Intended for healthcare professionals

Requesting Relenza data

In 1989 scientists at Glaxo Wellcome formulated the first of a new class of drugs, neuraminidase inhibitors, for the treatment of influenza A and B infections. Zanamavir, marketed as Relenza, was approved for use in the US in 1999.

Alongside Tamiflu, Relenza was included in the Cochrane review on neuraminidase inhibitors. Like Tamiflu, it became apparent to Cochrane researchers Tom Jefferson and Peter Doshi that they had not been able to access the full dataset available on the drugs.

As Relenza has to be administered by inhalation, Tamiflu formed the majority of antiviral stockpiling. But Relenza was stockpiled by governments worldwide and the Cochrane reviewers also campaigned to gain access to the underlying trial data. The correspondence chain below documents the team’s efforts to gain access to the data from the drug’s manufacturer, GlaxoSmithKline. Each entry contains the correspondence in a three month period.

After a period of wrangling, the reviewers and GSK reached agreement and were drawing up contracts to facilitate the data sharing, when GSK suddenly announced a new policy to make clinical-trial data from many more of it’s pharmaceuticals available to independent scrutiny. In an interview, Andrew Witty, then CEO of GSK, told The BMJ how he saw the open data movement as an opportunity rather than a threat.

On 14 February 2013, GSK shipped a DVD containing redacted versions of its clinical study reports to Carl Heneghan, Director of the Centre of Evidence Based Medicine at the University of Oxford. Like Tamiflu, the Cochrane reviewers made all Relenza reports publicly available when they published their 2014 update.

Attention to Relenza, the less known of the two then registered antivirals, generated interest in the circumstances of its licensing in the EU (Mulinari and Davis).