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.

Xenotransplantation is any transplantation, implantation, or infusion of either live cells, tissues, or organs from a nonhuman animal source, or human bodily fluids, cells, tissues, or organs that have had ex vivo contact with live nonhuman animal cells, tissues, or organs into a human recipient. Most scientists agree that clinical xenotransplantation should not be performed in the absence of accompanying public health safeguards The science upon which that consensus is based has been extensively described in the literature. By and large the most compelling reason for public health safeguards is the possible introduction of new infectious agents into the human life cycle as a result of xenotransplantation.

The most frequent source of new infectious diseases in human populations is the transfer of agents, such as viruses, bacteria, or prions, from animals to man. Human diseases and infectious agents that are thought to have originated from animals include influenza, rabies, malaria, lassa fever, lyme disease, AIDS, yellow fever, tuberculosis, the human t-cell lymphotropic virus, the herpes B virus, the hantavirus, and even the bubonic and pneumonic plagues.

The purpose of this paper is to encourage reflection about the harm that could result if the positive aspects of team-organized health care are compromised during the health care reform process. While other models of health care delivery could replace teamwork and serve patients as well or better, the interdisciplinary health care team (IHCT) probably will not be abandoned. However, one or more disciplines whose members play important roles on various teams may be sacrificed in the hasty effort to define essential health care. Moreover, a significant proportion of the types of IHCTs in existence could be rashly eliminated from health plans. These changes should not take place randomly or by default.

Shared decision-making has become a new focus of health policy. Though its core elements are largely agreed upon, there is little consensus regarding which outcomes to prioritize for policy-mandated shared decision-making.

Recent cases involving biosamples taken from indigenous tribes and newborn babies reveal the emptiness of informed consent. This venerable doctrine often functions as a charade, a collective fiction which thinly masks the uncomfortable fact that the subjects of human research are not actually afforded full information regarding the types of research that may be contemplated, nor do they provide meaningful consent. But if informed consent fails to provide adequate protection to the donors of biological materials, why not turn to principles of property law? Property is power, yet current law permits everyone except for those who donate biological materials to possess property rights. The reluctance to invoke property probably stems from fears of resurrecting slavery and the commodification of human beings. But ironically, avoidance of property transforms the subjects of human research into objects that can be owned only by others, resulting in new forms of oppression and exploitation. Human research subjects are autonomous individuals who should not only possess the power to contribute their biological materials, but also the right to help control the course of research, and to share in the resulting benefits or profits. Conferring body property might enable research subjects to regain power and a measure of self-sovereignty.

The authors surveyed hospitals across the country on their policies regarding overlapping surgery, and found large variation between hospitals in how this practice is regulated. Specifically, institutions chose to define “critical portions” in a variety of ways, ultimately affecting not only surgical efficiency but also the autonomy of surgical trainees and patient experiences at these different hospitals.

Despite the enormous progress made in the advancement of health technologies over the last century, infectious diseases continue to cause significant morbidity and mortality in developing countries. Neglected diseases are a subset of infectious diseases that lack treatments that are effective, simple to use, or affordable. Neglected diseases primarily affect populations in poor countries that do not constitute a lucrative market sector, thus failing to provide incentives for the pharmaceutical industry to conduct R&D for these diseases. Of the treatments that do exist for neglected diseases, most are completely out-dated, with poor side-effect profiles, cumbersome logistics of administration, and inadequate efficacy. Historically, the impetus for a majority of neglected disease research was driven by early 20th-century colonialism, and in the post-colonial era, these diseases have been virtually ignored. Of the 1556 New Chemical Entities (NCEs) brought to market during the 30-year period from 1975 to 2004, only 20 — less than 0.02% — were for neglected diseases.

This text is about obtaining and sharing genetic information when there is a potential conflict of interests between patients and their families and relatives. The patient or, in this text, the “index-person,” is someone who is considering obtaining or already has obtained genetic information about herself through genetic testing.

The index-person can have several reasons to take an interest in obtaining her genetic information. She may want to know if she has a genetic predisposition for a disorder in order to take measures for preventing its development. Even if there are no preventive measures, as is the case with Huntington's disease, for instance, she may still want to know whether she has the mutation, in order to adjust her future plans. These interests that an individual may have in obtaining genetic information have been used to argue in favour of a right to know.

Law is indispensable to the public's health. The twentieth century proved this true as law contributed to each of the century's ten great public health achievements: vaccination, healthier mothers and babies, family planning, safer and healthier foods, fluoridation of drinking water, the control of infectious diseases, the decline in death from heart disease and stroke, recognition of tobacco use as a health hazard, motor vehicle safety, and safer workplaces.

The readers of this journal can give examples of the relevant types of laws with ease: Jacobson v. Massachusetts, the 1905 U.S. Supreme Court case that upheld the constitutionality of compulsory vaccination; mandatory immunization for school admission; authorization of state prenatal care programs; mandatory fortification of foods; Title X of the Public Health Service Act; the Pure Food and Drugs Act of 1906; the Safe Drinking Water Act of 1974, and hundreds of state and local enactments regulating food; fluoridation ordinanceswater, and sanitation; the Surgeon General's warning notices on cigarette packs and restrictions on marketing tobacco; seat belt laws and mandated vehicle and highway design features; and laws like the federal Occupational Safety and Health Act of 1970 that regulate working conditions.

This article examines various methodologies used to measure implementation of human rights norms. As the above quotations demonstrate, society's need for measurement to evaluate progress and change over the centuries has not diminished. One of the purposes of measurement is to move human rights discourse beyond the aspirational, which has made achievement of these rights elusive, to an approach that makes them more concrete and practical through accurately testing the extent of their implementation. Measurement can simply involve the assignment of variable values - for example, numbers - to objects or events, such as law, according to rules. A link can then be provided between abstract concepts, such as human rights, to empirical indicants. This article aims to draw general principles to guide and make better use of measurement methodologies, such as statistical analysis and audits, in human rights areas generally, but with particular emphasis on the health area, especially HIV/AIDS.

Law is an essential tool for public health practice, and the use of a systematic legal framework can assist with preventing chronic diseases and addressing the growing epidemic of obesity.The action options available to government at the federal, state, local, and tribal levels and its partners can help make the population healthier by preventing obesity and decreasing the growing burden of associated chronic diseases such as cardiovascular disease and Type 2 diabetes. The Centers for Disease Control and Prevention (CDC) uses the four-part systematic legal framework commonly referred to as “public health legal preparedness” to demonstrate the essential role law can play for any public health issue. This paper uses the “laws and legal authorities” component of the framework and should be considered in combination with the competencies, coordination, and information-best practices components of the framework.

Since 1980. the Supreme Court of Canada has handed down two judgments which have had a major impact on the law of informed consent in this country. These are Reibl v. Hughes and Hopp v. Lepp. The doctrine of therapeutic privilege, the subject of this article, was discussed in both cases. But, in order to examine this doctrine, first, a brief explanation of the Court's more fundamental ruling on the doctrine of informed consent is needed.

The Basic Structure of Informed Consent and Therapeutic Privilege

Citing and relying on the United States case of Canterbury v. Spence, the Supreme Court of Canada changed the reference point for establishing the standard to be used to determine the legally required scope of disclosure of information to a patient in order to obtain his or her informed consent. Previously, this standard had been set according to the information that “the reasonable physician in the same circumstances” would disclose. It became what “the reasonable patient in those circumstance? would want to know, which encompasses information concerning “the nature of the proposed operation, its gravity, any material risks and any special or unusual risks attendant upon the performance of the operation.”

Discussions of medical malpractice seem to end up at either of two extremes: the trial lawyer's view that injured patients deserve compensation, with the treating physician the best source; and the doctor's view that such suits unfairly penalize judgmental errors while raising the costs of practicing medicine. The parties to this debate make different assumptions about the nature, purpose, and likely impact of malpractice suits; as a result, the issues are muddied rather than clarified. This article suggests that, viewed in light of recent studies of iatrogenic illness in hospital settings, malpractice litigation may help rather than hinder the quality of medical care delivered.

latrogenesis, defined as the undesirable side-effects of medical interventions, is not a new phenomenon. The major study undertaken by the Department of Health, Education and Welfare in 1973 noted that a substantial percentage of adverse medical outcomes occur as the result of treatment. Others have concluded that many surgical deaths are avoidable.

Expectations of a vaccine to prevent acquired immunodeficiency syndrome (AIDS) are rising. Not only are the prospects for an effective immunogen improving, but immunization appears to hold the greatest promise for halting the spread of infection and disease. Identification of the causal agent—the retrovirus called HTLV-IIII, LAV, or generically, HIV (human immunodeficiency virus)—has provided the direction and limited the options for containing the disease.

Prevention is, of course, critical where the disease must be presumed to be fatal in all cases. Although there is no clear evidence that any single exposure-to HIV will result in infection or disease, prudence dictates that all exposures be considered potentially infectious and, ultimately, disease-producing until more is known. Public education or, more specifically, behavior modification, intended to reduce or eliminate unsafe sexual contact and the sharing of syringes and needles by users of illicit intravenous (IV) drugs, is perhaps the only effective means of prevention that currently exists.

The promise of personalized medicine and the quest for a greater understanding of the genetic basis of disease has transformed the research enterprise. The Director of the National Institutes of Health (NIH), Elias A. Zerhouni, M.D., recently predicted “that comprehensive, genomics- based health care will become the norm, with individualized preventive medicine and early detection of illnesses.” This excitement about the potential scientific and clinical advances that may come from genomics- based research has led several NIH institutions to launch initiatives for genome-wide association studies (GWAS), calling on researchers and institutions to utilize the new DNA analysis technologies to study the genetic variation between individuals with a particular illness and healthy controls.

The diversity of state confidentiality laws governing public health data presents a significant challenge for public health initiatives. This challenge is further complicated by the array of confidentially laws that are relevant within a state as disclosure and usage standards vary depending upon data holder, type, and source. These laws often have not been updated to address modern confidentiality risks such as unlawful data linkage or breach, leaving many public health organizations without clear guidance in the contentious area of individual privacy. To address these challenges, public health organizations have increasingly turned to the science of de-identification, but whether de-identification adequately meets the many and varied state confidentiality legal requirements remains an unanswered question.

The writers in this symposium are drawn together under the topic of medicine — not to discuss any new discovery in the prevention or treatment of disease. Quite the contrary. We are drawn here to consider a phenomenon. We are here to consider whether a collective romantic fantasy called alternative medicine that has seized our society really deserves the acclaim it is receiving. This, for the most part, is what people like us do when we gather in symposia or meetings to discuss alternative medicine. We argue about beliefs and claims, not results. Are the beliefs and claims of this collective romantic fantasy justified by empirical data? Or rather, will the beliefs and claims of this collective romantic fantasy be justified by empirical data because the fantasy is already securely in place in our political and fiscal, medical and educational, structures?