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After a long legal battle, unpublished data from the trial was released and, when independently analysed, it showed no difference between the different treatments being tested and that reported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


Monday, 19 February 2018

Infection Elicited Autoimmunity and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: An Explanatory Model



Jonas Blomberg 1*,  Carl-Gerhard Gottfries 2,  Amal Elfaitouri 3,  Muhammad Rizwan 1 and Anders Rosén 4

1 Department of Medical Sciences, Uppsala University, Clinical Microbiology, Academic Hospital, Uppsala, Sweden

2 Gottfries Clinic AB, Mölndal, Sweden

3 Department of Infectious Disease and Tropical Medicine, Faculty of Public Health, Benghazi University, Benghazi, Libya

4 Department of Clinical and Experimental Medicine, Division of Cell Biology, Linköping University, Linköping, Sweden

Myalgic encephalomyelitis (ME) often also called chronic fatigue syndrome (ME/CFS) is a common, debilitating, disease of unknown origin. Although a subject of controversy and a considerable scientific literature, we think that a solid understanding of ME/CFS pathogenesis is emerging. In this study, we compiled recent findings and placed them in the context of the clinical picture and natural history of the disease. A pattern emerged, giving rise to an explanatory model. ME/CFS often starts after or during an infection. A logical explanation is that the infection initiates an autoreactive process, which affects several functions, including brain and energy metabolism. According to our model for ME/CFS pathogenesis, patients with a genetic predisposition and dysbiosis experience a gradual development of B cell clones prone to autoreactivity. Under normal circumstances these B cell offsprings would have led to tolerance. Subsequent exogenous microbial exposition (triggering) can lead to comorbidities such as fibromyalgia, thyroid disorder, and orthostatic hypotension. A decisive infectious trigger may then lead to immunization against autoantigens involved in aerobic energy production and/or hormone receptors and ion channel proteins, producing postexertional malaise and ME/CFS, affecting both muscle and brain. In principle, cloning and sequencing of immunoglobulin variable domains could reveal the evolution of pathogenic clones. Although evidence consistent with the model accumulated in recent years, there are several missing links in it. Hopefully, the hypothesis generates testable propositions that can augment the understanding of the pathogenesis of ME/CFS.

To read the full article, go to –


Thursday, 8 February 2018

He Careth For You


Casting all your care upon him; for he careth for you – 1 Peter 5:7

A WORD FOR THE NEW YEAR

Peter wrote his first letter as one who had been with Jesus for those three years on earth, and then saw Him alive after His death and burial. This is, of course what qualified him to be an apostle of Christ: he had seen the risen Lord. Those beautiful words, “Whom having not seen, ye love” (1:8) was not true for him, although they applied to his readers afterwards. However, they became true for Peter and for us all: we view our dear Redeemer by faith, and know Him in heart-experience (Acts 1:13,14; 2 Corinthians 5:16; John 14:18). That said, Peter had been one of those who “have heard … seen with our eyes … looked upon, and our hands have handled, of the Word of life” (1 John 1:1).

Failed
But he also wrote this as a man who had failed His Master many times. Mostly, it was well-meaning blunders, because his heart was right. It is a comfort to know that the Lord distinguishes between sincerity when we fail, and guilt because of rebellion and disobedience. However, like David, almost Peter’s Old Testament counterpart, the time came when he fell guiltily and grievously. Through a combination of pride, and then cowardice, (Proverbs 16:18), Peter denied his Master, even to oaths and curses (Mark 14:71).

Repented
However, through grace, Peter quickly repented (“he went out and wept bitterly” Luke 22:62) and was wonderfully restored. Moreover, our Lord reinstated him to that place of trust as His apostle (“Lovest thou me?” … “Feed my sheep,” John 21:17). This reminds us that when repentance is genuine, it leads all the way back to “from whence thou art fallen” (Revelation 2:5). As Thomas Adams put it, “Sin is so remitted, it is as though it never were committed.” Now, Peter is able to “strengthen thy brethren” (Luke 22:32), and his two epistles show him doing this. How blessed to realise that even our sins can be worked together for our good, and by them the Lord brings greater blessing to ourselves and others! As Erskine wisely puts it,

Sin, to do thee good, will work and win,
But ‘tis not good for thee to sin.

Therefore, when the apostle says to his readers, and to us, “… he careth for you,” he does so from personal experience he could never forget. We almost hear him exclaiming, “Oh, how He did that for me!” Truly, Peter, and many others since, have “tasted that the Lord is gracious” (1 Peter 2:3).

Witness
However, in addition to this, is Peter’s witness to this. He was, “a witness of the sufferings of Christ” (1 Peter 5:1) and one of the “eyewitnesses of his majesty” (2 Peter 1:16). But he also saw, while with the Master, how Jesus treated people.

We can find a fuller account of this in Mark’s gospel. It is believed that Peter’s witness lies behind the second gospel. Peter had a close relationship with the younger Mark (Acts 12:12; 1 Peter 5:13). And Papias of Hierapolis (60-130 AD) in his Ecclesiastical History, echoed the common belief that “Mark became Peter’s interpreter and wrote accurately all that he remembered.” The vivid, fast-moving action in Mark is certainly redolent of Peter’s personality.

Therefore, when Mark’s gospel shows our Lord caring for others, it will be Peter’s recollection of that. The touching examples that follow are worth pondering in the light of our verse, “he careth for you:” Mark 1:30,31; 2:5-12; 4:35-41; 5:36; 6:50; 9:23,24; 10:49; 11:15 notice, “the seats of them that sold doves” – not the tables: He even cares for caged birds; 14:8; 16:7.

We can be sure He is the same now in heaven. Notice the present continuous tense: “careth.” It is not that He used to, or will – but He does – He “careth.” This is the heart of Christ in heaven toward His people on earth. He has a kind interest in us, is attentive to our needs and troubles, and looks after us with wise forethought. The original Greek of our verse can be rendered more literally, “it matters to Him concerning you.”

Let us pursue this, and think about,

1. His Care

“All your care.” That is a small word for a large problem. We all feel care. Modern life seems to create many care-worn, insecure, anxious, and troubled souls – sometimes ourselves among them. Perhaps the year that is past has been particularly so for you.

1] It is a meaningful word.
Merimnah comes from a word which means, “to draw in different directions.” Therefore, it means to be distracted and in a whirl about things. This is typical of what we find. Competing demands, so much requiring our attention, things spiralling out of control. It can get too much for us.

Alternatively, perhaps we do not know what to do regarding something. An important decision has to be made, but it keeps us in suspense and fretfulness.

Or, it may be a deep concern about something. It has become a burden and an anxiety. We feel it’s weight, are bowed down by it; it saps our strength and joy.

As Christians, we take life seriously. Amidst the joys and encouragements are the difficulties and challenges. We cannot be careless and indifferent. The more conscientious we are the more we are liable to bring ourselves down with burdens and cares. For some, it can reach breaking-point. Our Lord’s care for us is always a word in season.

2] The word has a double meaning.
“All your care.” In a good sense, it refers to the legitimate responsibilities of life. We care about our family, work, health, about others’ needs, things that are not right, and so on. For Paul, it was the huge “care of all the churches” (2 Cor.11:28).

However, it also has a dangerous meaning to it. In Mark 4:19 our Lord warns us about “the cares of this world, and the deceitfulness of riches, and the lusts of other things.” The thorny ground hearer in the parable of the sower is in danger of cares choking the word and making it unfruitful. Every day cares be as dangerous and riches and lusts. Tragically, for some, this has been the end of their Christian profession. They have become imbittered, cynical, and have given up, and succumbed to the world’s embrace. Therefore, we learn that “all your care” will either take us from Christ or bring us nearer to Christ (John 6:68).

2. Our Casting

“Casting all your care upon him; for he careth for you.”

1] Here, there is Someone to whom we can go.
“Your care upon him.” Who is meant here? We have said it is Jesus, for this looks back to verse 4, about the Chief Shephard rewarding His under-shepherds. However, its antecedent could be God the Father, whom Peter mentions in verses 5,6. If that is so, we should notice in these verses the connection between humble submission and our being relieved of care. To “humble (ourselves) under the mighty hand of God” is the best place from which to cast our care upon Him. A humble spirit is before God, acknowledging Him, conscious of His presence continually (Micah 6:8). If sometimes we are not helped with our cares, is it because of pride: we try to manage things ourselves, we fail to acknowledge the Lord, we are prayerless?

2] Let us also beware of an unbecoming spirit.
Martha, in the midst of her care, spoke impatiently to the Lord, “dost thou not care that my sister hath left me alone? bid her therefore that she help me.” Clearly circumstances have overwhelmed her, and she is hasty, critical and presumptuous. How far this is from being under God’s hand! It is as if she is all alone, yet the Lord is right there. His gracious reply reveals the cause of her trouble: “Martha, Martha, thou art careful and troubled about many things: But one thing is needful” (Luke 10:41,42). He says in effect, “Martha, I do care – but your care is wrong and unnecessary; you have forgotten Me and tried to manage things yourself.” To remember that He is always there is the beginning of victory.

A similar example is when the disciples were in the boat in the storm. Our Lord was in the same boat, and when it began to rock and fill with water, they panicked, woke Him and cried, “Master, carest thou not that we perish? And he arose, and rebuked the wind, and said unto the sea, Peace, be still. And the wind ceased, and there was a great calm. And he said unto them, Why are ye so fearful? how is it that ye have no faith?” (Mark 4:38-40). How could they drown when the Son of God was with them? And how could they doubt His care? The problem was their faith was not in exercise: they saw and felt the storm but forgot the Master! Let us of doing the same.

3] This involves calm, deliberate prayer.
“Casting … your care upon Him.” When we tell the Lord about it (even in short, mental prayer, Nehemiah 2:4,5) is like offloading the care onto Him. “Casting” is the same word for when, before our Lord’s triumphal ride into Jerusalem, “they cast their garments upon the colt” (Luke 19:35). Their other garments felt lighter because divested of their outer ones. They no longer felt them – they were on the colt instead. Let us do that with our “care.” Prayerfully tell Him about it, put it into His hands, trust Him to deal with it. Believe that it is His responsibility more than yours, and expect the Lord to come in for you.

David bids us do the same in Psalm 37, where he cautions us against fretfulness, and envy of others who seem carefree (verse 1). And even from anger and being tempted to evil (verse 8). And the remedy? “Commit thy way unto the LORD; trust also in him…” (verse 5). The word is literally “roll thy way upon the LORD” (margin). When something is too heavy for us, and we roll it upon something or someone that can bear it, we are relieved and free of it. It is a blessed lightness and joy that comes instead. As Doddridge said,

I’ll drop my burden at His feet
And bear a song away.

4] Nothing is excluded.
“Casting all your care upon him.” We tend to do this with the major things in life, but not with the more every day, minor matters – yet they are the ones that often defeat us. Yet, that lost item, that decision, that phone that is ringing, finding a parking place, the wisdom needed and so on. What does it not cover for an exercised Christian?

5] It brings peace to our heart.
“Upon him” – we can see it now as His concern and responsibility. We can look forward to seeing what He will do for us.

Remember then, that “he careth for you.” Believe that He is there with you, always (Matthew 28:20). Pray, and give your care to Him, and know the comfort of His care for you. Be like Ruth (3:18) and “sit still … until thou know how the matter will fall: for the man will not be in rest, until he have finished the thing this day.”

All your anxiety, all your care,
Bring to the Mercy Seat, leave it there,
Never a burden He cannot bear,
Never a Friend like Jesus!

6] A remaining problem is when we think about it again.
Satan will bring it back and make us “careful” again (Philippians 4:6). How often we have found peace, only to lose it soon afterwards! We lay it down at His feet, and then seem to pick it up again. The remedy here is to repeat the process of casting it upon Him by prayer. If it comes back, pray again – and again – and again. Eventually, the devil will realise that he is only sending you to the Lord and give up! You will then have the victory. Only do not give up before he does!

by Rev. John Thackway, Pastor of Holywell Evangelical Church

Used with kind permission of the author

Tuesday, 6 February 2018

Neurologic Abnormalities in Myalgic Encephalomyelitis / Chronic Fatigue Syndrome: A Review


Komaroff AL 1, Takahashi R, Yamamura T, Sawamura M.

1 Department of Medicine, Brigham & Women's Hospital, Harvard Medical School.

Abstract

Myalgic encephalomyelitis / chronic fatigue syndrome (ME/CFS) is an illness characterized by fatigue lasting for at least six months, post-exertional malaise, unrefreshing sleep, cognitive impairment and orthostatic intolerance. ME/CFS has been a controversial illness because it is defined exclusively by subjective complaints. However, recent studies of neuroimaging as well as analysis of blood markers, energy metabolism and mitochondrial function have revealed many objective biological abnormalities. Specifically, it is suspected that the symptoms of ME/CFS may be triggered by immune activation - either inside or outside the brain - through release of inflammatory cytokines. In this review, we summarize potentially important recent findings on ME/CFS, focusing on objective evidence.

PMID: 29348374   DOI: 10.11477/mf.1416200948

Thursday, 1 February 2018

The TYMES Trust: No Reported Harassment at Bristol University (Information Obtained Under FOI)

The Young ME Sufferers Trust - www.tymestrust.org/

No Reported Harassment at Bristol University (Information Obtained Under FOI)


There has been no reported harassment of staff at Bristol University.

Yes, you read that correctly.

We have all become accustomed to the increasingly shrill ‘harassment’ accusations against ME patients and ‘activists’, both via the media and in lectures. This campaign appears to have originated at that now infamous meeting of the Science Media Centre, revealed by our original 2014 Freedom of Information Report, now updated under the title Shining a Light on the CMRC Setup (http://www.tymestrust.org/pdfs/shiningalight.pdf). Members of the UK Research Collaborative have continued to spread these allegations ever since its launch.

In Shining a Light we stated: In the records of the meeting where ‘harassment’ of researchers was discussed, no mention was made of personal threats such as have been reported in the media. Freedom of Information (FOI) requests were listed as the most damaging type of ‘harassment’. The 2016 tribunal appeal Judgement ordering QMUL to release the PACE trial data highlights that Professor Trudie Chalder accepts that “no threats have been made either to researchers or participants”.

And yet the accusations persist and have even escalated. Tymes Trust has found this constant narrative so abhorrent that we have sought some answers. We have, once again, sought evidence.

A Freedom of Information request was submitted to Bristol University, as that is where many of the accusations are coming from, to find out just how bad this claimed harassment has become. Was it just in the field of ME and CFS that this was happening, or was it more widespread?

The request was submitted to Bristol University on 19th March 2017 asking for: the number of reports of harassment that members of staff have officially recorded with Bristol University between July 2015 and January 2017. I am only interested in those reports where the harassment came from outwith the university.

Five days before the deadline for the FOI response on 13th April, the University emailed back: The University has made an initial assessment of your request, and in order to progress it further we first require clarification from you. Specifically, can you please confirm whether you require details of a third party harassing members of staff at the University, or matters where members of staff at the University have been harassed by a third party? [SIC]

Confirmation was provided on the 17th April that the harassment should be by a third party.

Bristol University finally responded to the 19th March FOI request on 9th June, stating:

We have received no recorded instances of harassment of staff by a third party between July 2015 and January 2017.

We decided that this response required further investigation and a second FOI was then submitted to Bristol University on 12th June asking: Can you please provide the number of reports of harassment that members of staff have officially recorded with Bristol University between September 2010 and June 2015? I am only interested in those reports where the harassment came from outwith the university; that is, harassment of university staff by a third party.

After the 20 day statutory deadline passed with no response, a request for an internal review by Bristol University was submitted on 11th July.

Again, no response was received from the University and on 9th August an email was sent to the Information Commissioner (ICO) requesting that the appeal process be started with regard to this failure to respond.

The ICO replied on 12th August, saying that they had: written to the public authority to provide them with a copy of your original request, reminding them of their responsibilities and asking them to respond to you within 10 working days of receiving our letter (that is, by 29 August 2017). The ICO added that if you do not receive any response within 10 working days, please contact us.

By the 30th August, one day after the 10 working day deadline, no response had been received from Bristol University and a further email was sent to the ICO advising them of this fact.

At 5.21pm that same day, Bristol University then responded to the FOI request of 12th June, stating: We have received no official reports of harassment of University staff by a third party between September 2010 and June 2015.

Conclusion

The 2016 tribunal appeal Judgement ordering QMUL to release the PACE trial data, which had found, in the Judge’s words, no threats have been made either to researchers or participants, taken together with this new information that Bristol University have no reports of harassment of University staff by a third party between September 2010 and January 2017 raises questions about such accusations and about those who make them.

Why did we use Freedom of Information?

Freedom of Information requests provide the public with access to information held by public authorities. The aim of the Freedom of Information Act was a more open government based on mutual trust.

The ICO website states that Public authorities spend money collected from taxpayers and make decisions that can significantly affect many people’s lives. The decisions and actions of researchers in the field of ME and CFS do significantly affect many people’s lives. The Government White Paper Your Right to Know: Freedom of Information 1998 stated: Unnecessary secrecy in government leads to arrogance in governance and defective decision making.