After getting the 6S trial published in the NEJM, Anders Perner – the lead investigator of this multi center trial – has gotten angry letters from Fresenius Kabi, the producer of Voluven 130/0.4 HES. Fresenius Kabi had sponsored the Scandinavian Starch for Severe Sepsis/Septic Shock trial, and didn’t like the results.
Voluven and its siblings have often been used in resuscitation settings, also for septic patients. The 6S trial showed these HES solution to have a negative effect on outcome for septic patients in ICUs across Scandinavia. Increased mortality, increased need for renal replacement therapy and no real difference in fluid volumes received.
It’s the first time I’ve heard of farmaceutical companies threatening to sue for economical loss over a scientific trial. And a dangerous turn of events for science, if we’re about to be held liable for the economic effects of our research. Wonder if we will also get a cut of the profit if we publish favourable data? Anyway, I don’t believe something like this will ever hold up in court – but the scare tactics are worrying and annoying.
Fresenius Kabi seems to believe the 6S trial is based on false presumptions and reach wrong conclusions – in strong contrast to the investigators and the NEJM peer review team. The article is out there for all to read, so go through it an see what you think. Is Fresenius Kabi losing money over bad science, or is simple saline just the better resuscitation choice in severe sepsis?