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.