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Full Results of PACE Trial Withheld From Public Scrutiny

  [ 17 votes ]   [ Discuss This Article ] • June 17, 2013

Editor's Comment: This article appeared on June 12, 2013 on the UK Human Rights Blog. Mr. Courtney's unsuccessful attempt to gain access to the complete results from the PACE trial brings up two important points: 1) While the write-up in the Lancet claimed that there was an improvement in patients with ME/CFS after treatment with GET and CBT, it failed to account for the number of patients who got significantly worse on each treatment during the trial, and 2) When complete results from a medical trial are withheld from the public, how does that affect the right of patients to know if a therapy might potentially harm them?

Freedom of information and unpublished data from a randomised controlled trial on ME/CFS

By David Hart, Barrister

"Between 2005 and 2010 Queen Mary ran a trial into the efficacy and safety of the current treatments for Chronic Fatigue Syndrome/Myalgic Encephalopathy, namely Adaptive Pacing Therapy, Cognitive Behaviour Therapy and Graded Exercise Therapy. £5m of public money was spent, and the perceived benefits (and some of the detriments) were written up into a major article published in the Lancet in March 2011. The upshot, said this article, was that CBT and GET could be safely added to current medical care with a moderate improvement in outcomes. This recommendation has already fed into an interim review of the NICE guidelines on CFS/ME.

However, the data on deterioration within the trial had not been fully published. You could not see how many patients deteriorated in response to each therapy, just the net deterioration over the whole cohort. Our appellant, Mr Courtney, is evidently a bit sceptical about the results of this trial. As he pointed out, the deterioration data had a 20 point difference, whereas the improvement had only to be modest – an 8 point difference. And, he said, how can patients sensibly form a view on treatment without knowing how much deterioration that specific treatment might cause?"

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