Roche to release Tamiflu data
pharmafile | November 23, 2012 | News story | Sales and Marketing | BMJ, Cochrane, Goldacre, NHS, Roche, Tamiflu
Roche has said it will let researchers have access to more data on its influenza vaccine Tamiflu, apparently under pressure from campaigners who have criticised the Swiss pharma company.
The Basel-based firm has been the subject of calls from the British Medical Journal and the Cochrane Collaboration to release more data on the drug. The organisations have been conducting a public ding-dong for more than a year over access to complete trial findings.
Earlier this month European pharma body EFPIA said it was against what it called the ‘indiscriminate’ release of data. But the European Medicines Agency has now said it will ‘proactively’ publish trial data on a range of medicines and enable access to full data sets by those who request it.
Speaking to the Financial Times, Roche said: “[We plan] to set up a multi-party advisory board comprising experts from academia and private institutions, including the Cochrane Collaboration, to review the totality of Tamiflu data.”
The objective of these discussions would be “to agree on a statistical analysis plan outlining the types of analyses that would be useful in a public health discussion on Tamiflu”.
While the EMA says a number of practical and policy issues need to be addressed – including questions of patient and commercial confidentiality – the wind appears to be changing.
In Westminster the health select committee is also to look at the issue of pharma companies witholding data as ‘a matter of priority’ in the next year. Committee chairman Stephen Dorrell made the pledge at the NHS Alliance’s conference in Bournemouth yesterday, the BMJ reports.
Roche’s management of Tamiflu data is one of several case studies which come in for sharp criticism in Ben Goldacre’s latest book Bad Pharma. The doctor and writer accuses a number of pharma firms of cherry-picking results to inflate a drug’s apparent effectiveness while downplaying side effects.
He calls for all data to be released for all trials, with appropriate patient safeguards, to allow in-depth analysis.
More clarity is particularly important in the case of Tamiflu, Roche’s critics argue, because it is on the World Health Organisation’s list of essential medicines, is the mainstay of influenza treatment in several countries, and governments have spent billions stockpiling it.
Those who oppose greater transparency worry that data may be open to misinterpretation – perhaps misleading patients – and that the financial costs involved in making all results public would be high.
Adam Hill
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