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.”


Friday, 22 September 2017

When you beckon lightning and invite it in for tea



By February 2007, I had been receiving daily Nexavir injections (an antiviral) for six months and I was actually starting to see small improvements in my health for the first time in over two years of being acutely ill. But friends and relatives kept sending me newspaper cuttings of articles about the Lightning Process (LP) curing people with ME. I became under enormous pressure to do the LP (“What’s the harm in trying it?” “Don’t you want to get better?” “It has helped others so it’s worth a shot”). I was only 20 years old, vulnerable because of my desperation to get better, and didn’t know much about Myalgic Encephalomyelitis and what the illness actually was (a multi-systemic, neuroimmune illness). By that time, I also had been gaslighted by so many NHS doctors and private doctors about my illness and symptoms, that I was doubting myself. When so many people disbelieve you, you start disbelieving yourself, despite all physical evidence to the contrary. In the end, I buckled and, although sceptical, I agreed to do the LP. I was so ill and I just wanted to get better.

Ironically, I wouldn’t have even been able to get to the LP practitioner’s house (he was an NHS doctor but did the LP privately) even a couple of months previously but because of the small improvements due to the Nexavir injections, I was able to get down the stairs and lie down in the back of our car to get there. There were consequences for my body but I thought that it would be worth it.

I’m not going to go into detail about the “mechanics” of the LP; other people have debunked the methods far better than I’m currently able to. Back then, I decided to throw myself into the LP and be totally committed to doing it properly. The results, however, were nothing less than disastrous for me.

First, the fully-qualified practitioner artfully gaslighted us (a group of four patients) with what I now know is pseudoscience quackery about M.E.; it was done in such a subtle, convincing and skilful way (even experienced scientists have been taken in by it). Using “science” to explain, he told us how we didn’t ‘have’ an illness but that we were ‘doing’ an illness; it was our thoughts, behaviours, and fears about post-exertional symptoms that were causing us to stop ourselves from living normally and causing us to believe that we had symptoms and to believe that we were ill.

He then put mechanisms into place in my brain, via neuro-linguistic programming, that made my own brain automatically gaslight me constantly and stop any thoughts of symptoms dead in their tracks. He added repetitive gestures/movements/phrases that I had to continually apply to my thoughts and body in order to reinforce the programming. This is brainwashing.

It’s hard to describe being brainwashed. The next six months in 2007 after the LP are still a hazy blur to me. Not only did the neuro-linguistic programming in my brain not allow me to ever mention any symptoms to anyone, I was not even allowed to think that I had any symptoms. I wasn’t allowed to be ill anymore. I pushed and pushed myself, even when in the most excruciating pain, even when I was in heart failure or experiencing seizures or passing out, because they didn’t exist. My illness didn’t exist [even though I was extremely ill, I honestly believed that I wasn’t ill anymore, that I was cured]. It sounds ridiculously idiotic but that’s what brainwashing can do. My body was becoming more and more damaged from the enforced gradual Graded Exercise Therapy that the programming in my brain was imposing on myself. It was completely out of my control; I felt glazed over and not with it.

As per what I’d been conditioned and instructed to do during the LP training, I told everyone that I was no longer ill and that I was recovering. I’m pretty sure that I told all my friends and family that I was in recovery, that the Lightning Process had been successful and had worked. I even had a huge 21st birthday/’I’m better now’ party in a village hall, celebrating recovery from illness. Remembering it now is upsetting. I had the biggest smile on my face the whole time and looked fine to everyone but would have to frequently escape into the toilets where I would almost black out and would collapse on the floor for a while. I was in oxygen starvation from being upright and from heart failure. I was very dizzy and everything was spinning around me because of my very low blood pressure. All my muscles were screaming at me. Nobody had any idea that this was happening to me; the LP programming prevented me from being able to tell anyone or from even acknowledging my symptoms to myself. They didn’t exist because I wasn’t ill. It’s just a haze to me now.

In the following months, I kept on pushing myself, doing insane damage to my body (I pushed myself to the point where I was going on a slow 5-minute walk every few days, which was a huge deal for me considering I had been bed-bound for two years) until one day in August 2007, when my parents were away, I pushed myself too far and went on a longer walk. At the end, my body failed and packed in completely; the six months caught up with me and I collapsed. I was never able to get up again. Ever since, I have been bed-bound, unable to sit up and unable to speak, struggling to breathe and swallow. The permanent organ damage that was done during March to August 2007 during the self-imposed GET due to the LP brainwashing, was devastating. I never recovered from it and my health has only deteriorated since. The hold that the brainwashing had over me was broken pretty quickly and thoroughly that August, thank goodness. But I can’t remember much from those six months.

Today it is being reported in the news that an experimental trial of the LP on children and teens with M.E. has been successful. The fact that the results are based on the children and teens themselves saying that they have recovered, is extremely worrying to me. During the six months that I was brainwashed with the LP, I would have said the same: that I was cured, that I was recovering and that the LP was successful. Those poor children. They are even more vulnerable than I was. What they have been subjected to is nothing short of abuse and should never have been allowed to happen in the first place.

Whatever you do, please don’t send news articles about the Lightning Process to anyone with M.E. It’s a dangerous thing. Don’t beckon lightning and invite it in for tea; it will burn your house to the ground with you inside until you’re nothing but ashes.

Monday, 18 September 2017

And they follow Me

http://bible.christiansunite.com/Morning_and_Evening/chme0918.shtml

C H Spurgeon's Evening Devotional for 18th September

"And they follow Me."

John 10:27

We should follow our Lord as unhesitatingly as sheep follow their shepherd, for He has a right to lead us wherever He pleases. We are not our own, we are bought with a price-let us recognize the rights of the redeeming blood. The soldier follows his captain, the servant obeys his master, much more must we follow our Redeemer, to whom we are a purchased possession. We are not true to our profession of being Christians, if we question the bidding of our Leader and Commander. Submission is our duty, cavilling is our folly. Often might our Lord say to us as to Peter, "What is that to thee? Follow thou Me." Wherever Jesus may lead us, He goes before us. If we know not where we go, we know with whom we go. With such a companion, who will dread the perils of the road? The journey may be long, but His everlasting arms will carry us to the end. The presence of Jesus is the assurance of eternal salvation, because He lives, we shall live also. We should follow Christ in simplicity and faith, because the paths in which He leads us all end in glory and immortality. It is true they may not be smooth paths-they may be covered with sharp flinty trials, but they lead to the "city which hath foundations, whose builder and maker is God." "All the paths of the Lord are mercy and truth unto such as keep His covenant." Let us put full trust in our Leader, since we know that, come prosperity or adversity, sickness or health, popularity or contempt, His purpose shall be worked out, and that purpose shall be pure, unmingled good to every heir of mercy. We shall find it sweet to go up the bleak side of the hill with Christ; and when rain and snow blow into our faces, His dear love will make us far more blest than those who sit at home and warm their hands at the world's fire. To the top of Amana, to the dens of lions, or to the hills of leopards, we will follow our Beloved. Precious Jesus, draw us, and we will run after Thee.

Saturday, 2 September 2017

The Emotional Toll Of Not Being Heard


By Christina Baltais

This story won’t be particularly unique or shocking to anyone living with ME. Every single one of us has a plethora of stories like this, and far worse than this. It has happened so many times over the last 11 years. What shocks me is the degree to which it still occurs and manages to affect me, no matter how much time I spend trying to advocate for ME.

I was out to eat with extended family members. It was my first outing in weeks, since I had been housebound due to symptoms. An outing after a long period of solitary confinement is a rather momentous occasion. I was so grateful to be out of that bed, out of that bedroom, out of that house. The vibrant world that felt so far away, I now found myself immersed in, taking in everything around me like a grateful sponge. I was basically a bear emerging from a den after a long, long hibernation (minus any refreshing sleep).

When I sat down, the usual catch-up conversation ensued. Updates on my health eventually came up. I said that its been my first outing in quite some time after a rough patch. This statement could have been followed by words that were supportive/empowering/neutral, but it wasn’t. This family member went on to comment that I looked fine, and was sitting up just fine at the table right now. I responded by saying that sitting up was actually very difficult for me because I was experiencing a great deal of weakness, and would need to rest after this outing when I got home. This was followed by a comment indicating that if I was sitting up now, why couldn’t I find a job where all I had to do was sit up and type? Why couldn’t I look for jobs like that? Was I not even going to try? After all that schooling, was I just going to waste my life?

You have got to be kidding me. (And some other words that I can’t say.)

A long uncomfortable silence ensued. I felt the familiar pangs of shame, humiliation, and judgement by someone who not only knew nothing about ME, but who also did not want to listen. No one at the table said anything in my defence, their passive silence feeling like implied agreement. I honestly believe this person’s intent was good, but how disconnected from my experience could they possibly have been to not realize the impact of their words and the implications of their statements. I really embrace the importance of talking about my body and ME as a source of education, but the first caveat always has to be that my voice and experience is heard, valued, and respected. This was another case where it clearly had not been. For if anyone was connected to the experience of ME, they would understand the absolute hell a person goes through. The depths of despair and grief this disease drags you through; it was never a choice. The inner turmoil of having a heart that wants the world everyday, but having a body constantly saying no; you forfeit any control over the direction of your life. I chose ME just as much as the millions of people around the world chose ME; we didn’t. I realize I’m preaching to the choir. The point is, I should not have to spend an outing defending and proving in hopes of understanding. I’m not wasting any precious spoons on that. It just hurts so much, still, even after 11 years.

As human beings we all need to feel love and connection. There is a deep-seated need to feel unified, to have approval, acknowledgement, acceptance—-to feel connected with, intimate and loved by, other human beings. When you are already so physically isolated due to illness, situations that make you feel emotionally and socially isolated take it to an entirely different level. It adds another layer of suffering. As if I didn’t feel disconnected and like an outsider enough already. It’s situations like this that make me realize how much during these 11 years I have not been believed or heard. It’s situations like these that make me realize how exhausting it is to constantly be vying for the understanding of others.

What’s even harder is when it comes from family, as this one did. What’s even more disheartening is that this individual is also a doctor. When I was undergoing medical training myself, some supervisors I highly respected displayed a clear lack of understanding about ME.  One spoke of how you have to wonder how much of “the behaviour” is learned as it runs in families. I was told to recommend to an ME patient that they strap on a backpack full of weights and jump on a trampoline to increase bone mineral density. It was explained to me how a new physical symptom could only be psychosomatic “as anxiety is common in that demographic so that is the only plausible explanation for that extreme symptom.” Unbeknownst to them, I had ME and these comments illuminated the presumptions, assumptions, and rampant inaccuracies perpetuated by a lack of knowledge in our medical systems. They were extremely disappointing and painful to hear, as I’ve been on the receiving end of all these assumptions and exacerbating recommendations as a patient myself. The lack of knowledge and understanding is systemic; experiencing and bearing witness to how ME has been relegated to the margins of our medical system has been traumatic.

The history of ME’s constant invalidation and abhorrent lack of research funding is disturbing. I wish people would listen. I wish they would trust our experiences and accounts of our own bodies, or in some cases, of our children’s bodies. How healing the words, “I believe you,” would would be for all of us. Sometimes, the emotional toll feels worse than the actual disease itself.

We don’t know when the pathological basis of ME will finally be understood. We should not have to wait for that, to be shown the much needed empathy and compassion which we deserve. Why it takes “proof” in order to actually listen to literally millions of voices saying the same thing over decades of time baffles me. When I think of the millions of lives lived, and some ended, in complete suffering—-without voices, it enrages me. If their suffering had been validated and acknowledged, even if treatment was still not available, would it not have made a difference? The injustice of it all enrages me. Anger is often a signal something is not working, and that means something needs to change. Change is possible and can come soon for all of us. Change needs to come especially for those of us who are unable to use their voices, or even read this.

There are many ways to get involved in creating change for health equality and ME awareness. Be a part of the #TimeforUnrest global impact campaign. This campaign advocates for more recognition, education, research, and funding around ME. You can help advocate for our voices to be heard, by hosting a screening of Unrest in your community. You can join the #TimeforUnrest Facebook group, and share and promote the campaign on social media.  For more ideas on how to be a part of the change, click here.

Imagine how different the world’s perception of this disease could be; and for an end to the stigma and misconceptions we’ve all experienced. Imagine with research the pathological basis of ME understood, and treatments being offered. We can make this change happen, and we can make this change happen together.

About the author: Christina, 31, lives in Toronto, ON. She holds a Bachelor’s Degree in Science and has a fine arts background. She became ill with ME while completing her Bachelors. This inspired her to become a naturopathic medical doctor in order to better understand how to heal the body. One month before completing her medical degree, her ME progressed. She has been slowly recovering, using writing, music, art, and nature as a means for processing this experience.

Friday, 1 September 2017

At symposium, researchers and patients examine molecular basis of chronic fatigue syndrome

(Again, if only they would say ME, Myalgic Encephalomyelitis, instead of CFS)


Posted on: August 25, 2017

by Raeka Aiyar, PhD

Ron Davis, PhD, calls chronic fatigue syndrome (also known as myalgic encephalomyelitis, or ME/CFS) the “last major disease about which we know almost nothing.” That’s because at least a million Americans are debilitated by ME/CFS, and yet no clear cause is known, no treatments are approved; funding, understanding, and awareness are disproportionately limited. Yet thanks in part to a boost in advocacy and fundraising efforts, there is increasing cause for hope, many researchers and patients believe.

Earlier this month, several hundred researchers, doctors, patients and caregivers joined forces for the Open Medicine Foundation’s Community Symposium on the Molecular Basis of ME/CFS chaired by Davis at Stanford University, with another 2,700 worldwide joining online. Known for his contributions in biotechnology and genomics, Davis has rerouted his career to tackle this disease and save his critically ill son. He’s brought together an interdisciplinary team of collaborators, many of whom spoke at the symposium. “The Human Genome Project taught us that we can take on a large project like this and succeed,” Davis said.

The event focused on a new understanding of ME/CFS as a molecular disease. Davis’ team has taken this perspective in an omics and big data study of severely ill patients. Wenzhong Xiao, PhD, Davis’ collaborator at Massachusetts General Hospital and Harvard Medical School, presented a preliminary analysis of this dataset, including efforts to use it to define biomarkers and predict causative factors.

Davis presented his technology-driven approach to unraveling ME/CFS, noting that if sequencing technologies had been available at the time, “we would have figured out AIDS in a couple of weeks.” He presented a nanotechnology developed at the Stanford Genome Technology Center that can successfully distinguish patient blood samples from healthy ones, based on their response to stress in the form of increased salt concentration. This presents the potential for a blood-based diagnostic – a transformative prospect for a field reliant on lengthy, subjective diagnoses.

A core issue in ME/CFS is massive energy depletion, so much research is focused on the mitochondria, the organelles inside cells that are responsible for energy generation. Keynote speaker and mitochondrial physiologist Robert Naviaux, MD, PhD, from the University of California, San Diego, suggested that the ‘cell danger response’ to stressors, which prevents cells from returning to baseline function until healing is complete, is prolonged in ME/CFS, which is consistent with observations of reduced metabolism in patients.

Naviaux’s theory also syncs with reports of common infections triggering the development of ME/CFS. In fact, Davis’ cell-free DNA sequencing revealed no exceptional types or levels of pathogens in patients. “It’s not the stressors themselves, but an inability to resolve them and heal afterwards,” Naviaux said.

Stanford immunologist Mark Davis, PhD, presented evidence suggesting that ME/CFS could be an autoimmune disease: using single-cell sequencing, his lab has observed an increase in patient T cells that share a particular target, a signature of an immune response. He said he is investigating what these T cells are targeting.

Nobel Laureate Mario Capecchi, PhD, from the University of Utah, presented a study in mice that shows a connection between the immune system and the brain in a genetic condition that shares some traits with ME/CFS. He also noted how important patient participation is in studying any disease, and how impressed he was with the ME/CFS patient community.

With so much patient engagement, collaboration, and community spirit – not to mention the many theories and new datasets, researchers say it is an exciting time for the field. Many attendees said they were amazed at how much has been accomplished with such scant resources. The event closed with a standing ovation.

To support ME/CFS research, please donate to OMF today. For more about the symposium, check out the YouTube video of the event or read coverage in The Mercury News.

A version of this post originally appeared on the Stanford Medicine Scope Blog.