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Donald Darnell

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What's the source for: "Industry funded trials are four times more likely to give a positive result than independently-sponsored trials..."

Dr. Goldacre mentions in his talk that "Industry funded trials are four times more likely to give a positive result than independently-sponsored trials..." This is a powerful quote and I would be interested to know the source. Would someone please share references to the research behind this statement?

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    Oct 2 2011: Dear Donald,

    http://www.bmj.com/content/326/7400/1167

    BMJ. 2003 May 31;326(7400):1167-70.

    Pharmaceutical industry sponsorship and research outcome and quality: systematic review.
    Lexchin J, Bero LA, Djulbegovic B, Clark O.

    School of Health Policy and Management, York University, Toronto, ON, Canada M3J 1P3. joel.lexchin@utoronto.ca

    Abstract
    OBJECTIVE:
    To investigate whether funding of drug studies by the pharmaceutical industry is associated with outcomes that are favourable to the funder and whether the methods of trials funded by pharmaceutical companies differ from the methods in trials with other sources of support.

    METHODS:
    Medline (January 1966 to December 2002) and Embase (January 1980 to December 2002) searches were supplemented with material identified in the references and in the authors' personal files. Data were independently abstracted by three of the authors and disagreements were resolved by consensus.

    RESULTS:
    30 studies were included. Research funded by drug companies was less likely to be published than research funded by other sources. Studies sponsored by pharmaceutical companies were more likely to have outcomes favouring the sponsor than were studies with other sponsors (odds ratio 4.05; 95% confidence interval 2.98 to 5.51; 18 comparisons). None of the 13 studies that analysed methods reported that studies funded by industry was of poorer quality.

    CONCLUSION:
    Systematic bias favours products which are made by the company funding the research. Explanations include the selection of an inappropriate comparator to the product being investigated and publication bias.

    PMID: 12775614 [PubMed - indexed for MEDLINE] PMCID: PMC156458

    Kind regards,

    Paul Wicks
    • Oct 2 2011: Thank you, Paul. Just what I was looking for. Fascinating!
  • Oct 4 2011: As important as the answer is the question here. I'm glad it was asked, because just as Dr. Goldacre rails against bad science, without verifying his own claims, we've no foot to stand on.

    As a scientist, I am appalled at how often these questions aren't even asked.
  • Oct 2 2011: He gave it at the bottom of his slide: Lexchin Bero BMJ ( British Medical Journal) 2003
    • Oct 2 2011: Thanks. I was not able to make that out on the slide.
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    Oct 6 2011: The research was conducted by Professor Joel Lexchin et al and the objective was, "To investigate whether funding of drug studies by the pharmaceutical industry is associated with outcomes that are favourable to the funder and whether the methods of trials funded by pharmaceutical companies differ from the methods in trials with other sources of support."

    The research clearly shows that there is a systematic bias towards companies funding research with relation to their own products which has resulted in [some] publication bias by both research and medical journals.

    From the data gathered it becomes clear that for Pharmaceutical industry sponsored research the outcomes are more about marketing their product than it is about accurately reporting the core findings, as those findings may not provide the funder of the research with 'saleable' data. [Direct link to data - Pharmaceutical industry sponsorship and research outcome and quality: systematic review - http://www.ncbi.nlm.nih.gov/pmc/articles/PMC156458/]
  • Oct 12 2011: Good question.

    This is a broad statement that appears to be addressing the pharmaceutical industry... currently. I note, however, that the end-date of the data used is almost 10 years old and does not state what countries the data is drawn from...?!

    After reading through the report cited (and not conducting an exhaustive study of each paper cited at the end), I have several questions about the original studies themselves...
    - were the studies examined conducted in the same country
    - what was the regulatory climate where the original studies were conducted
    - how did this climate impact study reporting
    - what kind of companies were studied (new/existing, pharma/biotech)
    - were like therapeutics reviewed (pharma funded/independantly funded)
    - were the therapeutics new/existing

    The answer to the first question was found after reviewing the reference list - studies were conducted in numerous countries.

    As regulatory bodies have become more progressive and proactive in industry oversight, opportunities for technological advancement have been embraced. This has lead to greater transparency and collaboration between pharma/regulatory to achieve the same end - efficacious product and patent safety.

    It appears the data was selected to support the researcher's bias - instead of allowing the data to speak for itself and guide the researchers.
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    Oct 3 2011: I am glad someone gave you the proper answer because I am going to quip that the source is probably a pharmaceutical rep who knows that the 'expert' has been wined and dined at every pharma meeting that the company had.