Requesting Relenza data

Pan flu

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 systematic review and meta-analysis  Neuraminidase inhibitors for preventing and treating influenza in healthy adults. 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, during the swine flu pandemic it wasn’t stockpiled as a frontline drug. This concentrated the Cochrane reviewers’ attention on Tamiflu. Their campaign to gain access to the data can be seen in a series of email correspendence between the principla stakeholders at bmj.com/Tamiflu.

In that time though, the team still sought access to the clinical trial data for Relenza as shown in the correspondence chain below. 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.

Andrew Witty, GSK’s CEO, recently joined us to explain what had inspired this new direction for the company, and why 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 Henneghan, Director of the Centre of Evidence Based Medicine at the University of Oxford.

The latest email from Tom Jefferson to Helen Steel requests clarification of the redacted data, particularly why specific items were chosen for redaction