This cross-sectional study uses data from the Open Payments database to assess trends and characteristics of payments for ophthalmology research from industry.
Key Points
Question
What are the trends and characteristics of industry-funded research payments reported to have been made to ophthalmologists as documented in the Open Payments database?
Findings
In this cross-sectional study, 2102 ophthalmologists were reported to have received a total of $825 417 233 in industry-funded research payments from 2014 to 2020. Total industry funding increased 203% from 2014 to in 2020, and the top 10% of ophthalmologists received 65.7% of industry funding.
Meaning
Results of this study support the hypothesis that research collaborations between industry and ophthalmology are extensive and increasing in scope, with a few ophthalmologists receiving most of the funding.
Abstract
Importance
Characterizing industry-ophthalmology collaborations in research can highlight current areas of focus, improve transparency, and identify potential sources for conflicts of interest.
Objective
To assess the trends and characteristics in research payments reported from industry to ophthalmologists from 2014 to 2020.
Design, Setting, and Participants
This cross-sectional study used data from the Centers of Medicare & Medicaid Services’ Open Payments database (OPD), which contains public records of payments between industry and physicians, to identify all ophthalmologists who received industry payments for research purposes between 2014 and 2020. Industry funding was compared with public research funding by the National Eye Institute.
Main Outcomes and Measures
The value and distribution of payments, sponsoring manufacturers, and research products were assessed. Changes in aggregate and per individual-level funding were characterized using formal trend analysis.
Results
From 2014 to 2020, 2102 ophthalmologists were reported to have received $825 417 233 in industry research payments. Industry funding increased 203% from $62 924 525 in 2014 to $190 714 508 in 2020 (P = .01). Comparatively, total National Eye Institute research funding during the same period was $5 003 407 764 and increased 6.6% from $701 313 262 in 2014 to $747 929 556 in 2020 (P = .04). The share of all medical research funding from industry directed specifically toward ophthalmology research increased from 1.2% in 2014 to 3.2% in 2020 (P = .04). The distribution of industry payments was skewed, with the top 15 of 108 manufacturers accounting for 93.9% of funding. The top 10% of ophthalmologists (210) were reported to have received 65.7% of all research dollars ($542 299 121). The highest funded research products were anti–vascular endothelial growth factor agents, glaucoma treatments, and intraocular lenses.
Conclusions and Relevance
Although unequal in distribution, industry-funded research in ophthalmology is extensive and increasing in scope. Industry funding for research is less than that of public funding; however, industry funding increased faster between 2014 and 2020. Results of this study highlight the increasing importance of industry funding in ophthalmology research, but it may also present ethical challenges for clinicians collaborating with industry.
Introduction
Medical research often involves substantial collaboration and interaction between physicians and industry. The Physician Payments Sunshine Act was enacted in 2010 as a part of the Affordable Care Act to increase transparency in financial interactions between physicians and medical device and pharmaceutical companies.1 As a result, the Centers for Medicare & Medicaid Services (CMS) established the Open Payments database (OPD), a nationwide public database reporting industry payments to physicians.2
The CMS differentiates between general payments and research payments. General payments are all forms of payment not related to research, such as food, speaking fees, and consulting fees. Research payments are defined by the CMS as “Payments for different types of research activities, including the time a physician spends enrolling patients in studies for new drugs or devices. Research payments can include direct compensation to physicians, funding for research study coordination and implementation, or payments to study participants to cover expenses associated with the study.”3
Previous studies on industry payments to ophthalmologists have largely focused on general payments.4,5,6,7 Between 2013 and 2017, 20 943 ophthalmologists reportedly received general and research payments totaling $543 679 603, which constituted 1.9% of all industry-funded medical research and general payments documented in the OPD. Research payments constituted 57.1% ($310 142 152) of all payments.4 Despite research funding constituting most of reported industry payments to ophthalmologists, there is limited information on the nature of and long-term changes in research payments.4 There are also limited data comparing the changes in industry funding of research with changes in public funding. Understanding the extensive industry-physician interactions pertaining to ophthalmology research may improve transparency and highlight areas of research collaboration. Therefore, the aim of this study was to investigate the trends and characteristics of research payments reported from industry to ophthalmologists using the OPD.
Methods
In accordance with the Common Rule, institutional review board approval was not required for this study as no patient data were reviewed. This retrospective, longitudinal cross-sectional study followed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting guideline.
Individual-level research payment data were obtained from the CMS OPD for all years between 2014 and 2020.3 Data from the 2013 collection year were excluded from analysis because the CMS did not collect a full year of records. The CMS recorded all payments greater than $10 received by any physician practicing in the US. Payment records contained information on the physician recipient, the sponsoring manufacturer, the value of the payment, and the name of the drug or device being investigated. We restricted the analysis to physician primary investigators who indicated their specialty as ophthalmology or any ophthalmologic subspeciality. To obtain information on public funding of ophthalmology research, we collected individual-level payment data for research funding from the National Eye Institute (NEI) to principal investigators between 2014 and 2020 using the National Institute of Health RePORTER tool.8 Principal investigators included physician and nonphysician research scientists leading NEI-funded projects. National Eye Institute funding for internal operations and infrastructure was excluded from analysis.
Payments reported to have been made to ophthalmologists were adjusted for inflation to January 2021-equivalent dollars using the Bureau of Labor Statistics’ Consumer Price Index Calculator.9 Payment values were rounded to the nearest dollar. Data processing and statistical analysis were performed with Excel, version 16 (Microsoft Corporation) and RStudio (RStudio, PBC, version 2022.07.01). Descriptive statistics regarding payments, manufacturers, and research products were reported for each year from 2014 through 2020. Formal trend analysis was performed using the Mann-Kendall trend test. All P values were 2-sided, the threshold for statistical significance was P < .05, and there were no adjustments to P values for multiple analyses.
Results
From 2014 to 2020, ophthalmologists were reported to have received $1 277 627 383 in general and research payments from industry. Total research payments were $825 417 233 compared to $452 210 150 for general payments. Industry research funding increased 203% from $62 924 525 in 2014 to $190 714 508 in 2020 (P = .01). Additionally, the share of all payments that went toward research increased from 56.1% in 2014 to 82.7% in 2020 (P = .23). A total of 2102 ophthalmologists were reported to have received a total of $825 417 233 in research funding which constituted 2.0% of all research payments to any medical specialty (Table 1). Similarly, the share of all medical research funding received by ophthalmologists increased from 1.2% in 2014 to 3.2% in 2020 (P = .04). The number of ophthalmologists reported to have received payments was 755 in 2014 and 1025 in 2020, an overall increase of 35.8% (P = .04). In comparison, 2474 principal investigators received a total of $5 003 407 764 in research funding by the NEI from 2014 to 2020. National Eye Institute research funding increased 6.6% from $701 313 262 in 2014 to $747 929 556 in 2020 (P = .04).
Table 1. Characteristics of Research Payments Reported to Have Been Made to Ophthalmologists From 2014 to 2020a.
| Year | Ophthalmologists receiving payments, No. | Payments, $ | Mean (SD) funding per ophthalmologist, $ | Median (range) funding per ophthalmologist, $ | Share of total value of research payments, % |
|---|---|---|---|---|---|
| 2014 | 755 | 62 924 525 | 83 343 (185 372) | 20 861 (13-2 632 988) | 1.2 |
| 2015 | 926 | 81 319 775 | 87 818 (176 205) | 28 084 (37-2 225 162) | 1.4 |
| 2016 | 1050 | 135 381797 | 128 935 (239 418) | 48 440 (6-2 791 967) | 2.2 |
| 2017 | 997 | 128 272 772 | 128 658 (226 516) | 46 871 (20-2 348 812) | 2.2 |
| 2018 | 951 | 85 457 393 | 89 860 (162 975) | 33 358 (13-2 023 964) | 1.4 |
| 2019 | 1183 | 141 346 463 | 119 481 (302 199) | 29 454 (4-4 623 399) | 2.4 |
| 2020 | 1025 | 190 714 508 | 186 062 (694 336) | 30 602 (4-14 723 549) | 3.2 |
Data were obtained from the Centers for Medicare & Medicaid Open Payments database.
The mean (SD) value of industry-funded research payments reported per ophthalmologist across all years was $392 681 ($1 106 054). The single year with the highest mean (SD) payment ($186 062 [$694 336]) was 2020. However, the median (range) funding per ophthalmologist across all years was $71 027 ($6-$19 219 146). Although both the reported mean and median funding increased from 2014 to 2020, there was year-to-year variation and thus no trend was observed for either measure. Of the 2102 ophthalmologists reported to have received research payments across all years, 1162 (55.3%) received less than $100 000, 569 (27.1%) received between $100 000 and $500 000, 169 (8.0%) received between $500 000 and $1 000 000, and 202 (9.6%) received $1 million or more. Furthermore, the top 10% of ophthalmologists (210) received 65.7% ($542 299 121) of all payments reported from 2014 to 2020. Comparatively, the mean (SD) NEI funding per principal investigator across all years was $2 022 396 ($3 153 055), whereas the median (range) funding per principal investigator was $1 231 434 ($1-$64 155 143). The top 10% of NEI-funded principal investigators (247) received 41.0% ($2 053 072 125) of all funding.
From 2014 to 2020, there were 108 manufacturers with recorded payments to ophthalmologists. The 15 highest-paying manufacturers (13.9%) paid $775 120 889, which constituted 93.9% of all funding (Table 2). Genentech distributed the highest aggregate funding with $239 188 537 (29.0% of total research funding) funded to 389 (18.5%) ophthalmologists, a mean payment of $614 880. Following Genentech in total funding, Allergan distributed $145 255 760 (17%) to 752 (35.8%) investigators, a mean (SD) payment of $193 159 ($461 213). Allergan paid a higher number of prinicipal investigators than any other manufacturer.
Table 2. Top 15 Manufacturers Reporting Research Payments to Ophthalmologists From 2014 to 2020a.
| Manufacturer | Payments, $ (%) | Ophthalmologists receiving payments, No. (%) |
|---|---|---|
| Genentech | 239 188 537 (29.0) | 389 (18.5) |
| Allergan | 145 255 760 (17.0) | 752 (35.8) |
| Novartis | 86 708 288 (10.2) | 494 (23.5) |
| Alcon | 85 136 498 (10.0) | 186 (8.9) |
| Regeneron Pharmaceuticals | 80 091 332 (9.4) | 302 (14.4) |
| AbbVie | 31 056 918 (3.6) | 113 (5.4) |
| Glaukos Corporation | 23 296 690 (2.7) | 179 (8.5) |
| Johnson & Johnson | 22 791 286 (2.7) | 108 (5.1) |
| Abbott Laboratories | 11 489 493 (1.3) | 102 (4.9) |
| Ocular Therapeutix | 11 369 117 (1.3) | 144 (6.9) |
| Otsuka Pharmaceutical | 11 061 770 (1.3) | 50 (2.4) |
| Shire North American Group | 9 071 900 (1.1) | 113 (5.4) |
| Bausch Health | 6 937 492 (0.8) | 81 (3.9) |
| GlaxoSmithKline | 5 851 245 (0.7) | 45 (2.1) |
| Sanofi | 5 814 556 (0.7) | 35 (1.7) |
Data were obtained from the Centers for Medicare & Medicaid Open Payments database.
There were 251 products recorded as the subject of research endeavors between 2014 and 2020. However, a substantial number of payment records did not specify the research product being investigated, and these unspecified products received $472 129 281 (57.2%) in payments. Of the payment records that included associated products, the top 15 products received $288 306 881 (34.9%) in funding (Table 3). Of the top 15 identified products, there were 11 drugs and 4 devices (Tecnis intraocular lenses, iStent, Dextenza, and AcrySof intraocular lenses, Table 3). The anti–vascular endothelial growth factor (VEGF) agents brolucizumab (Beovu), aflibercept (Eylea), and ranibizumab (Lucentis) were the 3 highest-funded products, receiving $183 077 869 (22.2%) in research payments. Funding for anti-VEGF research increased 268.7% from $13 974 328 in 2014 to $51 518 314 in 2020 (P = .02). Other highly funded products were associated with the management of glaucoma, cataracts, and inflammatory eye conditions.
Table 3. Top 15 Products Associated With Research Payments Reported to Ophthalmologists From 2014 to 2020a.
| Product | Payments, $ (%) |
|---|---|
| Beovu (brolucizumab) | 68 713 321 (8.3) |
| Eylea (aflibercept) | 58 288 833 (7.1) |
| Lucentis (ranibizumab) | 56 075 714 (6.8) |
| Lumigan (bimatoprost) | 35 695 293 (4.3) |
| Humira (adalimumab) | 30 125 287 (3.6) |
| Tecnis IOL | 13 731 853 (1.7) |
| Tesidolumab | 4 768 397 (0.6) |
| Acthar (adrenocorticotropic hormone) | 3 258 043 (0.4) |
| Lotemax (loteprednol) | 2 713 739 (0.3) |
| Tepezza (teprotumumab) | 2 625 590 (0.3) |
| iStent | 2 563 065 (0.3) |
| Dextenza (dexamethasone ophthalmic insert) | 2 531 326 (0.3) |
| Gilenya (fingolimod) | 2 490 018 (0.3) |
| AcrySof IOL | 2 397 154 (0.3) |
| Photrexa (riboflavin 5′-phosphate) | 2 329 248 (0.3) |
Abbreviation: IOL, intraocular lens.
Data were obtained from the Centers for Medicare & Medicaid Open Payments database.
Discussion
In this longitudinal, retrospective cross-sectional study, we evaluated industry-ophthalmology interactions pertaining to drug and device research. Reported industry payments to ophthalmologists increased 203% from $62 924 525 in 2014 to $190 714 508 in 2020, substantially outpacing the growth in NEI funding (6.6%) during the same period. The distribution of industry payments recorded per ophthalmologist was unequal with the top 210 (10%) ophthalmologists receiving $542 299 121 (65.7%) of all research payments. Similarly, 15 (13.9%) manufacturers contributed $775 120 889 (93.9%) of all funding. The highest funded research products were aimed at treating age-related macular degeneration, glaucoma, and cataracts. Interestingly, over one-half of funding ($472 129 281) went toward unspecified products for which no information about the topic of research was available.
Although total public research funding from the NEI ($5 003 407 764) was substantially higher than total industry funding ($825 417 233), NEI funding increased only 6.6% from 2014 to 2020 compared with a 203% increase in industry funding. Additionally, the mean and median NEI funding per principal investigator ($2 022 396 and $1 231 434) were 5.2- and 17.3-fold higher, respectively, than the average and median industry payments per ophthalmologists ($392 681 and $71 027). The distribution of NEI funding was also less skewed than industry funding, with the top 10% of principal investigators receiving 41.0% of all funding compared with 65.7% of industry payments. The variations in the amount and distribution of public and industry funding may be in part owing to the types of projects funded by each source. The NEI emphasizes a greater focus on basic research whereas industry-funded research largely consists of clinical trials of drugs and devices.10
Several studies have examined interspecialty differences in non–research-related, general payments reported from industry.11,12 In an analysis of 36 specialties, ophthalmologists ranked 11th in average payments reported per physician, with 26 069 ophthalmologists receiving an average of $11 445 in reported general payments.12 Although there is less information available on research payments, ophthalmology appears to be well-funded compared with other surgical specialties. Between 2014 and 2017, ophthalmologists ranked second in the value of research payments reported per individual, following only thoracic surgeons.11
Although collaboration with industry is important for the development and evaluation of new treatments, it does present the risk of potential conflicts of interest. Taylor et al6 found that physicians receiving payments associated with brand name anti-VEGF agents were more likely to prescribe those agents than the cheaper bevacizumab. Patients have also expressed concern about their ophthalmologists receiving industry payments, with 42% disapproving of the receipt of payments greater than $100 in a survey of 407 participants.13 Although the implications of research and general payments for prescribing and practicing patterns is difficult to fully ascertain, physicians collaborating with industry need to continue to remain transparent about these ties and uphold their ethical obligations to provide the best care for their patients according to their means and resources.
Limitations
The limitations of this study largely pertain to the underlying design of the OPD. In many cases, the OPD reported industry payments made to a single physician in a group practice. It is unclear how funds may have later been internally distributed among physicians within these groups. As a result, there are likely a greater number of ophthalmologists receiving industry payments than reported in this study. Additionally, this study’s reported mean and median payments per ophthalmologists are likely an overestimate because we lacked information on internal distribution of industry funds within physician groups. Another potential limitation of this study is that 2014 was the first full year of payments recorded in the OPD. The tracking and reporting mechanisms in 2014 may not have been as robust as in later years, which could have contributed to the substantially lower number of reported ophthalmologists in 2014 compared with other years. In addition, there were substantial missing data pertaining to the products in the research contracts, preventing a complete depiction of trends in funding. Finally, the database is reliant on industry self-reporting; thus, errors in accuracy or omission would also affect the present analysis. Regular auditing and oversight pertaining to standardization and completeness of data would allow more accurate future analyses.
Conclusions
Findings of this study highlight the growing role of industry funding in ophthalmology research. Although industry-ophthalmologist interactions are crucial to the development of improved treatments, they may present ethical challenges to clinicians who must still base their practicing patterns on individual patient means and needs.
References
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