Write to the University of NSW and ask them not to allow this trial to proceed: contact the ethics department via email:
and the study’s contact
You may wish to also contact the administrator of the Mason Foundation, who are funding the work
There is a proposed study/trial starting in 2016 which I am deeply concerned about:
“There is Level One evidence indicating that graded exercise therapy (GET) and cognitive behavioural therapy (CBT) is currently the most effective means to manage CFS (for review see Larun et al, 2015; Prince et al, 2008). Despite GET and CBT being widely acknowledged as best-practice interventions for CFS, the great majority of patients in Australia are not receiving these appropriate evidence-based interventions. Recent studies have demonstrated that the reason for this documented gap between research and practice is largely due to practicing health professionals lacking the knowledge and skills to provide appropriate care.
In order to address this lack of knowledge, our group has developed a CFS Treatment Manual and accompanying DVD aimed at providing clinicians with the knowledge and skills required to effectively manage CFS.”
Firstly “being widely acknowledged as best-practice interventions for CFS” is absolutely not true. They have been shown to cause harm in many people.
The PACE trial, which recommended use of graded exercise therapy and cognitive behavioural therapy, has breached the UK’s Information Commissioner’s Office’s orders to release their data and has been criticised earlier this month in the Wall Street Journal.
Here is the ‘widely-read scientific blog’ that the Wall Street Journal mentioned, it explains the flaws well: ‘Trial by Error’ from David Tuller.
More than 40 scientists, including Nobel laureates and world-leading CFS and ME scientists signed a letter to ask for an independent review of the PACE trial.
Eleven thousand patients (including me) signed a petition for the Lancet to withdraw it’s misleading PACE trial paper.
Emerge Australia (Australia’s leading patient advocacy organisation) say “There is no good evidence to support the use of graded exercise therapy or cognitive behaviour therapy and there is important emerging evidence on genetic and immune markers for the condition, so we ask the Department of Health not to waste precious research dollars on those studies”.
In an interview, Senator Ludlam said “Australia shouldn’t be funding research into totally inappropriate exercise regimes or therapy, “these remedies are actually counter-productive and dangerous”.
The UK’s ME Association surveyed 1428 respondents and say “73% of respondents reported that CBT had no effect on their symptoms and 74% that their symptoms were made worse by GET”.
The (Australian) National Centre for Neuroimmunology’s Dr Don Staines says “anyone who suggests that this might be fixed by exercise therapy should probably be de-registered I think”.
The latest International Consensus Primer for ME (published in 2012, after the PACE trial) details (or references studies showing) many of the muscle acid differences, orthostatic problems and immune/inflammatory markers. It does not recommend cognitive behavioural therapy or graded exercise therapy.
It also has a narrower set of criteria than older CFS definitions, such as the Oxford criteria used in the PACE trial. The US National Institute of Health’s report says “continuing to use the Oxford definition may impair progress and cause harm. Thus, for needed progress to occur we recommend that the Oxford definition be retired.”
Please reassure me that this trial will not go ahead.