“Independent” reanalysis of landmark starch solutions trial was published by original authorsBMJ 2017; 358 doi: https://doi.org/10.1136/bmj.j3552 (Published 21 July 2017) Cite this as: BMJ 2017;358:j3552
- Peter Doshi, associate editor
- The BMJ
Academics who refused calls to share the data underlying their landmark trial that triggered the downfall of starches for fluid resuscitation have announced an “independent reanalysis,” which confirms their original findings.1
However, they have not made their data available to the wider scientific community—a key element of transparent research practice and what other academics have been calling for.23
The 7000 patient trial, CHEST (Crystalloid versus Hydroxyethyl Starch Trial),4 is one of the most important pieces of evidence concerning the effects of hydroxyethyl starch solutions for increasing intravascular volume in patients in intensive care.
Published in the New England Journal of Medicine in 2012, CHEST reported that the hydroxyethyl starch investigated, Voluven, was no different than saline in terms of mortality but led to greater use of renal replacement therapy. The trial helped persuade drug regulators in Europe and the US to issue safety warnings in 2013.
In February the US health watchdog Public Citizen sent a petition to the Food and Drug Administration calling for hydroxyethyl starch intravenous solutions to be removed from the market,5 a move supported by CHEST’s lead author, John Myburgh.6
But the global healthcare company Fresenius Kabi, which makes Voluven and was a major funder (€3.5m (£3.15m; $4m)) of the trial, has long contended that the study was improperly reported.2 Before the trial the company took the unusual step of signing away all rights to the data, a decision it later came to regret. In 2014 it sought the assistance of The BMJ to intervene with the CHEST investigators. It then asked the Yale Open Data Access Project (YODA) to serve as an independent intermediary between the CHEST investigators and a reanalysis team to be determined, but the academic investigators rejected YODA’s offer.2
The latest “independent analysis” is …