As if there were not enough concerns about the PACE trial, we at Tymes Trust have the added concern, on behalf of parents and families of children with ME, that a children's version of PACE is being set up. Below is the text of a letter we have sent to QMUL which was of course set out on our headed paper.
LETTER TO QUEEN MARY UNIVERSITY LONDON
Records and Information Compliance Manager, QMUL
Copy to: Professor Simon Gaskell, Principal, QMUL
RELEASE OF PACE TRIAL DATA
We understand from your December 2015 statement that you wish to receive patients' views on the release of the PACE trial data.
Tymes Trust is the longest established UK service for children with ME and their families. We are frequently contacted by parents whose children's condition has deteriorated after various regimes of graded exercise, graded activity, and graded school attendance, with its demands upon both body and brain. Therefore we are extremely concerned that, before any fresh analysis of the PACE trial data by independent scientists has taken place, a PACE trial for children (under the appellation MAGENTA) is being set up. This will subject children to graded exercise therapy.
Given the many concerns about the methodology used in the PACE trial, and given the fact that its conclusions are starkly at odds with the findings of patient organisation surveys into graded exercise therapy, which consistently show three quarters of patients reporting deterioration as a result, you must surely agree that parents are entitled to have access to the results of an independent analysis of the PACE trial data before agreeing to subject their children to this therapy.
You may be aware that the published information about the MAGENTA trial confidently states: “There are no risks of participating in the study.” Contrast this with one of the latest patient messages we have received: “Save our children from GET. I know what I am talking about, from an ex triathlete who went from mild to severe ME because of GET.”
We are well aware of the controversy surrounding the release of the PACE trial data, and are amazed that you appear so reluctant to put a speedy end to this potentially damaging and unseemly stand-off between yourselves and a world renowned group of scientists who are only the latest among many to request the release of this data. We hope you will reconsider, rather than fighting the Information Commissioner's order to release the data. It is surely the responsible thing to do.
The Young ME Sufferers Trust