Thursday, May 29, 2008

Prucalopride: When Delivery is so Suspicious that the Entire Message Seems Corrupt

In this week's NEJM, ( Camilleri (of the Mayo Clinic) and comrades from Movetis (a pharmaceutical company) report the results of a study of Prucalopride, a prokinetic agent, for the treatment of chronic constipation. What is striking about this study is not the agent's relation to Ciaspride (Propulsid, an agent removed from the market a number of years ago because of QTc prolongation and associated cardiac risk) but rather the fact that this study was completed nearly a decade ago, and was only just now published. Such a delay is certainly worthy of concern as astutely pointed out by an editorialist (

A colleague and I recently pointed out the unethical practice of witholding the results of negative trials from the scientific community (see;jsessionid=L2bQSl9ygT9BzlZq81qlnJGfyfG2Jh2f2qQvP4XTp0YqMQ1ZD3T1!195308708!181195628!8091!-1?index=1&database=ppvovft&results=1&count=10&searchid=2&nav=search#P6), but the Prucalopride trial takes the cake. Here, positive results were either intentionally witheld from that community or by happenstance were omitted from publication, delaying further study of this agent (if it is indeed even warranted) and undermining the altruistic basis of subjects' participation in the trial, which, ostensibly, was to advance science (unless they participated for financial incentives, which I might argue [as others already have] should be disclosed in the reporting of a trial - see

I will leave it to other bloggers and commentators to speculate whether the profit or other motives were the impetus behind this delay and whether medical ghostwriting was in any way involved in the publication of this article. Suffice it to say that there are certain irregularities in the way a trial is reported (in addition to those with which it was conducted) that should give us pause. Prucalopride has now shown itself to be worthy of a bright spotlight of intense scrutiny.

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