Essential or useless? (Image: Paul Brown/Rex Features)

Editorial: “Don’t stop stockpiling Tamiflu“

Is the anti-flu drug Tamiflu no more likely to save you from a pandemic than ordinary painkillers – or even a shot of Scotch?

It’s a serious charge: because flu vaccine production is slow and limited, Tamiflu and other antiviral drugs are the main first-line defence against a pandemic. The US, UK and other countries have stockpiled them. The cost of this in the UK alone has been £522 million.


“[Tamiflu] has never been directly compared with paracetamol – or indeed a stiff whisky – so we’re left with some doubt as to its effectiveness,” Fiona Godlee, editor of the BMJ (British Medical Journal), told a UK parliamentary committee last week. Because not all the trials of the drug have been published, she says there are “serious doubts” about whether Tamiflu is any better than such cheap painkillers.

Jonathan Van-Tam of the University of Nottingham, UK, has no such doubts. He has assembled data on 168,000 people in 37 countries who were hospitalised with flu during the 2009 H1N1 swine flu pandemic. Some 15,000 of these patients died.

At a meeting in Brussels, Belgium, in May, Van-Tam reported that those who were given Tamiflu within two days of falling ill were only half as likely to die as those who got it late or not at all. Preliminary results were published in February.

Saving lives

Other research has found that Tamiflu reduces deaths from H5N1 bird flu – and that in 2009, the more Tamiflu a country had, the fewer people died. In the UK, one in ten people with flu in 2009 took Tamiflu – but a study of severe cases found that very few of those received it before going to hospital, says Peter Openshaw of Imperial College London. “We think one reason our patients were in hospital was that they didn’t take antivirals early enough.”

These studies, however, are not randomised controlled trials, the gold standard, in which people randomly get placebos or drugs. Tom Jefferson of the Cochrane Collaboration, an international group that assesses medical evidence, looked at Tamiflu in 2012 using all randomised controlled trials for which it could obtain detailed clinical study reports, including regulatory documents, and found that it reduces flu duration, not severity.

The US Centers for Disease Control and Prevention issued a rare rebuttal in response, saying the studies were in otherwise healthy people with mostly mild winter flu, not the older, sicker people who need Tamiflu most. Moreover, there are no randomised controlled trials of people who have pandemic flu. Pandemic viruses replicate for longer in the deep lungs, causing lethal pneumonia.

Tamiflu blocks that replication – hence its apparent effect in Van-Tam’s data. In contrast, an earlier review of Tamiflu trials by Jefferson in 2009 assessed the drug’s impact on secondary bacterial infections, which is not its main use in pandemics.

Unreleased data

Yet since then, Cochrane and the BMJ have campaigned against stockpiling Tamiflu for pandemics.

“We simply don’t know whether the stockpiling of Tamiflu in 2009 was value for money, as we do not have access to good evidence as to whether the drug is safe or effective,” Godlee told New Scientist.

Her main worry is that most clinical trial data on the drug have not been published. Roche, the Swiss company that makes Tamiflu, has been promising to release the data since 2009. It has not so far released everything.

Because more positive than negative trial results are published, Godlee says she fears that when all data is considered together, Tamiflu will turn out to be not helpful, and perhaps even harmful.

Those trial results should finally be coming. “There has been a real change in attitude in the industry,” says Don MacLean, head of Tamiflu at Roche. All its Tamiflu data will be released once patients’ identities are hidden. European flu researchers plan to independently review it, but, says Godlee, “I doubt we will be able to say much more than that the clinical trial data are inadequate”.

Godlee wants the drug withdrawn until all trial data is reviewed. That would leave the world at risk if another flu – such as the H7N9 bird flu in China – goes pandemic. “The clear scientific consensus is that these drugs are absolutely vital to prevention or amelioration of the worst outcomes during a severe pandemic,” says Jon McCullers of the University of Tennessee Health Sciences Center in Memphis. “Arguing against this without evidence seems self-serving at best and dangerous to public health at worst.”

Fred Hayden of the University of Virginia at Charlottesville says that both Tamiflu and placebo patients in the Tamiflu randomised controlled trials were on paracetamol, so it was indeed compared to Tamiflu. It was more effective than either placebo or paracetamol.

As for alcohol, he says, research shows it makes flu even nastier.

Clarification: Since this story was first published on 24 June 2013, we have clarified the extent of the Cochrane Collaboration’s assessment of medical evidence on Tamiflu.