Roche and the Tamiflu data

Under pressure from campaigners, it looks as if Roche’s position on clinical trial data might now be softening.

The Swiss pharma company has agreed to talk to external groups about full access to data for antiviral Tamiflu (oseltamivir) tablets, according to a letter published by the British Medical Journal (BMJ). Specifically, it will ‘set up a multi-party advisory board…to review the totality of Tamiflu data with the objective to agree on a statistical analysis plan outlining the types of analyses that would be useful in a public health discussion on Tamiflu’.

Governments around the world stockpiled the drug during the 2009 swine flu pandemic at a cost of billions of pounds. In the aftermath, the Cochrane Collaboration, a non-profit organisation that performs large-scale reviews of medical data, called out the Swiss drug maker for not making available all the data on efficacy and safety. The Cochrane respiratory group, led by Tom Jefferson, complained that it could not get the data it needed about oseltamivir for an update of its review of neuraminidase inhibitors commissioned by the UK government.

Roche resisted, claiming variously that patient or commercial confidentiality would be impacted or that sufficient data was already in the public domain. But the pressure refused to go away. In an October editorial, the BMJ – which has fronted the open data campaign against Roche along with the Cochrane Collaboration – said that from January 2013 it would publish clinical trial results (whether industry funded or not) ‘only where there is a commitment to make the relevant anonymised patient level data available on reasonable request’.

Data mines

Other drug makers appear to be embracing the open data campaign, albeit tentatively. GSK announced on 11 October a series of initiatives to make clinical trial data publically available, a move cautiously welcomed by many campaigners. Meanwhile, the data hassles for Roche extend beyond oseltamivir. In June, the European Medicines Agency opened a legal investigation into how side effects of drugs have been reported by Roche. The EMA said that 80,000 reports for medicines marketed by Roche in the US had been collected but not evaluated to determine whether or not they should be sent to the EU authorities as ‘suspected adverse reactions’.