Roche to Cochrane: Critical Tamiflu study made 'fundamental mistakes'

Tamiflu capsules--Courtesy of Roche

Back in April, a study conducted by the nonprofit Cochrane Group suggested that the $2 billion worth of Roche's ($RHHBY) Tamiflu and other flu fighters stockpiled by the U.S. and the U.K. to protect against a pandemic has essentially amounted to money thrown down the drain. Now Roche is fighting back, claiming the Cochrane researchers, whose paper was published in the British Medical Journal, failed to include all the relevant data, and furthermore didn't seem to understand how Tamiflu works. The BMJ recently posted Roche's response to the study on its website.

Daniel Thurley, Roche's medical director in the U.K., told the Financial Times yesterday that Roche found shortcomings in the Cochrane study, and he was worried that the confusion it wrought among doctors and patients could present a public health risk. "It is clear they made some fundamental mistakes and did not use appropriate or rational analyses," Thurley told the FT.

The Cochrane researchers said they examined 170,000 pages of data from 20 trials of Tamiflu and 26 trials of GlaxoSmithKline's ($GSK) rival drug Relenza. They found that the drugs did reduce the length of flu symptoms by about a half a day, but evidence that they lowered the risk of complications like pneumonia was inconclusive. Tamiflu itself appeared to reduce the pneumonia risk only slightly in adults and not at all in children. The report's co-author, Tom Jefferson, told the FT that Cochrane stood by the findings and was working on a response to Roche's rebuttal.

The brawl between Roche and Cochrane dates back to 2009, when Cochrane first criticized the Swiss drug giant for withholding Tamiflu data in an e-mail chain that was later posted by the BMJ. The journal's editor, Fiona Godlee, took Cochrane's side, demanding that Roche release the results of Tamiflu studies. In late 2012, Roche said it handed over the data as requested. Now Roche is saying Cochrane cherry-picked the studies, using data from only 15 of 77 trials the company released.

The Tamiflu debate just keeps getting louder. Earlier this year, The Lancet Respiratory Medicine published a Roche-funded study reporting Tamiflu reduced the risk of death in flu patients by 19% over no treatment at all.

Still, Tamiflu is nowhere near its 2009 high, when stockpiling pushed the product's sales beyond $3 billion. In 2013, Roche sold $726 million worth of Tamiflu. Sales of the product in the first quarter of this year, the height of flu season, remained strong in Europe but definitely showed weakness in the U.S., dropping 9% year-over-year to $178 million Swiss francs ($201 million).

- access Roche's response in the BMJ here
- here's the FT story (reg. req.)

Special Report: Top 10 pharma companies by 2013 revenue - Roche

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