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 (
back story).
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 (read here). Now, though, Perner may finally have the last laugh. That's because a new study finds hydroxyethyl starch was associated with a significantly increased risk of mortality and acute kidney injury, and that clinical use is not warranted due to serious safety concerns.
The conclusion, which was published in the Journal of the American Medical Association, came after a review of 38 clinical trials that included 10,880 patients in studies contributing mortality data (here is the abstract). This is not good news for Fresenius, of course, and we have asked the drugmaker for a reaction. If one is received, we will update you accordingly.
As for Perner, he writes us this: "This is the well-established track record of evidence based medicine. The results are clear and should inform clinicians, guideline committee members and medicines agencies around the world."
As an aside, the JAMA study pointed out that the findings were all the more notable after excluding seven clinical trials performed by an investigator, Joachim Boldt, a prominent German anesthesiologist, whose research has been retracted because of scientific misconduct. As reported last year, Boldt failed to otain Institutional Review Board approval to conduct research for 92 articles (read more here).
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