Research: Bioethics

My work in bioethics is focused on the treatment and regulation of addiction, and is informed by my broader views on responsibility. In particular, I am engaged in research on the practice of using opioid treatment agreements, on e-cigarette regulation, and on the ethics of harm reduction.


“Clinician Perspectives on Opioid Treatment Agreements: A Qualitative Analysis of Focus Groups,” (with Nathan Richards, Martin Fried, Nicole Thomas, Patricia Zettler, and Dana Howard), forthcoming, American Journal of Bioethics Empirical, (available upon request)

Background: Patients with chronic pain face significant barriers in finding clinicians to manage long-term opioid therapy (LTOT). For those patients who access LTOT, it is increasingly common to have them sign opioid treatment agreements (OTAs). OTAs enumerate the risks of opioids, as informed consent documents would, but also the requirements that patients must meet to receive LTOT. While there has been an ongoing scholarly discussion about the practical and ethical implications of OTA use in the abstract, little is known about how clinicians use them and if and how OTAs themselves modify clinician prescribing practices.

Objective: To determined how clinicians use OTAs in practice and the potential impact of OTAs on opioid prescribing.

Design: We conducted qualitative analysis of four focus groups of clinicians from a large Midwestern academic medical center. Groups were organized according to self-identified prescribing patterns: two groups for clinicians who identified as prescribers of LTOT and two who did not. 17 clinicians from General Internal Medicine, Family Medicine, and Palliative Care were recruited using purposive sampling. Discussions were recorded, transcribed, and analyzed for themes using grounded theory by a multidisciplinary team.

Key Results: Our analysis identified three main themes: (1) OTAs did not influence clinicians’ decisions whether to use LTOT generally, but did shape clinical decision-making for individual patients, (2) Clinicians feel OTAs intensify the power they have over patients, though this was not uniformly judged as harmful, (3) There is a potential misalignment between the purposes of OTAs and their implementation.

Conclusion: This study reveals a complicated relationship between OTAs and access to pain management. While OTAs seem not to impact clinicians’ decisions whether to use LTOT generally, they can influence prescribing decisions for individual patients. Clinicians shared complex views about OTAs’ purposes, which shows the need for more clarity about how OTAs could promote shared decision-making, joint accountability, informed consent, and patient education.

E-cigarettes, the FDA, Public Health, and Harm Reduction: A Response to the Open Peer Commentaries,” (with Dana Howard and Micah Berman), 2022, American Journal of Bioethics

We appreciate that all our commentators accepted the central framework we argued for, namely that the FDA has multiple roles and attendant responsibilities, and we are excited to see this framework extended in interesting and fruitful directions. In particular, we appreciated how this framework was used to illuminate the ethics of FDA decision-making and communications around pediatric COVID-19 vaccines (Lanphier and Bessias 2022) and opioid analgesics (Rand and Kesselheim 2022; Monaghan and del Pozo 2022), as well as how this framework could be used to inform comparative analyses of different countries’ regulatory approaches to e-cigarettes (Zhang et. al. 2022).

Our focus was on the FDA’s responsibilities as a knowledge purveyor, knowledge producer, an advisor regarding public health, and a market agent that determines the sorts of products that are available to consumers. However, this list may very well not be exhaustive, nor did we intend to argue that certain roles should be given priority over others; people may reasonably disagree about how the FDA should balance its multiple responsibilities in different situations. We hope that our paper convinces others that it is a myopic to attend to one of the FDA’s responsibilities—particularly the FDA’s responsibility to inform the public about the risks of nicotine products in its role as knowledge purveyor—without consideration of its other roles and responsibilities. The challenges that the FDA faces in attempting to balance its multiple roles in the context of e-cigarette regulation exemplify the difficult ethical problems that may arise when its various roles come into conflict, and the commentaries illustrate how differing assessments of the existing evidence may produce a range of opinions about how these roles should be balanced (Gaidarav and Asher 2022; Grill 2022; Monaghan and del Pozo 2022).

This response offers some brief points of clarification about our public health approach to thinking about the multiple responsibilities of the FDA. We highlight some complexities in discerning an effective harm reduction strategy – including the challenge of dual use and the distinctive nature of harm reduction in the tobacco context. 

E-cigarettes and the Multiple Responsibilities of the FDA, (with Dana Howard and Micah Berman) 2021, American Journal of Bioethics

This paper considers the responsibilities of the FDA with regard to evidence about the benefits and harms of e-cigarettes.  Tobacco harm reduction advocates claim that the FDA has been overcautious and has violated ethical obligations by failing to clearly communicate to the public the differential risks of e-cigarettes and combustible cigarettes.  We argue, by contrast, that the FDA’s obligations in this arena are more complex than they may appear at first blush. Though the FDA is accountable for informing the public about the health risks and benefits of products it regulates, it also has other roles (and attendant responsibilities) that inform when and how it should disseminate information.  In addition to being a knowledge purveyor, it is also a knowledge producer, an advisor to the public, and a practical agent shaping the material conditions in which people make health-related choices.  In our view, those other roles call for caution in the way the FDA interprets and communicates the available evidence.

“Opioid Treatment Agreements and Patient Accountability,” 2021, Hastings Center Report

Opioid treatment agreements are written agreements between physicians and patients enumerating the risks associated with opioid medications along with the requirements that patients must meet to receive these medications on an ongoing basis. The choice to use such agreements goes beyond the standard informed consent process, and has a distinctive symbolic significance.  Specifically, it suggests that physicians regard it as important to hold their patients accountable for adhering to various protocols regarding the use of their opioid medications. After laying out a taxonomy of accountability relations between physicians and patients, I argue that opioid treatment agreements are only justifiable for physicians to use in their provision of care if they improve patient or public health outcomes, which has yet to be demonstrated.

First, Do No Harm: Physician Discretion, Racial Disparities, and Opioid Treatment Agreements,” (with Adrienne Beck and Dana Howard) 2021, Journal of Medical Ethics

The increasing use of opioid treatment agreements (OTAs) has prompted debate within the medical community about ethical challenges with respect to their implementation. The focus of debate is usually on the efficacy of OTAs at reducing opioid misuse, how OTAs may undermine trust between physicians and patients, and the potential coercive nature of requiring patients to sign such agreements as a condition for receiving pain care. An important consideration missing from these conversations is the potential for racial bias in the current way that OTAs are incorporated into clinical practice and in the amount of physician discretion that current opioid guidelines support. While the use of OTAs has become mandatory in some states for certain classes of patients, physicians are still afforded great leeway in how these OTAs are implemented in clinical practice and how their terms should be enforced. This paper uses the guidelines provided for OTA implementation by the states of Indiana and Pennsylvania as case studies in order to argue that giving physicians certain kinds of discretion may exacerbate racial health disparities. This problem cannot be addressed by simply minimizing physician discretion in general, but rather by providing mechanisms to hold physicians accountable for how they treat patients on long-term opioid therapy to ensure that such treatment is equitable.