• A Breakthrough with the TPP: The Tobacco Carve-out

      Puig, Sergio; Shaffer, Gregory (2017-03-26)
      The United States has made great progress in reducing tobacco consumption at home while spending taxpayer money to promote its consumption abroad. 1 While U.S. tobacco consumption rates have fallen dramatically since the 1960s, they are soaring in the developing world. 2 Today, about twenty percent of adults in the world smoke, and more than eighty percent of them live in low- and middle-income countries. 3 As a result, tobacco could kill one billion people this century, and largely in these lower-income countries.
    • A Human Rights Approach to Routine Provider-Initiated HIV Testing

      Rajkumar, Rahul (2013-03-03)
      This Article describes the ethical, legal and public health implications of routine HIV testing - that is, testing such that individuals receive a routine offer of an HIV test whenever they come into contact with the health care system. In recent months, the consensus in favor of voluntary testing has yielded to a debate over whether efforts to curb the spread of HIV and to treat individual patients themselves would benefit from health care providers initiating testing. This Article first describes the history of HIV testing policy in the United States and internationally. It outlines the arguments in favor of routine provider-initiated testing and responds to objections that have been raised in the literature. Finally, it describes a proposal for an ethical routine testing regime that is consistent with human rights principles as well as U.S. and international statutes and case law on testing. This Article also proposes model legislation that addresses the issues of counseling, confidentiality, and informed consent in the context of routine-offer HIV testing.
    • A Jurisprudence of Dysfunction: On the Role of "Normal Species Functioning" in Disability Analysis

      Satz, Ani (2013-03-02)
      The Americans with Disabilities Act (ADA) was signed into law by President George H. W. Bush on July 26, 1990. After twenty years of struggle and compromise by civil rights and disability advocacy groups, the legislation was hailed as a victory. The Act established civil rights protection for disabled persons in the workplace and in the provision of services (most notably transportation services) and public accommodation. The Act sought to "provide a clear and comprehensive national mandate for the elimination of discrimination against individuals with disabilities ... [via] clear, strong, consistent, enforceable standards." Fifteen years later, the Act is widely recognized as a failure. Judicial construction of the eligibility requirements of the Act severely undermines disability protections. In 1999, the United States Supreme Court, in opposition to the Equal Employment Opportunity Commission (EEOC) and Department of Justice (DOJ) guidelines at the time, held that plaintiffs' eligibility for disability protections must be determined after measures to mitigate disability are employed. The definition of disability, "a physical or mental impairment that substantially limits one ... of the major life activities," has met other judicial bars with regard to the interpretation of "substantial" and "major life activity."
    •  A Mental Health Checkup for Children at the Doctor's Office: Lessons from the Medical-Legal Partnership Movement to Fulfill Medicaid's Promise

      Cannon, Yael (2018-06-16)
      Traumatic childhood events and the stress they cause can negatively affect health over a lifetime. For children with Medicaid coverage, visits to the doctor's office present an opportunity to improve this trajectory. Medicaid's Early Periodic Screening Diagnostic and Treatment (EPSDT) mandate requires that children receive more than a basic physical when they see a doctor for regular "well-child checks."
    • A Perspective from Within the White Coat

      Chow, R (2013-01-09)
      One can easily generate a noisy and angry discussion in any physicians' dining room in the United States by bringing up the subject of managed care systems and their use of financial incentives to control physicians' behavior. Generally, the reaction will range from a palpable frustration among the younger physicians to a feeling of resignation in the senior colleagues. The latter group will then reflect back on the era before managed care, when compensation was on a per diem basis. The more vocal younger generation will continue to vent their spleens about the illogical and unfair nature of their compensation systems, and then realize that they must quickly return to their respective offices, less their productivity be undermined. Having entered clinical practice during the adolescence of managed care, I can provide one clinician's perspective, but cannot pretend to speak for all physicians. There are many of my colleagues who have taken to arms, securing M.B.A. degrees and reviewing HMO contracts every evening before bed. It is easy to discern who these people are: They talk about covered lives, contractual withholds, and capitation systems. I am not among their number. Naive as it is to say, I chose to enter medicine to take care of patients, and I assumed that I would be compensated fairly and live comfortably. If indeed, I had wanted to maximize my future income, I would have sought my fortune in the business world, or failing that, the legal profession.
    • A Scientific Rationale for Human Embryonic Stem Cell Research

      Kaufman, Dan (2013-02-23)
      Stem cell biology has recently been at the forefront of a national discussion combining science, politics, and ethics. Few aspects of medicine and scientific research have been the subjects of a frenzy like that surrounding human embryonic stem (ES) cell research. Often lost amidst the opinions of pundits and op-ed writers in articles about research on human ES cells is: (1) the scientific basis of this research; and (2) the reasons why scientists and physicians are so interested in pursuing these studies. Quite simply, human ES cells are uniquely suited for research that uncovers the fundamental basis of human developmental biology. They might revolutionize areas of medicine such as transplantation medicine or gene therapy, and research on them will likely impact a wide variety of other fields. Indeed, in describing human ES cells, Harold Varmus, former director of the National Institutes of Health (NIH), said "It]here is almost no realm of medicine that might not be touched by this innovation." Under Varmus, the NIH released a report in which nineteen of its institutes each answered the question, "What would you hope to achieve from human pluripotent stem cell research?" The health conditions potentially better understood or treated range from cancer to neurological diseases, to HIV and AIDS, to burns and trauma, to hearing and sight, and to drug abuse and mental illness. The scientific and medical impact of this research is almost endless. The federal government, primarily through the NIH, provides the largest single source of funding for basic biological and medical research in the country. Whether or not the NIH is allowed to fund studies of human ES cells will determine how quickly scientific research on human ES cells will progress. On August 9, 2001, President George W. Bush gave his first nationally televised address since his inauguration. This speech addressed solely human ES cell research and the role the federal government should play in funding studies of these cells. In general, the President agreed that federal funding of research involving human ES cells would be permitted, but only on sixty or so human ES cell lines created prior to his speech. While this compromise did not fully satisfy either supporters or opponents of this research, it did set the stage to use federal dollars to move this research forward more rapidly.
    • Adding Life to the Adolescent's Years, Not Simply Years to the Adolescent's Life: The Integration of the Individualized Care Planning & Coordination Model and a Statutory Fallback Provision

      Gordy, Kimberly (2013-03-03)
      Yesterday Tyler had friends over playing x-box and rock band. They were laughing, joking, and the biggest question on their minds was will tomorrow be a snow day. Today Tyler is surrounded by a team of nurses and doctors injecting 5 different toxic chemotherapy drugs directly into his heart . . . . By 5:00 the side effects had already begun. I am continually amazed at how smoothly Tyler makes the transition between these two worlds. It is a sign of great strength and maturity. He does a far better job than I do . . . . It is an amazing and humbling thing when your greatest life lesson is taught to you by your own teenage son. The above passage was written by the parent of seventeen-year-old Tyler Alfriend, a patient with stage IV Burkitt's Lymphoma and Leukemia. Tyler's ability to balance these opposing worlds exemplifies the dignity and maturity exhibited by so many teenage patients coping with critical illness. For these young adults, their teen years are not the jaunty bridge between childhood and adulthood, a time during which teens discover their world without regard for mature considerations. Instead, the reality of their illness often results in fulminant entry into adulthood. While coping with the realization that they may not reach their next birthday, these teens also assume the responsibility of assuaging the grief of their families. Although there is never a good time in one's life to face a life-threatening illness, experts have recognized that the adolescent years may be among the hardest. Many physicians admit that critically ill adolescent patients are in a relative "no man's land." In many ways, adolescent patients are like pediatric patients, needing both emotional and physical support from their families. However, these patients are not children, and the maturity demonstrated by many teens warrants the medical decision-making autonomy given to adult patients. Take the case of Michael Miller, who at age sixteen was diagnosed with cancer so advanced that his treatment included fifty-one weeks of chemotherapy, radiation, and surgery. In the wake of his diagnosis and his parent's admitted hopelessness, Michael's physician stated that Michael showed maturity when he "calmed his parents' fears and helped them focus on the task ahead."
    • Advocating for a Medicare Prescription Drug Benefit

      Rother, John (2013-02-25)
      Efforts to enact a prescription drug benefit in Medicare date back more than forty years. Since then, drugs have continuously grown in importance; they have also grown in cost. Design and enactment of a Medicare. drug benefit is therefore one of the most challenging health policy tasks before Congress. Many policy trade-offs have to be brokered, powerful interests acknowledged, budget limits respected, and public expectations rewarded. Ideology and partisan considerations also play a prominent role. As the benefit finally nears becoming law, as it inevitably must, the ongoing tension between adequacy and cost-containment has begun to play out in earnest. In all, the Medicare prescription drug debate serves as a microcosm of the competing forces that make the American health care system so challenging to reformers.
    • Altered States: State Health Privacy Laws and the Impact of the Federal Health Privacy Rule

      Pritts, Joy (2013-02-23)
      Medical records contain some of the most intimate details about an individual that can be found in a single place. Health information privacy is based on the principle that individuals should be able to exercise control over this intimate information, both by having full knowledge about what information is contained in the records and by being able to control who has access to the information. Because professional ethical requirements do not adequately protect health information in today's complex health care system, we have increasingly turned to the law as a source of protection. Until the recent promulgation of the Federal Health Privacy Rule, states have been the primary regulators of health information through their constitutions, common law, and statutory provisions. Although all three of these legal sources remain important, recent focus has been on the enactment of detailed health privacy statutes that apply the fair information practice principles to health information. However, for the most part states have adopted these principles in a fairly haphazard fashion resulting in a patchwork of legal protections both within and between states. The recently issued Federal Health Privacy Rule has effectively evened out some of this discrepancy by establishing a federal floor of privacy protections based on fair information practices. The Federal Rule, however, does not afford adequate protection of health information because it has limited applicability and areas of lax protection. Because the Federal Rule only preempts conflicting, less protective state laws, there is still room for states to protect their own citizens by retaining or enacting health privacy protections that mirror and improve upon those in the Federal Health Privacy Rule.
    • 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.
    • American Meat: A Threat to Your Health and to the Environment

      Walker, Polly; Lawrence, Robert (2013-02-25)
      Slaughterhouse Blues: The Meat and Poultry Industry in North America. By Donald D. Stull and Michael J. Broadway. Belmont, CA: Thomson/ Wadsworth, 2003. Pp. 172. In 1923 Mrs. Cecile Steele of Delaware received 500 chicks instead of the fifty she had ordered to restock her flock of laying hens. When she decided to keep all 500 chicks and found she could turn a profit selling them as food, the era of "big chicken" was born on the eastern shore of Maryland. In Slaughterhouse Blues: The Meat and Poultry Industry in North America, anthropologist Donald Stull and social geographer Michael Broadway team up to investigate the impact of the unprecedented changes that followed in the poultry industry and similar changes that occurred in the beef and pork industries. Slaughterhouse Blues is an important book and should be of interest to all who care about sustainable agriculture, the future of rural communities, and the health and environmental consequences of the current industrial agricultural system. The book is an excellent introduction to the important links between public health and food production.
    • An Ethical Defense of Federal Funding for Human Embryonic Stem Cell Research

      Childress, James (2013-02-23)
      Should the Federal Government fund human embryonic stem cell research? In addressing this question and answering it affirmatively, I will draw from testimony I was asked to prepare for the Hearing on "Stem Cell Research" conducted by the U.S. Senate Committee on Health, Education, Labor and Pensions, chaired by Senator Edward M. Kennedy, on September 5, 2001. Even though I did not testify on that occasion on behalf of the National Bioethics Advisory Commission (NBAC), on which I served until its demise at the end of September 2001, I drew, then as well as now, on the NBAC's 1999 report on Ethical Issues in Human Stem Cell Research, which, as a commissioner, I helped to prepare and also endorsed.
    • An Evidence-Based Objection to Retributive Justice

      Mammarella, Brian (2017-03-26)
      Advancements in neuroscience and related fields are beginning to show, with increasing clarity, that certain human behaviors stem from uncontrolled, mechanistic causes. These discoveries beg the question: If a given behavior results from some combination of biological predispositions, neurological circumstances, and environmental influences, is that action unwilled and therefore absolved of all attributions of credit, blame, and responsibility? A number of scholars in law and neuroscience who answer "yes" have considered how the absence of free will should impact criminal law's willingness to justify punishments on the basis of retribution, with some arguing that criminal law ought to dispense with retributive justice because the concept of blameworthiness is out of touch with scientific reality. This Note posits a more practical reason for reform by reviewing available empirics on the way people perceive human agency. The research suggests that as the science of human agency becomes increasingly vivid and reductionistic, laypeople will become proportionally less willing to attribute blame, and these shifting societal intuitions will ultimately diminish criminal law 's moral credibility.
    • Approaching Universal Coverage with Better Safety-Net Programs for the Uninsured

      Hall, Mark (2013-03-03)
      The Patient Protection and Affordable Care Act (PPACA) will extend public and private insurance to about thirty million people, which will cover more than half of those who currently are uninsured. This is a monumental achievement, but it still will leave more than twenty million residents uninsured-or about 8% of the nonelderly population. Therefore, the United States will continue to lag well behind peer industrialized nations in providing nearly universal access to a decent level of care. To approach universal coverage, additional efforts will be required to improve access to care for those who continue to lack insurance coverage. Insurance, after all, is not an end in itself; it is the best means of access to affordable care. But, if other means to minimally acceptable access exist, they may provide a form of non-insurance, direct-access coverage that helps to fill the remaining coverage gap for the uninsured.
    • Are Independent Pharmacies in Need of Special Care? An Argument Against an Antitrust Exemption for Collective Negotiations of Pharmacists

      Rosenthal, Danielle (2015-10-04)
      The last half-century has witnessed a dramatic rise in both health care spending and associated efforts to rein in costs.I As these factors and others coalesced, the "managed care revolution" was born.2 In the last several decades, health maintenance organizations (HMOs) - along with other managed care organizations (MCOs), such as preferred provider organizations (PPOs), point of service (POS) plans, and managed indemnity plans - have attempted to balance patients' quality of care against steadily rising health care costs.3
    • Artificial Intelligence and Discrimination in Health Care

      Hoffman, Sharona; Podgurski, Andy (2021-01-30)
      Artificial intelligence (AI) holds great promise for improved health-care outcomes. It has been used to analyze tumor images, to help doctors choose among different treatment options, and to combat the COVID-19 pandemic. But AI also poses substantial new hazards. This Article focuses on a particular type of healthcare harm that has thus far evaded significant legal scrutiny. The harm is algorithmic discrimination. Algorithmic discrimination in health care occurs with surprising frequency. A well-known example is an algorithm used to identify candidates for “high risk care management” programs that routinely failed to refer racial minorities for these beneficial services. Furthermore, some algorithms deliberately adjust for race in ways that hurt minority patients. For example, according to a 2020 New England Journal of Medicine article, algorithms have regularly underestimated African Americans’ risks of kidney stones, death from heart failure, and other medical problems.
    • Australia-United States Free Trade Agreement and the Australian Pharmaceutical Benefits Scheme

      Sainsbury, Peter (2013-02-25)
      This Case Study examines, with particular reference to the Australian Pharmaceutical Benefits Scheme (PBS), the events that occurred during the negotiation of the Australia-United States Free Trade Agreement (FTA) in 2003 and early 2004. The inclusion of the PBS in the FTA was a source of considerable concern in Australia due to its potential impact on health, and was a sticking point in negotiations. Following brief descriptions of the PBS and the relationship between drug companies and the PBS, I outline in roughly chronological order some of the significant developments in the negotiations from a public health viewpoint. I also analyze the framing of the negotiations by the United States and Australian governments and the lack of transparency and public accountability with which the negotiations took place. I argue that trade negotiations, like the FTA, can have important health consequences; as such, public health advocates must become more active participants in the negotiations process. This Case Study tells a story of process, not outcomes. In the telling I wish to stimulate consideration of the role public health workers can play in international trade negotiations, an arena in which they have not traditionally been much involved, but one that will assume increasing importance for the health of both individuals and nations.
    • Barrier to Trade or Barrier to Profit? Why Australia's Pharmaceutical Benefits Scheme Worries U.S. Drug Companies

      Hamilton, Clive; Lokuge, Buddhima; Denniss, Richard (2013-02-25)
      Much of the rhetoric that underpins arguments for "free trade" relies on the assertion that free trade agreements between nations are "win-win" arrangements. That is, it focuses on the textbook conclusion that by reducing trade barriers the total volume of goods and services available for consumption will increase and that, as a result, people in participating countries will likely benefit. In reality, free trade agreements are about winners and losers. Individual industries use their political influence to fight for or to defend their domestic or international profitability. For example, in the recently concluded negotiations of a free trade agreement between the United States and Australia, U.S. sugar farmers succeeded in convincing U.S. negotiators to defend them against increased import competition. The "win-win" rhetoric was further challenged during those same negotiations when U.S. pharmaceutical companies convinced U.S. negotiators to press hard for changes to Australian drug pricing policies that limit pharmaceutical profits.
    • Battling Over Patents: The Impact of Oil States on the Generic Drug Industry

      Darrow, Jonathan J.; Sarpatwari, Ameet; Curfman, Gregory (2020-07-25)
      In the 2018 case of Oil States Energy Services v. Greene’s Energy Group, the U.S. Supreme Court upheld the constitutionality of inter partes review, a non-judicial proceeding for challenging patents that was created by Congress as part of the 2011 Leahy-Smith America Invents Act. By establishing inter partes review, Congress hoped to rebalance patent policy to make it faster and less costly to invalidate erroneously granted patents in all fields of technology. In the pharmaceutical industry, generic drug companies have embraced inter partes review, filing hundreds of challenges in the first five years after its creation, with moderate success. Biologics, which make up a growing class of pharmaceutical products, are sometimes covered by dozens or scores of patents. As more of these complex therapeutics are developed and approved, inter partes review is expected to play an increasingly important role.