Transparency Urged in Drug Trials

By ~lostgurl~ · Jul 3, 2006 · ·
  1. ~lostgurl~
    Transparency urged in drug trials
    BBC News

    o.gif start_quote_rb.gif Getting clinical trials results publicly registered and published is important end_quote_rb.gif

    Sir Iain said a lack of transparency is endangering patients health

    A scientist has called for stricter regulations to ensure that pharmaceutical companies do not under-report clinical trials.

    Sir Iain Chalmers has said that research undertaken by drugs companies cannot be trusted until they change their practices.
    He also reports that doctors are colluding with industry, often seduced by financial rewards.
    His article is published in the Journal of the Royal Society of Medicine.

    The pharmaceutical industry has, in the past, been accused of selectively publishing the results of clinical trials, allowing unflattering results to remain hidden.
    Sir Iain, a former director of the Cochrane Centre, and now editor of the James Lind Library, which documents the evolution of fair tests of medical treatments, said: "The pharmaceutical industry is not making fully available the results of tests of treatment, and in essence is suppressing uncomfortable information that might challenge the sales of their products, and putting people's health at risk."

    Financial incentives

    He said an initial push in the mid-1990s by some companies to increase openness and transparency had failed.
    He has called for all drug companies to sign up to the Good Publication Practice Guidelines for Pharmaceutical Companies, which encourage companies to publish all trial results, and to put into place mechanisms to oversee adherence to these guidelines.
    He adds that some medical professionals are colluding with industry, because of the financial incentives being offered, in a way that is "not compatible for a doctor to look after their patients".
    He said: "Whether industry does anything about this really depends on how seriously they are taking the very bad reputation they have in the public."
    Some have called for all clinical trials to be registered with the public, at inception, to avoid any publication bias.
    A spokesperson, from the Association of the British Pharmaceutical Industry (ABPI) commenting on the article, said: "Getting clinical trials results publicly registered and published is important and it is for this reason the ABPI took a leading role in framing a global agreement which came into force in January 2005.
    "Under this agreement, all clinical trial results - positive and negative - must be published within a year of a medicine being licensed for use in patients and, for studies of existing medicines, within a year of that trial."

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  1. ~lostgurl~
    Drug Firms Attacked on Marketing

    Drug firms attacked on marketing
    BBC News

    [​IMG][​IMG] The current regulatory framework is clearly insufficient to prevent systemic violations of marketing regulations [​IMG]
    - Consumers International

    [​IMG][​IMG] As producers of life-saving medicines it is important that we ensure doctors know full details [​IMG]
    - ABPI

    Drug firms' annual marketing spend is $60bn, the report says

    Top European pharmaceutical firms are using unscrupulous marketing practices to promote their products, a consumer report says.

    The Consumers International lobby group accused drugmakers of using the methods to get doctors to prescribe products and persuade consumers they need them.
    It said there was a "shocking" lack of publicity about where the $60bn (£33bn) annual marketing spend went.
    Drug firms say that they act within strict guidelines.
    The Association of the British Pharmaceutical Industry (ABPI) told the BBC News website that for UK-based firms there was "a stringent and transparent code of practice that goes beyond the requirements of UK law and the industry regulator".


    Consumers International said it had analysed the selling techniques of many leading companies, including Bayer, GlaxoSmithKline and Johnson & Johnson.

    Richard Lloyd, the group's director general, said: "The pharmaceutical industry spends nearly twice as much on marketing as it does on research and development, yet consumers know next to nothing about where this money is going."
    He called for a revision of marketing regulations to achieve "more transparency from drug companies".
    In most Western markets direct advertising to consumers is banned.
    But Mr Lloyd said there were other methods drug companies were using to influence opinion.
    These include the sponsoring of patient lobby groups, funding disease awareness campaigns and use of hospitality packages for medical experts.

    The report cites sponsorships by such firms as Eli Lilly and Pfizer. The latter, the maker of Viagra, sponsored a campaign by the Impotence Association which sported the Pfizer logo.
    The report said only one of the firms studied, Orion Pharma, provided specific marketing budget information.
    It also pointed to the "large numbers of serious, recent and repeated breaches of marketing codes".
    This showed the "current regulatory framework is clearly insufficient to prevent systemic violations of marketing regulations".
    However, the ABPI said the number of complaints raised showed the system, which had been strengthened this year, was working.
    It said complaints from drug companies about fellow firms' activities showed the self-regulation was effective.
    But it also said it was vital for doctors to know about products.
    "There is no point having innovative new medicines if they remain unused," an association spokesman said.
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