P4.045: Industry Sponsored Research Payments to Non-Covered Entities in Pediatrics

Background: In 2023, pharmaceutical and medical device companies invested $291 million in pediatric medicine. While collaboration between industry and clinicians can often be beneficial, concerns exist that these interactions may negatively impact provider decision-making, potentially compromising patient care. To enhance transparency, the Open Payments Program (OPP) was established in 2013 to track financial relationships between healthcare providers and industry. While “covered recipients” of industry payments are clearly defined, “non-covered entities (NCEs)” remain a less precisely defined group. Furthermore, transactions with NCEs become reportable only when covered medical providers, such as those employed by teaching institutions, serve as Primary Investigators (PIs). The intent of this study is to perform a detailed analysis of industry sponsored research payments, the largest payment category in the OPP, to NCEs with a pediatric physician as the principal investigator from 2015 to 2023.

Methods: This cohort study follows the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting guideline. We used OPP data to identify ISRPs inflation-adjusted to 2022 United States dollar values during 2015 to 2023. We analyzed ISPRs to NCEs with physician PIs because these constituted most ISRPs by value (>70%). Where multiple (up to 5 could be listed per ISRP) PIs were listed for an ISRP, we attributed the full amount of that ISRP to the primary PI given a lack of disclosure requirements about fund allocations within an ISRP. This attribution avoided double counting of the same ISRP. We tested trends in total values using linear regression and trends in per-physician ISRPs using generalized linear models with a γ distribution to account for physician effects, with a 2-sided α < .05 applied. We used Stata statistical software version 18.0 (StataCorp).

Results: We found a statistically significant increase in the total number of ISRPs to NCEs with an overall growth of 57%. Also, during the study period, a 53% increase in research payment values was identified and accounted for $250.2 million dollars in 2023 alone. Organizations with the largest overall research payment contribution included Pfizer and Novartis, both producers of commonly prescribed pediatric medication. The combined payment value between these two organizations from 2015 to 2023 equaled an impressive $695.4 million dollars.

Conclusion: ISRPs to NCEs represent a potential area for significant industry influence on pediatrics through research funding. Future areas of focus for pediatric medicine should include improved clarity in relation to defining NCEs as well as transparency of spending patterns for these organizations. Providers acting as PIs should also have well defined roles which correlate appropriately within their area of medical expertise. While the OPP has begun to shed light on the complex relationship between medicine and industry, our study shows there is still much work to be done.