BarryBlackwell: The Baby and the Bathwater
Glen Spielmans’comment on Jay Amsterdam’s comment on Edward Shorter’s comment
I was familiar with some of the details, having read the excellent Jureidini, Amsterdam and McHenry article from 2016 on the CIT-MD-18 trial. This morning, I read through the Baum Hedlund document from Jay's email. This really was a "masterful stroke of euphemism" on the part of Forest. This has it all: inappropriate including unblinded patients in analyses (and being cleverly deceitful about it) - which magically made the study "positive", moving around primary and secondary outcomes, attempting to transform negative secondary outcomes into positive outcomes, bringing KOL extraordinaire Karen Wagner on board to sell an ineffective antidepressant for children (as she so often does), FDA dropping the ball on their analysis, and more. Right up there with the GSK paroxetine for youth depression program.
Thanks to Jay for passing on this enlightening, if depressing, material.
June 28, 2018