Over 12,000 sufferers, caretakers and doctors have signed a petition claiming that the £5m PACE trial misrepresented the proportion of patients who regained their health and calling on its authors to release their data for independent analysis.
The study’s authors claimed that twice as many people receiving cognitive behavioral therapy (CBT) or graded exercise therapy (GET) “got back to normal” compared with the other two treatment groups, even though “normal” could include patients with levels of function associated with congestive heart failure.
The petition coincides with an open letter signed by 42 academics and clinicians in the UK, US, Europe and Australia. The letter calls on leading medical journal The Lancet, which published the study five years ago, to agree to an independent re-analysis of the data.
British M.E. patient Ollie Cornes wanted to present the petition at the offices of The Lancet on behalf of the global campaign group #MEAction but the editor, Dr Richard Horton, refused to meet him.
Mr Cornes, 43, who has had M.E. – otherwise known as chronic fatigue syndrome – for 17 years said: “I’m shocked he won’t even talk to me. This study has influenced medical attitudes around the world towards the use of cognitive behavioural therapy and graded exercise in M.E. for years – but many patients say their health has been harmed by graded exercise, not improved by it”.
The petition has also been delivered by mail to the Richmond, Virginia and London offices of Psychological Medicine, who published another controversial paper on the study, and to the main author’s home institution, Queen Mary University of London (QMUL).
Leading geneticist Professor Ronald Davis, interviewed by Dr David Tuller, said, “I’m shocked that the Lancet published it…The PACE study has so many flaws and there are so many questions you’d want to ask about it that I don’t understand how it got through any kind of peer review.”
Both patients and researchers have requested the anonymised trial data but the trial’s authors have denied them all.
In November, the Information Commissioner ruled that the University must release the data to a patient who requested it under the Freedom of Information Act. QMUL is appealing the decision. A tribunal will rule on the case in April.
UK charities including the ME Association, ME Research UK, Action for ME, Invest in ME and the The Young ME Sufferers Trust have also called for the release of the data.
#ME Action petition
The PACE Lancet paper
Open letter to The Lancet from 42 scientists and doctors
Dr David Tuller’s article on the PACE trial
Information Commissioner’s decision on PACE data release
Queen Mary University of London’s appeal against the Information Commissioner’s decision