Imagine that you possess an indicator for a disease or illness that has nothing to do with your body. It is not a genetic predisposition to acquire cancer or a vice that raises the probability of contracting some dread disease, though estimates of its health risks have placed it on par with having diabetes. It has nothing to do with the environmental pollutants you are exposed to or whether you can afford health care. It is not a physical susceptibility that renders you more easily reachable by the clutches of pathology. No, this indicator of health hinges on certain learned abilities and skills, and it is a barrier to health that is totally within the health field's power and resources to lift.

The condition hinted at above is the inability to speak English proficiently in the United States. Today, more than one-sixth of the United States population speaks a language other than English at home, and this number (approximately 50 million people) is increasing rapidly.

Tens of millions of adults and children die each year from illnesses that are treatable or preventable with existing medicines. Each year over 500 million people are infected with malaria, and the disease kills two million people annually. Hundreds of thousands more die annually from a myriad of lesser known diseases including diphtheria, measles, tetanus, and syphilis. Approximately 30 percent of the world’s population, over 1.7 billion people, has inadequate access or no access at all to essential medicines.

Not surprisingly, the vast majority of these illnesses are contracted in poor countries. Four million lives could be saved annually through prompt diagnosis and treatment of illnesses in Africa and Southeast Asia alone, and access to pharmaceutical drugs could likely save millions more. Many of the health problems facing the developing world do not arise from lack of understanding of complex diseases. Rather, the problem arises from a striking lack of availability of life-saving medicines for the consumers that need these medicines the most.

Many proposals to reform health care finance and delivery require individuals or private employers to pay for private health insurance. Senators Ron Wyden and Robert Bennett’s Healthy Americans Act, for instance, would require every adult person who is not covered by a public program to purchase health insurance. Similarly, President Obama’s campaign proposal requires that parents arrange for coverage of their minor children and that all but small employers pay a tax if they do not provide their workers health insurance.

This paper addresses the constitutionality of such proposals. Compulsory health insurance might raise constitutional concerns because there is no existing social legislation that serves as a perfect legal analogy to an individual mandate for private health insurance. Insurance mandates are familiar in other contexts, such as automobile liability, but they present an easier case for constitutionality because they are a condition of exercising a privilege, such as driving a car.

This paper discusses the relationship between obesity, law, and public health preparedness as well as the relevant roles of public health practitioners, policymakers, and lawyers. Each group believes they have a unique role in this relationship although there can be overlap and/or lack of clarity as to what that role may be.

The role of the lawyer in the public policy process is to identify relevant legal issues, to analyze them and give advice on the risks of taking a given action, and to communicate legal advice in a clear manner. Simply put, the lawyer’s role is to dive deep into the law surrounding the topic at hand and to offer advice regarding the permissible limits of policymakers’ options and the associated risks.

Translational science is a 21st century mission. Government officials and industry leaders are making huge investments in an attempt to transform more basic science discoveries into therapeutic applications. Scientists and policymakers express great excitement about the medical advances that could come with the current bench-to-bedside campaign.

A key step in translational science is the move from animal and other preclinical studies to initial human testing. Researchers ability to predict human effects is limited, and first-in-human (FIH) tests present significant uncertainty. Participants in this form of research face risks and can experience serious, even lethal, harm. Well-known incidents involving Jolee Mohr and Jesse Gelsinger, as well as subjects in the 2006 study of the investigational agent TGN1412, show the dangers that can arise in early human research.

The bench-to-bedside campaign will need many volunteers to participate in early human testing. Investigators and regulators must not allow the policy enthusiasm for translational science to overshadow the commitment to protect human subjects. Participants in exploratory research are diverse and as a group lack characteristics usually associated with vulnerable populations, such as impaired decisional ability or economic or educational disadvantage.

The tension between economic policy and health policy is a longstanding dilemma, but one that was brought to the fore with the World Trade Organization’s (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement in 1994. The pharmaceutical industry has long argued that intellectual property protection (IPP) is vital for innovation. At the same time, there are those who counter that strong IPP negatively impacts the affordability and availability of essential medicines in developing countries. However, actors on both sides of the debate were in agreement that something needed to be done to address the HIV/AIDS crisis, especially in developing countries. In response to sustained and significant pressure from civil society groups, members of the World Trade Organization agreed to the Declaration on the TRIPS Agreement and Public Health (the Doha Declaration) in 2001. The Declaration clarified that countries unable to manufacture the needed pharmaceuticals could obtain more affordable generics elsewhere if necessary.

Wide-spread criticism of the pharmaceutical industry’s extravagant marketing practices and some doctors’ undignified, even appalling eagerness to stuff themselves, their pockets and their offices with the industry’s “stuff,” prompted physician groups, the drug and device industry itself (albeit synergized by the federal government’s ominous shadow) to institute reforms designed better to limit industry influence on physicians.

But according to Troyen Brennan and his coauthors, the reforms, while reducing some of the most egregious instances of industry influence peddling and physicians’ self-debasement, were doomed fundamentally, for three reasons. First, they were based on common sense but incorrect assumptions about the mechanism of industry influence and on myths about the efficacy of disclosure as an ethical disinfectant. Second, they relied on voluntary adherence and so failed to pinpoint responsibility for monitoring compliance and enforcement.

This article evaluates the oversight of drugs and medical devices by the U.S. Food and Drug Administration (FDA) using an integration of public policy, law, and bioethics approaches and employing multiple assessment criteria, including economic, social, safety, and technological. Throughout, assessments employing both the multiple criteria and a method of expert elicitation are combined with the existing literature, case law, and regulations providing an integrative historical case study approach. The goal is to provide useful information from multiple disciplines and perspectives to guide discussions regarding appropriate oversight frameworks for nanobiotechnology applications under the FDA’s purview.

This “Legal Solutions in Health Reform” paper identifies and analyzes the legal issues raised by health insurance exchanges. Like all Legal Solutions papers, it does not purport to provide a concrete proposal as to how health insurance exchanges should be organized or even whether they should play a role in health care reform. Rather, it attempts simply to describe the legal issues that health insurance exchanges raise, and to propose alternative solutions to legal problems where useful. More specifically, it analyzes and offers alternative solutions to the legal problems raised by proposals to establish insurance exchanges by the federal government, by state governments, and by private entities or associations. Because the focus of this project and paper is on legal issues, discussion of policy and design issues is attenuated. Nevertheless, some attention to policy issues is unavoidable because law is the realization of policy.

Antibiotic resistance is a serious public health problem on a global scale. In both developed and developing countries, the unpleasant consequences of the phenomenon are being felt. Bacterial diseases that in prior years were relatively easy and cheap to cure are now proving exceedingly difficult and expensive to treat because resistant strains have developed. A number of measures can be implemented in order to minimize the problem of antibiotic resistance. Conservation efforts on the use of antibiotics, educational campaigns about hygienic behavior, “cycling efforts” of antibiotics, efforts to stamp out misuse of antibiotics (of both the over- and under-use kind), and efforts to monitor and share information about the spread of resistant strains are examples of such measures. It is instructive to think of these measures as belonging to the “demand-side conservation response” to the problem of antibiotic resistance.

Suppose that someone has a serious illness. The illness will likely lead to significant disabilities, and may even cause death. Existing treatments are unsatisfactory. The patient learns about a clinical trial, in which some allegedly promising new treatment for that illness is being tested.

Such seriously ill patients for whom existing treatments are unsatisfactory have sometimes been categorized as medically vulnerable in the literature. Should these patients indeed be considered vulnerable subjects and be provided with special protections? And if the answer is yes, then what are those special protections? This article explores the possible answers to these questions.

The federal regulations for the protection of research subjects have several provisions addressing the concept of vulnerability. The three subparts Subparts B (pregnant women, fetuses, and neonates), C (prisoners), and D (children) deal with specific categories of vulnerable subjects, but do relatively little to address broader issues relating to vulnerability that might apply to a category such as the medically vulnerable. The Common Rule (Subpart A) is the only section containing general discussions of vulnerability.

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.

Like all interventions in health care, direct-to-consumer (DTC) advertising should be evaluated by comparing its risks to its benefits, in the context of the available or potentially available alternatives. The objective, of course, is to realize any unique benefits while minimizing the risks. On balance, the adverse effects of DTC advertising outweigh the still-undemonstrated benefits of the advertising.

DTC advertising must be seen in the context of overall pharmaceutical company expenditures on advertising. In 2005, the industry spent $29.9 billion dollars on promotions (up from $11.4 billion in 1996), of which a relatively small fraction, $4.2 billion (14.2%), was spent on DTC advertising. The percentage spent on DTC advertising has been relatively constant this decade. Promotions to professionals (24.2%) and samples (61.8%) accounted for far larger percentages of total promotional spending in 2005.

This Legal Solutions in Health Reform paper discusses the role that tax law can play in the implementation of health reform. The tax code has served as the primary vehicle for subsidizing health care in the U.S. for most of the last century and will likely play a role in any future reform efforts. However, the interplay between tax law and health policy presents a series of critical design and implementation challenges with which any health care reform package — be they liberal or conservative — must grapple. This paper considers some of the most pressing of these issues. While it does not prescribe a particular outcome, it will attempt to identify potential tax solutions that might receive broad support and to observe the policy and administrative design questions that any discussion of these solutions should take into account.

As early as the 1960s and 1970s, astute commentators began to call into question the degree of influence that the pharmaceutical industry was exercising over all aspects of medical research, education, and practice in the U.S. More recently, a spate of books and articles demonstrates that the issue has only become more serious in the last decade or two.

My focus in this paper will be on the industry’s influence on medical education. The influence that the industry exerts on undergraduate and graduate medical education (that is, the training of medical students and residents) often occurs through the system of pharmaceutical sales representatives, who also “detail” drugs to practitioners; or through the influence that the industry exerts over medical research. I will therefore devote my attention here primarily to the system of continuing medical education (CME) by which practitioners receive information about medical advances. The pharmaceutical industry currently supports about one-half of the costs of CME in the U.S., so it seems appropriate to question the degree of industry influence over the content of CME.

Obesity is the result of people consistently consuming more calories than they expend. A complex interaction of social and environmental conditions affects both energy consumption and physical activity levels. These conditions include, but are not limited to the following factors: the availability of affordable and healthy food; price disparities between healthy and less healthy foods; access to or perceived safety of recreation facilities; and the conduciveness of the physical environment to active modes of transportation, such as walking and biking. As outlined in the “Assessing Laws and Legal Authorities for Obesity Prevention and Control” paper in this supplement issue, laws and government policies in the United States influence nearly all of these social and environmental factors.

It should come as no surprise to any observer of health policy debates that the preemption provisions of the Employee Retirement Income Security Act (ERISA) will play a major role in determining the contours of any health reform initiative. For the past few years, many states have been aggressively pursuing health reform experiments, while congressional action has essentially been deadlocked along partisan political lines. Yet after the 2008 election results, there is reason to expect considerable congressional attention to health reform. President Obama has made health reform a priority of his administration, and several members of Congress have long been waiting for an opportunity to pursue health reform legislation.