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Kerfuffle Over Antishock Drug Paper

A slight flaw in a study on the effectiveness of a drug widely used to combat shock in critically injured patients almost gets a Danish researcher sued for millions.

By | August 3, 2012

image: Kerfuffle Over Antishock Drug Paper Flickr, Crytstl

Copenhagen University Hospital researcher Anders Perner was one decimal point away from getting sued for millions of dollars. In June, his paper comparing two treatments used in patients who had lost large amounts of blood, was published in the New England Journal of Medicine. Perner and colleagues found that hydroxyethyl starch (HES), a widely used synthetic version of regular starch, carried more risks and was less effective than Ringer's acetate, a mildy hypotonic solution used to replace lost blood. But Perner and his team rounded to the nearest tenth when identifying the type of HES used in their study: they stated in the title and methods section that they used HES 130/0.4, when in fact it was HES 130/0.42. The first number (130) describes the molecular weight of the compound, and the second gives the number of hydroxyethyl groups in the starch. That would seem like a small and inconsequential mistake, unless you're German pharmaceutical company Fresenius Kabi, which manufactures HES 130/0.4, also called Voluven. HES 130/0.42 is called Tetraspan and is made by German company B. Braun.

Executives at Fresenius Kabi fired off an email to Perner last month, telling him that if he didn't correct his mistake, they'd take the case to court and recoup any losses resulting from Perner's misidentification. Because Voluven is a drug that is used all over the world, the damage may have come to millions of dollars.

But Perner and the journal corrected the online versions of the article, adding the 0.42 to the HES description both in the title and in the methods section. And Fresenius Kabi backed off. "It was our aim to have the scientific misinformation in the title and the text of the article in NEJM corrected," a spokesperson from the company told ScienceInsider. "This has happened so we see no need for legal action."

Perner claims that his mistake was inconsequential from a scientific standpoint, telling ScienceInsider that the results likely would have been the same no matter which company's HES product he would have used. "The paper is more precise now," he said, "but from a scientific point of view, I think, it makes no difference."

The row highlights doubts that some researchers have been voicing for years about HES treatment. Side effects, such as severe bleeding and needing renal-replacement therapy, have been noted previously, as they were in Perner's study. An Australian clinical trial analyzing the effects of Fresenius Kabi's HES product in patients is expected this month.

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