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A Doctor Can Finally Tell Fresenius Kabi AG: "I Told You So"


2/20/2013 8:17:03 AM

Last year, we wrote that Fresenius Kabi got into a tussle with a Danish professor after he and several colleagues published a paper in The New England Journal of Medicine that concluded its hydroxyethyl starch treatment for sepsis may cause kidney failure and hemorrhages that may lead to patient death. The drugmaker reportedly threatened a lawsuit after the professor told ScienceNordic the treatment should not be used for sepsis. The spat between the drugmaker and the professor may not have normally generated much notice had the spector of litigation not been raised. Although Fresenius later denied threatening litigation, the possibility that the drugmaker may have been willing to file a lawsuit raised concerns over academic freedom and drew greater attention to the findings and the treatment. The dispute was resolved when the initial study was subsequenlty corrected to indicate the treatment in question was actually made by a rival company. In the fall, however, Anders Perner, a professor at the Intensive Therapy Clinic at the Copenhagen University Hospital, was partly vindicated after the European Medicines Agency decided to review solutions containing hydroxyethyl starch for infusion due to safety concerns. Now, though, Perner may finally have the last laugh. That’s because a new study finds hydroxyethyl starch was associated with a significant increased risk of mortality and acute kidney injury, and that clinical use is not warranted due to serious safety concerns.

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