Intended for healthcare professionals

Rapid response to:

Observations BMJ Open Data Campaign

Open letter to Roche about oseltamivir trial data

BMJ 2012; 345 doi: (Published 29 October 2012) Cite this as: BMJ 2012;345:e7305

Rapid Response:

Re: Open letter to Roche about oseltamivir trial data

European governments should sue Roche

At an open seminar arranged by Health Action International (Europe) on 12 October about access to medical research data, I asked why European governments had not sued Roche to get the money back 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.

None of those present at the seminar could explain why our governments have not sued Roche but another speaker told me in private that the likely reason is that they don't want to lose face. Well, it's better to lose face than lose billions of taxpayers' money I think. As far as I can work out, Tamiflu is likely not any better than paracetamol. The FDA required Roche to print a disclaimer on the lables: "Tamiflu has not been proven to have a positive impact on the potential consequences (such as hospitalizations, mortality, or economic impact) of seasonal, avian, or pandemic influenza" (1). When the FDA first reviewed a similar drug, zanamivir (Relenza) from GlaxoSmithKline, the advisory committee recommended that the drug should not be approved. Zanamivir was no better than placebo when the patients were taking other drugs such as paracetamol. However, FDA overruled the committee, probably for political reasons. When that was done, FDA also had to approve oseltamivir later the same year (2).

European governments should sue Roche, which might also have the effect that the hidden trial results come out in the open. Furthermore, I suggest we boycott Roche's products until they publish the missing Tamiflu data.

1 Doshi P. Neuraminidase inhibitors: the story behind the Cochrane review. BMJ 2009;339:b5164.
2 Cohen D, Carter P. WHO and the pandemic flu 'conspiracies.' BMJ 2012;340:c2912.

Competing interests: No competing interests

08 November 2012
Peter C Gøtzsche
Nordic Cochrane Centre