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The study, led by Professor Chris del Mar of the Cochrane Collaboration, with Dr Tom Jefferson as researcher, and published by the British Medical Journal (8 December 2009), found no evidence that Tamiflu prevents serious complications, hospitalization, or death in people that have the flu.
It further suggests that Roche Pharmaceuticals, the Swiss company that manufactures and markets Tamiflu, may have misled governments and physicians by withholding vital information through not publishing critical studies that showed Tamiflu to be ineffective.
But Roche maintains that it “has never concealed (or had the intention to conceal) any pertinent data.” And the company now says it will publish all the study data on a password-restricted website.
New doubts over Tamiflu effectiveness
The latest findings on Tamiflu effectiveness come from a re-evaluation of an earlier 2006 study by Cochrane, which is a highly respected not-for-profit organisation that evaluates the effectiveness of various treatments. In that earlier study, Cochrane Collaboration generally agreed with claims by Roche that Tamiflu reduces:
That 2006 Cochrane review was based largely on a paper that looked at 10 studies, all of them funded by Roche. But following concerns expressed by a Japanese doctor about the lack of medical evidence on Tamiflu effectiveness, the Cochrane team decided to re-examine the earlier study. In doing so, they found that only two of the 10 studies had ever been published in medical journals. Those two studies on Tamiflu effectiveness showed the drug had very little effect on complications compared to a placebo.
Meanwhile, attempts to trace the data from the remaining eight studies were not entirely successful. Said Prof Chris del Mar:
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The most important finding we found, which is a change from the previous review, was that we didn’t have enough data to know whether it reduces the complications of influenza.
There was a study written by professor Laurent Kaiser from Geneva in Switzerland, which was a summary of about 10 different trials that had been conducted by Roche Pharmaceuticals. When we actually put the data together and analysed them, we found that we couldn’t draw the conclusions that Kaiser had drawn. And so we felt very insecure about that. In fact we didn’t think it was proper to use those data. When we wrote to Kaiser and said ‘can you give us these data because we need to sort it all out properly’, he wrote back and said, ‘I’m very sorry I don’t have the data’. That’s a very weird thing to say. And he referred us to Roche. He said, ‘You’ll have to go and talk to the pharmaceutical company that funded it’. |
According to Professor Del Mar, Roche never gave out the data that the research team requested, but only some tables of data that were not what they needed. The study report said Roche “offered the data under conditions we thought unacceptable, and what was offered to us was insufficient to analyze properly.” So now, Roche is accusing the Cochrane researchers of conducting an incomplete review of Tamiflu effectiveness, because those eight studies had been left out.
Prf Chris del Mar added:
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I can only speculate. It would be pure guesswork. But I do know that this is a drug which has made a lot of money based on the conclusions drawn from this and maybe they’re not keen for other scientists to scrutinise it in the way that the Cochrane Collaboration does.
I do think that we need the data before we can draw conclusions and that’s why we’ve had to withdraw that conclusion that we had previously made. It’s something that makes me feel that we were rather naive as an organisation. I think this does call into question a lot of things about scientific debate and I am worried about it.” |
Adding to the doubts about Tamiflu effectiveness, two former employees of a large communications company, Adis International, have come forward with documents showing they had ghostwritten some of the published studies of Tamiflu. One of the ghostwriters revealed:
| The Tamiflu accounts had a list of key messages that you had to get in. It was run by the [Roche] marketing department and you were answerable to them. In the introduction . . . I had to say what a big problem influenza is. I’d also have to come to the conclusion that Tamiflu was the answer. |
All in, the latest Cochrane study evaluated 20 published trials. It concluded that drugs like Tamiflu are, at best, are modestly effective against flu symptoms in otherwise healthy adults and that there is a “paucity of good data” to support claims that such drugs can prevent complications from flu.
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