Wednesday, 22 November 2017

Invest in ME Research Initial Statement on Norwegian Phase III Rtiuximab Clinical Trial

http://www.investinme.org/IIMER-Newslet-1711-03.shtml

Rituximab Trial Status   November 2017

Norwegian Statement on Phase III Trial

Professor Olav Mella recently publicly released early details from the Phase III multi-centre double-blinded placebo-controlled Rituximab Clinical Trial which has been ongoing in Norway for the past year.

Invest in ME Research have been informed by Dr Oystein Fluge of this.

Invest in ME Research have issued this preliminary statement (below).

The Haukeland team will be presenting at the IIMEC13 13th International ME Conference in London on 1st June 2018


Invest in ME Research Initial Statement on Norwegian Phase III Rtiuximab Clinical Trial

November 21, 2017

The statement from Haukeland University, Bergen from Professor Mella is a major disappointment for people with ME and their families.

What had looked to be a promising line of research that could lead to an effective treatment for a subgroup of patients defined by the Canadian Criteria and major understanding of the pathology of this disease has proven to be inconclusive.

Naturally, at the charity, everyone is disappointed. We are disappointed for all the ME patients and carers and families and friends.

We are especially disappointed for all of our supporters and all who have made such generous and tireless efforts to raise funds and awareness of our campaign.

We are very disappointed also for the Haukeland research team - a wonderful team who have brought hope to all patients - and, importantly, brought new insight into this disease and new interest from other areas. 

However, we have found, throughout 12 years of trying to change the way that ME is perceived, researched and treated that it is never easy.

It would be easy to give up, to resign oneself to nothing changing, to accept the status quo.

But we think differently.

At the 2017 Colloquium/Conference we invited Karolinska Institutet in Stockholm to present negative results. Because it is important to use negative results for positive effects. Negative results are data and the Norwegian rituximab trial has generated a lot of data that needs to be looked at very carefully. 

When we first engaged Professor Jonathan Edwards into research into ME one of the earliest comments he made was that he was pleased to note that our conference did contain negative results.

We see the positives in this research which has been performed by researchers of the utmost integrity who have not made headlines for the sake of it but have thoroughly conducted outstanding research, and still retained a humility that is to their credit and that of their colleagues and team.

We have an excellent research team in Norway which has served the ME patient community and their families with honesty, integrity, professionalism, detemination and an empathy which had never been seen before in this field.

We have established good working relationships between the Norwegian researchers and the UK Centre with input from UCL and UEA/Quadram Institute.

We have data now – more than before.

We have research which IiMER has established and a foundation for the Centre of Excellence for ME.

We have international collaboration in research into ME that will continue.

And we have new plans – already in the making.

The researchers from Haukeland will give more detail on their results and publish a paper or two which will benefit all studying ME. 

For us, we have invited the Haukeland team to Norwich to discuss the way forward.

We remain positive. Another setback, another day.

We have already been in discussion with our advisors and with the Norwegian team and we will meet to clarify the best way forward in the near future with our major funder and researchers.

We still have much good research being funded and being planned and feel our stategy is, and will pay off and lead to the most rapid route to finding cause(s) of ME and effective treatments.

In another age, and in another struggle which has some parallels to that which is forced upon people with ME, these words strike a chord -

“We must accept finite disappointment, but never lose infinite hope. ” 

- Dr Martin Luther King

Friday, 10 November 2017

The eternal God is thy refuge


C H Spurgeon's Morning Devotional for 10th November 

"The eternal God is thy refuge."

Deuteronomy 33:27

The word refuge may be translated "mansion," or "abiding-place," which gives the thought that God is our abode, our home. There is a fulness and sweetness in the metaphor, for dear to our hearts is our home, although it be the humblest cottage, or the scantiest garret; and dearer far is our blessed God, in whom we live, and move, and have our being. It is at home that we feel safe: we shut the world out and dwell in quiet security. So when we are with our God we "fear no evil." He is our shelter and retreat, our abiding refuge. At home, we take our rest; it is there we find repose after the fatigue and toil of the day. And so our hearts find rest in God, when, wearied with life's conflict, we turn to Him, and our soul dwells at ease. At home, also, we let our hearts loose; we are not afraid of being misunderstood, nor of our words being misconstrued. So when we are with God we can commune freely with Him, laying open all our hidden desires; for if the "secret of the Lord is with them that fear Him," the secrets of them that fear Him ought to be, and must be, with their Lord. Home, too, is the place of our truest and purest happiness: and it is in God that our hearts find their deepest delight. We have joy in Him which far surpasses all other joy. It is also for home that we work and labour. The thought of it gives strength to bear the daily burden, and quickens the fingers to perform the task; and in this sense we may also say that God is our home. Love to Him strengthens us. We think of Him in the person of His dear Son; and a glimpse of the suffering face of the Redeemer constrains us to labour in His cause. We feel that we must work, for we have brethren yet to be saved, and we have our Father's heart to make glad by bringing home His wandering sons; we would fill with holy mirth the sacred family among whom we dwell. Happy are those who have thus the God of Jacob for their refuge!

Friday, 3 November 2017

Will The UK Establishment Finally Stop Denying The Reality Of ME?


By Dr Simon Duffy, Director of the Centre for Welfare Reform

Jennifer Brea's powerful film Unrest exposes the reality of Myalgic Encephalopathy or ME. This condition leaves people utterly exhausted, or as Brea puts it, like a broken battery, unable to charge beyond 10%.

ME is poorly understood and receives minimal research. Brea was repeatedly misdiagnosed and, on one occasion, even told that it was all in the mind - the result of some long-forgotten trauma.

Eventually Brea discovered that there was not only a name for her condition but that there are millions of other people suffering with ME. With the correct diagnosis she has managed to reduce the impact of ME on her life, but she also came to understand how this real disease creates double-barrelled suffering: first, it devastates your life by robbing you of energy; second, the failure of society to respect the reality of your illness makes you invisible and defenceless.

So, why has ME been so badly misunderstood?

Dr Charles Shepherd explains that in the UK two psychiatrists played a particularly damaging role, by treating an outbreak of ME (within a hospital) in 1955 as an example of hysteria. This dangerous desire to solve a problem by evading the problem, has been made all the easier by the emergence of something called the biopsychosocial (BPS) model: this is an all encompassing framework for rethinking illness - making it part biological, part mental, part social. This may seem reasonable, but it easily becomes a way of blaming the victim and claiming it's all in the mind.

The PACE Scandal also demonstrates the powerful forces at work. PACE was a research programme to test two 'therapies' for people with ME - Cognitive Behaviour Therapy (CBT) and Graded Exercise Therapy (GET). Although these therapies did not prove effective, researchers amended the rules of the evaluation so that people who had got worse were counted as having benefited from these therapies.

Outside the UK the PACE research has been severely criticised; but the Countess of Mar believes that the UK media has been frightened into silence by the Science Media Centre whose board members include Sir Simon Wessely, one of the psychiatrists connected to the PACE scandal. Even more disturbing is that Mrs May has now asked Wessely to lead an Independent Review of the Mental Health Act 1983 - a decision heavily criticised by independent advocates.

The UK Government also seems to have a stake in maintaining the belief that ME is all in the mind. Mo Stewart, in her book Cash Not Care, has shown how the US Insurance Company Unum has promoted the BPS model within the DWP, encouraging the UK Government to reduce disability benefits in order to grow the market for their own disability insurance products. Lord Freud cited the PACE research as important evidence to justify the use of BPS in their welfare 'reforms' and medical diagnoses have now been replaced with dubious catch-all assessments of 'readiness for work' or 'level of help.' The film I, Daniel Blake accurately captures many of the horrors of these mindless and inhuman processes.

Fortunately, in the USA, researchers are now taking ME seriously, and making important progress. CBT and GET are no longer recommended as helpful therapies and instead there is increasing recognition that excessive exercise can be extremely dangerous. The level of research is still inadequate, but no one doubts the reality of the illness and important and revealing tests have been developed.

Brea's film, which is winning awards and being widely seen, may help undermine the resistance of the UK establishment, but there is still a long way to go. Even if there are research breakthroughs people will still be living with the disabling consequences of ME. It is for this reason that the Centre for Welfare Reform is supporting the Chronic Illness Inclusion Project. Our aim is to help the community of people suffering from chronic illnesses (including, but going beyond, ME) to find their own voice, to build alliances with other disabled people and to ensure that they are no longer invisible before the eyes of the powerful.

Wednesday, 1 November 2017

ME sufferers being shamefully let down by professionals


LINDA BURNIP and DENISE McKENNA from Disabled People Against Cuts spotlight how people with ME are having their health and welfare harmed by poor research and misuse of statistics

LAST week, over 65 deaf and disabled people’s organisations, campaigns and mental health professionals wrote to the Prime Minister asking her to urgently rethink her decision to appoint Professor Sir Simon Wessely to lead the much-anticipated independent review of the Mental Health Act as announced in her speech at the Conservative Party conference on October 4.

Wessely’s body of work on myalgic encephalomyelitis (also known as chronic fatigue syndrome), and his conduct in relation to people with ME, make him resoundingly unfit to lead an inquiry into the Mental Health Act.

ME is a poorly understood illness, believed by most researchers in the field to have a physical cause. But the “psychiatrisation” of ME through a cognitive-behavioural approach to the illness led by Wessely since the late 1980s has resulted in treatment (particularly graded exercise therapy, or GET) which can be harmful and even coerced, in the stigmatisation of patients and let to the frequent denial of their entitlement to social security and support.

Wessely has consistently promoted the unsubstantiated suggestion that ME is caused or maintained by patients’ false illness beliefs and abnormal behaviour.

As a result, the integrity of patients’ experience of this devastating illness been destroyed as their testimony is deemed unreliable.

This form of “epistemic injustice” (according to medical ethics scholars Blease et al) has seen people with ME derided within the medical profession and wider society for misperceiving, exaggerating, even creating their own illness.

Wessely’s approach to ME involves treatment with GET, aimed at reversing the physical consequences of what he sees as their dysfunctional behaviour.

Nearly 50 per cent of people with ME surveyed reported that treatment with GET made their condition worse.

Yet Wessely and his colleagues are silent on the subject or dismiss patient experience as unreliable evidence or poor treatment compliance.

As a result, thousands of people with ME have received NHS treatment informed by his model that has further damaged their health.

Wessely continues to defend the notorious Pace trial, a study into CBT and GET treatment for ME/CFS part-funded by the Department for Work and Pensions and widely condemned by academics for misuse of statistical methods in order to produce positive-looking results.

Wessely’s involvement in media discussions about ME has further suppressed patients’ voices. Following the publication of results from the Pace trial, Wessely and his colleagues responded to concerns about their work by taking part in media campaign which promoted prejudice and led to those patients who had identified serious methodological and statistical problems being dismissed as irrational extremists motivated by anti-psychiatry.

The Science Media Centre, for which Wessely is a trustee, has played a key role in promoting misleading information about the Pace trial, and smearing critics.

During the 1990s Wessely advised the DWP (then DSS) that classifying ME as a neurological illness, as the World Health Organisation does, would perpetuate patients’ false beliefs, prolong their illness and result in a deluge of disability claims.

The influence of Wessely and his colleagues on DWP training manuals on CFS/ME has undoubtedly resulted in a disability assessment system biased against people with ME and caused them great additional difficulty in accessing support with the extra costs of their disability.

The work of Jonathan Rutherford reveals how Wessely was among a group of medical and insurance industry professionals whose work on “malingering and illness deception” influenced the DWP’s understanding of ill-health and disability.

Wessely and his colleagues shaped the ideology underpinning the disastrous work capability assessment (WCA) known as the “biopsychosocial model.” According to Professor Tom Shakespeare and colleagues who have exposed the poor science underpinning the biopsychosocial model, this approach to disability effectively blames disabled people seeking social security support for their own misfortune.

The WCA has had a devastating impact on the lives of disabled people as part of a package of welfare reforms leading, in the words of the UN disability committee, to “human catastrophe.”

All of these activities amount to an abuse of power by Wessely against people with ME. His thoughts and actions have led to stigma, iatrogenesis and a denial of their rights to support, all of which have compounded the burden of this illness immeasurably.

Monday, 23 October 2017

ME Association petition has been sent to Sir Andrew Dillon at NICE: M.E. is not a functional disorder


The most recent ME Association petition called on NICE to amend its proposed guideline on suspected neurological conditions, and remove all reference to ME/CFS being a functional disorder.

We wrote to Sir Andrew Dillon last Friday, with a covering letter (below) and enclosed the final petition – supported by 13,593 people – along with 199 pages of comments; such was the strength of feeling shown.


Dear Sir Andrew,

Firstly, thank you for the recent decision to fully review and update the NICE guideline for ME/CFS. It was a very welcome development and, as registered stakeholders, The ME Association and Forward ME Group (a collaboration of ME/CFS charities of which we are a member) are very much looking forward to representing the patient community at future meetings.

I am writing to you today in support of the Forward ME Group submission as stakeholders in the development of a new guideline for suspected neurological conditions. The draft guideline currently includes reference to ME/CFS being an example of a ‘functional disorder’ which the guideline  defines as a condition that is ‘emotionally generated’ and ‘which may mimic physical disease’. This ‘functional disorder’ classification is then used as a basis for advising health professionals to not refer patients with specific ME/CFS symptoms such as deteriorating cognitive dysfunction for a neurological opinion.

The submission sets out the reasons why this description of ME/CFS is inaccurate and rather alarming – especially as it is not reflected in CG53, the guideline for ME/CFS, and as this disease is recognised by the World Health Organisation (in ICD10) and Department of Health, as being neurological.

In support of this submission, The ME Association launched a public petition for a period of two weeks, that enabled people who are affected by ME/CFS to demonstrate their support that this erroneous description and implied causation be removed.

The petition closed on 11th October and was supported by 13,593 people – all of whom want to see all references to ME/CFS being a ‘functional disorder’ removed from the new guideline and/or ME/CFS removed in its entirety.

As well as enclosing the petition for your reference, I have also enclosed 199 pages of comments – such was the strength of feeling about this error – from patients, carers, family members of the severely affected and health professionals working in this field, for example:

“Having been a specialist therapist for 20 years working with CFS/ME patients I can assure you that this is not a functional illness.”
“This devastating disease has destroyed my life and that of others I’ve met. Adding to that destruction by denying the revealing international medical research highlighting the physical dysfunctional processes and pretending it is psychological in origin is heartlessly cruel.”

Neurology should be welcoming people with ME/CFS and not trying to pass them off onto other specialisms, especially when neurology can play such a key role in diagnosis and management.

We would very much like the guideline development members, who are meeting to consider stakeholder submissions and finalise the suspected neurological conditions guideline, to consider the content and strength of feeling demonstrated by this petition and in the comments, it attracted.

If NICE can again show that it has listened to feedback from stakeholders, patients and their representatives – as well as professionals working in the field – and correct the error in this new guideline, we believe the decision will be as warmly welcomed by the ME/CFS patient community as your decision to review the guideline for ME/CFS.

We would welcome an explanation as to how this error arose and why, when NICE prides itself on consideration of the evidence-base, no evidence was considered before ME/CFS was deemed to be a ‘functional disorder’ and referral of patients to neurology was decided to be unnecessary.

Please show you have listened and take on board this significant feedback.

I look forward to hearing from you in due course.

With kind regards

Yours sincerely

Dr Charles Shepherd.
Hon Medical Adviser

Enclosures:



Wednesday, 18 October 2017

Trial By Error: Another Letter to NICE’s Sir Andrew Dillon


17 October 2017

By David Tuller, DrPH

First, for those who might have missed it, here’s a conversation from This Week in Virology (TWiV), posted a few days ago. Dr. Racaniello and I discuss the CDC, NICE, Esther Crawley’s ethically challenged behavior, the CMRC, and other stuff.

Second, earlier today, I sent the following e-mail to Sir Andrew Dillon, the NICE chief executive:

Dear Sir Andrew:

I would like to congratulate NICE on its decision to pursue a full update of CG53, the CFS/ME guidance, rather than accept the surveillance report’s recommendation to leave it as is. The Guidance Executive made the right call, based on the current science—and given the international controversy over PACE trial and other CBT/GET trials. In NICE’s announcement, the list of concerns about the 2007 guidance was a fair accounting of what has troubled people for years and led to the outpouring of stakeholder comments opposed to the initial recommendation.

The decision to pursue a full update leaves some unanswered questions. Given that the new guidance might not be available until 2020, I am hoping you or someone else at NICE can shed light on these issues. The first involves the official status of the current guidance. The second involves references to CFS/ME elsewhere within NICE that do not appear to be aligned with the decision to fully update the guidance.

1) What is the official status now of CG53? Is it considered “provisional” or on stand-by in some way? Or does it remain fully in force? In other words, if National Health Service clinics and doctors claim to be following the “NICE guidance” for CFS/ME, do they also have an obligation to inform patients that the current version has been deemed no longer fit for purpose and is undergoing a “full update”? If these clinics and doctors prescribe CBT and/or GET, citing NICE as evidence and support, do they now have an obligation to explain that the effectiveness of these two treatments is under serious question?

2) The decision to pursue a “full update” suggests that NICE has joined the international scientific community in questioning whether psychological and behavioral approaches are appropriate for this illness—especially given the extensive evidence of physiological dysfunction. Does that mean NICE will reconsider other references to CFS/ME in agency documents? So far, patients and advocates have noted two sets of references to CFS/ME that do not appear to reflect the updated NICE position on CG53 and the illness itself.

One involves a NICE initiative called Improving Access to Psychological Therapies. According to the IAPT site, NICE is working with NHS England on the program. IAPT is designed to “assess digitally enabled therapies for anxiety, depression and medically unexplained symptoms which offer the potential to expand these services further.”

Chronic fatigue syndrome is included in the list of thirteen conditions identified by “the NICE expert IAPT panel” as appropriate targets for interventions developed through this program. The IAPT site indicates that these interventions need to be consistent with NICE guidance. The site then refers readers to CG53 but makes no mention that this guidance is undergoing a full update.

Why is chronic fatigue syndrome still listed under the IAPT program? Does the Guidance Executive agree that it should be removed, since it is not a psychological or psychiatric disorder and the use of CBT and GET is very much under question? If it is not removed from under the auspices of IAPT, does that mean NICE intends to encourage the development of digital methods of delivering CBT and GET to people with CFS/ME, even as the guidance itself undergoes a full update?

Is the Guidance Executive aware that inclusion of CFS/ME in the IAPT program creates enormous concern among patients and advocates specifically because it suggests NICE might adopt or endorse some version of FITNET-NHS? That is the trial in which Professor Esther Crawley is examining the delivery of online CBT to children, based on the purported success of earlier Dutch research. Is the Guidance Executive aware that, as with the PACE trial, critics (including me) have documented serious methodological flaws in both the Dutch FITNET study and Professor Crawley’s own work in this field?

A second set of references to chronic fatigue syndrome is in a recent draft guideline on “suspected neurological conditions”—essentially, a primer on the symptoms and signs that might indicate a neurological condition and trigger a referral to specialist care. NICE published the draft in August and sought stakeholder comments. In its stakeholder submission, Forward ME noted that the draft guideline includes several unfortunate references to chronic fatigue syndrome as being a “functional” symptom or disorder.

As the draft guideline itself explains: “Functional symptoms are complaints that are not primarily explained based on physical or physiological abnormalities. They are likely to have an emotional basis. They may mimic neurological disorders.” The draft guideline suggests, for example, that “concentration difficulties” do not warrant referral to a neurologist if these difficulties are “associated with chronic fatigue syndrome or fibromyalgia.”

Psychiatrists and other adherents of the biopsychosocial field have long classified chronic fatigue syndrome, fibromyalgia, irritable bowel syndrome, and other conditions involving so-called “medically unexplained symptoms” as functional somatic syndromes or disorders. Given the current effort to revamp the CFS/ME guidance and the significant evidence of actual physiological dysfunctions, does NICE feel comfortable at this point describing the illness elsewhere as a “functional” symptom that is “not primarily” organic in nature but is “likely to have an emotional basis”?

Thank you, Sir Andrew. I look forward to your response. –

Best–David


Tuesday, 17 October 2017

He shall gather the lambs with His arm


C H Spurgeon's Evening Devotional for 17th October 

“He shall gather the lambs with His arm."

Isaiah 40:11

Our good Shepherd has in His flock a variety of experiences, some are strong in the Lord, and others are weak in faith, but He is impartial in His care for all His sheep, and the weakest lamb is as dear to Him as the most advanced of the flock. Lambs are wont to lag behind, prone to wander, and apt to grow weary, but from all the danger of these infirmities the Shepherd protects them with His arm of power. He finds new-born souls, like young lambs, ready to perish-He nourishes them till life becomes vigorous; He finds weak minds ready to faint and die-He consoles them and renews their strength. All the little ones He gathers, for it is not the will of our heavenly Father that one of them should perish. What a quick eye He must have to see them all! What a tender heart to care for them all! What a far- reaching and potent arm, to gather them all! In His lifetime on earth He was a great gatherer of the weaker sort, and now that He dwells in heaven, His loving heart yearns towards the meek and contrite, the timid and feeble, the fearful and fainting here below. How gently did He gather me to Himself, to His truth, to His blood, to His love, to His church! With what effectual grace did He compel me to come to Himself! Since my first conversion, how frequently has He restored me from my wanderings, and once again folded me within the circle of His everlasting arm! The best of all is, that He does it all Himself personally, not delegating the task of love, but condescending Himself to rescue and preserve His most unworthy servant. How shall I love Him enough or serve Him worthily? I would fain make His name great unto the ends of the earth, but what can my feebleness do for Him? Great Shepherd, add to Thy mercies this one other, a heart to love Thee more truly as I ought.


Tuesday, 3 October 2017

UK ME/CFS Biobank team receives largest ever grant to continue biomedical research project


Breaking News! UK ME/CFS Biobank team receives largest ever grant to continue biomedical research project

By Russell Fleming, Content Manager, ME Association.

ME Association trustees and staff were over the moon when we heard that the CureME team at the London School of Hygiene and Tropical Medicine had received a new grant of $2.1 million from the National Institutes of Health (NIH) in America.

The funding represents the biggest ever single investment in biomedical research to happen in the UK and it will enable a current project, that is searching for disease biomarkers, to be extended for another 4 years – until 2021.

The project is a longitudinal study that is measuring changes in the immune system and genetic profile of individuals in a disease whose symptoms are known to fluctuate over time. The initial £1 million project, which began in 2013, was over 3 years and had also been made possible by funding from NIH.

Dr Luis Nacul, who leads the CureME team, is also responsible for overseeing the UK ME/CFS Biobank, which has been built and maintained by charity support and the funding from America.

The new grant will enable the Biobank to increase in size as even more blood samples and clinical data will be collected from people with ME/CFS, multiple sclerosis, and healthy controls, and then made available to research applicants.

“The new grant from the NIH (US) will enable, for the first time, comprehensive prospective assessments of cases of ME/CFS at regular intervals.
“This greatly enhances the chances of a breakthrough in the understanding of the pathophysiology of this complex disease and the identification of much-needed biomarkers for the diagnosis of different sub-groups of patients.
“We very much look forward to continuing our partnership with the patient community, which has been key to the success of our research so far.” 
Dr Luis Nacul, Principle Investigator, CureME team, LSHTM.

The Biobank is the only resource in the world able to include samples from those most severely affected – the house- or bed-bound – and is the premier resource outside the United States for the study of the disease. All participants are examined by a clinician and must conform to the Biobank’s rigorous protocols.

The ME Association has been a long-time supporter of the Biobank and provides funding to support its development. This longitudinal project, that in total will amount to some £2.56 million, represents one of the most exciting opportunities to learn more about this devastating disease.

Dr Charles Shepherd, Hon. Medical Adviser to the ME Association, and Chair of the UK ME/CFS Biobank Steering Group, commented:

“This is a significant and vital sum of money that will help scientists unravel the mysteries of this devastating illness. 
“The irony is that the funding comes once again from America.
“What this seems to suggest is that the USA is far more serious about finding the underlying causes of M.E., while the UK seems most willing to invest in inappropriate studies using cognitive behavioural therapy and graded exercise.
“The fact that the NIH has decided to provide another major grant is an important endorsement of the ME/CFS Biobank, and we would like to congratulate all the staff who have been involved in setting up and developing what has become a vital new part of biomedical research infrastructure here in the UK.
“We hope that other research groups will also now start to make use of this unique resource to achieve desperately-needed breakthroughs into the cause and treatment of ME/CFS.” 
Dr Charles Shepherd, Hon. Medical Adviser, ME Association,Chair of the UK ME/CFS Biobank Steering Committee.

Research: A longitudinal immunological study for ME/CFS biomarker discovery

What are the UK ME/CFS Biobank team proposing to do with this funding?

  • They will be studying 110 ME/CFS cases (half severe, half mild-moderate) meeting all of the CDC, Canadian Consensus, and Institute of Medicine, criteria.
  • They will focus on detailed immunological and clinical phenotypes (subgrouping patients by immune differences, such as the number of different immune cells and cytokines, and clinical differences, such as severity).
  • Analyse inter-relationships (the relationship between the immune differences and differences in severity/symptoms and changes over time).
  • Cases will be assessed every 6-12 months, over 5 time points, to record changes in biomarker expression and link these to clinical parameters (whether their condition has gotten better, worse or remained stable) in order to analyse biomarkers at different stages of disease progression and try to identify subgroups.
  • Cases will be grouped according to trends in symptom severity using scores relating to pain, fatigue and functional status.
  • In-depth Immunological Profiling (to try and identify biomarkers) will involve:
* Phenotyping Lymphocytes (T cells, B cells and NK cells) and monocytes from the blood samples.
* Measuring the functional response of NK (natural killer) and T cells after stimulation (by a virus, for example).
* Analysing secreted cytokines from the stimulated NK and T cells.
* Genotyping the donors for MHC class 1 (molecules that trigger an immune response to a specific toxin or foreign substance) and KIR (recognise MHC class 1 cells and activates the killing response of NK cells).

  • They then want to determine whether changes in immune parameters come before, after or predict the changes observed in clinical presentation (changes in symptoms and severity over time).
  • This will be done by quantifying correlations between immunological biomarkers and by identifying biomarkers associated with changes in ME/CFS clinical status.
 Significance of the study

“This study is unique for its strict inclusion criteria and detailed clinical phenotyping, adding specificity and validity to our analysis.”

“This is, to our knowledge, the first long-term prospective study of ME/CFS to incorporate both ambulatory and severe cases and to include comprehensive clinical data and in-depth immunological profiling.”

“This research will contribute to the development of better diagnostic tools and treatments.”

“The inclusion of severe cases through home visits will allow for research on a subset of patients often neglected in ME/CFS studies.”

“Because 1- 2.5 million Americans have ME/CFS, this study has the potential to improve the lives of a large patient population in the U.S. as well as advance the state of the field in the U.S. and internationally.”

“Patients and stakeholders are involved in all aspects of the research.”

More study information, here.

More Reaction

“This is great news for quality research into ME/CFS. The Biobank team has always put the needs of the patient first and it’s fantastic that their good work can now continue”

Cecilia Finnerty, Patient Representative.

“Such wonderful news for people with ME.  It is a privilege to serve on the Steering Committee alongside a committed professional team who have such a heart for people with this illness.”

Hannah Clifton, Director, The ME Trust. 

“ME Research UK is delighted that the team has been awarded a new grant from the NIH worth $2.1m. The funding will enable further research on those affected by ME/CFS over the next 4 years and will ensure that the UK’s first biobank of human blood samples continues to be a valuable resource for all researchers in the UK and beyond.”

Sue Waddle, Vice-Chair, ME Research UK.

“Congratulations to the London School of Hygiene & Tropical Medicine team for their grant award from the NIH. This is the most important development in UK research into ME this year and all the more so because it shows the international standing of the group. Very well deserved.”

Professor Jonathan Edwards, Emeritus Professor of Connective Tissue Medicine, University College London

Monday, 2 October 2017

Individual Community Symposium talks available on the Open Medicine Foundation (OMF) YouTube Channel


The individual talks from August’s Community Symposium on the Molecular Basis of ME/CFS are now available as separate videos in a playlist on OMF’s YouTube channel.

Have a look to check out the speakers you are interested in hearing from, or the panel discussions where they answer questions from our worldwide audience.

The DVDs will be available soon and can still be ordered here.

Visit our website to learn more about the Symposium and OMF’s research.

From the OMF YouTube channel playlist –

The Community Symposium on the Molecular Basis of ME/CFS, sponsored by OMF, took place on August 12, 2017 at Stanford University. It brought together hundreds of researchers, clinicians, patients, caregivers, families, and advocates, and thousands more by livestream.

For more about the symposium, check out the following summaries:

To support ME/CFS research, please donate today: 


Monday, 25 September 2017

The SMILE Trial and Its Not-So-Happy Aftermath and Mutiny by ME sufferers forces a climbdown on exercise treatment

The SMILE Trial and Its Not-So-Happy Aftermath

http://www.investinme.org/IIMER-Statement-1709-01.shtml

A statement from Invest in ME Research

Invest in ME Research has never approved of the Lightning Process (LP) business and its model of operation where former 'recovered' patients pay a lot of money to become practitioners of this Trade Mark training programme.

We view this as a pyramid business – unregulated, unaccountable and unscientific.

Claims that it cures people with ME we find as risible hype.

Since 2010, we have made objections about the SMILE Trial [1] – an abhorrence in this age when we should be investing in biomedical research into ME in order to find causes for this disease.

Instead, funding is allocated to a commercial business enterprise to test it out on children.

It is shameful that any self-respecting researcher would participate in this.

It is disgraceful that any media outlet with any integrity would just take the press release of a media centre which is known for promoting a false view of ME and then avoid doing even the most basic of journalistic tasks – such as research of the information.

It is especially disgusting to witness the hypocrisy of some organisations who now complain about this training programme - yet all the while seem to be happy to sit in the same “big tent” along with the SMILE Trial PI, in a so-called collaborative organisation which continues to support this sea of research dross.

What a sickening spectacle! Any ME charity or researcher promoting this training programme, or working with the people that carry out this research, is doing a great disservice to ME patients.

On the day after what would have been the 40th birthday of a young woman, whose life was taken far too early by this disease, instead of remembering her ordeal we are, instead, treated to another media blitz from biased editors covering more junk research.  

The lemming-like media in the UK perform their usual subservient role and unhesitatingly follow the propaganda issued by the Science Media Centre (SMC) and continue their usual discrimination against people with ME and their families.

Not for the UK media any rational analysis of why people with ME are frustrated for a generation by mindless junk research or by disingenuous spokespeople claiming to represent them.

Instead the media trot out the same lies about death-threats against researchers (normally only two) - yet ignore the plain fact that patient-funded research is thriving with researchers clearly enthused about the possibilities of finding the real cause(s) of this disease.

What the media should really look at is the IIMEC11 pre-conference dinner presentation by Kjersti Krisner [2].

This clearly shows what harm ignorance about ME can be done when vested interests manipulate and distort the true nature of this disease.

Then the media should follow up by viewing David Tuller’s IIMEC12 pre-conference dinner presentation [3].

Two presentations clearly showing the failings of establishment organisations and their supporters – and the misery dished out to people with ME.

Effect and Cause.  

While Dr Esther Crawley - the SMILE PI – has been congratulated by the chair of the CFS/M.E. Research Collaborative (cmrc) for her stunning and amazing work;

while the chair of the cmrc may be “thrilled” that four years down the line from its inception his organisation merely has a room full of people at its meeting to show for that period – and is unable to avoid the realisation that this organisation has achieved nothing of significance;

while some are sitting happily in the establishment big tent alongside the SMILE Trial PI and do not see anything incongruous in that situation;

while some who never objected to the trial in the first place now seem to want to appear concerned;

while the establishment media centre pumps out more spin about ME,

while lazy journalists do no research on the subject and continue to act as puppets of biased media editors ;

while this entire circus continues people are suffering from this disease.

All of these years have gone past – and nothing has fundamentally changed regarding establishment policies towards research into ME it seems.

And the lives of patients roll by – with many who influence research policies for ME, and their supporters, seemingly oblivious to the waste of life, of opportunity, of any sense of really making a difference to families affected by this crippling disease.

The LP business has no place in serious research and cannot be researched seriously, as it tells people to keep its methods secret, to deny they have ME.

This alone should be a big red flag to anyone.

How funding could have been given to this in the first place ought to be a subject for the media to research.

These quick and dirty solutions to a society increasingly founded on soundbite healthcare will leave a trail of sick patients and despairing carers, and a tragic dystopia.

And everyone, save for perhaps the business practitioners, will be the poorer for it.




4. Crawley EM, Gaunt DM, Garfield K, et al Clinical and cost-effectiveness of the Lightning Process in addition to specialist medical care for paediatric chronic fatigue syndrome: randomised controlled trial Archives of Disease in Childhood Published Online First: 20 September 2017. doi: 10.1136/archdischild-2017-313375


Apart from the last two paragraphs, it’s encouraging to see this in The Times today -

The Times: Mutiny by ME sufferers forces a climbdown on exercise treatment


By Tom Whipple, Science Editor, The Times, 25 September 2017.

A patient revolt in collaboration with MPs and academics has led to a major review of NHS guidelines on the treatment of ME.

The reassessment of recommendations for the condition will consider the validity of a £5 million taxpayer-funded trial that claimed sufferers could be helped by simple lifestyle intervention.

About 200,000 people in the UK suffer from myalgic encephalomyelitis (ME), also sometimes known as chronic fatigue syndrome (CFS). Its symptoms include debilitating tiredness, joint pain and concentration problems, and its causes are poorly understood.

In 2011 a UK study published in The Lancet found that patients could experience significant improvements through exercise and cognitive behavioural therapy. Its findings have since formed the basis of treatment in the UK and abroad.

However, patient groups claimed that the interventions made them worse and argued that the treatment wrongly implied it was a psychological, rather than biological, illness. Some academics agreed.

In an open letter to The Lancet, more than 40 academics from UCL, Stanford, Columbia and University of California, Berkeley, among others, argued that the trial had “major flaws”, which included changing its criteria for patient improvement midway through.

They said that this was of particular concern “because of its significant impact on government policy, public health practice, clinical care and decisions about disability insurance and other social benefits”.

The severity of CFS means people are often unable to hold down jobs or live normal lives.

Keith Geraghty, from the University of Manchester, said that the apparent improvements in some patients could be better explained by initial misdiagnosis, and that the benefits were marginal. “The problem is, if you look at patients when you do nothing there is a similar level of recovery,” he said.

Because the criteria for measuring recovery was changed, it was also not clear what recovery even meant, he said. “It became farcical because once they did that patients who began the trial as sick could have been deemed recovered when they started.”

The debate about the trial has become one of the most acrimonious in science, with both sides claiming they have been abused by the other. The US has now changed its recommendations.

The National Institute for Health and Care Excellence (Nice) has been receiving strenuous lobbying to do the same, and this month pressure was increased when 30 MPs signed an early day motion urging a review.

This week Sir Andrew Dillon, chief executive of Nice, said that it would carry out a full review, expected to report back after 2020.

Trudie Chalder, professor of cognitive behavioural psychotherapy at King’s College London, was one of the authors of the original 2011 Lancet paper. She welcomed the review and said that subsequent trials showed that exercise and cognitive behavioural therapy remained the best treatment.

“There have been several well conducted trials from independent researchers showing that rehabilitative treatments such as cognitive behavioural therapy and graded exercise therapy improve people’s lives,” she said. “Professionals who provide evidence-based treatments need an update on the state of play.”