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.

Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs
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 prime clients, deepening the regulatory and cultural capture of the agency. Industry has demanded sho...
Source: The Journal of Law, Medicine and Ethics - October 1, 2013 Category: Medical Law Authors: Donald W. Light, Joel Lexchin, Jonathan J. Darrow Source Type: research

Five Un‐Easy Pieces of Pharmaceutical Policy Reform
This article examines five ways in which the public improperly depends on pharmaceutical firms that compromise the integrity of pharmaceutical policy. Today the public relies on pharmaceutical firms: (1) to set priorities on drug research and development; (2) to conduct clinical trials to test whether drugs are safe and effective; (3) to decide what clinical trial data to disclose to the public; (4) to monitor post marketing drug safety; (5) to supply product information to physicians and to finance continuing medical education and other professional activities. The article suggests options to overcome each of these depend...
Source: The Journal of Law, Medicine and Ethics - October 1, 2013 Category: Medical Law Authors: Marc A. Rodwin Source Type: research

Corruption of Pharmaceutical Markets: Addressing the Misalignment of Financial Incentives and Public Health
This paper explains how the current architecture of the pharmaceutical markets has created a misalignment of financial incentives and public health that is a central cause of harmful practices. It explores three possible solutions to address that misalignment: taxes, increased financial penalties, and drug pricing based on value. Each proposal could help to partly realign financial incentives and public health. However, because of the limits of each proposal, there is no easy solution to fixing the problem of financial incentives. (Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - October 1, 2013 Category: Medical Law Authors: Marc‐André Gagnon Source Type: research

Pharmaceuticals, Political Money, and Public Policy: A Theoretical and Empirical Agenda
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 pharmaceutical policy. Unless citizens mobilize...
Source: The Journal of Law, Medicine and Ethics - October 1, 2013 Category: Medical Law Authors: Paul D. Jorgensen Source Type: research

Parallel Problems: Applying Institutional Corruption Analysis of Congress to Big Pharma
Dennis Thompson and Lawrence Lessig are leading thinkers in the realm of institutional corruption, the notion that inappropriate dependencies and conflicts of interest undercut the ethical foundations of institutions on which society relies. Both are particularly known for their work on institutional corruption as it affects government and politics. This essay examines the applicability of their writing to the private sector, particularly as it relates to vital and influential industries like pharmaceuticals. (Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - October 1, 2013 Category: Medical Law Authors: Gregg Fields Source Type: research

FOREWORD: “Institutional Corruption” Defined
(Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - October 1, 2013 Category: Medical Law Authors: Lawrence Lessig Source Type: research

INTRODUCTION: Institutional Corruption and the Pharmaceutical Policy
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 skews the legislative process that sets pharmaceutic...
Source: The Journal of Law, Medicine and Ethics - September 1, 2013 Category: Medical Law Authors: Marc A. Rodwin Source Type: research

Legal Responses to Communal Rejection in Emergencies
(Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - June 26, 2013 Category: Medical Law Authors: James G. Hodge, Daniel G. Orenstein, Kim Weidenaar, Nick Meza, Laura Van Buren, Nick Wearne, Kristin Penunuri Source Type: research

HIPAA Privacy Rule 2.0
(Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - June 26, 2013 Category: Medical Law Authors: Mark A. Rothstein Source Type: research

Social Security Survivors Benefits: The Effects of Reproductive Pathways and Intestacy Law on Attitudes
Most minor children are eligible for Social Security survivors benefits if a wage‐earning parent dies, but eligibility of children not in utero at the time of death is more nuanced. The purpose of this study was to examine attitudes concerning access to Social Security survivors benefits in the context of posthumous reproduction. A probability sample of 540 Florida households responded to a multiple‐segment factorial vignette designed to examine the effects of state intestacy laws and five reproductive pathways – normative, posthumous birth, cryopreserved embryo, cryopreserved gametes, and posthumous gamete retrieval...
Source: The Journal of Law, Medicine and Ethics - June 26, 2013 Category: Medical Law Authors: Jason D. Hans, Martie Gillen Source Type: research

Caring for Elder Parents: A Comparative Evaluation of Family Leave Laws
As the baby boomer generation ages, the need for laws to enhance quality of life for the elderly and meet the increasing demand for family caregivers will continue to grow. This paper reviews the national family leave laws of nine major OECD countries (Canada, Denmark, France, Germany, Italy, Japan, Netherlands, Spain, and the United Kingdom) and provides a state‐by‐state analysis within the U.S. We find that the U.S. has the least generous family leave laws among the nine OECD countries. With the exception of two states (California and New Jersey), the U.S. federal Family Medical Leave Act of 1993 provides no right to...
Source: The Journal of Law, Medicine and Ethics - June 26, 2013 Category: Medical Law Authors: Y. Tony Yang, Gilbert Gimm Source Type: research

Advance Directives, Dementia, and Physician‐Assisted Death
Physician‐assisted suicide laws in Oregon and Washington require the person's current competency and a prognosis of terminal illness. In The Netherlands voluntariness and unbearable suffering are required for euthanasia. Many people are more concerned about the loss of autonomy and independence in years of severe dementia than about pain and suffering in their last months. To address this concern, people could write advance directives for physician‐assisted death in dementia. Should such directives be implemented even though, at the time, the person is no longer competent and would not be either terminally ill or suffe...
Source: The Journal of Law, Medicine and Ethics - June 26, 2013 Category: Medical Law Authors: Paul T. Menzel, Bonnie Steinbock Source Type: research

The Apomediated World: Regulating Research When Social Media Has Changed Research
Social Media, like Facebook and Twitter, are having a profound effect on the way that human subjects research is being conducted. In light of the changes proposed in ANPRM, in this article I argue that traditional research ethics and regulations may not easily translate to the use of social media in human subjects research. Using the conceptual model of apomediation, which describes the peer‐to‐peer way in which health information is shared via social media, I suggest that we may need to think again about the suitability of current regulations to deal with social media research. (Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - June 26, 2013 Category: Medical Law Authors: Dan O'Connor Source Type: research

Are Changes to the Common Rule Necessary to Address Evolving Areas of Research? A Case Study Focusing on the Human Microbiome Project
This article examines ways in which research conducted under the Human Microbiome Project, an effort to establish a “reference catalogue” of the micro‐organisms present in the human body and determine how changes in those micro‐organisms affect health and disease, raise challenging issues for regulation of human subject research. The article focuses on issues related to subject selection and recruitment, group stigma, and informational risks, and explores whether: (1) the Common Rule or proposed changes to the Rule adequately address these issues and (2) the Common Rule is the most appropriate vehicle to provide re...
Source: The Journal of Law, Medicine and Ethics - June 26, 2013 Category: Medical Law Authors: Diane E. Hoffmann, J. Dennis Fortenberry, Jacques Ravel Source Type: research

Biobanking, Consent, and Certificates of Confidentiality: Does the ANPRM Muddy the Water?
In its Advanced Notice of Proposed Rule Making (ANPRM), the U.S. Department of Health and Human Services proposed substantial changes to how biospecimen research is treated under the regulations governing human subjects research. Currently, much of this research can be conducted without consent because it may not be considered “human subjects” research, is considered exempt, or consent may be waived. Responding to criticisms that scientific changes have made biospecimen research riskier than contemplated when the Common Rule was last amended, the ANPRM proposes to require written consent for biospecimen research, even ...
Source: The Journal of Law, Medicine and Ethics - June 26, 2013 Category: Medical Law Authors: Brett A. Williams, Leslie E. Wolf Source Type: research