Dr Rebecca Goldin, blogging for Sense About Statistics, has said that flaws in the design of the PACE trial “were enough to doom its results from the start”.
Her 7,000-word post described the study’s design and the extensive changes to the planned analyses.
Dr Goldin, who is the Director of the organisation, writes, “The study is under increasing scrutiny by scientists and science writers about whether its conclusions are valid. The question of how all this happened and how the criticism is being handled have sent shockwaves through medicine”.
She added, “The results from PACE… have been published in prestigious journals and influenced public health recommendations around the world; and yet, unraveling this design and the characterization of the outcomes of the trial has left many people, including me, unsure this study has any scientific merit. How did the study go unchallenged for five years?”
Sense About Statistics is a collaboration between Sense About Science USA and the American Statistical Association. It is aimed particularly at journalists who need to understand statistics in order to accurately report the news. Dr Goldin’s analysis of the trial includes its media coverage as well as its design and statistical aspects.
She notes that “Patients pointed out flaws in the trial and asked for more data to analyze the claims, but their concerns were dismissed” until the appearance of Dr David Tuller’s analysis of the trial, which, she said, “described scientifically stunning problems”.
She reported that, now that 42 scientists have signed an open letter to The Lancet requesting independent re-analysis of the trial, the journal’s editor has invited the group to submit a letter about the concerns for publication.
Sense About Science’s director, Trevor Butterworth, accompanied the article with an editorial in which he described CFS as “a paralyzing syndrome that is as near to an off-switch on life as one can imagine”.
He wrote, “The reaction to patient criticism and Tuller’s story by the PACE researchers and the Lancet has been to deflect rather than to dissect… David Tuller may not get a Pulitzer Prize for investigating PACE trial on a blog; but his service to—and we do not exaggerate—millions of sufferers around the world make it hard for us to think of another work of journalism so deserving of commendation.”