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  1. Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs.Donald W. Light, Joel Lexchin & Jonathan J. Darrow - 2013 - Journal of Law, Medicine and Ethics 41 (3):590-600.
    Institutional corruption is a normative concept of growing importance that embodies the systemic dependencies and informal practices that distort an institution’s societal mission. An extensive range of studies and lawsuits already documents strategies by which pharmaceutical companies hide, ignore, or misrepresent evidence about new drugs; distort the medical literature; and misrepresent products to prescribing physicians. We focus on the consequences for patients: millions of adverse reactions. After defining institutional corruption, we focus on evidence that it lies behind the epidemic of (...)
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  • Toward a Jurisprudence of Drug Regulation.Matthew Herder - 2014 - Journal of Law, Medicine and Ethics 42 (2):244-262.
    Efforts to ensure greater transparency in the regulation of “drugs” are well underway. For example, laws in the United States and Europe now require registration of most clinical trials beyond phase 1. Yet instances of avoidable harm to patients continue to arise. In response, calls for disclosure of clinical trial data in the form of “clinical study reports,” not just trial designs and basic results, are growing. In this paper, I argue that disclosure of clinical trial data is necessary but (...)
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  • Toward a Jurisprudence of Drug Regulation.Matthew Herder - 2014 - Journal of Law, Medicine and Ethics 42 (2):244-262.
    Efforts to foster transparency in biopharmaceutical regulation are well underway: drug manufacturers are, for example, legally required to register clinical trials and share research results in the United States and Europe. Recently, the policy conversation has shifted toward the disclosure of clinical trial data, not just trial designs and basic results. Here, I argue that clinical trial registration and disclosure of clinical trial data are necessary but insufficient. There is also a need to ensure that regulatory decisions that flow from (...)
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