Feature

Data too important to share: do those who control the data control the message?

BMJ 2016; 352 doi: http://dx.doi.org/10.1136/bmj.i1027 (Published 02 March 2016) Cite this as: BMJ 2016;352:i1027
  1. Peter Doshi, associate editor, The BMJ
  1. pdoshi{at}bmj.com

Hydroxyethyl starch solutions for fluid resuscitation fell from grace in 2013 after European and American regulators issued severe warnings about their safety. But the academic investigators that led a landmark trial that helped precipitate this downfall are refusing to share their data. Is this acceptable? Peter Doshi reports

Yale cardiologist Harlan Krumholz has scored some notable successes in his advocacy of liberalising access to clinical trial data. Last year he embarked on a collaboration with one of the world’s largest drug companies—Johnson and Johnson—to open its vaults and begin sharing data with independent researchers.1 This feat followed a highly publicised reanalysis of a Medtronic spinal treatment that had come under fire for being unsafe.2 3

But Krumholz, always excited about the idea of applying his Yale open data access (YODA) model to new situations, admits defeat in his latest attempt at uncovering raw trial data.

It’s an important case because it flips the usual narrative of industry refusing to share data with academics. It involves a large randomised controlled trial comparing saline and hydroxyethyl starch (HES) to replace lost blood volume in critically ill patients (the CHEST trial) and a group of academics that refuse to share their data with an industry sponsor.

At the centre is John Myburgh, a well known figure in intensive care medicine and the principal investigator of the CHEST trial, which included 7000 patients.4 In 2012, Myburgh and colleagues from the George Institute for Global Health in Australia published their findings in the New England Journal of Medicine,5 raising safety concerns that helped seal the fate of starch solutions across much of the world.

In 2013 the US Food and Drug Administration added boxed warnings to HES products noting an increased risk of death and need for renal replacement therapy. …

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