The Roche affair

In an open letter published on the British Medical Journal (BMJ) on November 22nd, Donald MacLean, Roche Life Cycle Leader, says that Roche is going to set up a multi-party advisory board in order to review the totality of data regarding its antiviral Tamiflu. This letter is only the last act of an extended debate that opposed the Swiss global health-care company and the Cochrane Acute Respiratory Infections Group, concerning the evidence base for Tamiflu efficacy.

The story begun in 2009, when the Cochrane group released an updated systematic review on neuraminidase inhibitors – a class of antiviral drugs targeted at the influenza virus, which includes Tamiflu – where it has been revealed that 8 out of 10 randomized controlled trials (RCTs) on which effectiveness claims were based, were never published, while the other 2 were funded and authored by Roche.

The Cochrane group, supported by the BMJ, then requested all available data from the Swiss pharmaceutical company. In September 2009 Roche provided some data, which however turned out to be incomplete. Then, in December of the same year, Roche promised to make the missing data available to researchers but this never happened, as pointed out by BMJ editor in chief Fiona Godlee, in a mail dated October 2012 where she also highlighted that almost 60% of phase III completed trials on Tamiflu were still unpublished.

MacLean’s letter was addressed to Prof. Chris Del Mar, Coordinating Editor of the Cochrane Acute Respiratory Infections Group who is going to discuss about Roche’s proposal in a meeting to be held in the next weeks.

The whole email correspondence between Roche, Cochrane group and BMJ has been published on the BMJ website.