Feature Open Data

Tug of war for antiviral drugs data

BMJ 2014; 348 doi: http://dx.doi.org/10.1136/bmj.g2227 (Published 09 April 2014) Cite this as: BMJ 2014;348:g2227
  1. Julia Belluz, Knight science journalism fellow
  1. 1Massachusetts Institute of Technology, Cambridge, MA, USA
  1. jbelluz@gmail.com

Julia Belluz hears from both sides in the lengthy battle between the drug giants and researchers that led to the release of full clinical trial data on neuraminidase inhibitors. Does the release of these files herald a more transparent era?

Tom Jefferson can recite the details of every published study on the neuraminidase inhibitors oseltamivir (Tamiflu) and zanamivir (Relenza): date of publication, authors’ names, journal title, research question, methods, funder, and findings. But what has occupied the mind of the physician-academic from Cochrane’s Acute Respiratory Infections Group for the better part of five years is another detail about the science behind the influenza antivirals: that much of it has been missing or unpublished.

Before he knew better, in 2006, Jefferson waded into the evidence and released a Cochrane systematic review about the neuraminidase inhibitors based on published research findings. He and his coauthors found that the drugs decreased the risk of influenza complications and hospital admissions in adults.

By 2009, however, Jefferson’s opinion had started to shift. Europe was in the clutches of the influenza A/H1N1 panic, and he and his peers were asked to update their analysis of the flu drugs. Just as he was stepping into the research again, a letter arrived from a Japanese paediatrician, Keiji Hayashi. He was concerned that he could not verify the data that supported some of Jefferson’s conclusions about oseltamivir. In particular, he pointed out that the claims that the drug reduced secondary complications and hospital admissions were based on a 2003 analysis coauthored by Roche employees. Hayashi also noted that eight out of the 10 trials included in that analysis were never published in peer reviewed journals. In other words, Cochrane’s previous studies on the influenza treatments were based on an incomplete and possibly biased picture of the evidence.

The Cochrane …

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