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Between 2008 and 2012, two seminal studies were published showing increased mortality in patients with sepsis who received HES, as compared to crystalloids containing solutions, for intravascular volume expansion (1, 2). Also, septic patients receiving HES have shown increased need for renal replacement therapy (1-3). These results promptly triggered action by the Coordination Group for Mutual Recognition and Decentralised Procedures-Human (CMDh), a medicines regulatory body representing the European Union (EU) Member States, which on 23 October 2013 endorsed the recommendation of the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) that HES solutions must no longer be used to treat patients with sepsis or burn injuries or critically ill patients. Of note, it has been considered that HES solutions may continue to be used in patients to treat hypovolemia caused by acute hemorrhage, when crystalloid solutions are not considered sufficient. In the same document, the PRAC recommended that “in these patients, HES solutions should not be used for more than 24 hours and patients’ kidney function should be monitored after HES administration” (4). Also, the PRAC explicitly stressed that “further studies should be carried out on the use of these medicines in elective surgery and trauma patients”. Based on this recommendation, the pharmaceutical industry decided to conduct two independent, but interlinked trials on the use of HES, namely the so-called PHOENICS (Prospective, randomized, controlled, double-blind, multi-center, multinational study on the safety and efficacy of a 6% Hydroxyethyl starch sOlution versus an Electrolyte solutioN In patients undergoing eleCtive abdominal Surgery) and TETHYS (PragmaTic, prospEctive, randomized, controlled, double-blind, mulTi-centre, multinational study on the safety and efficacy of 6% Hydroxyethyl starch Solution versus an electrolyte solution in trauma patients). Given the importance of these studies to patients and the Anesthesiology community, the European Society of Anaesthesiology (ESA) took the decision to build an Academic Contract Research Organization (ACRO) and coordinate the conduction of the trials. Effectively, PHOENICS and TETHYS were launched early/mid 2017. The European Medicines Agency (EMA) has advised taking HES off the market. There are numerous questions arising from this decision: First, and most importantly, do you agree? Then: Since 2013, we have already several limitations of HES (in duration, dose and indications), which have been –albeit still questionablegenerally accepted. Currently, HES is indicated for surgical and trauma patients with hypovolaemia caused by acute blood loss when crystalloids alone are not considered sufficient. If the “ban” is accepted, (how) can we replace HES in these patients? Gelatins (Less effective) , or albumin (money!!!), or can we assume/hope that there is no case where crystalloids are not sufficient? Indeed, don’t we need any colloid anymore? The arguments of EMA are another topic to discuss: a) doctors ignore contraindications, b) it is too difficult to distinguish between patients who might profit or be harmed from HES; c) further measures would be ineffective. Do you agree these arguments? The authority banning from utilizing a drug because of ignoring contraindications, is this not a limiting behavior one considers fit for immature? Furthermore: If you start with “doctors ignore contraindications”, can it be possible we can ban any existing drug? (Or where is the breaking point?) HES’s scientific history is shameful. Can it be possible, that maybe-just maybethis fact has affected the recommendation of EMA? (A turkish quote says (liberally translated): “Do not forsake the church, even if you are angry with the priest”). As a matter of fact, we need to be more suspicious about the studies comparing different types of fluids, no matter if the results are “pro” or “con” the use of HES. How do you comment different studies?

The European Medicines Agency and the Authorization for Hydroxyethyl starch Containing Solutions–Killing the Cow to Get Rid of Ticks?