Recent Submissions

  • Federal Funding and the Regulation of Embryonic Stem Cell Research: The Pontius Pilate Maneuver

    Levine, Robert (2013-03-03)
    In this volume, my colleagues have presented a comprehensive account of the pros and cons of stem cell research and cloning; I will not repeat this discussion, nor will I focus on my own views regarding the moral acceptability of these activities. Instead, I plan to focus on the typical response of the federal government to issues of the type that are presented by embryonic stem cell research and cloning and to evaluate the consequences of this typical response. The issues to which I refer are, in general, features of much research in the field of reproductive biology. The issues arise when a particular project or a field of research or practice entails either the creation by any means other than "natural procreation" of an entity that could develop into a human person, or the destruction of such an entity, whether the entity was created "naturally" or in vitro. Embryonic stem cell research includes both problematic procedures: the creation of embryos via in vitro fertilization (IVF) or cloning, and the derivation of cell lines (necessitating the destruction of the potential for an embryo to develop into a person). Cell lines created from so-called "adult" stem cells do not fall under this category because an "adult" stem cell cannot develop into a human person. Federal officials would strongly prefer not to alienate those who believe destruction of embryos that could develop into human persons is murder (notably, but not exclusively, the religious right) or that the creation of human life by artificial means is morally wrong. They similarly do not want to appear to oppose the efforts of scientists to pursue cures for deadly or disabling diseases, particularly when the means to pursue such cures are advocated aggressively by popular public figures. The federal official who must produce a policy to govern such fields of research or practice appears to be ensnared in a true dilemma. To choose either side is fraught with grave political risk. In such circumstances, the official can, and often does, make a "safe" decision, choosing neither side in this controversy. The safe decision is to permit the conduct of the activity in the private sector while withholding the support of public funding for the field of study or practice. The official, like Pontius Pilate, washes his or her hands of the matter.
  • Cloning and Stem Cell Debates in the Context of Genetic Determinism

    Maienschein, Jane (2013-03-03)
    When I studied introductory biology at the newly-coeducated Yale in the early 1970s, we didn't hear anything about stem cells. For that matter, we heard relatively little about embryos and development and much more about genetics and cell biology. The impression given was that cells are complex, they divide and multiply, and together they make up organisms. What seemed to matter most, however, were the genes, the nucleus, and to some extent the ways that genes cause the cells to act. Led by cell biologist J.P. Trinkaus, our course placed more emphasis on the interactions of cells than most courses of the time, but cell-cell interaction was not the central theme. In biology generally, and certainly in the public mind, the "central dogma" of genetics had already taken hold and has only gained strength since. The message was that understanding biology must start with DNA, RNA, and their actions in producing proteins. Genes direct cells to develop, differentiate, and divide. Understanding development must start with the first cell, the egg cell, as it undergoes meiosis and casts off half its chromosomes in preparation for the fertilization process. Each cell division brings expression of different genes, and expression of these genes causes all the organic processes. And so it goes. Genes are inherited and they drive development; what follows is caused by heredity, or the doctrine of genetic determinism. Or so it has seemed since DNA and genetics assumed a core place in biology in the 1960s and 1970s. What had been called embryology, or the study of embryos, became known instead as developmental biology and developmental genetics. The older emphasis on morphogenesis, differentiation, and cellular changes took a back seat to presumptions of genetic determinism as the cause of those developmental processes. My contention is that this emphasis on genetic determinism has reinforced a popular misconception that what matters about the life of an individual organism, including its form and function, is laid out fully in all relevant respects with fertilization, at the time that the full complement of chromosomes comes together from the two parents. This mistake is serious, since development actually occurs gradually, depends from the beginning on the environmental context and on cell-cell interaction to guide and inform the process, and is an epigenetic process that unfolds over time as the complex system develops.
  • The Ethics of Embryonic Stem Cell Research and the Principle of "Nothing is Lost"

    Outka, Gene (2013-03-03)
    Hype tempts us all. It would be naive to exempt scientists from sometimes overstating the promise of their research. Early claims about what gene therapy would accomplish, for example, were arguably exaggerated and eroded public confidence. Yet claims about what stem cell research may accomplish belong in a class by themselves. The general public is now convinced that something momentous is occurring. Both professional and popular publications register the excitement that scientists evidence. This research, it is routinely said, will not only expand significantly what we know about cellular life, but it will also bring dazzling clinical benefits. Those who suffer from Alzheimer's disease, Parkinson's disease, and others are regularly identified as eventual beneficiaries. Because these possibilities are now widely accepted as truly feasible, researchers secure vaster amounts of material support all the while. Whether these claims too will prove exaggerated awaits research efforts that are still in their early stages. In the case of embryonic stem cell research, consider this sobering report: "To date, no therapeutic applications of embryoderived cells have been demonstrated, and only one preliminary human trial has been approved by the FDA (though it has yet to begin)." Some scientists acknowledge with an honesty I admire that they are still years away from broadly applicable therapies. We long for such benefits, of course, and most of us sense a genuinely other-regarding motive at work among those who make claims about benefits. That is, the prospect such research affords for bringing concrete relief to numerous human sufferers motivates scientists to engage in it. We discern and respect this motive, although we do well to acknowledge that less altruistic considerations, such as a search for funding and profits, sometimes operate as well. This Article takes general stock of moral judgments about embryonic stem cell research in particular and offers one specific resolution. It canvasses a spectrum of value judgments on sources, complicity, and "adult" stem cells. It proposes to extend the principle of "nothing is lost" to current debates. This extension links historic discussions of the ethics of direct killing with unprecedented possibilities that in vitro fertilization procedures yield. The creation of embryos solely for research purposes should be resisted, yet research on "excess" embryos is permissible by virtue of an appeal to the "nothing is lost" principle.
  • Beyond the Low-Hanging Fruit: Stem Cell Research Policy in an Obama Administration

    Fossett, James (2013-03-03)
    It has been widely expected that the installation of the Obama administration and an expanded Democratic majority in both houses of Congress would produce a major shift in federal human embryonic stem cell (hESC) research policy. During the Bush administration, hESC research was among the most controversial of scientific research topics, and the federal government's role in financing hESC research was limited both in scope and scale. Only certain embryonic stem cell "lines" were eligible for federal research support. Federal regulations prohibited the direct or indirect use of federal funds to finance research using other stem cell lines, so that laboratory space or equipment initially purchased with federal funds, for example, could not be used to support research on ineligible stem cell lines. Congressional attempts either to restrict this research further or to significantly expand the scope and scale of federal support were unsuccessful. In response to this deadlock in Washington, stem cell advocates turned to state political systems-governors, legislatures, and bureaucracies-to continue pursuing their agendas, with varying degrees of success. These efforts have increased the amount of money devoted to hESC research and established infrastructure-laboratory space, training programs, and the like-that was not subject to federal spending restrictions. While both state and private funding have been adversely affected by the recent recession and the sharp decline in the stock market, states and private donors now spend more money than the federal government to support hESC research. Many observers expected a major break in the Washington gridlock over stem cell research with the new administration. While a break has occurred, its significance is difficult to assess. President Obama has recently fulfilled his campaign promise to overturn executive orders that limited the scope and scale of federal stem cell funding, but he has also left action on other significant stem cell issues to the National Institutes of Health (NIH) and Congress. This paper examines the current and likely future funding picture for hESC research. It outlines the Bush administration's regulatory and funding policies, inventories current state and private funding for stem cell research, and evaluates the factors likely to shape future stem cell funding. My conclusions are cautionary-while it seems likely that a new administration and Congress may well harvest low-hanging legislative fruit that has already passed Congress by substantial margins, the odds of a major shift in federal stem cell policy, at least in the short run, are low. Many ethical and political issues surrounding stem cell research remain controversial; furthermore, major problems with the national economy, health care, wars in Iraq and Afghanistan, and recent problems in the Middle East seem likely to consume much of the political attention and resources available to both President Obama and Congress. The administration has also committed to positions on other reproductive health issues which may complicate political progress on stem cell questions. The recently enacted economic stimulus package dramatically increases federal spending for biomedical research, but a major increase in stem cell funding seems unlikely. What does seem likely, even if state and private funding for stem cell research decline and federal funding increases, is that most serious policymaking around stem cell research will continue at the state level, rather than relocating to Washington.
  • Alternatives to Embryonic Stem Cells and Cloning: A Brief Scientific Overview

    Rao, Rajesh (2013-03-03)
    Advances in recent years have begun to elucidate the distinct mechanisms that maintain embryonic stem cells (ESCs) undifferentiated, self-renewing, and pluripotent. One of the "grails" of therapeutic stem cell biology is the ability to confer these special properties of the embryonic stem cell onto an easily accessible, differentiated cell from the adult (such as a skin or blood cell) without the creation of an embryo as a necessary intermediate step. Such a technology would not only provide an ethically acceptable alternative to research cloning, but it would also offer a method to interrogate the biological basis of "sternness," the constellation of gene expression and protein signaling that underlie self-renewal and pluripotency. A landmark study published in 2006 and many subsequent reports demonstrate that the reactivation of a handful of particular genes can "reprogram" a differentiated cell from a variety of rodent and human tissues into a cell with several properties of embryonic stem cells, including self renewal and pluripotency. These reports demonstrate that much of the "grail" has now been found, albeit with some important limitations. A number of studies have successfully demonstrated the viability of theoretical proposals previously offered by President Bush's Council on Bioethics to generate alternative sources of pluripotent cells, at least in the experimental setting. These promising advances stand in stark contrast to the earlier revelation that reports of highly efficient derivation of several new human ESC lines through research cloning by South Korean researchers were false. Nevertheless, it remains clear that clever and innovative efforts to generate pluripotent stem cells through research cloning as well as through alternative methods continue unabated. In this Article, I discuss the recent development of "alternative" methodsthat is, techniques that do not involve research cloning-to derive pluripotent stem cells, most prominently among them, induced pluripotent stem (iPS) cells. Here, easily obtainable differentiated cells may be genetically manipulated to revert the cell to a stem cell state, from which clinically desirable cell types can be derived. Similarly, a "parthenote" (derived entirely from one parent) that does not have the potential to develop into a person might be a source of cell lines with potential comparable to that of embryonic stem cell lines. Ironically, this is what was proven to be the origin of the so-called "cloned" human embryonic stem (ES) cell lines claimed by South Korean researchers in 2005.
  • Demythologizing the Stem Cell Juggernaut

    Callahan, Daniel (2013-03-03)
    The national debate on embryonic stem cells and research cloning has brought out the best and the worst in American culture. The best is on display in many ways. It is a debate that has been marked by an outpouring of sympathy for those suffering from disease or disability or threatened with death. It has drawn on the deep historical reservoir in America of a devotion to research and technological innovation to relieve the human condition. Despite these intensely partisan times, support for the research has easily crossed party lines, among legislators and the public. And it has given hope to perhaps thousands of people suffering from tenacious afflictions and disabilities. Those elements of the debate are impressive and commendable. Far less commendable were many of the ways in which the campaign in favor of the research was waged to gain money to carry it out. The main focus of this paper is on the early years of the stem cell debate when that effort was most intense. There were, for openers, inflated claims about the value of the research, often in the face of cautions from the researchers themselves. There was also an egregious promotion of what I believe to be an utterly wrong view about a socalled moral obligation to pursue the research. And there was a full display of that most ancient of logical fallacies, the ad hominem argument. Many research proponents did not hesitate to label those on the other side as a noxious coalition of right-wing religious fanatics, the fearful, the superstitious, the ignorant, and those invincibly indifferent to human suffering. Some of that kind of rhetoric has been thrown in my direction. The right, sometimes not to be outdone in throwing mud, labeled proponents as enemies of human dignity, who were well down a slippery slope to manufacturing and instrumentalizing human embryos and thus life itself, the crudest kind of utilitarianism. There may have been bits of truth in each of these stereotypes, but they did not serve well to advance the discussion. There were some larger issues at stake in this conflict, most notably the excessive hype and hyperbole deployed by research supporters, the use of bad arguments, some ethical window-dressing to move the cause along, and a failure to take account of some little-noted but highly relevant facts.
  • Employment-Based Health Insurance and Universal Coverage: Four Things People Know that Aren't So

    Hyman, David (2013-03-03)
    In 2001, I published an article in this journal titled "Two Cheers For Employment-Based Health Insurance." That article opened with the following sentence: "Employment-based health insurance is the Rodney Dangerfield of health policy: it gets no respect from anyone." The article then cataloged criticisms of employment-based coverage (EBC) from across the political spectrum, offered various reasons why EBC deserves "two cheers," and proposed tax reform, Employee Retirement Income Security Act (ERISA) reform, and greater use of purchasing pools to address shortcomings in the EBC market. EBC may not get much respect, but it does have considerable staying power. Consider four recent developments (and non-developments). First, in the 2008 Democratic presidential primaries, only Representative Dennis Kucinich proposed outright replacement of EBC with a one-payer system - and he was out of the race on January 24, 2008, after receiving no delegates in Iowa, 1.35% of the vote in New Hampshire (fifth place), and 3.65% in Michigan (third place, but second place went to "uncommitted," who got 40% of the vote). Second, the two leading candidates in the Democratic primary (then-Senators Barack Obama and Hillary Clinton) both proposed to build on EBC instead of proposing to replace it. Democratic primary voters are the natural constituency for a one-payer system, but their revealed preferences (or, more likely, their expectations about the electoral appeal of that approach) obviously pointed in a rather different direction. Third, although the American Recovery and Reinvestment Act of 2009 (the "stimulus bill") expands Medicaid, unemployed workers may only participate if they qualify under existing income and wealth criteria. Instead of broadening access to Medicaid, the stimulus bill subsidizes the cost of COBRA premiums for those who wish to maintain their EBC after they have been laid off. Fourth, since taking office, President Obama has stuck to the basic position he took during the Democratic primaries: if an individual is happy with his existing coverage (which for a majority of Americans is EBC), he is free to keep it. These realities suggest that EBC has more staying power than its critics might have hoped-even if the principal explanation for that staying power is nothing more compelling than inertia, or a status-quo bias if you prefer the language of behavioral economics. To be sure, the past does not necessarily predict the future in politics, policy, or finance, and health insurance falls within all three of those categories. There are also plenty of reasons to worry about how long employers will want to remain the fiscal intermediaries for their employees to obtain health coverage. But, for the moment, EBC is here to stay-and there is (as yet) no evidence we are approaching a tipping point. Given the likely prevalence of EBC for the foreseeable future, it is worth emphasizing four important points about EBC and universal coverage. What these points have in common is that they are myths - most people believe they are true, even though they are not. The four "myths" are these: 1) Employers pay for EBC; 2) There are 45.7 million uninsured Americans; 3) Universal coverage means everyone will have access to high-quality care; and 4) Universal coverage will solve the cost problems of American health care.
  • Working Sick: Lessons of Chronic Illness for Health Care Reform

    Pendo, Elizabeth (2013-03-03)
    Although chronic illness is generally associated with the elderly or disabled, chronic conditions are widespread among working-age adults and pose significant challenges for employer-based health care plans. Indeed, a recent study found that the number of working-age adults with a major chronic condition has grown by 25% over the past ten years, to a total of nearly 58 million in 2006. Chronic illness imposes significant costs on workers, employers, and the overall economy. This population accounts for three-quarters of all health care expenditures in the United States, and a Milken Institute study recently estimated that lost workdays and lower productivity as a result of the seven most common chronic diseases results in an annual loss of over $1 trillion dollars. I am focusing on this significant and growing population as a challenge for employers and as a critical test case for current health care reform proposals. Many of the cost-control methods used by employer-based plans simply shift rather than lower health care costs. This disproportionately burdens people with chronic illnesses and creates long-term social and economic costs. The experiences and challenges of workers with chronic illness provide an opportunity to examine the larger framework of health care reform, not just the employer's role in isolation, and they make clear that chronic illness is an issue that must be addressed by employers and policymakers.
  • Preface: The Once and Future Debate on Human Embryonic Stem Cell Research

    Latham, Stephen (2013-03-03)
    In one Petri dish are scores, perhaps hundreds, of thrombocytes: human platelets, the cells that circulate in our bloodstream and help us stop bleeding when we're cut. Normally, platelets are produced when they bud off from megakaryocytes, their parent cells, in our bone marrow. The newly formed platelets circulate around our bodies for about a week, and then-if they haven't been used in clotting-they are destroyed in the spleen and liver, to be replaced by freshly created cells. But the platelets in this Petri dish have never been inside a bone or traveled through a vein or an artery; they will never encounter a spleen or a liver; they will never be a part of a human body or pumped by a heart. Only a few weeks ago, these cells were undifferentiated human embryonic stem cells, floating in this same Petri dish like clouds in a tiny sea of gel. Now, having been bathed by a researcher in the right combination of materials, they have become platelets. In a neighboring Petri dish there are still clouds floating: human embryonic stem cells from the same line as those that have already been transformed into platelets. These cells are being cultivated, divided, and multiplied. They will supply the researcher with an essentially limitless number of genetically identical cells on which to test and re-test techniques for inducing thrombocytic differentiation-for making specialized human blood cells without blood, bone marrow, or a human body. In these two Petri dishes we see the twofold magic of stem cells: they have the ability to replicate themselves repeatedly, and they can transform into a diverse range of specialized cells. So-called "embryonic" stem cells are taken from what is in fact the pre-embryonic blastocyst stage of development (i.e., a fertilized egg that has divided into a small cluster of cells). They have the capacity to develop into every kind of cell. So-called "adult" stem cells are found at numerous sites around the body at every post-embryonic stage of development. They have the capacity to differentiate into a range of specialized cell types found in their organs of origin; this permits them selectively to repair and replenish specialized tissue. Both adult and embryonic stem cells have tremendous potential for exploitation in the development of therapies for disease. The fact that they can self-replicate indefinitely means that they are of great utility in testing and comparing cellular responses to different drugs and biological materials. Moreover, if scientists can master the mechanisms by which stem cells can be made to differentiate into specialized cell types, stem cells may become a source of replacement cells for people with cellular diseases like diabetes, Parkinson's and Alzheimer's.
  • Prenatal Screening Policy in International Perspective: Lessons from Israel, Cyprus, Taiwan, China, and Singapore

    Fox, Dov (2013-03-03)
    Heredity and Hope: The Case for Genetic Screening. By Ruth Schwartz Cowan. Cambridge, MA: Harvard University Press, 2008. Pp. 304. The word "eugenics" derives from the Greek words eu (Ευ) [beautiful] and gen (γεν) [relating to birth], or eugenes, which means "good in stock." In Heredity and Hope, historian Ruth Schwartz Cowan defends modem genetic testing-the new genetics, by distinguishing it from twentieth century eugenics - the old genetics. While we rightfully recoil from the old genetics, with its coercive methods and hateful motives, Cowan maintains that we should embrace the new genetics to enhance reproductive choice and promote the well-being of our offspring. In this Review I argue that the analogy between the old and new genetics can be less readily cast aside than Cowan appreciates. In Part I, I discuss Cowan's historical arguments and theoretical commitments. In Part 1I, I argue that Cowan overlooks a crucial moral similarity between the old genetics and new genetics: namely, whatever the differences between the means by which each is carried out, both are biological approaches to solve what are in large part social ills. Part III concludes with two ways in which the new genetics, no less than the old, might undermine social equality for people with disabilities. First, the new genetics threatens to express demeaning judgments about the lives of persons with disabilities. Second, a tendency to treat disabilities as predominantly genetic problems worthy of reproductive prevention could weaken our collective willingness to welcome into the world those whose abilities fail to meet the demands of modem society.
  • Constitutional Constraints on the Regulation of Cloning

    Burt, Robert (2013-03-03)
    In 1995, Congress enacted a ban on federal funding for experimentation with human embryos. In 2001, President George W. Bush issued a presidential policy statement extending this funding ban to research on human stem cells extracted from embryos except for research on a limited number of cell lines that had previously been established; he reiterated this position in a 2007 executive order. In his 2008 presidential campaign, Barack Obama promised to support stem cell research. It now seems likely that in addition to rescinding Bush's executive order, Obama will ask Congress to repeal its funding ban from 1995, which still prohibits scientists from generating new stem cell lines. The politics surrounding this research could shift again-as the ethical issues of stem cell research are reopened, some critics may promote a total prohibition of human embryonic and stem cell research. Public debate on this issue has thus far focused on policy concerns. The purpose of this Article is to explore constitutional arguments that might be invoked to overturn any federal or state restrictions on human embryonic stem cell research. Broadly speaking, I will evaluate four different constitutional challenges to a total ban: 1) that such regulations violate researchers' constitutional right of free scientific inquiry; 2) that such regulations violate individual rights to reproductive freedom; 3) that the former Executive Branch restriction imposed an unconstitutional condition on the availability of government funding; and 4) that neither reproductive nor therapeutic cloning is a permissible subject for congressional enactment, but that both are reserved exclusively for state regulatory authority. Exhaustively evaluating these four possible constitutional objections would require writing at least a small textbook on constitutional law; I will instead be suggestive rather than exhaustive.
  • "Unnatural Deaths," Criminal Sanctions, and Medical Quality Improvement in Japan

    Leflar, Robert (2013-03-03)
    A worldwide awakening to the high incidence of preventable harm resulting from medical care, combined with pressure on hospitals and physicians from liability litigation, has turned international attention to the need for better structures to resolve medical disputes in a way that promotes medical safety and honesty toward patients. The civil justice system in the United States, in particular, is criticized as inefficient, arbitrary, and sometimes punitive. It is charged with undermining sound medical care by encouraging wasteful expenditures through defensive medicine; by driving information about medical mistakes underground where it escapes analysis, undercutting quality improvement efforts; and by forcing physicians in liability-prone specialties such as obstetrics out of practice. Similar charges are leveled against medical injury compensation systems in the United Kingdom, Australia, and elsewhere. While these criticisms have been strongly countered, they have gained a foothold in the public imagination sufficient to place structural reform of medical litigation on the American political agenda. One enlightened response to mounting concerns over medical error and liability has been a partial shift in focus, in the United States and other Western nations, from the blameworthiness of individual physicians to the correction of system-related deficiencies in the quality of care, and from confrontational litigation between patients and health care providers to a more integrative approach emphasizing disclosure to patients and families of the underlying facts and apology for harm done. Drawing in considerable measure on Wagatsuma and Rosett's pioneering 1986 article explaining the importance of apology (in non-medical settings) in Japan, the scholarship in this area portrays honest disclosure as more than an ethical and professional duty, and sincere apology as more than a way of fulfilling the emotional needs of patients, families, and medical personnel. These scholars, and the "Sorry Works!" movement that their writing has spurred, also assert that contrary to long-standing assumptions of liability insurers and hospital defense lawyers, disclosure and apology have in fact the practical benefit of diffusing some of the dissatisfaction that leads to compensation claims, thereby potentially shrinking liability burdens. While its likely effects on lawsuit filings are contested, the disclosure-and-apology philosophy is gaining considerable traction in medical practice. Compared with the United States, Japan (like most countries) enjoys a comparatively low rate of civil litigation over medical injury. What accounts for this relative paucity of medical lawsuits? The stereotype of a nation populated by long-suffering victims with a cultural aversion to the assertion of rights has long been punctured. Are there simply fewer medical injuries in Japan, due to the prevalence in hospitals of the strict quality control for which the nation's manufacturing enterprises are justly famed? When injury claims do arise, are they quickly resolved through non-punitive, harmony-promoting informal dispute resolution processes employing the traditional social lubricant of apology, as the scholarship drawing on the Wagatsuma-Rosett thesis would presume? Not exactly.
  • Retirees at Risk: The Precarious Promise of Post-Employment Health Benefits

    Kaplan, Richard; Powers, Nicholas; Zucker, Jordan (2013-03-03)
    The American conception of retirement has received a number of significantly jarring assaults in recent years. Employers have increasingly shifted the investment risk of funding retirement to their employees by switching from so-called "traditional" defined benefit plans that promise retirees a predictable paycheck for life to defined contribution arrangements that provide no such assurances. Other employers have frozen their traditional pension plans or otherwise terminated their employees' ability to accumulate further credits toward retirement. Even President George W. Bush added to the general anxiety about income in retirement by an extended campaign in 2005 that suggested that the federal government's venerable program for funding retirement-Social Security-was hopelessly outmoded and headed toward bankruptcy. This Article examines a source of retirement anxiety that has received far less attention but is of paramount importance for prospective and current retirees alike-namely, health insurance in retirement. Indeed, the presence of retiree health insurance is one of the most significant factors determining when people choose to leave the compensated workforce, especially if declining health is one of the reasons that they are considering retirement. As an important recent study concluded, without such insurance, "current employees will have strong financial incentives to work longer and retire later." Such incentives might therefore impact employment prospects for younger workers if older workers delay their retirement. Thus, this issue is enormously important to anyone connected to the U.S. workplace, regardless of age.
  • Stemming the Tide of Law Student Depression: What Law Schools Need To Learn from the Science of Positive Psychology

    Peterson, Todd; Peterson, Elizabeth (2013-03-03)
    In a country where the depression rate is ten times higher today than it was in 1960, lawyers sit at the unenviable zenith of depressed professionals. Of all professionals in the United States, lawyers suffer from the highest rate of depression after adjusting for socio-demographic factors, and they are 3.6 times more likely to suffer from major depressive disorder than the rest of the employed population. Lawyers are also at a greater risk for heart disease, alcoholism and drug use than the general population. In one sample of practicing lawyers, researchers found that 70% were likely to develop alcohol-related problems over the course of their lifetime, compared to just 13.7% of the general population; of these same lawyers, 20% to 35% were "clinically distressed," as opposed to only 2% of the general population. With such disproportionate levels of unhappiness, it is not surprising that the profession itself is suffering. Alcoholism or chemical dependency is the cause of the majority of lawyer discipline cases in the United States, and a growing disaffection with the practice of law pushes 40,000 lawyers to leaxve the profession every year. Unfortunately, these problems afflict not only practicing lawyers, but law students as well. While there has been less research on law students than on lawyers, a growing body of literature shows that they too exhibit signs of psychological distress, including elevated levels of depression, stress, and anxiety. One study found that 44% of law students meet the criteria for clinically significant levels of psychological distress. Law students also report significantly higher levels of alcohol and drug use than college and high school graduates of the same age, and their alcohol use increases between their second and third year of law school. Moreover, these problems seem unique to law students and are not generalizable to other overworked populations of graduate students. For instance, one study showed that compared to medical students in a similarly demanding academic situation, law students have significantly higher levels of stress, stress symptoms, and alcohol abuse.
  • Opening Stem Cell Research and Development: A Policy Proposal for the Management of Data, Intellectual Property, and Ethics

    Winickoff, David; Saha, Krishanu; Graff, Gregory (2013-03-03)
    Intellectual property scholars and the biomedical community have noted a decline in the tradition of openness and sharing in the biomedical sciences over the past thirty years. This decline appears to be a function of multiple factors. First, and best known, are changes in intellectual property (IP) law, specifically the Federal Circuit's re-interpretation of patent law to expand the scope of patentable claims; the passage of the Bayh-Dole Act of 1980, allowing universities to patent inventions made in the course of federally-funded research; and the creation of new legal rights and mechanisms for the privatization and commercialization of scientific data. Second, and perhaps as a direct consequence, universities and their life science researchers have significantly increased interaction with the private sector, whether through accepting sponsored research, licensing IP, or spinning off companies. These activities have dramatically increased the exchange of discoveries, capital, and labor across the industrial-academic interface, and they have added more private money to the mix of research support for university life sciences. But the increase in university participation in economic life has also introduced tensions between the emerging commodification of knowledge and longstanding scientific norms regarding open access and dissemination of research results, data, research tools, and other scientific advances. In traditional sociological accounts, the advance of science is predicated upon mechanisms of open information, peer review, and materials exchange, which are socially reinforced by norms that undergird open access. Knowledge that is withheld from community scrutiny cannot be validated or agreed upon by the community. On this basis, it is presumed that greater degrees of openness promote not only efficiency in the advance of science, but also trust in the scientific endeavor by society. Moreover, in standard economic accounts, the mechanisms of open exchange also have important efficiency, equity, and ethical implications in terms of the direct contributions that science makes to social welfare, particularly in the development of new technologies, products, and services. In theory, actors across industrial and state sectors can put scientific knowledge to efficient and equitable use when it is freely accessible as a public good, assuming full information and virtually costless transactions. When the results of scientific investigation are withheld in secrecy or maintained as private property, practical applications may be delayed, directed only towards lucrative markets, or priced in ways that are socially inefficient or unjust. However, it is not clear that efficiency and equity in the applications of science are always better served by greater openness. In terms of efficiency, openness can introduce a "free rider" problem, undermining incentives to invest in developing scientific discoveries that can contribute to social welfare. Indeed, this is arguably why our IP laws grant private exclusive rights for inventors to develop inventions into useful applications. Furthermore, in terms of equity, as Chander and Sunder argue in The Romance of the Public Domain, freely accessible materials and information are not necessarily accessed equally by all: Those with greater ability to exploit an open access information resource, such as those with greater knowledge, social stature, or control over complementary assets, will tend to benefit disproportionately. They suggest, however, that "[t]here are strategies available.., to help ... restructure the distribution of benefits ... especially the possibility of creating 'limited commons property' regimes for. . . information."' The solution for greater efficiency as well as equity in the exploitation of science, it seems, lies in finding a proper balance or hybridization between openness and enclosure, public good and private asset. Striking the most efficient and equitable balance between public and proprietary science is quite difficult in practice, in no small measure because the very categories of basic and applied science are breaking down in practice. Nevertheless, many legal commentators warn that with Bayh-Dole, the pendulum may have swung too far towards a private competitive model of university science.
  • "Till Naught but Ash Is Left To See": Statewide Smoking Bans, Ballot Initiatives, and the Public Sphere

    Kabat, Patrick (2013-03-03)
    The new millennium has witnessed a quiet revolution in smoking regulation. Legislation targeting secondhand smoke-formally known as Environmental Tobacco Smoke (ETS)-has erupted across the country in a majority of American states and countless municipalities. In the last five years, thirty-one states have passed comprehensive ETS regimes. In 2008 alone, Iowa, Nebraska, and Pennsylvania passed statewide smoking bans, Indiana debated and rejected one, the Illinois ETS statute took effect, and the Ohio Department of Health was dragged by advocacy groups through the full range of Ohio courts as it sought to implement the state's recent ban. Major ETS legislation is pending in South Dakota, substantial exemption revisions are pending in Ohio, and in the next few years, more restrictive provisions of several states' laws will kick in. These regimes are rapidly transforming the public domain from predominantly smokefriendly to presumptively smoke-free. It is high time to take stock of these developments, both to understand how the legal landscape is changing and to ensure that it develops responsibly. As this Note proposes, American states have been-and continue to be-engaged in the process of reversing the default rule on smoking in public from permissive to prohibitive. Whereas smoking was previously permitted in public, save for designated "No Smoking" areas, we increasingly live in a country where insular smoking spaces are carved out of a public domain in which smoking is generally forbidden.
  • Predicting Probability: Regulating the Future of Preimplantation Genetic Screening

    King, Jaime (2013-03-03)
    At the intersection of two rapidly developing areas of biotechnology, a revolution is about to take place. Although this revolution involves reproduction, it will not be sexual. A medical procedure, known as preimplantation genetic diagnosis (PGD), combines genetic testing and assisted reproductive technology (ART) to enable parents to screen their potential children before implantation for genetic or chromosomal characteristics. The technology has been a godsend to couples with family histories of genetic disorders and chromosomal mutations causing infertility. However, expanding its use to permit prospective parents to select embryos based on a wide array of genetic characteristics presents substantial risks to individuals involved in the procedure and to society as a whole. Although PGD use has remained extremely limited due to technological constraints, expense, and moderate success rates, recent advances in genetic testing procedures will remove many of these obstacles and significantly increase the benefits of its use. Better tests, providing better information, will expand the use of this technology from embryos known to be at risk for serious disease - preimplantation genetic diagnosis - to the testing of all or almost all in vitro embryos for multiple genetic characteristics - preimplantation genetic screening (PGS).
  • Non-Beneficial Pediatric Research and the Best Interests Standard: A Legal and Ethical Reconciliation

    Litton, Paul (2013-03-03)
    In 1966, Henry Beecher, a professor at Harvard Medical School, published an article in the New England Journal of Medicine describing twenty-two cases of unethical medical research, some of which involved children. In the infamous Willowbrook study, for example, researchers deliberately exposed children who were wards in a state facility to hepatitis to study preventive measures. Public attention to research tragedies led to the passage of federal regulations governing human subjects research, including special protections for children. The regulations restricted the participation of children in research, and, in that sense, they have protected children. However, this effort to protect children "may partly explain the underfunding and understudy of... health issues unique to children" that followed. Consequently, the vast majority of medications prescribed to children today have not been adequately studied in pediatric populations. Since the late 1990s, deploying an array of carrots and sticks, the federal government has sought to increase pediatric research, particularly with respect to pharmaceuticals, to address our lack of knowledge regarding the safety and efficacy of pediatric therapies. Its efforts have worked. Between 1990 and 1997, researchers completed eleven pediatric studies of marketed drugs; since 1997, the Food and Drug Administration (FDA) has requested approximately 800 studies involving 45,000 children in clinical trials. Pediatric research will continue to expand as the President recently signed into law measures to encourage pediatric research regarding medical devices.
  • Caring for the Uninsured: Are Not-for-Profit Hospitals Doing Their Share?

    Helvin, Lisa (2013-03-03)
    In 2004, the Robert Wood Johnson Foundation reported that 44 million individuals in the United States lacked health insurance, and the annual cost of uncompensated care for those individuals was $40.7 billion. When individuals lacking coverage for only part of the year were also included, total medical expenditures among all uninsured patients approached $125 billion. In August 2007, the Census Bureau reported even more alarming figures: The number of U.S. residents without health insurance rose by 2.2 million, to a total of 47 million, for 2006. According to the report, uninsured Americans represented 15.8% of the population. Given the growth in the number of uninsured Americans, it is unsurprising that health care providers across the country have noted a significant increase in demand for medical services from individuals lacking coverage. Many health care providers are struggling to keep up with this growing demand, particularly as state and federal funding has not kept pace with the increase in the number of uninsured patients seeking care. As a result of this lack of funding, hospitals nationwide shoulder an enormous burden in caring for the nation's uninsured; in fact, hospitals in 2001 covered over 60% of the costs for uncompensated care incurred annually in the United States.

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