Observations Open Data

What does oseltamivir do, and how will we know?

BMJ 2013; 347 doi: https://doi.org/10.1136/bmj.f4687 (Published 24 July 2013) Cite this as: BMJ 2013;347:f4687
  1. Trish Groves, deputy editor, BMJ
  1. tgroves{at}bmj.com

Two different groups are now working on meta-analyses of the unpublished patient level data on the effects of oseltamivir in flu. Will they come to the same conclusions?

Jonathan Nguyen-Van-Tam, a virologist and researcher from the University of Nottingham, told a group of triallists and virologists last month, “We must remember why we’re here: because of the controversies. The clinical world doesn’t believe that Tamiflu [oseltamivir] works. We should assess whether the regulatory approval/product insert for Tamiflu is valid.”

That group, the Multiparty Group for Advice on Science (MUGAS), was at a workshop in Brussels on 18 June organised by the European Scientific Working Group on Influenza and supported by an unrestricted grant from Roche, manufacturer of oseltamivir. Led by several of the original oseltamivir regulatory triallists, the workshop heard plenty of evidence to challenge current claims about the drug’s effects. MUGAS decided to plan and conduct individual participant data (IPD) meta-analyses of the randomised trial data—and observational data. That’s quite a remarkable turnaround, given the strength of claims made by some of the same people over the past decade.

BMJ readers will already be familiar with growing concerns about oseltamivir’s effectiveness. Earlier this year Harlan Krumholz and coauthors concluded in an editorial in the BMJ that, “despite government claims, we should acknowledge the uncertainty surrounding oseltamivir’s effectiveness and the gaps in publicly available evidence.”1 They continued, “On the basis of the available data, at best the drug shortens symptoms by about a day when used within the first two days of symptoms, but it has no effect on hospital admissions. In addition, trial data from which to draw conclusions about complications and transmission of flu are lacking.” …

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