Frensenius Threatens to Sue MD Over Clinical Study

Frensenius Threatens to Sue MD Over Clinical Study

August 13th, 2012 // 1:52 pm @ jmpickett

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Fresenius Kabi is threatening legal action against a Danish professor after he and several colleagues recently 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, ScienceNordic reports .

At the time the study was published in June, Anders Perner, a professor at the Intensive Therapy Clinic at the Copenhagen University Hospital, told ScienceNordic that “our results show that hydroxyethyl starch increases mortality rates by up to 17 percent in patients with severe sepsis, compared to treatment with a regular saline solution. This is a significantly increased risk, and the country’s intensive care units have stopped using this drug to treat sepsis.”

“The study is an eye opener and it shows that starch should not be used in the treatment of sepsis,” he added. says the professor. “Most Danish intensive care units have already changed their practice because they have participated in the study, and the staff has seen with their own eyes which consequences the treatment can have. The impact of the findings is enormous.”

But the drugmaker claims the study by Anders Perner – who was listed as lead author along with 30 other researchers- contains “incorrect and misleading information” and demands that Perner retract the article, corrects various details and publish a revised manuscript that declares the original article contained incorrect information, the web site writes. The New England Journal of Medicine did publish a few minor corrections, but nothing to suggest the article is incorrect (see this).

If these steps are not taken, Fresenius Kabi has threatented to take “all appropriate legal steps to rectify the financial losses it has suffered and will continue to suffer as a result of false information,” its US attorneys wrote in a letter to Perner, according to Videnskab, a Danish newspaper that first reported the dispute.

In response, Danish National Hospital medical director Jannik Hilsted called the move by the drugmaker an attempt to suppress academic freedom and labeled the threats as “bullying methods,” according to ScienceNordic. The hospital will provide Perner with legal assistance in the case, which it regards as a matter of principle for academic freedom. Meanwhile, the Danish Medical Association has also denounced Fresenius for threatening litigation.