Alternative medicine has been rapidly expanding as consumers drive the demand for more cost-effective, accessible and individualized healthcare. A commonly cited survey in the New England Journal of Medicine (NEJM) found that more Americans were consulting alternative care providers than allopathic/conventional physicians. In 1998, David Eisenberg published a follow up to this landmark survey, showing a marked increase in both the use of alternative care and the number of individuals seeking such care. The study revealed that 42.1% of Americans consulted at least 1 of 16 alternative therapies during 1997, an increase from 33.8% in 1990. Total visits to alternative practitioners soared from 427 million in 1990 to 629 million in 1997. This explosion of alternative care in the United States has begun to force prominent medical schools across the country to offer courses in alternative medical techniques. Over seventy-five major medical schools have begun to teach courses in alternative modalities. Moreover, the alternative care industry has established several journals to cover its expanding field.

Cervical cancer disproportionately affects women in lower- and middle-income countries. But the new vaccines developed to prevent infection with some strains of the human papillomavirus (HPV) that cause cervical cancer are priced beyond the reach of most women and health agencies in these regions, due in part to the monopoly pricing power of brand-name companies that hold the patents on the vaccines. Compulsory licenses, which authorize generic competition with patented products, could expand access to HPV vaccines under certain circumstances. If high-quality biogeneric HPV vaccines can be produced at low cost and be broadly and efficiently registered, and if Merck and GSK are unwilling to grant licenses on a voluntary basis, compulsory licensing could play a pivotal role in ensuring vaccinations against HPV are available to all, around the world, regardless of ability to pay.

Orphan drugs, essential for die treatment of persons widi rare diseases, generally are unprofitable for manufacturers to develop and market. While congressional and administrative efforts to promote die development of orphan drugs have met widi modest success, application of products liability doctrine to orphan drug sponsors could subvert those efforts. This Note describes die provisions of die Orphan Drug Act and analyzes products liability law with respect to orphan drug litigation. It argues that die goals of tort law support the imposition of liability for design defect, failure to warn and negligence in testing. Finally, die Note acknowledges diat liability costs create disincentives for orphan drug development and suggests mechanisms for reducing manufacturers’ liability concerns.

The current revolution in health care organization and financing, increased competition, and a retrenching of industry from its commitments to expansion of health care benefits challenge the nonprofit hospital's existence as a viable entity. Hospital governing boards and administrators have turned to corporate reorganization in order to maintain their financial position and to continue to serve their communities.

This Article examines the not-for-profit concept and the problems facing nonprofit hospitals. It reviews the pros and cons of reorganization and the for-profit/nonprofit controversy. It questions whether the hybridization of the hospital results in a stronger or weaker species and discusses the possible effects of the newly structured entity on the quality and delivery of health care. Finally, the Article suggests that the nonprofit hospital may survive only by a continued commitment to societal and communal values, to service rather than to profit; that this commitment is adequate justificaton for the preservation of the nonprofit system, and its preservation will reinforce and strengthen the concept.

An increase in malpractice claims is only one-indication of the problem physicians and attorneys have in their interprofessional relations. This Note explores the factors, such as increased specialization and social responsibility, that have given these professionals a myopic view of their respective roles.

The Note suggests that the crisis in interprofessional relations can be alleviated by interdisciplinary education in professional schools. It examines the problems inherent in current interdisciplinary programs and offers a model program jointly taught to law and medical students. The model course uses a problem solving approach that forces each student to examine the methods and limitations of both professions and to develop a concept of the professional’s role in society.

Despite the overall theme of this Issue being the future of global tobacco control, this Article is about Japan, with the conscious intention of presenting Japan as a demonstration of a different type of tobacco control environment. To be clear, I am not trying to suggest Japan is an unambiguously positive exemplar for other nations. Rather, it is with the idea that Japan's circumstances might be showing us that things are not always as bad as they might first appear. To quote Mick Jagger and Keith Richards, great philosophers of the twentieth century, “You can't always get what you want, but if you try sometimes, you just might find, you get what you need.”

There exists increasing concern that the Dietary Supplements Health and Education Act (“DSHEA”) has proven ineffective and perhaps counterproductive. Most illustratively, consider a recent and remarkably candid remark from Tommy Thompson, then Secretary of Health and Human Services: “I really think Congress should take a look at the food supplement law again. It doesn't make any sense to me.”

A health law that makes no sense to the Secretary of Health of Health and Human Services should certainly draw the attention of academics and policy-makers alike. Much of the debate concerning DSHEA regards the disparity in legislative treatment between dietary supplements, foods, and pharmaceutical drugs. Specifically, while pharmaceutical drugs must undergo years of costly pre-market testing, most dietary supplements—like most foods—can immediately enter the market, and only after repeated instances of adverse reactions can the Food and Drug Administration (“FDA”) remove them.

Recent surveys show an alarming rate of sexual exploitation of patients by psychotherapists. As such conduct often falls outside the scope of rape, which allows a defense of consent, the psychotherapist is not prosecuted. Although all sexual contact between therapist and patient is prohibited by codes of professional ethics, the licensing boards that enforce these codes do not possess adequate power to deter this behavior. Further, professional review boards have absolutely no authority over unlicensed therapists who sexually abuse their patients. As a result, licensed therapists who have been censured in one state may practice as unlicensed therapists in another state and continue to sexually abuse patients.

The only effective deterrent would be a uniform statute, adopted in all states, criminalizing this specific abuse of the unique therapist-patient relationship. Such a statute should include unlicensed therapists as potential offenders and consent to sexual contact should not be a defense. The statute also should provide for enhanced efforts to inform and protect victims. This Note first examines six of the nine criminal statutes that currently exist in order to show the full range of provisions presently in force to deter this conduct. This Note then proposes model provisions for a uniform statute.

The Physician Payments Sunshine Act (“Sunshine Act”), enacted to address financial conflicts in health care, is the first comprehensive federal legislation mandating public reporting of payments between drug companies, device manufacturers, and medicine. This article analyzes the Sunshine Act's uneven record, exploring how the law serves as an intriguing example of the uncertain case for transparency regulation in health care. The Sunshine Act's bumpy rollout demonstrates that commanding transparency through legislation can be arduous because of considerable implementation challenges. Capturing all the relevant information about financial relationships and reporting it with sufficient contextual and comparative data has proven disappointingly difficult. In addition, the law suffers from uncertainty and poor design as to the intended audience. Indeed, there is strong reason to believe that it will not significantly impact decision-making of primary recipients like patients.

Yet the Sunshine Act nonetheless retains important and perhaps underappreciated value. From the almost four years of information generated, we have learned that industry-medicine financial ties vary significantly by physician specialty, and somewhat by physician gender. In many medical fields the distribution of top dollar payments tends to be heavily skewed to a few recipients, all of which have important implications for optimal management of financial conflicts and for health policy more generally. Accordingly, the Sunshine Act's greatest potential is not guiding decisions of individual patients or physicians, but its downstream effects. This Article traces how secondary audiences, such as regulators, watchdogs, and counsel are already starting to make productive use of Sunshine Act information. Public reporting has, for example, made more feasible linking industry payment information with Medicare reimbursement data. As a result, policymakers can more closely examine correlations between industry spending directed at individual physicians and their prescribing and referral decisions. Moreover, savvy counsel are recognizing that Sunshine Act information provides explosive evidence in private civil litigation and this Article explores the first wave of cases.

In addition to provoking public and scholarly debate, the recent acquittal of John W. Hinckley, Jr. has prompted the Ninety-Seventh Congress to consider various bills that would abolish or reform the federal insanity defense. The following is an unedited version of Professor Arenella’s testimony concerning these bills given before the House of Representatives’ Subcommittee on Criminal Justice on August 12, 1982.

In this Article, I advance a new frame through which to organize discourse on disability and the law: the notion of ambivalence. I make two claims, one descriptive and one normative. Descriptively, I argue that ambivalence pervades encounters with disability. Disability attracts because it is a force that makes us human and disability repels because it is a force that threatens our humanity. The tension between these sentiments is not easily tolerated and tends to prompt denials of ambivalence; we embrace a conscious view of disability that belies our mixed sentiments and we suppress reactions to disability that conflict with this conscious view. Normatively, I argue that the law should express and expose ambivalence about disability. When we deny ambivalence, I argue, we cannot account for our genuine sentiments and we cannot prevent suppressed sentiments from emerging, intensified, in harmful and unanticipated forms. To avoid these dangers, the law should prevent the embrace of unequivocal views of disability as valued, devalued, or neutral, and seek to expose ambivalence about disability to the public. This prescription calls into question the prevailing orthodoxies of disability law.

In 1894, John Drinkwater, the befuddled, searching architect in John Crowley’s compelling fantasy, Little, Big, built his own home, Edgewood, “as a kind of compound illustration” of Victorian architectural styles.1 Rounding each corner, the visitor sees a different façade and interior – Italianate villa, Tudor manor house, neo-classical, country cottage – complete in itself, its attachment to the others invisible from a single perspective.

Reading a small flurry of articles from the past few years attempting to describe the field of health law, one feels like a visitor to Edgewood. The different perspectives are pleasing in themselves, without necessarily revealing the whole. This essay examines what I call the “architecture” of the health law field. By this I mean, without pressing the metaphor too far, the framework of beams and studs in which interior spaces can be designed, furnished and accessorized in different ways.

Refusals by individual pharmacies and pharmacists to fill prescriptions for emergency contraceptives (“EC”) have dominated news headlines, from the Washington Post to the Miami Herald. In the act that sparked a firestorm of controversy, an Eckerd pharmacist refused to fill a rape victim’s prescription for Plan B. A few months later, 11 Alabama nurses resigned positions at state clinics rather than provide EC against their moral convictions. These refusals do not seem to be driven by moral concerns about promiscuity, since pharmacists have refused to dispense Plan B to married couples as well. Instead, the refusals reflect moral and religious concerns about facilitating an act that would cut-off a potential human life.

Advances in medical technology offer infertile couples who wish to raise children alternatives to adoption. The increasing number of surrogate mother contracts creates a myriad of legal issues surrounding the rights of the natural mother, the natural father and die child that is produced. In this Article, the Author discusses the legal issues and rights of the parties under the Constitution, the surrogate contract and family law principles. The Author proposes that courts should consider a surrogate contract as a revocable prebirdi agreement which allows the natural mother to keep the child if she chooses. In addition, die Audior advocates an interpretation of the statutes forbidding baby selling that would prohibit surrogate contracts in which the mother is paid a fee for the child.

Perhaps no single policy topic better illustrates the tensions within American politics at the beginning of a new millennium than does Medicare, the nation's thirty-five year commitment to ensuring senior citizens' financial protection against the costs of acute medical care. Our politics seems nearly overwhelmed by conflicting promises to balance the budget and pay down the national debt, enact tax cuts and protect broadly popular “entitlements.” Medicare, one of the largest of such entitlement programs, has become a lightning rod for conflicts over how to resolve these competing goals. As a result, the nation finds itself in the midst of a bewildering mix of crisis talk, fact throwing and ideological name calling, with all the confusion and distortion one would expect from such a mix.

The health care market, the organizations that deliver health care, and health care payment mechanisms have all changed significantly in recent years and continue to change. In contrast, the so-called antikickback provision of the fraud and abuse statute remains much as it was in 1977, when it was amended into its current general form. By prohibiting financial incentives to induce referrals, the antikickback law counters abuses to the Medicare and Medicaid programs that are likely to proliferate in a cost-based, fee-forservice (FFS) health care market. In a FFS system, financial incentives stimulate increased use of services and often result in overutilization. The antikickback section has significantly less relevance to a capitated health care system in which the payment system itself inhibits overutilization and other costly practices. However, the antikickback section is broad and the regulatory safe harbors promulgated under it are narrow. As a result, practices such as capitation, which encourage cost-effective care and the formation of organizations to provide care on a capitated basis, are poorly insulated from the strictures of the statute.

This Article examines the potential stakeholder-related obstacles hindering the implementation of mechanisms to re-ignite the development of novel antibiotics. Proposed economic models and incentives to drive such development include: Public Funding of Research and Development (“R&D”), Tax Incentives, Milestone Prizes, End Payments, Intellectual Property (“IP”) and Exclusivity Extensions, Pricing and Reimbursement Incentives, Product Development Partnerships (“PDPs”), and the Options Market for Antibiotics model. Drawing on personal experience and understanding of the antibiotic field, as well as stakeholder consultation and numerous expert meetings within the DRIVE-AB project and Uppsala Health Summit 2015, the Authors identify obstacles attributable to the following actors: Universities and Research Institutes, Small and Medium-sized Enterprises (“SMEs”), Large Pharmaceutical Companies, Marketing Approval Regulators, Payors, Healthcare Providers, National Healthcare Authorities, Patients, and Supranational Institutions.

The analysis also proposes a characterization and ranking of the difficulty associated with implementing the reviewed mechanisms. Public Funding of R&D, Pricing and Reimbursement Incentives, and PDPs are mechanisms expected to meet highly systemic barriers (i.e., obstacles across the entire antibiotic value chain), imposing greater implementation challenges in that they require convincing and involving several motivationally diverse actors in order to have much effect.

Promises of confidentiality of HIV-related medical records and protection from discrimination based on HIV seropositivity are two of the legislative inducements state governments have offered to encourage voluntary HIV testing. Yet neither can be granted without impact on others whose interests range from those of a lover to those of an insurer. Politics as well as practicalities prevent the absolute protection of records from unauthorized disclosure and of individuals from discrimination. This article details the already enacted statutory compromises that have been made to resolve the conflicts of these competing interests and closely examines the myriad fine decisions made in reaching those legislative decisions.