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Emerge Aust calls for release of PACE data

New survey: 90% of ME and CFS patients report adverse effects from activity or exercise

ME and CFS advocacy org Emerge Australia has added its voice to international calls for the Queen Mary University London to release the PACE trial data to independent researchers for reanalysis.

In a strongly worded letter to the QMUL, Emerge said a recent Australia-wide survey found that 90% of ME/CFS patients experienced adverse effects from increased activity or exercise, contradicting the PACE trial authors’ claims that Graded Exercise Therapy (GET) is beneficial to patients.

Based on the theory that ME and CFS is the result of activity avoidance and deconditioning, the PACE trial has been used to legitimize GET and CBT psychotherapy protocols to treat the illness.

Published in 2011, the PACE trial paper argued that CBT and GET were, when combined with specialist medical care (SMC), ‘moderately’ effective, compared to SMC alone.

However, a long-term follow-up of PACE trial patients found that although improvements in fatigue and physical functioning were maintained, there was little difference between the various treatment groups.

ME/CFS patients have long claimed the failure of the authors to release the data was an admission of irregularities in the study.

Emerge said the use of GET was at odds with the Institute of Medicine’s (IOM) determination that “ME/CFS is a serious, chronic, complex and multisystem disease that frequently and dramatically limits the activities of affected patients”.

According to the advocacy group, much of the information available to Australian medical practitioners regarding treatment is based on the PACE trial, in particular from the Royal Australian College of General Practitioners‘ website.

Australia-wide survey contradicts PACE authors

In 2015, Federation University Australia, in collaboration with Emerge Australia, undertook an extensive research study into the health and wellbeing of Australians with ME/CFS.

The project was designed to identify the level and type of unmet healthcare needs of the ME/CFS community in Australia with the view to effect a positive change in attitudes, knowledge and increase access to critical health and financial services.

Preliminary findings of the survey (unpub.) show that 90% of the 608 respondents said that increasing their level of exercise/activity makes them feel worse.

In the UK, a survey carried out by the ME Association showed that 74% of the 233 people who tried GET reported that their condition had worsened.

QMUL appeals the ICO decision to release the PACE trial data

In October, last year, the Information Commissioner’s Office (ICO) issued a notice to the Queen Mary University to release requested information related to a clinical trial concerning treatments for chronic fatigue syndrome, namely the PACE trial data, to an anonymous complainant.

QMUL subsequently appealed the decision and an appeal hearing has been set for April 20-22 this year.

On Dec 18, in an apparent gesture of goodwill, the QMUL issued  a statement inviting submissions from ME/CFS patients regarding the issue of providing appropriate access to relevant research data.

International calls for the PACE trial data to be released

A number of patient and researcher groups accepted the QMUL’s invitation. In the UK, the ME Association, 25% ME Group, Invest in ME, Tymes TrustHope 4 ME & Fibro NI, and Action for ME, issued statements and letters requesting the release of the data.

ME Action Network recently submitted an 11,000-signature petition to The Lancet, calling for the retraction of “misleading” analyses and claims published in the PACE trial concerning the effectiveness of CBT and GET for ME/CFS.

The validity of the PACE trial has been challenged in several recent reviews, notably by US-based journalist David Tuller and James Coyne, Professor of Health Psychology at the University Medical Center, Groningen, the Netherlands.

An open letter from an international group of researchers, including world renowned geneticist Ron Davis, Professor of Biochemistry and Genetics at Stanford, was posted on Vincent Racaniello’s Virology Blog, citing a number of critical flaws in the PACE paper.

 

Please tap the toggle below to see the Emerge letter to QMUL in full.

Emerge letter to QMUL

Emerge Australia letter to QMUL:

Professor Simon Gaskell
President and Principal Queen Mary’s University London
Mile End Road London E1 4NS
United Kingdom

20th March 2016

Call for release of PACE trial data and independent analysis of data

Dear Professor Gaskell,

Emerge Australia is a not-for-profit organisation that supports people with ME/CFS and associated conditions. We are writing as an organisation representing and supporting Australians with ME/CFS, to express our concern about Queen Mary University of London’s (QMUL) refusal to comply with the UK Information Commissioner’s order to release the PACE trial anonymised raw data.

As QMUL is seeking the “advice of patients” on the matter, we are writing to convey our view to you. We support the request of an 11,000-signature petition hosted by the ME patient-advocacy organisation, ME Action Network, which asked “the study authors… to give independent researchers full access to the raw data”.1

Currently, much of the information available to Australian medical practitioners is based on the PACE trial, (in particular, the Royal Australian College of General Practitioners’ website). However, eminent scientists have identified serious flaws in the PACE trial data analyses, putting the authors’ claims of patient recovery in serious doubt .2

Contrary to the PACE trial authors’ claims, GET can be extremely harmful to people with ME/CFS. In 2015, Federation University Australia undertook an extensive research study into the health and wellbeing of Australian’s with ME/CFS. Preliminary findings of the survey (unpub.) show that 90% of the 608 respondents said that increasing their level of exercise/activity makes them feel worse. In the UK’s ME Association’s 2012 patient survey, 74% of the 233 people who tried GET report that their condition worsened.3 This anecdotal evidence is supported by studies reporting abnormal physiological responses to exercise in people with ME/CFS.4

PACE-style GET and CBT are based on the underlying rationale that ME/CFS is the result of activity avoidance and deconditioning. This view is at odds with the Institute of Medicine’s (IOM) determination that “ME/CFS is a serious, chronic, complex and multisystem disease that frequently and dramatically limits the activities of affected patients”.5 It is also at odds with the findings of eminent Australian researchers on the bio-medical basis of ME/CFS (Staines, Marshall- Gradnisik).6

Given these concerns with the trial, and in the interest of open and transparent science, we request that QMUL to comply with the Information Commissioner’s request to release the PACE trial data to independent researchers for reanalysis.

Yours sincerely,

Sally Missing President
cc: Rachael Cragg Group Manager Information Commissioner’s Office Wycliffe House Water Lane Wilmslow Cheshire SK9 5AF United Kingdom
ENDS

 

FEATURE PHOTO: Run! Run! by Billy Wilson

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Written by Russell Logan

Russell Logan worked as a magazine publisher and editor until forced into early retirement through ill health with ME. He has battled with moderate to severe ME for 25 years. He now lives in Noosaville, Australia.

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