchers. A tribunal upheld the ICO decision, published August 2016.
Professor Esther Crawley of the University of Bristol relies on the PACE trial as research evidence to support funding applications for studies into paediatric ME/CFS. She stated, during the extensive media coverage of her new FITNET trial at the beginning of November 2016, that PACE was a “great, great study”, and further demonstrated a lack of comprehension by misrepresenting the results of the recent reanalyses of the PACE trial data.
Esther Crawley is Vice-Chair of the CMRC and is listed by MEGA as an applicant in their petition to mainstream research funders. MEGA announced on 3rd October 2016 that Peter White had retired from the group and will have an advisory role.
Confusingly then, Chair of the CMRC Professor Stephen Holgate, has put in writing that MEGA and the CMRC have no connection with the PACE trial or Peter White now that he has retired.
It is refreshing to read that Kelvin Hopkins has asked such pertinent parliamentary questions, as the answers that various people are receiving in writing from members of the CMRC Board about MEGA sound as though they are coming from establishment politicians rather than scientists or medical doctors, and only serve to make us ever more certain that we are right to have no confidence in MEGA.
In case you missed it, unlikely but kudos if so, today (1 November) has seen considerable media coverage of the proposed FITNET trial  (of course the acronym has to include the word ‘fit’) being run by Professor Esther Crawley. Costing £1 million, we yet again see large sums of money being spent on studies promoting the biopsychosocial (BPS) model of the disease rather than decent biomedical research. Crawley’s trial draws on a Dutch study which showed no difference between treatment cohorts at long term follow up , though the BBC and their scientifically illiterate journalists imaginatively and dishonestly spun this as a 2/3rd cure rate. Again the laziness and uncritical reporting of any story concerning ME, promoted as usual by the Science Media Centre (SMC), by the UK media is glaring. They even dragged out their old canard, supposed victimisation of the brave researcher (that would be Crawley) by nasty ME activists, said researcher ‘heroically’ carrying on despite abuse from a minority of patients. Such claims were conclusively debunked by the recent First-Tier tribunal Judgement , which ordered the release of the PACE trial data but apparently no one told the BBC.
Today’s coverage of FITNET cannot be treated in isolation and should be compared with earlier reporting of the PACE trial by the British media, which was unfailingly enthusiastic, one-sided and uncritical. Both trials have been strongly promoted by the SMC, whose press releases are repeated more or less verbatim by the media, without any attempt to investigate the accuracy of their claims. This is possible in today’s media due to a combination of laziness, establishment cronyism and a lack of scientific understanding amongst journalists reporting on these issues. The extensive coverage of studies promoting the BPS model of ME is in stark contrast to the virtual non-reporting of any biomedical research. The failure of the media to cover the recent dismantling of PACE, extensively covered elsewhere but barely mentioned in the UK press, was particularly revealing. One would think there was a media blackout, with such coverage as there was focused more on defending the PACE researchers than exposing their fraudulent study.
Had the media noted the flaws in PACE and the reasoning that underlines such studies so they might have been able to interrogate Crawley regarding the potential flaws in her study. The fact that the participants in the FITNET study will be children, makes it more morally questionable, though her focus on fatigue as the primary symptom suggests many trial subjects probably won’t have ME, as was the case with PACE. No doubt this will flatter her results if/when they are published, not always guaranteed with Crawley as demonstrated by the SMILE trial .
It was inevitable the exponents of the BPS model would push back, ably abetted by the SMC, given the recent disaster that was PACE. The timing seems convenient given the IACFS/ME conference that recently ended in Florida, revealing promising biomedical studies  which you’ll have no hope of reading about in the British media. I find professor Stephen Holgate’s comments about FITNET, in which he promoted the study as an example of ‘high quality research’ particularly concerning for two reasons:
1 Crawley’s study is the converse of quality research CBT has yet to cure anyone suffering from a debilitating neurological disease
2 Both Holgate and Crawley* are involved in the proposed MEGA study, given their views this does not instil me with confidence regarding how this study will be conducted
Those promoting the MEGA study , including several ME charities, are encouraging patients to sign a petition in its support, an unprecedented action in the field of scientific research and arguably unethical. To expect ME patients to put their trust in a study involving Crawley in such a powerful role is, in my opinion, expecting too much, whatever the quality of the other researchers involved. Especially as those new to the field of ME are likely to put their trust in researchers with the most experience in the discipline, lacking the knowledge of just how flawed that experience is with its strong bias towards the psychological model of the disease. Considering these circumstances, I would encourage people to consider signing the OMEGA petition opposing MEGA  instead and direct their energies towards gaining funding for high quality ME research, an increasing amount of which is taking place, especially outside the UK.
One final point about today’s coverage of the FITNET trial and the free publicity professor Crawley has received to promote her controversial views. Dr Charles Shepherd, Medical Adviser to the ME Association, was apparently unaware this issue was going to be covered by the media, claiming complete ignorance . This is unacceptable. Our charities should be taking the lead in responding to such harmful propaganda**, as would be the case with any other disease, and their absence ‘missing in action’ on such an occasion, leaving us exposed to this reporting, is letting down the ME sufferers they are meant to be representing to an unforgivable degree.
Since writing this piece it has been brought to my attention that James Gallagher, the BBC’s Health Editor who so enthusiastically promoted FITNET, is on the advisory committee of the Science Media Centre that controlled today’s coverage (and pretty much all media reporting relating to ME). I don’t remember his pointing out this potential conflict of interest and I shall be making a formal complaint to the BBC (thanks to Jamie Sugg for bringing this to my attention).
*Needless to say the BBC failed to point out Holgate’s link to Crawley when reporting his comments
**Some charities are more culpable than others and I would exclude Tymes Trust from this description and recommend children suffering from ME to visit them for information about the disease (please avoid AYME)
Following yesterday's impressive media hijack by the Science Media Centre (there was no actual story; it was simply manufactured for the occasion, complete with misleading reference to the counterpart Dutch study), the total absence of a coherent media infrastructure within the UK's ME patient community became - yet again - painfully obvious. Alongside the urgent need to ramp up lobbying for an expedited review of the NICE Guidelines (in light of recent research developments outside the UK), this is arguably the most yawning gap within ME advocacy and requires immediate attention if this pattern of events is ever going to change (as anyone familiar with the last 60 years of our history will know).
There is little that individual patient advocates, bloggers or small groups can do to address this media imbalance; the only possible solution is to engage external expert, high-level professional advice and assistance to initiate a rapid, comprehensive media strategy. However, this could only be obtained via a broad coalition of the ME charities and groups who purport to represent the interests of patients. My attempts to negotiate that (as with the NICE Guidelines review) have yielded no results so far - and I think it's unlikely that they ever will.
I have been writing about this media lacuna for some time now. For example, in January 2015, I wrote this in a blog post:
"The complete absence of a visible patient narrative became painfully evident last week. The mainstream British media’s wilfully ignorant coverage of ME patients’ perceived “fear of exercise” gave the headline writers a field day (examples here and here). Journalists appear to have regurgitated mindlessly a press release from the Science Media Centre’s relentless propaganda machine and failed to make any responsible enquiry into the real story. Subsequent rebuttals from the charities limped in on the back foot; positive and corrective commentary was drowned out in the general furore; patients and supporters rallied but we were all too late to the party.
Why? How could this happen yet again? Because it can. Because that real story – patients’ actual lived experience – is invisible and therefore not officially documented. Accounts of individual patients’ experiences appear occasionally (usually in local media or the comment/blog sections of national media) but their impact is relatively low and they may even serve to normalise – rather than flag up the scandal of – the way in which the condition is treated and portrayed. Chronically sick ME patients are not up to the Herculean task of funding and managing a long overdue strategic initiative to disseminate our real story pro-actively and deflect negative publicity effectively. But without such a campaign in place, it will happen again; we will remain without a platform from which either to speak or to generate our own record for the archives.
Do media stories really matter? Yes, of course they do – because those stories are subsumed into the source materials which constitute our collective history. If there can be no aggregation of fair and accurate records, then history is falsely written and becomes a mere propaganda tool."
A UK medical research group called MEGA (M.E./CFS Epidemiology and Genomics Alliance) has set up a petition for public support to help them obtain millions of pounds (estimated minimum £9m) from research funding bodies for a prospective study of a neurological disorder known for research purposes as ME/CFS (Myalgic Encephalomyelitis/Chronic Fatigue Syndrome).
The professional ethics of petitioning the public for support in order to obtain research funds and petitioning support of a vulnerable community of patients/carers is questionable.
The MEGA petition includes words such as 'biological' 'biomedical' 'big data' 'potentially game-changing' - clickbait for patients/carers desperate for definitive diagnostic tests and medical treatments, yet updates show how little thought and planning has been given by the research team to their own proposal. They had not even thought of including the 25% most severely ill patient cohort in their proposed 12,000 participants.
A closer look at the MEGA petition reveals that key members and advisors of MEGA are involved in the discredited PACE trial, and the MAGENTA trial in children with ME/CFS which follows from the PACE trial, run by leaders of the bio-psycho-social (BPS) movement known collectively as 'The Wessely School'.
The BPS illness model of ME/CFS assumes that biological abnormalities and physical symptoms are caused or maintained by psychological or social problems and may be treated by changing the patient's thoughts and behaviours.
Decades of research shows that no matter how much 'bio' is found in ME/CFS (plenty has been found) it is interpreted by BPS proponents as due to psychosocial causes and amenable to behavioural therapies rather than signs of disease suffered through no fault of the patient or carer.
The BPS researchers and representatives involved in MEGA have already wasted millions of pounds of research funds in attempts to validate their model in ME/CFS by providing policy-based evidence for the psychosocial treatments recommended by the UK National Institute of Health and Care Excellence (NICE) prolonging suffering and causing immeasurable harm to patients and families.
There is no further room for The Wessely School, BPS model, or those advised by The Wessely School, in any context associated with the disease Myalgic Encephalomyelitis.
Following the Tribunal Decision published August 2016 upholding the decision by the Information Commissioner in favour of Matthees and providing for the release of raw data from the PACE Trial, which has subsequently proved that Trial to be a sham, it would be unreasonable to trust the very same people to have the best interests of patients at heart.
Thus in signing this petition we reject calls from the ME/CFS Epidemiology and Genomics Alliance to create any proposal for a ‘big data’ study, or any study of any description, regarding it as inevitably and irrevocably tainted.
No more wasting time, money, lives – not in our name.
There are genuine opportunities for UK biomedical researchers to get involved in ME/CFS research and to really make a difference to millions of people's lives. It is not a case of 'MEGA or nothing'.
KARINA HANSEN, “PRISONER OF DENMARK”, IS HOME AT LAST.
On Monday 17 October 2016, after three and a half years of incarceration, Karina finally returned home to her family. The arrangement was on a trial basis but in the hope and expectation that she would be finally and permanently back where she belongs.
In recent weeks, Karina’s condition had improved slightly and her parents were able to visit her on a regular basis (more detail in my previous post). As a result, meetings took place between those in charge of the Clinic at Hammel where she had been an inmate since February 2013 (see Karina’s Story below for background) and representatives of Karina’s family. An arrangement for Karina’s return home was agreed whereby her parents would take her home within the next few days and she would remain there for a trial period. If all went well, she would stay on at home permanently.
Significantly, Karina was well enough to sign a document saying that she wanted to go home with her parents. Although she was still unable to speak, she was able to communicate via gestures that she understood the plan and wished it to happen.
The trial period has now passed without incident and so Karina and her family have decided that they want to share the news with their friends and supporters all over the world.
Karina has finally come home.
A request for privacy
It is Karina’s birthday on 7 November, the first one she will have been able to enjoy at home with her family since 2012. Her supporters all over the world will be celebrating with her. There are various groups (on Facebook, for example) with more details of how to get involved.
The Hansen family is very grateful for the huge amount of support and many good wishes which they have received over the last few years. However, this is a time of enormous re-adjustment and they would like to request that, once Karina’s birthday is over, their privacy is respected. Karina has a long way to go with her recovery and her family members need time to adapt to their new situation and reflect on how to process the traumatic events of recent years.
Regular readers of this blog will be familiar with Karina’s horrifying story (as detailed in my series of posts) and with the often appalling treatment of ME patients generally. However, for new readers, and those needing a reminder, here is a summary:
ME patients in many countries are still routinely referred to psychiatrists who use the inappropriate, and sometimes dangerous, psychosocial treatment model; patients are frequently unable to access medical treatment with a knowledgeable physician. There is still no recognized diagnostic pathway or treatment for ME – and definitely no cure, despite the claims made by some.]
Inevitably, Karina’s diagnosis became the subject of a prolonged dispute. Her family continued to care for her at home, in accordance with her express wishes. However, in February 2013, then aged 24, she was forcibly removed from her home by a large team of police, doctors and social workers. She was taken to Hammel Neurocenter, against both her own will and that of her family. Hammel is part of “The Research Clinic for Functional Disorders” at Aarhus University Hospital.
Several doctors have been involved in Karina’s case but psychiatrists Nils Balle Christensen and Per Fink were in charge of her treatment at Hammel. Shortly after her initial detention, she was classed as a “voluntary” patient, despite having been taken there against her will; she was found by a court subsequently to lack capacity to make her own decisions. As a result of that finding, the court appointed a legal guardian to take responsibility for her welfare and make decisions on her behalf. Her condition deteriorated rapidly after her admission to the Clinic.
Three years on, in February 2016, Karina remained a de facto prisoner of the state. She had been moved to a nearby rehabilitation center but allowed very little contact with her family. Her father was permitted to visit her in December 2015. Whilst she was physically clean and cared-for, she was apparently immobilized, in a wheelchair and unable to speak except for incomprehensible mumbling and grimaces. At that time, she did not appear to recognize her own father.
During the course of 2016, I have written a series of blog posts chronicling and analyzing Karina’s story from my perspective as a lawyer, a journalist and a long-time ME patient. On 12 October, I wrote a short update detailing the changes which were beginning to come about in Karina’s condition. Although she still could not speak, her ability to communicate with gestures was increasing, her mobility was improving and her parents had been able to visit on a regular basis during the preceding weeks.
Official comments on Karina’s case
Regular readers may recall from earlier articles in this series that I contacted (via an academic colleague who is an expert on Open Justice in European countries) the Danish Ministers for Health and Justice and Hammel Neurocenter. These requests for comment were made in February 2016.
* The Minister for Health replied two months after the original request and refused to comment on the basis of patient confidentiality (although the request was worded as a general inquiry rather than for specific information about Karina).
* The Minister for Justice sent standard acknowledgments and eventually responded in July (nearly six months after the original request). The reply simply referred the inquiry back to the Minister for Health.
* Per Fink replied within two days on behalf of himself and Hammel. In summary, he stated that all patients are there on a voluntary basis and that the clinic is very popular
The Clinic has been contacted again for comment about Karina’s return home. I will update this article when I receive a response.
Where are we now?
The status of Karina’s legal guardian will need to be resolved formally by the Court. Whether or not his role in these proceedings (see previous posts) is subjected to any further scrutiny is another matter. Only time will tell. And there are other issues such as ongoing medical treatment which will still need to be addressed so the story is not necessarily over yet.
However, the question which I asked in Karina Hansen 3: Update March 2016 remains unanswered: “In the absence of any clear explanation, the inevitable question arises: [was] her condition the direct result of a state-orchestrated plan which went horribly wrong?” Perhaps this question will be addressed if there are any further legal proceedings in relation to these events.
How much damage has been done to Karina and her family remains to be seen. After three and a half years in an institutional environment, there will be considerable adjustments and adaptations to be made. It is to be hoped that plans have been put in place and that appropriate support will be made available to them.
Significance of Karina’s story for the future
Karina’s story is horrifying. It is a story which should be of the utmost international concern, as a salutary reminder not only of a shocking breach of one young woman’s rights but also of the continuing scandal of the appalling treatment and stigmatization of ME patients all over the world.
It is also of supreme importance that a permanent record of these events is publicly available as reference material for the future. That is why I have invested so much time and effort into researching and writing this series of articles (always whilst battling through my own brain-fog, one of the hallmark symptoms of ME and, for me, the most difficult of all to live with).
But, for now, the international ME community can celebrate the fact that Karina is free at last.
I would like to thank Bente Stenfalk of Borgerretsbevægelsen (Civil Rights Movement Group in Denmark) for keeping me up to date with the Group’s work in assisting Karina and her family.
I would also like to thank Rob Wijbenga from the Netherlands for his support and assistance.
I have lived with the illness ME since 1981. For more information see About.
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).