EMA recommendation on hydroxyethyl starch solutions obscured controversy
BMJ 2018; 360 doi: https://doi.org/10.1136/bmj.k1287 (Published 20 March 2018) Cite this as: BMJ 2018;360:k1287Feature
Data too important to share: do those who control the data control the message?
Opinion
Even normal saline is harmful if used wrongly, so why did EMA single out hydroxyethyl starch?
- Peter Doshi, associate editor, The BMJ
- pdoshi{at}bmj.com
For decades, intensive care doctors have used hydroxyethyl starch (HES) solutions to treat hypovolaemia and acute blood loss. But within days, the European Commission will register a deciding vote on the fate of HES, possibly suspending their licence across the EU.
The vote is the culmination of five years of controversy sparked by the publication of two randomised trials which reported that HES solutions carry serious risks.12 Based on these trial publications, in 2013, regulators began issuing warnings. The US added boxed warnings to drug labelling about increased risk of death and need for renal replacement therapy,3 and the EMA contraindicated HES solutions in critically ill patients or patients with sepsis or burns but allowed their continued use to treat acute blood loss when treatment with crystalloids alone is insufficient.4
Now the future of HES solutions is once again in the balance after the Swedish regulator called on the EMA to review the matter, citing drug use studies suggesting that the medicines continue to be used in prohibited populations.5 After an 11 week process, in January the EMA recommended HES solutions be withdrawn from market.6
But experts from whom the EMA sought independent advice are crying foul.
Obscuring a controversy
Before the EMA’s public recommendation, the medicines agency asked Thomas Scheeren, professor of anaesthesiology at the University of Groningen in the Netherlands, to chair an expert group to provide independent advice on whether a role remained for HES products.
But …