Debate over efficacy of stockpiled flu drug Tamiflu

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Vast sums may have been wasted on a flu drug that works no better than Paracetamol, reports [s]BBC News[/s]. The UK has spent £473m on [b]Tamiflu[/b], which is stockpiled by governments globally to prepare for flu pandemics. But a landmark analysis from the [b]Cochrane Collaboration[/b] claims that the drug does not prevent the spread of flu or reduce dangerous complications, and only slightly helps symptoms. While it concluded that the drug reduced the persistence of flu symptoms from seven days to 6.3 days in adults and to 5.8 days in children, the report’s authors said drugs such as [b]Paracetamol[/b] could have a similar impact. On claims that the drug prevented complications such as pneumonia developing, Cochrane suggested the trials were poor and there was ‘no visible effect’.

The row has drawn in drug maker, [b]Roche[/b], as well as regulators and independent scientists. ‘Remember, the idea of a drug is that the benefits should exceed the harms,’ says [b]Oxford University’s[/b] Prof Carl Heneghan, a lead investigator in the Cochrane review, in a [s]Reuters Health[/s] report. ‘So if you can’t find any benefits, that accentuates the harms.’ But Roche, which has been under fire for several years over its refusal to allow the Cochrane team unrestricted access to Tamiflu data, rejected the findings, saying it ‘fundamentally disagrees with the overall conclusions’. The drug, one of a class of medicines known as neuraminidase inhibitors, is also on the [b]World Health Organisation’s[/b] ‘essential medicines’ list. And, fueling the row, the [b]European Medicines Agency[/b] (EMA) – which approved the drug in Europe – disputed the claim they had not seen all the Tamiflu data. Dr Enrica Alteri, head of medicines evaluation, said the EMA had seen and reviewed all 20 studies referred to in the review and the latest analysis did not raise any new concerns or alter the agency’s assessment that the benefits of Tamiflu outweighed its risks.

Dr Ben Goldacre, author of [s]Bad Pharma[/s], writes in [s]The Guardian[/s] that the bigger scandal is that Roche broke no law by withholding vital information on how well its drug works. He says the methods and results of drug clinical trials are still routinely and legally being withheld from doctors, researchers and patients. The battle over Tamiflu ‘perfectly illustrates’ the need for full transparency, the importance of access to obscure documentation, and the failure of the regulatory system. He says trials transparency is ‘finally on the agenda’, and this may be the only opportunity to fix it in a decade.

The drugs were never purchased on a large scale by [b]SA’s Department of Health[/b], but it did acquire a stockpile preparation for a possible flu pandemic in 2009 and ahead of the [b]2010 Soccer World Cup[/b], reports [s]Business Day[/s].

Scientists may, meanwhile, have found a way to banish flu, after developing a drug that saw mice unaffected by lethal doses of the virus. The drug blocks a molecule called PGE2, and saw mice survive a dose of [b]H1N1[/b] – also known as swine flu – according to the [s]Daily Mail[/s]. The finding, published in [s]Immunity[/s] paves the way for an urgently needed therapy that is highly effective against flu and maybe other viral infections.

[i]And, reports [s]Medical News Today[/link][/i], researchers have discovered that the influenza A virus makes a protein called [b]NS1[/b] that undermines the body’s natural defences. This offers a potentially good target for drugs, says Prof Robert Krug, of the College of Natural Sciences at the [b]University of Texas[/b] at Austin, reporting the findings in [s]Cell Host & Microbe[/s].

Full BBC News report
Cochrane abstract
Cochrane full study
Full Reuters Health report
Full report in The Guardian
Full Business Day report
Full Daily Mail report
Immunity abstract
Full Medical News Today report
Cell abstract

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