The Journal of Law, Medicine and Ethics This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

Epigenetic Exceptionalism
This article considers the distinctive features of epigenetics and discusses whether, as a matter of ethics and law, epigenetics should be considered separate from genetics. (Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - October 1, 2013 Category: Medical Law Authors: Mark A. Rothstein Source Type: research

Producing Knowledge about Racial Differences: Tracing Scientists' Use of “Race” and “Ethnicity” from Grants to Articles
The research and publication practices by which scientists produce biomedical knowledge about race and ethnicity remain largely unexamined, and most of the existing research looks at the knowledge production process at a single point in time. In light of this, we specifically focus on the questions of whether and in what ways researchers' discussions of race and ethnicity change over the course of the research process by comparing grant proposals to published articles. Using content analysis, we investigated the use of race and ethnicity in 72 grants funded by the National Cancer Institute of the National Institutes of Hea...
Source: The Journal of Law, Medicine and Ethics - October 1, 2013 Category: Medical Law Authors: Asia Friedman, Catherine Lee Source Type: research

Ethical Quandaries in Gamete‐Embryo Cryopreservation Related to Oncofertility
While cancer rates continue to increase, therapy has dramatically decreased the mortality rates. The increased efficacy of current therapies may unfortunately have profound toxic effects on gamete function in both adolescent and reproductive age groups, with infertility as an expected consequence of cancer therapy. Significant progress in the advancement of fertility preservation therapies provides realistic options for future fertility in cancer survivors. However, a number of challenging issues need to be considered when presenting fertility preservation options. This overview highlights some of these considerations incl...
Source: The Journal of Law, Medicine and Ethics - October 1, 2013 Category: Medical Law Authors: Leslie Ayensu‐Coker, Ellen Essig, Lesley L. Breech, Steven Lindheim Source Type: research

“Something of an Adventure”: Postwar NIH Research Ethos and the Guatemala STD Experiments
The STD experiments in Guatemala from 1946–1948 have earned a place of infamy in the history of medical ethics. But if the Guatemala STD experiments were so “ethically impossible,” how did the U.S. government approve their funding? Although much of the literature has targeted the failings of Dr. John Cutler, we focus on the institutional context and research ethos that shaped the outcome of the research. After the end of WWII, Dr. Cassius Van Slyke reconstructed the federal research contracts process into a grant program. The inaugural NIH study section recommended approval of the Guatemala STD experiments at its fir...
Source: The Journal of Law, Medicine and Ethics - October 1, 2013 Category: Medical Law Authors: Kayte Spector‐Bagdady, Paul A. Lombardo Source Type: research

Approval and Withdrawal of New Antibiotics and Other Antiinfectives in the U.S., 1980–2009
Numerous reports have noted decreasing numbers of antibiotic approvals. To determine the context for this decline, we examined all new molecule entities (NMEs) and new biologic licenses (NBLs) approved by the FDA from 1980–2009, and compared approval rates of the 61 approved antibiotics to trends in other drug classes. We also tracked withdrawals of approved drugs and found more withdrawals for antibiotics than other drug classes. After adjusting for drugs subsequently withdrawn, the record for antibiotic innovation is less dire than previously reported. We also report problems with the quality of the approved antibiotic...
Source: The Journal of Law, Medicine and Ethics - October 1, 2013 Category: Medical Law Authors: Kevin Outterson, John H. Powers, Enrique Seoane‐Vazquez, Rosa Rodriguez‐Monguio, Aaron S. Kesselheim Source Type: research

Patient Advocacy Organizations: Institutional Conflicts of Interest, Trust, and Trustworthiness
This article extends the analysis developed in the Institute of Medicine report, Conflicts of Interest in Medical Research, Education, and Practice, and applies the analysis to understand PAOs and their relationships with industry. It argues that the preferred goal of institutional COI policies should not be to promote trust, but to promote trustworthiness and appropriately placed trust. (Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - October 1, 2013 Category: Medical Law Authors: Susannah L. Rose Source Type: research

From Community to Commodity: The Ethics of Pharma‐Funded Social Networking Sites for Physicians
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, market research and consulting firms, and hedge funds and other investors. In ex...
Source: The Journal of Law, Medicine and Ethics - October 1, 2013 Category: Medical Law Authors: Amy Snow Landa, Carl Elliott Source Type: research

Physicians under the Influence: Social Psychology and Industry Marketing Strategies
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 illusio...
Source: The Journal of Law, Medicine and Ethics - October 1, 2013 Category: Medical Law Authors: Sunita Sah, Adriane Fugh‐Berman Source Type: research

Rooting Out Institutional Corruption to Manage Inappropriate Off‐Label Drug Use
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 cause and control the practice. To manage inappropriate off‐label drug use, off‐...
Source: The Journal of Law, Medicine and Ethics - October 1, 2013 Category: Medical Law Authors: Marc A. Rodwin Source Type: research

Drug Firms, the Codification of Diagnostic Categories, and Bias in Clinical Guidelines
This article examines how commercial entities, such as pharmaceutical companies, influence psychiatric taxonomy and treatment guidelines. Using the conceptual framework of institutional corruption, we show that organized psychiatry's dependence on drug firms has led to a distortion of science. We describe the current dependency corruption and argue that transparency alone is not a solution. We conclude by taking the position that the corruption of the evidence base in diagnostic and practice guidelines has compromised the informed consent process, and we suggest strategies to address this problem. (Source: The Journal of L...
Source: The Journal of Law, Medicine and Ethics - October 1, 2013 Category: Medical Law Authors: Lisa Cosgrove, Emily E. Wheeler Source Type: research

Key Opinion Leaders and the Corruption of Medical Knowledge: What the Sunshine Act Will and Won't Cast Light On
The pharmaceutical industry, in its marketing efforts, often turns to “key opinion leaders” or “KOLs” to disseminate scientific information. Drawing on the author's fieldwork, this article documents and examines the use of KOLs in pharmaceutical companies’ marketing efforts. Partly due to the use of KOLs, a small number of companies with well‐defined and narrow interests have inordinate influence over how medical knowledge is produced, circulated, and consumed. The issue here, as in many other cases of institutional corruption, is that a few actors have accumulated the power to shape the information on which ma...
Source: The Journal of Law, Medicine and Ethics - October 1, 2013 Category: Medical Law Authors: Sergio Sismondo Source Type: research

The Ethics of Pharmaceutical Research Funding: A Social Organization Approach
This paper advances a social organization approach to examining unethical behavior. While unethical behaviors may stem in part from failures in individual morality or psychological blind spots, they are both generated and performed through social interactions among individuals and groups. To illustrate the value of a social organization approach, a case study of a medical school professor's first experience with pharmaceutical‐company‐sponsored research is provided in order to examine how funding arrangements can constrain research integrity. The case illustrates three significant ways that institutional corruption can...
Source: The Journal of Law, Medicine and Ethics - October 1, 2013 Category: Medical Law Authors: Garry C. Gray Source Type: research

Curbing Misconduct in the Pharmaceutical Industry: Insights from Behavioral Ethics and the Behavioral Approach to Law
This article therefore recommends using different sorts of regulation depending on the context. It suggests more tailored enforcement mechanisms that will be sensitive to the pharmaceutical researchers’ unique work motivations and to their awareness or lack of awareness of their own misconduct. (Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - October 1, 2013 Category: Medical Law Authors: Yuval Feldman, Rebecca Gauthier, Troy Schuler Source Type: research

Understanding Pharmaceutical Research Manipulation in the Context of Accounting Manipulation
This article analyzes pharmaceutical company manipulation of medical research as part of a broader problem of corporate manipulation of data in the creation of accounting profits. The article explores how our understanding of accounting fraud and misinformation helps us understand the risk of similar information manipulation in the medical sciences. This understanding provides a framework for considering how best to improve the quality of medical research and analysis in light of the current system of medical information production. I offer three possible responses: (1) use of the Dodd‐Frank whistleblower provisions to e...
Source: The Journal of Law, Medicine and Ethics - October 1, 2013 Category: Medical Law Authors: Abigail Brown Source Type: research

From Bad Pharma to Good Pharma: Aligning Market Forces with Good and Trustworthy Practices through Accreditation, Certification, and Rating
This article explores whether the bioethical performance and trustworthiness of pharmaceutical companies can be improved by harnessing market forces through the use of accreditation, certification, or rating. Other industries have used such systems to define best practices, set standards, and assess and signal the quality of services, processes, and products. These systems have also informed decisions in other industries about where to invest, what to buy, where to work, and when to regulate. Similarly, accreditation, certification, and rating programs can help drug companies address stakeholder concerns in four areas: cli...
Source: The Journal of Law, Medicine and Ethics - October 1, 2013 Category: Medical Law Authors: Jennifer E. Miller Source Type: research