In the wake of intensive pressure concerning its stance on transparency, Roche has offered to discuss the possibility of finally publishing the complete raw dataset on its antiviral Tamiflu.
As the European Medicines Agency held a workshop in London on access to clinical-trial data and transparency, the Swiss major revealed plans to set up “a multi-party advisory board comprising experts from academia and private institutions” to review the totality of Tamiflu (oseltamivir) data. It has invited the Cochrane Collaboration, which has repeatedly claimed that Roche has refused to provide full access to all its data which leaves questions about how well the drug works unresolved.
Tamiflu sales soared in 2009 to almost $3 billion, due to a huge rise in prescriptions being written during the H1N1 pandemic, although they have declined dramatically since.
Cochrane and the British Medical Journal have upped the pressure on Roche in the past month, to the extent of calling for a boycott of the firm’s products and suggesting that countries should sue Roche. The debate has raged for over three-and-a-half years but it seems the Basel-headquartered company may be prepared to budge.
Roche says it hopes that the board would be set up “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”. Its pharmaceuticals head, Daniel O’Day, told Reuters that “we think that would be an appropriate, fair and transparent way of handling this debate,” but added that complete transparency had to be balanced against the need to protect patient privacy, respect commercial sensitivity and ensure the scientific merit of any statistical analysis.
Ben Goldacre, author of Bad Pharma, the publication of which has caused a stir among the sector for its criticisms of companies and regulators alike over their lack of transparency, said on Twitter that Roche had acted “in desperation”. Dr Goldacre, who participated at the EMA workshop, added “not enough. Release the files”.
Meantime, the UK Government has announced that it will investigate pharma’s withholding of clinical trial data within the next 12 months (see first ‘related link’ on this page for more on this story).
