Public health agencies undertake a broad range of health promotion and injury and disease prevention activities in collaboration with an array of actors, such as the community, businesses, and non-profit organizations. These activities are “multisectoral” in nature and centered on public health agencies that oversee and engage with the other actors. Public health agencies can influence the hazardous activities in the private sector in a variety of ways, “ranging from prohibition and regulation to volunteerism, and from cooperation to cooption.” Hence, a public health agency that possesses the necessary administrative resources and authority is vital to the effective implementation of health policies and regulations.

In the developing world, however, many state health agencies lack these basic capacities in dealing with critical health threats, including their ability to avert epidemics of communicable diseases arising from poor sanitary conditions. A serious constraint is the shortage of public health funding for health agencies in the developing world for typical agency functions (e.g., surveillance, monitoring, assessment, and intervention). This is often aggravated by the transaction-intensive demands entailed in enforcing regulations among an array of private and public sector actors including individuals, businesses, and local bodies responsible for providing civic services.

The vignette described in the introduction of this symposium raises a number of ethical and legal problems for physicians who work for correctional institutions and death row inmates. They are not confined to correctional physicians, however, as states have requested aid from practicing physicians in the community, and even from other states, when conflicts have arisen in the treatment of death row inmates as they near the date of execution. As outlined, the case involves a 48-year-old man with a long history of schizophrenia, initially diagnosed at age 19. Compliant with medication, he remained generally free from positive symptoms-delusions and hallucinations. Nonetheless, he committed two murders during a robbery and was sentenced to death. Since his incarceration, the defendant has consistently refused psychotropic medications and has been forcibly medicated on several occasions when he exhibited violent outbursts and was overtly psychotic.

The intense and extensive debate over human embryonic stem cell (hESC) research has focused primarily on the moral status of the human embryo. Some commentators assign full moral status of normal adult human beings to the embryo from the moment of its conception. At the other extreme are those who believe that a human embryo has no significant moral status at the time it is used and destroyed in stem cell research. And in between are many intermediate positions that assign an embryo some degree of moral status between none and full. This controversy and the respective positions, like the abortion controversy, is by now well understood, despite the lack of progress in resolving it. I have argued briefly elsewhere that early embryos do not have significant moral status, but I do not want to reenter that debate here. Instead, I want to focus on an issue that has had relatively little explicit and separate attention, but is likely to loom larger in light of the Obama administration’s partial lifting of the Bush administration’s restriction on the embryos that can be used in stem cell research that receives federal funding.

The United States, like other countries facing rising health care costs, is pursuing a commitment to interoperable electronic health records. Electronic records, it is thought, have the potential to reduce the risks of error, improve care coordination, monitor care quality, enable patients to participate more fully in care management, and provide the data needed for research and surveillance. Interoperable electronic health records on a national scale — the ideal of a national health information network (or NHIN) — seem likely to magnify these advantages. Thus, the recent economic stimulus package contains considerable funding for the development of “health information technology architecture that will support the nationwide electronic exchange and use of health information in a secure, private, and accurate manner.”

Moral status is the moral value that something has in its own right, independently of the interests or concerns of others. Research using human embryonic stem cells (hESCs) implicates issues about moral status because the current method of extracting hESCs involves the destruction of a human embryo, the moral status of which is contested. Moral status issues can also arise, however, when hESCs are transplanted into embryonic or fetal animals, thereby creating human/ nonhuman stem cell chimeras (“chimeras” for short). In particular, one concern about chimera research is that it could confer upon an animal the moral status of a normal human adult, but then impermissibly fail to accord the animal the protections it merits in virtue of its enhanced status. Understanding the public policy implications of this ethical conclusion is complicated by the fact that certain views about the moral status of the embryo cannot legitimately be used to justify public policy decisions. Arguments like those employed in the abortion debate for the conclusion that abortion should be legally permissible even if abortion is not morally permissible also support, to a more limited degree, a liberal policy on hESC research involving the creation of chimeras.

The history of physician involvement in capital proceedings is longstanding and ripe with controversy and conflicts of ethical concerns. Previously one of us (Phillips) has written that the controversy is more appropriately characterized as a conflict of moral position rather than one of ethical dilemma.

In hindsight, we believe that analysis, while true, does not capture the depth or complexity of the issue.

Forensic psychiatric evaluations, including competency to be executed evaluations, are done with a clear understanding that no physician-patient relationship exists. Treatment, however, is not so neatly re-categorized in large measure because it involves the physician’s active provision of the healing arts.

Patients and their physicians frequently make important health care decisions with incomplete information. Memory fails; records are incomplete; the onset of significant events is confused with other life stories; and even the most basic information about medications, laboratory tests, allergies, and problems is often the result of guesswork. As providers and as patients, we suffer because information vital to health care is not available when and where it is needed. Data required for care are dispersed across various settings and represented in a range of formats; incentives to bring these data together do not exist.

In recent years, four specific approaches have emerged to address patient-centered information access. The first model attempts to consolidate all care into a single care delivery and financing system. This model — prevalent in many European countries — is to some degree extant at Kaiser-Permanente and other integrated care and financing systems. This model is ideal if and when one organization is responsible for all care delivery and financing. Such models present “one-stop shopping” for managing health information, coordinating care, communicating with providers and support groups, and ensuring both payment and accountability.

When 47-year-old Simba Abalo, an unemployed retired soldier in Lomé, Togo, found out that he had AIDS in September 2007, he was unable to receive government-supplied antiretroviral drugs: “CAMEG [the state’s central medicines purchasing organization],” he said, “told me they were not taking any new cases for six months because they had run out of drugs.

Stocks of antiretrovirals had become depleted after the Global Fund to Fight AIDS, Tuberculosis and Malaria suspended part of its grant to Togo in 2006 and failed to approve a new grant request in 2007, reportedly because of oversight irregularities. “Even if they had the drugs,” said Abalo, “I could not have paid more than US$4 a month since I had just lost my job as a security guard earning US$70 a month.”

The goal of my comments regarding the case study of Eve Hyde — presented in the introduction of this symposium — is not first and foremost to resolve the conflict between individual autonomy and medical paternalism regarding non-consensual psychiatric treatment. Instead, the goal is to step back far enough from what is generally accepted as the morally appropriate basis for non-consensual psychiatric treatment, including involuntary hospitalization and medication, and to ask very basic questions about when patients may permissibly be treated without their consent. My goal, in short, is Socratic — to explore aspects of what we take for granted in order better to determine whether we ought to take them for granted. Commentators routinely urge that it is morally permissible forcibly to treat psychiatric patients, such as Eve Hyde, in order to preserve the patient’s best interests and restore the patient’s autonomy. Such arguments typically specify duties of beneficence toward others, while appreciating personal autonomy as a positive value to be weighed against other factors.

One of the largest, oldest, and most interesting challenges in health care is the balancing act in which clinicians have generally uncontroversial duties both to individual patients and to communities. Physicians and nurses must — so we teach them — put patients first, and at the same time recognize that individuals are members of communities. Individuals affect the health of communities, and communities affect the health of individuals. Thus, the moral and professional duties that result are sometimes in conflict.

Moreover, the traditional, prosaic clinical encounter is evolving in an environment increasingly shaped (albeit too slowly according to some) by electronic health records, personal health records, pharmacogenomics and vast networks of data collection and storage for public health surveillance, human subjects research, health services evaluation, and comparative effectiveness research. Health information technology is changing everything. It would be perverse otherwise: imagine large amounts of data and information either ignored, missed, or collected and then ignored.

Acentral promise of human embryonic stem cell research is the potential to develop viable therapeutic approaches to a range of devastating diseases and conditions. Despite excitement over such advances, there are scientific and medical reasons to be cautious as stem cells and their products are introduced into patients. In response to such concerns, the International Society for Stem Cell Research (ISSCR) as well as ad hoc groups and individuals have offered approaches to governance of this research. While there are similarities among these governance models and they are in principle easily endorsable, in this paper I raise a set of concerns related to their implementation, suggesting areas where gathering data may facilitate more appropriate oversight. Next, I suggest areas that seem to have been neglected as these governance models have been developed so that they may be on the agendas of those seeking to revise these models in the future. Finally, I describe how some of the concerns that have arisen in considering the appropriate governance of stem cell research may be useful in science and translational research more broadly.

In January 2010 the Director General of the World Health Organization (WHO) called for an “informal consultation on the future of financing for WHO” and in her opening remarks expressed the need to make the WHO fit for purpose given the unique health challenges of the 21st century.

Margaret Chan referred to the constitutional role that WHO has to “act as the directing and co-ordinating authority on international health work” and stated clearly that global health leadership today and for the future must be earned through strategic and selective engagement. She said, “WHO can no longer aim to direct and coordinate all of the activities and policies in multiple sectors that influence public health today.” This is a clear challenge that she has put to the global health community in recognition that WHO’s role must be clarified in the face of major change.

In this paper I examine some of the significant moral concerns inherent in cases of treatment refusal involving patients with psychotic disorders. In particular, I explore the relevance of the principle of autonomy in such situations. After exploring the concept of autonomy and explaining its current and historical significance in a health care setting, I argue that because autonomous choice depends for its existence upon certain human functions such as the ability to reason, judge, and assess consequences, patients cannot be said to be making free and autonomous decisions if these capacities are compromised. I contend further that because psychotic disorders have the potential to compromise these functions in the future, it is appropriate, in some limited cases, to coerce patients with psychotic disorders to undergo treatment in order to preserve their future decisionmaking capacities and to protect their ability to recognize and respect the autonomy of others.

The United Nations Convention on the Rights of Persons with Disabilities (the CRPD or the Convention), adopted on December 13, 2006, and entered into force on May 3, 2008, constitutes a key landmark in the emerging field of global health law and a critical milestone in the development of international law on the rights of persons with disabilities. At the time of its adoption, the U.N. High Commissioner for Human Rights heralded the CRPD as a rejection of the understanding of persons with disabilities “as objects of charity, medical treatment and social protection” and an embrace of disabled people as “subjects of rights.”

The text of the Convention itself, and the highly participatory process by which it was negotiated, signal a definitive break from previous international approaches that focused on disability within a medical model framework. In contrast to traditional approaches, the CRPD embraces a social model of disability, concentrating the disability experience not in individual deficiency, but in the socially constructed environment and the barriers that impede the participation of persons with disabilities in society.

Stem cells derived from pluripotent cells offer the hope of new treatments for diseases for which current therapy is inadequate. Clinical trials are essential in developing effective and safe stem cell therapies and fulfilling this promise. However, such clinical trials raise ethical issues that are more complex than those raised in clinical trials using drugs, cord blood stem cells, or adult stem cells. Several clinical trials are now being carried out with stem cells derived from pluripotent cells, and many more can be expected in light of the rapid scientific progress in the field.

Degenerative neurological diseases are desirable targets for stem cell clinical trials. The FDA has approved Phase 1 clinical trials of neural stem cell transplantation for Batten Disease, Pelizaeus-Merzbacher Disease, and spinal cord injury. In Parkinson Disease (PD), stem cell transplantation could correct the primary pathophysiological defect — inadequate levels of the neurotransmitter dopamine. Current treatment is unsatisfactory in late-stage PD.

The term “Electronic Health Records” (EHR) means something different to each of the stakeholders in health care, but it always seems to carry a degree of emotional baggage. Increasingly, EHRs are advertized as a nearly unmitigated good that will transform medical care, improve safety and efficiency, allow better patient engagement, and open the door to an era of cheap, effective, timely, and patient-centered care. Indeed, for some EHR proponents the benefits of adopting them are so obvious that adoption has become an end in itself. But for others — and especially for a number of skeptical practitioners and patients — EHR is a code word that portends the corporate transformation of health care delivery, the loss of patient privacy, the demand that patients bear more responsibility in health care, and the unreflective takeover of the health care system by people who do not understand medical care or how health care relationships unfold.

Pharmaceutical companies have long relied on direct marketing of their drugs to physicians through one-on-one meetings with sales representatives. This practice of “detailing” is substantial in its costs and its number of participants. Every year, pharmaceutical companies spend billions of dollars on millions of visits to physicians by tens of thousands of sales representatives.

Critics have argued that drug detailing results in sub-optimal prescribing decisions by physicians, compromising patient health and driving up spending on medical care. In this view, physicians often are unduly influenced both by marketing presentations that do not accurately reflect evidence from the medical literature and by the gifts that sales representatives deliver in conjunction with their presentations.

A decade ago, Jonathan Mann made a powerful case that human rights could provide a vocabulary and mode of analysis for understanding and advancing health. He made the case well, and put the idea into inspired practice, but the idea was neither new nor his alone. The idea that social justice — and henceforth in this article we will use that term loosely (and with obvious imprecision) to embrace goods like human rights, social equality, and distributive justice — was intrinsically important to health resonated with the social epidemiology already gathering force (not to mention an enduring theme running through the history of public health work). That social structure and relations of power explain a great deal about the level and distribution of population health was implicit in the work of pioneers like Geoffrey Rose, evident in Marmot’s seminal Whitehall studies, explicit in the writings of Mervyn Susser, and the main thrust of scholars like Nancy Krieger and Meredeth Turshen. Although researchers tend to avoid using a term with such normative weight, it is safe to say that Mann — and Susser, and Marmot and Krieger among others — were right: social justice is central to the proper understanding of health.

Public policy tries to promote appropriate drug use by allowing firms to market drugs in interstate commerce only for uses that the Food and Drug Administration (FDA) has found to be safe and effective. Because of their medical knowledge, physicians are authorized to prescribe drugs even for uses unapproved by the FDA. Nevertheless, physicians have relied on drug firms for information on appropriate prescribing despite the inherent tension between drug firm dissemination of information to promote sales and rational prescribing. In the past, physicians often relied particularly on drug firm advertising for information on drug use. Today, physicians rely on drug firms to finance continuing medical education (CME). A historical review reveals connections between these two different ways commercial interests have influenced the information that physicians receive and points the way to needed reforms.

There are many kinds of clinical trials. The regulatory framework within which most drug development takes place appears to be the one that is to be applied to the development of novel stem cell-based clinical trials. In the standard drug development model, appropriate pre-clinical research is conducted (largely based upon non-human animal models), and investigators or research sponsors (typically a company) submit an investigational new drug (IND) application to the Food and Drug Administration (FDA).

If approved, typical clinical trials start with Phase I, which is usually a trial (with a small number of participants) to determine the maximum tolerable dose of a drug. Phase I trials are often referred to as “safety studies” because the primary goal of Phase I research is to determine if an intervention is safe (not whether it works).