Tuesday, 13 November 2012

Roche should be sued to release data on oseltamivir, says Cochrane leader

Roche should be sued to release data on oseltamivir, says Cochrane leader

BMJ 2012; 345 doi: (Published 12 November 2012)
Cite this as: BMJ 2012;345:e7658

A leading Cochrane researcher has suggested that European governments should sue the drug firm Roche and that doctors and others boycott the company’s products until it published all its data on oseltamivir (Tamiflu).
Peter G√łtzsche, head of the Nordic Cochrane Centre in Copenhagen, was responding to an open letter to Roche from the BMJ’s editor in chief, Fiona Godlee.
His plea came the same week as Godlee and other campaigners met with the health minster Lord Howe to discuss missing data, European Union clinical trial regulation, and the role of regulators.
Afterwards Sarah Wollaston, the Conservative MP who last month asked in parliament for a meeting on the issue,1 said she hoped to have a full day’s event to discuss further what could be done.
She told the BMJ, “Few would buy a car without comparing fuel economy and safety, yet the NHS pays for drugs without insisting on seeing all the data. We have many levers to insist on sharing this data, and we should use them.”
In October Godlee wrote to Roche as part of the BMJ’s open data campaign, saying that researchers were still being denied access to raw data on oseltamivir despite a promise from the company nearly three years ago to make trial data available for independent scrutiny.2
She wrote, “Billions of pounds of public money have been spent on [Tamiflu] and yet the evidence on its effectiveness and safety remains hidden from appropriate and necessary independent scrutiny.”
Cochrane researchers knew that there were at least 123 trials of oseltamivir and that most (60%) of the patient data from Roche’s phase 3 completed treatment trials remained unpublished. The researchers’ main concern related to the “likely overstating of effectiveness and the apparent under reporting of potentially serious adverse effects,” said Godlee.
In his response G√łtzsche 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.”3
He concluded: “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.”
Roche responded to Godlee’s letter in a “reactive statement” saying that it “does not accept or agree with the content of the letter regarding our transparency.”4

Cite this as: BMJ 2012;345:e7658