Harm Reduction Ethics, Public Health, and the Manufacture of Doubt.

Abstract

Svirsky, Howard, and Berman’s (2022) paper “E-Cigarettes and the Multiple Responsibilities of the FDA” offers a significant contribution to a knowledge domain that might be called “harm reduction ethics.” This domain is in turn an important subject area within public health ethics and population-level bioethics specifically focused on the enormous burdens of noncommunicable disease. Despite the more recent energy (understandably) focused on pandemic and infectious disease ethics, tobacco consumption remains one of the leading causes of preventable disease both in the U.S. and globally. While the present paper focuses on the US, it is also important to remember that FDA regulation has global impact, which matters inasmuch as 80% of the world’s 1.3 billion tobacco users live in lowand middle-income countries (“LMICs”) (World Health Organization 2022). Svirsky, Howard, and Berman offer a sophisticated analysis that sidesteps the wrangling over the precise state of the evidence in favor of a birds-eye view that addresses how evidence is weighed and acted upon within the larger regulatory state. Such a bird’s eye view is characteristic of population-level bioethics (Wikler and Brock 2007) and offers significant advantages in conceptualizing the role or lack thereof of ecigarettes in reducing the harm of combustible tobacco use. For example, Svirsky, Howard, and Berman highlight that the extent to which e-cigarettes reduce the harm associated with tobacco consumption is absolutely not an inherent feature of the product itself. Rather, they argue, “[w]hether e-cigarettes are a net benefit or detriment inherently depends upon the regulatory scheme in which these products are marketed and promoted. This regulatory framework is, in turn, overseen by the FDA” (16). They also note that FDA and agency regulation of combustible tobacco has a great effect on the extent to which e-cigarettes do or do not reduce the harms associated with tobacco consumption. This analysis not only underscores that analysis of benefits and harms cannot be performed solely by an internalist focus on biomarkers and randomized, controlled trials, but also emphasizes public health agencies’ general capacity to determine health outcomes and their distribution within the populations they serve. One of the foundations of the field of public health law is that law is a major social determinant of health (Burris et al. 2018). In emphasizing different roles that the FDA plays, Svirsky, Howard, and Berman are deepening collective understanding of the various tools and pathways through which public health regulatory bodies literally determine overall health outcomes and health inequalities. The FDA does not impact health merely through approval of drugs and devices, but also, as Svirsky, Howard, and Berman explain, via its roles as knowledge purveyor, knowledge producer, adviser, and as market agent. Nor do the authors claim that these four roles are exhaustive; there are likely other roles and mechanisms through which public health agencies like FDA impact population health and its distribution. As Eleanor Kinney (2002) pointed out years ago, there is a strong argument that the bulk of public health law is administrative law; Svirsky, Howard, and Berman’s paper is yet another manifestation of that essential point. Another key implication of the authors’ framework in the present paper is the significance of historical