Industry-Sponsored Research Funding to Rheumatologists in the United States Between 2014 and 2022

Rheumatologists are responsible for conducting research on, managing, and treating major autoimmune diseases (AIDs) such as rheumatoid arthritis (RA), systemic lupus erythematosus, and psoriasis. AIDs afflict up to 23.5 million people in the United States. Although most of these diseases remain incurable and their etiology is still largely unknown,¹ research investment in AIDs has led to the development of effective drugs for improving detection, diagnosis, and management of these diseases.² However, rheumatologists have been facing challenges in obtaining research funding from public sectors. Although the total research funding from public sectors increased by 10.1% from 2014 to 2017, research funding from the public sector to members of the American College of Rheumatology (ACR) decreased by 7.5% in inflation-adjusted amounts over the same period.³ The number of public research grants to ACR members also decreased by 8.1% during this period, from 903 to 830.³ Consequently, industry-sponsored research has become an increasingly important source of funding for rheumatologists, but this increased reliance on industry funding leads to a potential increase in focus and biases to what industry deems important.

The enactment of the Physician Payments Sunshine Act and the inception of the Open Payments Database (OPD) improved transparency in financial relationships between physicians and the healthcare industry in the US for both research and nonresearch purposes. Since 2014, the OPD has publicly disclosed nearly all financial transfers to physicians and teaching hospitals reported by pharmaceutical and device companies.^4-6 Even though the healthcare industry spends the majority of its expenditures on physicians for research rather than nonresearch purposes,⁷ previous studies focused primarily on nonresearch payments to rheumatologists.^5,6,8 Little is known about the industry-sponsored research payments to rheumatologists so far.

Using the OPD from 2014 to 2022, this longitudinal cross-sectional study examined the extent of and trends in industry-sponsored research payments to rheumatologists in the US. All pediatric and adult rheumatologists were identified and extracted from the National Plan and Provider Enumeration System database, as previously noted.⁷ The study then extracted from the OPD between 2014 and 2022 all research payments provided (1) directly to rheumatologists (direct research payments), and (2) to healthcare providers and healthcare organizations related to research whose principal investigator (PI) was a rheumatologist (associated research payments). Including only direct research payments to individual physicians leads to underestimating the magnitude of industry-sponsored research payments⁷; therefore, this study considered both direct and associated research payments. Associated research payments encompassed indirect research-related costs provided to institutions and teaching hospitals where the rheumatologist conducted research, such as costs for patient enrollment and screening, data/safety monitoring committees, article publication and proofreading services, and drugs and other supplies used in the research. Further, general payments to rheumatologists, which are payments for nonresearch purposes, were analyzed to compare to the amounts of industry-sponsored research payments.

Descriptive analysis was performed on the extracted payment data. Per-physician payments were calculated among physicians who received payments. Population-averaged generalized estimating equation (GEE) models at the individual physician level were employed to examine yearly trends in the number of rheumatologists receiving payments and per-physician payments. Interrupted time series analysis was used to adjust for the influence of the coronavirus disease 2019 (COVID-19) pandemic on industry payments. The study period was divided into pre-pandemic (2014-2019) and during the pandemic period (2020-2022).⁶ Inflation of US dollars was adjusted to the 2022 dollar value using the US Bureau of Labor Statistics Consumer Price Index Calculator (https://data.bls.gov/cgi-bin/cpicalc.pl). The payments were further analyzed by the content of the research and the companies making the largest payments. The top 150 research projects or studies funded by the healthcare industry with the largest associated research payments, accounting for 62.24% ($889.5 million) of all research payments, were manually researched in the OPD. When the research was a clinical trial registered with the National Institutes of Health, details of the research were obtained from the ClinicalTrials.gov database.

After adjusting for inflation, a total of $1.45 billion was allocated to rheumatologists by 196 companies for research purposes between 2014 and 2022. The amount of industry-sponsored research payments exceeded general payments to the rheumatologists by 3.9 times ($1.45 billion in research payments vs $368.4 million in general payments). Out of 7674 rheumatologists, 20.15% (1546 rheumatologists) received at least 1 research payment. Among them, 93.40% (1444 physicians) were identified as PIs for 98.65% of the overall industry-sponsored research payments including direct and associated research payments (Table 1). There was a substantial discrepancy between median and average per-rheumatologist payments. Of rheumatologists receiving associated research payments, the median 9-year combined amount of associated research payments was $173,021.7 (IQR $26,502.7–$806,040.3), whereas the average was $989,753.2 (SD $2,932,239.7).

The proportion of rheumatologist PIs ranged from 7.71% to 11.27% annually. Over the study period, there was a general downward trend in the annual amount of associated research payments and the number of rheumatologists receiving them. The GEE model revealed that the annual total amount of associated research payments peaked at $217.7 million in 2015 and declined by 8.51% (95% CI −8.52 to −8.50, P < 0.001) each year between 2014 and 2019. During the same period, per-rheumatologist associated research payments decreased significantly by 8.55% (95% CI −10.90 to −6.13, P < 0.001) each year. After 2020, the number of rheumatologists receiving direct and associated research payments also decreased significantly.

Only a few companies allocated significant funding to research for major autoimmune diseases. Of the 196 companies making research payments to rheumatologists, the top 10 companies distributed 74.80% of all research payments. Pfizer provided the largest amount of research payments, worth $266.6 million, followed by Novartis ($183.1 million), AbbVie ($146.2 million), Amgen ($97.0 million), and Eli Lilly ($97.0 million).

These payments were used to conduct clinical trials with large sample sizes and rigorous study designs to evaluate the safety and effectiveness of novel drugs. Of all associated research payments, 98.03% were allocated to research projects. Only 2.74% ($39.2 million) was distributed to preclinical research. Table 2 presents an overview of the top 10 clinical trials with the highest associated research payments. The associated research payments for these top 10 trials accounted for 20.28% ($289.9 million) of all research payments. Among these 10 trials, 4 evaluated the safety and efficacy of secukinumab. Nine trials were phase III or IV, multicenter, randomized, double-blind controlled trials. The number of study participants ranged from 258 to 956. There were 5 trials for psoriatic arthritis and 2 trials for RA.

This investigation examined all direct and associated research payments to rheumatologists, providing a more comprehensive evaluation of the industry’s investment in research in the field of rheumatology. Despite the growing partnerships and networks between rheumatologists, the public sector, and the healthcare industry to optimize research funding allocations, the declining trend in industry-sponsored research payments is a concerning sign for all rheumatologists. This finding suggests that more and more rheumatologists are facing difficulties in obtaining research funding from the healthcare industry. Many industry-sponsored research projects are initiated by the healthcare industry and are underinvested in preclinical research and knowledge production, as pointed out by Scher and Schett.⁹ Not surprisingly, to maximize the impact of their research findings, industry-supported research is conducted and authored by a small number of key opinion leaders, and the research funding is primarily allocated to them.⁹ Therefore, only a limited number of rheumatologists can receive research payments from the healthcare industry. A decrease in the number of rheumatologists receiving industry research payments indicates growing industry shifts to using key opinion leaders and optimizing the companies’ research investments.⁹

The author acknowledges that the findings of the study should not be interpreted as an argument against rheumatologists receiving research payments from the healthcare industry, nor does the study suggest that these industry-sponsored research payments necessarily create conflicts of interest that jeopardize patient care. Collaboration between physicians and the healthcare industry is undoubtedly essential for advancing disease understanding, diagnosis, and treatment.² To introduce new treatments to patients, the US Food and Drug Administration requires healthcare companies to establish the safety and efficacy of these treatments through clinical trials based on rigorous study designs and large sample sizes, where physicians served as PIs.¹⁰ However, physicians sometimes receive large financial and nonfinancial incentives to get involved in the industry-sponsored research, such as increased revenue, promotion, and professional recognition, as well as stronger ties to the healthcare industry. Further, clinical trial authors who receive honoraria and/or consulting fees have a more favorable interpretation of the trial results than those who do not.¹⁰ All rheumatologists need to pay more attention to the industry-sponsored research payments and the consequence of payment receipt, one of which could be conflicts of interest.

• Copyright © 2023 by the Journal of Rheumatology