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Pharmaceutical Knowledge Governance: A Human Rights Perspective

Journal of Law, Medicine and Ethics 41 (1):163-184 (2013)

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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.details 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 (...) Download Export citation Bookmark 22 citations
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.details Over the past 35 years, patients have suffered from a largely hidden epidemic of side effects from drugs that usually have few offsetting benefits. The pharmaceutical industry has corrupted the practice of medicine through its influence over what drugs are developed, how they are tested, and how medical knowledge is created. Since 1906, heavy commercial influence has compromised congressional legislation to protect the public from unsafe drugs. The authorization of user fees in 1992 has turned drug companies into the FDA's (...) Download Export citation Bookmark 18 citations
Toward a Jurisprudence of Drug Regulation.Matthew Herder - 2014 - Journal of Law, Medicine and Ethics 42 (2):244-262.details 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 (...) Download Export citation Bookmark
Toward a Jurisprudence of Drug Regulation.Matthew Herder - 2014 - Journal of Law, Medicine and Ethics 42 (2):244-262.details 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 (...) Download Export citation Bookmark

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