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P204: RWE Thought Experiment: Could RWE Have Prevented Today's Opioid Epidemic? Lessons from 19th Century China





Poster Presenter

      Sheila Mahoney Jewels

      • Small Business Innovation and Aggregator Advocate
      • LifeSciHub
        United States

Objectives

Thought experiment on how real world evidence (RWE) could have played a role in assessing addiction liability of pharmacotherapeutics. A case study is presented highlighting RWE from the opium epidemic in 19th century China to 21st century opioid epidemic in the U.S.

Method

We reviewed historical sources to identify quantitative and qualitative reports on opium and opium-related problems in 19th century China. Assessed two main quantitative data sources: measurable product quantity, usage relative to population.

Results

Opium consumption was positively correlated with opium imports into China and negatively correlated with opium price during the 19th century. Among licensed opium smokers in China, deaths increased from 1,181 in 1897 to 7,398 in 1900 (various historical sources) Analysis of temporal (historical) medical, hospital, death records. Comparison to modern consumption to be presented. Considerations: government regulated supply, non-governmental supply from both time periods, considering that both time periods opioids supply characterized by both channels.

Conclusion

Covid has commanded all of our attention the last two years but the opioid epidemic rages on, largely unchecked. This poster seeks to answer the question, why are any of surprised by the opioid crisis? Humanity had already learned what happens when opioids are made available in the population- millions of Chinese lives were ruined as proof. And yet, perhaps because it was over 100 years ago, this was not considered “proof” when health authorities considered oxycodone’s potential impact to patient safety. This thought experiment seeks to answer 3 fundamental questions: 1. Opioid crisis in 19th century China- was that RWD? Why/why not? 2. What RDE methodology could have been used to address 1) patient safety and 2) risk/benefit associated with releasing opioids into the human population? Historical sources will be mined for data points. RWD methodology will be applied to draw parallels between 19th Century China and today’s opioid epidemic data. The goal is to generate viable, qualified evidence from the real world experiences of 19th century China, that the health authorities could have used to evaluate oxycodone patient safety during the pre-approval process. 3. Finally, this poster considers the temporal nature of data- if we, today, reject all data generated outside of today’s commonly held “data standards”, such as data from previous time periods, what will happen 50 years from now, looking back on data from today?