10 Apr 2014

Drug trial data to be made available – a happy ending for the tale of Tamiflu

If science can be summed up in a slogan it’s this: “Nullius in verba.”

The Latin motto was chosen by the founding fellows of the Royal Society in 1663 to adorn their crest. It roughly translates as “take nobody’s word for it.”

Their thinking was simple. A scientist shouldn’t believe what anybody tells them unless they present empirical evidence that speaks for itself.

And judged against this one overriding principle the sorry tale of Tamiflu falls foul. Not once, but twice.

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First, claims made for the effectiveness of the medicine were not supported by evidence.

Yes, Tamiflu does reduce the length of duration of flu (a bit).

And yes, there is some evidence that in gravely ill people it can help them survive infection with the virus.

But its manufacturers Roche also claimed that it could reduce complications of the disease like pneumonia, despite having no clinical trial evidence to support that claim. They also supported claims that it could be effective in during a pandemic, despite having no evidence for that either.

Second, if governments or individuals wanted to make their own minds up about Tamiflu and decide whether it worked or not, they couldn’t have done.

That’s because data about its effectiveness was withheld by the manufacturer Roche, and publicly-funded drug regulators tasked with ensuring marketed medicines actually work.

Neither Roche nor the regulators broke any laws in withholding this information. But it still left us having to “take somebody’s word for it”.

Given it is one of the only medicines with any effectiveness against flu it’s understandable – though perhaps not excusable – that the government chose to stockpile the drug.

The World Health Organisation (WHO) endorsed its use, and in the early days of the 2009 swine flu pandemic there was intense pressure from the media for the government to stockpile flu drugs.

The government may even decide to maintain the stockpile given that there is nothing else available.

But some flu experts argue it might be better spend the money on other more reliable flu preparedness measures – or even spend the money on keeping people well during the majority of time when there is no flu around.

However, the tale of Tamiflu is starting to have a happy ending.

This group of unusually determined scientists refused to leave Roche and the regulators alone, and forced them to make data available.

Now Roche and other drug companies have taken the unprecedented step of agreeing to make past and future trial data available for independent analysis. In the not too distant future we won’t be left having to take other people’s word for it.

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