Patents and free trade make strange bedfellows. For most of their history, patents have been instruments deployed to resist trade with other countries, not to enhance it. Whether one looks at Venetian laws that punished citizens who practiced local crafts outside the city, the Mercantilist uses to which patents were put in Elizabethan England, or the cartels of the 19th and 20th centuries created on a foundation of interlocking patent rights, patents have had a distinctly protectionist function. It is thus ironic that it is intellectual property rights in general, and patents in particular, that have been held up in recent years as the poster child of much that is wrong with globalization and free trade. Nowhere is this more so than in debates concerning international human rights law and patents, in particular the position that patents violate an international right to health.

In Cruzan, the Supreme Court held that the refusal of treatment is a constitutionally protected right and that the methods for permitting its exercise should be crafted by the laboratory of the states. In June 1990, when the court ruled, there already existed a large and complex body of law concerned with the refusal of treatment which differed, sometimes considerably, from state to state. Generally, withholding or withdrawing life-sustaining treatment has been accepted by the states, but different systems of justification have been used.

Competent people are able to make decisions to refuse any form of medical treatment, regardless of their medical condition; competent people can also prepare written instructions describing the medical treatment they would want to receive in the future if incompetent, which have been endorsed by both state courts and legislatures.

Pressure is mounting to hold researchers and research institutions accountable for the protection of human subjects. When subjects or their family members believe they have been injured, they are increasingly willing to file lawsuits. Recent cases indicate that institutional review boards (IREs) and their members may be pulled more and more into the legal fray.

On September 17, 1999, 18-year-old Jesse Gelsinger died while participating in research conducted by the University of Pennsylvania's Institute for Gene Therapy. Gelsinger was involved in a Phase I clinical trial testing a new approach to treatment of ornithine transcarbamylase deficiency (OTC), a rare metabolic disorder. Although infants affected by the severe form of OTC die shortly after birth, Gelsinger suffered from a relatively mild form. It appears undisputed that the cause of Gelsinger's death was not the disorder itself, but multiple organ system failure triggered by the virus used to carry new genetic material into his system.

A bottom-up approach grounded in micro-level understanding of the thinking, feeling, behavioral, and social aspects of living with low income and associated low literacy can lead to greater understanding and improvement of interactions in the health arena. This paper draws on what we have learned about marketplace interactions in subsistence economies to inform innovations in medical education, design and delivery of healthcare for lowincome patients, outreach education, and future micro-level research at the human-healthcare interface.

Antiretroviral pre-exposure prophylaxis (PrEP) is protective against HIV. Low utilization rates amongst HIV vulnerable populations are due in part to the high cost of PrEP. Generic PrEP offers the potential to improve health at significantly reduced costs. In this study, we examine early utilization patterns and prices for generic PrEP. We discuss the opportunities and challenges for generic PrEP to improve health among HIV vulnerable populations.

Imagine a study in which HIV-infected pregnant women are given antiretroviral treatment (ART) to determine how effectively it will prevent HIV transmission during childbirth. Each mother’s involvement in this study ends with the birth of her child, at which time her access to antiretrovirals provided by the study also ceases. At the outset of the study, the investigator and sponsor agree that after the child’s birth, they will refer mothers who require treatment for their HIV to a national program that provides antiretroviral treatment and care. Assuming the Institutional Review Board (IRB) raises no objections to this plan, should the research team consider their ethical obligations to participants fulfilled? If the investigator and sponsor were to consult the Common Rule, they would find little to suggest that there are any further ethical issues to address.

No provision of the Patient Protection and Affordable Care Act (PPACA) has proven to be more contentious than the so-called “individual mandate.” Starting in 2014, the mandate will impose a penalty on non-exempt individuals who lack health insurance. According to Congress, the mandate is essential to ensuring near universal coverage. Without it, PPACA’s insurance reforms will lead healthy individuals to delay purchasing health insurance until they require medical care, resulting in risk pools with a disproportionate share of high-risk people. The price of insurance will then climb, causing more and more not-so-sick people to forego health insurance. The resulting “death spiral” will make insurance unaffordable to many more Americans.

The debate about medical futility is no longer in its infancy. Scholarly literature on this seemingly intractable problem is voluminous. The list of widely publicized cases in which physicians have wanted to discontinue life-sustaining medical treatment that families demand has grown to include not just Helga Wanglie, but also Baby Rena, Baby L, Jane Doe, Joseph Finelli, Baby K, and Teresa Hamilton. A futility case has now been decided at the appellate court level.

Commentators have generated three kinds of proposals for resolving these conflicts. One group contends that the problem can be solved within the physician-patient-family relationship. While some in this group view professional authority broadly enough to warrant unilateral judgments by physicians that interventions desired by the patient or family should not be provided, others contend that physician authority does not extend that far, and that any resolution must be constrained by informed consent requirements.

The paper outlines the policy context and summarizes the numerous policy issues that AD raises from the more generic to the unique. It posits that strong public fears of AD and its future prevalence projections and costs, raise increasingly difficult policy dilemmas. After reviewing the costs in human lives and money and discussing the latest U.S. policy initiatives, the paper presents two policy areas as examples the demanding policy decisions we face. The first focuses on the basic regulatory function of protecting the public from those who would exploit these fears. The second centers on the well-debated issues of advance directives and euthanasia that surround AD. Although more dialogue, education and research funding are needed to best serve the interests of AD patients and families as well as society at large, this will be challenging because of the strong feelings and divisions AD engenders.

As a consequence of the problems caused by genetic discrimination, federal and state law makers are being pressured to pass a legislative remedy. A primary question is whether the Americans with Disabilities Act of 1990 (ADA) applies to (1) individuals with a potentially disabling genetic disorder who are pre-symptomatic or asymptomatic and may never become ill and to (2) healthy individuals who are carriers of genetic conditions. At present, this question has relevance principally for individuals with the genotype for single gene disorders, like Huntington disease and hemochromatosis, and to asymptomatic carriers of single gene disorders such as cystic fibrosis. Although many such single gene conditions exist, the total incidence of these conditions in the U.S. population is less than 0.4 percent. However, the question concerning the applicability of the ADA will become increasingly important because genetic tests will almost certainly be developed in the near future for common multifactorial diseases like diabetes, heart disease, and certain forms of cancer.

“It was the best of times. It was the worst of times.” Charles Dickens easily could have been describing our time and the dilemma in which victims of nonmalignant chronic pain find themselves.

I am a forty-six-year-old registered nurse who specializes in oncology care and education. I am also a patient who suffers from chronic nonmalignant pain, and this malady has been the most frightening, the most humiliating, and the most difficult ordeal of my life.

The morning of February 1983 severed my life into “before” and “after,” as clearly as if it has been cut by a sharp knife. The “before” included my career as an oncology nurse, a college nursing professor, and a writer; but that was abruptly ended by the catastrophic rupture of a deep cerebral aneurysm. Surgery saved my life, but something unforeseen occurred during the procedure; and so, in the “after,” I have had to live with a serious seizure disorder and memory loss.

The question in my title—a deliberate inversion of Kuhse and Singer's now-famous question, “Should the baby live?”—is one that is being asked more and more frequently. As Gerald Gruman has observed:

The medical care needs of aged persons, and how we, as individuals and societies, will fulfill these needs in an era of a perceived scarcity of medical resources, are a frequent topic of discussion today. The “scarcity” of medical resources is frequently a given in discussions of allocation priorities.

Participant-driven research (PDR) is a burgeoning domain of research innovation, often facilitated by mobile technologies (mHealth). Return of results and data are common hallmarks, grounded in transparency and data democracy. PDR has much to teach traditional research about these practices and successful engagement. Recommendations calling for new state laws governing research with mHealth modalities common in PDR and federal creation of review mechanisms, threaten to stifle valuable participant-driven innovation, including in return of results.

The proposed changes to the Common Rule, described in the recent Advanced Notice of Proposed Rulemaking (ANPRM), come more than 20 years after the U.S. Department of Health and Human Services adopted the Rule in 1991. Since that time, human subjects research has changed in significant ways. Not only has the volume of clinical research grown dramatically, this research is now regularly conducted at multiple collaborative sites that are often outside of the United States. Research takes place not only in academic medical centers, but also at outpatient clinics, community hospitals, and other nontraditional venues. In addition, technological advances, such as sophisticated computer software programs, the Internet, social media, new research methods, and mobile applications have exponentially increased the volume of data available and the possibilities for accessing, analyzing, and sharing that data.

In most other nations, insurance for medical care is called sickness insurance, and it covers sick people. In the United States, we have “health insurance,” and its major carriers — commercial insurers, large employers, and increasingly government programs — strive to avoid sick people and cover only the healthy. This perverse logic at the heart of the American health insurance system is the key to reform debates.

Focusing on sick people versus healthy people might seem a strange way to view the coverage issue. Most discussions of insurance categorize people into other groupings: the insured versus the uninsured; Caucasian whites versus other racial and ethnic groups; men versus women; poor and low-income people versus everybody else; children, adults, and the elderly; or citizens versus immigrants and undocumented aliens. More recently, health researchers have begun talking about “vulnerable populations,” using most of the same demographic groupings and adding other illness-inducing factors such as social isolation, stress, and impoverished neighborhoods. But as I will show, insurance plans now use premiums, cost-sharing, and other design features in ways that indirectly divide each of these groups into the sick and the healthy, to the detriment of the sick. By shifting the costs of illness onto people who use medical care — that is, sick people — market-oriented reforms of the last few decades have eroded insurance in the name of strengthening it.

Amid the action of the 2013 Super Bowl aired the usual array of high-priced advertisements. Most ads were original. Some were unusual. One regional ad, however, seemed distantly familiar. The 30-second commercial promoted the NJOY King electronic (or e-) cigarette1 to at least 10 million viewers in several major markets. It featured an attractive male model taking a drag from what looks like (and NJOY calls) a cigarette. He then slowly blows smoke to the tune of Foreigner’s “Feels Like the First Time.” Of course, the “smoke” does not come from burning tobacco. Rather, it is the water vapor produced by an e-cigarette as part of its nicotine delivery process. This, however, was not evident from the imagery. For those watching the broadcast, including thousands of minors, NJOY’s advertisement depicted what tobacco companies have not portrayed on television for decades: a person engaged in smoking behavior.

When infertility clinics offer money-back guarantees, they prefer to give them more delicate names such as “shared risk,” “warranty,” or “outcome” programs. We should not allow such daintiness to distract us from the bottom line of these programs which are all about the bottom line.

John Robertson and Theodore Schneyer defend such programs as special forms of insurance, what they call “risk-of-failure insurance.” They argue, in “Professional Self-Regulation and Shared-Risk Programs for In Vitro Fertilization,” that the criticisms of in vitro fertilization (IVF) shared-risk programs by the American Medical Association (AMA) and others are off the mark. It would be sufficient, Robertson and Schneyer contend, to develop guidelines for informed consent or protocols that discourage risky clinical procedures. They acknowledge that shared risk plans “present problems if not offered with full disclosure and attention to patient interests,” but they insist that “there is no reason why they cannot be implemented in an ethically sound way.”