Essays on stem cell policy seem to fall into three categories. Some essays in this collection are about logic and principles. Others are about practices and beliefs. The former group draws lines and defends them, a normative project. The latter group attempts to explain the lines that already exist, a descriptive project that may have important normative goals. Still other essays, by scientists, are about growing stem cell lines instead of drawing them.

The purpose of this essay is to situate the lines being drawn around stem cell science in the larger landscape of health policy. I am interested in the things that cause health policy to take particular directions and the consequences of those directions for cost, access, and quality — all of which are determined in part by biomedical innovations such as those potentially derived from stem cells.

Washington, D.C.’s City Council has recently taken the first step towards legalizing the use of “medical marijuana” in accordance with the provisions of the Legalization of Marijuana for Medical Treatment Initiative of 1998 (Initiative 59). This action was not overruled by the United States Congress within the 30-day deadline imposed by the District of Columbia’s Home Rule Statute. The Council is now crafting regulations that will govern the therapeutic and palliative use of this drug with the goal of avoiding some of the problems faced by the other states that have legalized medical marijuana; however, the proposed rules do not establish criteria for legitimate medical practice when medical marijuana is recommended (discussed infra). If the enabling regulations are passed by the D.C. Council and not rejected by the Congress, the District of Columbia will join over onequarter of the states in legalizing medical marijuana (Table I). On the other hand, if the D.C. Council fails to act favorably on the final regulations (or if Congress nullifies the Council’s approval), then the effective legalization of medical marijuana will die and not be reconsidered until next year.

The seemingly interminable debates about health care reform in the last few years have focused mainly on health care access, quality, and cost. Debates on the medical malpractice component of the issue have focused almost entirely on cost. The familiar arguments in favor of limiting liability include the financial and health costs of defensive medicine; decreased physician supply in certain specialties and geographic areas; excessive awards; and high transaction costs, including attorney and expert witness fees. The equally familiar arguments in favor of maintaining tort liability include the need to promote civil justice, deter substandard care, identify incompetent practitioners, and encourage systemic quality improvement.

Numerous studies have explored the possible effects of damage caps and other measures on malpractice premiums, health care costs, and other financial endpoints. One relatively under-examined aspect of the issue is how federal legislation expanding access to health care might alter the number of medical malpractice claims. With the enactment of the Patient Protection and Affordable Care Act of 2010 (PPACA), it is especially appropriate to consider what effect, if any, the new law will have on the rate of medical malpractice claims.

The World Medical Association's (WMA) Declaration of Helsinki is one of the most important and influential international research ethics documents. Launched in 1964, when ethical guidance for research was scarce, the Declaration comprised eleven basic principles and provisions on clinical research. The document has since evolved to a complex set of principles, norms, and directions for action of varying degrees of specificity, ranging from specific rules to broad aspirational statements. It has been revised six times in an effort to maintain its influence. While all revisions were the result of vigorous debate, the 2000 revision and two subsequent notes of clarification spurred particular controversy surrounding the use of placebo in clinical research and the standard of care and post-trial obligations in research in developing countries. Several institutions opted to cite earlier versions of the Declaration, and the U.S. Food and Drug Administration (FDA) recently removed all reference to the Declaration in its approval requirements for drugs and biological products that are studied outside the United States.

Many writers suggest that managed care had a brief life and that we are now in a post-managed care era. Yet managed care has had a long history and continues to thrive. Writers also often assume that managed care is a fixed entity, or focus on its tools, rather than the context in which it operates and the functions it performs. They overlook that managed care has evolved and neglect to examine the role that it plays in the health system.

This article argues that private actors and the state have used managed care tools to promote diverse goals. These include the following: increasing access to medical care; restricting physician entrepreneurialism; challenging professional control over the medical economy; curbing medical spending; managing medical practice and markets; furthering the growth of medical markets and private insurance; promoting for-profit medical facilities and insurers; earning bounties for reducing medical expenditures; and reducing governmental responsibility for, and oversight of, medical care. Struggles over these competing goals spurred the metamorphosis of managed care internationally.

There is widespread concern among public health and emergency response officials that there could be a shortage of health care providers in a public health emergency. At least the following three factors could cause an inadequate supply of physicians, nurses, and other health care providers: (1) the severity of the emergency might greatly increase the demand for health services and outstrip the available supply; (2) health care providers might become unavailable because of their own high rates of illness, as was the case in the SARS epidemic; and (3) many health care providers might not report for duty for personal, family, or professional reasons.

One way of addressing the shortage is to encourage health care providers from unaffected areas or parts of the country to volunteer their services. A variety of measures have been enacted to facilitate the use of such volunteers.

The 1981 Uniform Determination of Death Act (UDDA) states:

The “whole-brain concept of death,” appealed to in the UDDA, has been roundly criticized for many years. However, despite a great deal of legitimate criticism in academic circles no real clinical or legislative changes have come about. At least one reason for this inertia is aptly stated by James Bernat, one of the principal and founding proponents of the brain death doctrine: “In the real world of public policy on biological issues, we must frequently make compromises or approximations to achieve acceptable practices and laws.” While acknowledging that the brain death doctrine is not flawless and that he and other proponents have been unable to address all valid criticisms, Bernat nonetheless maintains that the brain death doctrine is optimal public policy.

Last summer, I was thinking about a public service project for my disability discrimination law course. I teach the course in fall, and try to incorporate a project each year. Integrating a public service project into a traditional doctrinal course fits within the trend toward expanding teaching techniques beyond the case method in order to better prepare students for the practice of law. It was also inspired in part by the Carnegie Foundation's 2007 report, “Educating Lawyers: Preparation for the Profession of Law,” as a way to foster “civic professionalism,” and to “[link] the interests of legal educators with the needs of legal practitioners and with the public the profession is pledged to serve.” That link is especially important to disability discrimination law, as issues critical to the lives of people with disabilities often go unnoticed and unaddressed by people without disabilities.

Clinical research with children generates special ethical concern, raising the need for additional protections beyond those for research with competent adults. Most guidelines permit research with children when it offers a prospect of direct benefit, or poses minimal risk. Unlike many other guidelines, the U.S. federal regulations also allow institutional review boards (IRBs) to approve pediatric research that does not offer a prospect of direct benefit when the risks are no greater than a minor increase over minimal risk. To approve research in this category, IRBs must find that two additional conditions obtain:

The new science of genomics endeavors to chart the genomes of individuals around the world, with the dual goals of understanding the role genetic factors play in human health and solving problems of disease and disability. From the perspective of indigenous peoples and developing countries, the promises and perils of genomic science appear against a backdrop of global health disparity and political vulnerability. These conditions pose a dilemma for many communities when attempting to decide about participating in genomic research or any other biomedical research. Genomic research offers the possibility of improved technologies for managing the acute and chronic diseases that plague their members. Yet, the history of biomedical research among people in indigenous and developing nations offers salient examples of unethical practice, misuse of data and failed promises. This dilemma creates risks for communities who decide either to participate or not to participate in genomic science research.

Parents, providers, policy makers, and the public need to talk about the implications of advances in genomic technologies for state run newborn metabolic screening programs. Technologies, such as highly multiplex testing and whole genome sequencing, are raising old issues with new urgency and are posing new challenges that threaten to overwhelm newborn screening programs.

Newborn screening programs in their current form were born in the late 1960s. Robert Guthrie developed a screening test for phenylketonuria (PKU) that could be performed on blood spots collected on filter cards that Guthrie also developed. States rapidly established newborn screening programs, which were almost always mandatory, in response to advocacy by geneticists and parents. Although the programs initially varied in form and experienced significant pushback from the medical community, by the early 1970s, all states had established programs with centralized laboratories, and the medical community had come on board.

Recent studies indicate that patients who are diagnosed with vegetative states may retain more awareness than their clinical assessments suggest. Disorders of consciousness traditionally have been diagnosed on the basis of outwardly observable behaviors alone, but new functional imaging studies have shown surprising levels of brain activity in some patients, indicating that even higher-level cognitive functions like language processing and visual imagery may be preserved. For example, one recently developed method purports to detect voluntary mental imagery solely on the basis of neural response patterns observed with functional magnetic resonance imaging (fMRI). This line of research has already led to some widely reported cases of patients who were discovered to have more brain activity than expected. In November 2009, Rom Houben, a Belgian man who was thought to be in a coma for 23 years, was diagnosed with locked-in syndrome through the use of neuroimaging; however, that assessment was later overturned by further testing.

In September 2009, the First Circuit Court of Appeals decided Blue Cross & Blue Shield v. AstraZeneca Pharmaceuticals LP, part of the class action suit known as In re Pharmaceutical Industry Average Wholesale Price Litigation. The First Circuit upheld a Massachusetts District Court finding that AstraZeneca violated Massachusetts’ consumer protection laws by manipulating the “average wholesale price” of its physician-administered injectable cancer drug Zoladex, leading to overpayment by the government, third-party payers, and consumers. This case, which highlights the persistent tension between pharmaceutical pricing flexibility and consumer protection, has important implications for similar pending class actions.

Between 1991 and 2003, Medicare, as well as many private insurance companies, pegged reimbursement for certain pharmaceutical products to a national “average wholesale price” (AWP) for each drug. Although the amended 1991 Medicare Part B regulations3 that introduced the term “average wholesale price” failed to define it explicitly, there is some indication in the legislative history that AWP was intended to refer to the prices that physicians and pharmacists actually pay to the drug manufacturers.

Our course on social justice and health began as an experiment between Roger Williams University School of Law and the Warren Alpert Medical School of Brown University. As a course for both law and medical students, it broke relatively new ground by focusing on the intersection between law and the social determinants of health and the ways in which lawyers and doctors might partner to address social and health disparities. The course blends professionalism, ethics, and problem-solving by using case studies that raise practical challenges at the intersection of poverty, law, and health. This kind of collaborative, interdisciplinary teaching presents many challenges and rewards, which I discuss in this essay.

Military reproductive health policies affect large numbers of women. In 2006 servicewomen numbered nearly 350,000 and comprised 14.5% of active-duty forces and 17.4% of the reserve force. In addition, approximately 165,000 female dependents of active duty military personnel and 157,000 female dependents of reserve duty personnel are between the ages of 12 and 22 and are eligible for military health care services. Dependents of military personnel are eligible for military health care coverage until age 21, or up to the age of 23 if considered a full-time student.

About 10% of active duty female servicemembers become pregnant each year. Pregnant servicewomen are considered non-deployable and are usually not assigned to overseas commands. Pregnant women in the Army, the service branch with the greatest number of women on active duty, can choose to remain on active duty, request temporary leave from service, or request separation from service. Separation options include either discharge, honorable or uncharacterized depending on rank, or transfer to individual ready reserve.

The False Claims Act (FCA), 31 U.S.C. § 3729, a post-Civil War law inspired by cases of defense contracting fraud, was revitalized in 1986. Since then it has been used to sue both manufacturers and providers of pharmaceuticals. In some cases, these suits were meant to target offlabel marketing of pharmaceuticals. In 2009, the 11th Circuit rendered a decision in Hopper v. Solvay Pharmaceuticals that dramatically limits the ability of private plaintiff whistle-blowers to bring qui tam suits under the FCA for such marketing. In June 2010, the Supreme Court denied certiorari, making the Circuit court decision final. The Solvay decision creates a significant barrier to certain kinds of qui tam suits, requiring the plaintiff to demonstrate the intent to market off-label, including by showing specific prescriptions that were written as a result of efforts to do so.

Criminalistics laboratories routinely provide cold hits in police investigations by comparing DNA profiles from crime scenes to offenders residing in the Combined DNA Index System (CODIS). Forensic DNA analysis is often glamorized in popular culture, where the perpetrators are identified and crimes solved within a single television episode. In reality forensic DNA hits can identify perpetrators of violent offenses, link multiple crimes committed by the same individual, or exclude suspects and exonerate the falsely accused. Unlike the media portrayals, downstream activities after a DNA identification or cold hit are often more complex. While the Federal Bureau of Investigation (FBI) cites a national Data Bank of more than 7.2 million DNA profiles and 94,000 identifications nationwide, an in-depth analysis of public safety improvements made with CODIS is currently unavailable to forensic practitioners and public policy analysts. A review of case resolutions for 198 DNA database hits in San Francisco created performance metrics to provide a concrete measure of the effectiveness of DNA databasing efforts at the city and county level.