Inside "Operation Change Agent": Mallinckrodt's Plan for Capturing the Opioid Market.

CONTEXT: The United States is deeply entangled in an opioid crisis that began with the overuse of prescription painkillers. At the height of the prescription opioid crisis (2006-2012), Mallinckrodt Pharmaceuticals was the largest opioid manufacturer. This study explores Mallinckrodt strategies to expand its market share by promoting a new opioid. METHODS: Using the Opioids Industry Document Archive, we analyzed the incentive structures, sales contests, and rhetorical strategy behind Mallinckrodt's "Operation Change Agent," a campaign to switch patients from OxyContin to Mallinckrodt-branded painkillers. A structured search of the archive in October 2022 retrieved 464 documents dated between 2010 and 2020. FINDINGS: We identified a range of sales force motivational techniques, including hypertargeting high-decile prescribers, the provision of free trial kits, using emotion-based language to connect with prescribers, and strategies to oppose prescriber resistance. Throughout, managers used specific incentivization metaphors to frame strategies through sport and ultramarathons. CONCLUSIONS: This research on internal corporate strategy adds to growing challenges to industry claims that opioid sales teams simply educated providers and helped fill existing demand for their products. Moreover, this research has important implications for regulatory policy and consumer protections that can better protect health in the face of competitive market forces.

The opioid industry document archive: New directions in research on corporate political strategy.

The opioid crisis in the United States has resulted in more than 500,000 deaths since 1999, and recent estimates suggest that attributable deaths could reach 842,000 by 2032. While heroin and synthetic products such as fentanyl now account for the majority of opioid overdoses, the prescription opioid crisis that emerged in the mid-1990s was the primary antecedent to the current situation. Recent settlements in litigation against opioid producers, suppliers and retailers has resulted in the release of almost 2.5 million previously confidential internal documents that have been made publicly accessible via the online Opioid Industry Documents Archive, a collaboration between the University of California, San Francisco and Johns Hopkins University. These corporate records provide critical insights into the operations and strategies of manufacturers and other actors in the opioid supply chain. This article describes the provenance of the opioid documents and their potential value as a research resource. It then outlines methodological approaches to their analysis, drawing on comparisons in conducting research using the Truth Tobacco Industry Documents. The Opioid Industry Documents Archive is a new and important addition to existing industry document collections that enable scrutiny and analysis of the role of corporate actors in determining health outcomes. Beyond their immediate application to researching the corporate and regulatory foundations of the current opioid crisis, the opioid document collections will contribute to a greater understanding of the commercial determinants of public health by providing means to better locate the causes of public health crises, identify politically acceptable solutions to their resolution, and inform strategies for preventing future corporate-driven epidemics.

Measuring the Commercial Determinants of Health and Disease: A Proposed Framework.

The commercial determinants of health (CDoH) describe the adverse health effects associated with for-profit actors and their actions. Despite efforts to advance the definition, conceptualization, and empirical analyses of CDoH, the term's practical application to mitigate these effects requires the capacity to measure the influences of specific components of CDoH and the cumulative impacts of CDoH on the health and well-being of specific populations. Building on the Global Burden of Disease Study, we begin by conceptualizing CDoH as risk factor exposures that span agency and structural influences. We identify 6 components of these influences and propose an initial set of indicators and datasets to rank exposures as high, medium, or low. These are combined into a commercial determinants of health index (CDoHi) and illustrated by 3 countries. Although now a proof of concept, comparative analysis of CDoH exposures by population, over time and space, and their associated health outcomes will become possible with further development of indicators and datasets. Expansion of the CDoHi and application to varied populations groups will enable finer targeting of interventions to reduce health harms. The measurement of improvements to health and wellness from such interventions will, in turn, inform overall efforts to address the CDoH.

Defining Priorities for Action and Research on the Commercial Determinants of Health: A Conceptual Review.

In recent years, the concept of commercial determinants of health (CDoH) has attracted scholarly, public policy, and activist interest. To date, however, this new attention has failed to yield a clear and consistent definition, well-defined metrics for quantifying its impact, or coherent directions for research and intervention. By tracing the origins of this concept over 2 centuries of interactions between market forces and public health action and research, we propose an expanded framework and definition of CDoH. This conceptualization enables public health professionals and researchers to more fully realize the potential of the CDoH concept to yield insights that can be used to improve global and national health and reduce the stark health inequities within and between nations. It also widens the utility of CDoH from its main current use to study noncommunicable diseases to other health conditions such as infectious diseases, mental health conditions, injuries, and exposure to environmental threats. We suggest specific actions that public health professionals can take to transform the burgeoning interest in CDoH into meaningful improvements in health. (Am J Public Health. 2021;111(12):2202-2211. https://doi.org/10.2105/AJPH.2021.306491).