Clinical trials and drug promotion: Selective reporting of study 329

A paper by Jureidini, McHenry and Mansfield on the subject of Protocol 329. Dr Jureidini, you may remember, was one of the original critics of the paper that the Great Genius Who Is Professor Martin Keller "wrote," back in 2001. The paper is available on Healthy Skepticism, but has attracted attention from Fidders and Clinical Psych, the latter making the particularly pertinent observation that the various statistical shennanigans that took place in order to turn, quite magically, Paxil from a pile of kak into a pile of kak with a bow on top is anything but an isolated incident (although, I find that all magic is based on sleight of hand).

I'm not a statistician, and so I don't fully understand the nature of the argument, although I do understand that changing what one claims to have been looking for, after one has the results in front of one, probably isn't very scientific. No, to quote the Great Genius Who Is Professor Martin Keller, "I'm better with words"! And I'm still struck by the need that James McCafferty (the Paxil Phase 4 project manager, and a SKB employee), perceived to tell Sally Laden (the ghostwriter) that she oughtn't to be making grand claims as to safety, when she was also documenting lots of adverse events.

McCafferty and Rosemary Oakes, a senior statistician at SKB, who worked on the project, got their names on the paper, when it was published. Call me old-fashioned, but I should have thought that having the Company run the trial, crunch the numbers, and then write the paper, informing people of what the numbers meant, before using that paper as an adjunct to a marketing authorization application (and have the regulator accept said paper as valuable evidence), is probably open to abuse. What? Oh, yeah: it was abused, but I should state for legal reasons that it is only my opinion that this was abused. As such, it is merely my opinion that I cannot conceive of a more flagrant fraud.

Matt