Using opioid industry documents to understand marketing of addictive medications - ABSTRACT Prescription opioids have been a key driver of the US opioid crisis, resulting in nearly 500,000 overdose deaths from 1999 to 2019. The US has the highest rate of per capita opioid consumption in the world. Prior to class action lawsuits beginning in 2014, prescription opioids such as oxycodone were marketed by their producers as safe and non-addictive, resulting in a peak dispensing rate of 81.3 prescriptions per 100 Americans in 2012. As a result of these lawsuits there has been an unprecedented release of internal industry documents detailing prescription opioid manufacturers’ efforts to promote their products as safe and non-addictive to consumers, health care providers, and US regulators. We propose the first systematic analysis using the UCSF Opioids Industry Documents Archive (OIDA) of over 3.1 million documents that were obtained through the discovery process in litigation from pharmaceutical companies, trade associations, and government agencies (e.g., private correspondence by company executives, advertising firms, lobbying reports, corporate strategic plans, undisclosed company research). Expanding on industry documents analysis pioneered in research on tobacco, the proposed study will use novel new methods, including artificial intelligence guided search strategies, to assess how opioid manufacturers successfully marketed prescription opioids to patients, health care providers, and regulators, resulting in prescribing rates and consumption beyond medically warranted levels. There is limited evidence on how pharmaceutical companies established false claims that opioids were not addictive or harmful. Existing studies suggest a wide range of possibilities: aggressive marketing, industry interference in scientific research on opioid safety, weak state regulations, and exploitation of stigmatizing assumptions about addiction. We hypothesize that activities involved in marketing prescription opioids could be another commercial determinant of health, and our analysis will assess strategies used by opioid manufacturers to influence the behaviors of three key constituencies that resulted in increased consumption of prescription opioids. This knowledge will inform future regulatory actions on addictive pharmaceuticals that could be marketed as therapeutic, including cannabis, benzodiazepines, MDMA, and methamphetamines. Specific aims are: 1) Identify strategies used to market opioids directly to patients; 2) Assess pharmaceutical industry messages and marketing strategies directed at opioid prescribers and dispensers; and 3) Evaluate pharmaceutical industry outreach and advocacy to state and federal regulators. This unique scientific contribution, which focuses on the role of activities to market addictive prescription medications as commercial determinants of health, will inform federal and state policies on prescription drug advertising and prescribing, and clinician guidelines and ethical standards on prescriber engagement with pharmaceutical companies.
