Saturday, 21 April 2018

Forward ME – Meeting with Dr Diane O’Leary about possible WHO coding changes


ME Association - Forward ME – Meeting with Dr Diane O’Leary about possible WHO coding changes - 21 April 2018


Forward ME

Notes of meeting held on Wednesday 28 March 2018

1. Apologies

Hannah Clifton ME Trust, Dr Paul Worthley ME Trust, Dr Gareth Tuckwell ME Trust, Bill and Janice Kent ReMEmber, Cath Ross 25% ME Group, Tony Crouch 25% ME Group, Christine and Tanya Harrison BRAME.

2. Present

Carol Monaghan MP, Dr William Weir, Dr Charles Shepherd ME Association, Jane Colby Tymes Trust, Sarah Reed #MEAction, Clare Ogden Action for ME, Countess of Mar (Chairman).

3. Science Media Centre

There was discussion about the Science Media Centre Factsheet “CFS/ME – The illness and the controversy” which was published on the SMC website on 20 March 2018. It was agreed that the Chairman would write to the Chief Executive and to the Chair of the trustees of the SMC to object to the inaccuracies and distortions and to request that the factsheet be retracted.

4. Dr Diane O’Leary

Dr O’Leary presented a paper on the move within the WHO International Classification of Disease team working on the ICD11 revision to reclassify a number of disorders previously grouped as MUS (medically unexplained symptoms) into one large symptom cluster with criteria that would be used in primary care and which would ensure that all patients who qualified would be offered mental health care rather than medical care. None of these criteria were evidence-based.

(See “Bodily Stress Syndrome” info sheet).

The group discussed Dr O’Leary’s concerns and various actions were suggested. These included:
  • Publication of the info sheet on Forward-ME website with members either linking to it or publishing it themselves. It was agreed that this would not be done until after 12 April 2018 as there were to be discussions with the WHO.

(N.B. Subsequently, it was decided between the Chairman and Dr O’Leary to publish the info sheet as it was important that the information be disseminated as soon as possible).
  • The Royal Colleges of Physicians and of General practitioners might not be aware of the effects that this reclassification would have on their members’ diagnosis of patients’ symptoms so the Chairman agreed to write to them.

  • Other organisations representing people with MUS should be alerted so that, if they wish, they can make representations to the WHO. The Chairman would find as many of them as possible.

It was agreed that there should be another meeting soon so that further activities could be organised.

Note: A further communication about the possible changes to WHO coding has subsequently been placed on the Forward ME website dated 9 April 2018.

5. Any other business

Christine Harrison reported to the Chairmen that she was in regular contact with staff from Capita and that they were working on a new training programme for health professionals.

Charles Shepherd said that he was doing the same with Maximus.

Bill and Janice Kent asked that they be involved in any action that was to be taken with regard to BSS.

6. Date of next meeting

The next meeting would be held at 2.00 pm on Tuesday 1 May 2018.

Monday, 16 April 2018

Myalgic Encephalomyelitis, Chronic Fatigue Syndrome, and Systemic Exertion Intolerance Disease: Three Distinct Clinical Entities



Frank N.M. Twisk

Abstract

Many researchers consider chronic fatigue syndrome (CFS) to be a synonym of Myalgic Encephalomyelitis (ME). However, the case criteria of ME and CFS define two distinct clinical entities. Although some patients will meet both case criteria, other patients can meet the diagnosis of ME and not fulfil the case criteria for CFS, while the diagnosis of CFS is largely insufficient to be qualified as a ME patient. ME is a neuromuscular disease with distinctive muscular symptoms, including prolonged muscle weakness after exertion, and neurological signs implicating cerebral dysfunction, including cognitive impairment and sensory symptoms. The only mandatory symptom of CFS is chronic fatigue. Chronic fatigue must be accompanied by at least four out of eight nonspecific symptoms: substantial impairment in short-term memory or concentration, a sore throat, tender lymph nodes, muscle pain, multijoint pain, a new type of headaches, unrefreshing sleep, and postexertional “malaise” lasting more than 24 h. So, regardless whether the name ME is appropriate or not, ME is not synonymous to CFS. That is not a matter of opinion, but a matter of definition. Due to the definitions of ME and CFS, “ME/CFS” does not exist and cannot be replaced by a new clinical entity (SEID: Systemic Exertion Intolerance Disease), as recently suggested. View Full-Text

Friday, 13 April 2018

I Am Stuck In The Prison That Is ME

Ellie Bunce 

https://www.huffingtonpost.co.uk/entry/i-am-stuck-in-the-prison-that-is-me_uk_5acf4ab8e4b0648767777931

I had hopes of being an Olympian - now I’m bed-bound with an illness some people think doesn’t exist. 

ME, two simple letters that can rip apart everything you worked for and everything you ever dreamt of.

Myalgic encephalomyelitis is a soul destroying disease that leaves so many bedridden without anyone knowing.

I’ve had ME for two years now after coming down with glandular fever in Easter 2016. At the time I was 19, a student athlete - in my second year of university - with hopes of rowing internationally. I was fit, active, I ate well, I exercised. I was happy and positive and yet one day I woke feeling as if I was dying. It was like my whole body ached, in a way I’d never felt before - I felt drained of everything I had. I knew instantly something was wrong.

After calling 111 it was thought I had meningitis and an ambulance took me to A&E where various tests showed I had nothing wrong and was sent home with a suspected viral infection. However, that evening my tonsils went bright white and swelled so much I couldn’t breathe or swallow. Again I called 111 and was sent to an out of hours doctor where I was told I had tonsillitis.

A course of antibiotics cleared up my throat but I never felt the same again. Training was hard, I was always in pain and out of breath. After a week my tonsils flared up again. This time I was told in was glandular fever and to rest.

Months and months went past and I never got better.

Eventually it was thought I had chronic fatigue syndrome (ME). Since then I’ve spiralled downhill, getting more poorly everyday. From what I know, ME is an inflammation in my brain and nervous system which has left me in excruciating chronic pain, poor cognitive function, a weakened immune system and chronically fatigued.

Day to day every inch of my body is in pain, I struggle to read and concentrate, I’m sick, I’m too tired to move, bright lights hurt my eyes, loud noises hurt my head. I spend upwards of 20 hours in bed a day in order not to “crash”. In my crashes, I scream in pain, unable to talk, or move. My whole body shakes, my eyes roll. It’s like my whole body is screaming at me to stop.

Some days, when I feel a little better for an hour or two, I’ll see a friend. I look well. Nothing looks wrong with me. They don’t see me lying in bed screaming in pain. No one understands what truly goes on behind closed doors. People will ask me if I feel a bit tired. Or stare at me if I stand up after using a wheelchair. I’m questioned if it’s my mental health. If I’m lazy.

Have you ever laid in bed and felt so ill that you truly thought you were going to die?

ME is a hugely misunderstood and unheard of illness.

For years it was misdiagnosed and not believed. I’ve struggled with various doctors not understanding the condition and suggesting treatment, which in fact, made me worse. The first ‘specialist’ I saw suggested it was my personality.

He said, I should make more effort to wake up at 9am get showered, dressed and then go on a long walk. This was my ‘treatment plan’. However, the more I pushed myself to get out of bed, the more ill I got.

Imagine how you would feel if haven’t slept in three days, you caught the flu, had the worst hangover of your life - and you had to run a marathon feeling like this. This is how I feel everyday.

Having ME can leave me feeling invisible, unheard and misunderstood. It has lead to me developing various other conditions, such as depression, anxiety, eczema, migraines and tonsillitis. Because my immune system has been weakened I also regularly get viral infections on top of this.

My mind often wonders what I wish I could do if I wasn’t ill. I am stuck in the prison that is ME. When you are stripped of your hobbies, talents, energy and work then who do you become?

ME has made me become stronger mentally. I now find joy in the little things - a cuddle with my puppy, the blue sky, the sound of birds singing, the warm sun on my face.

I extremely grateful for all my family, relatives and the close friends who understand. I know it is hard for them to see me crumble into a shell of my former self. I live in the hope that one day doctors will find a treatment, one day there will be funding for more research, and one day I will be better.

The ME Association is at the forefront of improving access to care, treatment and research and removing the disease’s stigma.

MEA medical adviser Charles Shepherd said: “Several quality of life research studies have shown that the level of disability in ME can be just as great than many other serious medical conditions, including cancer and multiple sclerosis.

“While some some people with ME do improve over the course of time, it is only a small minority that return to full normal health.

“Despite being recognised by the World Health Organisation as a neurological disease, and a report from the Chief Medical Officer of Health calling for more research and a network of hospital based clinics, many doctors still don’t know how to diagnose and manage ME/CFS and lack or research means that we still don’t have any effective forms of treatment.

“This is a completely unacceptable situation for a disease that is twice as common as multiple sclerosis and where a new report has estimated that is costing the UK economy around £3.5 billion in lost taxes, healthcare and benefit costs.”

For more information on ME, or to donate towards research, visit the ME Association website: www.meassociation.org.uk 


Friday, 6 April 2018

Forward-ME Group Letter to the Science Media Centre, April 2018

http://www.meresearch.org.uk/news/forward-me-group-letter-science-media-group/

Forward-ME Group Letter

Forward-ME Group Chair, The Countess of Mar, has written on behalf of the members of the Group to the Chief Executive of the Science Media Centre asking for the SMC “to retract and replace your factsheet on CFS/ME, published on 21 March 2018”. The letter continues that the factsheet, entitled “CFS/ME – The illness and the controversy” “……. includes numerous inaccuracies and distortions; it denigrates patients and some doctors; it fails to reflect the numerous peer reviewed papers, published since the release of some of the raw data from the trial following legal action, which demonstrate serious defects in the PACE trial, and it fails to take into account the extensive research from the USA published since 2014. This will all have been available to you.”

The full text of the letter is as follows –

“Re: Science Media Centre Factsheet – CFS/ME – The illness and the controversy.

On behalf of Forward-ME I write to ask you to retract and replace your factsheet on CFS/ME, published on 21 March 2018, following the publication of a paper by Dr Carolyn Wilshire of the University of Wellington, New Zealand, which found that the findings of the Principal Investigators of the PACE trial were ‘not robust’ and showed ‘no long-term benefits’.

The factsheet includes numerous inaccuracies and distortions; it denigrates patients and some doctors; it fails to reflect the numerous peer reviewed papers, published since the release of some of the raw data from the trial following legal action, which demonstrate serious defects in the PACE trial, and it fails to take into account the extensive research from the USA published since 2014. This will all have been available to you.

The factsheet states: “CFS/ME is highly controversial with longstanding disagreements between the mainstream medical community and campaigners about its cause and treatment”. It also states that “amongst the mainstream medical research community, CFS/ME and NICE recommend management that is not especially controversial.”

These claims are patently inaccurate. The mainstream medical community in the USA concluded that the “campaigners” have actually been correct about the nature of the condition, stating that “ME/CFS is a serious, chronic, complex systemic disease” (Academy of Medicine), that it is not a primary psychological disease in aetiology” (National Institutes of Health). They state that guidance for managing ME/CFS should include a “declaration that the disease is not the result of fear-based avoidance of activity”, and a clear indication that the disease is not a psychiatric or somatoform disorder” (Chronic Fatigue Syndrome Advisory Committee of the Department of Health and Human Services). There certainly is controversy and disagreement at this time, but that disagreement is not between professionals and “campaigners”. It is between professionals in the UK and professionals elsewhere.

The factsheet claims that: “After sustained pressure from activists the CDC has removed mention of CBT and GET from its website”. This, too, is patently inaccurate and even a cursory investigation of the facts would make that clear. The CDC changed its recommendations at the urging of the Academy of Medicine, the National Institutes of Health, the Department of Health and Human Services, and the Agency for Healthcare Quality and Research, all of whom emphatically agree that the CDC’s former recommendations – that is, the current NICE recommendations – lack evidence based support.

The author of the factsheet states that existing evidence in favour of CBT and GET is “cited by the scientific community”, as if there are no reputable members of the scientific community, and no reputable health policy authorities who disagree. They go on to state that “those who disagree …. cite review articles and reanalyses of trial data published in low impact factor journals such as The Journal of Health Psychology and Fatigue: Biomedicine, Health and Behaviour”.

It is concerning that a reputable resource like the Science Media Centre would publish such a grossly inaccurate claim, one that can be so readily overturned. Those who disagree with the evidence for CBT and GET cite the extensive investigations of the US governmental health authorities. In particular they cite the Agency for Healthcare and Research Quality Publication No. 15-E001-EF, “Diagnosis and Treatment of Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome”. That document is readily available online and a quick investigation will reveal that it offers a very long and detailed list of unscientific practices and biases in the research that claims to support CBT and GET. There are a great many such reports by US governmental health organisations. It is unacceptable for the Science Media Centre to write as if these investigations did not take place; as if these documents do not exist – and it is unacceptable not to note that, by comparison, the professional reputations of these organisations far outstrip those of the PACE trial researchers.

The reality is that at this time there are no US governmental health authorities who agree that the PACE trial is “good quality”. It is absurd for any “Factsheet” on ME/CFS to overlook this fact.

Your Trustees’ Report for the year ended 31 March 2016 gives among the SMC objectives its overall goal to help to achieve the aim of the House of Lords Science and Technology Committee which sought to renew public trust in science “by working to promote more balanced, accurate and rational coverage of the important science, health and environment stories that appear in the media.” In the case of the promotion of the science relating to CFS/ME the Science Media Centre have singularly failed in its objectives over many years.

If you are not prepared to retract this factsheet I regret that we have no option but to report our concerns to the Charity Commission.

I look forward to hearing from you shortly.

Yours sincerely

Countess of Mar

Chairman – Forward-ME

Copy to: Professor Jonathan Baker, Chair of Trustees.”

By way of background information, the Science Media Centre (a registered charity) has as its stated mission “To provide, for the benefit of the public and policymakers, accurate and evidence-based information about science and engineering through the media, particularly on controversial and headline news stories when most confusion and misinformation occurs.”  It states that it provides “journalists with what they need in the timeframe they need it, from interviews with leading experts to timely press briefings on topical issues. We provide journalists with information about science and its related disciplines, making it easier for them to get access to the best evidence and expertise. Given our focus on science in the headlines, the SMC works mainly with science and news journalists in the UK’s national news outlets.” The Centre sends out quotes from experts, statistical analyses of scientific studies and Factsheets, in addition to running regular press briefings on the latest hot topic.

Thursday, 5 April 2018

Many woes had He endured


Having just had Easter weekend, I thought that the following hymn would be appropriate –

Many woes had He endured,
Many sore temptations met,
Patient, and to pains inured:
But the sorest trial yet
Was to be sustained in thee,
Gloomy, sad Gethsemane!

There my Saviour faced my guilt,
Pending judgement, unrelieved,
And the horrors which He felt
Were too vast to be conceived.
None can grasp the woe in thee,
Doleful, dark Gethsemane!

Sins against a holy God;
Sins against His righteous laws;
Sins against His love, His blood;
Sins against His name and cause;
Sins immense as is the sea −
Waited in Gethsemane!

On His dying love alone
I depend − with all my need,
Deeds of righteousness I’ve none,
Nothing of good works to plead.
O, how Christ must act for me,
Starting in Gethsemane.

Father, Son, and Holy Ghost,
One almighty God of love,
Hymned by all the heavenly host
In Thy shining courts above,
We poor sinners, gracious Three,
Bless Thee for Gethsemane.

(Joseph Hart, 1712-68)

Thursday, 22 March 2018

The PACE Trial continues to unravel …

A major study has been released today (22nd March) which again looks at the PACE Trial, and this in turn has led to a lot of coverage in the media.

“The message is clear – CBT and GET are not effective ways of treating a serious neuroimmune disease. The sooner this message gets across to health professionals the better.” (Dr Charles Shepherd, The ME Association).

The study –

Rethinking the treatment of chronic fatigue syndrome—a reanalysis and evaluation of findings from a recent major trial of graded exercise and CBT


PDF download: 

Some of the media coverage –

BBC

Chronic fatigue trial results 'not robust', new study says


Belfast Telegraph

Findings of chronic fatigue study ‘not reliable’
The study faced intense criticism from patients and charities


Daily Mail

Findings of chronic fatigue study `not reliable´


The Canary

The mainstream medical community just declared war on people living with ME


The Times

Findings of £5m ME chronic fatigue study ‘worthless’



The ME Association’s response

Reanalysis of the PACE trial finds impressive claims for recovery following CBT and GET are ‘not statistically reliable’


ME Association Press Release, 21st March 2018

Benefits reported in a controversial medical trial part-funded by the Department of Work of Pensions were “not reliable,” a major study has found.

A large-scale, government-funded trial, known as PACE, claimed psychotherapy and exercise helped the estimated 250,000 sufferers of the devastating illness, M.E. (myalgic encephalomyelitis).

Manifesting as unrelenting fatigue and profound pain, the condition, also known as chronic fatigue syndrome, has no known cure and is made worse by exertion.

Sufferers are often confined to their beds, unable to walk, and need help even to shower – an action that could then lay them low for hours, days, weeks or longer.

When the results of the five-year PACE trial were published in 2011, researchers claimed that graded exercise therapy (GET) and cognitive behaviour therapy (CBT) were “moderately effective” forms of treatment.

The trial concluded that both treatments led to recovery in over a fifth of patients.

But PACE has since faced intense criticism from patients and charities, such as the ME Association, over how the results were obtained, analysed and presented.

Parliament has previously heard claims that the data was deliberately flawed to “remove people from long-term benefits and reduce the welfare bill”.

After a long legal battle, unpublished data from the trial was released and has now been independently reanalysed. The paper, published in the journal BMC Psychology, has found that the benefits reported for psychotherapy and exercise therapy are modest and not statistically reliable.

Lead author Carolyn Wilshire, said:

“Our reanalysis was designed to explore how the PACE trial outcomes would have looked if the investigators had adhered to the primary outcome they described in their original published protocol.

“We also looked into the published data on long-term outcomes to examine whether they had been influenced by the treatments patients had received after the trial had ended.

“We found that the groups receiving CBT or GET did not significantly outperform the control group after correcting for the number of comparisons specified in the trial protocol. Rates of recovery were consistently low and not significantly different across treatment groups.”

In surveys carried out by the ME Association, more than half of patients who had followed the recommended graded exercise programme saw a worsening in their symptoms.

Dr Charles Shepherd, Honorary Medical Adviser to the ME Association, today said:

“The ME Association has always been very critical of the way in which the PACE trial was designed, especially the lack of any objective outcome measures.

“And we have not been impressed by the way in which the results have been reported in medical journals, especially claims relating to recovery following CBT and GET.

“So, it comes as no surprise to find that a very careful re-analysis of some of the PACE trial data by Carolyn Wilshire and colleagues has concluded that impressive claims for recovery following CBT and GET are not statistically reliable.

“It is also very concerning to note that this data was only released through use of the Freedom of Information Act and a very costly Tribunal – which ordered the release of data.

“This sends a powerful message to the research community that they must be willing to share data where there are serious concerns about protocols or the reliability of results from a clinical trial.

“The ME Association believes that it is very important to encourage research data sharing and, where appropriate, independent reanalysis – which is why we made a significant financial contribution towards the processing fee for publication of this paper.

“The message is clear – CBT and GET are not effective ways of treating a serious neuroimmune disease. The sooner this message gets across to health professionals the better.”

The PACE trial data was used justify NHS recommendations of exercise and cognitive behaviour therapy and no changes were made as a result.

But a patient revolt has forced the government and NICE (the National Institute of Clinical Excellence) to review the guidelines used by UK doctors. That review may not be completed before 2020.


Forward ME Letter to The Times: Patients with ME/CFS ‘are not simply “deconditioned” as claimed by many psychiatrists’ | 23 March 2018

http://www.meassociation.org.uk/2018/03/forward-me-letter-to-the-times-patients-with-me-cfs-are-not-simply-deconditioned-as-claimed-by-many-psychiatrists-23-march-2018/

Letter to The Times, 23rd March, 2018.

Treatment for patients with M.E.

Sir,

The article by Tom Whipple, (“Findings of £5m ME chronic fatigue study ‘worthless’,” Mar 22) highlights a long-standing problem.

The National Institute for Health and Care Excellence (Nice) is in the process of replacing its guideline for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), but this will take time.

Patients with ME/CFS in this country continue to receive damaging treatment in the form of graded exercise therapy (GET). Despite evidence of disabling metabolic abnormalities in their muscles, patients are advised to “exercise back to fitness”.

They are not simply “deconditioned” as claimed by many psychiatrists. Forced exercise above very low levels characteristically incapacitates most patients.

The “exercise will make you better doctrine” applied to ME/CFS is profoundly incorrect and has no scientific evidence base.

The human cost is enormous, with many sufferers from ME/CFS rendered worse by inappropriate medical management.

Even worse, such management is inflicted compulsorily on some patients, both adults and children, with their informed consent being bypassed via the use of mental health and child protection legislation.

Signatures

Countess of Mar, Forward-ME; Dr William Weir, infectious disease consultant; Dr Nigel Speight, paediatrician; Dr Charles Shepherd, ME association; Dr Vance Spence, ME research UK; Jonathan Davies, ME research UK; Dr Gareth Tuckwell, ME trust; Dr Paul Worthley, ME trust; Jane Colby, Tymes trust; Helen Brownlie, 25 per cent ME group; Tanya and Christine Harrison, Brame; William and Janice Kent, Remember; Hannah Clifton, ME trust; Clare Ogden, Action for ME

Wednesday, 14 March 2018

OMF-funded research: a metabolic ‘trap’ hypothesis for ME/CFS



March 14, 2018

On this #OMFScienceWednesday we highlight a new project that OMF is funding, which proposes a new metabolic ‘trap’ hypothesis for ME/CFS. This project is just getting started under the direction of Dr. Robert Phair, Chief Science Officer of Integrative Bioinformatics, Inc., an expert in computational modelling of biological processes. Dr. Phair has been collaborating with Dr. Ron Davis’ team at Stanford for nearly 2 years on investigating mechanisms behind ME/CFS. In this project, they will test a new hypothesis that could help to explain some of the genetic and metabolic characteristics of ME/CFS patients.

The big data study of severely ill ME/CFS patients that we funded identified several genes that carry damaging mutations. Dr. Phair’s hypothesis, based on computational predictions, suggests that some of these mutations may slow down enzymes that process important metabolites required for our energy, brain function, and immune system. If this is true, it could explain some of the symptoms of ME/CFS. Identifying interesting mutations is the (relatively) easy part, though – experimental evidence is needed to confirm their impact. During this project, the team will test how cells with these mutations carry out the relevant metabolic reactions, using special ‘tracer’ metabolites that can be easily followed as they are processed by the cells. These experiments will determine whether the mutations are indeed creating a metabolic ‘trap’ that could lead to the neurological and/or immunological symptoms of ME/CFS. We’ll be happy to share more details as the results provide more evidence. Stay tuned!

Read more about Dr. Phair and his research:

Wednesday, 7 March 2018

Trial By Error: News About My Plans by Dr David Tuller



5th March 2018

By David Tuller, DrPH

So I’ve been asked about my plans after June 30th, which is the end of the period covered by last year’s crowdfunding campaign. There’s been significant progress since I launched that effort. Among other developments, the CDC dropped its recommendations for CBT and GET, NICE decided to withdraw its preliminary reaffirmation of its disastrous 2007 guidance and pursue a full overhaul, and Scottish National Party MP Carol Monaghan recently held a groundbreaking parliamentary hearing about PACE.

In regards to the latter, it is awesome that a smart politician in a position to make noise [*This sentence has been changed for clarification; details at end of post] has noted publicly that PACE “will become known as one of the biggest medical scandals of the 21st century.” (Personally, I’d say PACE is on track to become one of the biggest scandals of the current millennium, even though the current millennium is less than 20 years old.) In reporting on MP Monaghan’s efforts, The National, a Scottish daily newspaper, noted the following: “After campaigners went to court to force researchers to release the raw data, that study, known as the PACE trial, has been discredited.”

What a delight to read such a statement in a mainstream U.K. news article. The sentence makes the point that the debunking of PACE is a fact—not just a hopeful assertion made by advocates.

All these changes unequivocally demonstrate that there has been significant erosion in support for the fake claims promoted by the CBT/GET ideological brigades. Besides the flaws in PACE, it has become apparent that many of the other studies from the biopsychosocial crowd are rife with ethical and methodological missteps. That’s on top of the fact that they are all open-label trials with subjective outcomes, which would present an insurmountable obstacle to obtaining reliable and valid results even without all the other violations of scientific principles.

I have recently documented such problems with two studies from the BMJ group of journals—last fall’s Lightning Process study, and the 2011 school absence study, both conducted by investigators from the University of Bristol. In both cases, the evidence shows that the investigators abused the ethical review process. Perhaps they presumed no one would read supporting documents, such as trial protocols or ethics committee opinions that have been wrongly cited to support problematic methodological choices.

So far, the journals have not taken the necessary steps to address these egregious problems. This sort of stonewalling will ultimately harm the reputations of all involved, and it indicates that this is not the time for me to stop examining the issues or to call it quits on this project. When I published my big PACE investigation in October, 2015, I assumed no study could survive the exposure of the nonsense perpetrated by the investigators. I didn’t recognize the degree to which the highest levels of the U.K. academic and medical establishment were ensnared in the delusion that PACE represented quality science and that the researchers involved were actually honorable and honest researchers.

I also had no idea how recalcitrant journals would be to acknowledge their self-evident mistakes, once these were authoritatively documented. And while I thought I might end up being sued, it didn’t occur to me that any self-respecting academic institution would try to squelch my accurate and necessary efforts to expose wrongdoing, the way Bristol University has in formally complaining about my work to Berkeley. I’m glad my own university retains some understanding, unlike Bristol, of the value of academic freedom and the importance of doing the right thing.

So I plan to conduct another crowdfunding campaign to support the project for another year—from July 1st, 2018, to June 30th, 2019. This time, I am working with Berkeley’s own crowdfunding platform, which is made available two or three times a year for university projects. Last year, that wasn’t an option; I was lucky that the foundation running Retraction Watch agreed to act as my fiscal sponsor and donate the money to Berkeley without taking any fees. This time, the funds will go directly to my home base at the university, the Center for Global Public Health, to support my half-time position.

Berkeley’s crowdfunding platform is open for the month of April. I’ll be providing more details about the campaign before or on the April 1st launch. My hope is that, with so much happening on multiple fronts, progress will actually accelerate in the next year and the CBT/GET paradigm will continue its downward spiral to oblivion–the fate it deserves.

*Clarification: The sentence originally referred to “a government official in a position of authority.” In the U.S., members of Congress are considered part of the government and they are considered to have authority, even if they are not in the executive branch. However, it was pointed out to me that the words mean something different in the U.K. The original sentence appeared to indicate that MP Monaghan is part of the government in power, which she clearly is not.

Saturday, 3 March 2018

I have chosen thee in the furnace of affliction



C H Spurgeon's Morning Devotional for 3rd March

"I have chosen thee in the furnace of affliction."

Isaiah 48:10

Comfort thyself, tried believer, with this thought: God saith, "I have chosen thee in the furnace of affliction." Does not the word come like a soft shower, assuaging the fury of the flame? Yea, is it not an asbestos armour, against which the heat hath no power? Let affliction come-God has chosen me. Poverty, thou mayst stride in at my door, but God is in the house already, and He has chosen me. Sickness, thou mayst intrude, but I have a balsam ready-God has chosen me. Whatever befalls me in this vale of tears, I know that He has "chosen" me. If, believer, thou requirest still greater comfort, remember that you have the Son of Man with you in the furnace. In that silent chamber of yours, there sitteth by your side One whom thou hast not seen, but whom thou lovest; and ofttimes when thou knowest it not, He makes all thy bed in thy affliction, and smooths thy pillow for thee. Thou art in poverty; but in that lovely house of thine the Lord of life and glory is a frequent visitor. He loves to come into these desolate places, that He may visit thee. Thy friend sticks closely to thee. Thou canst not see Him, but thou mayst feel the pressure of His hands. Dost thou not hear His voice? Even in the valley of the shadow of death He says, "Fear not, I am with thee; be not dismayed, for I am thy God." Remember that noble speech of Caesar: "Fear not, thou carriest Caesar and all his fortune." Fear not, Christian; Jesus is with thee. In all thy fiery trials, His presence is both thy comfort and safety. He will never leave one whom He has chosen for His own. "Fear not, for I am with thee," is His sure word of promise to His chosen ones in the "furnace of affliction." Wilt thou not, then, take fast hold of Christ, and say-

"Through floods and flames, if Jesus lead,
I'll follow where He goes."

Thursday, 1 March 2018

DNA gets away: Scientists catch the rogue molecule that can trigger autoimmunity and 'Low T3 Syndrome'


DNA gets away: Scientists catch the rogue molecule that can trigger autoimmunity

(This is not specifically about ME, but may be of interest as many believe that ME may well be an autoimmune condition.)


A research team has discovered the process -- and filmed the actual moment -- that can change the body's response to a dying cell

Date: February 22, 2018

Source: Monash University

Summary: A research team has discovered the process -- and filmed the actual moment -- that can change the body's response to a dying cell. Importantly, what they call the 'Great Escape' moment may one day prove to be the crucial trigger for autoimmune diseases like arthritis.

Full Story

A research team has discovered the process - and filmed the actual moment - that can change the body's response to a dying cell. Importantly, what they call the 'Great Escape' moment may one day prove to be the crucial trigger for autoimmune diseases like arthritis.

The research team, led by Professor Benjamin Kile from Monash University's Biomedicine Discovery Institute (BDI), has discovered - and filmed - the exact moment when DNA escapes out of the mitochondria (the organelles inside cells that produce energy) during cell death. The study, published today in the journal Science, involved major collaborators from the Walter and Eliza Hall Institute and the Howard Hughes Medical Institute's Janelia Research Campus in the US.

Mitochondria are the ultimate double agent; they are essential to keep cells alive, but when damaged, they can trigger the body's own immune system with potentially devastating consequences. Because the DNA inside mitochondria (mtDNA) has many similarities with bacterial DNA (they share common ancestry), the body reacts to its presence outside the mitochondria, or indeed, outside the cell, as if under attack from invading pathogens. It is a similar failure to distinguish 'self' from 'non-self' that underlies inflammatory and autoimmune diseases.

While the release of mtDNA is thought to contribute to autoimmune diseases such as lupus, how it escapes from the mitochondria has never been explained. Monash BDI researcher Dr Kate McArthur, while completing her PhD at the Walter and Eliza Hall Institute, used a revolutionary new microscope at the Janelia Research Campus in the US to capture the moment when mitochondria form a 'hernia' that balloons out of the mitochondria expelling the DNA into the rest of the cell.

The live-cell lattice light-sheet microscopy (LLSM) system developed by Nobel Prize winner Eric Betzig is a new technique that allows scientists to observe living cells at groundbreaking resolution. Dr McArthur travelled to the Janelia Research Campus in Virginia multiple times between 2015-2017, and remembers the moment when she witnessed, for the first time, the mitochondria actively expelling its DNA.

"As scientists, we are taught to be quite sceptical when we see something unexpected, so I think my initial reaction was 'no way...'

"It was only after I had carefully repeated the experiment many times that I began to realise what we had found," Dr McArthur said.

According to Professor Kile, when a cell commits suicide (a normal part of the human body's balancing act to control blood cell numbers), two proteins called BAK and BAX are triggered.

"What we witnessed - in real time - was these professional killer proteins opening up huge 'macropores' in the outer membrane of the mitochondria, leading the inner contents to herniate out, bringing the mtDNA with it," Professor Kile said.

"BAK and BAX deliver the 'kill shot' designed to permanently disable the cell. But in doing that, mtDNA is lost from the mitochondria. In essence, this is collateral damage, which, if it isn't controlled properly, triggers the immune system to drive pathological inflammation," he said.

The discovery was cemented by images captured by Monash University's Titan Krios cryo-electron microscope, currently the most advanced microscope for biological electron microscopy, and the Walter and Eliza Hall Institute's new lattice light-sheet microscope, custom built by collaborators in the Institute's Centre for Dynamic Imaging.

Professor Kile stressed that, in research, "fundamental discoveries such as this are rare, and this one has profound implications for the understanding of a wide range of autoimmune diseases and infections.

"This has been a brilliant collaboration - between Monash's Biomedicine Discovery Institute, the Walter and Eliza Hall Institute of Medical Research here in Melbourne and the Janelia Research Campus in the US - which has brought together cutting-edge technologies and first-class expertise to address questions that before now, had never been asked, and would have been impossible to answer," he said.


Higher prevalence of ‘low T3 syndrome’ in patients with chronic fatigue syndrome: A case-control study

(This very much fits in with the research showing that ME is a hypometabolic disease e.g, the research at Stanford University, California.)


Begoña Ruiz-Núñez 1, 2*, Rabab Tarasse 1, Emar Vogelaar 3, Janneke Dijck-Brouwer 1 and Frits Muskiet 1

1 Laboratory Medicine, University Medical Center Groningen, Netherlands
2 Healthy Institute, Spain
3 European Laboratory of Nutriënts (ELN), Netherlands

Chronic fatigue syndrome (CFS) is a heterogeneous disease with unknown cause(s). CFS symptoms resemble a hypothyroid state, possibly secondary to chronic (low-grade) (metabolic) inflammation. We studied 98 CFS patients (21-69 years, 21 males) and 99 age- and sex-matched controls (19-65 years, 23 males). We measured parameters of thyroid function, (metabolic) inflammation, gut wall integrity and nutrients influencing thyroid function and/or inflammation. Most remarkably, CFS patients exhibited similar TSH, but lower FT3 (difference of medians 0.1%), TT4 (11.9%), TT3 (12.5%), %TT3 (4.7%), SPINA-GD (14.4%), SPINA-GT (14.9%), 24-hour urinary iodine (27.6%) and higher %rT3 (13.3%). FT3 below the reference range, consistent with the 'low T3 syndrome', was found in 16/98 CFS patients vs. 7/99 controls (OR 2.56; 95% CI=1.00 - 6.54). Most observations persisted in two sensitivity analyses with more stringent cut-off values for BMI, hsCRP and WBC. We found possible evidence of (chronic) low-grade metabolic inflammation (ferritin and HDL-C). FT3, TT3, TT4 and rT3 correlated positively with hsCRP in CFS patients and all subjects. TT3 and TT4 were positively related to hsCRP in controls. Low circulating T3 and the apparent shift from T3 to rT3 may reflect more severely depressed tissue T3 levels. The present findings might be in line with recent metabolomic studies pointing at a hypometabolic state. They resemble a mild form of 'non thyroidal illness syndrome' and 'low T3 syndrome' experienced by a subgroup of hypothyroid patients receiving T4 monotherapy. Our study needs confirmation and extension by others. If confirmed, trials with e.g. T3 and iodide supplements might be indicated.

Tuesday, 20 February 2018

Government-funded ME/CFS trial ‘one of greatest medical scandals of 21st century’



From the ME Association website –

Government-funded ME/CFS trial ‘one of greatest medical scandals of 21st century’ | 20 February 2018

A controversial medical trial part-funded by the Department of Work of Pensions will emerge as “one of the greatest medical scandals of the 21st century” an MP today claimed.

A trial which claimed exercise helped the estimated 250,000 sufferers of the devastating illness, M.E., (myalgic encephalomyelitis) to recover was deliberately flawed to “remove people from long-term benefits and reduce the welfare bill”, a parliamentary debate heard.

Manifesting as unrelenting fatigue and profound pain, the condition, also known as chronic fatigue syndrome, has no known cure and is made worse by exertion.

Sufferers are often confined to their beds, unable to walk, and need help even to shower – an action that could then lay them low for hours, days, weeks or longer.

More than just bad science

When the PACE trial was published in 2011, researchers claimed that graded exercise therapy (GET) and cognitive behavioural therapy (CBT) were “moderately effective” forms of treatment.

But the trial has faced intense criticism from patients, charities – such as the ME Association – clinicians and researchers, over how the results were obtained, analysed and presented.

After a long legal battle, unpublished data from the trial was released and, when independently analysed, it showed no difference between the different treatments being tested and that reported recovery rates had been grossly inflated.

And in surveys carried out by the ME Association, more than half of patients who had followed the recommended graded exercise programme saw a worsening in their symptoms.

Carol Monaghan, the SNP MP for Glasgow North West, worked with the ME Association to hold the debate in Westminster Hall today, and had received nearly one thousand letters and emails from people affected by the condition.

She said: “The failure of PACE… could simply be put down to bad science. But unfortunately, I believe there is far more to this.

“One wonders why the DWP would fund such a trial, unless of course it was seen as a way of removing people on long-term benefits and reducing the welfare bill.”

Westminster Hall heard how people with M.E. struggle to obtain benefits because of treatment guidelines, which wrongly suggest that exercise can lead to recovery.

Former science teacher Ms Monaghan also told how a lack of medical education was leading to late and inaccurate diagnosis – along with absent, inappropriate or even harmful management advice – and that the M.E. field was plagued by a “woeful lack of research”.

She said: “Labels such as chronic fatigue syndrome and post-viral fatigue syndrome simply do not come close to the living hell experienced by many sufferers. A living hell made worse by a lack of understanding towards those seeking help.”

Complete rethink required

Speaking after the debate, the MP said: “The PACE trial was fundamentally flawed as it worked from the assumption that M.E. is a psychological condition.

“To describe somebody with M.E. as suffering from ‘fatigue’ is a gross misrepresentation of the symptoms they experience: debilitating muscle pain, excruciating headaches and exhaustion so severe that some sufferers cannot even chew solid food; is the reality for a person with M.E.

“There has to be a complete rethink of the medical advice given to sufferers of M.E. as even gentle exercise can set them back for weeks and, in some cases, months.

“However, unfortunately for many this is still the advice being offered. Discovering that the PACE trial was funded by the DWP, no doubt with the intention to reduce the amount of people on benefits, should cause great concern.

“As a scientist, I am appalled by the methods used in the trial, which included changing the parameters and success criteria midway through the study. This has been widely discredited in the research community.

“I hope that this debate will be the starting point for new medical advice and guidelines for people suffering from ME. I thank all of those who have taken the time to get in touch with me regarding their personal experiences of both living with M.E. and the PACE trial.”

Listen to what patients have to say

A spokesman for the ME Association, which campaigns for more awareness into the condition, said:

“It is vital the voice of M.E. patients is heard, and we are grateful that their plight, and the flawed PACE trial, has been raised today.

“Many of our members are housebound or bedbound and we cannot allow them to be forgotten about by society.

“Many have seen a worsening in their symptoms after undergoing CBT and GET and it is vital that this advice is no longer given out by medical professionals.

“M.E. patients are not hypochondriacs, hysterical or lazy – they are afflicted with a condition that is devastating and life-changing.”

The PACE trial data was used justify NHS recommendations of exercise and cognitive behaviour therapy and no changes were made as a result.

But a patient revolt has forced the government and NICE (the National Institute for Health and Care Excellence) to review the guidelines used by UK doctors. That review may not be completed before 2020.

An ME Association spokesman added: “We hope that NICE and the NHS will continue to listen to patients and adopt only practices that can truly help people with M.E.”

The government said it wants to put patients at the forefront of any new guideline and said it welcomed high-quality medical research applications into M.E.

For more information about M.E., visit meassociation.org.uk. For press enquiries, contact 07598032845.

For enquiries to Carol Monaghan MP, email craig.steele@parliament.uk

To watch the recording of today’s debate at Westminster Hall, visit parliament.tv – it was heard from 11.00-11.30am.