These Dangerous ME/CFS Exercise And Symptom Denial Trials Must Come To An End

  • September 25, 2017
  • By

The most morally generous description I can give to the majority of exercise and symptom-denial medical trials performed on ME/CFS patients is ‘torture born from ignorance‘. Even if you were to describe the evidence of harm as a result of the treatments explored by these trials as preliminary and often anecdotal, the designs of these trials demonstrate a clear failure in the duty of care that we should expect from those who grant them ethical approval.

 

The brazenly obvious propaganda campaign launched by the SMC last week to promote the SMILE trial gave far too much credence to what is perhaps one of the most horrifying examples of the inept ethical approval standards. Obviously, the researchers who developed the CBT/GET program used in MECFS clinics have no desire to see their life’s work superseded by the pebble-dashing of a snake oil salesman, but promoting the idea that the Lightning Process ‘inexplicably works’ in some cases is more about damaging the perception of the illness in the minds of both NICE guideline and Science writers. The intent is most likely to implant the thought in ME/CFS sceptics “They’re being cured by the ravings of a charlatan, this proves the disease is based on false illness beliefs and there is no underlying biological mechanism”. The perfect elixir of confirmation bias for the kind of sceptic who is ignorant of their own psychiatric pre-conceptions about ME/CFS.

 

The SMILE trial of the Lightning Process was performed on children. That fact alone is shocking enough, clearly it should of been preceded by a significant blinded trials involving consenting adults. As is the case with far too many British ME/CFS trials, SMILE refrained from using objective measures which are capable of giving an accurate picture of patient activity levels. The main objective measure was an increase in school attendance. Without actimeter data and data on parental caring hours, we learn nothing about the therapeutic effects of the Lightning Process. Similarly, without access to the full content of the treatment, it is hard to know whether or not trial participants were simply manoeuvred toward an easy goal post. The use of self-report questionnaires in trials where patients are taught to ignore their symptoms is also highly suspect.

 

In the absence of a successful 10-20 patient adult trial which includes the use of numerous and extensive objective measurement that precedes SMILE, I cannot imagine a reasonable argument that it was ethical to conduct this trial. While Dr Crawley deserves every of inch of criticism she receives for indulging in this Scientific farce, the time may of come to turn our attention to the people who are granting them ethical approval in the first place.

Clark Ellis recently wrote a compelling blog about the importance of reports and data on the failures of graded exercise. As patients, where possible it will make a big difference if we submit substantial accounts of the ways Graded Exercise Therapy has harmed and failed us to relevant organisations. This is because the most recent Graded Exercise Therapy handbooks do their best to portray symptoms as something to be ignored or a result of non-adherence to protocols. To give you an idea of the kind of information that would useful to report, I made a few notes.

 

What to report

  • Immediate and prolonged effects of GET:- Significant and severe discomfort, extended periods of muscle paralysis, significantly increased levels of disablement, increased fatigue both mental and physical.
  • Development of Secondary Diagnosis:- Such as POTS and Postural Hypotension
  • Inapplicability of GET schedules to the unpredictable stresses and necessities of daily life:- It’s important to note that GET itself is very rigid and is a highly implausible treatment for someone with the responsibilities of an adult. If your child is about to do something dangerous or foolish, you cannot simply do nothing to adhere to a GET schedule. An ME/CFS parent will have to budget energy and spend more of it during moments of necessity. Clearly in this incidence, the design of the treatment is makes it impossible to administer.
  • Physical inability to attempt GET without adverse reactions:- The effects were instantaneously disabling and you were unable to attempt the treatment as a result
  • Part of the advice of GET is ignoring symptoms, so it’s important to note symptoms that were persistent and unavoidable.
  • Lastly, it’s important to report incidences of complete and total inefficacy/inapplicability (often in this case it’s up to the carer to report):- ME/CFS so severe you are unable to attend a clinic to receive the treatment, unable to take part in telephone courses or unable to follow apps/online guides.

In the UK we have an organisation called Care Quality Commission that unfortunately you have to write to by post as their online forms do not list Chronic Fatigue Services specifically.

 

The address is as follows:

CQC National Customer Service Centre
Citygate
Gallowgate
Newcastle upon Tyne
NE1 4PA

 

If you send me the contact information for any other relevant bodies, also those in other countries that it is useful to report this kind of data to, I’ll gladly update the article.

 

Alongside an effort to submit more personal reports of harm and failure, I would encourage qualified researchers and advocates to submit letters to organisations like the Health Research Authority, outlining the unique implications and dangers of exercise and symtom-denial trials on ME/CFS patients. It is my hope that if we can remove the ignorance of the numerous and obvious ethical problems with trials that are conducted on ME/CFS patients, the ceaseless production of dangerous and useless research will be put to a stop.


Categories: Featured opinion, Opinion, Research, United Kingdom

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5 comments on “These Dangerous ME/CFS Exercise And Symptom Denial Trials Must Come To An End
  1. Rivka says:

    This is excellent. Smart and potentially effective plan. Is this only for people living in the U.K.?

    1. Matt says:

      I hope that it can be applied elsewhere. Any country that has a channel to log substantial patient reports has the potential to be used in international research.

      A lot of the data in the UK is collected via questionnaires which are a) pretty naff and b) do not create statistics about patients who physically cannot even attempt CBT/GET.

      In a lot of ways I’m on a journey here to find out how we can tell our stories in a official fashion that is conducive to building an accurate picture of the effect these treatments are having. So I’m learning as I go pretty much!

  2. Cindy Downey says:

    Thank you Matt, for your very insightful article about GET, including your list of what PWME should watch for, and report if they are forced to endure GET.

    I would like to make a few comments:
    1) As I understand it, in courts of law, both opposing teams, try to prove doubt; endeavour to show that the opponents’ arguments are not sound. If this succeeds, doubt has entered the picture. Doubt has definitely been proven in the GET/CBT arena, and yet the proponents of these so-called ME therapies continue, as you and Clark Ellis say, to be approved by ethics committees to visit these ME-inappropriate therapies on very physically sick people.

    Now that the safety of GET for ME patients is in doubt, why are ethics committees still approving these studies? Is it due to a lack of respect for the study participants, and therefore a lack of caution where safety is concerned? Is it because, as Clark Ellis says, the patients are seen as “benefit scroungers”, and are therefore considered less deserving of the usual level of care taken in drug trials? Is it because the ethics committees believe ME is fictitious; or because patients in general are not viewed as a reliable source of information? If PWME (persons with ME) say they have been harmed by GET, is it the usual protocol to ignore this information? It seems so.

    It is amazing, and yet not, that society still harbours primitive, outmoded beliefs about physical illnesses. Most, if not all human societies have a culture of blame. Blame, and ostracize the different, the ill, the struggling individual.The rest of society sees itself as immune from the outcast’s lot; “this will never happen to me”. And yet it can, and does.

    Throughout history, many diseases have been thought to be the fault of the sufferer; psychosomatic disorders. In the past we blamed sufferers for tuberculosis, stomach ulcers, asthma, epilepsy, MS, IBS, even cancer. It seems we still see sufferers of “medically unexplained symptoms” and even well recognized physical illnesses, as having chosen bad, or evil/faulty illness beliefs, that we have to exercise, or exorcise away: Graded Exorcise Therapy; Graded Exorcism Therapy. As you say “torture born from ignorance.”

    Two schools of thought concerned with the individual’s lot are: 1) outside or external actions, as well as the individual’s own actions determine their life situation; 2) the individual is completely responsible for their situation in life, including much, or all of their standard of health. This second school of thought is the one still applied by GET proponents to those with ME.

    If you look at the NICE Guidelines, and until very recently, the CDC information about ME, the implications are that ME is the fault of the individual. The recommendations for GET and CBT imply this. So does the advice to avoid any testing, as there is none that will show any abnormality.

    I hope that PWME when possible are able to fight back against the anachronistic belief that ME is the fault of the individual, with proof that ME is a physcial disease. As Dr. Lily Chu, MD, and ME expert says: ” Contrary to the idea that all tests are normal in CFS patients, we found that 66% of our respondents had at least one abnormal test out of five commonly given to patients by ME/CFS specialists.” iacfsme.org/portals/0/pdf/FDA-AugustFinalReportforUS-version2.pdf

    Dr. Chu’s research found that natural killer cell activity, repeated cardiopulmonary exercise testing, brain imaging, neuropsychological testing, and tilt table testing revealed abnormalities in many of the 623 PWME who participated in her study.

    Society needs to move away from the backward belief that ME is the fault of the individual. ME, and PWME should be viewed as deserving of fair and equal care in research studies, medical education, research funding, and public awareness.

    Thank you Matt, for your thought provoking article about the GET holdouts, and the questions surrounding their continued approval by ethics committees.

  3. Stephen says:

    HI Matt, your above work certainly makes interesting reading. As somebody who has recently been diagnosed with CFS and subsequently been referred by the NHS to receive professional support from a specialist CFS/ME team I am understandably spending lots of time researching both the condition itself and any steps I can take to help me minimise symptoms/recover. The massive and sometimes bewildering plethora of often contradictory information available on-line is both frightening and somewhat disheartening.

    After attending my initial consultation with the specialist team I have been offered CBT and GET and I am now just waiting for my first appointment. During my consultation I made it clear that I was not willing to undertake any tasks that that I felt would put me at a high risk of a subsequent crash. I re-counted a couple of recent incidents where I over-exerted myself and subsequently ended up being bed-bound and in pain for days afterwards. I was reassured that they were on hand to help aid and not hinder my recovery.

    Prior to getting ill I ran 3 to 4 times a week covering 5 miles in around 40 minutes. The CFS ‘me’ could just about walk my 4 year old and youngest son to the park (so lucky to have one just over the road from where I live) to watch him play football by himself and then walk us both back home where I would need to rest and elevate my legs to reduce the pain and subsequent tiredness that was sure to present itself.

    This is where my point around GET kicks in. I am the owner of my body and as a result I am the only person who at any time truly knows my own limitations. I have proven that when I was healthy I was able to use my own version of GET to increase my running time to one that is quite acceptable for most people of my age (getting close to 40). I still have the same mind and body and now that I am ill I know that at the moment I am unable to walk too far, or force any activity, or go too long without rest; so I listen to my body and do what is right in any given situation. Times that I have been unable to listen or taken on a bit too much I have paid the price afterwards.

    I find it bizarre that anybody who is unable to find a scientific cause for an illness (or even pinpoint what it is that is broken) can profess a cure, especially one as seemingly unfitting as graded exercise. In almost all other life circumstances common sense tends to prevail. People rightly take caution with a better to be safe than sorry approach if they are unsure what problem they are facing. One good example of such is not to take off the motorcyclists helmet as we don’t know what injury they may have.

    A gym instructor will always advise a customer to listen to their body – stop exercising if you get too dizzy or faint, if you pull a muscle rest it as over-training with any injury could lead to more permanent damage etc.

    If somebody is clearly ill and in many cases debilitated to the same extent as someone who carries a serious injury why would you want them to do any exercise until you knew what was wrong with them?

    With the above said there is currently a bigger problem all CFS sufferers face and I can’t see a way around this issue within the confines of our current set up in the UK. This issue is that all people diagnosed here get sent for CBT/GET treatment and nothing else is recognised by the NHS. A full proposed treatment for an unknown illness is given to everyone. Without other proposed treatments running side-by-side there is a big risk that this capture all approach with CBT/GET will severely impede the results of any future treatments offered as many participants will have also undergone/be undergoimg CBT/GET.

    Another important factor to take into account is the supposed recovery rates of those undergoing CBT/GET. As an example I am 100% focussed towards making as full a recovery as possible; I have totally changed my lifestyle, diet, worked on mindfulness and meditation, changed everyday products I come into contact with, massively changed the material I read and use a variety of supplements on a trial and error basis. Just one such dietary change is the 100% removal of any sugar for 5 months (including fruit). As you can see by this sugar example each of these changes undertaken are massive on their own right and could have a positive/negative impact on my symptoms/condition.

    So now, like all my fellow CFS/ME sufferers with a recent diagnosis, I am sent to my CFS specialist with around a 3 month wait to undergo treatment that starts with a pain/activity questionnaire followed by another 3 month wait for the first CBT/GET session. Surely at some point in the future another questionnaire will be handed to me and I am confident that my score will have shown an improvement on my condition.

    Regardless of how my intervention goes I will then become a statistic within the CBT/GET database showing the positive impact it has had on my recovery. Could the one-hour conversation/s I am due to have with somebody have more of a positive impact on my recovery than the aforementioned changes that being struck with such chronic condition forced onto me? Either way how can this level of detail be stripped from the all-encompassing data to even begin to summarise the impact the delayed GET/CBT is having on people?

  4. Cindy Downey says:

    Hello Stephen, I am sorry you have this diagnosis, and have to undergo GET
    that has been reported by many with ME to cause harm. I wish I had the answers.

    I don’t know if you have come across the research of the Workwell Foundation: http://www.workwellfoundation.org/sample-page/ This group has proven that post-exertional malaise (PEM) can be objectively measured with 2 day, back to back cardiopulmonary bicycle testing. This organization’s work, and others’, was sufficient to prove to the prestigious Institute of Medicine (IOM) that ME is a serious physical disease: http://www.iom.edu/MECFS

    The Workwell Foundation is one of the research groups featured in the 2016 documentary, “Forgotten Plague M.E. and the Future of Medicine.” Health care practitioners who have seen this film said they had no idea ME (CFS) was so bad. You can find info about this film online.

    The 2015 IOM report has gained some traction in North America, but given the news from Britain, the IOM report does not seem to have affected NHS policy. Although, I understand the NICE guidelines for ME may be reviewed. This seems to be more do with current advocacy in your country putting forward the IOM report and other research ,rather than NHS being proactive about taking on board biomedical ME discoveries.

    You make a very good point about gym instructors cautioning against pushing too hard and having an injury. Odd, that another group of practitioners would urge ignoring one’s symptoms, and the potential for injury when exercising.

    As well, there are always media campaigns designed to get us to pay attention to potential symptoms of stroke, heart attack, diabetes, cancer etc. According to medical authorities, we are not supposed to ignore those symptoms. However, the GET/CBT anti-ME movement apparently advises ignoring all symptoms when exercising. Contradictory messages coming from various health authorities: on the one hand some say don’t dismiss physical symptoms, and on the other, CBT/GET/ME practitioners say do dismiss physical symptoms. Of course, the anti-ME movement assumes those with ME have a psychological condition, based on faulty illness beliefs and a fear of exertion, and therefore any symptoms they may have will be imaginary. The compartmentalizing of medical advice should be held up to the light.

    Contrary to the GET gang, persons with ME (PWME) do ignore physical symptoms if possible to get some things done. You say you take your children to the park. Many with ME, although very compromised, must of course do some tasks. And, in order to do that, feelings of faintness, palpitations, burning muscles, headaches, muscles weakness, extreme fatigue etc. have to temporarily be ignored. These practitioners don’t seem to get this. PWME are already exerting a great deal within the very restrictive boundaries imposed by this physical disease, and ignoring symptoms because there are demands in life that if one is at all capable, must be fulfilled. They wouldn’t tell people with MS to ignore their symptoms.

    Thank you for pointing out the contradictions in exercise advice. Have you been in contact with UK ME groups to see what they suggest? I hope the Workwell Foundation, and IOM info helps with more insight. I wish there was more out there to help. It may also help to know the CDC dropped its recommendations for GET and CBT for ME. I wish you all the best, take care.

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