SAN ANTONIO — There is a prevalence of conflicts of interest (COIs) and lack of transparency of reporting COIs in gastroenterology guideline authors, according to findings presented at the American College of Gastroenterology 2019 Annual Scientific Meeting, held October 25 to 30 in San Antonio, Texas.

The common practice of industry payments to physicians presents an ever-growing problem of COI, which may influence clinical decision-making, creating bias, such as what drugs physicians prescribe, increased prescribing of biologics as an entity over conventional therapies, and pushing for positive findings. Furthermore, irrespective of physicians’ ability to separate their financial conflicts from their treatment recommendations, payments from for-profit initiatives may prompt a lack of trust from patients and the general public. Physicians who receive considerable payments are often opinion leaders,1 and their expertise is valued not only by industry but also by committees that draft clinical guidelines. These financial COIs are not exclusive to gastroenterology, as this issue is virtually universal across various fields of medicine; nevertheless, elucidating the issue through the lens of this specialty may provide an instructive case study.

Accordingly, Shah and colleagues conducted several studies that sought to understand and characterize the prevalence of COIs and transparency of reporting COIs among authors of gastroenterology guidelines, using The Sunshine Act of the Centers for Medicare & Medicaid Services Open Payment Database (Sunshine database) for comparison.2,3,4

Guidelines and reporting habits of guideline authors using GRADE methodology from the American Association for the Study of Liver Disease, American College of Gastroenterology, American Gastroenterology Association, and American Society of Gastrointestinal Endoscopy societies from 2013 to October 15, 2018, were analyzed.2,3,4

The Sunshine database is a congressionally mandated program meant to track and increase the reporting of payments from drug and device manufacturers to physicians. Although it is the largest and most reliable source of such data, there is a clear discordance between COIs reported in the Sunshine database and those self-reported by authors in medical journals. Moreover, medical journals often establish individual standards for COI disclosure, and some journals may not require disclosure of conflicts considered irrelevant to the presented topic, even if they are listed in the Sunshine database. However, this discrepancy in reporting can lead to questions of bias, intended or unintended, and a lack of transparency surrounding COIs.

In one study, Shah and colleagues delineated the financial relationships between industry and guideline authors in gastroenterology, using the Sunshine database.2 The researchers searched the Sunshine database for each author the year the guideline was published and the year before the publication date, when available. Only general payments were examined. Authors who published many guidelines in the same year were only counted once when calculating general payments.

A total of 562 authors were included, 249 of whom were found on the open payment website with available data: 95.5% of authors received general payments at the time of their publication, and 44.3% of authors received general payments in the period evaluated by the study.2 Collectively, the total sum of general payments for all authors was approximately $5,775,403, and the average payment per author was $24,266.2 Roughly 75% of authors received a payment over the amount of $500.2

In a second study, Shah et al reviewed each guideline to determine whether COI information was provided and any lack of transparency of COI among guideline authors.3 They investigated COI disclosure statements for each author on all guidelines, regardless of the presence of a COI. In addition, they characterized conflicts as “research/academic funding” (not directly paid to the individual) or “other.” The “other” classification comprised disclosures such as speaker’s bureau, advisory board, honoraria, consulting, stocks, nonresearch funding, and industry-sponsored continuing medical education activities. Funding from nonprofit organizations or government was excluded.

Seventy-eight gastroenterology guidelines published between 2013 and 2018 were reviewed. Of these, 11 did not inform, or only vaguely informed, readers about COI; 10 provided general statements about COI without details informing the reader whether they were present or not; and 1 guideline did not report COI.3

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When COI was examined at the level of individual authors, 823 were identified across the 78 guidelines, and approximately 25% of these gastroenterology guideline authors self-reported having potential conflicts.3,4 Further, 510 (61.9%) of them were identified on review on the Sunshine database; the remaining authors were not found on the database.4 However, 338 (66.2%) did not disclose any COI.4 Of these 338 authors, 325 (96.1%) and 220 (65%) received general payments in the same year the guideline was published and the year before, respectively.4 As a result of the self-reporting nature of these data, underreporting may inflate this issue.

Limitations of the study included that the Sunshine database does not include information regarding the frequency, duration, or content of consultative interactions. Therefore, the researchers could not assess the value of these interactions beyond the literal value in dollars.

Clinical guidelines exert a significant effect on prescribing patterns, and thus it can be concerning that physicians with financial COIs may be writing them. Shah et al concluded that there is a discordance between guideline self-disclosures and the Sunshine database. Approximately two-thirds of all guideline authors who reported payments on the Sunshine database do not seem to report COIs on the guideline they published during the same period. However, completely eliminating these physicians from such processes may result in the exclusion of experts who provide valuable insight.

As a consequence, it is imperative that medical societies and healthcare organizations create well-defined processes to mitigate external influences in the guideline development process so that healthcare development and delivery remain transparent and unbiased. Future research should investigate how improved transparency of potential COI affects authors and presenters, as well as their respective target audiences.

References

1. Rebala P, Wilson C. How much money does your doctor get from medical companies? TIME. https://time.com/3453649/doctors-drug-company-search-tool/. Published October 2, 2014. Accessed October 25, 2019.

2. Shah R, Numan L, Chandar AK, et al. Financial relationships of gastroenterology guideline authors: analysis of Sunshine Act CMS Open Payments Database. Presented at: American College of Gastroenterology (ACG) 2019 Annual Scientific Meeting; October 25-30, 2019; San Antonio, TX. Poster P0772.

3. Shah R, Numan L, Chandar AK, et al. Conflict of interest in gastroenterology guidelines: a lack of transparency. Presented at: American College of Gastroenterology (ACG) 2019 Annual Scientific Meeting; October 25-30, 2019; San Antonio, TX. Poster P0773.

4. Shah R, Numan L, Chandar AK, et al. Discordance between self-reported COI and CMS Open Payment Database among gastroenterology guideline authors. Presented at: American College of Gastroenterology (ACG) 2019 Annual Scientific Meeting; October 25-30, 2019; San Antonio, TX. Poster P0774.