Tuesday, 25 July 2017

Trial by Error: NICE Declines to Disclose Names of Experts


24 July 2017

By David Tuller, DrPH

The Countess of Mar, a well-known advocate for ME/CFS patients in the House of Lords, has received a negative response to her request for the names of the experts involved in the review of the NICE guideline for CFS/ME. The ME Association has not yet received a response related to the same question, nor have I. But the response to the countess indicates that the process is proceeding with a lack of full transparency.

Here’s the response from the Department of Health:

“The National Institute for Health and Care Excellence (NICE) routinely consults a range of topic experts as part of its surveillance review process. NICE is currently consulting on a review proposal for its clinical guideline on the diagnosis and management of chronic fatigue syndrome and myalgic encephalomyelitis. NICE does not routinely publish the names of topic experts as they are not part of the decision making [sic] process for the surveillance review.”

This answer is of course unsatisfactory. The last sentence is the operative one, so let’s deconstruct it. In the first part of the sentence, NICE is telling us that it does not routinely publish the names of topic experts. But just because it doesn’t routinely do something is not necessarily relevant to whether it should take this step now. Perhaps no one has asked for these names before. Presumably the development or review of most guidelines is not so controversial as this particular one for CFS/ME. (The patient-preferred name for the illness, and the most appropriate one, is of course just ME, without the CFS tacked on.)

It is also not routine that more than 15,000 people sign petitions expressing serious dissatisfaction with existing clinical guidelines. But that’s how many have put their names to the petition launched by the ME Association. That’s a huge number of unhappy patients and advocates; NICE would be well-advised not to ignore them. Perhaps the strict adherence to routine measures—like not disclosing the names of topic experts involved in the process—should be reconsidered in the current urgent context. (The petition drive closed today to coincide with the deadline for the stakeholder comments on the NICE guidelines.)

The second part of the sentence explains the purported reason for not sharing the topic expert names: they are not part of the decision-making process. First of all, what does that mean? Given that topic experts have been consulted in this instance, it is bizarre to read that they are “not part of the decision-making process”? Is their advice then ignored completely? Are they just a fig leaf to create the appearance of consultation while NICE does what it wants? If their advice is reviewed and considered rather than tossed right in the trash, why does the statement declare that they are not part of the decision-making process?

Perhaps the statement means that the topic experts are not officially in the room or on the conference call when the final approval is made. But even if that were the case, why would that mean their names should be kept from the public? Is the development process of NICE guidelines an official state secret that demands utmost protection?

And if the topic experts are not involved in the decision-making, as the statement asserts, then what exactly is their function? And who are the people involved in making the decision? Are they themselves experts, or just functionaries listening to others? Is it the group that originally developed the 2007 guideline? That group includes Professor Esther Crawley [Correction–see below], a close colleague of the PACE authors-—so that’s not a particularly good sign. Given the enormous impact of these guidelines, it is imperative that the process be conducted as openly as possible—which, given the response to the Countess of Mar’s question, is so far not the case.

Correction, July 24th: In the initial post, I mistakenly wrote Professor Trudie Chalder.

Monday, 17 July 2017

Knowing, brethren beloved, your election of God


C H Spurgeon's Morning Devotional for 17th July

“Knowing, brethren beloved, your election of God.”

1 Thessalonians 1:4

Many persons want to know their election before they look to Christ, but they cannot learn it thus, it is only to be discovered by "looking unto Jesus." If you desire to ascertain your own election;-after the following manner, shall you assure your heart before God. Do you feel yourself to be a lost, guilty sinner? go straightway to the cross of Christ, and tell Jesus so, and tell Him that you have read in the Bible, "Him that cometh unto me, I will in no wise cast out." Tell Him that He has said, "This is a faithful saying, and worthy of all acceptation, that Christ Jesus came into the world to save sinners." Look to Jesus and believe on Him, and you shall make proof of your election directly, for so surely as thou believest, thou art elect. If you will give yourself wholly up to Christ and trust Him, then you are one of God's chosen ones; but if you stop and say, "I want to know first whether I am elect," you ask you know not what. Go to Jesus, be you never so guilty, just as you are. Leave all curious inquiry about election alone. Go straight to Christ and hide in His wounds, and you shall know your election. The assurance of the Holy Spirit shall be given to you, so that you shall be able to say, "I know whom I have believed, and I am persuaded that he is able to keep that which I have committed to Him." Christ was at the everlasting council: He can tell you whether you were chosen or not; but you cannot find it out in any other way. Go and put your trust in Him, and His answer will be-"I have loved thee with an everlasting love, therefore with lovingkindness have I drawn thee." There will be no doubt about His having chosen you, when you have chosen Him.

"Sons we are through God's election,
Who in Jesus Christ believe."

Thursday, 13 July 2017

CDC removes CBT and GET as recommended treatments for ME/CFS


In America, the Centers for Disease Control and Prevention (CDC) has updated its website information for ME/CFS, improving diagnostic criteria and removing previous recommended treatments – CBT and GET.

While it seems that we must wait to see if this new information is reflected in updated guidance for medical professionals, it is nonetheless being heralded as an important development.

Yesterday, in the UK, NICE published its consultation document which confirmed the recommendation to take no action with regards to the current guideline.

The ME Association is protesting this decision and is currently considering its written response as a stakeholder in the consultation process.

We feel there are many aspects of the current guideline that warrant review including the continued recommendation of CBT and GET.

The ME Association’s online petition ‘The NICE guideline for CFS/ME is not fit for purpose and needs a complete revision‘, has attracted over 4,000 supporters in less than 24 hours. 

It will close on Monday 17th July at 5pm, when we will present it to the review committee for delivery to Sir Andrew Dillon (chief executive, NICE guidance executive).

David Tuller in his latest blog, Trial By Error: The CDC Drops CBT/GET, explains in more detail what has happened at the CDC and why this may herald an important and fundamental change for ME/CFS.

We have selected pertinent extracts from his blog, and reproduced them below:

“Just as The Lancet has published more “evidence” for graded exercise, the CDC has moved decisively in the opposite direction. In revamping the information on the part of its website geared toward the general public, the agency has “disappeared” all mention of CBT and GET as treatment or management strategies. Patients and advocates have long pushed for this step, as did Julie Rehmeyer and I in a New York Times opinion piece in March. Although the revised text is dated as having been reviewed on May 30th, it apparently went live sometime during the first week of July. (The CDC has still not revised the pages designed for health care providers, although old information has been removed. The agency calls the illness ME/CFS.)”

“For advocates, the CDC’s removal of the CBT/GET recommendations represents a major victory. “I think it’s huge,” said Mary Dimmock, an advocate who has long pressured the CDC to revise its website. Given the agency’s stature, she added, the decision could have widespread impact, not just in the U.S. but internationally as well. Many health care providers and institutions here and abroad look to the CDC for guidance in public health matters.”

“So many patients have been made worse by the treatments,” said Dimmock, who became an advocate after her son became seriously ill several years ago. “While there is more to be done, removing these recommendations is a significant step forward in protecting ME patients from harm.”

“In the revision, the CDC website has dropped the agency’s 1994 definition of the illness. The new definition, based on the one proposed in a 2015 report from the Institute of Medicine (now the Academy of Medicine), requires the presence of “post-exertional malaise.” In the 1994 definition, that was only one of eight optional symptoms. The immediate implication of the shift is that GET should likely be considered contraindicated, given the premium this intervention places on steadily boosting activity levels. The form of CBT prescribed in PACE could also be contraindicated, since the ultimate goal of that intervention is likewise to increase activity. (The CDC has not adopted the name proposed by the IOM report, “systemic exertion intolerance disease.”)”

“In addition to symptomatic relief, the revised CDC website suggests such management strategies as a balanced diet, nutritional supplements and complementary medicine.”

“Of course, avoiding “push-and-crash” is what patients already do when they practice pacing. The “push-and-crash” language itself appears to be closely aligned with the arguments provided by the PACE investigators and their colleagues; many patients might describe their experiences differently. Nevertheless, removing the CBT/GET recommendations is a welcome step, if overdue. For years, patients and advocates pointed out the problems with PACE and related research, and also cited the evidence that too much exertion caused harm because of physiological abnormalities, not the deconditioning presumed by CBT and GET. But until now, the agency refused to make the necessary changes.”

“The CDC has another urgent obligation: To communicate with the U.K.’s National Institute for Health and Care Excellence, which develops clinical guidelines for various medical conditions. NICE is currently debating whether or not its recommendations for the illness—which it calls CFS/ME–need to be reviewed; of course, these recommendations include CBT and GET as indicated treatments. NICE is soliciting input this month from stakeholders, but the expert panel assessing the situation has apparently made a provisional decision that no review is required.”

“The CDC has a long history of collaborating with key members of the PACE team and others in the U.K. medical and public health establishments; it is not surprising that prescribing CBT and/or GET should have become standards of care in both countries. It is now incumbent on U.S. public health officials to alert their British colleagues, including those at NICE, that they have just abandoned these longstanding recommendations. They should also explain why they have taken that major step, and why NICE should consider doing the same. (More on the NICE guidelines later this week.)”

David’s latest blog can be read in full, here.

Monday, 3 July 2017

THE SMILE TRIAL (part 1) – Author: johnthejack

Why the trial should never have been allowed in the first place.


There is no evidence the Lightning Process (LP), a mish-mash of elements of cognitive behavioural therapy, neurolinguistic programming, hypnotherapy, life coaching and osteopathy, is anything other than quackery. For decades Phil Parker has made claims for its efficacy, including as a treatment for myalgic encephalomyelitis (ME), but no proper trial has ever supported these claims.

The Advertising Standards Authority (ASA) guidance is clear:
To date, neither the ASA nor CAP has seen robust evidence for the health benefits of LP. Advertisers should take care not to make implied claims about the health benefits of the three-day course and must not refer to conditions for which medical supervision should be sought.

There are people who claim to have been helped, of course, but such claims are made for all bogus therapies. It seems that some people are simply amenable to these interventions. In addition, perhaps there are those who have become stuck in a rut, experiencing a generic chronic fatigue, believing themselves to have ME, and who are helped to kickstart their lives again by the LP. Since there is no biomarker for ME, diagnosis of the illness can be difficult: 40% of patients in an ME clinic may not actually have ME.

There is currently no treatment for ME, so it is understandable that some patients would be easy prey for and would seek more information about interventions hawked about with exaggerated claims.

Parents of children with ME were apparently contacting the charity Association of Young People with ME (AYME) (1) and asking whether it was worth trying the LP. Bewilderingly, Esther Crawley, a Bristol paediatrician and then medical adviser to AYME, instead of telling patients and parents that the LP had no scientific basis and was not worth the considerable amount of money it costs, decided to do a trial. Just as bewilderingly, the SMILE trial received funding and ethical clearance.

First, this trial should never have been allowed. Good science is not just about evidence, but about plausibility, so any such trial immediately gives a spurious credibility to the LP. Asking a question, even sceptically, can offer an implicit endorsement of its premises.

Second, it was the first study of any kind to use the Lightning Process, and it was doing so with children. There had been no opportunity to measure harms: there have been reports of patients who do not respond to the LP who then blame themselves and in desperation contemplate killing themselves. Exposing vulnerable adolescents to such a potential risk would seem particularly irresponsible.

Third, LP patients are made to accept a number of onerous conditions (such as taking responsibility for their illness) before taking the course. It is ethically questionable to ask trial participants to agree to such conditions in order to take part in a trial of a possible treatment for their illness. Making these demands of children would seem even more ethically dubious.

Fourth, patients are told to ignore their symptoms and to resume normal activity (from SMILE study):
‘It has been a bit confusing, I have to say, because obviously we have got the [Lightning Process practitioners] approach, where, “Right, finally, done this, now you don’t need to do the pacing; you can just go back to school full time.” I think, the physical side of things, YP9 has had to build herself up more rather than just suddenly go back and do that’.

Research, backed up by patient surveys, shows the harms caused by exertion in patients with ME (see Kindlon). The recent report to the US Institute of Medicine found post-exertional malaise to be so central to the illness that it suggested a new name: systemic exertion intolerance disease or SEID. Even in disputed clinical trials such as PACE which use graded exercise therapy, patients are monitored by physiotherapists and nurses and plan a gradual increase in activity. Here service providers with no professional qualifications simply tell child patients that after three sessions in three days they should return to normal activity. It is deeply irresponsible.

Fifth, to anyone with genuine ME, that is ME as defined by the International Consensus Criteria, the Lightning Process is a form of torture. It is a physical torture simply to complete the course, again from the SMILE study:
In addition to specialist medical care, children and their parents in this arm were asked to read information about the Lightning Process on the internet. They then followed the usual LP procedure (reading the introductory LP book or listening to it in CD form) and completing an assessment form to identify goals and describe what was learnt from the book. On receiving completed forms, an LP practitioner telephoned the children to check whether they were ready to attend an LP course. The courses were run with two to four children over three sessions (each 3 hours 45 minutes) on three consecutive days.

That is a very heavy burden. The homework is taxing enough but then to undergo 3 sessions of almost 4 hours each on 3 consecutive days is immense. The effort, the intensity and the busyness, would be punishment to anyone hypersensitized by the illness.

It is also a form of emotional torture as fundamental to the process is that patients take responsibility for their health, their illness and their recovery, from here, here,  here and here:
LP trains individuals to recognize when they are stimulating or triggering unhelpful physiological responses and to avoid these, using a set of standardized questions, new language patterns and physical movements with the aim of improving a more appropriate response to situations.

* Learn about the detailed science and research behind the Lightning Process and how it can help you resolve your issues

* Start your training in recognising when you’re using your body, nervous system and specific language patterns in a damaging way

What if you could learn to reset your body’s health systems back to normal by using the well researched connection that exists between the brain and body?

the Lightning Process does this by teaching you how to spot when the PER is happening and how you can calm this response down, allowing your body to re-balance itself.

The Lightning Process will teach you how to use Neuroplasticity to break out of any destructive unconscious patterns that are keeping you stuck, and learn to use new, life and health enhancing ones instead.

The Lightning Process is a training programme which has had huge success with people who want to improve their health and wellbeing.

This responsibility is an enduring one: patients must continue to apply the training to their lives after their course and accept that improvement in their health lies entirely within themselves.

To take chronically ill patients, who want only to get better, and spend three days attempting to brainwash them into believing their illness and recovery lie within their control is deeply unethical. Adult patients in the days after enduring this nonsense, blaming themselves for lack of improvement, have been left in such depths of despair as to want to take their own life. To expose chronically ill adolescents to such a danger was extraordinarily irresponsible.

Of course, with the broad criteria and the self-selection involved in determining who took part in the trial, it may well be that not a single participant actually had ME but had instead simply ‘chronic fatigue’. That would be even worse, though: the results may show that the LP has some effect with ‘chronic fatigue’ but would be used to claim effectiveness for patients with ME. Many children who genuinely do have ME could be gulled into paying for this nonsense only, potentially, to do themselves considerable harm.

This trial was unnecessary, gave spurious credibility to quackery and was unethical. It was also very poorly conducted, as will be shown in part 2.

1. AYME has now ceased trading and its role has effectively been taken over by Action for ME 

Saturday, 1 July 2017

Looking back with ME

Looking back with ME – Living for a quarter of a century with the neuroimmume disorder ME (Myalgic Encephalomyelitis). 

Published by Day One Publications – click here for further details or contact -

Day One Publications, 
Ryelands Road, 
Leominster, 
HR6 8NZ

Phone: 01568 613 740   
Email: sales@dayone.co.uk

Also on Amazon at http://amzn.eu/hzuH9Yo

From Page Three of Looking back with ME -

I appreciated reading Hazel’s witness to the Lord’s grace in saving her, and all His subsequent dealings, which comes over very well and much to His glory. I trust the information given about ME may open the eyes of people to take this condition seriously, especially the medical profession.
Rev. John Thackway, Pastor, Holywell Evangelical Church

It was most moving to read of the way the Lord has led Hazel these past years, and I was richly blessed by her regular reminders that God is sovereign in every detail of our lives.
Derek French, Elder, Hanney Chapel near Wantage

This book documents Hazel’s life both before and since her illness. No, it isn’t cheerful to read about a chronic illness and some of the difficulties both with diagnosis and in terms of management of the condition. Yet Hazel is a Christian and is clear that she has a hope greater than this life. Of course, this book is of relevance to people with ME, but it is also relevant to those of us who have been given many years of good health. It is easy to moan and forget to be thankful for this gift. It is encouraging to be reminded of the Lord and His promises.
Sarah Jones, former consultant physician, London