Tuesday, 16 October 2018

A Review of BMJ Best Practice Document on Chronic Fatigue Syndrome by Professor James Baraniuk

[Professor Hooper’s peer-review comments were written to indicate the accurate situation that now obtains concerning the PACE trial raw data. People can judge for themselves if his comments were accepted by the BMJ by looking at their updated version of “Best Practice on CFS” released in September 2018.]

A Review of BMJ Best Practice Document on Chronic Fatigue Syndrome by Professor James Baraniuk

Professor  Malcolm Hooper          24th June 2018


NOTE:  I was asked by the BMJ Section Editor (BMJ Best Practice and BMJ Learning) to provide a peer review of Professor James Baraniuk’s document on “CFS”, to which I agreed. My comments below relate to the version sent to me. In my opinion, it indicated how dangerous the medical education programme about ME/CFS is in the UK. This was borne out by my face-to-face discussion with Professor Baraniuk himself on 1st June 2018 in London: he confirmed to me that his original report had already been sent by the BMJ to other referees and that he had received 156 comments which he was instructed had to be incorporated in his report. It was plainly obvious that those comments had been included in the version sent to me. Professor Baraniuk assured me that I should go ahead and respond as I wished, so it seems he knew his report was not as he intended it to be. In telephone discussions with the BMJ Section Editor, it was stressed to me that the BMJ had to have (quote) “equality”.

Current BMJ Best Practice for CFS/ME (October 2018):

My Review

My response to reading this long document of 102 pages is such that I am unable to carry out the review by simple annotations or minor additions to it.

I am grateful for the invitation to respond by means of a single document that sets out my major concerns which I hope the editor(s) will find helpful.


1.              Introduction

The document is far too long if it is intended to be a BMJ Best Practice reference tool help GPs and others to quickly diagnose and support their patients presenting with ME/CFS.

As it stands, it is not fit for purpose.  The document is badly presented: it needs to be clear and factually accurate.

It lacks focus and any critical awareness of the issues under consideration.

It shows little understanding of the latest research, or the social and political considerations (eg. access to social security payments) that patients and informed clinicians feel so strongly about.

The confusion and complexity of the Best Practice document is far from satisfactory and in need of a thorough overhaul.

It is a wasted opportunity to clarify a situation that has evaded medical education for the last three decades.


2.            The Title

The report is entitled “Chronic Fatigue Syndrome” but throughout the text the term “CFS/ME” is used, yet the name myalgic encephalomyelitis does not even feature in the title.

Myalgic Encephalomyelitis (ME) has been classified as a neurological disorder by the World Health Organisation (WHO) in its International Classification of Diseases (ICD) since 1969, but there is no mention of this anywhere in the document.

Throughout the document there is confusion about terminology (ME, CFS/ME, fatigue) but it is essential to be aware that the terms are not clinically interchangeable.

On pages 11, 19, 22, 23, 28, 30, 51 and 102, Baraniuk refers to “CSF/ME”, which appear to be typographical errors, since cerebrospinal fluid (CSF) is not being discussed.


3.            Historical perspective

The term myalgic encephalomyelitis was coined in 1955 (Lancet 1955:394-395) and in 1969 it was formally classified by the WHO as a neurological disorder; it was accepted by The Royal Society of Medicine as a distinct disease in 1978; in 1987 the term “chronic fatigue syndrome” was introduced at a meeting of CDC scientists for political, not medical reasons, at which it was decided to change the name from ME to CFS and “CFS” appeared in publications from 1988 onwards. 

In 1992 the term “CFS” was included in ICD-10 as a synonym for ME (referable only to ME at G93.3), but in the UK, a group of psychiatrists intended to eradicate the neurological disease ME and introduced the term “CFS/ME” (in that order, as distinct from “ME/CFS”) with their stated intention of dropping “ME” from “CFS/ME” when expedient and then reclassifying “CFS” as a behavioural disorder (BMJ 2003:326:595-597).

In the UK, recruitment for the PACE Trial began in 2004 and the Patient Clinic Leaflet stated:  “Chronic fatigue syndrome” is “also known as postviral fatigue syndrome, myalgic encephalomyelitis (ME) or myalgic encephalomyelopathy….Medical authorities are not certain that CFS is exactly the same illness as ME but until scientific evidence shows that they are different they have decided to treat CFS and ME as if they are one illness”. 

To complicate things even further, despite his having received ethical approval and funding to include ME in the clinical trial, following publication in 2011 of selective PACE Trial results in The Lancet, the Chief Principal investigator, psychiatrist Professor Peter White, wrote to Richard Horton, editor-in chief of The Lancet, denying outright that the PACE Trial had been studying patients with ME: “The PACE trial paper refers to chronic fatigue syndrome (CFS) which is operationally defined; it does not purport to be studying CFS/ME”.

CFS came to be applied to many different things and considerably broaden the meaning of CFS/ME making it virtually meaningless. Hence, it allowed consideration of other chronic infections, EBV and other herpes viruses, lyme, chlamydia, rickettsia, some vaccines, eg Hep B and latterly HPV and other intracellular organisms eg brucellosis, chemical and environmental toxins, organophosphates, Gulf War Syndrome, Aerotoxic Syndrome, some metals etc. This is ‘confusion worse confounded.’

Clinically, ME is a separate disorder from what is now termed CFS or “CFS/ME”: ME is a recognisable post-enteroviral disease with specific features; it may also follow vaccinations (for which significant evidence already exists and more evidence is emerging).  However, there are a number of states of chronic fatigue which now fall under the “CFS/ME” umbrella and the resultant confusion is responsible for the heterogeneity of the patient population and hence the diverse research findings.

Unless the report author provides the contextual background, he affords a disservice not only to the physicians he is endeavouring to educate but – more importantly -- to those patients who depend on those clinicians.


4.  The way forwards

The term “CFS/ME” now has come to mean a behavioural disorder and this report repeatedly portrays CFS as deconditioning which can be effectively treated by cognitive behavioural therapy (CBT) and graded exercise therapy (GET), but there is no evidence whatsoever of deconditioning in patients with ME/CFS.  If this whole document is not based on ME/CFS as a neurological/neuroimmune disorder, then it is falsely grounded.

The report does mention biomedical research, but it appears to look on it sceptically, and the take-home message is clear: “Patients should be educated on how secondary physical deconditioning can emerge due to increased resting and activity restriction” (page 76).  This is misleading and it perpetuates the widely-disproven psychosocial dogma that “CFS/ME” is a mental disorder.

It is essential to gain the immediate attention of the reader seeking up-to-date information, so it would be better to start off with a high impact paragraph such as:
“Studies suggest that there is a risk of earlier mortality in ME/CFS and UK Coroners have recorded ME as the cause of death.  ME is a serious, disabling, chronic neuroinflammatory disorder: as long ago as August 2004 the US CDC added it to its top priority list of emerging infectious diseases.  It is not a behavioural disorder; it is not a form of chronic fatigue (which is not the same as chronic fatigue syndrome as listed in ICD-10 at G93.3), nor is it a form of depression and most patients have no psychiatric disorder. There is a state of chronic, low-grade immune activation, with abnormal T-helper/T-suppressor cells and extremely low NK cell numbers/function; brain abnormalities have been proven, as have neuroendocrine abnormalities. ANS dysfunction is integral to the diagnosis, as is disordered gene expression (important in energy metabolism – metabolomics have convincingly demonstrated defects in pathways converting sugars, lipids and amino acids into energy https://www.youtube.com/watch?v=VprqU9knS4Y). There is evidence of biochemical dysregulation in the 2-5A synthetase/RNASE L pathway (ie. an abnormally elevated anti-viral response). Cardiovascular abnormalities are seminal (including altered brain perfusion, reduced cardiac mass and low circulating blood volume), as is an abnormal response to exercise, with muscle weakness (enteroviral sequences being found in muscle), as well as evidence of impaired oxygen delivery to muscles, with recovery rates for oxygen saturation being 60% lower than in normal controls (Kevin K McCully  et al. Clinical Science 1999:97:603-608). Since 2000, patients with ME have been advised to consider taking legal action against health professionals when inappropriate exercise is prescribed. (ME Association). Inability to tolerate medication is well-documented as being virtually pathognomonic (Professor Charles Poser, Department of Neurology, Harvard Medical School, Dublin International Meeting on ME/CFS, 18th-20th May 1994, World Federation of Neurology). There is high occurrence of allergies and hypersensitivities.  25% of patients with ME are severely affected and are bed/house-bound.  80% of patients do not get better: published CDC statistics show only 4% in remission (not recovery) at 24 months (US CDC CFS Programme Update, 29th August 2001)”.

Physicians need to be presented right from the beginning of the document with a clear list of key physical symptoms, but as it stands, the document fails to do so and the author focuses on cognitive problems.  He does not mention immune, cardiovascular, neuroendocrine or gastro-intestinal symptoms until much later in the document, whereas from the outset there needs to be a prominent box listing the cardinal symptoms; these include:

post-exertional malaise (PEM); exhaustion; muscle pain and weakness; abdominal pain; diarrhoea; balance disturbance/dizziness; shortness of breath; palpitations; joint pain; easy bruising; allergies/hypersensitivities to foods previously tolerated; chemical sensitivities (including to therapeutic drugs); frequency of micturition including nocturia; visual problems; flushing (not the same as hot flushes); emotional lability; lack of restful sleep and cognitive problems.  Pain may be intractable but it may sometimes be absent; hair loss may be total or partial.


To read the rest of the document, please go to –



Wednesday, 10 October 2018

Faultless before the presence of His glory

http://bible.christiansunite.com/Morning_and_Evening/chme1010.shtml

C H Spurgeon's Morning Devotional for 10th October

"Faultless before the presence of His glory."

Jude 24

Revolve in your mind that wondrous word, faultless!" We are far off from it now; but as our Lord never stops short of perfection in His work of love, we shall reach it one day. The Saviour who will keep His people to the Lend, will also present them at last to Himself, as "a glorious church, not having spot, or wrinkle, or any such thing, but holy and without blemish." All the jewels in the Saviour's crown are of the first water and without a single flaw. All the maids of honour who attend the Lamb's wife are pure virgins without spot or stain. But how will Jesus make us faultless? He will wash us from our sins in His own blood until we are white and fair as God's purest angel; and we shall be clothed in His righteousness, that righteousness which makes the saint who wears it positively faultless; yea, perfect in the sight of God. We shall be unblameable and unreproveable even in His eyes. His law will not only have no charge against us, but it will be magnified in us. Moreover, the work of the Holy Spirit within us will be altogether complete. He will make us so perfectly holy, that we shall have no lingering tendency to sin. Judgment, memory, will-every power and passion shall be emancipated from the thraldom of evil. We shall be holy even as God is holy, and in His presence we shall dwell for ever. Saints will not be out of place in heaven, their beauty will be as great as that of the place prepared for them. Oh the rapture of that hour when the everlasting doors shall be lifted up, and we, being made meet for the inheritance, shall dwell with the saints in light. Sin gone, Satan shut out, temptation past for ever, and ourselves "faultless" before God, this will be heaven indeed! Let us be joyful now as we rehearse the song of eternal praise so soon to roll forth in full chorus from all the blood-washed host; let us copy David's exultings before the ark as a prelude to our ecstasies before the throne.

Thursday, 4 October 2018

The impact of profound Multiple Chemical Sensitivity in Severe ME

By Greg Crowhurst

https://25megroup.org/2311-2

A Painfully Nuanced Life: The impact of profound Multiple Chemical Sensitivity in Severe ME.

(Published in the latest edition of “MCS Aware Magazine”)

‘How can I convey to you that I live in a totally different world than you, even if I am in the same room as you, even if you appear to be in the same physical space as me, believe me I am not experiencing anything in the same way as you.’

This is a very short extract, from my new book: ‘Caring for ME’. It is a quote from my wife.

I am sure that everyone who experiences MCS can relate to what she is saying. Suddenly when you develop MCS, a whole invisible world, previously unknown and unimagined, opens up. Smells and chemicals that others tolerate or do not notice, perfumes that they adore, become a nightmare for you.

In the most extreme cases, it cuts people off completely from normality as it was known, on every level, leaving them totally isolated in a world that torments or harms them. Their symptoms are very painful and difficult to manage.

Suddenly you are in danger from letters in the mail, which often come doused in perfume, from shopping in bags covered in perfume, especially if it delivered via a home delivery scheme, from the fresh air even, saturated by laundry conditioners, barbecue smoke, deodorants that give you a severe headache or cause you to be nauseous, develop rashes and severe symptoms such as throat paralysis.

Suddenly your world becomes painfully nuanced by other people’s lives, in ways that you simply could not have imagined and which those who perpetrate the problem cannot imagine either!

MCS makes an impossible life a nightmare. I have had to become very good at asking any tradesman who has to visit, not to wear any aftershave or perfumed product.

If someone pats our irresistibly cute Corgi, who goes around wagging his tail and making eyes at everyone, it’s horrifying if they are wearing perfume. Hours of torment can follow.

We have not been able to find a mask that my wife can tolerate, her skin is so painful and sore to touch that she cannot bear the pressure. One that we did order had to be hung on the line for days, it smelled so much and was still unusable, sadly.

If I dare go anywhere, I need to shower and change very, very quickly.

MCS; it is a disabling lonely experience.

Into this world, the carer is thrown, having to learn what is unseen. Life with a person with MCS demands that you become acutely aware and sensitive, that you develop skills and practices in order to live with or help the other person to deal with all that is required. Not easy, especially when you cannot even smell the scent that your wife is getting so disturbed by, the one that is going to cause a devastating deterioration in her health and much more disturbance to an already painful and difficult life.

My new book is about caring for people with multiple sensitivities to chemicals, noise, light, movement, touch, food and the host of other agonising; all, disabling symptoms, that are found in Severe ME, yet are so often unseen and unknown by the normal world.

Many people do not have a clue how to approach someone safely. I have been caring for my wife full time for the last 25 years, I am still learning.

How to provide the best care then? It is only possible, we have discovered, by taking a moment by moment approach, seeing what is possible in each moment, dealing with issues that come up as and when it is possible – some moments are too incredibly difficult and painful to achieve anything. Even your presence with the person may be too much. In all moments the greatest possible tenderness and awareness, on the part of the carer is required.

This book is witness to a secret, hidden, tormented existence and unimaginable, intractable suffering, that never ends. That is its starting point. The book is part information, part a journey of self-discovery, through questions designed to challenge and hopefully affirm the carer, helping them identify areas they may need to develop further. I have answered many of the questions myself, to encourage and enable.

“Caring For ME” is a little pocketbook of encouragement and affirmation hopefully for difficult days and happier days alike.

By Greg Crowhurst

http://stonebird.co.uk/CARE/index.html 

https://www.mcs-aware.org/mcs-magazine

Monday, 1 October 2018

Hospital Booklet

Strange as it may sound to some, one of the worst places for a person with ME to be is a hospital, not least because it often leads to a deterioration in health and an increase in symptoms. The noise, light, use of chemicals, a higher risk than usual of catching bugs / infections, and a general lack of understanding about ME, can all cause major problems.

If hospital treatment – either as an inpatient or an outpatient – becomes absolutely necessary, The Grace Charity for ME (www.thegracecharityforme.org) has produced a helpful booklet entitled “Information for patients and hospital staff regarding treatment of patients with ME (Myalgic Encephalomyelitis)”. The booklet includes information about ME and hospital environments, chemicals and drugs (including anaesthetics), surgery, exercise and ME, and diet and allergies.

To download the booklet as a pdf file –


To download as a Word document –


Friday, 21 September 2018

Open Medicine Foundation Delivers Hope to Millions of Patients

https://www.omf.ngo/2018/09/20/omf-sponsors-second-annual-community-symposium-stanford-university/

For Immediate Release

Sept. 20, 2018 (Los Angeles, CA) – Open Medicine Foundation (OMF), the premier nonprofit organization investing in research to cure myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), sponsors the Second Annual Community Symposium on the Molecular Basis of ME/CFS on September 29, 2018, at Stanford University. This event is expected to draw more than 300 scientists, clinicians, patients, and caregivers as well as over 3,000 attendees globally via livestream.

OMF is working to put an end to ME/CFS – estimated to afflict 20 million globally — by funding a global research effort to identify diagnostic biomarkers, effective treatments, and ultimately a cure. As part of its efforts to foster open, collaborative research, the Foundation is funding a three-day scientific working group meeting in which over 50 world-class scientists with diverse expertise will share their latest results and chart a path forward, followed by the Community Symposium, at which highlights of these results will be shared with the public.

Linda Tannenbaum, OMF founder and CEO/President, will welcome guests at this year’s Symposium and highlight the importance of open collaboration to fast track solutions. The keynote address will be delivered by Oystein Fluge, MD, PhD, of Norway. Additional scientists speaking include the Symposium Chair Ronald Davis, PhD; the Symposium Moderator Raeka Aiyar, PhD; Maureen Hanson, PhD; Jonas Bergquist, MD, PhD; Wenzhong Xiao, PhD; Alain Moreau, PhD; Ronald Tompkins, MD, ScD; Jared Younger, PhD; Michael Sikora, graduate student; and Rob Phair, PhD, who will speak about the new metabolic trap hypothesis.

OMF currently funds ME/CFS Collaborative Research Centers at Stanford and Harvard. Scientists from both Centers will present their research at this year’s symposium.

To register for the Symposium Livestream, click here.

Tuesday, 18 September 2018

Trial By Error: Bruce Levin on “How Not to Conduct a Randomized Clinical Trial”

http://www.virology.ws/2018/09/18/trial-by-error-bruce-levin-on-how-not-to-conduct-a-randomized-clinical-trial/ 

18 September 2018

By David Tuller, DrPH

When I first began examining the PACE trial in detail, I turned to clinical trial experts to vet my concerns. One of them was biostatistician Bruce Levin, a professor at Columbia University’s Mailman School of Public Health, to whom I was referred by a mutual colleague. After he reviewed the trial, he pronounced it to be a mess—a conclusion that fueled my determination to investigate the matter.

Professor Levin identified many faults in the PACE trial’s design and conduct. In particular, he found the overlaps between the entry and outcome thresholds for the key outcomes of physical function and fatigue to be unacceptable peculiarities of the study. “I have never seen a trial design where eligibility requirements for a disease alone would qualify some patients for having had a successful treatment,” said Levin told me for my initial series of articles. “It calls into question the diagnosis of an illness whose patients already rate as ‘recovered’ or ‘within normal range.’ I find it nearly inconceivable that a trial’s data monitoring committee would have approved such a protocol problem if they were aware of it.”

Levin also said the mid-trial publication of a newsletter featuring glowing testimonials from earlier participants and positive news about interventions under investigation created legitimate concerns that subsequent responses might have been biased, especially in an unblinded study with subjective outcomes like PACE. “It is highly inappropriate to publish anything during an ongoing clinical trial,” he told me. “To let participants know that interventions have been selected by a government committee ‘based on the best available evidence’ strikes me as the height of clinical trial amateurism.” (In fact, “the height of clinical trial amateurism” is probably one of my favorite quotes of all time.)

Anyway, last week Professor Levin took his criticism a step further with a public talk about PACE at Columbia. The talk was called, appropriately enough, “How Not to Conduct a Randomized Clinical Trial.” For the last couple of years, I have been pointing out that PACE has been used at Berkeley as a case study of bad science in epidemiology courses. Now it is legitimately possible to say that it has been presented at multiple major American universities as a case study of bad science. Thanks, Bruce!!!

Here is a link to his slide presentation:


Thursday, 13 September 2018

This Man receiveth sinners


C H Spurgeon’s Evening Devotional for 13th September 

"This Man receiveth sinners."

Luke 15:2

Observe the condescension of this fact. This Man, who towers above all other men, holy, harmless, undefiled, and separate from sinners-this Man receiveth sinners. This Man, who is no other than the eternal God, before whom angels veil their faces-this Man receiveth sinners. It needs an angel's tongue to describe such a mighty stoop of love. That any of us should be willing to seek after the lost is nothing wonderful-they are of our own race; but that He, the offended God, against whom the transgression has been committed, should take upon Himself the form of a servant, and bear the sin of many, and should then be willing to receive the vilest of the vile, this is marvellous.

"This Man receiveth sinners"; not, however, that they may remain sinners, but He receives them that He may pardon their sins, justify their persons, cleanse their hearts by His purifying word, preserve their souls by the indwelling of the Holy Ghost, and enable them to serve Him, to show forth His praise, and to have communion with Him. Into His heart's love He receives sinners, takes them from the dunghill, and wears them as jewels in His crown; plucks them as brands from the burning, and preserves them as costly monuments of His mercy. None are so precious in Jesus' sight as the sinners for whom He died. When Jesus receives sinners, He has not some out-of-doors reception place, no casual ward where He charitably entertains them as men do passing beggars, but He opens the golden gates of His royal heart, and receives the sinner right into Himself-yea, He admits the humble penitent into personal union and makes Him a member of His body, of His flesh, and of His bones. There was never such a reception as this! This fact is still most sure this evening, He is still receiving sinners: would to God sinners would receive Him.

Thursday, 6 September 2018

Complaint Report offers hope for those living with ME in Ireland

https://meadvocatesireland.blogspot.com/2018/09/complaint-report-offers-hope-for-those.html?m=1

[This is a long article but well worth reading. I'm posting some of it here; to read the rest, click on the link.]

Christine Fenton

In this post MEAI Advocate Christine Fenton describes her journey with ME and the HSE, elements of which we'll all recognise. The Result? Recommendations for actions by the HSE.

I was diagnosed with Myalgic Encephalomyelitis (ME) in 1990 and retired from my career in teaching, a Deputy Head of a high school in the UK, in 2000. Two years later I moved to Ireland to renovate a derelict house and enjoy my passion for dogs and horses.

In 2003 I deteriorated and was surprised that my then GP was dismissive of the ME diagnosis and regarded it as a mental health issue.

By 2006 I was losing the use of my arms and legs, I'd suddenly find myself sitting on the ground as my legs gave way, often with a horse above me! My arms couldn't manage any repeated use of muscles. I collapsed at an out of hours GP surgery and became paralysed for a short period. The attending GP said she'd never seen anything like this and I should go to Dublin to find the cause.

By chance I had an Out-Patient appointment the week after the collapse and was fortunate to meet with a Consultant new to the local hospital. He was willing to listen and regarded my presentation as an 'interesting challenge'.

My health continued to deteriorate and from 2011-2016 I was spending approx. 3 months annually in acute care.

The difficulties in achieving a home care package to enable me to access the very limited life I was capable of were legion.

Given the limitations of my body, I needed everything available within arms-reach of my resting place. At that time a wooden steamer chair with settee cushions on it was my bed and day chair.

I also needed a consistent temperature as overheating caused me to be unwell very quickly. If my fingers got cold it would trigger severe pain throughout my body, then my legs would give way and I would end up sitting on the floor, sometimes in an unheated room with no ability to return to a warm, comfortable space. I had to resort to pulling ‘something’ from nearby to cover me to increase my core temperature so that I could recover and crawl/push myself, back to safety.

On the days I was too unwell to move, food had to be beside me, small, easy to digest quantities, taken when I had the energy to put food to my mouth, chew, swallow and digest – you’d never believe how hard the action of eating is, something I took for granted when healthy.

At home, as stairs were beyond me and the bathroom was upstairs I had no facilities available to me. Initially I tried a camping cassette toilet, but it was too heavy to empty and needed emptying too frequently. Often it was full on a day I was struggling to use it, never mind empty it. I needed a better solution which met my needs and capability. I decided to use coal buckets as my toilets. When you live in one room and everything, including eating, is done in that room, a steaming commode is just not welcome - we all know the gut problems which accompany ME. There are some indignities I am not willing to contemplate!

The HSE ‘experts on disability’ were nowhere in sight. My request for support at home had been refused without a visit or an assessment being undertaken, no reason was given to explain why I was not worthy of an assessment. Just a refusal letter from an HSE disability manager who made a judgement without any evidence of my needs on which to base it.

So, I was on my own and had no choice but to create a system which allowed my needs to be met, within the resources available to me.

To continue reading the article, click on –

Saturday, 1 September 2018

Letter to Professor Watt of MRC



This letter from Professor Fiona Watt of the Medical Research Council in support of the PACE Trial appeared a few days ago in response to the Times article about the growing pressure on The Lancet concerning the trial:

CHRONIC FATIGUE

Sir, Further to your report “Call for review of ‘flawed’ ME research”(Aug 21), as funders of the Pace trial we reject the view that the scientific evidence provided by the trial for using cognitive behavioural theory and managed exercise in the treatment of chronic fatigue syndrome (also known as ME) was unsound. The Pace trial was funded following expert peer review, was overseen by an independent steering committee, and its published findings have also been independently peer-reviewed. Other research groups have drawn similar conclusions. Chronic fatigue syndrome/ME remains a priority for the Medical Research Council (MRC), and it is important that researchers are not discouraged from working on the disease because of concerns that they could be subject to the level of hostility that Pace researchers have experienced. Medical research can only flourish when there is mutual respect between all parties.

Professor Fiona Watt Executive chairwoman, Medical Research Council

There have been other responses from patients. Here is mine, which I decided to send directly to Prof Watt.

Maybe she will see it. Maybe she will read it. Maybe she will do as I ask! I’ve sent it anyhow. You don’t win the lottery if you don’t buy a ticket…

Dear Professor Watt,

Like many patients with M.E. I was surprised and disappointed by your letter to The Times wholeheartedly supporting the PACE trial. There are so many misconceptions in the letter that it is clear that you have not investigated this matter yourself but have – apparently- assumed that what the PACE authors tell you about it is correct and what patients tell you is not. I can only assume that this is because they are doctors and we are merely patients.

Yet you say in your letter that ‘medical research can only flourish when there is mutual respect between all parties’. I would certainly not disagree with that. Please then show patients the respect of being open to the possibility that what we (and indeed many distinguished researchers and other informed parties) say about PACE may actually be correct.

I am not asking you to take us at our word, but please look into the matter yourself instead of simply believing what you are told by the PACE authors and their friends. It will not take you long. I have provided a few references at the end of this letter which you will find useful. For the sake of the patients you say you wish to respect, please take the trouble to do this.

Thank you,

Useful references:

Rethinking the Treatment of Chronic Fatigue Syndrome – A Reanalysis and Evaluation of Findings from a Recent Major Trial of Graded Exercise and CBT by Wilshire et al. – Jan 2018 (A comprehensive re-evaluation of PACE following the release of data from the Freedom of Information Act Tribunal.)

Journal of Health Psychology Vol 22 No.9 Aug 2017 – A Special Issue on PACE. “On the basis of this Special Issue, readers can make up their own minds about the merits and demerits of the PACE Trial,” writes Editor David F Marks.

A letter to The Lancet signed by over a hundred scientists, clinicians, academics, MPs and other experts plus over sixty local, national, and international patient organisations, calling for an independent re-analysis of PACE and setting out the reasons why.

The August 2016 PACE Trial Freedom of Information Tribunal Judgement has useful information about so called hostility to PACE researchers, an unfounded allegation which your letter unfortunately perpetuates.

Two notes relating to this issue:

Allegations were made at the Tribunal by a representative of the PACE proponents that ME patients, described as ‘activists’ were ‘borderline sociopathic and psychopathic’ and posed ‘a serious threat of violence to trial participants and researchers’ but the Commissioner described these as ‘wild speculations’ which did the representative ‘no credit’ (see pages 22 and 36). PACE researcher Prof Chalder accepted that ‘there had been no threats made either to researchers or participants’ The Commissioner stated that the ‘assessment of activist behaviour was grossly exaggerated. The only actual evidence was that an individual at a seminar had heckled Prof Chalder.’ (see page 40)
Your letter also suggests that researchers might be ‘discouraged from working on the disease because of concerns that they could be subject to the level of hostility that PACE researchers have experienced’. The idea that researchers are being discouraged in this way is another often repeated misconception which seems to be intended to vilify patients. Working for the MRC, you will be fully aware of how little funding M.E. has received over the years. Nevertheless there is research going on worldwide, strongly supported by patients and often funded by them. (Many of these researchers are critical of PACE and have signed the letter to The Lancet requesting its independent reassessment – see above.) Patients do however object – in the form of letters such as this and other peaceful means – to the squandering of funds on poorly conducted research such as PACE, money which is desperately needed for high quality biomedical research into the condition.

Tuesday, 21 August 2018

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

https://www.meassociation.org.uk/2018/08/the-times-call-for-review-of-flawed-me-research-in-lancet-letter-21-august-2018/

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.

Sincerely,

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

http://bible.christiansunite.com/Morning_and_Evening/chme0817.shtml

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

https://25megroup.org/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

https://www.huffingtonpost.co.uk/amp/entry/myalgic-encephalomyelitis-how-it-feels_uk_5b61badbe4b0fd5c73d524cc/

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

03/08/2018

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.