These words, the first bit of advice given to space travelers in the late Douglas Adams' Hitchhiker's Guide to the Galaxy, were also issued to the medical community recently regarding the anti-coagulant medication Pradaxa (dabigatran).
In light of the number of serious and even fatal hemorrhaging allegedly caused by this medication, should patients panic?
Not according to three physicians, who recently published a piece in the New England Journal of Medicine (NEJM). The piece, published under the journal's “Perspectives” page, suggests in that light of the fact that Pradaxa is a relatively new medication and has been hailed by many in the medical community as somewhat of a miracle drug, reports of adverse events may have been perceived as worse than they actually were.
The authors of the piece, all of whom work for the U.S. Food and Drug Administration, state that “...the novelty of dabigatran (relative to the well-established warfarin) and the coverage of novel drugs in the media, which can greatly influence how and when adverse events are reported, were not generally considered” when it came to general media coverage of the drug.
According to their disclosures, these three physicians have no ties, financial or otherwise, to the drug's manufacturer, German pharmaceutical company Boehringer-Ingelheim (BI). However, they do cite the RE-LY trial. This trial, the authors point out, demonstrated that the risks of an adverse event (in this case, the hemorrhaging) were no greater with dabigatran than with warfarin.
This may in fact be technically true, however, the authors either were unaware, or did not bother to mention that there were questionable aspects of the RE-LY trial. A letter from researchers at the University of British Columbia Health Sciences reported that the study was not “sufficiently blinded,” (in other words, the researchers in the study had some knowledge of which subjects were receiving dabigitran as opposed to those being treated with warfarin). Furthermore, it was revealed over two years after the RE-LY study that the lead researcher had “significant financial ties” to Boehringer-Ingelheim.
Questions about the RE-LY notwithstanding, the recent article in the NEJM will not affect litigation over Pradaxa, nor relieve BI of its potential liability. The reason is that these injury cases do not depend soley on whether dabigatran is any more or less dangerous than warfarin. Pradaxa may be alleged to be better than warfarin in some ways, including a claimed low number of potential interactions with other drugs often prescribed to geriatric patients. The primary problem – for BI – lies in allegations that the company knew there was no antidote for hemorrhaging like there is for warfarin, and failed to warn physicians and patients of this fact.
Myerburg, Robert J, MD and Stuart J. Connolly MD. “Balancing Safety and Efficacy in Appropriately Selected AF Patients” (Faculty and Disclosures). Medscape LLC, 16 February 2012. Available athttp://www.medscape.org/viewarticle/758487_slide.
N/A. “Dabigatran for Atrial Fibrillation: Why We Can Not Rely on RE-LY.” Therapeutics Initiative, University of British Columbia Department of Anesthesiology, Pharmacology and Therapeutics (January - March 2011). Available at http://www.ti.ubc.ca/letter80.
Southworth, Mary Ross, et. al. “Perspectives: Dabigatran and Postmarketing Reports of Bleeding.” New England Journal of Medicine, 13 March 2013.
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