Wow - on Racaniello's Virology of all places...
There should at least be an investigation...at least by Lancet to review the claims....wouldn't that be something if they retracted the paper?
Dr. Ronald Davis, Stanford University: “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.”
Some key points:
- The PACE team changed all the methods outlined in its protocol for assessing the primary outcomes of physical function and fatigue, but did not take necessary steps to demonstrate that the revised methods and findings were robust, such as including sensitivity analyses.
- The researchers relaxed all four of the criteria outlined in the protocol for defining “recovery.”
- The PACE claims of successful treatment and “recovery” were based solely on subjective outcomes. All the objective measures from the trial—a walking test, a step test, and data on employment and the receipt of financial information—failed to provide any evidence to support such claims. Afterwards, the PACE authors dismissed their own main objective measures as non-objective, irrelevant, or unreliable (!)
- *The trial included a bizarre paradox: Participants’ baseline scores for physical function and fatigue could qualify them simultaneously as sick enough to get into the trial but already “recovered” on those indicators–even before any treatment. In other words, the thresholds for being “recovered” demonstrated worse health than the scores required in the first place to demonstrate the severe disability needed to enter the trial. This anomaly meant that some participants could get worse on physical function and fatigue during the trial and still be included in the results as being “recovered.” .....13 percent of the participants were already “recovered” for physical function or fatigue, or both, when they joined the study—a fact not mentioned in any of the published papers.
From a statistician:
“I have never seen a trial design where eligibility requirements for a disease alone would qualify some patients for having had a successful treatment,” said Levin, who has been involved in research on the illness and has reviewed the PACE study. “It calls into question the diagnosis of an illness whose patients already rate as ‘recovered’ or ‘within normal range.’ I find it nearly inconceivable that a trial’s data monitoring committee would have approved such a protocol problem if they were aware of it.”
Part II is coming up tomorrow...
As a guest blogger at Vincent Racaniello's
Virology , David Tuller examines the PACE trial and the researchers:
http://www.virology.ws/2015/10/21/trial-by-error-i/
I've just begun to read. Excellent so far. Amazing the level of incompetence and the corruption among the researchers and the editors at the
Lancet.
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