Annual payment trends from 2014 to 2022
After excluding several general-payment categories for acquisition, debt forgiveness, and long-term medical supply or device loans from GPEOR, the time series analyses showed that per-physician GPEOR significantly decreased by 4.4% (95% CI: -5.7% to -3.3%, p<0.001), while there was no significant change in the number of endocrinologists receiving GPEOR between 2014 and 2019 (Supplemental Material 5). As compared to 2014-2019, the number of endocrinologists accepting GPEOR significantly decreased by more than half and per-physician GPEOR also decreased by approximately 20% during the COVID-19 pandemic period (2020-2022). There were slight increasing trends in both the number of endocrinologists receiving GPEOR and per-physician GPEOR increased between 2020 and 2022, although the number of endocrinologists receiving GPEOR (4358) and total amounts of GPEOR ($37.2 million) in 2022 were still substantially under those (5034 and $68.9 million) in 2019.
Median per-physician associated research payments were the lowest in 2021 at $40,300 (IQR: $7,715–$179,700) and there were no significant trends in per-physician annual associated research payments before (2014-2019) and during the COVID-19 pandemic (2020-2022) (Supplemental Material 5). The time series analyses showed the number of endocrinologists receiving associated research payments decreased between 2014 and 2019 and showed more marked decreases at the beginning of the COVID-19 pandemic (2020). The number of endocrinologists receiving direct research payments also decreased at the beginning of the COVID-19 pandemic: however generally there were no significant changes in per-physician direct research payments over the study period.
Discussion
This study sheds light on physician-industry financial relationships in the field of endocrinology reported under the Sunshine Act in the US. The study analyses show that US endocrinologists received a total of $2.06 billion from 891 pharmaceutical and medical device companies during the 9 years between 2014 and 2022, and most industry payments were made for research purposes. Although 50.5% to 68.0% of all endocrinologists received at least one GPEOR each year, less than 10% of endocrinologists received associated research funding each year. Per-physician annual general payments decreased by 4.4% between 2014 and 2019. Industry general payments were disproportionately distributed to a small number of endocrinologists. Although prior studies have investigated the financial relationships between physicians and healthcare industries in specialties, few have been conducted in endocrinology.
The study found that endocrinologists received high median general (non-research) payments in the healthcare industry, especially compared to other specialists and primary care physicians (4,16,25,28,29). This is consistent with a previous three-year analysis by Inoue et al. (28). According to a previous study by Tringale et al. (4), primary care physicians, who care for and manage most diabetes and obesity patients, received $179 in median per-physician general payments in 2015. The prevalence of obesity and diabetes in the US have increased over the past several decades (6,30). Additionally, a previous study by Inoue et al. reporting approximately 92% of all general payments related to non-insulin glucose-lowering therapies such as sodium glucose co-transporter 2 (SGLT2) inhibitors and glucagon-like peptide-1 receptor agonists (GLP-1RAs) in the US were paid for these same two classes of medications (31).
The study found that large GPEOR were disproportionately concentrated among a few endocrinologists. Only 1% (80 endocrinologists) of physicians received 29.1%-38.3% of all GPEOR in endocrinology each year. As shown in previous studies (20,21,29), the healthcare industry made large consulting, speaking, and research payments to physicians with substantial clinical or research experience, often called “key opinion leaders” (KOLs) (32). KOLs frequently hold influential positions such as professional medical association leaders, clinical-practice guideline authors, and academic journal editors (16,33,34).
This study showed that more than 80% of GPEOR were made for food and beverage in the number of payments and about 10% of GPEOR paid to the top 10% endocrinologists were provided for travel and lodging. However, industry sponsorship for the sole purpose of travel, accommodation and meals associated with attending international or national conferences is not allowed in the US. Thus, reported travel expenses likely primarily reflect participation in company-sponsored consulting meetings, advisory boards, investigator meetings, rather than the provision of funds that did not involve a formal company activity.
The author recognize that the receipt of industry-sponsored research payments does not necessarily increase the risk of a biased outcome due to a conflict of interest. Industry-sponsored research expenses should be considered separately from general payments. The analysis shows that healthcare companies invested substantial amounts in research payments in the field of endocrinology. Although previous studies only analyzed research payments paid directly to individual physicians (16,28), this study included all research payments made to endocrinologists and their institutions, including research payments for trials where the principal investigators were endocrinologists. These estimates give a more comprehensive evaluation of industry research investment in endocrinology (18,19).
Research payments were distributed to only 6.0% to 9.3% of all endocrinologists each year and 15.3% over nine-years in the US, and per-physician research payments were substantially higher than other specialists (15,17,18,35-38). However, these payments should be viewed with caution because they include research costs at a time when many studies of SGLT2 inhibitors and GLP-1RAs were ongoing and nearly all of these funds were paid directly to institutions. An important caveat is also that the costs of trial medications sponsored by government organizations such as the National Institutes of Health NIH would have been included in the breakdown of research payments to principal investigators even though the medications were donated to the government organizations as part of a research agreement. The study was unable to discern which these may have been from the publicly available data. The high research payments in endocrinology indicate that companies are focused on this area. Prior work has suggested that industry-sponsorship can influence the outcome and interpretation of clinical trial findings (39,40).