Zita Lazzarini

The Law and the Public's Health: A Study of Infectious Disease Law in the United States

Law plays crucial roles in the field of public health, from defining the power and jurisdiction of health agencies, to influencing the social norms that shape individual behavior. Despite its importance, public health law has been neglected. Over a decade ago, the Institute of Medicine issued a report lamenting the state of public health administration, generally, and calling, in particular, for a revision of public health statutes. The Article examines the current state of public health law. To help create the conditions in which people can be healthy, public health law must reflect an understanding of how public health agencies work to promote health, as well as the political and social contexts in which these agencies operate. The authors first discuss three prevailing ways in which the determinants of health are conceptualized, and the political and social problems each model tends to create for public health efforts. The analysis then turns to the core functions of public health, emphasizing how law furthers public health work. The Article reports the results of a fifty-state survey of communicable disease control law, revealing that few states have systematically reformed their laws to reflect contemporary medical and legal developments. The Article concludes with specific guidelines for law reform.

Water Quality Laws and Waterborne Diseases: Cryptosporidium and Other Emerging Pathogens

Waterborne diseases, such as cryptosporidiosis, cause many cases of serious illness in the United States annually. Water quality is regulated by a complex system of federal and state legal provisions and agencies, which has been poorly studied. The authors surveyed state and territorial agencies responsible for water quality about their laws, regulations, policies, and practices related to water quality and surveillance of cryptosporidiosis related to drinking water. In this commentary they review the development and current status of federal drinking water regulations, identify conflicts or gaps in legal authority between federal agencies and state and territorial agencies, and describe court-imposed limitations on federal authority with regard to regulation of water quality. Recommendations are made for government actions that would increase the efficiency of efforts to ensure water quality; protect watersheds; strengthen waterborne disease surveillance; and protect the health of vulnerable populations.

Boltushka: A homemade amphetamine-type stimulant and HIV risk in Odessa, Ukraine

BACKGROUND Homemade amphetamine-type stimulants (ATSs) have been reported in Russia and Eastern Europe for decades. Recipes differ geographically and over time producing differing active ingredients. Vint and jeff (active ingredients methamphetamine and methcathinone, respectively) are two such homemade ATSs originally produced from over-the-counter cold medications and household chemicals. METHODS During a Rapid Policy Assessment and Responses (RPAR) project in Odessa, Ukraine, researchers found use of boltushka, a novel homemade ATS. Fourteen supplemental qualitative interviews were conducted, including ten interviews with boltushka injectors and four interviews with pharmacists. We report patterns of boltushka use among local injection drug users (IDUs) as well as the role of laws, regulations, and current pharmacy practices. RESULTS Legal restrictions on over-the-counter cold medicines in Ukraine led to products containing phenylpropanolamine (PPA), which oxidised with KMnO(4) (potassium permanganate), produces a weak ATS, cathinone, called boltushka. Boltushkas ingredients are easily available in pharmacies or on the black market. IDUs reported a mean age at first use of 16 years old (range 12-21). While published data are scant, anecdotal evidence reported here include amphetamine-like effects on energy and appetite, binging patterns of use, and some reports of shaking and other neurological damage consistent with earlier reports from exposure to KMnO(4). Users reported sharing syringes and other non-sterile injection practices. No users reported specific treatment or prevention programs for boltushka users. CONCLUSIONS Although Ukrainian government regulations have limited access to precursor chemicals, IDUs have continued to make and use boltushka. The actual extent and demographics of boltushka use are unknown. Besides risk of bloodborne disease, the health effects of injected homemade ATSs and their constituent chemicals are poorly documented. Interventions beyond available harm reduction efforts may be required. Education/treatment specific to boltushka users and screening for other physical harms are critical interventions.

HIV and the law: integrating law, policy, and social epidemiology.

n the foundational piece in this issue of the journal, “Integrating Law and Social Epidemiology,” Burris, I Kawachi, and Sarat present a model for understanding the relationship between law and health.’ This article uses the case of a specific health condition, the human immunodeficiency virus (HIV) infection, as an opportunity to flesh out this schema and to test how the model “fits” the world of the HIV pandemic. In applying the model to this communicable disease, we hope to illustrate the multitude of ways that laws affect the course of the pandemic as well as the course of an individual’s vulnerability or resilience to the disease, and how the complexities of an individual’s life dealing with the virus interface with the world of laws and legal institutions. Ultimately, we believe that in the case of HIV infection we will learn something about the nature of the connections between law and health. We give a brief overview of the epidemiology of HIV infection that is partidatly relevant from the perspective of the role of law By epidemiology we mean both the more common analysis that focuses on geographic, risk behavio~ age, gender, and temporal distribution of disease, including what we know of incidence and prevalence data, as well as social epidemiolw, specifically the relationships between HIV infection and social determinants such as socioeconomic status, education, race, social cohesion, and social capital. This integrated framework sets the stage for the next step, seeking evidence of how law might act either as a pathway to disease or how it mght structure the social determinants for disease that have been identified. At its core, the HIV pandemic involves the deceptively simple act of the virus passing directly or indirectly from the body of one individual to the body of another. Laws, however, may affect many of the variables that determine when

South Dakota's Abortion Script — Threatening the Physician–Patient Relationship

Under a new law, physicians in South Dakota must tell any woman seeking an abortion that she is terminating the life of “a whole, separate, unique, living human being.” Zita Lazzarini argues that these provisions mark a substantial inroad into the physician–patient relationship — one that ought to worry any practicing physician.

Forensic Epidemiology: Law at the Intersection of Public Health and Criminal Investigations

Journal of Law, Medicine & Ethics, 31 (2003): 684–700.

The Role of State Law in Protecting Human Subjects of Public Health Research and Practice

Public health activities present important ethical issues and risks to human subjects, whether these activities are considered research or practice. The federal regulations designed to protect human subjects during research studies, known as the Common Rule, may apply to a number of public health activities, such as disease reporting, surveys, or review of medical records. The extent that the Common Rule should apply to public health practice is still debated, but the National Bioethics Advisory Commission (NBAC) suggests that state law could offer meaningful guarantees that public health activities will protect the rights and welfare of individuals. This study sought to evaluate whether state public health law provides protection for people comparable to the Common Rule. State statutes that set the powers and duties of health agencies were reviewed to identify provisions that provided protections analogous to those provided by the Common Rule. The Common Rule contains six key protections: 1) consent for data collection; 2) protection of private information in collected data; 3) use of a bona fide, safe, and effective research design; 4) equitable selection of subjects; 5) appropriate data safety monitoring; and 6) protection of vulnerable populations. Our analysis showed that the protection provided to the subjects of public health practice by state law is comparable to the protection provided to research subjects under the Common Rule, but clearly not identical. The Common Rule requires individual informed consent prior to information collection. By contrast, there is no state law requirement for individualized consent for many kinds of data collection; consent may not be revoked; and notice for most people will be formal rather than actual. Privacy protections and data security requirements, which are explicitly outlined in the Common Rule, vary greatly under state public health laws. Data collection plans are not required under state law to be formally reviewed for either scientific or ethical quality. Ethical performance, including protection or inclusion of vulnerable populations, is not an explicit performance measure in the accountability/ management framework of public health. The Common Rule achieves accountability through the Institutional Review Board system; state law obtains accountability more indirectly through courts, elections, and the media. Ultimately, state public health law is an important regulatory resource to protect human subjects, complementing not only the Common Rule, but other ethical standards. The importance of effective public health practice justifies the development and understanding of regulatory approaches that promote excellent public health practice, including respect for human subjects.

Criminal HIV exposure laws: moving forward.

The year 2011 marked a quarter of a century since the first criminal HIV exposure laws were enacted. These laws—which typically criminalize undisclosed exposure to HIV through any of a number of sexual activities—have generated considerable commentary in the public health community, most of which has been negative. Two of the more memorable comments on these laws include Australian Justice Michael Kirby’s characterization of a second epidemic that arose in tandem with the HIV pandemic—the proliferation of what he described as “HIL,” or “highly inefficient laws,” among which were laws criminalizing HIV exposure [1]. In the first comprehensive survey and empirical investigation of state HIV exposure laws and associated criminal cases, Lazzarini et al. [2] reviewed classic purposes of criminal laws (deterrence and incapacitation) and upon finding little evidence that the laws achieve either, concluded that the actual purpose of HIV-specific exposure laws was largely symbolic, “rooted in the profound social differences over the acceptability of homosexuality and drug use, and the clash of values that those entail”.

Alcohol Industry Self-Regulation: Who is it really protecting?

Self-regulation has been promoted by the alcohol industry as a sufficient means of regulating alcohol marketing activities. However, evidence suggests that the guidelines of self-regulated alcohol marketing codes are violated routinely, resulting in excessive alcohol marketing exposure to youth and the use of content that is potentially harmful to youth and other vulnerable populations. If the alcohol industry does not adhere to its own regulations the purpose and design of these codes should be questioned. Indeed, implementation of alcohol marketing self-regulation in Brazil, the United Kingdom and the United States was likely to delay statutory regulation rather than to promote public health. Moreover, current self-regulation codes suffer from vague language that may allow the industry to circumvent the guidelines, loopholes that may obstruct the implementation of the codes, lax exposure guidelines that can allow excessive youth exposure, even if properly followed, and a standard of review that may be inappropriate for protecting vulnerable populations. Greater public health benefits may be realized if legislative restrictions were applied to alcohol marketing, and strict statutory alcohol marketing regulations have been implemented and defended successfully in the European Union, with European courts declaring that restrictions on alcohol marketing are proportional to the benefits to public health. In contrast, attempts to restrict alcohol marketing activities in the United States have occurred through private litigation and have been unsuccessful. None the less, repeated violations of industry codes may provide legislators with sufficient justification to pass new legislation and for such legislation to withstand constitutional review in the United States and elsewhere.

Criminalization of HIV Exposure: A Review of Empirical Studies in the United States

This review of literature identifies and describes US empirical studies on the criminalization of HIV exposure, examines findings on key questions about these laws, highlights knowledge gaps, and sets a course for future research. Studies published between 1990 and 2014 were identified through key word searches of relevant electronic databases and discussions with experts. Twenty-five empirical studies were identified. Sixteen of these studies used quantitative methods with more than half of these being cross-sectional survey studies. Study samples included male and female HIV-positive persons, HIV-positive and -negative men who have sex with men, public health personnel, and medical providers. Research questions addressed awareness of and attitudes toward HIV exposure laws, potential influences of these laws on seropositive status disclosure for persons living with HIV, HIV testing for HIV-negative persons, safer sex practices for both groups, and associations between HIV exposure laws and HIV-related stigma. Surveys of the laws and studies of enforcement practices were also conducted. Attention should be shifted from examining attitudes about these laws to exploring their potential influence on public health practices and behaviors related to the HIV continuum of care. Studies examining enforcement and prosecution practices are also needed. Adapting a theoretical framework in future research may be useful in better understanding the influence of HIV exposure laws on HIV risk behaviors.ResumenEsta revisión de la literatura identifica y describe los estudios empíricos sobre la penalización de la exposición al VIH en los Estados Unidos, analiza los resultados de los estudios sobre cuestiones claves en cuanto a estas leyes, pone de relieve las lagunas del conocimiento sobre el tema y establece un curso para futuras investigaciones. A través de palabras clave en bases de datos electrónicas y de la consulta con expertos, se localizaron los estudios publicados entre 1990 y el 2014. Se identificaron 25 estudios empíricos. Dieciséis de estos estudios utilizaron métodos cuantitativos y más de la mitad encuestas transversales. Las muestras incluyeron hombres y mujeres VIH-positivos y negativos, hombres que tienen sexo con hombres, personal de salud pública y proveedores de servicios médicos. Las investigaciones se centraron en el conocimiento y las actitudes hacia las leyes de exposición al VIH, la posible influencia de las leyes sobre la comunicación del estatus seropositivo por parte de las personas que viven con VIH, el acceso a la prueba de VIH entre las personas VIH-negativas, las prácticas sexuales seguras para ambos grupos y la relación entre las leyes de exposición al VIH y el estigma asociado con el VIH. También se realizaron encuestas sobre las leyes y estudios sobre las prácticas de su aplicación. El énfasis debe cambiar de las actitudes acerca de las leyes, a explorar su posible influencia sobre las prácticas de salud pública y los comportamientos relacionados con el continuo de atención del VIH. También se necesitan estudios que examinen las prácticas en cuanto al cumplimiento de las leyes y enjuiciamiento. En la investigación futura, adaptar un marco teórico puede ser útil para entender mejor la influencia de las leyes de exposición al VIH sobre las conductas de riesgo de VIH.