Endoscopy-Guideline Authors Often Fail to Report Conflicts of Interest

By Will Boggs MD

December 27, 2019

NEW YORK (Reuters Health) - More than three-quarters of recent endoscopy guidelines fail to disclose some payments to authors from drug and medical-device manufacturers, a new analysis discovered.

The findings "highlight the need for increased transparency of reporting by members of guideline committees in endoscopy, a field characterized by greater conflict of interest due to the use of expensive and modern devices and drugs," Dr. Samir C. Grover of St. Michael's Hospital, University of Toronto, Canada, said in an email. "Moreover, they underscore the need for sponsoring societies to fastidiously identify conflicts of interest among potential candidates for guideline committees a priori and make their selection based on that information."

In 2016, pharmaceutical and medical device industries spent an estimated $29.9 billion on marketing, including an estimated $991.9 million in direct payments to physicians. Several studies have identified high levels of undeclared and relevant financial conflicts of interest (FCOI) among guideline-panel members, but this had not yet been studied in endoscopy.

Dr. Grover's team used data from the Center for Medicare and Medicaid Services Open Payments (CMS-OP) database, which includes industry payments to U.S. physicians, to examine industry payments to authors of 37 clinical-practice guidelines in gastrointestinal endoscopy published between 2014 and 2017.

These guidelines included 91 unique authors and 569 contributions to an article, with a median of two contributions per author. The researchers found CMS-OP profiles for 468 of these contribution episodes.

Overall, according to the disclosure section of the guidelines and CMS-OP, 451 episodes (79%) involved FCOI, 445 of which were relevant to the particular guideline.

There were additional payments in CMS-OP beyond what was disclosed in guidelines for 451 episodes (79%), and authors did not fully disclose relevant FCOI in 445 episodes (77%), the researchers reported in Gastrointestinal Endoscopy.

The median total FCOI for episodes with available data was $6207 (interquartile range, $505-$56,044), the median total undisclosed FCOI was $4807 (IQR, $335-$20,580), and the median total undisclosed and relevant FCOI was $484 (IQR, $0-$5372).

The odds of having undeclared payments were 2.23-fold higher among male authors (versus females) and 8.87-fold higher among authors affiliated with an academic hospital (versus those with nonacademic affiliations).

The researchers also examined the data from the perspective of National Academy of Medicine standards for clinical-practice guidelines.

Most guidelines (63%) did not adhere to the standard of appointing a chair with no FCOI, 65% did not meet the standard of limiting authors with FCOI to <50% of the committee, and no guideline met the standard of having full written disclosure of all potential FCOI.

"We believe that the societies responsible for creating guidelines act in good faith and ensure that recommendations are evidence-based," Dr. Grover said. "However, we know that there is an association between conflicts of interest and potential bias, though no study has directly measured the direct impact of FCOI on decision making."

"Our authorship believes that further efforts should be taken to make the reporting of all conflicts of interest more transparent and clear in future guidelines so that readers are well apprised of any competing interests," he said. "This may include having sponsoring societies themselves use databases such as the Open Payments database to collect information on payments made to guideline authors prior to publication of those guidelines."

"Recent studies have identified similar results across multiple disciplines, including otolaryngology, dermatology, oncology, orthopedic surgery, and ophthalmology," Dr. Grover said. "That said, we also emphasize that these relationships are not inherently detrimental, and in many cases, can be fruitful for the development of new drugs and devices. What is of concern is the possibility that these relationships could impact the trust placed in guidelines if they are not properly disclosed."

SOURCE: https://bit.ly/2QZQT4q Gastrointestinal Endoscopy, online November 15, 2019.

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