The Tamiflu kerfluffle continues in the British Medical Journal's new issue, with dueling letters from Roche ($RHHBY) and its lead critic, the Nordic Cochrane Centre. The journal's open data campaign has a willing ally in Cochrane, whose director not only stepped up demands that Roche hand over every scrap of data on its flu-fighter, but also advised European governments to retaliate until it does so.
Last week, BMJ slapped Roche around, saying the Swiss drugmaker hadn't followed through on its pledge to release full data on Tamiflu, the influenza drug stockpiled by many European governments--as well as the U.S.--in anticipation of a flu pandemic. The journal published correspondence with Roche about the Tamiflu data, and demanded that Roche offer full access.
Roche dashed off a defense, saying that it had handed over thousands of pages to Cochrane and made full clinical study data available to health regulators as required. Plus, it said, researchers could get access to all completed Roche-sponsored studies. "We continuously monitor for side effects and notify the relevant regulatory authorities so that doctors have the most up to date information," the letter stated.
But Cochrane fired back with a point-by-point rebuttal; among other things, the organization said European regulators do not have all of the data. It also pointed out that Roche is under scrutiny for failing to file adverse-event reports on a number of drugs, including Tamiflu.
So what's next? Cochrane Centre Director Peter Gøtzsche says European officials should sue for the data. Legal action "might have the effect that the hidden trial results come out in the open," he said in a statement. As added leverage, he suggests that European governments stop using Roche drugs. "I suggest we boycott Roche products until they publish missing Tamiflu data," he said.
We can only imagine the outcry from patients if European governments cut off the flow of Roche drugs, so the boycott seems unlikely. Whether officials will otherwise respond remains to be seen. The only certain outcome from this latest salvo is plenty of debate, in the pages of the BMJ and elsewhere.
- read the BMJ release
- see the latest Tamiflu letters at BMJ
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