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Contents - JLME - 2010 Volume 38: 2
Table of Contents
  1. Table Of Contents
Letter From The Editor
  1. Letter From The Editor
Symposium Articles
  1. Law, Science, and Innovation: Introduction to the Symposium
  2. Embryo Stem Cell Research: Ten Years of Controversy
  3. Why Scientific Details Are Important When Novel Technologies Encounter Law, Politics, and Ethics
  4. Old and New Ethics in the Stem Cell Debate
  5. Political Interventions in U.S. Human Embryo Research: An Ethical Assessment
  6. Creating Embryos for Use in Stem Cell Research
  7. Chimeras, Moral Status, and Public Policy: Implications of the Abortion Debate for Public Policy on Human/Nonhuman Chimera Research
  8. Reflections on Governance Models for the Clinical Translation of Stem Cells
  9. Resolving Ethical Issues in Stem Cell Clinical Trials: The Example of Parkinson Disease
  10. Translating Stem Cell Research: Challenges at the Research Frontier
  11. Allowing Innovative Stem Cell-Based Therapies Outside of Clinical Trials: Ethical and Policy Challenges
  12. Overseeing Innovative Therapy without Mistaking It for Research: A Function-Based Model Based on Old Truths, New Capacities, and Lessons from Stem Cells
  13. Stem Cell Research and Economic Promises
  14. WARF's Stem Cell Patents and Tensions between Public and Private Sector Approaches to Research
  15. Stem Cell Research as Innovation: Expanding the Ethical and Policy Conversation
  16. Will Embryonic Stem Cells Change Health Policy?
Independent Articles
  1. The Metamorphosis of Managed Care: Implications for Health Reform Internationally
  2. Interpretation of the Subjects' Condition Requirement: A Legal Perspective
  3. Diagnosing Consciousness: Neuroimaging, Law, and the Vegetative State
  4. Damage Control: Unintended Pregnancy in the United States Military
  5. Beyond the Cold Hit: Measuring the Impact of the National DNA Data Bank on Public Safety at the City and County Level
Columns
  1. Currents in Contemporary Ethics
  2. Teaching Health Law
  3. Reviews in Medical Ethics
  4. Recent Case Developments in Health Law
Table of Contents
Table Of Contents
Letter From the Editor
Letter From The Editor
ASLME - [PDF]

Letter From The Editor Over the last decade there have been few public debates in the United States more interesting, intense, or politicized than the one concerning the use of embryonic stem cells in medical research. The debate has engaged scholars, philosophers, physicians, attorneys, scientists, presidential commissions, and presidents, as well as the passionate beliefs of thousands of everyday people, each of whom hold very real and very legitimate hopes, concerns, and ideas about the benefits and costs of stem cell research. In the popular press and in the mind of the public, this debate has encompassed a relatively simple dichotomy: on one side are those who support "science" and the potential benefits of research, while the other is occupied by those deeply concerned with the morality and ethics of experimenting on what is functionally an essential building-block of human life, if not actual early human life itself.
Symposium Articles
Law, Science, and Innovation: Introduction to the Symposium
John A. Robertson - [PDF]

Law and lawyers play an ever more important role in the development and use of science. Often, the relations between law and science are the stuff of ordinary business, fitting scientific activity into an existing infrastructure of intellectual property, contract, products liability, and tort law. At other times lawmakers may use science to identify harms and take regulatory action, which then lead regulated industries to use law to bend or distort science in their favor.1 One of the most important interactions between law and science is use of the legal system to create a favorable environment for innovation.2 Especially at early stages of research, law can encourage, facilitate, or retard the development of new science and technology and the benefits it might bring.
Embryo Stem Cell Research: Ten Years of Controversy
John A. Robertson - [PDF]

Embryonic stem cell (ESC) research has been a source of ethical, legal, and social controversy since the first successful culturing of human ESCs in the laboratory in 1998. The controversy has slowed the pace of stem cell science and shaped many aspects of its subsequent development. This paper assesses the main issues that have bedeviled stem cell progress and identifies the ethical fault lines that are likely to continue. The time is appropriate for such an assessment because the field is poised for a period of rapid development. President Obama has removed the Bush administration's restrictions on federal funding. A huge influx of federal research funds is in the offing and presumably a more rapid maturing of the science will take place. Stem cell science is also moving into the clinical realm. In March 2009, the Food and Drug Administration (FDA) approved the first clinical trial with an ESC-derived therapy for spinal cord injuries, an important first step - though by no means a final or a sure one - in moving ESC research out of the laboratory into clinical medicine.1 Finally, recent work with induced pluripotent stem (IPS) cells suggests that non-embryonic sources of pluripotent stem cells may one day be routinely available. Such a development will lessen the temperature of the ethical debate while raising other issues.
Why Scientific Details Are Important When Novel Technologies Encounter Law, Politics, and Ethics
Lawrence Goldstein - [PDF]

Lost at times in the heat of debate about stem cell research, or any controversial advanced technology, is the need for precision in debate and discussion. The details matter a great deal, ranging from the need to use words that have precise definitions, to accurately quote colleagues and adversaries, and to cite scientific and medical results in a way that reflects the quality, rigor, and reliability of the work at issue. Regrettably, considerable inaccuracy has found its way into the debates about stem cells, on all sides, with consequent fogging of the issues.
Old and New Ethics in the Stem Cell Debate
Richard M. Doerflinger - [PDF]

The ethical debate on embryo research, particularly on whether to destroy human embryos for stem cell research, is sometimes said to involve a confrontation between religion and science. The claim is misleading at best. Ironically, religious claims have not infrequently been invoked by those who support human embryonic stem cell research, who have said that such research will enable us to "answer the prayers of America's families" or present us with "the biblical power to cure." 1 And even religious organizations (as well as scientists and ethicists who share some of their concerns on this issue) have often made the case against the ethical acceptability of this research relying on science, and on general ethical considerations that transcend religious divisions. The Catholic Church, in particular, maintains that the ethical norm against directly taking the life of any innocent human being can be understood and embraced by people of good will, with or without religious faith, and that the application of this norm to the present controversy depends on an understanding of some basic facts about early human development.
Political Interventions in U.S. Human Embryo Research: An Ethical Assessment
Ronald M. Green - [PDF]

Although the first human embryonic stem cells (hESCs) were produced in 1998, the direction of U.S. policy on stem cell research was set nearly 20 years earlier when the recommendations of a congressionally established Ethics Advisory Board were ignored by the Reagan administration. Thus began an unprecedented and unparalleled 30-year-long history of political intrusions in an area of scientific and biomedical research that has measurable impacts on the health of Americans. Driving these intrusions were religiously informed public policy positions that have usually escaped critical ethical analysis. Here I record my own encounters with this history of intrusions and the thinking behind them.
Creating Embryos for Use in Stem Cell Research
Dan W. Brock - [PDF]

The intense and extensive debate over human embryonic stem cell (hESC) research has focused primarily on the moral status of the human embryo. Some commentators assign full moral status of normal adult human beings to the embryo from the moment of its conception. At the other extreme are those who believe that a human embryo has no significant moral status at the time it is used and destroyed in stem cell research. And in between are many intermediate positions that assign an embryo some degree of moral status between none and full. This controversy and the respective positions, like the abortion controversy, is by now well understood, despite the lack of progress in resolving it. I have argued briefly elsewhere that early embryos do not have significant moral status, but I do not want to reenter that debate here.1 Instead, I want to focus on an issue that has had relatively little explicit and separate attention, but is likely to loom larger in light of the Obama administration's partial lifting of the Bush administration's restriction on the embryos that can be used in stem cell research that receives federal funding.
Chimeras, Moral Status, and Public Policy: Implications of the Abortion Debate for Public Policy on Human/Nonhuman Chimera Research
Robert Streiffer - [PDF]

I. Introduction Moral status is the moral value that something has in its own right, independently of the interests or concerns of others. Research using human embryonic stem cells (hESCs) implicates issues about moral status because the current method of extracting hESCs involves the destruction of a human embryo, the moral status of which is contested. Moral status issues can also arise, however, when hESCs are transplanted into embryonic or fetal animals, thereby creating human/nonhuman stem cell chimeras ("chimeras" for short).1 In particular, one concern about chimera research is that it could confer upon an animal the moral status of a normal human adult, but then impermissibly fail to accord the animal the protections it merits in virtue of its enhanced status.2 Understanding the public policy implications of this ethical conclusion is complicated by the fact that certain views about the moral status of the embryo cannot legitimately be used to justify public policy decisions. Arguments like those employed in the abortion debate for the conclusion that abortion should be legally permissible even if abortion is not morally permissible also support, to a more limited degree, a liberal policy on hESC research involving the creation of chimeras.
Reflections on Governance Models for the Clinical Translation of Stem Cells
Jeremy Sugarman - [PDF]

A central promise of human embryonic stem cell research is the potential to develop viable therapeutic approaches to a range of devastating diseases and conditions. Despite excitement over such advances, there are scientific and medical reasons to be cautious as stem cells and their products are introduced into patients. In response to such concerns, the International Society for Stem Cell Research (ISSCR) as well as ad hoc groups and individuals have offered approaches to governance of this research.1 While there are similarities among these governance models and they are in principle easily endorsable, in this paper I raise a set of concerns related to their implementation, suggesting areas where gathering data may facilitate more appropriate oversight. Next, I suggest areas that seem to have been neglected as these governance models have been developed so that they may be on the agendas of those seeking to revise these models in the future. Finally, I describe how some of the concerns that have arisen in considering the appropriate governance of stem cell research may be useful in science and translational research more broadly.
Resolving Ethical Issues in Stem Cell Clinical Trials: The Example of Parkinson Disease
Bernard Lo and Lindsay Parham - [PDF]

Stem cells derived from pluripotent cells offer the hope of new treatments for diseases for which current therapy is inadequate. Clinical trials are essential in developing effective and safe stem cell therapies and fulfilling this promise. However, such clinical trials raise ethical issues that are more complex than those raised in clinical trials using drugs, cord blood stem cells, or adult stem cells. Several clinical trials are now being carried out with stem cells derived from pluripotent cells, and many more can be expected in light of the rapid scientific progress in the field.
Translating Stem Cell Research: Challenges at the Research Frontier
David Magnus - [PDF]

Frontier Research There are many kinds of clinical trials. The regulatory framework within which most drug development takes place appears to be the one that is to be applied to the development of novel stem cell-based clinical trials.1 In the standard drug development model, appropriate pre-clinical research is conducted (largely based upon non-human animal models), and investigators or research sponsors (typically a company) submit an investigational new drug (IND) application to the Food and Drug Administration (FDA).
Allowing Innovative Stem Cell-Based Therapies Outside of Clinical Trials: Ethical and Policy Challenges
Insoo Hyun - [PDF]

Armed with expanded federal funding for human embryonic stem cell research and new methods for deriving pluripotent stem cells, stem cell researchers in the U.S. are poised to proceed with unprecedented speed toward the development of new clinical therapies. Staring into the new dawn of regenerative medicine, many observers may assume that the only responsible route to the clinic, both scientifically and ethically, is through FDA-approved clinical trials processes. Conventional wisdom dictates that, like pharmaceutical drugs and the use of biological therapeutics, stem cell-based therapies will have to pass through a series of controlled studies - initially to assess safety and toxicity, then efficacy and comparative efficacy - before they can be justifiably administered to patients outside a clinical trials context.
Overseeing Innovative Therapy without Mistaking It for Research: A Function-Based Model Based on Old Truths, New Capacities, and Lessons from Stem Cells
Patrick L. Taylor - [PDF]

I. Introduction Innovative therapy is the name we give to novel medical interventions, radically different from the standard of care, provided in order to benefit a patient, rather than to acquire new knowledge. They are paradigm-shifting, not incremental, responses to serious patient problems that standard medical care inadequately addresses. Innovative therapies are often devised by clinicians, not basic science researchers; they do not follow the linear model of basic research, to translation, to clinical research, to application. Instead, they come from thinking backwards from the patient's circumstances, and forward from deep knowledge of how the body functions, to challenge the limits of current mechanisms for effecting cures.
Stem Cell Research and Economic Promises
Timothy Caulfield - [PDF]

I. Introduction Policy arguments in support of stem cell research often use economic benefit as a key rationale for permissive policies and increased government funding. Economic growth, job creation, improved productivity, and a reduction in the burden of disease are all worthy goals and, as such, can be used as powerful rhetorical tools in efforts to sway voters, politicians, and funding agencies. However, declarations of economic and commercial benefit - which can be found in policy reports, the scientific literature, public funding policies, and the popular press - have arguably created a great deal of expectation. Can stem cell research deliver on the economic promise? And what are the implications of this economic ethos for the researchers who must work under its shadow?
WARF's Stem Cell Patents and Tensions between Public and Private Sector Approaches to Research
John M. Golden - [PDF]

While society debates whether and how to use public funds to support work on human embryonic stem cells (hESCs), many scientific groups and businesses debate a different question - the extent to which patents that cover such stem cells should be permitted to limit or to tax their research.1 The Wisconsin Alumni Research Foundation (WARF), a non-profit foundation that manages intellectual property generated by researchers at the University of Wisconsin at Madison,2 owns three patents that have been at the heart of the latter controversy. The story of WARF's patents and the controversy they have fostered highlights not only continuing tensions between proprietary and nonproprietary approaches to developing science and technology, but also an at least partly reassuring capacity of public and private sectors to deal with those tensions in a way that can render them substantially manageable, and frequently more manageable as a technology matures. More particularly, the cumulative story of WARF's patents features three leitmotifs that suggest how an attentive and engaged public sector might commonly succeed in working with public and private sector actors to achieve workable balances between proprietary rights and more general social interests: (1) right holders' decisions to pursue less than full rights assertion or enforcement; (2) the ability of government and other public sector actors to help bring about such decisions through co-option or pressure; and (3) frequent availability or development of technological alternatives that limit research bottlenecks.
Stem Cell Research as Innovation: Expanding the Ethical and Policy Conversation
Rebecca Dresser - [PDF]

In 1998, researchers established the first human embryonic stem cell line. Their scientific triumph triggered an ethics and policy argument that persists today. Bioethicists, religious leaders, government officials, patient advocates, and scientists continue to debate whether this research poses a promise, a threat, or a mixed ethical picture for society.
Will Embryonic Stem Cells Change Health Policy?
William M. Sage - [PDF]

Essays on stem cell policy seem to fall into three categories. Some essays in this collection are about logic and principles.1 Others are about practices and beliefs.2 The former group draws lines and defends them, a normative project. The latter group attempts to explain the lines that already exist, a descriptive project that may have important normative goals. Still other essays, by scientists, are about growing stem cell lines instead of drawing them.
Independent Articles
The Metamorphosis of Managed Care: Implications for Health Reform Internationally
Marc A. Rodwin - [PDF]

Many writers suggest that managed care had a brief life and that we are now in a post-managed care era. Yet managed care has had a long history and continues to thrive. Writers also often assume that managed care is a fixed entity, or focus on its tools, rather than the context in which it operates and the functions it performs. They overlook that managed care has evolved and neglect to examine the role that it plays in the health system.
Interpretation of the Subjects' Condition Requirement: A Legal Perspective
Seema Shah and David Wendler - [PDF]

I. Introduction Clinical research with children generates special ethical concern, raising the need for additional protections beyond those for research with competent adults. Most guidelines permit research with children when it offers a prospect of direct benefit, or poses minimal risk. Unlike many other guidelines, the U.S. federal regulations also allow institutional review boards (IRBs) to approve pediatric research that does not offer a prospect of direct benefit when the risks are no greater than "a minor increase over minimal risk." To approve research in this category, IRBs must find that two additional conditions obtain:
Diagnosing Consciousness: Neuroimaging, Law, and the Vegetative State
Carl E. Fisher and Paul S. Appelbaum - [PDF]

Recent studies indicate that patients who are diagnosed with vegetative states may retain more awareness than their clinical assessments suggest. Disorders of consciousness traditionally have been diagnosed on the basis of outwardly observable behaviors alone, but new functional imaging studies have shown surprising levels of brain activity in some patients, indicating that even higher-level cognitive functions like language processing and visual imagery may be preserved. For example, one recently developed method purports to detect voluntary mental imagery solely on the basis of neural response patterns observed with functional magnetic resonance imaging (fMRI). This line of research has already led to some widely reported cases of patients who were discovered to have more brain activity than expected. In November 2009, Rom Houben, a Belgian man who was thought to be in a coma for 23 years, was diagnosed with locked-in syndrome through the use of neuroimaging; however, that assessment was later overturned by further testing. 1 More recently, investigators using fMRI studied over 50 patients with disorders of consciousness: five were able to perform a willful mental imagery task, and on follow-up testing one was able to use this task to answer basic yes-or-no questions.2 These findings have led to several suggestions that neuroimaging might play a role in decision-making at the end of life, and it seems likely that such tests will soon be offered as evidence in court proceedings. For example, in one recent English case the Official Solicitor objected to the withdrawal of treatment from a patient on the grounds that fMRI might reveal covert consciousness, although this objection was eventually withdrawn.3 The specific legal scenarios that might arise from such a challenge, and the broader legal and ethical significance of this application of neuroimaging, however, remain relatively unexplored in the legal, clinical, and bioethics literature.
Damage Control: Unintended Pregnancy in the United States Military
Kathryn L. Ponder and Melissa Nothnagle - [PDF]

Military reproductive health policies affect large numbers of women. In 2006 servicewomen numbered nearly 350,000 and comprised 14.5% of active-duty forces and 17.4% of the reserve force.1 In addition, approximately 165,000 female dependents of active duty military personnel and 157,000 female dependents of reserve duty personnel are between the ages of 12 and 22 and are eligible for military health care services.2 Dependents of military personnel are eligible for military health care coverage until age 21, or up to the age of 23 if considered a full-time student.
Beyond the Cold Hit: Measuring the Impact of the National DNA Data Bank on Public Safety at the City and County Level
Matthew Gabriel, Cherisse Boland, and Cydne Holt - [PDF]

Criminalistics laboratories routinely provide "cold hits" in police investigations by comparing DNA profiles from crime scenes to offenders residing in the Combined DNA Index System (CODIS). Forensic DNA analysis is often glamorized in popular culture, where the perpetrators are identified and crimes solved within a single television episode. In reality forensic DNA hits can identify perpetrators of violent offenses, link multiple crimes committed by the same individual, or exclude suspects and exonerate the falsely accused. Unlike the media portrayals, downstream activities after a DNA identification or cold hit are often more complex. While the Federal Bureau of Investigation (FBI) cites a national Data Bank of more than 7.2 million DNA profiles and 94,000 identifications nationwide,1 an in-depth analysis of public safety improvements made with CODIS is currently unavailable to forensic practitioners and public policy analysts. A review of case resolutions for 198 DNA database hits in San Francisco created performance metrics to provide a concrete measure of the effectiveness of DNA databasing efforts at the city and county level. Our findings indicate that the impact of DNA identifications achieved using CODIS is complicated by societal issues and systemic challenges in the administration of criminal justice. When the performance metrics presented here are applied to other jurisdictions, they have the ability to drive public policy as part of a clear strategy to future success of a unified national public safety endeavor.
Columns
Currents in Contemporary Ethics
Mark A. Rothstein - [PDF]

The 2009 pandemic of influenza A (H1N1) was relatively mild, but a subsequent outbreak of pandemic influenza could be much worse. According to projections from the Department of Health and Human Services, the potential health consequences of a severe (1918-like) influenza pandemic in the United States could be literally overwhelming: up to 1.9 million deaths; 90 million people sick; 45 million people needing outpatient care; 9.9 million people hospitalized, of whom 1.485 million would need treatment in an intensive care unit (ICU); and 742,500 patients needing mechanical ventilators.1 Even a less cataclysmic, "moderate" pandemic (like 1958 or 1968) would result in 209,000 deaths; 90 million people sick; 45 million people needing outpatient care; 865,000 people hospitalized, of whom 128,750 would need treatment in an ICU; and 64,875 patients needing mechanical ventilators.
Teaching Health Law
Susan B. Apel - [PDF]

Interdisciplinary teaching can be a hard sell to the legal academic community. Over almost three decades, I have spoken at conferences on a variety of subjects. When I have presented on this particular topic, however, I have drawn my most meager crowds. Is it because we think interdisciplinary pedagogy is a bad idea, that we are ill-equipped, or that it is generally too difficult to do successfully? After a dozen years of creating and teaching an interdisciplinary course in law and medicine, I confess that it is now my other, "law-only" courses that I feel I have to justify. Why is an interdisciplinary approach to teaching law the exception rather than the rule?
Reviews in Medical Ethics
Thaddeus Mason Pope - [PDF]

Through the Louisiana Purchase in 1803, the United States expanded its size by over 800,000 square miles. But neither President Thomas Jefferson nor Congress knew exactly what they had bought until 1806, when Meriwether Lewis and William Clark returned from their famous expedition.1 One of the most significant contributions of the Expedition was a better perception of the geography of the Northwest.2 Lewis and Clark prepared approximately 140 maps and "filled in the main outlines of the previously blank map of the northwestern United States." 3 Robert I. Field has done much the same for the vast territory of U.S. health care regulation.
Recent Case Developments in Health Law
Kate Wevers - [PDF]

A 2009 decision by a Florida state trial court marks a recent addition to the long line of cases authorizing compelled medical treatment of pregnant women for the benefit of their unborn children. Despite recurring judicial and academic consideration of the issues involved, there is no consensus regarding the correct approach to take in cases that pit a woman's right to refuse medical treatment against the state's interest in protecting fetal health. Burton v. Florida, currently under appeal to Florida's First District Court of Appeals, demonstrates the difficulty of emergency decision-making in this area and the need for robust ex ante consideration of the important interests at stake.