Editor’s note: Below are two responses to Robert Schneider’s defense of his Transcendental Meditation paper, which Schneider wrote in response to my earlier article about the publication of his paper. In the first part I respond to some of the general issues raised by Schneider. The second part, from Sanjay Kaul, addresses the statistical issues discussed by Schneider.
I’m grateful for Kaul’s highly technical analysis of the statistical issues raised by Schneider, but I don’t think this case really requires a terribly high level of technical expertise. Common sense actually works pretty well in this case. A trial with barely 200 patients can not be expected to provide broad answers about the health benefits of a novel intervention. As Kaul and others have stated on many other occasions, “extraordinary claims require extraordinary evidence,” and it is quite clear that the evidence in this trial is not extraordinary, at least in any positive sense.
Questions About Trial Reliability And Data– In his response Schneider tries to skate away from the inevitable questions raised about this paper when Archives of Internal Medicine chose to withdraw the paper only 12 minutes before its scheduled publication time. Schneider can pretend that this incident never occurred, but outsider readers can not help but wonder what sparked this extraordinary incident, and will not be satisfied until the details are fully explained.
There are additional red flags about the trial. Schneider told WebMD that since the Archives incident “the data was re-analyzed. Also, new data was added and the study underwent an independent review.” Said Schneider:
“This is the new and improved version.”
This is an extraordinary claim, because a clinical trial can not be “new and improved” unless there were serious flaws with the earlier version. What exactly does it mean to say that a paper published in 2012 about a trial completed in 2007 is “new and improved”? (According to ClinicalTrials.Gov the study was completed in July 2007, while June 2007 was the “final data collection date” for the primary endpoint.)
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