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.

Often advocates for persons with disabilities are resistant to what might appear to be the banal truism that, at bottom, disability is a decrement in health. Disability advocates have long objected to the “medicalization” of disability, when that means focusing entirely on a person’s underlying impairments and ignoring all of the manifold obstacles in his or her environment — e.g., physical, human-built, attitudinal, social, political, and cultural — that makes living with those impairments at least disadvantageous and socially devalued. Over-medicalization is another and well understood problem that people with disabilities are justifiably concerned about. Yet it is somewhat of a mystery why anyone with an impairment would ever deny, or feel uncomfortable being told, that their impairment is a health problem. Surely, people with disabilities are unhealthy, by virtue of their impairments and to the degree according to the severity of those impairments. How could it be otherwise?

Scientific reports about clinical research appear objective and straightforward. They describe a study's findings, methods, subject population, number of subjects, and contribution to existing knowledge. The overall picture is pristine: the research team establishes the requirements of study participation and subjects conform to these requirements. Readers are left with the impression that everything was done correctly, by the book.

In other places, however, one finds a different and messier picture of clinical research. In this picture, research subjects deviate from the prescribed plan. One author contrasted the “tidy graphics” and “crisp prose” of the New England Journal of Medicine's HIV/AIDS trial publications with reports that subjects shared medications and broke other trial rules. Awareness of this behavior, he wrote, could lead insiders to “conclude that knowledge was resting on something rather less solid than bedrock.”

Alyne da Silva Pimentel Teixeira died of postpartum hemorrhage (PPH) following the stillbirth of a 27-week-old fetus on November 16, 2002 in Rio de Janeiro, Brazil. Her death led in 2011 to the first decision of an international treaty body holding a government accountable for a preventable maternal death. The decision, Alyne da Silva Pimentel Teixeira (deceased) v. Brazil, was given by the Committee on the Elimination of Discrimination against Women (the Committee), established to monitor compliance by member states with the UN Convention on the Elimination of All Forms of Discrimination against Women (the Convention). The decision upheld a complaint, filed in 2007 against the state and government of Brazil, finding discrimination in the field of health care for Alyne’s avoidable maternal death, in breach of the Women’s Convention.

Even though health care provider reporting of diseases to public health authorities is common, often there is under-reporting by providers, including for notifiable diseases; frequently, under-reporting occurs by wide margins. Two causal factors for this under-reporting by providers have been that: (1) disclosing data may violate their patients’ privacy, and (2) disclosed data may be used to evaluate their performance. A reluctance to disclose information due to privacy concerns exists despite the U.S. Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule permitting disclosures of personal health information (PHI) for public health purposes without patient authorization. On the other hand, such patient privacy concerns are somewhat justified: there have been documented breaches of patient information from public health data custodians.

A common way to address this privacy issue is to de-identify patient data before it is disclosed to public health.

Could an accreditation, certification, or rating mechanism help the pharmaceutical industry improve both its bioethical performance and its public reputation? Other industries have used such systems to assess, improve, distinguish, and demonstrate the quality of their services, processes, and products. These systems have also helped increase transparency, accountability, stakeholder confidence, and awareness of industry best practices. This article explains how market forces can be harnessed to recognize and promote better bioethical performance by pharmaceutical companies when there are good systems to accredit, certify, or rate. It concludes with a review of relevant failures of credit-rating agencies — such as conflicts of interests and revolving-door practices — to illuminate some of the pitfalls of developing a bioethics accreditation, certification, or rating system for pharmaceutical companies.

On May 7-9, 2012, obesity prevention leaders, including public health professionals across federal, state and local levels, policymakers and decision makers, community leaders as well as researchers engaged in policy, systems and environmental (PSE) efforts related to obesity prevention, convened at the Weight of the Nation (WON) conference in Washington, D.C. In recognition of the growing interest in the relationship between the food system and public health, and obesity in particular, organizers of the WON invited leading experts from multiple disciplines to work as a committee to plan five sessions related to these topics. These experts decided to expand the focus of the sessions to include public drinking water systems and to organize sessions with the goal of identifying solutions to create a healthy, sustainable, and equitable food and water system. This paper presents the key themes, challenges, and potential solutions and discussed within the Food and Water System: Agriculture, Access and Sustainability track (hereinafter referred to as the “Food and Water System Track”).

Social media, meaning digital technologies and platforms such as blogs, wikis, forums, content aggregators, sharing sites, and social networks like Facebook and Twitter, have profoundly changed the way that information can be shared online. Now, almost anyone with a broadband internet connection or a smart phone can share ideas, data, and opinions with just about anyone else on the planet. This change has serious implications for the way in which human subjects research can be conducted and, concomitantly, for the ways in which such research may be regulated. This article explores some of these issues.

In recent decades, advances in information technology have given rise to a post-industrial society in which emphasis on the manufacture of material goods has been supplanted by the creation of intellectual property. Indeed, this new “knowledge economy” can be tracked by the exponential growth in patented products across a range of sectors since the 1980s (see Figure 1). According to the United States Patent and Trademark Office, the number of annual patent applications submitted grew from 112,379 to 520,277 over the past three decades, a 464% increase.

The transformation in the industrial markets has been accompanied by the rise of a new, global institution for coordinating intellectual property rights (IPRs): the World Trade Organization (WTO).

Good decision-making requires reliable information. In medicine, relevant information comes from clinical trials and other forms of scientific research. In business, one source is in corporate annual financial statements. As for-profit, publicly traded companies whose business is discovering, manufacturing, and marketing drugs, pharmaceutical companies sit at the nexus of these two fields. Determining the safety and efficacy of a pharmaceutical product and determining the profitability of a complex enterprise are similarly difficult tasks: each is fraught with deeply ambiguous information that requires sophisticated judgment to interpret reasonably.

According to the Institute of Medicine, chronic pain affects at least 116 million adults in the United States (U.S.), which is more than the total affected by heart disease, cancer, and diabetes combined. Pain costs the nation up to $635 billion each year in medical treatment and lost productivity. It has been conceptualized as a public health problem due to its prevalence, seriousness, disparities, vulnerable populations, the utility of population health strategies, and the importance of prevention at both the population and individual levels. For many patients, treatment of pain is inadequate due to uncertain diagnoses, societal stigma, the lack of effective treatments, and inadequate patient and clinician knowledge about the best ways to manage pain. This article explores the inadequate treatment of pain in the U.S. and the subsequent rise of prescription painkiller abuse, misuse, and overdoses. This is followed by a review of the actions taken by states to regulate the prescribing of controlled substances.

Almost all jurisdictions where physician-assisted death (PAD) is legal require that the requesting individual be competent to make medical decisions at time of assistance. The requirement of contemporary competence is intended to ensure that PAD is limited to people who really want to die and have the cognitive ability to make a final choice of such enormous import. Along with terminal illness, defined as prognosis of death within six months, contemporary competence is regarded as an important safeguard against mistake and abuse, arguably the strongest objections to legalizing PAD.

The insistence on contemporary competence is problematic. It means that someone who has dementia is ruled out as a candidate for PAD, even if she is terminally ill and suffering terrible and unrelievable pain. It also rules out individuals with strong and unwavering desires not to end their life in dementia.

The 1988 Brazilian Constitution establishes a right to health in two of its provisions. The first provision provides a relatively long list of social rights, which includes not only the right to health, but also the right to the determinants of health such as education, food, employment, and shelter (Art. 6). The second provision (Art. 196) recognizes the two components of the right to health, namely: (i) factors that are likely to affect a person’s health, such as access to clean water, sanitation and nutrition; and (ii) medical care or health services. This second provision establishes that the right to health “shall be guaranteed by means of social and economic policies aimed at reducing the risk of illness and other hazards and by the universal and equal access to actions and services for its promotion, protection and recovery.” It also enumerates state obligations, the first and most important one being the duty of the Brazilian state to guarantee the right to health to every citizen.

Each of the five main goals set out in the IOM’s report, Accelerating Progress in Obesity Prevention (“IOM Report”), includes recommended strategies and actions that raise questions of law and legal authority. In many instances, the IOM’s recommendations can be accomplished most directly and efficiently through mandatory regulation or legislation — for example, imposing taxes to decrease consumption of sugar-sweetened beverages (SSBs), passing laws that require substantial physical education periods in schools, or promulgating regulations that ensure nutrition standards for foods and beverages sold or served in educational settings. Much has been written on using legislation to support obesity prevention efforts. The route of direct legislation, however, is not always readily available — as the so-far-unsuccessful effort to pass taxes on SSBs, for example, vividly illustrates.

Sugar consumption has long been linked with a host of chronic health problems, including obesity, diabetes, and cardiovascular disease. To reduce Americans’ intake, many have called for taxing sugary products or limiting access in certain environments like schools and workplaces. These sometimes controversial calls for new public policy to curb consumption may soon be eclipsed by newly emerging links between sugar and addiction.

Attaching the label “addictive” to a substance like sugar, which is necessary for human life, challenges widely held beliefs about addiction. But the extraordinary increase in sugar consumption during the past century, with related tripling of chronic diseases like obesity and diabetes, means our common understandings may be outdated.

Part I of this paper will define “addiction” — especially as it relates to what was once a naturally occurring food nutrient and now is a highly concentrated food additive — and present evidence of the addictive potential of sugar.

The call for family and medical leave reform in the United States was largely the result of sweeping demographic shifts that occurred in the workforce after the 1950s, coupled with an ever-increasing life expectancy and changing social norms concerning the role of women as caretakers. By the early 1990s, the number of women in the workforce had nearly tripled from 1950. During that same period, life expectancy increased by six years for males and seven for females. Meanwhile, the first wave of the Depression-era generation began to reach the age of retirement. In short, the parents of American workers were living longer and retiring in greater numbers while more women, who were more likely to be informal caregivers, decided to join the workforce. As a result, many families with ill or elder parents began to turn to institutional long-term care.

The harmful impact of an adverse event ripples beyond injured patients and their families to affect physicians, nurses, and other health care staff that are involved. These “Second Victims” may experience intense feelings of anxiety, guilt, and fear. They may doubt their clinical competence or ability to continue working at all. Some go on to suffer post-traumatic stress disorder and depression.

Medical institutions long ignored this problem, preferring to believe that adverse events, or “errors,” occur due to incompetence — the unfortunate work of a few “bad” practitioners who deserve, if anything, a reprimand for their negligence. Study after study has rejected this attribution and shown that adverse events in health care stem primarily from systemic flaws, not “bad apples.” Devastating errors, in other words, can, do, and always will happen in the care of competent, well-trained, and caring practitioners.

Recent years have seen an increase in the turn to rights discourse within the context of access to health and specifically health care. Developments took place at both the national and global levels, with a significant increase in right to health litigation around the world1 and developments at the international level, such as the appointment of a Special Rapporteur on the Right to Health and the adoption of a “General Comment” on the topic by the UN Committee on Economic, Social and Cultural Rights.

To sell a new drug, pharmaceutical companies must discover a compound, run clinical trials to test its efficacy and safety, get it approved by regulatory bodies, produce the drug, and market it. As this process brings the drug through so many hands, there are risks of many kinds of corruption. The pharmaceutical industry has recently gone from being one of the most admired industries to being described by the majority of Americans as “dishonest, unethical, and more concerned with profits than with individual and public health.” Legal scholar Marc Rodwin suggested that the pharmaceutical industry can be viewed through the lens of institutional corruption as defined by legal scholar Lawrence Lessig, whereby widespread or systemic practices undermine the main purposes of drug therapy — healing illness, preventing medical problems, and alleviating suffering. Many drugs do serve these goals, yet a significant number of drugs churned out by pharmaceutical companies are ineffective or have dangerous side effects that could have been predicted had the companies conducted the appropriate research.