Issues arising from the study design, conduct, and promotion of clinical trials funded by opioid manufacturers: a review of internal pharmaceutical industry documents

Abstract

Background:From 1999 to 2021 opioid overdoses caused over one million deaths in the US. The pharmaceutical industry has been held legally responsible in some cases for overstating the benefits and understating the risks of opioid use, leading to overprescribing that contributed to these deaths. Aims and objectives:In this study we describe issues with research funded by opioid manufacturers that was used to support increased opioid prescribing. Methods:We analysed 503 internal industry documents from opioid manufacturers released from State of Oklahoma v. Purdue Pharma, LP, et al in January 2020. Findings:Internal documents identified three research practices of concern – enriched enrollment, ghostwriting, and overstatement of research findings – that resulted in claims that opioids were safe, nonaddictive, and effective in treating pain. These claims were used to promote increased opioid use. Discussion and conclusions:Research created by opioid manufacturers distorted the addictive potential of opioids using strategies that hid authorship and overstated findings. The claims were used in marketing and promotional materials to promote opioids as being safe and effective.