Will Doctor Tell Fresenius 'I Told You So?'

File this under 'doth protest too loudly.' Last summer, Fresenius Kabi got into a spat 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 Anders Perner, a professor at the Intensive Therapy Clinic at the Copenhagen University Hospital, also told ScienceNordic starch should not be used to treat sepsis ( back story).

Fresenius later denied threatening litigation, a prospect that raised concern over academic freedom, and noted the paper was subsequenlty corrected to indicate the treatment in the study was actually made by a rival company. At the time, Perner declined to discuss the episode, other than to say the "imprecision" in the article was corrected (here is the abstract and the correction).

Now, though, the researcher may have the last laugh. The European Medicines Agency has decided to review hydroxyethyl-starch-containing solutions for infusion due to "safety concerns that have been raised following the publication of recent studies comparing HES with other volume expanders in critically ill patients with severe sepsis," according to an EMA statement (read more here).

Two studies cited by the EMA indicated that patients treated with HES required treatment for kidney failure and one found a higher rate of death. And so, the EMA "will evaluate the benefit-risk balance of HES containing solutions and issue an opinion on whether their marketing authorisations should be maintained, varied, suspended or withdrawn across the EU." One study was the paper published in the New England Journal of Medicine.

The EMA published a list of products that are going to be reviewed (here it is), and a Fresenius spokesman acknowledged in a note to us last summer that the Voluven treatment is derived from waxy maize starch (here is the monograph). We asked Fresenius for comment and will update you accordingly. Meanwhile, Perner wrote us to say that the EMA review "sounds appropriate."