There are many reasons for dissatisfaction with current U.S. health care. One-sixth of the population is uninsured, costs are 150-200% of those in other economically advanced nations, and the quality of care, as measured by disease specific mortality and morbidity data, is rarely better and often worse than in others nations’ less costly systems. A case for reform can mirror any or all of these concerns: cover more of the population with insurance, control costs, improve the effectiveness of prevention and treatment. I argue that two of these goals — greater population coverage and more disciplined costs — gain a significant part of their justification from moral beliefs about justice and fairness.

A major issue facing the health of both minors and young adults in the United States is the often unintentional lack of confidentiality maintained in the provision of sensitive health services. Studies have shown that access to confidential care is crucial for minors seeking preventive care and treatment for sensitive services. Evidence demonstrates that many minors will not seek health care if confidentiality cannot be ensured, which can have significant negative health implications; this finding can be extended to young adults covered under their parents health plans. Young adults, not just minors, also often forgo important sensitive services when they face a breach of confidentiality, which most likely occurs when their parents have access to the adult child's health information.

Currently, private insurance companies generally send the policyholder an explanation of benefits (EOB) whenever a service is provided under a plan. EOBs generally include information identifying the patient, provider, type of care received, total charge for services, amount paid by the insurance company, and any financial obligation of the policyholder.

In 1878, Friedrich Engels famously wrote that on the road to realizing the communist utopia, “the state is not abolished, it withers away.” In a similar manner, biomedical researchers telling us that come the promised land of individualized genomic medicine, the need for using race will also “wither away” in the face of scientific progress. Such millennial hopes are, no doubt, sincere, but they enable the continued casual proliferation of racial categories throughout biomedical research, product development, marketing, and clinical practice. My contrasting quotation to frame this article is drawn from the 20th century pioneer of rock and roll, Buddy Holly (né Charles Hardin Holley) whose 1957 hit “Not Fade Away” begins with the line, “I’m gonna tell you how it's gonna be” — the point being that far from withering away, race is persisting even as genomic milestones are being reached and passed.

Personalized medicine with its promise of developing interventions tailored to an individual's health need and genetically related response to treatment might seem a promising antidote to the documented underutilization of standard depression treatments by African Americans. In addition, understanding depression not merely in biochemical terms but also in genetic terms might seem to counter cultural beliefs and stigma that attach to depression when conceived as a mood or behavioral problem under an individual's control. After all, if there is one thing for which a person is not responsible and cannot be blamed, it is her genes. Nevertheless, for multiple reasons, a personalized medical approach to depression treatment, and its attendant conceptualization of depression and treatment response as genetically influenced, present the risk of exacerbating well-documented disparities in access to, and utilization of, treatment for depression among African-American and Caucasian elderly adults.

The “Father of the United States Constitution,” James Madison, once described justice as “the end” of both government and of civil society. Yet curiously, Madison said little about justice in elaborating the principles of American federalism in The Federalist Papers and elsewhere. His fundamental concerns, to the contrary, were in contriving a system of separated, countervailing powers and in establishing a first federal principle of enumerated powers — in which federal powers “are few, and defined.” This strategy, for Madison, was the most feasible way of checking the innate tendency of political power to accumulate, centralize, and trample on citizens’ liberties.

There is a concern that physicians/researchers are inappropriately profiting (by buying or selling stock) from information derived from advance copies of high-impact clinical trial data distributed by medical conferences or journals. Despite these concerns, it has never been systematically evaluated, and little is known about the degree to which it exists. This is largely due to difficulties associated with directly verifying whether or not such activities have taken place and, furthermore, many medical conferences/journals today have taken the necessary actions to guard against this. One medical association in particular, the American Society of Clinical Oncology (ASCO responsible for conducting the largest annual oncology-related medical conference), only began responding to such concerns several years ago. Their actions during that time serve as a compelling case study, with wide-ranging ramifications, and provide the unique opportunity to delve into this phenomenon.

Up until 2008, ASCO selectively and discreetly distributed abstracts from all forthcoming presentations (at the ASCO Conference) to ASCO members two weeks prior to it becoming publicly accessible during the conference.

Health professionals around the world have played an integral role in state-sponsored torture during numerous historical episodes, at times providing “expertise and a veneer of legitimacy to a process that involved violations of basic human rights.” These incidents demonstrate why legal and ethical standards among health professionals should be upheld, no matter the context. For example, health professionals during the Third Reich in Germany notoriously worked with the Nazi government to perform painful medical experiments on individuals without their consent and to supervise systematic killings. During the dictatorships in Brazil, Chile, and Uruguay and during apartheid in South Africa, medical professionals also participated in torture. In recent years, government documents, news reports, articles, books, and testimonies by detainees and health professionals have exposed the involvement of health professionals in the abuse and torture of detained individuals at U.S. detention facilities around the world.

When the Supreme Court in PLIVA v. Mensing determined that certain state tort law failure-to-warn claims against generic drug companies were pre-empted by federal drug regulations, the pronouncement was met with substantial criticism. In light of the Court's decision two years earlier in Wyeth v. Levine, where the Court allowed a similar claim against a brand-name drug manufacturer to proceed, many complained the resulting Levine-Mensing dichotomy created an arbitrary distinction between brand-name and generic drugs, allowing an injured patient's ability to recover to hinge solely on the happenstance of whether the individual had taken the brand-name or generic version. But, although Mensing cut back significantly on the ability of plaintiffs to make state law failure-to-warn claims against generic drug manufacturers, the case did not completely prohibit such claims. Instead, the Court banned only failure-to-warn claims premised on an argument that the generic drug company needed to change its label in order to meet state tort law duties. If plaintiffs can advance other theories independent of a formal label change, such as a failure to adequately warn a physician about a recent change to the drug's label, then they may still be able to proceed against generic drug manufacturers.

Consider this hypothetical scenario involving a choice not to vaccinate a child. Ms. S has a niece who is autistic. The girl's parents are suspicious that there is some relationship between her autism and her Measles Mumps and Rubella (MMR) vaccination. They have shared their concerns with Ms. S. She then declines to have her own daughter, Jinny S., vaccinated with the MMR vaccine. To bypass the state's mandatory vaccination requirement, Ms. S claims a state-legislated philosophical exemption, whereby she simply attests to the fact that she is opposed to vaccinating her daughter due to a conscientiously held belief. At the age of four, Jinny goes on a trip by airplane to Germany with her mother. After returning to the United States, she attends daycare despite having some mild cold symptoms. Subsequently, she develops a classic measles rash, at which point her mother brings her to a pediatrician and keeps her home from daycare.

For decades, the dominant research paradigm has included trials conducted in clinical settings with little involvement from communities. However, concerns about the relevance and applicability of the processes or outcomes of such research have led to calls for greater community engagement in the research process. As such, there has been a shift in emphasis from simply recruiting research participants from community settings to engaging community members more broadly in all aspects of the research process. The move toward community engaged research (CEnR) is in part driven by the recognition that inclusion of diverse perspectives in multidisciplinary teams is essential to addressing complex problems. Investigators have come to recognize the inherent value of engaging community members as collaborators in multidisciplinary teams that are conducting research on issues of concern to communities. The insider perspective from community members is now recognized as essential in designing effective and well-received recruitment strategies, culturally appropriate measures, and identifying meaningful and broad-reaching venues for dissemination.

In the past several years, the Office of Inspector General (OIG), the branch of the Department of Health and Human Services that combats fraud and abuse, has begun enforcing a little-used provision that allows the government to exclude owners and managers of sanctioned entities based on their position in the company. The OIG's exclusion authority under 42 USC § 1320a-7(b)(15) is not unique in applying strict liability to individual executives as a tool to halt corporate misconduct, but it represents a startling change for health care executives who could now face exclusion for their company's misdeeds. While the OIG has expanded its use of this statute, it has indicated some hesitancy in exercising the full scope of its statutory power.

Pursuant to §1128 and §1156 of the Social Security Act, the OIG can exclude individuals and entities from participating in federal healthcare programs. The OIG has both mandatory and permissive exclusion power, based on the circumstances of the offense.

The government-sponsored Tuskegee syphilis study had a huge impact on U.S. research ethics and policy. Study investigators regarded subjects as “mere means” to their research ends, which led to a variety of ethical violations. Investigators used deception so that subjects would see participation as therapeutic — researchers promoted the therapeutic misconception because this advanced study objectives. The research would produce important information, and this justified lying to research subjects.

Today we see this sort of intentional deception as unjustified no matter how important a study might be. But what do we make of the claim that the syphilis study had value? As James Jones reported, its objectives were to test the prevailing views that syphilis affected blacks and whites differently, and that the disease was less harmful to blacks than whites. U.S. Public Health Service researchers and officials assumed the study had sufficient value to justify not only deceiving subjects, but also depriving them of safe and effective treatment.

The current ethical norms of genomic biobanking creating and maintaining large repositories of human DNA and/or associated data for biomedical research have generated criticism from every angle, at both the practical and theoretical levels. The traditional research model has involved investigators seeking biospecimens for specific purposes that they can describe and disclose to prospective subjects, from whom they can then seek informed consent. In the case of many biobanks, however, the institution that collects and maintains the biospecimens may not itself be directly involved in research, instead banking the biospecimens and associated data for other researchers. Moreover, the future uses of biospecimens may be unknown, if not unknowable, at the time of collection. Biobanking may thus stretch the meanings of inform and consent to their breaking point: if you cannot inform subjects about what their biospecimens will be used for (because you do not know), what can they consent to? Given that informed consent by individual subjects is the ethical gold standard, the seeming dilution of the concept in the context of biobanking is a profound problem.

Over the past 40 years, a complex review and oversight system has grown within the United States and internationally to regulate the conduct of human subjects research. This system developed in response to revelations of abuses of human subjects in experiments such as those conducted in the Nazi concentration camps, the Tuskegee Study of Untreated Syphilis in the Negro Male, the Willowbrook Hepatitis Studies, and the studies described by Beecher in his 1966 article in the New England Journal of Medicine. The oversight system is based on a foundation, first implemented by the U.S. Public Health Service (PHS) in 1966 and by the U.S. Food and Drug Administration in 1971, of prior review and approval of a written experimental protocol by an independent committee. The World Medical Association articulated the ethical centrality of independent review in its 1975 revision of the Declaration of Helsinki, and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research endorsed the requirement in its flagship Belmont Report.

Can a country with a free press and a robust political debate provide its citizens with actionable information so that they can protect themselves from a threat to their health or safety? By actionable information, I mean accurate facts and reasonable interpretations of those facts upon which an individual should rely in making reason-based decisions. In the context of public health, this includes information that allows an individual to weigh the risk to one’s self, family, and community before deciding to act in an uncertain environment under threatening conditions. The recent H1N1 pandemic, and in particular the government’s campaign for public acceptance of the vaccine, highlights the challenges in ensuring that individuals receive accurate information and perceive that such information should be the basis on which to make potential life-saving decisions.

To judge from the rash of recent law review articles, it is a miracle that research with human subjects in the U.S. continues to draw breath under the asphyxiating heel of the rent-seeking, creativity-stifling, jack-booted bureaucrethics that is the current system of research ethics oversight and review. Institutional Review Boards (IRBs), sometimes called Research Ethics Committees (RECs), have been accused of perpetrating “probably the most widespread violation of the First Amendment in our nation's history,” resulting in a “disaster, not only for academics, but for the whole nation.” One member of the President's Council on Bioethics went so far as to assert, “There has been no greater damage to academic freedom in the United States in my lifetime. And my lifetime encompasses McCarthy and it encompasses political correctness, both.” Locked in the bureaucratic “iron cage” of IRB oversight, critics charge that researchers have been transformed into a vulnerable, exposed population, subject to domination, that has been likened in one case to a kind of “Tuskegee in reverse.”