Pressure is mounting on Roche to release all of the data for its influenza drug Tamiflu as both Cochrane and the BMJ make a public plea for the information.
In October, the British Medical Journal’s editor Dr Fiona Godlee wrote an editorial piece demanding the raw data from Roche.
This week Peter Gøtzsche, head of the Nordic Cochrane Centre in Copenhagen, went one step further and has said governments should sue the Swiss firm to get the data, while recommending that countries should boycott the company’s products.
The issue surrounds Roche’s influenza drug Tamiflu (oseltamivir). Cochrane wants to do a meta-analysis on the drug’s trials to test its overall safety and efficacy, but it has not been given access to all of the raw data sets for the drug, which means its analysis will be incomplete.
Some of the missing data can be accessed by the European Medicines Agency, but they are also refusing to release the information - at the request of Roche - stating that it has tested the drug’s safety and efficacy and are happy for it to be on the market.
But both Cochrane and the BMJ says that these data should be open for scrutiny by everyone and that this is especially important, given that governments around the world have spent billions on Tamiflu, and it was widely used and stockpiled during the swine flu outbreak in 2009 and 2010.
This week Gøtzsche said that he questioned “why European governments had not sued Roche to get the money they had spent on needlessly stockpiling Tamiflu. Roche has withheld data that purports to show that Tamiflu has dramatic effects. We all wonder why it is so difficult to get these data from Roche and why Roche has not published them if it is really true that they show these effects. European governments should sue Roche, which might have the effect that the hidden trial results come out in the open. Furthermore, I suggest we boycott Roche’s products until they publish missing Tamiflu data,” he added.
The fight over the data has been raging for three-and-a-half years – Cochrane asked Roche for these data in 2009. However, neither it nor the European Medicines Agency has budged despite the firm promising to release the information.
This type of behaviour has been documented in Dr Ben Goldacre’s new book Bad Pharma, and he recently spoke to PharmaTimes UK News expressing his disbelief that both the firm and the regulator continue to delay releasing the data.
Roche was not available for comment, but it told the BMJ last month that it had provided the Cochrane group with 3,200 pages of information “enabling their questions to be answered,” and that a further request for information was denied because the researchers “declined to sign a confidentiality agreement”.
However, the Cochrane researchers said that they were never offered a confidentiality agreement at the time of the further request. They said that they had “found misleading statements in each of the document’s [Roche’s statement] four paragraphs.”
In a letter to Roche they have asked the company to correct the record.
Join the debate at PharmaTimes’ ‘Bad Pharma or bad examples?’ where Ben Goldacre and ABPI chief executive Stephen Whitehead will debate the issues of missing trial data and whether pharma undermines the scientific process in favour of profits.