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Contents - JLME - 2012 Volume 40: 3
Table of Contents
  1. Table Of Contents
Letter From The Editor
  1. Letter From The Editor
Introduction
  1. Introduction: Insights from a National Conference: "Conflicts of Interest in the Practice of Medicine"
  2. Introduction: The Health Care Reform Law (PPACA): Controversies in Ethics and Policy
Symposium Articles
  1. The Future of Conflicts of Interest: A Call for Professional Standards
  2. Effect of Financial Relationships on the Behaviors of Health Care Professionals: A Review of the Evidence
  3. Is It Really All about the Money? Reconsidering Non-Financial Interests in Medical Research
  4. Conflicts of Interest and Your Physician: Psychological Processes That Cause Unexpected Changes in Behavior
  5. Medical Journals and Conflicts of Interest
  6. Toward Evidence-Based Conflicts of Interest Training for Physician-Investigators
  7. Conflicts of Interest, Institutional Corruption, and Pharma: An Agenda for Reform
  8. Physicians Have a Responsibility to Meet the Health Care Needs of Society
  9. Medical Responsibility
  10. Market-Based Reforms in Health Care Are Both Practical and Morally Sound
  11. Government Intervention in Health Care Markets Is Practical, Necessary, and Morally Sound
  12. Expanding Choice through Defined Contributions: Overcoming a Non-Participatory Health Care Economy
  13. Cost-Sharing under Consumer-Driven Health Care Will Not Reform U.S. Health Care
  14. Justice and Fairness: A Critical Element in U.S. Health System Reform
  15. No Theory of Justice Can Ground Health Care Reform
Independent Articles
  1. Free to Choose but Liable for the Consequences: Should Non-Vaccinators Be Penalized for the Harm They Do?
  2. A Trade Secret Model for Genomic Biobanking
  3. The Challenge of Providing the Public with Actionable Information during a Pandemic
  4. When Does an Illness Begin: Genetic Discrimination and Disease Manifestation
  5. Pediatric Participation in Non-Therapeutic Research
  6. Too Fast or Not Too Fast: The FDA's Approval of Merck's HPV Vaccine Gardasil
Columns
  1. Currents in Contemporary Bioethics: The Case against Precipitous, Population-Wide, Whole-Genome Sequencing
  2. Public Health and the Law: "Gaming the System" During Public Health Emergencies
Recent Court Decisions
  1. Recent Developments in Health Law: Brazil's Pregnancy Registration Requirement and International Commitments to the Rights of Women
Table of Contents
Table Of Contents
ASLME - [PDF] (Free Download)
THE JOURNAL OF LAW, MEDICINE & ETHICS CONTENTS VOLUME 40:3 FALL 2012 436 Introduction Aaron S. Kesselheim and David Orentlicher 441 The Future of Conflicts of Interest: A Call for Professional Standards Bernard Lo Stricter policies regarding conflicts of interest policies will increase transparency but have limitations and unintended adverse consequences. Physicians and the medical profession should take the lead in developing policies, rather than responding to external regulations. The goal is to reduce significant risks of undue influence, while keeping the burdens and opportunity costs of policies acceptable.
Letter From the Editor
Letter From The Editor
ASLME - [PDF]

On October 27-28, 2011, the American Society of Law, Medicine & Ethics hosted the national conference "Conflicts of Interest in the Practice of Medicine" in Pittsburgh, Pennsylvania. The conference was generously funded by the Highmark Foundation, with additional support provided by the Jewish Healthcare Foundation of Pittsburgh and the University of Pittsburgh Schools of Law and the Health Sciences. The Conflicts of Interest Conference was attended by more than one hundred registrants and speakers from across North America, who gathered to discuss, debate, and propose best practices and approaches to the problem of conflicts of interest. This conference furthered ASLME's mission to foster cross-disciplinary perspectives on pertinent issues, and brought together scholars and experts from many different fields and specialties to fashion recommendations for the key players in shaping policy and identify other key steps in moving forward.
Introductions
Introduction: Insights from a National Conference: "Conflicts of Interest in the Practice of Medicine"
Aaron S. Kesselheim and David Orentlicher - [PDF]

The practice of medicine is indelibly intertwined with the personal interests of the people and institutions delivering the care. Doctors and hospital executives worry about the physical and mental health of their patients, but they also worry about the financial health of their families and institutions. For-profit pharmaceutical and medical device companies seek to develop important new medical technologies, but also have a responsibility to their shareholders. Conflicts of interest are inevitable and pervasive in our health care system. And while they can promote better patient care, they also can compromise patient well-being. When surgeons are rewarded with royalties for their innovative devices, they are more likely to develop better devices, but they also may favor their own devices over alternative and better options.
Introduction: The Health Care Reform Law (PPACA): Controversies in Ethics and Policy
Robert M. Sade - [PDF]

In March, 2010, the Patient Protection and Affordable Care Act (PPACA) was signed into law by President Obama. The law has been controversial, to say the least. Both political parties believe that it is one of the most important pieces of social legislation to have been enacted in several decades, but they look at this law through decidedly different lenses. The same can be said of scholars and think tanks on the left and on the right. What are the fundamental differences between these contrasting views? In October 2011, 19 months after passage of the law, a conference - The Health Care Reform Law (PPACA): Controversies in Ethics and Policy - was held at the Medical University of South Carolina to explore some of those differences.
Symposium Articles
The Future of Conflicts of Interest: A Call for Professional Standards
Bernard Lo - [PDF]

Financial relationships between physicians and industry are widespread.1 Highly publicized financial relationships between physicians and industry raised disturbing questions about the trustworthiness of clinical research, practice guidelines, and clinical care decisions. Recent incidents spurred calls for stricter conflict of interest policies and led to new federal laws and NIH regulations.2 These stricter policies have evoked praise, concerns, and objections. Because these new federal requirements need to be interpreted and implemented, spirited discussions of conflicts of interest in medicine will continue.
Effect of Financial Relationships on the Behaviors of Health Care Professionals: A Review of the Evidence
Christopher Robertson, Susannah Rose, and Aaron S. Kesselheim - [PDF]

Physicians, scholars, and policymakers continue to be concerned about conflicts of interests among health care providers. At least two main types of objections to conflicts of interest exist. Conflicts of interests may be intrinsically troublesome if they violate providersí fiduciary duties to their patients or they contribute to loss of trust in health care professionals and the health care system. Conflicts of interest may also be problematic in practice if they bias the decisions made by providers, adversely impacting patient outcomes or wastefully increasing health care costs. This latter objection may be observed in differences in the prescriptions written, procedures performed, or costs billed by health care professionals who have conflicting interests, when compared to those that do not have such financial relationships.
Is It Really All about the Money? Reconsidering Non-Financial Interests in Medical Research
Richard S. Saver - [PDF]

Conflicts of interest have been reduced to financial conflicts. The National Institutes of Health's (NIH) new rules for managing conflicts of interest in medical research, the first major change to the regulations in over 15 years, address only financial ties. Although several commentators urged that the regulations also cover non-financial interests, the Department of Health and Human Services declined to do so. Similarly, the Institute of Medicine's (IOM) influential 2009 Conflict of Interest Report focuses almost exclusively on financial conflicts. Institutional policies at academic medical centers and guidance from professional bodies and medical journals also primarily emphasize financial ties. Even broadly worded rules are applied more readily to financial ties than non-financial interests, such as the regulations that restrict institutional review board (IRB) members with conflicting interests from participating in protocol reviews.
Conflicts of Interest and Your Physician: Psychological Processes That Cause Unexpected Changes in Behavior
Sunita Sah - [PDF]

The medical profession is under a state of increasing scrutiny. Recent high profile scandals regarding substantial industry payments to physicians, surgeons, and medical researchers have raised serious concerns over conflicts of interest. Amidst this background, the public, physicians, and policymakers alike appear to make the same assumption regarding conflicts of interest; that doctors who succumb to influences from industry are making a deliberate choice of self-interest over professionalism and that these doctors are corrupt.1 In reality, a myriad of evidence from social science indicates that influence from conflicts of interest often occurs on a subconscious and unintentional level. This poses an important issue, since such conflicts can steer wellintentioned physicians away from their primary professional goal to provide the best medical advice and treatment possible.
Medical Journals and Conflicts of Interest
Robert Steinbrook and Bernard Lo - [PDF]

Physicians and patients rely on medical journals as trusted sources of medical information. Unfortunately, in multiple instances conflicts of interest have undermined the credibility of the medical literature.
Toward Evidence-Based Conflicts of Interest Training for Physician-Investigators
Kate Greenwood, Carl H. Coleman, and Kathleen M. Boozang - [PDF]

In recent years, the government, advocacy organizations, the press, and the public have pressured universities, academic medical centers, and physicianinvestigators to do more to ensure that their financial interests and relationships do not conflict with their duties to conduct high-quality research and protect the safety and welfare of clinical trial participants. A number of factors underlie the increased focus. First, private sector funding of clinical research has grown both in absolute terms and as a proportion of overall funding. In 2008, the pharmaceutical, medical device, and biotechnology industries' domestic research and development expenditures constituted approximately 60.9% of funding for biomedical research in the United States; the next largest funder, the National Institutes of Health, funded 27.9%. Private industry spent $58.6 billion on research in 2007, up from $40 billion in 2003, an increase of 25% after adjusting for inflation. Second, after the passage of the Bayh-Dole Act in 1980, which allowed universities to patent inventions resulting from federally-funded research, collaborations between academic research institutions and the pharmaceutical and medical device industries increased substantially. Many academic research institutions now own biomedical patents which they strive to commercialize through licensing agreements or stakes in companies founded to exploit the patents. Finally, while not a new phenomenon, the prevalence of financial ties between pharmaceutical, medical device, and biotechnology companies and physician-investigators - such as free meals, drug samples, and payments for, among other things, service on advisory boards and giving promotional talks - continues to cause concern about bias in both government- and industry-funded research. In 2008, a congressional investigation spearheaded by Senator Charles E. Grassley revealed that a number of prominent researchers failed to report millions of dollars in payments from the makers of drugs that the researchers had been awarded government grants to study.
Conflicts of Interest, Institutional Corruption, and Pharma: An Agenda for Reform
Marc A. Rodwin - [PDF]

Why do physicians have financial conflicts of interest? They arise because society expects physicians to act in their patients' interest, while simultaneously, financial incentives encourage physicians to practice medicine in ways that promote their own interests or those of third parties. Because physicians' clinical choices, referrals, and prescriptions affect the fortune of third parties (providers, medical facilities, insurers, drug firms and suppliers of ancillary services), these third parties may offer physicians financial incentives to make income-driven clinical choices. In the past, physicians and scholars typically conceived of conflicts of interest as an ethical issue to be resolved according to individual judgment or professional and organizational norms. However, society can mitigate or eliminate conflicts of interest by changing financial and organizational arrangements in medicine. Conflicts of interest, therefore, are as much matters of public policy and management as individual choices or social norms.
Physicians Have a Responsibility to Meet the Health Care Needs of Society
Allan S. Brett - [PDF]

In one of the televised debates among Republican primary candidates for the 2012 U.S. presidential election, moderator Wolf Blitzer presented this hypothetical case to candidate Ron Paul.
Medical Responsibility
Ronald Hamowy - [PDF]

These comments seek to take issue with the contention that society has a responsibility to provide its members with any needed health care. In order to deal with this claim, we must first make clear exactly what it meant by the proposition. I take it that those who embrace this view mean considerably more than that each of us has a moral obligation to contribute to those in need of medical attention who are unable, for one reason or another, to afford the necessary care. This is a moral proposition and is traditionally dealt with under the heading of charity. But the contention, as here used, means considerably more since its main implications are not moral but primarily political.
Market-Based Reforms in Health Care Are Both Practical and Morally Sound
James Stacey Taylor - [PDF]

Markets have long had a whiff of sulphur about them. Plato condemned innkeepers, whose pursuit of profit he believed led them to take advantage of their customers, Aristotle believed that the pursuit of profit was indicative of moral debasement, and Cicero held that retailers are typically dishonest as this was the only path to gain. And even those who are more favorably disposed towards markets in general are frequently inclined to be suspicious of markets in medical goods and services. For example, Margaret Thatcher (to take someone far removed - in many respects! - from Plato, Aristotle, and Cicero) supported the legal prohibition of markets in kidneys despite being arguably the most pro-market Prime Minister the United Kingdom saw in the 20th century.
Government Intervention in Health Care Markets Is Practical, Necessary, and Morally Sound
Len M. Nichols - [PDF]

The intensity of the opposition to health reform in the United States continues to shock and perplex proponents of the Patient Protection and Affordable Care Act (PPACA).1 The emotion ("Abort Obama") and the apocalyptic rhetoric ("Save our Country, Protect our Liberty, Repeal Obamacare"), render civil and evidence-based debate over the implications and alternatives to specific provisions in the law difficult if not problematic. The public debate has largely barreled down two non-parallel yet non-intersecting paths: opponents focus on their fear of government expansion in the future if PPACA is implemented now, while proponents focus on the urgency and specifics of our health care market problems and the limited number of tools we have to address them. Frustration on both sides has led opponents to deny the seriousness of our health system's problems and proponents to ignore the risk of governmental overreach. These non-intersecting lines of argument are not moving us closer to a desired and necessary resolution.
Expanding Choice through Defined Contributions: Overcoming a Non-Participatory Health Care Economy
Robert E. Moffit - [PDF]

The Patient Protection and Affordable Care Act of 2010 (the Affordable Care Act) is the law of the land. But it faces an uncertain future.
Cost-Sharing under Consumer-Driven Health Care Will Not Reform U.S. Health Care
John P. Geyman - [PDF]

Various kinds of consumer-driven reforms have been attempted over the last 20 years in an effort to rein in soaring costs of health care in the United States. Most are based on a theory of moral hazard, which holds that patients will over-utilize health care services unless they pay enough for them. Although this theory is a basic premise of conventional health insurance, it has been discredited by actual experience over the years. While ineffective in containing costs, increased cost-sharing as a key element of consumer-driven health care (CDHC) leads to restricted access to care, underuse of necessary care, lower quality and worse outcomes of care. This paper summarizes the three major problems of U.S. health care urgently requiring reform and shows how cost-sharing fails to meet that goal.
Justice and Fairness: A Critical Element in U.S. Health System Reform
Paul T. Menzel - [PDF]

Various kinds of consumer-driven reforms have been attempted over the last 20 years in an effort to rein in soaring costs of health care in the United States. Most are based on a theory of moral hazard, which holds that patients will over-utilize health care services unless they pay enough for them. Although this theory is a basic premise of conventional health insurance, it has been discredited by actual experience over the years. While ineffective in containing costs, increased cost-sharing as a key element of consumer-driven health care (CDHC) leads to restricted access to care, underuse of necessary care, lower quality and worse outcomes of care. This paper summarizes the three major problems of U.S. health care urgently requiring reform and shows how cost-sharing fails to meet that goal.
No Theory of Justice Can Ground Health Care Reform
Griffin Trotter - [PDF]

The "Father of the United States Constitution," James Madison, once described justice as "the end" of both government and of civil society. Yet curiously, Madison said little about justice in elaborating the principles of American federalism in The Federalist Papers and elsewhere. His fundamental concerns, to the contrary, were in contriving a system of separated, countervailing powers and in establishing a first federal principle of enumerated powers - in which federal powers "are few, and defined." This strategy, for Madison, was the most feasible way of checking the innate tendency of political power to accumulate, centralize, and trample on citizens' liberties.
Independent Articles
Free to Choose but Liable for the Consequences: Should Non-Vaccinators Be Penalized for the Harm They Do?
Arthur L. Caplan, David Hoke, Nicholas J. Diamond, and Viktoriya Karshenboyem - [PDF]

Consider this hypothetical scenario involving a choice not to vaccinate a child. Ms. S has a niece who is autistic. The girl's parents are suspicious that there is some relationship between her autism and her Measles Mumps and Rubella (MMR) vaccination. They have shared their concerns with Ms. S. She then declines to have her own daughter, Jinny S., vaccinated with the MMR vaccine. To bypass the state's mandatory vaccination requirement, Ms. S claims a state-legislated "philosophical exemption," whereby she simply attests to the fact that she is opposed to vaccinating her daughter due to a "conscientiously held belief." At the age of four, Jinny goes on a trip by airplane to Germany with her mother. After returning to the United States, she attends daycare despite having some mild cold symptoms. Subsequently, she develops a classic measles rash, at which point her mother brings her to a pediatrician and keeps her home from daycare.
A Trade Secret Model for Genomic Biobanking
John M. Conley, Robert Mitchell, R. Jean Cadigan, Arlene M. Davis, Allison W. Dobson, and Ryan Q. Gladden - [PDF]

The current ethical norms of genomic biobanking - creating and maintaining large repositories of human DNA and/or associated data for biomedical research - have generated criticism from every angle, at both the practical and theoretical levels. The traditional research model has involved investigators seeking biospecimens for specific purposes that they can describe and disclose to prospective subjects, from whom they can then seek informed consent. In the case of many biobanks, however, the institution that collects and maintains the biospecimens may not itself be directly involved in research, instead "banking" the biospecimens and associated data for other researchers. Moreover, the future uses of biospecimens may be unknown, if not unknowable, at the time of collection. Biobanking may thus stretch the meanings of "inform" and "consent" to their breaking point: if you cannot inform subjects about what their biospecimens will be used for (because you do not know), what can they consent to? Given that informed consent by individual subjects is the ethical gold standard, the seeming dilution of the concept in the context of biobanking is a profound problem.
The Challenge of Providing the Public with Actionable Information during a Pandemic
Leslie E. Gerwin - [PDF]

Can a country with a free press and a robust political debate provide its citizens with actionable information so that they can protect themselves from a threat to their health or safety? By actionable information, I mean accurate facts and reasonable interpretations of those facts upon which an individual should rely in making reason-based decisions. In the context of public health, this includes information that allows an individual to weigh the risk to one's self, family, and community before deciding to act in an uncertain environment under threatening conditions. The recent H1N1 pandemic, and in particular the government's campaign for public acceptance of the vaccine, highlights the challenges in ensuring that individuals receive accurate information and perceive that such information should be the basis on which to make potential life-saving decisions.
When Does an Illness Begin: Genetic Discrimination and Disease Manifestation
Anya E. R. Prince and Benjamin E. Berkman - [PDF]

Congress passed the Genetic Information Nondiscrimination Act of 2008 (GINA) in order to remove a perceived barrier to clinical genetic testing. By banning health insurance companies and employers from discriminating against an individual based on his or her genetic information, legislators hoped that patients would be encouraged to seek genetic testing that could improve health outcomes and provide opportunities for preventive measures. Their explicit legislative goal was "to fully protect the public from discrimination and allay their concerns about the potential for discrimination, thereby allowing individuals to take advantage of genetic testing, technologies, research, and new therapies."
Pediatric Participation in Non-Therapeutic Research
Marilyn C. Morris - [PDF]

Pediatric participation in non-therapeutic research that poses greater than minimal risk has been the subject of considerable thought-provoking debate in the research ethics literature. While the need for more pediatric research has been called "morally imperative," and concerted efforts have been made to increase pediatric medical research, the importance of protecting children from undue research risks remains paramount.
Too Fast or Not Too Fast: The FDA's Approval of Merck's HPV Vaccine Gardasil
Lucija Tomljenovic and Christopher A. Shaw - [PDF]

There are not many public health issues where views are as extremely polarized as those concerning vaccination policies. Ever since its Fast Track approval by the U.S. Food and Drug Administration (FDA) in 2006, Merck's human papilloma virus (HPV) vaccine Gardasil has been sparking controversy. Initially, the criticism has been focused at Merck, due to their overly aggressive marketing strategies and lobbying campaigns. According to a 2007 editorial in Nature Biotechnology, "Surrounded by a chorus of disapproval, Merck cracked. As Nature Biotechnology went to press, the company announced a cessation of all efforts to lobby for US state laws requiring compulsory vaccination."
Columns
Currents in Contemporary Bioethics: The Case against Precipitous, Population-Wide, Whole-Genome Sequencing
Mark A. Rothstein - [PDF]

From the earliest days of the Human Genome Project, the holy grail of genomics was the ability to perform whole-genome sequencing quickly, accurately, and relatively inexpensively so that the benefits of genomics would be widely available in clinical settings. Although the mythical $1,000 genome sequence seemed elusive for many years,1 next-generation sequencing technologies and other recent advances clearly indicate that inexpensive whole-genome sequencing is at hand.
Public Health and the Law: "Gaming the System" During Public Health Emergencies
James G. Hodge, Jr., Lexi C. White, and Andrew Sniegowski - [PDF]

Whether the result of natural or manmade causes, public health emergencies are typified by a crisis of allocation. Essential resources (e.g., drugs, vaccinations, equipment, medical supplies, and personnel) can quickly become limited as public demand increases. As clarified by the Institute of Medicine, a declaration of emergency may be sustained by the ensuing predicament when supplies of essential public health or medical resources cannot meet demand. Countless efforts to address allocation challenges have been offered by public and private actors. They tend to focus on strict inventory controls and priority setting for distribution of scarce resources. A primary goal is to assure that those most in need of resources, based on epidemiologic or other public health evidence, are most likely to get them. Meeting this objective, however, may be compromised through bad data, inaccurate criteria, inadvertent misallocations, or political factors. The objective may also be subverted through attempts to "game the system."
Recent Court Decisions
Recent Developments in Health Law: Brazil's Pregnancy Registration Requirement and International Commitments to the Rights of Women
Adam Chilton - [PDF]

In the last several years, Brazil has gained international attention as an emerging "BRIC" economy, was awarded the 2014 World Cup and 2016 Olympics, and elected its first female president. This has led many to declare that Brazil is emerging as a potential world power for the 21st century. In addition to improving its international stature, in the last several decades Brazil has also significantly improved the availability and quality of health care within the country.