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the researchers who developed the CBT/GET program used in MECFS clinics have no desire to see their life’s work superseded by the pebble-dashing of a snake oil salesman, but promoting the idea that the Lightning Process ‘inexplicably works’ in some cases is more about damaging the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
Newcastle upon Tyne
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.