After months of hard work from #MEAction, #MEAction Network UK, and many others including advocates, government officials, lawyers, and PACE experts, a group of concerned global citizens have crafted a petition to the UK government to stop graded exercise therapy trials in ME/CFS. If this petition reaches 10,000 signatures from UK citizens, its content will have to be addressed by the Government. The team has also crafted a global support petition, an explanatory website, and an FAQ about the creation of the petition itself.
Learn more below:
Advocates were moved to action by MAGENTA, a trial of graded exercise therapy for children with myalgic encephalomyelitis, conducted in the UK. A feasibility trial on 100 children began last year and is likely to lead to a much larger trial.
Modern research show abnormalities in ME patients’ energy production systems including research demonstrating that cellular metabolism is dramatically slowed. This indicates that ME patients cannot generate the resources to exercise as MAGENTA and other graded exercise studies recommend. Telling a child with an energy metabolism disorder that if she is more active, she will gain the ability to do so without damage is like telling a diabetic that if she consumes more and more sugar, she will be able to eat cake. It is like advising someone on the verge of bankruptcy that their problems will be solved if they spend more and more money at a time.
“It is, of course, completely unacceptable that any study should justify itself based on the uninterpretable findings of the PACE trial.” — Vincent Racaniello, Professor of Microbiology and Immunology, Columbia University
The MAGENTA researchers justify a trial in children on the basis of the 2011 PACE trial, which has been featured on Retraction Watch and is notorious for its flaws. It has so many problems that a group of over 40 scientists and clinicians — including specialists in child medicine — have published an open letter saying that PACE’s “major flaws… have raised serious concerns about the validity, reliability and integrity of the findings”. These flaws include but are not limited to:
- setting recovery criteria below entry criteria (patients could worsen and still researchers would label treatment as successful)
- setting recovery criteria so low that a patient with late-stage congestive heart failure would have been considered recovered
- started off with objective measures (actometers) but quickly abandoned their use in the trial
- provided promotional material about their therapies to trial participants during the trial, introducing more bias into a trial that relied on self-reported improvements
- showed no evidence of efficacy on long-term follow-up and trivial/placebo outcomes following the original trial protocol
None of this information appears in MAGENTA’s participant information sheets, raising serious concerns about whether the children in the trial, and their parents or carers have given genuine informed consent.
Please help us stop MAGENTA, and all trials of graded exercise therapy in ME.
Visit www.stopGET.org to learn more.