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  1. Rooting Out Institutional Corruption to Manage Inappropriate Off-Label Drug Use.Marc A. Rodwin - 2013 - Journal of Law, Medicine and Ethics 41 (3):654-664.
    The Food and Drug Administration authorizes the marketing of a drug only for uses that the manufacturer has demonstrated to be safe and effective, based on evidence from at least two clinical trials. However, the FDA does not regulate the practice of medicine, so physicians may prescribe drugs in any manner they choose. Prescribing drugs in ways that deviate from the uses specified in the FDA-approved drug label, package insert, and marketing authorization is referred to as off-label prescribing. This occurs (...)
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  • Free Markets and Public Interests in the Pharmaceutical Industry: A Comparative Analysis of Catholic and Reformational Critiques of Neoliberal Thought.Mathilde Oosterhuis-Blok & Johan Graafland - forthcoming - Business Ethics Quarterly:1-28.
    The rise of liberal market economies, propagated by neoliberal free market thought, has created a vacant responsibility for public interests in the market order of society. This development has been critiqued by Catholic social teaching, forcefully arguing that governments and businesses should be directed to the common good. In this debate, no attention has yet been given to the Reformational tradition and its principle of sphere sovereignty, which provides guidelines on the responsibilities of governments and companies for the public interest (...)
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  • Pharmaceuticals, Political Money, and Public Policy: A Theoretical and Empirical Agenda.Paul D. Jorgensen - 2013 - Journal of Law, Medicine and Ethics 41 (3):561-570.
    Why, when confronted with policy alternatives that could improve patient care, public health, and the economy, does Congress neglect those goals and tailor legislation to suit the interests of pharmaceutical corporations? In brief, for generations, the pharmaceutical industry has convinced legislators to define policy problems in ways that protect its profit margin. It reinforces this framework by selectively providing information and by targeting campaign contributions to influential legislators and allies. In this way, the industry displaces the public's voice in developing (...)
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  • Physicians Under the Influence: Social Psychology and Industry Marketing Strategies.Sunita Sah & Adriane Fugh-Berman - 2013 - Journal of Law, Medicine and Ethics 41 (3):665-672.
    Pharmaceutical and medical device companies apply social psychology to influence physicians' prescribing behavior and decision making. Physicians fail to recognize their vulnerability to commercial influences due to self-serving bias, rationalization, and cognitive dissonance. Professionalism offers little protection; even the most conscious and genuine commitment to ethical behavior cannot eliminate unintentional, subconscious bias. Six principles of influence — reciprocation, commitment, social proof, liking, authority, and scarcity — are key to the industry's routine marketing strategies, which rely on the illusion that the (...)
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  • Curbing Misconduct in the Pharmaceutical Industry: Insights From Behavioral Ethics and the Behavioral Approach to Law.Yuval Feldman, Rebecca Gauthier & Troy Schuler - 2013 - Journal of Law, Medicine and Ethics 41 (3):620-628.
    Two insights of psychology on which we would like to draw are that people react to law in more complex ways than rational-choice models assume and that good people sometimes do bad things. With that starting point, this article provides a behavioral perspective on some of the factors that policymakers seeking to reduce the level of misconduct in the pharmaceutical industry should consider. Effective regulation and enforcement need to address the following questions: Who are the regulation's targeted actors — researchers (...)
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  • Institutional Corruption and the Pharmaceutical Policy.Marc A. Rodwin - 2013 - Journal of Law, Medicine and Ethics 41 (3):544-552.
    Today, the goals of pharmaceutical policy and medical practice are often undermined due to institutional corruption — that is, widespread or systemic practices, usually legal, that undermine an institution's objectives or integrity. In this symposium, 16 articles investigate the corruption of pharmaceutical policy, each taking a different look at the sources of corruption, how it occurs, and what is corrupted. We will see that the pharmaceutical industry's own purposes are often undermined. Furthermore, pharmaceutical industry funding of election campaigns and lobbying (...)
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  • Rooting Out Institutional Corruption to Manage Inappropriate Off‐Label Drug Use.Marc A. Rodwin - 2013 - Journal of Law, Medicine and Ethics 41 (3):654-664.
    Prescribing drugs for uses that the FDA has not approved — off-label drug use — can sometimes be justified but is typically not supported by substantial evidence of effectiveness. At the root of inappropriate off-label drug use lie perverse incentives for pharmaceutical firms and flawed oversight of prescribing physicians. Typical reform proposals such as increased sanctions for manufacturers might reduce the incidence of unjustified off-label use, but they do not remove the source of the problem. Public policy should address the (...)
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  • From Community to Commodity: The Ethics of Pharma‐Funded Social Networking Sites for Physicians.Amy Snow Landa & Carl Elliott - 2013 - Journal of Law, Medicine and Ethics 41 (3):673-679.
    A growing number of doctors in the United States are joining online professional networks that cater exclusively to licensed physicians. The most popular are Sermo, with more than 135,000 members, and Doximity, with more than 100,000. Both companies claim to offer a valuable service by enabling doctors to “connect” in a secure online environment. But their business models raise ethical concerns. The sites generate revenue by selling access to their large networks of physician-users to clients that include global pharmaceutical companies, (...)
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  • Pharmaceuticals, Political Money, and Public Policy: A Theoretical and Empirical Agenda.Paul D. Jorgensen - 2013 - Journal of Law, Medicine and Ethics 41 (3):561-570.
    The point, for the 946,326th time is that people get elected to office by currying the favor of powerful interest groups. They don’t get elected for their excellence as political philosophers.Congress has consistently failed to solve some serious problems with the cost, effectiveness, and safety of pharmaceuticals. In part, this failure results from the pharmaceutical industry convincing legislators to define policy problems in ways that protect industry profits. By targeting campaign contributions to influential legislators and by providing them with selective (...)
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  • From Community to Commodity: The Ethics of Pharma-Funded Social Networking Sites for Physicians.Amy Snow Landa & Carl Elliott - 2013 - Journal of Law, Medicine and Ethics 41 (3):673-679.
    In September 2006, a small start-up company in Cambridge, MA called Sermo, Inc., launched a social networking site with an unusual twist: only physicians practicing medicine in the United States would be allowed to participate. Sermo, which means “conversation” in Latin, marketed its website as an online community exclusively for doctors that would allow them to talk openly about a range of topics, from challenging and unusual medical cases to the relative merits of one treatment versus another. “Sermo enables the (...)
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  • Curbing Misconduct in the Pharmaceutical Industry: Insights From Behavioral Ethics and the Behavioral Approach to Law.Yuval Feldman, Rebecca Gauthier & Troy Schuler - 2013 - Journal of Law, Medicine and Ethics 41 (3):620-628.
    To sell a new drug, pharmaceutical companies must discover a compound, run clinical trials to test its efficacy and safety, get it approved by regulatory bodies, produce the drug, and market it. As this process brings the drug through so many hands, there are risks of many kinds of corruption. The pharmaceutical industry has recently gone from being one of the most admired industries to being described by the majority of Americans as “dishonest, unethical, and more concerned with profits than (...)
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  • Physicians Under the Influence: Social Psychology and Industry Marketing Strategies.Sunita Sah & Adriane Fugh-Berman - 2013 - Journal of Law, Medicine and Ethics 41 (3):665-672.
    It is easier to resist at the beginning than at the end.– Leonardo da VinciPhysicians often believe that a conscious commitment to ethical behavior and professionalism will protect them from industry influence. Despite increasing concern over the extent of physician-industry relationships, physicians usually fail to recognize the nature and impact of subconscious and unintentional biases on therapeutic decision-making. Pharmaceutical and medical device companies, however, routinely demonstrate their knowledge of social psychology processes on behavior and apply these principles to their marketing. (...)
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