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 questionable-generally 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 maybe-this 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?

Pelosi, Paolo;
2018-01-01

Abstract

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 questionable-generally 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 maybe-this 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?
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11567/945244
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