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Contents - JLME - 2011 Volume 39: 3
Table of Contents
  1. Table Of Contents
Letter From The Editor
  1. Letter From The Editor
Introduction
  1. Introduction: The Prospects for Public Health Reform
Symposium Articles
  1. Improving the Population's Health: The Affordable Care Act and the Importance of Integration
  2. From Health Care Reform to Public Health Reform
  3. The Patient Protection and Affordable Care Act, Public Health, and the Elusive Target of Human Rights
  4. The Affordable Care Act's Preventive Services Mandate: Breaking Down the Barriers to Nationwide Access to Preventive Services
  5. PPACA and Public Health: Creating a Framework to Focus on Prevention and Wellness and Improve the Public's Health
  6. Obesity and Health System Reform: Private vs. Public Responsibility
  7. Combating Obesity through the Built Environment: Is There a Clear Path to Success?
  8. Congress, Courts, and Commerce: Upholding the Individual Mandate to Protect the Publicís Health
  9. The Individual Mandate: Implications for Public Health Law
  10. Conscripted Physician Services and the Public's Health
  11. Improving Health Care Outcomes through Personalized Comparisons of Treatment Effectiveness Based on Electronic Health Records
  12. The New Era of Comparative Effectiveness: Will Public Health End Up Left Behind?
  13. The Law, Policy, and Ethics of Employers' Use of Financial Incentives to Improve Health
  14. When Public Health and Genetic Privacy Collide: Positive and Normative Theories Explaining How ACA's Expansion of Corporate Wellness Programs Conflicts with GINA's Privacy Rules
Independent Articles
  1. Justice, Fairness, and Membership in a Class: Conceptual Confusions and Moral Puzzles in the Regulation of Human Subjects Research
  2. Inclusion of Racial and Ethnic Minorities in Genetic Research: Advance the Spirit by Changing the Rules?
  3. Views and Experiences of IRBs Concerning Research Integrity
  4. Minimal Risk in Research Involving Pregnant Women and Fetuses
  5. Improve Medical Malpractice Law by
  6. Paying Human Subjects in Research: Where Are We, How Did We Get Here, and Now What?
Columns
  1. Currents in Contemporary Bioethics: Waiving Informed Consent to Prenatal Screening and Diagnosis? Problems with Paradoxical Negotiation in Surrogacy Contracts
Table of Contents
Table Of Contents
ASLME - [PDF] (Free Download)
THE JOURNAL OF LAW, MEDICINE & ETHICS CONTENTS VOLUME 39:3 Fall 2011 Symposium Articles 312 Introduction Elizabeth Weeks Leonard 317 Improving the Population's Health: The Affordable Care Act and the Importance of Integration Lorian E. Hardcastle, Katherine L. Record, Peter D. Jacobson, and Lawrence O. Gostin Despite evidence indicating that public health services are the most effective means of improving the population's health status, health care services receive the bulk of funding and political support. The recent passage of the Affordable Care Act, which focused on improving access to health care services through insurance reform, reflects the primacy of health care over public health. Although policymakers typically conceptualize health care and public health as two distinct systems, gains in health status are most effectively and cost-efficiently achieved through their integration into a single health system. The Act does little to compel integration; however, there are numerous opportunities to encourage the coordination of public health and health care in the Act's implementation. 328 From Health Care Reform to Public Health Reform Micah L. Berman Even when turning its attention to public health topics such as preventive care and workplace wellness, the Affordable Care Act law embodies a highly individualistic paradigm of health. The provisions of the law implicitly assign the primary responsibility for prevention to individuals, who should be urged to make more responsible and healthier choices about what they consume and how they live. Relatively little in the law reflects the "population perspective" set forth in public health scholarship that focuses on environmental and social determinants of health. This article explores the cultural and economic factors that led Congress to embrace a highly individualist conception of public health, and it suggests how public health advocates and legal scholars might seek to reframe the public discourse surrounding preventive health issues.
Letter From the Editor
Letter From The Editor
ASLME - [PDF]

To be sure, the health reform laws passed in 2010 have come under intense scrutiny, including in the pages of the Journal of Law, Medicine & Ethics. However, in this special symposium issue, we turn our attention to a particular subset of the Patient Protection and Affordable Care Act: the implications for the public's health. Our Guest Editor for this issue, Elizabeth Weeks Leonard, asks some tough questions about the Act and its impact: is it, as some say, a monumental achievement that will have a lasting legacy, or is it, as many authors in this symposium argue, a monument only to missed opportunity? Leonard and her authors - who include many old friends of JLME, such as Larry Gostin, James Hodge, Jr., Wendy Parmet, and Richard Saver - argue above all that the ultimate outcomes of the Act will be mixed, and that the deeply complex public health situation in the United States will not yield to simple solutions. The diversity and richness of a multidisciplinary approach to the problem, one that JLME so uniquely provides, is the first step in examining these thorny issues. I also encourage you to take a look at this issue's particularly varied independent articles, including a fascinating look at human subjects research by former Editor-in-Chief of JLME, Ana Illtis, an examination of IRBs and research integrity by Robert Klitzman, and a thorough overview of paying human subjects for research. Taken together, it is another abundant collection of interesting and diverse articles.
Introductions
Introduction: The Prospects for Public Health Reform
Elizabeth Weeks Leonard - [PDF]

The Patient Protection and Affordable Care Act of 2010 (PPACA) represents a monumental political achievement and promises dramatic changes for the United States health care delivery system. But what impact will the law have on public health? In the view of many of the commentators included in this symposium, PPACA was a missed opportunity to accomplish foundational health reform in terms of addressing root causes of poor health and putting structures in place to improve the health status of the population as a whole. PPACA's primary aim is increasing access to affordable health insurance coverage for all Americans. Increased access to insurance should improve access to medical care, which should improve the health of individuals and, thereby, the population. Was public health merely an afterthought in the comprehensive package of reforms, or does PPACA offer real possibilities for strengthening the public health system and improving the population's health?
Symposium Articles
Improving the Population's Health: The Affordable Care Act and the Importance of Integration
Lorian E. Hardcastle, Katherine L. Record, Peter D. Jacobson, and Lawrence O. Gostin - [PDF]

Heath care and public health are typically conceptualized as separate, albeit overlapping, systems. Health care's goal is the improvement of individual patient outcomes through the provision of medical services. In contrast, public health is devoted to improving health outcomes in the population as a whole through health promotion and disease prevention. Health care services receive the bulk of funding and political support, while public health is chronically starved of resources. In order to reduce morbidity and mortality, policymakers must shift their attention to public health services and to the improved integration of health care and public health. In other words, health care and public health should be treated as two parts of a single integrated health system (which we refer to as the health system throughout this article). Furthermore, in order to maximize improvements in health status, policymakers must consider the impact of all governmental policies on health (a Health in All Policies Approach). The Patient Protection and Affordable Care Act of 2010 (ACA or the Act)1 reflects the dominance of health care over public health. As its name suggests, the statute's primary goal is to improve access to health care services through insurance system reforms. In contrast, politicians neglected the goal of improving the population's health in this monumental overhaul of our health system. Although the ACA does little to mandate health system integration, various opportunities exist within the Act's implementation for decision makers to improve coordination between health care and public health.
From Health Care Reform to Public Health Reform
Micah L. Berman - [PDF]

According to Congressional Budget Office projections, the Patient Protection and Affordable Care Act (Affordable Care Act or Act) - assuming it survives the pending legal challenges and is fully implemented - will provide health insurance to 34 million additional Americans by 2021. This will increase the percentage of non-elderly Americans with health insurance from the current rate of 83 percent to 95 percent. Although enactment of the Affordable Care Act constitutes a historic step forward in the nearly century-long effort to ensure universal health insurance coverage, relatively little in the Act focused on the potentially transformative impact of public health efforts that prevent disease. Chronic diseases such as heart disease, cancer, stroke, and diabetes are now responsible for more than 75 percent of health care costs, and reducing the incidence of these diseases - which are often entirely preventable - could dramatically improve the nation's physical and fiscal health.
The Patient Protection and Affordable Care Act, Public Health, and the Elusive Target of Human Rights
Lance Gable - [PDF]

The passage of the Patient Protection and Affordable Care Act (ACA) in March 2010 represents a significant turning point in the evolution of health care law and policy in the United States. By establishing a legal infrastructure that seeks to achieve universal health insurance coverage in the United States, the ACA targets some of the major impediments to accessing needed health care for millions of Americans and by extension attempts to strengthen the health system to support key determinants of health. Yet, like many newly passed legislative provisions, the ultimate effects and significance of the ACA remain uncertain. Those charged with implementing the ACA face formidable obstacles - indeed, some of the same obstacles that have been erected to impede other major pieces of social legislation in the past - including entrenched political opposition, constitutional challenges, and what will likely be a prolonged struggle over the content and direction of how the law is implemented. As these debates continue, it is nevertheless important to begin to assess the impact that the ACA has already had on health law in the United States and to consider the likely effects that the law will have on public health going forward.
The Affordable Care Act's Preventive Services Mandate: Breaking Down the Barriers to Nationwide Access to Preventive Services
John Aloysius Cogan Jr. - [PDF]

The most prominent - and certainly the most controversial - feature of the Patient Protection and Affordable Care Act (the ACA, or the Act) is the so-called "individual mandate," which attempts to address the problem of 50 million uninsured by requiring nearly all Americans, beginning in 2014, to obtain health insurance. While expanded access to health insurance has been both the cornerstone and the lightening rod of the ACA, the Act also contains significant public health provisions focusing on, among other things, promoting the availability of prevention and wellness services. Although these public health provisions have been greeted with mixed reviews, there has been very little discussion of what may be the ACA's most significant public health feature: the preventive services mandate. In a bold stroke, the ACA changes the way evidence-based preventive services will be provided and paid for by private health insurance plans, Medicare, and Medicaid. By requiring these health plans to provide evidence-based preventive services with no out-of-pocket costs, the ACA transforms the U.S.'s public and private health care financing systems into vehicles for promoting public health.
PPACA and Public Health: Creating a Framework to Focus on Prevention and Wellness and Improve the Public's Health
Gwendolyn Roberts Majette - [PDF]

On March 23, 2010, President Obama signed the Patient Protection and Affordable Care Act (PPACA), a major piece of health care reform legislation. This comprehensive legislation includes provisions that focus on prevention, wellness, and public health. Some, including authors in this symposium, question whether Congress considered public health, prevention, and wellness issues as mere afterthoughts in the creation of PPACA. As this article amply demonstrates, they did not. This article documents the extent of congressional consideration on public health issues based on personal experience working on the framework for health care reform - specifically, my experience as a Fellow for a member of the Health Subcommittee of the Senate Finance Committee from 2008-2009. I also include a review of congressional activity in the United States House of Representatives. Analysis of the congressional meetings and hearings reveals that Congress had a deep understanding about the critical need to reform the U.S. public health and prevention system. The article illustrates how PPACA will have a positive impact on public health by examining the infrastructure that Congress designed to focus on prevention and wellness, with a particular emphasis on the National Prevention, Health Promotion and Public Health Council, the National Prevention, Health Promotion, Public Health, and Integrative Health Care Strategy, and the Prevention and Public Health Fund. The Council, strategy, and fund are especially important because they reflect compliance with some of the Institute of Medicine's recommendations to improve public health in the United States, as well as international health and human rights norms that protect the right to health.
Obesity and Health System Reform: Private vs. Public Responsibility
Y. Tony Yang and Len M. Nichols - [PDF]

The obesity epidemic is not only impairing the health of millions of Americans but also giving rise to billions of added dollars in health care spending. Climbing rates of obesity over the past decades are one of the predominant determinants behind the surging progression of health care expenses in the United States. Moreover, the less fit and less productive U.S. workforce has gradually eroded the nation's industrial competitiveness. Since the early 1970s, adult obesity rates have doubled and childhood obesity rates have more than tripled, while health expenditures have risen two percentage points faster than the Gross Domestic Product (GDP), burgeoning from 8.8 percent in 19803 to a projected 17.9 percent in 2011. Studies analyze that greater than a quarter of America's health care expenses are attributed to obesity. The stunning growth in obesity has been imputed for 20 to 30 percent of the increase in health care costs since the late 1970s. If the proportion of obese population had stayed unchanged, then health care expenditures in America would be approximately 10 percent less on a per capita average than they are today.
Combating Obesity through the Built Environment: Is There a Clear Path to Success?
Fazal Khan - [PDF]

It is no secret that one of the biggest public health challenges facing this nation is the obesity epidemic. Two-thirds of adults and one-third of children and teens are either obese or overweight. For adults, the number of obese has doubled since 1980, and for children age 6-11 the number of obese has quadrupled. The epidemic has changed what we thought we knew about medicine. For example, until fairly recently, type 2 diabetes was known as "adult-onset" diabetes. But doctors have dropped this moniker as youth account for almost half of new type 2 diabetes in certain communities. Further, there has always been an assumption that life spans and health would improve with advancements in medicine and technology. However, obesity is related to over 20 major chronic diseases, and therefore obese children are more than twice as likely to die before the age of 55 compared to healthy-weight children. In other words, if trends are not reversed, America's current generation of children are likely to have shorter life spans than their parents.
Congress, Courts, and Commerce: Upholding the Individual Mandate to Protect the Publicís Health
James G. Hodge, Jr., Erin C. Fuse Brown, Daniel G. Orenstein, and Sarah O'Keefe - [PDF]

Despite historic efforts to enact the Patient Protection and Affordable Care Act (PPACA) in 2010, national health reform is threatened by multiple legal challenges grounded in constitutional law. Premier among these claims is the premise that PPACA's "individual mandate" (requiring all individuals to obtain health insurance by 2014 or face civil penalties) is constitutionally infirm. Attorneys General in Virginia and Florida (joined by 25 other states) allege that Congress' interstate commerce powers do not authorize federal imposition of the individual mandate because Congress lacks the power to regulate commercial "inactivity." Stated simply, Congress cannot regulate individuals who choose not to obtain health insurance because they are not engaged in a commercial venture. Several courts initially considering this argument have rejected it, but two federal district courts in Virginia and Florida have concurred, leading to numerous appeals and the near promise of United States Supreme Court review.
The Individual Mandate: Implications for Public Health Law
Wendy E. Parmet - [PDF]

No provision of the Patient Protection and Affordable Care Act (PPACA) has proven to be more contentious than the so-called "individual mandate." Starting in 2014, the mandate will impose a penalty on non-exempt individuals who lack health insurance. According to Congress, the mandate is essential to ensuring near universal coverage. Without it, PPACA's insurance reforms will lead healthy individuals to delay purchasing health insurance until they require medical care, resulting in risk pools with a disproportionate share of high-risk people. The price of insurance will then climb, causing more and more not-so-sick people to forego health insurance. The resulting "death spiral" will make insurance unaffordable to many more Americans.
Conscripted Physician Services and the Public's Health
Marshall B. Kapp - [PDF]

The Patient Protection and Affordable Care Act of 2010 (PPACA) purportedly assures almost all Americans of the right to health insurance coverage. The long-term success of this legislation in improving the public's health in the United States will likely hinge in no small part on the degree to which statutorily establishing a right to health insurance coverage translates into actual timely, meaningful access to health services, particularly physician services, for specific individuals. Historically, the physician-patient relationship has been one into which each party enters voluntarily. According to the American Medical Association, "A patient-physician relationship exists when a physician serves a patient's medical needs, generally by mutual consent between physician and patient (or surrogate)." Moreover, "Although the concept of free choice assures that an individual can generally choose a physician, likewise a physician may decline to accept that individual as a patient."
Improving Health Care Outcomes through Personalized Comparisons of Treatment Effectiveness Based on Electronic Health Records
Sharona Hoffman and Andy Podgurski - [PDF]

The unsustainable growth in U.S. health care costs is in large part attributable to the rising costs of pharmaceuticals and medical devices and to unnecessary medical procedures. This fact has led health reform advocates and policymakers to place considerable hope in the idea that increased government support for research on the comparative effectiveness of medical treatments will eventually help to reduce health care expenses by informing patients, health care providers, and payers about which treatments for common conditions are effective and which are not. Comparative effectiveness research (CER) has shown in some cases that expensive but commonly used treatments are significantly less effective than relatively inexpensive alternatives. Critics warn, however, that CER will homogenize patient care, limit patient choices, and lead to improper health care rationing and even to the denial of lifesaving treatments. In 2009, Congress allocated $1.1 billion in funding for CER, as part of the American Reinvestment and Recovery Act (ARRA). The Patient Protection and Affordable Care Act of 2010 (PPACA) embraced CER as an important health care reform initiative and established the Patient-Centered Outcomes Research Institute to oversee CER in the United States. CER represents a major public health enterprise, since public health, broadly defined, includes all "federal, state, and local governmental efforts to maintain and protect the health of the general population."
The New Era of Comparative Effectiveness: Will Public Health End Up Left Behind?
Richard S. Saver - [PDF]

As a result of health care reform, medicine has entered a new era of comparative effectiveness. The Patient Protection and Affordable Care Act (PPACA) created the nation's first comprehensive comparative effectiveness research (CER) program, investing in CER at record levels and establishing a new regulatory framework for oversight of the research. CER attracts considerable enthusiasm as a tool for reform because it compares competing interventions to determine which works best, supplying critical information for medical decision-making and health policy. In theory, better evidence of how treatments fare relative to one another will translate to better medical care. According to some optimistic accounts, CER can lead to a "revolution" in clinical practice, has transformative power "to reshape major portions of the practice of medicine," and represents a major "turning point" for the health care system. But what about public health? There are reasons for concern that it could end up left behind in the new era of comparative effectiveness. This article analyzes the considerable promise and serious limitations of applying CER to public health. It also highlights important issues that will likely emerge for public health law and policy as the health care system transitions to greater reliance on CER.
The Law, Policy, and Ethics of Employers' Use of Financial Incentives to Improve Health
Kristin M. Madison, Kevin G. Volpp, and Scott D. Halpern - [PDF]

Individuals can often take steps to preserve or improve their own health. They can eat appropriate quantities of healthy foods, exercise, and refrain from smoking. They can obtain preventive care and adhere to their physicians' advice about how best to manage their health. But they often fail to take these steps. A widespread failure to adopt healthy behaviors can significantly erode public health while increasing health care costs. Obesity, for example, increases the risk of heart disease, stroke, liver disease, and certain cancers. By one estimate, it is responsible for almost 10 percent of medical spending in the United States, or about $147 billion per year. Smoking increases the risk of heart disease, stroke, lung disease, and cancer; it accounts for nearly 20 percent of deaths each year in the United States and about $96 billion in health care expenditures. Public health officials, health care providers, health insurers, and others have historically used many techniques to encourage individuals to improve their own health. In recent years, however, one particular mechanism for health improvement has attracted increasing attention: financial incentives.
When Public Health and Genetic Privacy Collide: Positive and Normative Theories Explaining How ACA's Expansion of Corporate Wellness Programs Conflicts with GINA's Privacy Rules
Jennifer S. Bard - [PDF]

The passing of the Patient Protection and Affordable Care Act (ACA) is a triumph for the field of public health. Its inclusion of many provisions intended to prevent illness and promote health endorses the core belief of public health as expressed by Dr. Georges Benjamin, the long-time executive director of the American Public Health Association, in a Washington Post opinion piece praising ACA for "provid[ing] care as far upstream as possible... [in order to] reduce costs by identifying problems early and then managing them to reduce or eliminate the need for more costly care in the future." In this article, I consider the conflict between ACA's adoption of public health goals seeing population health and societal interests in protecting individuals from discrimination based on their health. The article focuses on one aspect of ACA which seeks to lower the costs to employers who provide health insurance for their employees by making it easier for them to offer their employees substantial incentives for participating in and meeting the goals of employer-sponsored Wellness Programs.
Independent Articles
Justice, Fairness, and Membership in a Class: Conceptual Confusions and Moral Puzzles in the Regulation of Human Subjects Research
Ana S. Iltis - [PDF]

Much of the human research conducted in the United States or by U.S. researchers is regulated by the Common Rule. The Common Rule reflects the decision of 17 federal agencies, including the Department of Health and Human Services (whose regulations appear at 45CFR46), to require that investigators follow the same rules for conducting human research. (The Food and Drug Administration [FDA] has its own rules (at 21CFR50 and 21CFR56), though there is significant overlap with the Common Rule.) Many of the obligations delineated in the Common Rule can be traced back to the work of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (hereafter the National Commission). The National Commission was appointed in 1974 as part of the National Research Act (P.L. 93-348) in response to revelations about serious abuses involving human subjects, most notably the Tuskegee/United States Public Health Service Syphilis Study. The National Commission was appointed both to identify ethical principles for the conduct of human research and to recommend regulations that would protect research subjects' rights and welfare. The Commission relied heavily on philosophers, historians, and theologians in conducting its work. It issued a series of reports on the ethical conduct of human research including research on children, prisoners, the institutionalized as mentally infirm, and fetuses. The most general and perhaps well-known of these is the Belmont Report, in which the Commission articulated three principles (respect for persons, beneficence, and justice) that could serve as the basis for formulating specific rules concerning the ethical conduct of research involving human subjects. The Commission's work continues to be highly influential, and even today when institutions apply for a federal wide assurance (FWA), which is an agreement between an institution and the federal government (specifically, the Office for Human Research Protections) that assures the federal government that all research conducted by an institution or its agents will comply with the federal regulations governing research, they are asked to verify that they will adhere to the Belmont principles or to cite another code of ethics that will inform their review and oversight of human research. Moreover, many of the regulations governing research were heavily influenced by the National Commission's work. So, the National Commission's reports are not merely historical artifacts. They continue to shape our understanding of human research ethics and the proper regulation and oversight of such research.
Inclusion of Racial and Ethnic Minorities in Genetic Research: Advance the Spirit by Changing the Rules?
Sarah Knerr, Dawn Wayman, and Vence L. Bonham - [PDF]

As genetic and genomic research has progressed since the sequencing of the human genome, scientists have continued to struggle to understand the role of genetic and socio-cultural factors in racial and ethnic health disparities. Recognition that race and ethnicity correlate imperfectly with differences in allele frequency, environmental exposures, and significant health outcomes has made framing the relationship between genetic variation, race, ethnicity, and disease one of the most heated debates of the genome era. Because racial and ethnic identities reflect a complicated mix of social and genetic factors, critics have argued that use of racial and ethnic categories as analytical variables in biomedical research lacks rigor, leads to potentially dangerous stereotyping in medical practice, and sends harmful messages of innate racial difference to the broader public.
Views and Experiences of IRBs Concerning Research Integrity
Robert Klitzman - [PDF]

Institutional Review Boards (IRBs) can play vital roles in observing, monitoring, and responding to research integrity (RI) issues among researchers, yet many questions remain concerning whether, when, and in what ways these boards in fact adopt these roles. Increasingly, RI is being challenged due to many factors, yet the extent of violations, and institutional responses to these, remain unknown. As the amount and complexity of experiments on human participants, often funded by for-profit industry, mushrooms, scandals have occurred, posing dilemmas concerning how to best oversee research to protect these participants from harm. For over 15 years, many institutions have been developing research compliance programs that monitor misconduct and conflict of interest (COI), and may interact with IRBs. In 2002, the Institute of Medicine (IOM) report, "Responsible Research: A Systems Approach to Protecting Research Participants," called for increased assessment of the overall human research protections system, and oversight of research. This report recommended several activities, including identifying, adopting, refining, and disseminating best practices, enhancing Quality Assurance/Quality Improvement (QA/QI), examining the type and number of FDA and OHRP investigations, and enhancing accountability and transparency. The report also suggested differentiating IRBs from other institutional compliance, risk management, and COI offices, and having institutions provide adequate resources for these activities. Yet authors of this IOM report felt "repeatedly confounded by the lack of data regarding the scope and scale of current protection."
Minimal Risk in Research Involving Pregnant Women and Fetuses
Carson Strong - [PDF]

How should the definition of "minimal risk" in the federal research regulations be interpreted in regard to pregnant women and fetuses? Surprisingly, there has been little discussion of this question. There is, after all, a substantial amount of published work addressing the question of how "minimal risk" should be interpreted. Similarly, there is a large body of literature on the ethics of research involving pregnant women and fetuses, particularly maternal-fetal surgery. However, in neither of these bodies of work can one find an analysis of minimal risk in regard to fetuses or pregnant women. The concept of minimal risk is defined in the regulations as follows: Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. What would it mean to speak of risks ordinarily encountered in daily life by a fetus? And how is the concept of risks during the performance of routine physical or psychological examinations or tests to be applied to fetuses and pregnant women? These questions suggest that it is not clear how the concept of minimal risk should be translated into specific levels of risk for this category of research subjects.
Improve Medical Malpractice Law by
Kenneth S. Reinker and David Rosenberg - [PDF]

The general consensus is that reform of medical malpractice law should be part of the health care system's overhaul. Medical malpractice litigation results in the expenditure of tens of billions annually, largely paid out of health care insurance funds and mostly (roughly two-thirds) paid to defendants' and plaintiffs' lawyers. By all accounts, this tort law regime ill serves the basic deterrence and compensation goals of civil liability. The causes and magnitude of these failings are disputed, and many typical reform proposals sidestep the basic problems and may do more harm than good. In contrast, we advance a straightforward way to improve both deterrence and compensation. Essentially, the proposal is to remove current legal limitations on the scope of insurance subrogation that bar private and public health care insurers from "buying" the whole of their insureds' potential medical malpractice claims in exchange for lower premiums and taxes and expanded insurance coverage. Our proposal's benefits accrue regardless of the cause and magnitude of the failings of malpractice law or the further reforms that might be adopted.
Paying Human Subjects in Research: Where Are We, How Did We Get Here, and Now What?
Ari VanderWalde and Seth Kurzban - [PDF]

On November 14, 1996, an in-depth report on the recruiting and testing practices of Lilly Pharmaceuticals appeared in the Wall Street Journal. Laurie Cohen reported that most pharmaceutical companies had difficulty recruiting healthy subjects to participate in testing of "untried and potentially dangerous" drugs. These companies often had to pay subjects up to $250 a day to ensure adequate enrollment, and some even gave referral bonuses to doctors who sent potential subjects their way. Cohen then exposed how Lilly was able to keep costs down: by recruiting homeless alcoholics to serve as research guinea pigs. "In many ways," Cohen reported, "the practice is mutually beneficial. For Lilly, it is efficient and limits the risk that subjects will sue if harmed by an experiment or divulge particulars of a drug." And the subjects "get several weeks or months of free room and board, and in interviews they express voluble gratitude for what they often call 'easy money.'" But, Cohen pointed out that "such subjects are hardly ideal drug-test candidates." These subjects - the homeless and alcohol abusers - were not reliable in reporting adverse events, both because they feared disqualification from the study and because they confused adverse reactions with their normal symptoms. In the meantime, a test subject interviewed by Cohen was unable to even tell her what drug he was on, though he had signed an informed consent form. The homeless shelters of Indianapolis, where Lilly had its headquarters, reported that the Lilly Endowment had given charity to every shelter, and thus the shelters turned a blind eye to Lilly's recruiting practices, though the huge amounts of money given to the homeless often resulted in binges and destructive behavior. When asked about subject participation, Lilly's executive director of clinical pharmacology responded that the subjects were driven to participate by altruism: "'These individuals want to help society.'"
Columns
Currents in Contemporary Bioethics: Waiving Informed Consent to Prenatal Screening and Diagnosis? Problems with Paradoxical Negotiation in Surrogacy Contracts
Katherine Drabiak-Syed - [PDF]

Recently, an agonizing twist intersecting predictive genetic tests and surrogacy contracts made news headlines in Canada. The intended parents, a couple from British Columbia, instructed the surrogate mother with whom they were working to undergo First Trimester Screening and Chorionic Villi Sampling (CVS), which revealed the fetus likely had Down syndrome. The parents directed the surrogate to terminate the fetus or they would abdicate their parental claim upon birth. This story raised numerous legal and ethical questions relating to the transferability of decision making for prenatal screening, diagnostic tests, and the connected decision of termination when additional interested parties - the intended parents - are involved in the medical decision-making relationship. First, although the surrogate is the patient, what are the implications when the intended parents'í wishes influence or even dictate the relationship between her and her obstetrician and genetic counselor? Second, if the intended parents' level of authority reaches explicit demands, may the intended parents ethically and legally require the surrogate to waive her right to informed consent for prenatal screening and diagnosis?