Tamiflu ..............the continuing story

They say that Roche, which makes the antiviral, has failed to supply them with full clinical trials data on the drug, despite repeated requests.

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The Department of Health invested heavily in Tamiflu after the avian flu scare in 2005.

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Derived from spice star anise, it ordered 14.6 million doses that year at a cost of £200 million.

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Trials have shown that it helps alleviate serious flu symptoms and could reduce hospitalisations by 60 per cent.

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Ministers decided to buy so much because vaccines cannot be made quickly enough to protect populations against emerging strains.

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They have now stockpiled enough Tamiflu and another antiviral, called Relenza, to cover half the population.

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But when scientists at the Cochrane Collaboration, which aims to assess evidence on medical treatments, asked Roche for full details of 10 treatment trials, they say the firm only provided them with partial information.

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Each report contains four or five modules, but they say Roche only supplied the first in each case

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They had to resort to freedom of information requests to the European Medicines Agency (EMA), which supplied them with the second modules.

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The reviewers then spotted "discrepancies between the reporting of trials in clinical study reports sent to regulators versus published papers" which "led us to lose confidence in the journal reports", according to their analysis, published in the British Medical Journal.

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For example, "in one case the published version of a trial unambiguously states that 'there were no drug-related serious adverse events', while the clinical study report lists three that were possibly related to oseltamivir", the generic name for the branded drug Tamiflu.

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They also found evidence from one trial that Tamiflu "may inhibit the body's ability to mount a normal immune response to influenza".

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If confirmed, this meant Roche's claim that Tamiflu does not impair immune response was "wrong", claimed the authors, led by Peter Doshi of Johns Hopkins University School of Medicine in Baltimore, US.

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He commented: In the BMJ in December 2009, Roche promised full study reports to any legitimate investigators. 

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They have not provided a single full study report to Cochrane, despite our repeated requests.

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The BMJ has been running a campaign highlighting the problems of unpublished trials, accusing drugs companies of only publishing favourable results.

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Dr Fiona Godlee, its editor-in-chief, said the EMA had told the journal that it planned to start publishing reports for all drugs submitted for approval in the next few years.

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But we are still a long way away from having a full trial history for all drugs in clinical use, she noted.

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Public safety and the proper use of public money demands that we should stop at nothing less than this.

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Roche, which made £1.9 billion from Tamiflu in 2009, defended its record on the drug. 

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A spokesman said: Roche has made full clinical study data available to health authorities around the world for their review as part of the licensing process.

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It is the role of global health authorities to review detailed information on medicines when assessing benefit and risk.

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He added: Numerous clinical studies – and real-life medical experience - show Tamiflu is effective in reducing the severity and duration of influenza symptoms as well as secondary complications in children and adults.

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Regarding the question of the effect of immune repsonse, he said: "Research presented at the ICAAC conference in 2008 confirmed that oseltamivir did not prevent the mounting of an immune response to the influenza virus.

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A spokesman for the Department of Health said: "We rely on expert advice, which is regularly updated to ensure that our antiviral use is based on the best available scientific evidence.

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At the end of last year we published a major review of the scientific evidence base, which showed a clear benefit in offering antivirals to those with severe illness and those with additional risk factors.

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Stephen Adams

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Notice anything in the company statements?

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Carefully worded to avoid answering the legitimate concerns raised.
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Power allows such prevarication as no one wants to go after the spin.
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Most journalists work for organisations, which do not want to upset advertisers.
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In these difficult times holding on to your advertisers is paramount.
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So for you personally please think twice before taking any flu vaccinations.
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Go and look on line at the many articles on this subject.