Tamiflu effects 'still uncertain'

 

The effects of antiviral drug Tamiflu - which was stockpiled by the Government at the height of the swine flu pandemic - are still uncertain, researchers said as they accused pharmaceutical giant Roche of withholding data.

A 2009 study in the British Medical Journal (BMJ) found the drug may cut the length of time people have symptoms but found no clear evidence that it prevented complications like pneumonia.

Experts from the Cochrane Collaboration conducted a review of 20 existing studies.

They found Tamiflu "did not reduce influenza-related lower respiratory tract complications" but did induce nausea.

Evidence of other adverse reactions to the drug were "possibly under-reported", they said.

The study criticised the evidence available from Roche and said the firm had not been able "unconditionally" to provide the information needed for the study.

At the height of the swine flu pandemic, the UK Government had contracts in place for 50 million doses of Tamiflu - enough for 80% of the population.

Tamiflu is still available for use when flu is circulating at high levels.

Today, a new report from the Cochrane Collaboration said the question of how well Tamiflu works remains unresolved owing to Roche's continued refusal to provide full access to its data.

Following the 2009 study, Roche did provide 3,195 pages of study reports for 10 treatment trials of Tamiflu but these were incomplete, the experts said.

"We cannot be certain whether the trial evidence supports the conclusion that (Tamiflu) reduces complications," they added.

"Nor do we understand if and how (Tamiflu) changes immune response, and important questions about its mode of action remain.

"But we think a critical analysis of the full clinical study reports - comprising tens of thousands of pages we have not yet seen - may provide critical answers."

The team added that "open access to all relevant trial data is a necessity to make ethical decisions in healthcare".

Dr Fiona Godlee, editor-in-chief of the BMJ, which ran an accompanying investigation about access to drug data, said "we are still a long way away from having a full trial history for all drugs in clinical use".

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

Dr Peter Doshi from Johns Hopkins University School of Medicine, who worked on the new study, added: "In the BMJ in December 2009, Roche promised full study reports to any legitimate investigators.

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

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

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

"All completed Roche-sponsored clinical studies on the safety and efficacy of Tamiflu are available as peer-reviewed publications or in summary form on www.roche-trials.com.

"More detailed clinical trial reports are available for use by investigators on a password-protected site, enabling researchers to verify the findings of these studies and publications relating to them.

"Roche provided the Cochrane group with access to 3,200 pages of very detailed information, enabling their questions to be answered.

"Roche stands behind the robustness and integrity of our data supporting the efficacy and safety of Tamiflu."

A spokeswoman for the Department of Health said: "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."

PA

Life and Style
ebookNow available in paperback
ebooks
ebookPart of The Independent’s new eBook series The Great Composers
Latest stories from i100
Have you tried new the Independent Digital Edition apps?

ES Rentals

    Independent Dating
    and  

    By clicking 'Search' you
    are agreeing to our
    Terms of Use.

    iJobs Job Widget
    iJobs General

    Jemma Gent: Year End Accountant

    £250-£300 Day Rate: Jemma Gent: Are you a qualified accountant with strong exp...

    Jemma Gent: Management Accountant

    £230 - £260 Day Rate: Jemma Gent: Do you want to stamp your footprint in histo...

    Beverley James: Accounts Payable

    £22,000 - £23,000: Beverley James: Are you looking for the opportunity to work...

    Beverley James: Accounts Assistant

    £30,000: Beverley James: A fantastic opportunity has arisen for a person looki...

    Day In a Page

    HIV pill: Scientists hail discovery of 'game-changer' that cuts the risk of infection among gay men by 86%

    Scientists hail daily pill that protects against HIV infection

    Breakthrough in battle against global scourge – but will the NHS pay for it?
    How we must adjust our lifestyles to nature: Welcome to the 'Anthropocene', the human epoch

    Time to play God

    Welcome to the 'Anthropocene', the human epoch where we may need to redefine nature itself
    MacGyver returns, but with a difference: Handyman hero of classic 1980s TV series to be recast as a woman

    MacGyver returns, but with a difference

    Handyman hero of classic 1980s TV series to be recast as a woman
    Tunnel renaissance: Why cities are hiding roads down in the ground

    Tunnel renaissance

    Why cities are hiding roads underground
    'Backstreet Boys - Show 'Em What You're Made Of': An affectionate look at five middle-aged men

    Boys to men

    The Backstreet Boys might be middle-aged, married and have dodgy knees, but a heartfelt documentary reveals they’re not going gently into pop’s good night
    Crufts 2015: Should foreign dogs be allowed to compete?

    Crufts 2015

    Should foreign dogs be allowed to compete?
    10 best projectors

    How to make your home cinema more cinematic: 10 best projectors

    Want to recreate the big-screen experience in your sitting room? IndyBest sizes up gadgets to form your film-watching
    Manchester City 1 Barcelona 2 player ratings: Luis Suarez? Lionel Messi? Joe Hart? Who was the star man?

    Manchester City vs Barcelona player ratings

    Luis Suarez? Lionel Messi? Joe Hart? Who was the star man at the Etihad?
    Arsenal vs Monaco: Monaco - the making of Gunners' manager Arsene Wenger

    Monaco: the making of Wenger

    Jack Pitt-Brooke speaks to former players and learns the Frenchman’s man-management has always been one of his best skills
    Cricket World Cup 2015: Chris Gayle - the West Indies' enigma lives up to his reputation

    Chris Gayle: The West Indies' enigma

    Some said the game's eternal rebel was washed up. As ever, he proved he writes the scripts by producing a blistering World Cup innings
    In Ukraine a dark world of hybrid warfare and murky loyalties prevails

    In Ukraine a dark world of hybrid warfare

    This war in the shadows has been going on since the fall of Mr Yanukovych
    'Birdman' and 'Bullets Over Broadway': Homage or plagiarism?

    Homage or plagiarism?

    'Birdman' shares much DNA with Woody Allen's 'Bullets Over Broadway'
    Broadchurch ends as damp squib not even David Tennant can revive

    A damp squib not even David Tennant can revive

    Broadchurch, Series 2 finale, review
    A Koi carp breeding pond, wall-mounted iPads and a bathroom with a 'wellness' shower: inside the mansion of Germany's 'Bishop of Bling'

    Inside the mansion of Germany's 'Bishop of Bling'

    A Koi carp breeding pond, wall-mounted iPads and a bathroom with a 'wellness' shower