Two of the patient's rights in a Uniform Act for the Terminally Ill should he a) the right to be treated if there is reasonable doubt of the patient's wishes until it becomes clear that the treatment is not beneficial and that the patient is indeed terminally ill, and b) the right not to he subjected to treatment with no medical benefit. A physician with appropriate supporting independent opinions would he the logical individual to whom the responsibility of protecting those rights should be given. This is particularly true when the patient is incapable of his or her own medical decisions and has left no instructions regarding his or her personal goals in medical care in the event of severe illness. Two cases and an analysis of power in medical decision-making illustrate these points.

The unsustainable growth in U.S. health care costs is in large part attributable to the rising costs of pharmaceuticals and medical devices and to unnecessary medical procedures. This fact has led health reform advocates and policymakers to place considerable hope in the idea that increased government support for research on the comparative effectiveness of medical treatments will eventually help to reduce health care expenses by informing patients, health care providers, and payers about which treatments for common conditions are effective and which are not. Comparative effectiveness research (CER) has shown in some cases that expensive but commonly used treatments are significantly less effective than relatively inexpensive alternatives. Critics warn, however, that CER will homogenize patient care, limit patient choices, and lead to improper health care rationing and even to the denial of lifesaving treatments.

In vitro fertilization (IVF) is now a well-established practice in the field of assisted reproduction. In 1995, over 41,000 IVF cycles were done in the United States, at a cost of more than $300 million. The overall success rate has risen to 22.8 deliveries per 100 egg-retrieval procedures (19.6 deliveries per initiated cycle). As the field has matured, the attention of policy-makers has shifted from questions about the ethical and legal status of human embryos to concerns about providing access and protecting consumers.

Three such concerns have emerged. One is the danger that IVF programs will disseminate misleading information about their success rates in order to attract patients. This problem, however, may be alleviated by the publication in late 1997 of the first of annual national and clinic specific reports, based on randomly audited data, by the Centers for Disease Control and Prevention, the American Society of Reproductive Medicine (ASRM), the Society for Assisted Reproductive Technology (SART), and RESOLVE, pursuant to the federal 1992 Fertility Clinic Success Rate and Laboratory Certification Act.

Professor Gostin is a leading authority on health law, whose writing and teaching are among the most authoritative in the United States, as exemplified by his recent work, Public Health Law: Power, Duty, Restraint. Gostin's article in this issue of the Journal of Law, Medicine & Ethics pays homage to Jonathan Mann (1947-1998) by expressing the debt he feels toward this extraordinary doctor and public health official with whom he had collaborated on several projects.

As many will remember, Mann held high-level positions at the Centers for Disease Control and worked on AIDS research in Central Africa before setting up the World Health Organization's Global Programme on AIDS, which he ran from 1986 to 1990. Thanks to his profound commitment and consummate communication skills, he achieved the unprecedented feat of raising the budget within two years to almost $100 million from the initial set-up of “himself, a secretary, and one typewriter,” as described by Daniel Tarantola.

The current debate about physician-assisted suicide and the question of whether patients would ask for such help if their pain were adequately controlled place in sharp focus the issue of undertreated pain. Studies have repeatedly documented the scope of the problem. A 1993 study of 897 physicians caring for cancer patients found that 86 percent of the physicians reported that most patients with cancer are undermedicated for their pain. A 1994 study found that noncancer patients receive even less adequate pain treatment than patients with cancer-related pain, and that minority patients, the elderly, and women were more likely than others to receive inadequate pain treatment. Although the problem of undertreatment of pain is multifaceted, I only address how state medical boards contribute to the problem and suggest possible remedies.

The literature on palliative care describes the numerous barriers that impede effective pain management and that result in the inadequate prescribing of pain-relieving drugs for terminally and chronically ill patients.

Many of today’s uses of nanotechnology and nanomaterials can comfortably fall under the current regulatory system with minor adjustments. However, the Woodrow Wilson Center’s Project on Emerging Nanotechnologies has pointed out that the U.S. regulatory system is not prepared to deal with successive generations of nanotechnology and emergent technologies. Nanotechnology presents a challenge. The current regulatory standards and methods are no longer sufficient to help ensure the public’s safety. It is an area of high uncertainty in which environment, health, and safety information is scarce; there is no single index such as concentration to measure toxicity; standards do not yet exist; the ready environmental transport of nanomaterials can increase the chance of exposure; real-time monitoring is not available; and nanomaterials might have systemlevel human and environmental risks. Thus, there is a need for a new and improved oversight system. Within this system there is a need for quickly assessing risks of emergent technologies so that informed policy decisions can be made.

Pharmaceutical companies routinely engage physicians, particularly those with prestigious academic credentials, to deliver educational talks to groups of physicians in the community to help market the company's brand-name drugs. These speakers receive substantial compensation to lecture at events sponsored by pharmaceutical companies, a practice that has garnered attention, controversy, and scrutiny in recent years from legislators, professional associations, researchers, and ethicists on the issue of whether it is appropriate for academic physicians to serve in a promotional role. These relationships have become so contentious that three years ago the pharmaceutical industry trade association, the Pharmaceutical Research and Manufacturers of America (PhRMA), adopted voluntary guidelines stating that drug companies should stop giving doctors free pens, calendars, sports bags, or tickets to entertainment events. Further, numerous medical associations, such as the Association of American Medical Colleges (AAMC), the American Board of Internal Medicine (ABIM) and the Institute on Medicine as a Profession (IMAP), and government bodies such as the Institute of Medicine (IOM) have recommended that medical schools and teaching hospitals prohibit or strongly discourage faculty from participating in so-called industry Speakers Bureaus — promotional events designed solely to market pharmaceutical products.

The opioid epidemic has claimed the lives of more than 183,000 individuals since 1999 and is now the leading cause of accidental death in the United States. Meanwhile, rates of incarceration have quadrupled in recent decades, and drug use is the leading cause of incarceration. Medication-assisted treatment or MAT (i.e. methadone, buprenorphine) is the gold standard for treatment of opioid use disorder. Incarcerated individuals with opioid use disorder treated with methadone or buprenorphine have a lower risk of overdose, lower rates of hepatitis C transmission, and lower rates of re-incarceration. Despite evidence of improved outcomes, many jails and prisons do not offer MAT to individuals with opioid use disorder. This seems partly due to a scientifically unjustified preference for an abstinence-only treatment approach. The absence of MAT in prisons and jails results in poor outcomes for individuals and poses a public health threat to communities. Furthermore, it disproportionately harms poor communities and communities of color. Health care providers in prisons and jails have an ethical obligation to offer MAT to individuals with opioid use disorder to mitigate risk of infectious diseases, opioid overdose and health disparities associated with incarceration.

Involuntary civil commitment (ICC) to treatment for opioid use disorder (OUD) prevents imminent overdose, but also restricts autonomy and raises other ethical concerns. Using the Kass Public Health Ethics Framework, we identified ICC benefits and harms. Benefits include: protection of vulnerable, underserved patients; reduced legal consequences; resources for families; and “on-demand” treatment access. Harms include: stigmatizing and punitive experiences; heightened family conflict and social isolation; eroded patient self-determination; limited or no provision of OUD medications; and long-term overdose risk. To use ICC ethically, it should be recognized as comprising vulnerable patients worthy of added protections; be a last resort option; utilize consensual, humanizing processes; provide medications and other evidence-based-treatment; integrate with existing healthcare systems; and demonstrate effective outcomes before diffusion. ICC to OUD treatment carries significant potential harms that, if unaddressed, may outweigh its benefits. Findings can inform innovations for ensuring that ICC is used in an ethically responsible way.

Due to society's need to control health care costs and to the failure of legislated health care reform, managed care is expanding at a rapid rate and will soon be the predominate form of health care delivery. Plans by Congress to bring Medicare and Medicaid under managed care will further consolidate this trend. Barring some legislative fiat, managed care is here to stay.

The term managed care describes a diverse set of organizational forms. Wide variations in approach, financing, physician involvement, and philosophy exist among the different types of managed care organizations (MCOs). While many articles on the ethics of managed care acknowledge this variety, most analyses focus on the for-profit entities, paying less attention to the ethical distinctions among the different forms of managed care. This paper discusses the key distinctions among MCO types, in particular the difference between for-profit and non-profit plans; the relationship of the physician to the MCO; the incentives used to control costs; the incentives that improve patient care; and the organizational features that nurture the principled practice of medicine.

Risk is the most often cited reason for ethical concern about any medical science or technology, particularly those new technologies that are not yet well understood, or create unfamiliar conditions. In fact, while risk and risk-benefit analyses are but one aspect of ethical oversight, ethical review and risk assessment are sometimes taken to mean the same thing. This is not surprising, since both the Common Rule and Food and Drug Administration (FDA) foreground procedures for minimizing risk for human subjects and require local IRBs to engage in some sort of risk-benefit analysis in decisions to approve or deny proposed research. Existing ethical review and oversight practices are based on the presumption that risk can be clearly identified within the planned activities of the protocol, that metrics can reasonably accurately predict potential hazards, and that mitigation measures can be taken to deal with unintended, harmful, or catastrophic events.

A central principle of bioethics is “subject autonomy,” the acknowledgement of the primacy of the informed consent of the subject of research. Autonomy requires informed consent — the assurance that the research participant is informed about the possible risks and benefits of the research. In fact, informed consent is difficult when a single drug is being tested, although subjects have a baseline understanding of the testing of a pharmacological agent and the understanding that they can stop taking the drug if there were an adverse event. However, informed consent is even less easily achieved in the modern arena of complex new molecular and cellular therapies. In this article, we argue that as science confronts new issues such as transplantation of stem cell products, which may live within the participant for the rest of their lives, researchers must carefully consider and constantly re-examine how they properly inform subjects considering participation trials of these novel therapeutic strategies.

For example, the manufacture of a vial of a cell product that consists of a collection of growing cells is very different than the production of a vial of identical pills, which can be presumed to be identical. The scientific concepts on which these cellular approaches are based may seem alien and incomprehensible to a research subject, who thinks of a clinical trial as simply the selection and testing of the most efficacious pharmaceutical agent already proven to work in preclinical animal studies. The research subject would be wrong.

Academic medical centers and drug manufacturers have traditionally occupied very distinct positions with regard to public trust. As collaborations among medical researchers and pharmaceutical companies expand, however, worries about the aggressive pursuit of profit that has tarnished the reputation of the pharmaceutical industry may be transferred to medical institutions and clinical investigators, suggesting to some that biomedical research is more about increasing profit than promoting public health. Consequently, when medical institutions forge research collaborations with industry they should be mindful of the potential for these relationships to erode public confidence in the integrity of clinical research.

Recent events have heightened concerns about the financing of clinical research. These include the widely publicized deaths of several research volunteers, scandals at the nation's largest funder of biomedical research, and evidence of fabricated research findings in prominent medical journals. These unfortunate events have prompted many to re-examine strategies for managing industry relationships and the financial conflicts of interest they may create.

The provision of police services and the suppression of crime is one of the first functions of civil government. Article 3 of the Universal Declaration of Human Rights speaks of a right to “security of person.” “The term ‘police’ traditionally connoted social organization, civil authority, or formation of a political community—the control and regulation of affairs affecting the general order and welfare of society,” including the protection of public health. Civil dispute resolution is also an important part of a system that moves people away from self-help and toward reliance on collectively constituted, peaceful channels for working out problems.

A safe and secure environment is tied to health. Research in social epidemiology suggests that a shared sense of security from physical violence and interference with property can contribute to better community health.

Health care decision making has changed profoundly during the past several decades. Advances in scientific knowledge, technology, and professional skill enable medical providers to extend and enhance life by increasing the ability to cure disease, manage disability, and palliate suffering. Ironically, the same interventions can prolong painful existence and protract the dying process. Recognizing that medical interventions, especially lifesustaining measures, are not always medically appropriate or even desired by a patient or family, health care professionals endeavor to determine who should make health care decisions and according to what standards. The importance that Western culture places on individual rights and self-determination is reflected in the growing advocacy for patient autonomy and the discrediting of physician paternalism. However, the question of autonomy becomes more complex when patients lack the capacity to decide for themselves.

Advance directives represent one response to the dilemma of decision making for incapacitated patients. The original advance directive, the living will, is a written list of instructions reflecting the individual's wishes about care, usually at the end of life.

Natural selection generated a natural sense of justice. This natural sense of justice created a set of natural rights; rights humans accorded to each other in virtue of being members of the same tribe. Sharing the responsibility for natural rights between all members of the same tribe allowed humans to take advantage of all opportunities for cooperation. Human rights are the present day political emanation of natural rights. Theoretically, human rights are accorded by all humans to all humans in virtue of being humans; however, the idea that the corresponding responsibility is now shared among all humans is not broadly accepted. The natural sense of justice creates an ambiguity: on the one hand humans consider the nation they belong to as the social system that should guarantee their human rights (and likewise they do not consider themselves as having responsibility for the human rights of inhabitants of other nations); on the other hand, as cooperation between nations intensifies, expectations of global mutual responsibility increase as well.

Recently, John Doe, an undocumented immigrant who was detained by United States Immigration and Customs Enforcement (ICE), was admitted to a hospital off-site from a detention facility. Custodial officers accompanied Mr. Doe into the exam room and refused to leave as physicians examined him. In this analysis, we examine the ethical dilemmas this case brings to light concerning the treatment of patients in immigration detention and their rights to privacy. We analyze what US law and immigration detention standards allow regarding immigration enforcement or custodial officers’ presence in medical exams and documentation of detainee health information. We describe the ethical implications of the presence of officers in medical exam rooms, including its effects on the quality of the patient-provider relationship, patient privacy and confidentiality, and provider's ability to provide ethical care. We conclude that the presence of immigration enforcement or custodial officers during medical examination of detainees is a breach of the right to privacy of detainees who are not an obvious threat to the public. We urge ICE and the US Department of Homeland Security to clarify standards for and tighten enforcement around when officers are legally allowed to be stationed in medical exam rooms and document detainees’ information.

Overdose deaths involving prescription opioids killed more than 17,000 Americans in 2017, marking a five-fold increase since 1999. High prescribing rates of opioid analgesics have been a substantial contributor to prescription opioid misuse, dependence, overdose and heroin use. There was recognition approximately ten years ago that opioid prescribing patterns were contributing to this startling increase in negative opioid-related outcomes, and federal actions, including Medicare reimbursement reform and regulatory actions, were initiated to restrict opioid prescribing. The current manuscript is a description of those actions, the effect of those actions on opioid prescribing and related patient outcomes. We also describe our proposal of methods of expanding these efforts as an important piece to further reduce opioid-related misuse, dependence, and overdose death.

The current ethical norms of genomic biobanking creating and maintaining large repositories of human DNA and/or associated data for biomedical research have generated criticism from every angle, at both the practical and theoretical levels. The traditional research model has involved investigators seeking biospecimens for specific purposes that they can describe and disclose to prospective subjects, from whom they can then seek informed consent. In the case of many biobanks, however, the institution that collects and maintains the biospecimens may not itself be directly involved in research, instead banking the biospecimens and associated data for other researchers. Moreover, the future uses of biospecimens may be unknown, if not unknowable, at the time of collection. Biobanking may thus stretch the meanings of inform and consent to their breaking point: if you cannot inform subjects about what their biospecimens will be used for (because you do not know), what can they consent to? Given that informed consent by individual subjects is the ethical gold standard, the seeming dilution of the concept in the context of biobanking is a profound problem.