Followers of Ring of Fire radio probably noticed a disturbing report recently about Boehringer-Ingelheim's (BI) efforts to expand the use of its anticoagulant drug, Pradaxa (dabigatran) in Europe – despite the fact that the medication has been implicated in the deaths of more than five hundred patients. The argument from Klaus Dugi, BI's corporate senior vice president, is that the company's own studies “have demonstrated that Pradaxa® offers an effective treatment with significant safety benefits compared to warfarin both for acute treatment as well as in the long-term prevention of recurrent events.”
To which studies is Professor Dugi referring? According to a report on Zenopa.com, it's none other than the RE-LY study, published in the New England Journal of Medicine (NEJM) almost four years ago. Not long afterward, a letter from the University of British Columbia revealed that comparisons between warfarin and dabigatran were “not blinded,” adding that “outcomes are subject to performance and ascertainment bias favoring dabigatran.”
A correction published in the NEJM the following year acknowledged “possible underreporting of events,” but continued to insist that this had no impact on the results. However, it was later revealed that the lead researcher in the RE-LY study had significant financial ties to BI, having had served as a consultant.
Since all of this has come out, BI has continued to cite the RE-LY study in support of its highly profitable medication. There have been meta-analyses and most recently, a “sub-analysis,” published in the European Journal of Heart Failure, demonstrating that “Pradaxa can offer advantages over warfarin among difficult-to-treat patients” with certain types of heart conditions.
Be that as it may, this does not change the fact that there is still no antidote for hemorrhaging brought on by a dose of Pradaxa, and nothing erases allegations that BI’s corporate officers and researchers were aware of its dangerous side effects and chose to keep that knowledge a secret.
N/A. “Boehringer Ingelheim's Pradaxa Shows Benefits in Hard-to-Treat Patients.” Zenopa.com, 18 July 2013.
N/A.”Boehringer Submits Application to EMA For Use of Pradaxa For Treatment of Acute DVT, PE.”
News-Medical.net, 24 June 2013.
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