The Journal of Law, Medicine and Ethics
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Dangerous Liaisons? Industry Relations with Health Professionals
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(Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - August 29, 2009 Category: Medical Law Authors: Robert M. Sade Tags: Symposium Articles Source Type: journals
Angela Roddey Holder (1938–2009)
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(Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - August 27, 2009 Category: Medical Law Tags: Columns Source Type: journals
Recent Developments in Health Law
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(Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - August 27, 2009 Category: Medical Law Authors: Carmel Shachar, Pooja Nair Tags: Columns Source Type: journals
Reviews
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(Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - August 27, 2009 Category: Medical Law Authors: John G. Browning Tags: Columns Source Type: journals
Teaching Health Law
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(Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - August 27, 2009 Category: Medical Law Authors: Diane E. Hoffmann Tags: Columns Source Type: journals
Currents in Contemporary Ethics
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(Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - August 27, 2009 Category: Medical Law Authors: Mark A. Rothstein Tags: Columns Source Type: journals
Data and Safety Monitoring Boards: Some Enduring Questions
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Data Safety and Monitoring Boards (DSMBs) have been referred to as a "growth industry," and this trend continues to be fueled by recent FDA guidance and the NIH's requirement that DSMBs be employed in virtually all phase III clinical trials. The widening role of DSMBs has been sporadically questioned on ethical grounds, but growth has continued, despite the fact that many of the questions endure, unanswered, save for repeated references to safeguarding the scientific integrity of trials. This may be about to change. The recently appointed director of the Office for Human Research Protections (OHRP), Jerry Menikoff, is on r...
Source: The Journal of Law, Medicine and Ethics - August 27, 2009 Category: Medical Law Authors: Charles J. Kowalski, Jan L. Hewett Tags: Independent Articles Source Type: journals
Futility Clarified
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Futility is easily defined as uselessness. The mistaken appearance that it cannot be defined is explained by difficulties applying it to particular cases. This latter problem is a major goal of clinical training and cannot be solved in a pithy statement. (Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - August 27, 2009 Category: Medical Law Authors: Eric Chwang Tags: Independent Articles Source Type: journals
Off-Label Prescribing: A Call for Heightened Professional and Government Oversight
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Under current U.S. law, physicians may prescribe drugs and devices in situations not covered on the label approved by the Food and Drug Administration. Those supporting this system say that requiring FDA approval for off-label uses would unnecessarily impede the delivery of benefits to patients. Patients do benefit from off-label prescribing that is supported by sound scientific and medical evidence. In the absence of such evidence, however, off-label prescribing can expose patients to risky and ineffective treatments. The medical community and federal authorities should more actively promote patients' interests in receivi...
Source: The Journal of Law, Medicine and Ethics - August 27, 2009 Category: Medical Law Authors: Rebecca Dresser, Joel Frader Tags: Independent Articles Source Type: journals
The Ethical Health Lawyer: An Empirical Assessment of Moral Decision Making
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Writing in 1999, legal ethics scholar Brad Wendel noted that "[v]ery little empirical work has been done on the moral decision making of lawyers." Indeed, since the mid-1990s, few empirical studies have attempted to explore how attorneys deliberate about ethical dilemmas they encounter in their practice. Moreover, while past research has explored some of the ethical issues confronting lawyers practicing in certain specific areas of practice, no published data exists probing the moral mind of health care lawyers. As signaled by the creation of a regular column "devoted to ethical issues arising in the practice of health law...
Source: The Journal of Law, Medicine and Ethics - August 27, 2009 Category: Medical Law Authors: Joshua E. Perry, Ilene N. Moore, Bruce Barry, Ellen Wright Clayton, Amanda R. Carrico Tags: Independent Articles Source Type: journals
Pharmaceutical Industry Financial Support for Medical Education: Benefit, or Undue Influence?
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Presently, the pharmaceutical industry funds about half of the costs of continuing medical education (CME) programs in the U.S. This contributes to the ethical problems that pervade the relationship between medicine and the pharmaceutical industry: trustworthiness and conflicts of interest. The problems are exacerbated by rationalizations prevalent on both sides that deny the ethical concerns. Commercialism and commercial bias are highly visible at large CME gatherings, and available data, while scanty, back up the view that physician attendees' subsequent prescribing practices are influenced by the commercial message. The...
Source: The Journal of Law, Medicine and Ethics - August 27, 2009 Category: Medical Law Authors: Howard Brody Tags: Symposium Articles Source Type: journals
DTC Advertising Harms Patients and Should Be Tightly Regulated
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The objective, of course, is to realize any unique benefits while minimizing the risks. On balance, the adverse effects of DTC advertising outweigh the still-unde-monstrated benefits of the advertising. (Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - August 27, 2009 Category: Medical Law Authors: Peter Lurie Tags: Symposium Articles Source Type: journals
Drug Reps Off Campus! Promoting Professional Purity by Suppressing Commercial Speech
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In the name of restoring professionalism, an influential group of physician-educators have urged academic medical centers to take the lead in purging the house of medicine of the conflicts of interest created by industry's marketing. I argue that this revivalist movement is misguided, uses "conflict of interest" as an epithet, creates counter-productive incentives, and fails the duty to prepare physicians for ethical engagement with their commercial partners in patient care. (Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - August 27, 2009 Category: Medical Law Authors: Lance K. Stell Tags: Symposium Articles Source Type: journals
More Regulation of Industry-Supported Biomedical Research: Are We Asking the Right Questions?
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Industry-sponsored biomedical research is under the microscope. In an attempt to achieve just results in extraordinary cases, critics are suggesting regulations that would pervert the U.S. clinical trial process. However, the arguments made to justify such regulation are weak at best. All the proposals to regulate industry sponsorship of clinical trials that we surveyed (over a hundred articles and ten books, most written in the past decade) suffer from some form of fallacious reasoning. In the interest of advocating sound policy, this article points out some of the most common reasoning errors found in the literature on f...
Source: The Journal of Law, Medicine and Ethics - August 27, 2009 Category: Medical Law Authors: Sigrid Fry-Revere, David Bjorn Malmstrom Tags: Symposium Articles Source Type: journals
Better Regulation of Industry-Sponsored Clinical Trials Is Long Overdue
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Regulating clinical trials for testing new drugs is fraught with risk. Misregulation can slow development of innovative and useful new drugs, but in other ways misregulation can foster trials that are inefficient and unethical, driven by commercial rather than scientific ends, and that can harm patients. In this paper, we argue not for more but for better regulation, based on the goal of rapidly producing innovative and safe products that represent significant advances in medical care. Data on industry-funded, late-stage clinical trials demonstrate an urgent need for dramatic changes in how these trials are designed, condu...
Source: The Journal of Law, Medicine and Ethics - August 27, 2009 Category: Medical Law Authors: Matthew Wynia, David Boren Tags: Symposium Articles Source Type: journals
Altruism and Self Interest in Medical Decision Making
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We seem to prefer that medicine and medical care be provided through altruistic motives. Even the pharmaceutical industry justifies its behavior in terms of altruistic purposes. But economists have known since Adam Smith that self-interested behavior can create large and growing social benefits. This is true for medical care as well as for other goods. First, I consider specifically the case of pharmaceutical promotion, both to physicians and to consumers. I argue that such promotion is highly beneficial to patients and leads to health improvements. I consider some criticisms of promotion, and show that they are misguided....
Source: The Journal of Law, Medicine and Ethics - August 27, 2009 Category: Medical Law Authors: Paul H. Rubin Tags: Symposium Articles Source Type: journals
Calendar of Events
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(Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - June 3, 2009 Category: Medical Law Tags: Columns Source Type: journals
Recent Case Developments in Health Law
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(Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - June 3, 2009 Category: Medical Law Authors: Brett Hartman, Faina Shalts, Caitlyn Ross Tags: Columns Source Type: journals
Teaching Health Law
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(Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - June 3, 2009 Category: Medical Law Authors: Jonathan Todres Tags: Columns Source Type: journals
Currents in Contemporary Ethics
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(Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - June 3, 2009 Category: Medical Law Authors: Cynthia Marietta, Amy L. McGuire Tags: Columns Source Type: journals
The Pharmacist's Obligations to Patients: Dependent or Independent of the Physician's Obligations?
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It has been 40 years since the seminal papers on pharmacy's status as a profession sparked debate about the pharmacist's role in health care, yet the questions they raised are just as poignant today as they were then. Questions about whether pharmacists are the experts when it comes to drug therapy information can be answered practically by assessing the perception of pharmacists' obligations to patients as being dependent on or independent of physicians' responsibilities. Both options have important implications for pharmacy's status as a profession, the value that pharmacists can add to health care, and a pharmacist's ri...
Source: The Journal of Law, Medicine and Ethics - June 3, 2009 Category: Medical Law Authors: Jason V. Altilio Tags: Independent Articles Source Type: journals
Differences in Regulatory Frameworks Governing Genetic Laboratories in Four Countries
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The purpose of this article is to determine how the heterogeneity of the different regulatory frameworks governing genetic laboratories in Australia, France, the United Kingdom, and the United States hinder the international availability of genetic tests. We conclude that a better understanding of the various national standards governing genetic laboratories may help health professionals choose laboratories for referral in an evidence based manner in order to protect the patient's best interests. (Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - June 3, 2009 Category: Medical Law Authors: Anne Marie Tassé, Élodie Petit, Béatrice Godard Tags: Independent Articles Source Type: journals
When Scientists Deceive: Applying the Federal Regulations
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Deception is a useful methodological device for studying attitudes and behavior, but deceptive studies fail to fulfill the informed consent requirements in the U.S. federal regulations. This means that before they can be approved by Institutional Review Boards, they must satisfy the four regulatory conditions for a waiver or alteration of these requirements. To illustrate our interpretation, we apply the conditions to a recent study that used deception to show that subjects judged the same wine as more enjoyable when they believed it had a higher price. (Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - June 3, 2009 Category: Medical Law Authors: Collin C. O'Neil, Franklin G. Miller Tags: Independent Articles Source Type: journals
Pushing the Dead into the Next Reproductive Frontier: Post Mortem Gamete Retrieval under the Uniform Anatomical Gift Act
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This article recommends that the National Conference of Commissioners on Uniform State Laws explicitly address the issue of post mortem gamete retrieval for reproductive purposes; that legislators specify whether their states will follow the Christy ruling; and that ethics committees and consultants prepare for the questions about human identity and self determination that post mortem gamete retrieval raises. (Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - June 3, 2009 Category: Medical Law Authors: Bethany Spielman Tags: Independent Articles Source Type: journals
Collaborated Death: An Exploration of the Swiss Model of Assisted Suicide for Its Potential to Enhance Oversight and Demedicalize the Dying Process
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Death, like many social problems, has become medicalized. In response to this medicalization, physician-assisted suicide (PAS) has emerged as one alternative among many at the end of life. And although the practice is currently legal in the states of Oregon and Washington, opponents still argue that PAS is unethical, is inconsistent with a physician's role, and cannot be effectively regulated. In comparison, Switzerland, like Oregon, permits PAS, but unlike Oregon, non-physicians and private organizations play a significant role in assisted death. Could the Swiss model be the answer? The following essay explores the Swiss ...
Source: The Journal of Law, Medicine and Ethics - June 3, 2009 Category: Medical Law Authors: Stephen J. Ziegler Tags: Independent Articles Source Type: journals
Riegel v. Medtronic, Inc.: Revisiting Pre-emption for Medical Devices
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The recent United States Supreme Court decision in Riegel v. Medtronic, Inc. affirmed the doctrine of pre-emption protection only for those medical devices reaching U.S. markets via the PMA (premarketing approval) process and preserved the previous Lohr v. Medtronic decision's lack of preemption protection for those medical devices marketed via the generally more abbreviated 510(k) clearance mechanism. This paper reviews the logic and faults of the Riegel decision and discusses the implications of the Riegel decision for pre-emption protection for other classes of FDA-approved medical products. (Source: The Journal of Law,...
Source: The Journal of Law, Medicine and Ethics - June 3, 2009 Category: Medical Law Authors: Bruce Patsner Tags: Symposium Articles Source Type: journals
Prizes and Parasites: Incentive Models for Addressing Chagas Disease
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Recent advances in immunology have provided a foundation of knowledge to understand many of the intricacies involved in manipulating the human response to fight parasitic infections, and a great deal has been learned from malaria vaccine efforts regarding strategies for developing parasite vaccines. There has been some encouraging progress in the development of a Chagas vaccine in animal models. A prize fund for Chagas could be instrumental in ensuring that these efforts are translated into products that benefit patients. (Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - June 3, 2009 Category: Medical Law Authors: Sara E. Crager, Matt Price Tags: Symposium Articles Source Type: journals
Just a Spoonful of Sugar: Drug Safety for Pediatric Populations
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Children deserve optimal medical care. Although prescription drugs play a prominent and essential role in pediatric health care delivery, health care providers often must make prescribing decisions for their young patients based on imperfect or absent safety and efficacy data for pediatric populations. The safe and effective use of prescription drugs in children depends on a thorough understanding of the physiologic differences between children and adults. Currently, only one-third of drugs prescribed to children have been studied for safety and efficacy in pediatric populations. Until relatively recently, the Food and Dru...
Source: The Journal of Law, Medicine and Ethics - June 3, 2009 Category: Medical Law Authors: Barbara A. Noah Tags: Symposium Articles Source Type: journals
Right to Experimental Treatment: FDA New Drug Approval, Constitutional Rights, and the Public's Health
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On May 2, 2006, a divided panel of the U.S. Court of Appeals for the District of Columbia, in a startling opinion, Abigail Alliance for Better Access to Developmental Drugs v. Eschenbach, held that terminally ill patients who have exhausted all other available options have a constitutional right to experimental treatment that FDA has not yet approved. Although ultimately overturned by the full court, Abigail Alliance generated considerable interest from various constituencies. Meanwhile, FDA proposed similar regulatory amendments, as have lawmakers on both sides of the aisle in Congress. But proponents of expanded access f...
Source: The Journal of Law, Medicine and Ethics - June 3, 2009 Category: Medical Law Authors: Elizabeth Weeks Leonard Tags: Symposium Articles Source Type: journals
Commentary: Innovation Policy for a New Era
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This commentary offers a response to the Sonderholm, Bird, and Flynn et al. articles, and argues that the current innovation crisis requires more ambitious approaches, as well as a serious consideration of alternative mechanisms for R&D such as prizes. (Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - June 3, 2009 Category: Medical Law Authors: Amy Kapczynski Tags: Symposium Articles Source Type: journals
Comment: Compulsory Licensing of Patented Pharmaceutical Inventions: Evaluating the Options
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In this Comment, the author traces the relevant legislative history pertaining to compulsory licensing of patented pharmaceuticals from the TRIPS Agreement of 1994 to the 2003 waiver to, and later proposed amendment of, article 31, which enables poor countries to obtain needed medicines from other countries that possess manufacturing capacity. The Comment then evaluates recent, controversial uses of the relevant legislative machinery as viewed from different critical perspectives. The Comment shows how developing countries seeking access to essential medicines can collaborate in ways that would avoid undermining incentives...
Source: The Journal of Law, Medicine and Ethics - June 3, 2009 Category: Medical Law Authors: Jerome H. Reichman Tags: Symposium Articles Source Type: journals
Wild-Card Patent Extensions as a Means to Incentivize Research and Development of Antibiotics
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Antibiotic resistance is a serious public health problem on a global scale. In both developed and developing countries, the unpleasant consequences of the phenomenon are being felt. This paper discusses wild-card patent extensions as a means to incentivize research and development of new antibiotics. The thesis defended in the paper is that the implementation of such patent extensions is an appropriate legislative response to the problem of antibiotic resistance. The general idea of wild-card patent extensions is presented in the first part of the paper. A number of objections to the idea are thereafter discussed and rejec...
Source: The Journal of Law, Medicine and Ethics - June 3, 2009 Category: Medical Law Authors: Jorn Sonderholm Tags: Symposium Articles Source Type: journals
Compulsory Licensing in Canada and Thailand: Comparing Regimes to Ensure Legitimate Use of the WTO Rules
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This paper examines two recent examples of compulsory licensing legislation: one globally embraced regime and one internationally controversial regime operating under the same WTO rules. In particular, we consider Canadian legislation and the use of compulsory licensing for HIV/AIDS drugs destined for a developing country. This is then contrasted with the conditions under which Thai authorities are pursuing compulsory licenses, the outcomes of their compulsory licenses, as well as the likely impact of the Thai policy. Finally, we construct a rubric to evaluate characteristics of a successful regime. This is used to analyze...
Source: The Journal of Law, Medicine and Ethics - June 3, 2009 Category: Medical Law Authors: Kristina M. Lybecker, Elisabeth Fowler Tags: Symposium Articles Source Type: journals
Developing Nations and the Compulsory License: Maximizing Access to Essential Medicines While Minimizing Investment Side Effects
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This manuscript addresses how developing countries can maximize access to essential medicines and minimize unwanted side-effects within the legal environment of a compulsory license regime. While compulsory licensing can play a role in improving public health, external social and political conditions must be considered in order to make licensing an effective practice. (Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - June 3, 2009 Category: Medical Law Authors: Robert C. Bird Tags: Symposium Articles Source Type: journals
An Economic Justification for Open Access to Essential Medicine Patents in Developing Countries
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This paper offers an economic rationale for compulsory licensing of needed medicines in developing countries. The patent system is based on a trade-off between the "deadweight losses" caused by market power and the incentive to innovate created by increased profits from monopoly pricing during the period of the patent. However, markets for essential medicines under patent in developing countries with high income inequality are characterized by highly convex demand curves, producing large deadweight losses relative to potential profits when monopoly firms exercise profit-maximizing pricing strategies. As a result, these mar...
Source: The Journal of Law, Medicine and Ethics - June 3, 2009 Category: Medical Law Authors: Sean Flynn, Aidan Hollis, Mike Palmedo Tags: Symposium Articles Source Type: journals
Using Patent Data to Assess the Value of Pharmaceutical Innovation
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Though many more patents emerge from industry sources, drug-related patents generated in the non-profit setting appear to have greater importance than patents arising from the commercial sector, which helps demonstrate the value non-profit research institutions can have in driving drug development. (Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - June 3, 2009 Category: Medical Law Authors: Aaron S. Kesselheim, Jerry Avorn Tags: Symposium Articles Source Type: journals
INTRODUCTION: Pharmaceutical Innovation: Law & the Public's Health
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(Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - June 1, 2009 Category: Medical Law Authors: Kevin Outterson Tags: Symposium Articles Source Type: journals
Introduction: Vulnerability in Biomedical Research
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(Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - February 26, 2009 Category: Medical Law Authors: Ana S. Iltis Tags: Symposium Articles Source Type: journals
Calendar of Events
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(Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - February 25, 2009 Category: Medical Law Tags: Columns Source Type: journals
Index to Volume 36
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(Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - February 25, 2009 Category: Medical Law Tags: Columns Source Type: journals
Recent Developments in Health Law
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(Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - February 25, 2009 Category: Medical Law Authors: Ching Ping Ang, Joseph Wolpin, Elisha Baron Tags: Columns Source Type: journals
Reviews in Medical Ethics
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(Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - February 25, 2009 Category: Medical Law Authors: Nancy M. P. King Tags: Columns Source Type: journals
Teaching Health Law
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(Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - February 25, 2009 Category: Medical Law Authors: Elizabeth Weeks Leonard Tags: Columns Source Type: journals
Currents in Contemporary Ethics
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(Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - February 25, 2009 Category: Medical Law Authors: Heather Harrell Tags: Columns Source Type: journals
Prejudice and the Medical Profession: A Five-Year Update
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Over the past decades the mortality rate in the United States has decreased, and life expectancy has increased. Yet a number of recent studies have drawn Americans' attention to the fact that racial and ethnic disparities persist in health care. It is clear that the U.S. health care system, which is the envy of the world, is not only flawed by basic injustices, but may be the cause of both injury and death for members of racial and ethnic minorities. Progress has been made in several areas since the original Institute of Medicine 2002 report. However, five years later, the 2007 National Healthcare Disparities Report (NHDR)...
Source: The Journal of Law, Medicine and Ethics - February 25, 2009 Category: Medical Law Authors: Peter A. Clark Tags: Independent Articles Source Type: journals
iPLEDGE Allegiance to the Pill: Evaluation of Year 1 of a Birth Defect Prevention and Monitoring System
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The United States Food and Drug Administration (FDA), in collaboration with pharmaceutical manufacturers, have recently implemented a heavily revised risk-management program for patients on isotretinoin (Accutane), a drug with known and pronounced teratogenic effects. This revised risk management plan places significant burdens on both providers and patients in the hopes of achieving its goal of reducing fetal exposure to isotretinoin. The main focus of this paper is to discuss the burdens of various aspects of the program in relationship to potential corresponding benefits. In particular, we evaluate the pregnancy rates o...
Source: The Journal of Law, Medicine and Ethics - February 25, 2009 Category: Medical Law Authors: Toby L. Schonfeld, N. Jean Amoura, Christopher J. Kratochvil Tags: Independent Articles Source Type: journals
A Walk in the Park: A Case Study in Research Ethics
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Can researchers, interested in novel ways to assess HIV seroprevalence among populations which are otherwise hidden, collect condoms that have been discarded on the ground in a public sex environment and test them for HIV? Researchers, who use other types of abandoned samples, such as discarded syringes, hair or saliva samples, or excess biological samples, confront similar issues. This review evaluates whether such abandoned tissues can be studied based on U.S. Code of Federal Regulations and literature on related issues including: research involving banked tissues, blinded seroprevalence studies, and property claims that...
Source: The Journal of Law, Medicine and Ethics - February 25, 2009 Category: Medical Law Authors: Zita Lazzarini, Patricia Case, Cecil J. Thomas Tags: Independent Articles Source Type: journals
In Defense of Bioethics
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Although bioethics societies are developing standards for clinical ethicists and a code of ethics, they have been castigated in this journal as "a moral, if not an ethics, disaster" for not having completed this task. Compared with the development of codes of ethics and educational standards in law and medicine, however, the pace of pro-fessionalization in bioethics appears appropriate. Assessed by this metric, none of the charges leveled against bioethics are justified. The specific charges leveled against the American Society for Bioethics and Humanities (ASBH) and its Core Competencies report are analyzed and rejected a...
Source: The Journal of Law, Medicine and Ethics - February 25, 2009 Category: Medical Law Authors: Robert Baker Tags: Independent Articles Source Type: journals
Vulnerable Brains: Research Ethics and Neurosurgical Patients
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Seven specific challenges in patient vulnerability related to neurosurgical advancement highlight needed augmentations for standards in innovation and research that do not unduly inhibit access to potential therapies while assuring just treatment of patients. (Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - February 25, 2009 Category: Medical Law Authors: Paul J. Ford Tags: Symposium Articles Source Type: journals
Vulnerability in Clinical Research with Patients in Pain: A Risk Analysis
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Some have characterized patients living with intractable pain as a vulnerable population in both clinical and research settings. Labeling the population as vulnerable, however, does not provide clarity regarding the potential risks that they face when they participate in research. Instead, research vulnerability for patients in pain is a function of an interaction between their pain conditions and elements of the research enterprise. Therefore, the identification of potential risks requires consideration not only of characteristics of patients with chronic pain, but also consideration of features of researchers, the qualit...
Source: The Journal of Law, Medicine and Ethics - February 25, 2009 Category: Medical Law Authors: Raymond C. Tait Tags: Symposium Articles Source Type: journals
