Clinical Trial Prestidigitation - Making Old Data Look Worse So New Data Looks Better

Prestidigitation, also known as sleight of hand or legerdemain, is a form of stage magic which uses dextrous manipulation and misdirection to distract the viewer from seeing it. The example, reported by Bloomberg on 26 February, 2014, is discussed late because the nature of the trick meant it took me a while before I understood how it was done.BackgroundPradaxa, a new anticoagulant, was approved by the US Food and Drug Administration (FDA) in 2010 for use by patients with atrial fibrillation to prevent strokes.  We discussed previously the release of documents during litigation that showed how marketers from its manufacturer, Boehringer - Ingelheim, attempted to manipulate the results of a clinical study of the drug.  The study results initially seemed to suggest that blood tests should be used to monitor therapy with it.  However, that would have contradicted a key marketing message, that Pradaxa was more convenient than warfarin because it did not require blood tests for monitoring.Litigation by patients alleging that Boehringer-Ingelheim concealed the severity of the bleeding risks caused by the drugcontinues.  The Bloomberg report dealt with how the company responded to requests by the FDA for data about these risks.     The Question from the FDAAs per Bloomberg,In the Pradaxa case, the regulators asked Boehringer to compare fatal bleeding reports received by the FDA against the number of patients using the drug in order to establish a death ...
Source: Health Care Renewal - Category: Health Medicine and Bioethics Commentators Tags: Boehringer Ingelheim deception FDA manipulating clinical research Pradaxa Source Type: blogs