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

BMJ 2012; 345 doi: http://dx.doi.org/10.1136/bmj.e7658 (Published 12 November 2012) Cite this as: BMJ 2012;345:e7658
  1. Zosia Kmietowicz
  1. 1London

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 Gøtzsche, 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trials of oseltamivir and that most (60%) of the patient data from Roche’s phase 3 completed treatment trials remained unpublished.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 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.”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

The company said that it had provided the Cochrane group with 3200 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.5 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.

Although Roche said that it “has made full clinical data . . . available to national health authorities,” the Cochrane researchers said that the European Medicines Agency had confirmed to them that it did not have some modules of the studies. They added, “We know for at least 15 Roche Tamiflu Clinical Study Reports, [the] EMA does not hold the full report.”

In her letter, addressed to John Bell, regius professor of medicine at Oxford University and the only medically qualified member of Roche’s board, Godlee reminded Roche that in December 2009 the company promised to make full study reports available, but the statement from Roche failed to discuss this question.

The Cochrane researchers asked why Roche made the promise “if it has no intention of actually doing so.”

They concluded, “We remain interested in conducting the most rigorous, independent assessment of Tamiflu that is possible, and remain interested in obtaining the full study reports promised in December 2009 and complete de-identified electronic patient level reports.”

In a rapid response to the BMJ Iain Chalmers, coordinator of the James Lind Initiative, has highlighted the fact that he is still awaiting a response from Bell to a question he asked six years ago. In October 2006 and again in June 2007 Chalmers wrote to Bell, who was then president of the Academy of Medical Sciences, asking about the academy’s position on under-reporting of medical research.

Chalmers wrote, “This dismissive attitude to a form of scientific misconduct which has been shown to result in the avoidable suffering and deaths of patients, as well as wasted resources, does not reflect well on the leadership of the medical research community.”6

Notes

Cite this as: BMJ 2012;345:e7658

Footnotes

  • All correspondence can be seen on the BMJ’s website dedicated to the missing data on oseltamivir (www.bmj.com/tamiflu).

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