Drug compounding is the long-standing pharmacy practice of mixing, combining, or altering ingredients to create drugs tailored to individual patient needs. Compounding is as old as the practice of pharmacy and close to the heart of the modern profession. Indeed, the mortar and pestle – an iconic emblem of compounding – have long been the prevailing symbol of pharmacy. Prior to the emergence of commercially available drug products, the practice of compounding was the practice of pharmacy – to create medicines, early pharmacists inevitably needed to extract and compound natural vegetable, animal, and mineral substances. In one impressive example of successful early compounding, God commanded Moses to “compoundeth” a holy anointing oil of myrrh, cinnamon, cassia, olive oil, and sweet calamus. Not generally one to shrink from a challenge, Moses followed God’s recipe and used his compounded oil to anoint the vessels of the Tabernacle and High Priest.

Current estimates approximate that the population over sixty-five years of age will increase from 40 million in 2010 to 72.1 million by 2030. As society ages, the number of elderly with cognitive deficits that impair decision-making abilities will also increase. This will place additional burdens on families and probate courts seeking to balance individual autonomy with necessary protections. A legal determination of incompetency is a prerequisite to a judicial order appointing a guardianship or other protective mechanism. The current legal-medical model for competency determinations fails to reflect the complexities of declining capacity in an aging population. A global structure for competency determinations leaves a critical gap between competent and incompetent. The gap between competence and incompetence not only raises concerns about how to classify those that fall between the two, but also highlights the lack of legal protections for those within the gap. A revised model is needed to provide protections to individuals who do not yet meet the threshold for incompetence but require additional protections for their personal or financial welfare. This Article provides an unprecedented examination of the legal model for determining competence through a comparison of the medical model for evaluating capacity. While a number of legal scholars have examined the appointment and oversight of guardians, fewer articles have critically examined the process by which individuals are declared incompetent. This Article presents a comprehensive overview of competency and clinical capacity determination procedures, legal mechanisms available to protect individuals with declining capacity, and policy recommendations for improving legal protections in light of inefficiencies related to legal competency determinations.

Certificates of Confidentiality (“Certificates”) are a federal legal tool designed to protect sensitive, identifiable research data from compelled disclosure. Congress first authorized their use in 1970 to facilitate research on illegal drug use. The scope of their use was later expanded to cover mental health research and then again to apply broadly to identifiable, sensitive research data, regardless of topic. Certificates can be critical to enabling conduct of essential research on sensitive topics, such as effective interventions to curb the opioid epidemic or reduce HIV transmission among minority youth. Nevertheless, there have been criticisms about Certificates and their use on several grounds. For example, researchers and institutional review boards (“IRBs”) may lack sufficient knowledge about them and, therefore, may not consider using them in studies for which they would be appropriate. In contrast to other protections, such as Department of Justice Privacy Certificates, Certificate protections were not automatically extended to these studies, but instead required an application. In addition, the concept of identifiable data had not kept up with technological changes that may allow for reidentification of data previously considered unidentifiable. Although a researcher who obtained a Certificate could use it to resist a legal demand for identifiable data, little was known about the actual effectiveness of the protection provided.

The 21st Century Cures Act substantially revises the Certificates authorizing statute, and many of the changes are directly responsive to the criticisms that have been raised. Significantly, the Secretary of the Department of Health and Human Services (“HHS”) must issue Certificate protection to federally funded research involving identifiable, sensitive research data, and the National Institutes of Health (“NIH”) will automatically include such protections to research it funds. Non-federally funded researchers can continue to apply for Certificate protection. The definition of identifiable has been expanded to include data “for which there is at least a very small risk” of identification. Certificates will now not only protect against compelled disclosure, but also render protected data inadmissible in legal proceedings without participant consent. In addition, voluntary disclosure is no longer authorized, but there is now a broad exception for disclosure as required by federal, state, and local laws. In this paper, based on our previous research on Certificates, we critically evaluate the 21st Century Cures Act's Certificates revisions and their positive and negative impact on the dual goals of facilitating important, sensitive research while maximally protecting individual research participants.

This Article offers a thorough analysis of an important public health issue, namely how to confront the growing problem of deceptive claims regarding foods and dietary supplements, including increasingly prevalent but unverifiable claims. The authors call for the creation of a limited private right of action under the Federal Trade Commission (FTC) Act for deceptive health-related claims for these products. The proposal responds to the growing market for these products and the inadequacy of current laws and enforcement actions to prevent such claims. In crafting the limited private right of action, the authors attempt to enhance consumer protection without undermining federal agency primacy in enforcement. The Article ends with an appendix setting forth proposed language for a statutory amendment to the FTC Act incorporating the authors' proposal.

The development and application of technologies will arguably be the major driving force for the evolution of world society in the first part of our new century. In medicine, agriculture, material science, communications and a host of other areas, new technologies promise unimaginable changes in our lives. And yet, in the midst of the euphoria surrounding this rush of invention, there is concern. When asked, people often say they are scared of what they do not know and scared of today's pace and power of invention. Putting aside the voice of the modern Luddite, it appears that while few want to stop the rush toward more and better technology, there is apprehension about the potential risks of the new technologies—risks that have not been sufficiently considered.

The healthcare system is sick. The players are incentivized to maximize their own benefit and externalize their costs onto the other parties. This paper examines the warped incentives that underlie the system. The tort system, lacking expertise and slow to adapt, is unable to overcome cognitive biases to adequately solve the problems. Clinical practice guidelines could pose a solution, but not as they are currently developed. Guidelines promulgated by healthcare associations are infected by a web of conflicts of interest with every player in the industry. Government agencies, and their revolving doors, are underfunded and also subject to the industry's web of conflicts. Even if adequate guidelines could consistently be produced, state legislatures and courts have been unwilling and unable to substantially incorporate guidelines into the legal landscape. Lastly, this article proposes a private regulation regime that could be a solution which would align all of the players' incentives to society's interests.

Infanticide, like most other species of homicide, is probably coeval with the human race itself. In modern Western civilization, what were formerly the most powerful incentives to infanticide have virtually disappeared. As with other social problems that affluence has seemed to solve, however, infanticide has reappeared in a new form that seems to have been made possible by affluence itself. This "new infanticide" occurs in a place whose very existence is the result of a tremendously wealthy society's devotion to its most vulnerable and least “useful” members. The modern neonatal intensive care unit, which treats, and often saves, extremely ill newborn children, who during most of history would surely have died, has proven to be a setting where many of the age-old incentives for infanticide have begun to operate again. The “new infanticide” consists of withholding food or needed medical treatment from selected infants who suffer from one or more serious, though treatable, medical problems. The national government has now enacted legislation designed to curtail the practice of infanticide by the medical profession. This paper traces the genesis of that legislation, explores the problem to which it is addressed, and evaluates its prospects for success.

To allow the state to first choose the criminal sanction, which requires a finding of a specific state of mind, and when that sanction is completed, to choose another sanction which requires a finding of the opposite state of mind, is a mockery of justice which places both the criminal and civil systems for dealing with sexual predators in disrepute.

By committing individuals based solely on perceived dangerousness, the Statute in effect sets up an Orwellian “dangerousness court,” a technique of social control fundamentally incompatible with our system of ordered liberty guaranteed by the constitution….

Managed health care has recently generated a great deal of distrust, even anger, in the public mind. To be sure, much of this public reaction is based on anecdotal evidence and one-dimensional thinking. But many unbiased experts observing managed care today are themselves unhappy with the health care industry's performance. While these observers find little justification for the current political backlash against managed care, they are also disappointed that today's health plans have not made a more positive difference. Indeed, informed observers commonly regret that the new arrangements for the financing and delivery of care have done so little to get physicians to adopt truly efficient practices, achieving not only cost reductions but also substantial improvements in health status and patient outcomes— that is, in the quality of care. Although managed care has not demonstrably harmed the overall quality of health care in the United States, it has done little to improve it.

Medicaid has failed in its mission to care for the poor because doctors refuse to participate in the program. New ways are needed to entice physicians to treat Medicaid patients. TennCare, Tennessee’s Medicaid managed care demonstration project, shows that managed care plans can induce physicians to treat the poor by creating substantial collective purchasing power and by conditioning access to middle class patients on treatment of the poor, thus appealing to physicians’ financial self-interest. TennCare shows a new and promising approach, no matter how vociferously physicians complain about it.

TennCare, Tennessee’s Medicaid experiment, seeks to double Medicaid coverage in Tennessee—from approximately 750,000 people to 1.5 million. TennCare removes limits on Medicaid services, expands the medical services offered, and emphasizes low cost, cost-effective primary care. Perhaps most importantly, TennCare promises to mainstream health care for the poor by providing preventive and primary care in private physicians’ offices, moving the site of care away from expensive emergency rooms and hospitals. TennCare sounds like an ideal solution.

“On the Internet, nobody knows you're a dog,” says one canine to another as they sit in front of a computer in the classic New Yorker cartoon. This can also apply to those who seek or provide medical care online. On the Internet, nobody knows if you're male or female, elderly or adolescent, fit or obese, hirsute or bald, virile or impotent. In addition, in many cases, nobody knows if the “physician” or “pharmacist” on the other end of the line is a properly licensed physician or pharmacist, where they are located, what the knowledge level or training of the consulting practitioner is, or whether the medications being shipped are of the appropriate level of quality, potency or dosage. And, if the ease with which one is able to procure pharmaceuticals online is any indication, there are plenty of unscrupulous entrepreneurs selling drugs on the Internet who do not appear to care.

Selective non-treatment decisions involving severely handicapped neonates have recently come under renewed judicial and legislative scrutiny. In this Article, the Author examines the legal, ethical and social considerations attendant to the non-treatment decision. In Part II of this Article the Author discusses the predominant ethical viewpoints relating to this issue and proposes a new moral standard based on personal interests. Part III presents a survey of the jurisprudence relating to selective non-treatment decisions. Parts IV and V of this Article provide a critical examination of the recently enacted Child Abuse Amendments of 1984, a federal legislative initiative designed to regulate treatment decisions relating to handicapped infants. The Author suggests that the ethical standards and treatment criteria proposed in this Article may prove useful to courts seeking to balance the handicapped neonate's constitutional right to privacy with the requirements of the new federal law.

The global Human Genome Project (HGP) promises dramatic advances in biomedical science and in identifying and treating diseases and illnesses that exact an enormous toll on people throughout the world. The HGP portends a conceptual revolution in health care: many foresee a new “predictive medicine” based on the development of genetic screening, testing and gene therapy.

Although advances in genetic science create the potential for dramatic progress against disease in rich and poor states, they also pose profound national and global policy concerns, including the potential impact of the scientific developments on human rights and public health. The development of more precise genetic information raises the specter of genetic discrimination by public and private sectors in all nations with access to the new technologies. In addition, nations will grapple increasingly with the appropriate balance between screening for and treatment of genetic diseases in order to promote public health and protect individual rights to privacy and confidentiality. Genetic screening and services also raise human rights questions relating to equitable resource allocation and the protection of public health.

What proportion of health care resources should go to programs likely to benefit older citizens, such as treatments for Alzheimer’s disease and hip replacements, and what share should be given to programs likely to benefit the young, such as prenatal and neonatal care? What portion should go to rare but severe diseases that plague the few, or to common, easily correctable illnesses that afflict the many? What percentage of funds should go to research, rehabilitation or to intensive care? Many nations have made such hard choices about how to use their limited funds for health care by explicitly setting priorities based on their social commitments. In the United States, however, allocation of health care resources has largely been left to personal choice and market forces. Although the United States spends around 14% of its gross national product (GNP) on health care, the United States and South Africa are the only two industrialized countries that fail to provide citizens with universal access.

The Patient Protection and Affordable Care Act (PPACA), as amended by the Health Care and Education Reconciliation Act of 2010, initiated comprehensive health reform for the healthcare sector of the United States. PPACA includes strategies to make the American healthcare sector more efficient and effective. PPACA's comparative effectiveness research initiative and the establishment of the Patient-Centered Outcomes Research Institute are major strategies in this regard. PPACA's comparative effectiveness research initiative is one in a long line of federal initiatives to address the rising costs of healthcare as well as to obtain better value for healthcare expenditures. The key question is whether the governance and design features of the institute that will oversee the initiative will enable it to succeed where other federal efforts have faltered. This Article analyzes the federal government's quest to ensure value for money expended in publically funded healthcare programs and the health sector generally. This Article will also analyze what factors contribute to the possible success or failure of the comparative effectiveness research initiative. Success can be defined as the use of the findings of comparative effectiveness to make medical practice less costly, more efficient and effective, and ultimately, to bend the cost curve.

Implicit in any discussion of quality in health care are ideas about responsibility: who is responsible to define quality, who is responsible to deliver it, and who is responsible when the quality of care is unsatisfactory. The thesis of this article is that due to economics, ethics, and law, we have placed these responsibilities almost exclusively on physicians, but that powerful economic changes now require a reallocation of the responsibilities of providers, patients, and payers in defining and delivering quality in health care.

In the past half-century an extraordinarily generous, uncritical reimbursement system has empowered physicians to define and deliver quality that is interventionist and highly technological. Longstanding ethical precepts hold that physicians are responsible for their patients, and modern economic arrangements have encouraged physicians to focus on their patients’ welfare, virtually to the exclusion of costs or other competing considerations.

The World Health Organization’s CHOICE program analyzes the cost effectiveness of various health interventions related to the Millennium Development Goals. The program identifies the best strategies for improving health in low-income countries, using a standard set of methodological assumptions. These studies evaluate interventions in many areas, including child health and HIV/AIDS.

For some of these treatments, drug costs are a significant variable: if the drug price doubles, the intervention becomes less cost effective. But if the drug price is reduced by 90%, then more therapies become affordable.

Drug prices are uniquely susceptible to radical price reductions through generic competition. Patented pharmaceuticals may be priced at more than 30 times the marginal cost of production; the excess is the patent rent collected by the drug company while the patent and exclusive marketing periods remain. Patent rents are significant. AIDS drugs which sell for US$10,000 per person per year in the US are sold generically for less than US$200. If patented drugs could be sold at the marginal cost of production, cost effective treatments would become even more attractive, and other interventions would become affordable.

The rapid growth of medical technology gives rise to difficult dilemmas concerning the appropriateness of, and access to, new equipment and devices capable of maintaining life or improving its quality. Such a dilemma already exists, for example, with regard to kidney dialysis machines. In 1972, Congress amended the Social Security Act to make such machines available under Medicare to all who needed them. But almost immediately the overwhelming cost of such equipment—in the billions of dollars—made the original appropriations totally inadequate, and prompted serious questions of whether access to kidney dialysis should be made available at public expense—and, if so, to whom.

This Comment takes the reader 25 years into the future through the medium of a hypothetical U.S. Supreme Court decision** regarding a federal health agency's regulations that establish a system for allocating artificial hearts to those whose lives can be lengthened by implantation. The author assumes that a national health insurance system has been enacted and implemented, that all physicians are employees of the federal government, and that the enabling legislation has placed broad powers in the hands of the federal government to regulate the development and allocation of scarce and expensive medical resources. The opinions of the various Supreme Court Justices reflect a broad range of legal and ethical viewpoints, and—in keeping with the difficult, indeed frightening, life-or-death issues involved—are often intensely personal in nature.

Now in its second decade, functional magnetic resonance imaging (fMRI) localizes changes in blood oxygenation that occur in the brain when an individual performs a mental task. Physicians and scientists use fMRI not only to map sensory, motor, and cognitive functions, but also to study the neural correlates of a range of sensitive and potentially stigmatizing conditions, behaviors, and characteristics. Poised to move outside the traditional clinical and research contexts, fMRI raises a number of ethical, legal, and social issues that are being explored within a burgeoning neuroethics literature.

In this Article, I place these issues in their proper historical context. The ethical, legal, and social issues raised by advances in functional neuroimaging are challenging and somewhat distinctive, but they are not entirely new. Earlier methods of body imaging and brain mapping, including phrenology, x-ray, positron emission tomography, and single-photon emission computed tomography, raised similar issues, and perhaps we can use our experiences with these sciences and technologies to help guide current functional neuroimaging policy.