Quantifying Industry Spending on Promotional Events Using Open Payments Data

Key Points Question Is an event-centric method of analysis for Open Payments data a valid tool for quantifying pharmaceutical and medical device industry-sponsored events for health professionals? Finding This cross-sectional study using Open Payments data identified 1 154 806 events sponsored by pharmaceutical and medical device companies during 2022 and found that 7 companies sponsored 16 031 dinners for the top 10 products. Meaning This finding suggests that taking an event-centric approach to analysis of publicly available Open Payments data is a valid method to quantify the scope and spending on industry-sponsored events, and illustrates the limitations of the existing mandates on financial transparency.


Introduction
2][3] For example, the promotion of gabapentin included events directly sponsored by the manufacturer such as speakers' bureaus at which paid physicians presented to peers as well as continuing medical education activities funded by the manufacturer through unrestricted educational grants to third-party medical education companies. 1However, there are little empirical data regarding the nature, scope, scale, and spending on sponsored events, and what is known, has largely been derived from internal industry documents made public through litigation, whistleblowers, or key informants. 4In Australia, from 2007 through 2015, the pharmaceutical industry's code of conduct required member companies to publicly report all details of sponsored events for registered health professionals. 5Analyses of these data suggest that sponsorship of events occurs frequently and is national in scope; specifically, in Australia, the pharmaceutical industry sponsored an average of 608 events for health professionals per week and more than 40% of events included attendees from multiple health professions. 6Furthermore, these sponsored events nearly always included food and beverages. 6e lack of public transparency around the nature and extent of industry sponsorship of events for health professionals makes it difficult to assess the impact that these events have on prescribing, and ultimately, on health outcomes.Events sponsored by pharmaceutical and medical device companies are designed to increase familiarity and use of promoted products among attendees and speakers as well. 3,7,8Analysis of the content of industry-funded continuing medical education suggests that these events are designed to overemphasize the benefits of the promoted product, minimize its risks, and exaggerate the harms of the competitors' products. 8Sponsored events are often designed to promote emerging or off-label uses of brand drugs or pipeline and newly marketed products. 8Sometimes these drugs have cost, efficacy, and/or safety concerns. 9,10The evidence also suggests that sponsored events are an effective strategy for increasing prescription of promoted products: physicians who received a single sponsored meal at an event were more likely to prescribe the promoted product. 11Moreover, as the number of events and the total dollar value spent per physician increased, so did the likelihood of prescribing the promoted product. 11 event-centric perspective may be useful to understanding and quantifying the reach of promotional campaigns in terms of attendees, across clinical specialties and professions.Lawmakers recently expanded Open Payments reporting requirements to cover all prescribing clinicians including physicians, physician assistants (PAs), and advanced practice registered nurses (APRNs), which includes nurse practitioners (NPs), clinical nurse specialists, certified registered nurse anesthetists, and certified nurse-midwives. 12PAs and APRNs, comprise a large and growing group of prescribers, who provide care in one-quarter of all health care visits in the US. 13 More than 70% of the 325 000 NPs in the US primary care workforce and those in full-time practice provide an average of 21 prescriptions per day. 14Consequently, APRNs represent an important target for pharmaceutical industry marketing: analyses of the 2021 Open Payments data found that a similar proportion of physicians, PAs, and APRNs (approximately 35%) received payments. 15 sought to devise a method to construct and categorize sponsored events for particular products using Open Payments records.By linking records that were plausibly associated with the same event, we aimed to quantify and describe sponsored events for particular products and to compare the characteristics of events across APRNs, physicians, and mixed audiences.Then we applied these methods to illustrate how they might be used to study promotional campaigns by identifying the top companies and drugs or devices associated with sponsored dinner events during 2022, finding patterns in promotional strategies targeted at various professional groups.We then validated our methods and typology by matching events constructed using Open Payments data with registration details provided for all industry-sponsored events on the websites of state-level NP associations.

JAMA Health Forum | Original Investigation
Quantifying Industry Spending on Promotional Events Using Open Payments Data

Methods
This study was reviewed and approved by The University of Toronto Research Ethics Board (No.42961); informed consent was waived because all of the data are publicly available, and the study did not involve recruitment of human participants.The study followed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting guideline.

Design and Data Sources
This was a cross-sectional study using Open Payments data (Centers for Medicare & Medicaid) for payments made from January 1 to December 21, 2022, to characterize and quantify sponsored events.We downloaded the 2022 dataset from the Open Payments website on June 30, 2023.We included all records for NPs, clinical nurse specialists, certified registered nurse anesthetists, certified nurse-midwives, and allopathic and osteopathic physicians (hereafter, physicians).To ensure consistency in the classification of these health professionals, we linked the Open Payments data to the National Plan and Provider Enumeration System data (accessed June 30, 2023) by National Provider Identifier and the National Uniform Claim Committee; individuals with ambiguous data on their provider type were excluded.

Event-Centric Analysis to Create an Event Typology
Previous research identified that more than 90% of pharmaceutical company−sponsored events include food and beverage, 6 and in 2021, food and beverage accounted for 91% of the total number of industry payments to physicians and 97% to APRNs. 16Thus, we included only payments classified as food and beverage to reliably identify distinct sponsored events.We reasoned that food and beverage would be consumed on the same day in the same place, and thus that records for food and beverage associated with the same event would share the same date of payment and location.We also assumed that the reported value of a food and beverage payment was the total cost of the hospitality, divided by the number of attendees; therefore, we grouped payment records with the same amount (rounded to the nearest dollar).
Inferring which Open Payment records were related to the same sponsored event required analytic decisions regarding the selection and representation of variables that define an event.To understand the impact of these choices, we undertook a sensitivity analysis to explore alternative ways to group Open Payments records for food and beverage, to determine how a combination of variables, including date (specific date or within the same calendar week), amount (rounded to nearest dollar), and recipient's state may affect the identification of sponsored events in the Open Payments dataset (eTable in Supplement 1).We chose to define a sponsored event as a cluster of 3 or more individual payment records for food and beverage (nature of payment) with the following matching Open Payments record variables 17 : • Submitting applicable manufacturer (name) • Product category or therapeutic area • Name of drug or biological or device or medical supply After evaluating the distribution of the data, we classified events by size (large, Ն20 attendees; small, 3 to <20) and dollar amount per person.In line with detailed pharmaceutical companyreported descriptions of industry-sponsored events, 6 we categorized events with a per person cost of less than $10 as coffee, $10 to less than $30 as lunch, $30 to less than $150 as dinner, and $150 or higher as banquet.We conducted descriptive analyses to understand the number and total spending for all types of events (coffees, lunches, dinners, and banquets, and for small and large audiences) attended by 3 different types of covered recipients: APRNs only; physicians only; and mixed (any combination of both APRNs and physicians).To illustrate the use of this method for identifying sponsored events, we identified the top products as those with the highest number of dinners across professional groups during 2022.

Validation
To validate our typology, we identified 4 state NP associations, selected to represent 4 geographic areas (Northwest, Midwest, Southeast, and West) and which hosted many in-person industrysponsored events in 2022 for their NP members and provided full event details on their websites to prospective attendees.We assumed that the details for these events would be as or more specific and accurate than details in Open Payments given that the information was targeted at prospective attendees.Furthermore, given that events were advertised to members of the NP association, we assumed that attendees would be mostly NPs (ie, APRNs) and that these events were dinners according to their locations (ie, restaurants) and timing (ie, evening hours) listed on the event registration websites.We extracted details for all of the in-person industry-sponsored events being hosted from the association's web-based event listings or event calendars including event title, date, and location; sponsor; drug or medical device, if listed; and health condition, if featured.
Using our dataset of events constructed from the Open Payments food and beverage records, we assessed how many events took place overall for each of the 4 states, by type of event, and specifically, by the number of sponsored meal events (lunches, dinners, and banquets) with APRNonly audiences.Then, for each sponsored event for APRNs hosted by the NP associations, we coded the event as a match if all information for event characteristics were consistent with 1 or more events in the Open Payments dataset, or we coded it a nonmatch if 1 or more variables differed.We furthered categorized reasons for nonmatches as: (1) sponsor not a covered entity in Open Payments; (2) product not covered by Open Payments (eg, not a drug or device or not yet on the market); (3) reported in Open Payments 1 day later; and (4) no apparent match.

Event-Centric Analysis of Open Payments Records
We identified 4 969 423 sets of Open Payments records for food and beverage payments with unique date, recipients' state, and payment amount.Among these sets, 1 154 806 (23.2%) contained 3 or more payment records and were therefore classified as 1 event.These events represented $137 481 620 of food and beverage payments, representing 52.1% of the total spending on food and beverages to physicians and APRNs in 2022.Other combinations of identifying variables led to as few as 91 973 distinct events while covering 98.8% of total event-related payments (eTable in Supplement 1).
Using the most conservative combination of identifying variables, we identified 1 154 806 events, 1 151 351 (99.7%) of which had fewer than 20 attendees, and 922 214 (80.0%) of which we categorized as lunch (Table 1).Although dinners made up 10.4% of the total number of events, they accounted for 39.2% of the total spend on events, although manufacturers still spent more on lunch overall ($72 847 103 [53.0%]).Physicians engaged in a much larger proportion of banquets (6695 [2.3%] of 394 339) than did APRNs or mixed audiences (banquets accounted for 0.4% of APRN and 0.3% of mixed audiences) and banquets accounted for 11.9% of event spending on physicians compared with 3% on APRN and 2.6% on mixed events.
To illustrate the use of this method, we selected the top 10 products based on the number of sponsored dinner events for physicians, PAs, and APRNs.Seven companies sponsored the events for the top 10 health products in terms of number of associated dinner events (Table 2).For 8 of the 10 top products, most dinner events included mixed audiences.However, for 2 products there were more APRN-only events than physician-only events, although the most dinners were still for mixed audiences: 253 events for APRNs (vs 181 for physicians) associated with valbenazine tosylate, a vesicular monoamine transporter 2 inhibitor indicated for tardive dyskinesia and chorea; and 224 APRN dinners (vs 157 for physicians) for cariprazine, an atypical antipsychotic indicated for treatment of schizophrenia and bipolar disorder and as an adjunctive therapy to antidepressants in major depression.For a surgical system, there were almost no events for audiences that did not include physicians.For the drugs, dupilumab (a monoclonal antibody for allergic diseases) and upadacitinib (indicated for moderate to severe rheumatoid and psoriatic arthritis, inflammatory bowel disease, atopic dermatitis, and ankylosing spondylitis 18 ), there were more physician-only dinners than for mixed or APRN audiences.

Validation
We identified 131 200 meal events across the 4 states, 23 050 dinners, and 776 dinners specifically for APRNs only (Table 3).The sponsored events hosted by the 4 NP associations represented 0.2% (227 of 131 200) of all meal events; 1.0% (227 of 23 050) of dinners; and 29.3% (227 of 776) of APRN-only dinners.The registration details for 168 of the 227 meals (74.0%) matched events constructed from Open Payments data; however, we had misclassified 10 dinners as lunch (ie, these dinners cost <$30 per person) and for 22, the otherwise matching Open Payments records did not specify an associated product or therapeutic area.For 19 events (8.4%), the registration details matched more than 1 and as many as 6 Open Payments events, suggesting sponsors may have hosted multiple events for the same product on the same date.Among those that had no matching Open Payments event (59 of 227 [26.0%]), 12 (5.3%)matched an Open Payments event reported for the previous or the next day, and 19 (8.4%) were sponsored by companies that were not covered entities or for products that were not covered by Medicare (eg, diagnostic or genetic tests).Table 4 provides illustrative examples of industry-sponsored events hosted by the NP associations that matched or did not match Open Payments events.
The events hosted by the 4 state-level NP associations also reflect a facet of larger promotional campaigns for the top 10 products based on the highest number of sponsored dinners in Open Payments.Of the 227 events hosted by the NP associations, 47 (20.7%) were sponsored by manufacturers of the top 10 products, including 35 events (15.4%) explicitly associated with 1 of the top 10 products and approved indications, or in 1 case, an indication currently under clinical trial.

Discussion
Our event-centric analysis of Open Payments data suggests that pharmaceutical and medical device companies are sponsoring a minimum of 3000 events a day for prescribing clinicians, suggesting that sponsored events are part of their national promotional campaigns targeted across professional groups.An event-centric analysis is a valid method to understand the nature and quantify the scope of manufacturer-sponsored events in the context of a product's promotional campaign.However, the true extent of the scope of all sponsored events targeted at prescribing clinicians is likely an underestimate given that our parameters for defining an event were conservative and because certain manufacturers and products are exempt from reporting requirements.1][22] An event-centric approach allows for a better understanding of the nature and impacts of prescriber-industry interactions in the social contexts in which they occur.
Future research could explore the impact of drug promotion on a professional group or clinical specialty, and the ways that promotion may variably target different groups.Detailed analyses of events for highly promoted drugs could also shed light on the breadth of industry promotional strategies, for example, by comparing the prevalence of events vs individual payments for consulting or advisory board membership associated with different products.Analyses of multiple years of data could also assess the timing of sponsored events in relation to key points in a drug's life cycle (eg, market access, Medicare reimbursement, and patent status).
The findings of this analysis suggest that there is a need for key policy actions that further expand and enforce Open Payments reporting requirements to achieve transparency goals.Among a sample of industry-sponsored dinner events hosted by state-level NP associations, we were only able to match approximately three-quarters of events to those in Open Payments.Many of the missing events were sponsored by manufacturers whose products were not covered by Medicare, such as genetic or diagnostic tests or products not yet on the market, and thus, were not eligible for inclusion in the Open Payments database.
Given the proven impacts on prescribing outcomes, commercial entities-regardless of their industry or product portfolio-should report the provision of payments, meals, and gifts to any registered health professional, including trainees, such as medical residents. 23Because dinner events were publicly advertised to prospective attendees through professional associations, it is likely that more informal coffee-and lunch-type events may be even more infrequently reported.However, previous analyses suggest that most sponsored events occur in clinical settings, 6 which suggests that health care facilities should have a greater role in ensuring transparency and/or regulating industrysponsored events.a Copied verbatim from the event's internet registration page.
b Upadacitinib, marketed by AbbVie, is currently under clinical trial for this indication. 18

Table 2 .
Audience Type (APRNs, Physicians, or Mixed/Both) and Spending on Events for the Top 10 Products Based on the Number of Sponsored Open Payments Dinners ($30 to <$150 per Person) in 2022 Abbreviation: APRNs, advanced practice registered nurses.

Table 3 .
Open Payments Events Typology Validated Against Sponsored Dinner Events Hosted by 4 State-Level NP Associations in 2022 Kentucky NP association reported events only for September to December 2022, so validation with Open Payments dataset was restricted to September 1 to December 31, 2022, for Kentucky.Match was defined as dinner events for APRN-only or mixed audiences with same date, sponsor, state, and product and/or therapeutic area.Either the sponsor (ie, applicable manufacturer making payment) or product was not a covered entity under the Open Payments reporting requirements.

Table 4 .
Illustrative Industry-Sponsored Dinner Events Hosted by 4 State-Level NP Associations in 2022 Abbreviations: APRNs, advanced practice registered nurse; BSN, Bachelor of Science in Nursing; FACP, fellow of the American College of Physicians; FACR, fellow of the American College of Radiology; MSN, Master of Science in Nursing; NP, nurse practitioner; NS, not specified; PA-C, physician assistant, certified; PhD, doctor of philosophy; PMHNP-BC, psychiatric mental health nurse practitioner-board certified; RN, registered nurse.