Roche suggested that the “debate” over its non-disclosure of trial data on the antiviral be resolved through joint discussion of what kind of analysis public health studies require.
The Cochrane Collaboration, Europe’s leading drug appraisal authority, rejected the implied criticism of its methods and insisted that Roche honour its 2009 promise to publish the data.
Tamiflu (oseltamivir) neared £3 billion sales worldwide in 2009, allegedly due to Roche telling governments that it was about to publish trial data proving its effectiveness in combating ‘swine flu’.
Roche has still not released most of the data, citing lack of confidentiality as the reason. The available data are described by the Cochrane group as not supporting the drug’s widespread use.
Weeks ago, the BMJ published an ‘open letter’ to Roche insisting that it should publish the trial data or be disgraced in the medical world.
Editor-in-chief Fiona Godlee said that “billions of pounds of public money” had been spent on Tamiflu, but the evidence of its value “remains hidden from appropriate and necessary independent scrutiny”.
Peter Gøtzsche, head of the Nordic Cochrane Centre in Copenhagen, argued that doctors should boycott Roche’s products until it published the missing data.
Don MacLean, Roche’s lifecycle leader for Tamiflu, wrote to the Cochrane group, offering to construct an expert advisory board with their input “to agree on a statistical analysis plan outlining the types of analyses that would be useful in a public health discussion on Tamiflu.”
MacLean argued that this proposal “is a sensible, fair and transparent way of addressing this public debate” and ensuring the need for transparency is balanced with the need to respect commercial sensitivity.
The Cochrane Collaboration responded: “We have requested these data numerous times and have yet to receive a single full study report from Roche.
“There is no debate nor can there be any debate about the data whilst you do not honour your promise.”
It rejected the implicit criticism of its study methods: “Given the same methods and analyses have now been applied to over 5000 reviews in the Cochrane Library, what are your disagreements?”
With the European Medicines Agency moving towards an ‘open data’ policy, the pharma industry is under increasing pressure to be more transparent.