Drugs giant Roche accused of sitting on trial data for flu treatment

Doubts remain about efficacy and safety of Tamiflu, stockpiled for use in pandemics

The pharmaceutical giant Roche is being accused of irresponsibly withholding key trial data about a vital flu drug on which governments around the world have spent billions of pounds.

The anti-flu drug Tamiflu has been stockpiled by countries against the outbreak of a flu pandemic since 2004. The UK alone has spent £500m.

Yesterday, the British Medical Journal launched a campaign to persuade Roche to give doctors and patients the full data on Tamiflu, three years after doubts about its safety and efficacy emerged.

In 2009, researchers from the Cochrane Collaboration found that results of eight out of 10 key trials of Tamiflu were never fully published and concluded there was "insufficient data" to show it reduced complications – a vital factor in a pandemic which could save lives.

Roche promised to release the full data, but then reneged on its promise, according to the BMJ. The journal's editor, Fiona Godlee, published an open letter to Sir John Bell, the Regius Professor of Medicine at Oxford University and a board member of Roche, in which she appeals to him to use his influence to persuade the company to release the data "for independent scrutiny".

The two trials that have been published, she says, "were funded by Roche and authored by Roche employees and Roche-paid external experts" and "could not be relied on".

There have now been 123 trials of Tamiflu but 60 per cent of the patient data "remains unpublished", she says. "I am appealing to you as an internationally respected scientist and clinician and a leader of clinical research in the UK to bring your influence to bear," she writes.

"In refusing to release these data of enormous public interest, you [the company's directors] put Roche outside the circle of responsible pharmaceutical companies. Billions of pounds of public money have been spent on [Tamiflu] and yet the evidence on its effectiveness and safety remains hidden from appropriate and necessary independent scrutiny."

The European Medicines Agency announced last week that it was investigating Roche's alleged failure to report side-effects of some of its drugs in as many as 80,000 patients, following a review by the UK Medicines and Health Products Regulatory Agency. If found guilty, the company could be fined up to 5 per cent of its sales in the EU – which amounted to 8.2bn Swiss francs (£5.4bn) in 2011.

In the Commons, the Conservative MP Sarah Wollaston, a GP, called last week for drug companies to publish all clinical trial results, saying it was "vitally important for patient safety" and would give a "completely different evidence base for medicine."

The UK was among the first countries to place bulk orders for Tamiflu (and smaller amounts of Relenza, a rival drug made by GlaxoSmithKline) for stockpiling when fears about a possible avian flu pandemic emerged in 2003 and 2004.

The stockpile was used during the swine flu outbreak of 2009, but because the illness was mild in most people demand remained low.

Dr Godlee said yesterday: "Tamiflu was licensed over 10 years ago and has been in widespread use since. Once a drug is licensed it becomes a drug on which public money is spent and lives may be put at risk. Inevitably if there is information we are not allowed to see we wonder what is in there. There is a legitimate scientific question [about its safety and efficacy] which can only be answered by looking at the data. It is just shocking."

A spokesman for Roche said: "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."

Sir John Bell was not available for comment yesterday.

Life and Style
ebookNow available in paperback
ebooks
ebookPart of The Independent’s new eBook series The Great Composers
Arts and Entertainment
Books should be for everyone, says Els, 8. Publisher Scholastic now agrees
booksAn eight-year-old saw a pirate book was ‘for boys’ and took on the publishers
Life and Style
Mary Beard received abuse after speaking positively on 'Question Time' about immigrant workers: 'When people say ridiculous, untrue and hurtful things, then I think you should call them out'
tech
Life and Style
Most mail-order brides are thought to come from Thailand, the Philippines and Romania
life
News
i100
Life and Style
tech
Voices
Margaret Thatcher, with her director of publicity Sir Gordon Reece, who helped her and the Tory Party to victory in 1979
voicesThe subject is being celebrated by the V&A museum, triggering some happy memories for former PR man DJ Taylor
  • Get to the point
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

    Recruitment Genius: Installation and Service / Security Engineer

    £22000 - £40000 per annum: Recruitment Genius: This company is part of a Group...

    Recruitment Genius: Service Charge Accounts Assistant

    £16000 - £18000 per annum: Recruitment Genius: Are you a a young, dynamic pers...

    Cancer Research UK: Corporate Partnerships Volunteer Events Coordinator – London

    Voluntary: Cancer Research UK: We’re looking for someone to support our award ...

    Ashdown Group: Head of IT - Hertfordshire - £90,000

    £70000 - £90000 per annum + bonus + car allowance + benefits: Ashdown Group: H...

    Day In a Page

    General Election 2015: Chuka Umunna on the benefits of immigration, humility – and his leader Ed Miliband

    Chuka Umunna: A virus of racism runs through Ukip

    The shadow business secretary on the benefits of immigration, humility – and his leader Ed Miliband
    Yemen crisis: This exotic war will soon become Europe's problem

    Yemen's exotic war will soon affect Europe

    Terrorism and boatloads of desperate migrants will be the outcome of the Saudi air campaign, says Patrick Cockburn
    Marginal Streets project aims to document voters in the run-up to the General Election

    Marginal Streets project documents voters

    Independent photographers Joseph Fox and Orlando Gili are uploading two portraits of constituents to their website for each day of the campaign
    Game of Thrones: Visit the real-life kingdom of Westeros to see where violent history ends and telly tourism begins

    The real-life kingdom of Westeros

    Is there something a little uncomfortable about Game of Thrones shooting in Northern Ireland?
    How to survive a social-media mauling, by the tough women of Twitter

    How to survive a Twitter mauling

    Mary Beard, Caroline Criado-Perez, Louise Mensch, Bunny La Roche and Courtney Barrasford reveal how to trounce the trolls
    Gallipoli centenary: At dawn, the young remember the young who perished in one of the First World War's bloodiest battles

    At dawn, the young remember the young

    A century ago, soldiers of the Empire – many no more than boys – spilt on to Gallipoli’s beaches. On this 100th Anzac Day, there are personal, poetic tributes to their sacrifice
    Dissent is slowly building against the billions spent on presidential campaigns – even among politicians themselves

    Follow the money as never before

    Dissent is slowly building against the billions spent on presidential campaigns – even among politicians themselves, reports Rupert Cornwell
    Samuel West interview: The actor and director on austerity, unionisation, and not mentioning his famous parents

    Samuel West interview

    The actor and director on austerity, unionisation, and not mentioning his famous parents
    General Election 2015: Imagine if the leading political parties were fashion labels

    Imagine if the leading political parties were fashion labels

    Fashion editor, Alexander Fury, on what the leaders' appearances tell us about them
    Phumzile Mlambo-Ngcuka: Home can be the unsafest place for women

    Phumzile Mlambo-Ngcuka: Home can be the unsafest place for women

    The architect of the HeForShe movement and head of UN Women on the world's failure to combat domestic violence
    Public relations as 'art'? Surely not

    Confessions of a former PR man

    The 'art' of public relations is being celebrated by the V&A museum, triggering some happy memories for DJ Taylor
    Bill Granger recipes: Our chef succumbs to his sugar cravings with super-luxurious sweet treats

    Bill Granger's luxurious sweet treats

    Our chef loves to stop for 30 minutes to catch up on the day's gossip, while nibbling on something sweet
    London Marathon 2015: Paula Radcliffe and the mother of all goodbyes

    The mother of all goodbyes

    Paula Radcliffe's farewell to the London Marathon will be a family affair
    Everton vs Manchester United: Steven Naismith demands 'better' if Toffees are to upset the odds against United

    Steven Naismith: 'We know we must do better'

    The Everton forward explains the reasons behind club's decline this season
    Arsenal vs Chelsea: Praise to Arsene Wenger for having the courage of his convictions

    Michael Calvin's Last Word

    Praise to Wenger for having the courage of his convictions