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.

Nanomedicine is yielding new and improved treatments and diagnostics for a range of diseases and disorders. Nanomedicine applications incorporate materials and components with nanoscale dimensions (often defined as 1-100 nm, but sometimes defined to include dimensions up to 1000 nm, as discussed further below) where novel physiochemical properties emerge as a result of size-dependent phenomena and high surface-to-mass ratio. Nanotherapeutics and in vivo nanodiagnostics are a subset of nanomedicine products that enter the human body. These include drugs, biological products (biologics), implantable medical devices, and combination products that are designed to function in the body in ways unachievable at larger scales. Nanotherapeutics and in vivo nanodiagnostics incorporate materials that are engineered at the nanoscale to express novel properties that are medicinally useful. These nanomedicine applications can also contain nanomaterials that are biologically active, producing interactions that depend on biological triggers. Examples include nanoscale formulations of insoluble drugs to improve bioavailability and pharmacokinetics, drugs encapsulated in hollow nanoparticles with the ability to target and cross cellular and tissue membranes (including the bloodbrain barrier) and to release their payload at a specific time or location, imaging agents that demonstrate novel optical properties to aid in locating micrometastases, and antimicrobial and drug-eluting components or coatings of implantable medical devices such as stents.

Institutional Review Board (IRB) decisions hinge on the availability and interpretation of information. This is demonstrated by the following well-known historical example. In 2001, 24-year-old Ellen Roche died from respiratory distress and organ failure as a result of her participation in a study at Johns Hopkins Asthma and Allergy Center. The non-therapeutic physiological study, “Mechanisms of Deep Inspiration-Induced Airway Relaxation,” was designed to examine airway hyperresponsiveness in healthy individuals in order to better understand the pathophysiology of asthma. Participants inhaled hexamethonium, a chemical ganglionic blocker that was not FDA-approved for use as specified in the experimental protocol. Risks of inhaling hexamethonium, including lung damage, had been reported in the 1950s and ‘60s. An investigation conducted after Roche's death determined that the study's principal investigator had failed to adequately search the medical literature; the protocol submitted for IRB review cited articles indexed in online literature databases that went back only as far as the 1970s.

In this paper, we explore the perspectives of expert stakeholders about who owns data in a medical information commons (MIC) and what rights and interests ought to be recognized when developing a governance structure for an MIC. We then examine the legitimacy of these claims based on legal and ethical analysis and explore an alternative framework for thinking about participants' rights and interests in an MIC.

Doctors or hospitals facing the issue of withholding or withdrawing treatment from patients voice a number of concerns, some factually based and some less so. One important concern is the possibility that such behavior will lead to an indictment for murder. How realistic is this fear? This article will review the U.S. cases involving withholding or withdrawing treatment, as they pertain to the issue of criminal liability.

The criminal law, in general, has not been used as a tool to regulate medical practice. While criminal actions against medical professionals are not unknown, few such actions arise dircctly from the practice of medicine. A physician charged with Medicaid fraud, sexually molesting patients, or prescribing drugs for non-therapeutic purposes has not been charged with a crime that involves scrutinizing the standard of care he or she uses in practicing medicine. For example, by definition, there is no medical standard for the non-therapeutic use of prescription drugs.

In recent years, the development process of pharmaceuticals, medical devices, and related products and the overall market of these products have become increasingly global. This paper discusses the need for better governance of one aspect of this market: the production, distribution, and use of pharmaceutical knowledge. Various controversies, some of which will be described in this paper, highlight how industry control over pharmaceutical data production has resulted in very serious threats to public health. Different practices and regulatory fields that affect what I will refer to in this paper as “pharmaceutical knowledge production” are all too often artificially separated and dealt with in isolation, which seriously affects the quality of the available information on the safety and effectiveness of products. I will examine here how a human rights-based approach should inspire us to look more carefully not only at the significant human rights-related interests that are at stake, but also at the relations between the different interwoven regulatory, cultural, and social factors and how these play out at the various stages of knowledge production.

The Food and Drug Administration (FDA) authorizes the marketing of a drug only for uses that the manufacturer has demonstrated to be safe and effective, based on evidence from at least two clinical trials. However, the FDA does not regulate the practice of medicine, so physicians may prescribe drugs in any manner they choose. Prescribing drugs in ways that deviate from the uses specified in the FDA-approved drug label, package insert, and marketing authorization is referred to as off-label prescribing. This occurs when physicians prescribe a drug for a therapeutic purpose other than the one approved by the FDA; treat patients in a different age cohort or gender than the population on which it was tested; or prescribe a different dose, for a different duration of use, or a different mode of administration than indicated on the label.

Antibiotic resistance (ABR) poses an urgent public health risk. High rates of ABR have been noted in all regions of the globe by the World Health Organization. ABR develops when bacteria are exposed to antibiotics either during treatments in humans or animals or through environmental sources contaminated with antibiotic residues (Figure, Panel A). Spread beyond those administered antibiotics occurs through direct contact with the infected or colonized person or animal, through contact or ingestion of retail meat or agricultural products contaminated with ABR organisms, or through the environment. ABR bacteria spread from individuals to populations and across countries (Figure, Panel B).

It has been pending in Congress for twelve years, despite the support of the last two presidential Administrations and the National Institutes of Health. It has been the subject of extensive affirmative lobbying by academic medical centers, pharmaceutical and biotech companies, genetic disease advocacy groups, and civil rights organizations. It has overcome vehement objections by employers and insurers. Its final passage, however, has been thwarted by a few Congressional leaders, who have prevented enactment despite overwhelming bipartisan support in both houses of Congress.

Based on this legislative history, one could not help but assume that the Genetic Information Nondiscrimination Act (GINA) is a revolutionary piece of legislation that, if finally enacted, would provide extensive, effective, and comprehensive protection against genetic discrimination in health insurance and employment Unfortunately, such an assessment would be incorrect. Indeed, GINA may be a case of too much ado about too little.

Whether or not to offer individual genetic results to research participants has been the subject of considerable debate, yet consensus regarding what, when, and how to return remains elusive. Despite this lack of clarity, the discussion has moved to the offer of research results to family members of participants, including when the participant is deceased. Given the familial implications of genetic information, this extension is perhaps logical. But it raises concerns throughout the research process, including, for example, questions about disclosures and choices on consent forms, procedures for identifying and contacting family members, and how any such obligations might apply to secondary users of biospecimens and data.

Futile treatment. Do not resuscitate (DNR). These terms and the thoughts they evoke may be unfamiliar to families with ill children. Similarly, laws, such as the Americans with Disabilities Act or the Emergency Medical Treatment and Active Labor Act, are probably unfamiliar. Yet these terms and laws, and, more important, their implications, are part of a new world of health care into which more families are thrust—the world of wrenching and complicated decisions.

Although the number of these situations is increasing and even predictable, the infrastructure of support services for families dealing with these medical decisions for seriously ill children has not been adequately addressed or developed. Parents know that some children are born with or develop serious illnesses and die. Amid absorbing large amounts of new information and interpreting the parameters and implications of what they are learning about their child's condition, families are forced by circumstances to assess—and to act on—their most critical, and perhaps previously unexamined, values.

Devising appropriate oversight for nanotechnology is a challenge. The field spans many scientific disciplines and product areas, capitalizing on the unusual properties and capabilities of material at the atomic scale. The critical feature of nanotechnology is not only the size at which manufacture occurs (˜1-100 nanometers), but also the ability to control and manipulate the novel chemical, physical, and mechanical properties that emerge at this scale, including increased conductivity, optical properties, and reactivity. As nano-products enter the research and development (R&D) phase, hit the market, and enter consumer households, debate has emerged on oversight approaches. Regulators, manufacturers, and commentators are considering whether existing oversight systems are sufficient, those oversight systems need adjustment, or new oversight systems are needed.

This article explores challenges to accessing opioid treatment programs in rural areas, and offers solutions that would ease these problems.

A mother new to my general pediatrics practice says that she wants no vaccines for her infant because she says, “I have read on the internet…,” or “I heard from a nurse…,” or “So-and-so celebrity says they can cause autism, brain damage, poisoning, cancer, neurological disorders, and even death.” Perhaps she has read about “the dangers” of vaccines in the first edition of Dr. Sears’ The Vaccine Book. Or people on her Facebook page also say that the “preventable” diseases are just too rare anymore to ever take “the risk” of a vaccine with “known” risks. These vaccine risks are clearly explained, and even sometimes overstated (such as a risk of death for Haemophilus influenzae type B (HIB) vaccine) in the routinely distributed Centers for Disease Control and Prevention (CDC) Vaccine Information Sheet (VIS). On the other hand, the families typically overlook the risks of “omission,” or non-vaccination, such as brain damage or meningitis, etc., which are also clearly stated in the VIS.

Federal and state laws create a tightly controlled system for distribution of those drugs that have recognized value in therapy, but also have the potential for abuse. The challenges pharmacists face in keeping controlled substances within the closed system are many and complex. Drug abusers and drug dealers have at times seen pharmacists as easy marks for access to abusable drugs. Unfortunately, pharmacists often find themselves in a game with criminals, who use both sophisticated and dangerous methods of inducing pharmacists to divert controlled substances. The effects of this problem on the health-care system have been judicially noted:

Imagine your body is populated by billions of respirocytes capable of delivering 236 times more oxygen than your natural red blood cells. These mechanical, micron sized spheres are appropriately programmed by your physician to meet your personal requirements, be it the treatment of anemia or the enhancement of your physical abilities. Robert Freitas’ vision of such artificial blood cells comprised of nanometer-scale components was published in 1998 in a peer-reviewed medical journal, and was the first medical nanorobot design paper to be published.

The fact that this proposal for a future blood substitute was accepted as worthy of publication in a scientific journal, despite the inventor's explicit statement that such a device could not be built at the time, clouds the criteria upon which an informed opinion about the feasibility of such devices could be formed. In that respect, the idea of respirocytes formidably testifies to the current “blurring of fact and fiction” occurring in the field of nanotechnology.