Roche rebuts criticism of Tamiflu stockpiling

Roche has hit back against what it termed a "seriously flawed" study that said the UK government had wasted almost £500m stockpiling the Swiss drugmaker's Tamiflu medicine as a defence against flu pandemics.

A report by independent academics in April concluded that Tamiflu was not proven to be more effective than aspirin and one of its authors said governments around the world had thrown money "down the drain" on the drug.

Roche on Monday said it had found "many shortcomings" in the report and warned of public health risks from what it described as the confusion caused among patients and doctors.

The rebuttal represented the latest twist in a dispute that has raised questions over government preparations for a flu pandemic and fuelled debate over the reliability of clinical trial data produced by the pharmaceuticals industry.

Roche opened all its data on Tamiflu to independent scrutiny last year after lobbying from campaigners and scientists who questioned its clinical value.

The April study by the Cochrane Collaboration, a network of academics who review drug data, said Tamiflu offered only a small benefit to flu victims, with no evidence that it reduced the risk of hospitalisation or death.

The findings attracted media attention and prompted David Davis, the senior Tory MP, to call for Roche to refund UK taxpayers if they were true.

Daniel Thurley, medical director for Roche in the UK, said on Monday that the Cochrane researchers "appear not to have understood how Tamiflu works" and failed to take into account all of the data available to them.

"It is clear they made some fundamental mistakes and did not use appropriate or rational analyses," he said. "Roche continues to stand behind the abundance of data available for Tamiflu from the 15 years of experience in over 130m patients."

Tom Jefferson, co-author of the Cochrane report, said he and his colleagues stood by their findings and were working on a detailed rebuttal of Roche's criticism.

Tamiflu was approved by US regulators in 1999 but rose to prominence a decade later when governments rushed to respond to the H1N1 swine flu pandemic.

It has subsequently become the most visible flashpoint in the debate over transparency in drug trial data, with critics accusing the industry of cherry-picking results to exaggerate the benefits of medicines and downplay risks.

Roche, which reported SFr635m ($713.6m) in Tamiflu sales last year, claims the Cochrane scientists did their own cherry-picking by using only 15 of the 77 studies made available to them.

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Mr Jefferson said many of the studies were unreliable because they were based on observational patient data rather than controlled clinical trials.

"It is a basic principle of scientific research, since the days of Galileo, that you make an observation and then you follow it up with a controlled experiment."

Wendy Barclay, an influenza expert at Imperial College London, said she agreed with Roche that the Cochrane study was too selective and warned it would be a mistake to abandon Tamiflu.

But she said the medicine was most effective when prescribed quickly after flu symptoms arose and questioned whether the National Health Service had the capacity to deploy it effectively.

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