by Sasha Nimmo
Write to the University of NSW and ask them not to allow this trial to proceed: contact the ethics department via email: ted.rohr@unsw.edu.au, humanethics@unsw.edu.au and the study’s contact s.h.li@unsw.edu.au .
You may wish to also contact the administrator of the Mason Foundation, who are funding the work, charities@eqt.com.au
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.”https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370222&isReview=true
Firstly “being widely acknowledged as best-practice interventions for CFS” is absolutely not true. They have been shown to cause harm in many people. Here is a paper detailing the evidence: Reporting of Harms Associated with Graded Exercise Therapy and Cognitive Behavioural Therapy in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome.
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 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 was quoted as saying “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 and Emerging Diseases’ (NCNED) Dr Don Staines says “anyone who suggests that this might be fixed by exercise therapy should probably be de-registered I think”.
NCNED are also on the record saying “scientific data from NCNED do not indicate any therapeutic value from these interventions. While harm is difficult to predict we reiterate that we believe these interventions have no scientific merit in ME/CFS and may do harm.”
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.
Response from UNSW
UNSW human research proposals are reviewed by the UNSW Human Research Committees or delegated bodies in accordance with the requirements of the National Statement on Ethical Conduct in Human Research. As such, human research proposals are reviewed to meet the requirements of the principles embedded in the National Statement, namely research merit and integrity, justice, beneficence and respect. The proposed study you refer to will be reviewed accordingly.
Dr Ted Rohr BSc (Hons) PhD, Director, Research Ethics & Compliance Support
Response from the Mason Foundation
The grant made to the University of New South Wales for medical research was made from private monies held in the Mason Foundation for which we act as trustee. The trustee distributes funds in accordance with the directions of the benefactor of the charitable trust. In many charitable trusts we are directed to make grants to medical research, and sometimes to specific fields of medical research. There are limitations placed on a trustee in the distribution of funds for charitable purposes that would not apply to an individual or to another type of company. The trustees are not at liberty to impose their personal views or values in respect of distributing money that is held in trust. We must comply with these directions in order to fulfil our legal duty as trustee to the benefactors who left these funds in our care.
As trustee our duty is to act impartially between beneficiaries and in order to do so we utilise and respect the advice of experts in the arena of medical and scientific research. The Mason Foundation makes use of a specially convened panel of scientists from a range of prominent medical institutions to provide advice on the quality and value of the scientific research proposal. We only fund projects that have approval from their University or Institute, and we rely on those organisations to make judgements on and maintain appropriate standards.
We won’t be disclosing any information with regards to the panel.
Update October 2016: Since the Freedom of Information Request revealed new information in September 2016, the UNSW’s ethics committee were provided with the details and asked further questions.
14 thoughts on “Ask UNSW to cancel CBT/GET training chronic fatigue syndrome study”
Emails sent to all involved. Thanks so much for fighting this fight. We are having similar problems here in Canada, with the Complex Chronic Diseases Program in Vancouver offering the only government funded program for those with ME/CFS. They too are being swayed by PACE, and we too have our fight here.
It is heartening to have your support from Canada, thanks Elizabeth. It really is a global problem we can tackle together.
Thank you very much Sasha,your blog so well researched and written and your form letter will be especially handy for my wife Tracey and myself.
Your excellent research (particularly in adopting the 2012ICC-ICP urgently), writing and advocacy is invaluable, especially to all Australian sufferers and their families.
All the best,David and family.
David,
Thank you for the message, I know you are severely ill and appreciate how much this effort costs you.
As a community, I hope we can use the good research and guidelines that exist and change things for the better.
Sasha
The Mason Foundation fund administrators will not disclose who their scientific panel is and whether they sought legal advice on the potential harm to patients. Here is their response:
“Thank you for your email expressing concerns about the Judith Jane Mason and Harold Stannett Williams Memorial Foundation’s (“Mason Foundation”) involvement in medical scientific research.
The grant made to the University of New South Wales for medical research was made from private monies held in the Mason Foundation for which we act as trustee. The trustee distributes funds in accordance with the directions of the benefactor of the charitable trust. In many charitable trusts we are directed to make grants to medical research, and sometimes to specific fields of medical research. There are limitations placed on a trustee in the distribution of funds for charitable purposes that would not apply to an individual or to another type of company. The trustees are not at liberty to impose their personal views or values in respect of distributing money that is held in trust. We must comply with these directions in order to fulfil our legal duty as trustee to the benefactors who left these funds in our care.
As trustee our duty is to act impartially between beneficiaries and in order to do so we utilise and respect the advice of experts in the arena of medical and scientific research. The Mason Foundation makes use of a specially convened panel of scientists from a range of prominent medical institutions to provide advice on the quality and value of the scientific research proposal. We only fund projects that have approval from their University or Institute, and we rely on those organisations to make judgements on and maintain appropriate standards.
Thank you for your enquiry and for your interest in our processes.
Rebecca David
Grant Program Manager
Level 2, 575 Bourke Street Melbourne Victoria 3000 Australia
+61 3 8623 5000
+61 3 8623 5200
eqt.com.au
RDavid@eqt.com.au “
Sasha,
Thank you for your efforts to have this study cancelled. As a sufferer it is certainly discouraging to constantly be confronted by ill informed medical professionals who believe CBT and GET are the answer to ME.
It is a disappointing response from the Mason Foundation given we have no idea who the specially convened panel of scientists are and whether it included any world leading well read ME specialists. Do these Foundation seek overseas opinions?
I do fear the statement that the Foundation “only funds projects that have approval from their University or Institution, and we rely on those organisations to make judgements on and maintain apprioate standards” as they are leaving the duty of care with the very Institutions benefiting financially from their grants.
While there is some amazing research happening here in Australia, the education of medical professionals is sadly lacking and a constant frustration to most sufferers. This study will only add more frustration. When will we be heard?
(Excuse me for my clumsy grammar and spelling, this is not my best work)
Hi Kellie,
Thank you so much for your feedback and thoughtful comments.
I don’t know if they seek overseas opinions, they weren’t as forthcoming about the process as I would like.
It is frustrating and hopefully by exposing the situation, asking questions, complaining (and explaining) about poor research and bringing good research to the fore, we can change things.
Thank you for all of the work you do, it is very much appreciated . I’m wondering if anyone who contacted the Uni of NSW received a response? If our concerns aren’t being addressed, it may be worth re-sending another letter with updated links to the latest findings that invalidate the PACE trial.
No ‘Recovery’ in PACE Trial, New Analysis Finds (Sep 16, based on the court ordered data release).
http://www.virology.ws/2016/09/21/no-recovery-in-pace-trial-new-analysis-finds/
– The Implosion of a Breakthrough Study on Chronic Fatigue Syndrome (republished on SBS, Sep 16)
http://www.sbs.com.au/topics/science/humans/article/2016/09/22/implosion-breakthrough-study-chronic-fatigue-syndrome
Bad science misled millions with chronic fatigue syndrome. Here’s how we fought back (Sep 16)
https://www.statnews.com/2016/09/21/chronic-fatigue-syndrome-pace-trial/
AHRQ Evidence Review Changes Its Conclusions (Aug 16)
http://occupyme.net/2016/08/16/ahrq-evidence-review-changes-its-conclusions/
“This Addendum downgrades the conclusions on the effectiveness of cognitive behavioral therapy (CBT) and graded exercise therapy (GET), and this has tremendous implications for medical education and treatment recommendations.”
Hi Karen,
Thank you for reading and for your thoughtful response. Those link are excellent.
It prompted me to update the article with the responses I received from the Mason Foundation and the UNSW a few months ago, as well as contact UNSW again now that the PACE trial data has been revealed.
I’ve also used MEAction’s tools to create a petition so once that is up, I’ll provide a link here as well.