In a little noted passage in A Theory of Justice, John Rawls argued that genetic intervention in the traits of offspring may be morally required as a matter of distributive justice. Given that the “greater natural assets” of each “enables him to pursue a preferred plan of life[,]” Rawls wrote, the parties to the original position “want to insure for their descendents the best genetic endowment.…Thus over time a society is to take steps at least to preserve the general level of natural abilities and to prevent the diffusion of serious defects.…The pursuit of reasonable policies in this regard is something that earlier generations owe to later ones.” (Emphasis added.) Whether biological enhancement actually is a moral obligation we owe to future generations is a question that I have taken up elsewhere, but which lies beyond my scope here. If we agree with Rawls that some measure of safe and effective genetic intervention may be required as a matter of justice, it stands to ask how the distribution of genetic goods – that is, the hereditary basis of human traits – should be carried out.

As I write, I hear that Dr. Jack Kevorluan has delivered another victim to the emergency room of his local Michigan hospital. Why do physicians and terminally ill patients feel we need to change the law with respect to assisted suicide when a rogue pathologist, who has been stripped of his medical license, is allowed to pursue his appetite for providing his clients with inhalation treatments of carbon monoxide gas? If no court will convict this outlaw, what makes the physicians and patients who brought Compassion in Dying v. State of Washington and Quill v. Vacco fear that any court would ever convict a licensed physician of assisting in a suicide when he/she writes one of her established patients a prescription for a short-acting barbiturate? Moreover, it is not even clear that laws against assisted suicide in most jurisdictions were ever intended to apply to the actions of licensed physicians. Nonetheless, the plaintiffs in the Second and Ninth Circuit Courts of Appeals were clearly seeking some kind of redress, some kind of protection from potential legal claims they feared might be made against them.

The goal of this paper is to present a succinct overview, from a clinician’s perspective, of the importance and implications of research on heart failure in African Americans. It first gives a brief outline of the rationale and results of the African-American Heart Failure Trial (A-HeFT), which showed evidence for the effectiveness of fixed-dose combination of isosorbide dinitrate and hydralazine (ISDN/Hyd), marketed as BiDil (NitroMed Inc.), in this population. Finally, it underscores the necessity of treating African Americans with evidence-based medicine given that humanistic physicians and other clinicians strive to provide holistic treatment to their patients.

Most researchers and clinicians recognize the difficulty with utilizing race as a category for inclusion in trials. While race lacks any true biologic definition, it is potentially beneficial as a consideration in clinical studies, based on prior evidence of certain potential differences across self-identified racial/ethnic groups in morbidity and mortality and responses to medicine. Even though use of race as a classification is a problematic distinction, it should not be ignored. If clinical trials demonstrate significant improvement with targeted treatment in African Americans, clinicians should not withhold life-saving drugs that result from such studies.

The idea that disability insurers would benefit if the use of predictive genetic testing expands may seem little short of obvious. If individuals with higher than species-typical genetic propensities for illness or disease are identified, and barred or discouraged from participating in disability insurance programs, is it not obvious that the amount that disability insurers pay out will decrease? Is there any reason to doubt that insurers thus would gain advantage by promoting genetic testing? Writers on this subject typically have taken on faith that advantage goes to whoever knows most about the genetic characteristics of the individual seeking insurance. They therefore have assumed, without proving, that insurers’ interests lie with proliferating genetic information about insurance seekers.

Consequently, from a perspective that gives priority to commercial interests, denying insurers the freedom to obtain genetic information about insurance seekers or holders appears obviously damaging and even unfair. On the other hand, from a perspective that gives priority to the interests of citizens who may use insurance, the greater use of and access to predictive genetic testing sets off ethical alarms.

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.

While the global threat of Ebola Virus Disease (EVD) in 2014 was concentrated in several West African countries, its effects have been felt in many developed countries including the United States. Initial, select patients with EVD, largely among American health care workers (HCWs) volunteering in affected regions, were subsequently transported back to the states for isolation and treatment in high-level medical facilities. This included Emory University Hospital, which sits adjacent to the federal Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia.

The first domestic case of EVD occurred in late September in Dallas, Texas. Additional exposures of two HCWs generated an array of legal issues for state and local public health authorities, hospitals, and providers. Consideration of these issues led to extensive discussion among lawyers, public health practitioners, and other attendees at a late-breaking session on EVD and Legal Preparedness at the 2014 National Public Health Law conference. In this commentary, session presenters from CDC and Emory University share their expert perspectives on legal and policy issues underlying state and local powers to quarantine and isolate persons exposed to or infected with Ebola, as well as facets of hospital preparedness underlying the successful treatment of patients with EVD.

The law applicable to genomics in the United States is currently in transition and under debate. The rapid evolution of the science, burgeoning clinical research, and growing clinical application pose serious challenges for federal and state law. Although there has been some empirical work in this area, this is the first paper to survey and interview key scientific and legal stakeholders in the field of genomics to help ground identification of the most important legal problems that must be solved to successfully integrate genomics into clinical care. The respondents in this study identified a wide range of interconnected issues, focusing specifically on the need for clear guidelines about how to use these data, fear of liability for those who use these data, and the need to protect patients from use of this information particularly by insurers, while endorsing data sharing. Developing legal strategies to support appropriate use of genomics now and in the future clearly will require making trade-offs, taking into account the full complexity of this legal ecosystem.

The flu has an interesting history with respect to health care rationing in the United States. Consider that just about two years ago, the American public faced a shortage of influenza vaccine. Dire predictions were made about how many people might perish, and rationing protocols were created. However, many of the rationing protocols were ignored. Luckily, that flu season did not result in the horrible fatalities that were predicted. For these reasons, problems of health care rationing around issues of the flu were postponed, rather than resolved.

Over the last year, the public has focused its anxious attention on the possible avian influenza pandemic. Last week I noticed that at least once each day I heard mention in some discussion or another of the threat of this disease becoming easily transmissible from human to human.

New causes of action in tort law do not simply emerge, fully grown, like Athena from the head of Zeus. They develop as a result of a struggle between older case law on the one hand and the need to respond to an emerging problem on the other. This metamorphosis can be seen in many areas of jurisprudence, but most notably in the fields of products liability and medical malpractice litigation.

The explosion in products liability litigation, for example, is linked in part to the vastly increased proliferation of a variety of consumer goods and to new forms of marketing mechanisms for selling these goods, so that consumers are exposed to a wider range of risks. Medical malpractice litigation in the “wrongful life” area similarly reflects not only a change in social values toward abortion, but also changes in the perceived ability of medicine to detect and predict defects in the unborn fetus or the likelihood of such defects based upon the genetic history of the potential parents.

The global market for biologics and biosimilar pharmaceutical products is experiencing rapid expansion, primarily driven by the continuous discovery of new molecules. However, information regarding Latin America’s biological market remains limited.

Surveillance capitalism companies, such as Google and Facebook, have substantially increased the amount of information collected, analyzed, and monetized, including health information increasingly used in precision medicine research, thereby presenting great challenges for health privacy.

Does a hospital have the right to prevent a qualified male nurse from working in its labor and delivery section? In Backus v. Baptist Medical Center, this question was answered in the affirmative by a United States District Court in Arkansas. The case, now on appeal, serves as an obstacle to professional nursing and an affront to the rights of female patients.

The plaintiff, Gregory Backus, is a registered nurse who, while employed by the defendant hospital, twice requested and was refused full time placement in its labor and delivery section. The refusals were based upon an unwritten policy that the hospital “did not employ male R.N.s in OBGI” positions because of the concern of our female patients for privacy and personal dignity which make it impossible for a male employee to perform the duties of this position effectively.”

Disease classification systems and surveillance definitions are ordinarily tools for medical professionals, not matters for political debate and patient advocacy. It is hard to imagine a protest march complaining about the classification system for colon cancer. But when it comes to AIDS, nothing is ordinary.

The Centers for Disease Control's (CDC) case definition of AIDS is used by public health officials, researchers, clinicians, hospital administrators, disability specialists, insurance administrators, health economists, legislators, social workers, policy makers, and the media. It has influenced the way the HIV epidemic is perceived, managed, and funded.

It is not surprising, then, that the CDC definition of AIDS and its proposed revision is currently the subject of intense scrutiny. The case definition has transcended epidemiology to become a symbol for the inadequacies of the U.S. government's response to the HIV epidemic, and a particular symbol for the failure to address the needs of HIV-infected women.

In a survey on research misconduct, roughly 20% of the respondents admitted that they have submitted federal grant proposals that include scholars as research participants even though those scholars were not expected to contribute to the research effort. This manuscript argues that adding such false investigators is illegal, violating multiple federal statutes including the False Statements Act (18 U.S.C. §1001), the False Claims Act (31 U.S.C. §3729), and False, Fictitious, or Fraudulent Claims (18 U.S.C. §287). Moreover, it is not only the offending academics and the false investigators that face civil and criminal penalties because administrators may also be liable if they sign off on proposals and are in a position to know that false investigators might be included. Policy recommendations that should reduce the use of false investigators include changing institutional cultures, better training and oversight of the responsible conduct of research, and, most importantly, making all grant reviews double blind.

The normative approach to defining an ethic of a field, which focuses on one disciplinary field, requires modification in the consideration of a biodefense ethic to include not one discipline, but many. The consideration of an ethic in biodefense must capture issues in a multidisciplinary scope, including the ethical studies in the disciplines of medicine, sciences, technology, law, international relations, public health, environment, and war, each having their unique framework of ethical constructs.

An ethic of bioterrorism and biodefense raises issues which can be examined utilizing multidisciplinary ethical considerations. The disciplines of medicine, sciences, technology, law, international relations, public health, environment, and war each have a framework of ethical principles which are essential in the scope of ethics which are incident to bioterrorism and biodefense; the absence of any one of which would create a void in our understanding of the complexity of this subject.

On November 2, 2004, California voters approved Proposition 69, “The DNA Fingerprint, Unsolved Crime, and Innocence Protection Act” by a margin of approximately 60 to 40 percent. Given the limited amount of information provided to voters during the initiative process, it is unclear how many of the yea-sayers were apprised of the full implications of this measure. Indeed, by voting “yes” on Proposition 69, California has elected to house the most radical and costly state criminal DNA database in the country. This dangerous expansion of California's database poses tremendous threats to civil liberties and social justice while offering little, if anything, by way of increasing the safety of its citizens.

Prior to November 2, California law required the permanent retention of DNA samples from felons convicted of serious, violent crimes. The new law expands the database to include DNA samples from all felons and individuals with past felony convictions - including juveniles - and, beginning in five years, all adults arrested for any felony offense.