The concept of vulnerability has been the topic of considerable discussion in research bioethics, largely because of dissatisfaction with early constructions of the concept that were based on subpopulations of research subjects. These subpopulations have attributes likely to undermine their capacity to provide autonomous informed consent: persons who are relatively or absolutely incapable of protecting their own interests through negotiations for informed consent. Several subpopulations were seen as requiring special protections, including children, pregnant women, prisoners, racial minorities, the economically disadvantaged, the very sick, and the institutionalized. Recent years have witnessed the identification of other subpopulations with attributes that could render them vulnerable, as well. For example, the Council for the International Organization of Medical Societies has named such potentially vulnerable groups as the homeless, nursing home residents, patients with incurable diseases, patients in the emergency department, employees, students, and members of communities who are unfamiliar with modern medicine.

Few topics in international intellectual property law have been as controversial in recent years as the one we are about to examine. In the 1980s and early 1990s, a Diplomatic Conference attempted to revise the oldest international convention providing some protection for patented inventions outside of the domestic laws. Those efforts broke down, largely because developed and developing countries could not agree on the powers that governments should retain to issue compulsory licenses or on the grounds for which these powers could be exercised. The failure of this Conference, held under the auspices of the World Intellectual Property Organization (WIPO), persuaded the technology-exporting countries to link future negotiations concerning international intellectual property protection to the Multilateral Trade Negotiations, known as the Uruguay Round, which got underway in 1986. The end result was Annex IC of the Agreement Establishing the World Trade Organization of 1994, which incorporated a new, comprehensive and relatively elevated set of international minimum standards of patent protection into the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement).

America’s increasing obesity problem requires federal, state, and local lawyers, policymakers, and public health practitioners to consider legal strategies to encourage healthy eating and physical activity. The complexity of the legal landscape as it affects obesity requires an analysis of coordination across multiple sectors and disciplines. Government jurisdictions can be viewed “vertically,” including the local, state, tribal, and federal levels, or “horizontally” as agencies or branches of government at the same vertical level. Inspired by the successful tobacco control movement, obesity prevention advocates seek comprehensive strategies to “normalize” healthy behaviors by creating environmental and legal changes that ensure healthy choices are the default or easy choices. With many competing demands on diminishing municipal budgets, strategic coordination both vertically and horizontally is essential to foster the environmental and social changes needed to reverse the obesity epidemic.

The vulnerability of patients receiving significantly innovative neurosurgical procedures, either as research or as non-standard therapy, presents particularly potent challenges for those attempting to substantially advance clinical Neurosurgical practice in the most ethically and efficacious manner. This beginning formulation has built into it several important notions about research participation, balancing values, and clinical advancement in the context of neurological illness. For the time being, allow vulnerability to act as a placeholder for circumstances or states of being wherein the established checks and balances of power and interest are no longer sufficient in promoting the just treatment of persons. Further, the phrase to substantially advance Neurosurgical practice encompasses radical innovation as well as significant research into new procedures. Finally, few of these explorations involve true randomized placebo controlled trials, but rather they enroll patients rightfully hoping for some benefit by means of undergoing the procedure.

When a neurosurgeon asks me, as an ethicist, to meet with a patient who has medically refractory disease and no good standard therapy options remaining, he is asking for help concerning whether to offer, as a last chance, an unproven therapy as either innovation or research.

Intellectual property policy is a key social and political issue for all countries today. This is particularly evident in the area of pharmaceutical and other medical technologies, especially given the appalling global disparities in health outcomes around the world, the importance of health to development, and the high economic returns of investment in health. Appropriate medicines, diagnostics, vaccines, and monitoring equipment are, of course, a key component of health care systems. And intellectual property policy — and most particularly, patent policy — can have substantial effects on the price and availability of medicines and other medical technologies.

This is an important time to focus on the question of insurance discrimination based on health status. The nation once again is poised to embark on a major health care reform debate. Even as the number of uninsured stands at some 45 million persons, millions more may be poised to lose coverage during the worst economic downturn in generations. In addition, a large number of persons may be seriously under-insured, with coverage falling significantly below the cost of necessary health care. In recent years, the proportion of insured persons who are underinsured has grown by 60% since 2003, reaching an estimated 25 million persons in 2007. Health care costs experienced by insured persons now account for more than 75% of all personal bankruptcies related to medical care. Underlying these figures is a national approach to health care financing for the non-elderly that effectively increases the odds that those who are in poor health status will be uninsured or underinsured.

Nanotechnology is a collection of different technologies and approaches dealing with manipulating matter with dimensions on the nanometer scale. The growth of nanotechnology has been rapid in recent years and encompasses a range of industries including pharmaceuticals, chemicals, robotics, medicine, agriculture, electronics, national defense, fiber optics, and energy. Nanoparticles with shapes, morphologies, and chemical compositions engineered for specific functions and applications are now common. While estimates of the numbers of new types of nanoparticles being produced in academic and industrial labs that combine these different characteristics are uncertain, it is likely that they run into the hundreds.

The empirical literature exploring lawyers and their moral decision making is limited despite the “crisis” of unethical and unprofessional behavior in the bar that has been well documented for over a decade. In particular we are unaware of any empirical studies that investigate the moral landscape of the health lawyer’s practice. In an effort to address this gap in the literature, an interdisciplinary team of researchers at Vanderbilt University designed an empirical study to gather preliminary evidence regarding the moral reasoning of health care attorneys. The primary research question was how health lawyers respond when they encounter ethical or moral dilemmas in their practice for which the law fails to offer a bright-line solution. In exploring this question, we sought to understand better what motivations or influences guide action when health lawyers confront ethical quandaries, and whether there are specific differences, e.g., gender, experience, or religiosity, that are associated with specific responses to situations testing ethical or moral boundaries.

In discussions of health reform, the increased use of health information technology (health IT) is a common element of nearly every serious proposal on the table. Health IT includes electronic health records kept by providers, personal health records offered by health insurance plans or owned by consumers, and electronic health information exchanges. Although health reform initiatives being discussed contain little detail regarding health IT, in general they promote health IT to facilitate the electronic sharing of health information to improve individual and population health. During the 2008 presidential campaign, the health care proposals of both President Obama and Senator McCain discussed health IT. President Obama’s proposal invests $50 billion over the next five years to promote the adoption of health IT with privacy safeguards. Senator McCain’s plan also encouraged the adoption of health IT, with an emphasis on coordination.

In 2008, Representative John Read of Mississippi recently co-sponsored state legislation that would ban restaurants from serving obese customers. He later admitted that the bill was a publicity stunt,meant to “shed a little light on the number one problem in Mississippi.” Although controversial, Read’s bill exemplifies both the current perception of obesity as a national public health problem and the general sentiment underlying the types of interventions that are being considered to address this issue. The proposed legislation also demonstrates how policymakers can use or, in this case misuse, information about obesity to generate significant discussion on an issue along with ill-conceived legal interventions.

Information sharing and the methods used to share best practices are components of the fourth core element of public health legal preparedness.

Off-label prescribing is an integral part of contemporary medicine. Many patients benefit when they receive drugs or devices under circumstances not specified on the label approved by the Food and Drug Administration (FDA). An off-label use may provide the best available intervention for a patient, as well as the standard of care for a particular health problem. In oncology, pediatrics, geriatrics, obstetrics, and other practice areas, patient care could not proceed without off-label prescribing. When scientific and medical evidence justify off-label uses, physicians promote patients’ interests by prescribing products off label.

Off-label prescribing can also harm patients, however. The potential for harm is greatest when an offlabel use lacks a solid evidentiary basis. A 2006 study examining prescribing practices for 169 commonly prescribed drugs found high rates of off-label use with little or no scientific support. Researchers examining off-label use in U.S. children’s hospitals concluded, “[W]e still have incomplete knowledge about the safety and efficacy of many medications commonly used to treat children across a range of drug classes and clinical diagnoses.”

Reading Scofield’s scathing indictment of my field, bioethics, reminded me of how it felt, as an American liberal committed to the cause of racial justice, to read Soviet diatribes against American racism published during the Cold War. I shared with the authors a deep commitment to rectify the injustices they protested. Yet, like Scofield, they proffered accounts of events so radically selective and decontextualized that their version of history seemed more akin to fiction than to fact.

Do terminally ill patients who have exhausted all other available, government-approved treatment options have a constitutional right to experimental treatment that may prolong their lives? On May 2, 2006, a divided panel of the U.S. Court of Appeals for the District of Columbia, in a startling opinion, Abigail Alliance for Better Access to Developmental Drugs v. Von Eschenbach, held “Yes.” The plaintiffs, Abigail Alliance for Better Access to Developmental Drugs (Abigail Alliance) and Washington Legal Foundation, sought to enjoin the Food and Drug Administration (FDA) from refusing to allow the sale of investigational new drugs that had not yet received FDA approval. The terminally ill plaintiffs contended that they quite literally could not wait that long for the drugs. With no other treatment options available, the plaintiffs urged the court to recognize a fundamental, constitutional right to take potentially life-saving or life-prolonging drugs, even though the treatment had not been fully tested through human trials for safety and effectiveness and could not be legally marketed to the public.

Children deserve optimal medical care. Although prescription drugs play a prominent and essential role in pediatric health care delivery, health care providers often must make prescribing decisions for their young patients based on imperfect or absent safety and efficacy data for pediatric populations. Until relatively recently, the Food and Drug Administration (FDA) made surprisingly little effort to improve the quality or quantity of clinical research data for this patient group. Despite recent agency efforts to improve the situation, only one-third of drugs prescribed to children currently have been studied for safety and efficacy in pediatric populations. Moreover, recent agency initiatives to encourage pediatric drug research have generated mixed results and unintended consequences. The complex of issues surrounding the testing and prescribing of prescription drugs used for children will require that pharmaceutical companies, the FDA, and health care providers examine current practices, acknowledge their shortcomings, and consider cooperative, creative solutions.

This paper is one of four interrelated action papers resulting from the 2008 National Summit on Legal Preparedness for Obesity Prevention and Control. Summit participants engaged in discussions on the current state of the law with respect to obesity, nutrition and food policy, physical activity, and physical education. Participants also identified gaps in the law at all jurisdictional levels and relevant to numerous sectors and disciplines that have a stake in obesity prevention and control.

The companion paper, “Assessment of Laws and Legal Authorities for Obesity Prevention and Control,”identified numerous laws and policies enacted to target the three domains of healthy lifestyles, healthy places, and healthy societies. That paper identified several gaps in the law that require attention and action. This paper addresses those gaps and presents applicable laws and legal authorities that public health professionals and lawyers can consider to implement to close the gaps.

Futility has had a rough time in recent medical ethics literature. From about 1987 to 1996, various writers and groups tried to define futility within the context of medical treatment, but without success. Baruch Brody and Amir Halevy give an excellent summary of the morass in their 1995 article “Is Futility a Futile Concept?” where they argue that none of the then-proposed definitions succeed. While a smattering of other attempted definitions have appeared since then, for the most part writers about futility have found it more profitable to stop trying to define futility and instead move in a different direction, that of figuring out how to resolve disputes where patient families want more treatment which clinicians think is futile. This is, for example, the approach taken by the Texas Advance Directives Act (1999), which was the first futility legislation in North America and is often seen as an appropriate template. The idea embodied in this influential legislation is that our energies should be focused on creating a process which we can use to resolve difficult cases, and which everyone finds legitimate, rather than in trying to find a definition which everyone finds legitimate.

This paper analyzes the legal issues associated with the leading and much-debated proposals that aim to revitalize state regulatory competition and allow individuals to purchase insurance across state lines (PASL). These proposals seek to reverse decades-old principles of state preeminence in the regulation of individual health insurance and instead create “jurisdictional competition” in the individual market by allowing an insurer to choose the state under whose law it wishes to be regulated, subject to certain consumer protections. Advocates say this type of jurisdictional competition would reform perceived problems in the individual market and lower the costs of individual health insurance by imposing the regulatory authority of only the insurer’s selected “home” state.

Can researchers, interested in novel ways to assess HIV seroprevalence among populations which are otherwise hidden, collect condoms that have been discarded on the ground in a public sex environment (PSE) and test them for HIV? Does the Code of Federal Regulations address this question, and if not, what areas of research ethics might provide guidance to an IRB considering such a study? These questions arose as part of a preliminary study to test the feasibility of collecting discarded condoms from a public sex environment in Massachusetts, and testing contained semen for HIV. Although the methodology of this study is somewhat unusual, the questions raised are not. Researchers, who wish to use other types of abandoned samples such as discarded syringes, hair or saliva samples, or even excess biological samples, commonly confront similar issues, and the analysis utilized here could guide design and review of other studies.

Nanotechnology is the “next small thing” in technological innovation. Spanning a range of science and engineering disciplines, nanotechnology will dramatically alter products and processes upon which we currently rely and promises significant advances in technology. Federal agencies taking part in the National Nanotechnology Initiative (NNI) have attempted to articulate a suitable definition for nanotechnology. The NNI definition refers to “[r]esearch and technology development at the atomic scale, molecular or macromolecular levels, in the length scale of approximately 1-100 nanometer range[; creating] and using of structures, devices and systems that have novel properties and functions because of their small size and/or intermediate size[; and the ability] to control or manipulate at the atomic scale.” Nanotechnology thus refers to material engineered or altered at the nanoscale, in order to take advantage of unique properties that emerge at that scale.