Tuesday, 21 August 2018

The Times: Call for review of ‘flawed’ ME research in Lancet letter


On the ME Association website – 

Tom Whipple, Science Editor, The Times, August 21, 2018.

More than a hundred academics have joined ten MPs and scores of patient groups from around the world to sign an open letter calling for The Lancet to reanalyse a study into treatment for myalgic encephalomyelitis (ME).

The letter follows a debate in parliament in which one MP said that the study, which is used to set NHS guidelines, “will go down as one of the biggest medical scandals of the 21st century”.

The authors of the research paper stood by their findings and said that the letter represented a campaign to discredit solid research and force the retraction of papers simply because patients disagreed with their findings.

The signatories, who include academics from Harvard, Stanford, UCL and the London School of Hygiene and Tropical Medicine, said that the 2011 Pace trial, which recommended therapy and exercise as a treatment for the condition, had “major flaws” and “unacceptable methodological lapses”.

The £5 million publicly funded trial was published in The Lancet and has informed advice on treating people with ME in the NHS and abroad, but is controversial among ME sufferers. Some claim that its advice perpetuates an idea that the disease, which causes debilitating disability, is all in the mind.

The Lancet declined to comment.


Virology Blog:

Trial By Error: Open Letter to The Lancet, version 3.0

David Tuller, 13 August 2018

Two months ago, Professor Racaniello sent Lancet editor Richard Horton an open letter about the indisputable methodological and ethical failings of the PACE trial. This was a follow-up to Virology Blog’s 2016 open letter to Dr. Horton; the new one detailed what has happened since then. Last month, I re-sent and reposted this new open letter, with organizations also signed on. Given Dr Horton’s persistent defense of a study in which 13 % of the participants had already met a key outcome threshold at baseline, it is not surprising that he has failed to respond.

Yesterday I sent the letter to The Lancet for the third time, with more individual experts and organizations adding their voices to the demand for a reassessment of the reported PACE findings. For reasons only Dr Horton can explain, he appears determined to undermine his journal’s reputation for scientific integrity with his robust support for a trial that objective observers clearly recognize as a piece of crap. PACE has caused great harm to the patient community. Dr Horton’s refusal to take appropriate corrective action has amplified that harm many times over. He and his journal have a lot to answer for.

Dear Dr. Horton:

In February, 2011, The Lancet published an article called “Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomized trial.” [1] The article reported that two rehabilitative approaches, cognitive behavioural therapy (CBT) and graded exercise therapy (GET), were effective and safe treatments for chronic fatigue syndrome, also often referred to as myalgic encephalomyelitis, ME/CFS and CFS/ME. The PACE study received international attention and has had widespread influence on research, treatments prescribed for patients, and attitudes toward the illness of both the medical community and the public at large.

At the press conference promoting the Lancet paper, one of the lead investigators stated that twice as many participants in the treatment groups got “back to normal,” compared to those in the other study arms. [2] An accompanying Lancet commentary similarly claimed that these “back-to-normal” participants had met a “strict criterion for recovery.” [3]

In fact, we now know that 13 % of the participants qualified at baseline as “recovered” or “within the normal range” for one of the study’s two primary measures, self-reported physical function–even as they were simultaneously classified as disabled enough on the same measure to enter the study. [4] This anomaly, which occurred because the investigators weakened key outcome thresholds after data collection, invalidates any claims that patients “recovered” or got “back to normal.” The overlap in entry and outcome criteria is only one of the trial’s unacceptable methodological lapses.

The treatments investigated in the PACE trial were based on the hypothesis that ME/CFS patients harbor “unhelpful” convictions about having an ongoing organic disease and that the perpetuation of their devastating symptoms is the result of deconditioning. In contrast, a 2015 review from the U.S. Institute of Medicine (now the National Academy of Medicine), reported that ME/CFS is a complex, multi-system illness characterized by neurological, immunological, autonomic, and energy metabolism dysfunctions. [5] The cardinal symptom, noted the review, is a systemic intolerance to exertion; if patients exceed their available energy resources, they can suffer serious and prolonged relapses.

After The Lancet published the first PACE results, ME/CFS patients and advocates immediately pointed out major flaws. But few people outside the field took notice until the science site Virology Blog published a 15,000-word investigation by David Tuller, a public health researcher and journalist at the University of California, Berkeley, in October of 2015. [6] Subsequently, in February of 2016, many of us signed an open letter to The Lancet requesting an independent investigation of the study. [7]

Since then, much has happened:

* In August of 2016, a U.K. tribunal, citing that open letter, ordered Queen Mary University of London to release raw trial data from the PACE study, sought by Australian patient Alem Matthees in a freedom of information request so that he and others could calculate the outcomes promised in the PACE trial protocol. [8]

* Analyses of these data [9], including a study published in BMC Psychology in March [10], have confirmed what has long been argued: The PACE investigators engaged in such extensive outcome-switching that they were able to report dramatically better findings than the null or minimal results obtained under the original measures they promised in their protocol.

* The U.S. Agency for Healthcare Research and Quality (AHRQ) downgraded its recommendations for CBT and GET. [11] This downgrading occurred after the agency removed from its analysis the PACE trial and other studies using overly broad selection criteria that generated cohorts of patients with a grab-bag of fatiguing conditions. And while the PACE trial claimed that GET is safe, AHRQ found that the therapy was associated with more adverse events.

* Last summer, the U.S. Centers for Disease Control abandoned the recommendations that ME/CFS patients be treated with CBT and GET [12], having already removed references to the PACE trial. A couple of months later, the U.K. National Institute for Health and Care Excellence announced that it would pursue a full update of its 2007 guidance, citing concerns about the reliability and validity of the evidence base. [13]

* Earlier this year, a report from the Dutch Health Council recommended that GET should not be used in the Netherlands as a treatment for the illness. [14]

* In March, a group of leading American clinicians who specialize in ME/CFS unanimously agreed that the two PACE treatments are inappropriate and possibly harmful for patients with the illness and should therefore not be prescribed. [15]

Given the worldwide impact of PACE, we urge The Lancet to do what the open letter two years ago requested: commission an independent re-analysis of the individual-level trial data, with appropriate sensitivity analyses, from highly respected reviewers with extensive expertise in statistics and study design. The reviewers should be from outside the domains of psychiatry and psychological medicine and predominantly from outside the U.K. They should also be completely independent of, and have no conflicts of interests involving, the PACE investigators and the funders of the trial.

Thank you for your quick attention to this matter.


For the full list of signatories please refer to virology blog. Dr Charles Shepherd and Dr Nigel Speight, medical advisers to the ME Association, together with the Countess of Mar, representing Forward ME, also signed the letter.

The UK Members of Parliament who signed were as follows:

Sir Edward Davey MP
Kingston and Surbiton, England, UK

David Drew MP
Stroud, England, UK

Patricia Gibson MP
North Ayrshire and Arran, Scotland, UK

Mary Glindon MP
North Tyneside, England, UK

Sandy Martin MP
Ipswich, England, UK

Carol Monaghan MP
Glasgow North West, Scotland, UK

Nicky Morgan MP
Loughborough, England, UK

Alex Sobel MP
Leeds North West, England, UK

Graham Stringer MP
Blackley and Broughton, England, UK

Stephen Timms MP
East Ham, England, UK

Friday, 17 August 2018

This Sickness Is Not Unto Death


C H Spurgeon’s Evening Devotional for 17th August

“This sickness is not unto death”

John 11:4

From our Lord's words we learn that there is a limit to sickness. Here is an "unto" within which its ultimate end is restrained, and beyond which it cannot go. Lazarus might pass through death, but death was not to be the ultimatum of his sickness. In all sickness, the Lord saith to the waves of pain, "Hitherto shall ye go, but no further." His fixed purpose is not the destruction, but the instruction of His people. Wisdom hangs up the thermometer at the furnace mouth, and regulates the heat.

1. The limit is encouragingly comprehensive. The God of providence has limited the time, manner, intensity, repetition, and effects of all our sicknesses; each throb is decreed, each sleepless hour predestinated, each relapse ordained, each depression of spirit foreknown, and each sanctifying result eternally purposed. Nothing great or small escapes the ordaining hand of Him who numbers the hairs of our head.

2. This limit is wisely adjusted to our strength, to the end designed, and to the grace apportioned. Affliction comes not at haphazard-the weight of every stroke of the rod is accurately measured. He who made no mistakes in balancing the clouds and meting out the heavens, commits no errors in measuring out the ingredients which compose the medicine of souls. We cannot suffer too much nor be relieved too late.

3. The limit is tenderly appointed. The knife of the heavenly Surgeon never cuts deeper than is absolutely necessary. "He doth not afflict willingly, nor grieve the children of men." A mother's heart cries, "Spare my child"; but no mother is more compassionate than our gracious God. When we consider how hard-mouthed we are, it is a wonder that we are not driven with a sharper bit. The thought is full of consolation, that He who has fixed the bounds of our habitation, has also fixed the bounds of our tribulation.

Thursday, 16 August 2018

25% ME Group Launches New Website


By Simon Lawrence

Sound the fanfares!! We are delighted to launch our new website, which is now live, and also to apologise for any inconvenience caused to members, as our old site had to be suspended for a few weeks since it was not GDPR compliant, and also to enable construction of the new site. This again, along with many other changes that we have had to make, has been an involved undertaking, but I hope you will agree, it has been well worth it!

The site has new interactive functions like: fully digital membership forms, renewing slips, e-news slips and the like. This will enable people who visit our site to be able to join online and allow members who are able, to renew and pay online, which we hope will help some people.

We hope that the new layout and colours will be good for members to see and navigate around; we tried to make sure that the colour scheme would be acceptable for people with severe ME, as well as the general public who may visit our site (ie not to bright and ‘in-your-face’.) We hope members find this helpful.

Our new members area is very user friendly and easy to sign up for and into. This area will host a forum and contain other information useful to members such as the latest newsletter, contact list etc. This area will ONLY be available to paid up members, so you can feel assured that it is private and this will enable members to chat and discuss issues with others. Members can post pics and other media items and share them within this secure area.

The site will still hold much of the original useful information in areas like advocacy and medical information etc. but with the new search function, it will be much easier to search for a specific document or documents on a certain subject.

I have also been informed that our charity is now more prominent within Google Search which should hopefully attract more visitors to the site.

Friday, 3 August 2018

Having ME Is Like Being Permanently Encased In A Suit Of Armour


I have, for a long time, struggled to fully get across the impact this illness has on my life


By Jonathan Davis

I have been asked many times what it is like to have myalgic encephalomyelitis (ME) and I have, for a long time, struggled to fully get across the impact this illness has on my life. To say that I am sick, tired and sore is just too vague.  Plus, the condition fluctuates and everyone’s experience of ME is different. But, for me, this is how I would describe what it’s like.

Imagine that you are permanently encased head to toe in a suit of armour. The suit is rusted, stiff, unwieldy and incredibly heavy. Simple tasks like getting out of bed require an enormous effort, even lifting your arms to wash your hair is often too much. Walking around is extremely strenuous causing you to rapidly deplete your glycogen reserves. Within moments you have “hit the wall”. Your muscles shake and cramp, you feel sick and dizzy. If you don’t stop, you will almost certainly collapse. Cruelly, you may feel a sense of accomplishment in your efforts only to look behind you to see you have moved from your chair to the door. Anger and resentment build as you recall how you once took moving with ease for granted. But such intense emotions will rob you of what little precious energy you have left, so you catch yourself, and breathe.

On the inside of the suit of armour are thousands of spikes that press and tear into you whenever you move. Everything you do has to be measured and is carried out with trepidation. The spikes are not clean either so you are constantly fighting infection. Your bones, muscles, and joints ache, your temperature fluctuates wildly. The helmet, instead of protecting you, massively intensifies light and sound. Everyday noises such as the stacking of crockery or a door closing are excruciating and frightening. Light disorientates and burns.  You retreat into darkness and silence, where you are isolated, scared and lonely. The outside world is now a painful place to be. In time your home will become a prison; a mausoleum, occupied by a living corpse.

The suit has poisoned your body. Eating causes intestinal discomfort leading to multiple, exhausting and painful trips to the toilet. Your brain is also affected.  Words are hard to find. You can’t recall the names of people, even those you are close to, places or everyday items. Conversation is as challenging as a finals exam and reading, even simple text, tests your concentration to the limit. Your short-term memory is poor and you forget important information, constantly having to rely on others for help. Those around you become frustrated because you can’t express yourself or your needs, so you withdraw so as not to be a burden. Lack of interaction reduces your resilience; despair and boredom start to overwhelm you. Your confidence is lost in a sea of self-doubt.

Although your body yearns for rest, there is no refuge in sleep. You are haunted by dreams and nightmares. Even past memories of happy times or achievements are a reminder of what the suit has snatched away from you.  What you were once so proud of is now torn to shreds, like a spiteful playground bully destroying a fellow pupil’s prize-winning project.

In such discomfort, you plead with others for help, but there is very little to aid your plight. The suit is invisible to all except you, or others who have similar suits. There is no test yet developed that can detect it and nothing has been proven effective in removing it or mitigating its impact. You draw ire and derision from friends, family, colleagues, and peers who have no knowledge of the suit and what it does to you. Opinion-makers and celebrities mock your condition, even supposed experts in suit-related treatment cast aspersions, abandoning you to your fate. How can you be affected so badly by something that doesn’t exist, they cry, it must all be in your mind.

And yet, every suit of armour has a weakness; in this case, it is knowledge and acceptance. Knowledge through increased funding and medical research and acceptance socially through sharing experiences and education.

ME may be an invisible illness but the people who have it are not.

Wednesday, 1 August 2018

GP system updated to reflect ME as neurological


August 01, 2018

The latest update to the electronic health records system used by GPs in England was launched yesterday, listing M.E. as a neurological disorder. Previously it had sat under two unhelpful and inaccurate headings, mental disorder and multisystem disorder.

The system, SMOMED CT, provides a standard mechanism for recording and collating data across populations which is important for public health monitoring, reporting and analysis as well as influencing decision making. The way it classifies illnesses influences how that illness may be perceived by doctors and other medical professions and others.

Until 2015, CFS (the term SNOMED uses for CFS and/or M.E.) had sat under two headings in SNOMED CT: mental disorder and multisystem disorder, which was clearly unhelpful and inaccurate. Following advocacy efforts made by the Countess of Mar and Forward M.E., the mental disorder heading was retired.

After discussion with Lady Mar, Action for M.E. agreed to take on the role of ‘Coordinator, Classification and Terminology Response Group’ on behalf of Forward M.E.

In February, SNOMED decided to retire the multisystem disorder heading too, leaving CFS (plus around 90 other concepts) without a heading.

With detailed technical advice from long-term SNOMED and ICD-11 advocate, Suzy Chapman, our Chief Executive Sonya Chowdhury contacted SNOMED CT in February to ask that:

  • a new parent term should be assigned given the conflict of classification between SNOMED and various versions of the ICD, the system used by the World Health Organisation (WHO)

  • based on the Institute of Medicine report (2015), CFS (and its related term, M.E.) should be assigned under the heading of Disorder of nervous system parent, until research provides an evidence base for a change.

We are pleased to confirm that this request has been granted, and are hugely grateful to Suzy Chapman, without whom this success would not have been achieved. A more detailed and technical description of how SNOMED classifies illnesses, and the changes made, has been published by Suzy.