From Vincent Rancaniello’s Virology blog, 21 September 2016.
No ‘Recovery’ in PACE Trial, New Analysis Finds
Last October, Virology Blog posted David Tuller’s 14,000-word investigation of the many flaws of the PACE trial (link to article), which had reported that cognitive behavior therapy and graded exercise therapy could lead to “improvement” and “recovery” from ME/CFS. The first results, on “improvement,” were published in The Lancet in 2011; a follow-up study, on “recovery,” was published in the journal Psychological Medicine in 2013.
The investigation by Dr. Tuller, a lecturer in public health and journalism and UC Berkeley, built on the impressive analyses already done by ME/CFS patients; his work helped demolish the credibility of the PACE trial as a piece of scientific research. In February, Virology Blog posted an open letter to The Lancet and its editor, Richard Horton, stating that the trial’s flaws “have no place in published research.” Surprisingly, the PACE authors, The Lancet, and others in the U.K. medical and academic establishment have continued their vigorous defense of the study, despite its glaring methodological and ethical deficiencies.
Today, I’m delighted to publish an important new analysis of PACE trial data—an analysis that the authors never wanted you to see. The results should put to rest once and for all any question about whether the PACE trial’s enormous mid-trial changes in assessment methods allowed the investigators to report better results than they otherwise would have had. While the answer was obvious from Dr. Tuller’s reporting, the new analysis makes the argument incontrovertible.
ME/CFS patients developed and wrote this groundbreaking analysis, advised by two academic co-authors. It was compiled from data obtained through a freedom-of-information request, pursued with heroic persistence by an Australian patient, Alem Matthees. Since the authors dramatically weakened all of their “recovery” criteria long after the trial started, with no committee approval for the redefinition of “recovery,” it was entirely predictable that the per-protocol results would be worse. Now we know just how much worse they are.
According to the new analysis, “recovery” rates for the graded exercise and cognitive behavior therapy arms were in the mid-single-digits and were not statistically significant. In contrast, the PACE authors managed to report statistically significant “recovery” rates of 22 percent for their favored interventions. Given the results based on the pre-selected protocol metrics for which they received study approval and funding, it is now up to the PACE authors to explain why anyone should accept their published outcomes as accurate, reliable or legitimate.
JULIE REHMEYER’S TAKE ON ALL THIS PUBLISHED BY STATNEWS.COM: “Bad science misled millions with chronic fatigue syndrome. Here’s how we fought back”.