PACE trial[edit | edit source]
David Tuller spoke at length and in detail on the PACE trial on the TWiV podcast: TWiV 397: Trial by Error. He called the PACE trial preposterous and a pack of nonsense, and a piece of crap. He discussed the FINE trial, The Lancet, British Medical Journal (BMJ) and PLOS ONE, patients being ill yet deconstructing the PACE Trial, how ME/CFS is a disease being treated inappropriately with Exercise, GET and CBT, touches on the Institute of Medicine report and SEID, Valerie Eliot Smith and Karina Hansen, and more.
Data release[edit | edit source]
This article has a link to the RAW DATA at Reference 10.
No ‘Recovery’ in PACE Trial, New Analysis Finds
By: Vincent Racaniello
"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 at 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 (link) 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."
Trial By Error, Continued: The Real Data
By: David Tuller
"‘The PACE trial is a fraud.’ Ever since Virology Blog posted my 14,000-word investigation of the PACE trial last October, I’ve wanted to write that sentence. (I should point out that Dr. Racaniello has already called the PACE trial a “sham,” and I’ve already referred to it as “doggie-poo.” I’m not sure that “fraud” is any worse. Whatever word you use, the trial stinks.)
Let me be clear: I don’t mean “fraud” in the legal sense—I’m not a lawyer–but in the sense that it’s a deceptive and morally bankrupt piece of research. The investigators made dramatic changes from the methodology they outlined in their protocol, which allowed them to report purported “results” that were much, much better than those they would have been able to claim under their originally planned methods. Then they reported only the better-looking “results,” with no sensitivity analyses to analyze the impact of the changes—the standard statistical approach in such circumstances."