Observations Open Data Campaign

Withdraw approval for Tamiflu until NICE has full data

BMJ 2012; 345 doi: http://dx.doi.org/10.1136/bmj.e8415 (Published 12 December 2012) Cite this as: BMJ 2012;345:e8415
  1. Fiona Godlee, editor, BMJ
  1. fgodlee@bmj.com

In an open letter sent this week to Professor Sir Michael Rawlins, chairman of the National Institute for Health and Clinical Excellence, BMJ editor Fiona Godlee calls on him to withdraw approval for oseltamivir until NICE has received and reviewed the full clinical trial data and those anonymised data are made available for independent scrutiny. The letter is the latest addition to the BMJ’s open data campaign, which aims to achieve appropriate and necessary independent scrutiny of data from clinical trials. Here we publish Fiona Godlee’s letter and Mike Rawlins’s response (BMJ 2012;345:e8420)

Dear Mike

I wanted to congratulate you on all you have achieved with the National Institute for Health and Clinical Excellence (NICE) in the past 10 years, now that your time as its chairman is coming to an end. However, I also wanted to ask you about something that I have found increasingly puzzling. Why does NICE not require access to all the clinical trial data on a drug when it is making a decision to approve the drug for purchase by the NHS? And given the European Ombudsman’s ruling against such data being commercial in confidence, why does NICE not make public the full information on which its decisions are based?

I ask this because, as you will know, the BMJ has been trying to help the Cochrane Collaboration gain full access to the data on oseltamivir (Tamiflu) in order to complete the systematic review commissioned by the National Institute for Health Research (NIHR) in 2009.1 2 3 Roche gave a public commitment …

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