August 25, 2021
2 min read
Geirsson reports receiving consultant fees as a member of the Medtronic Strategic Surgical Advisory Board. Hameed, the other study authors and the editorial authors report no relevant financial disclosures.
Fifteen percent of editorial commentary authors whose work accompanied randomized controlled trials on invasive CV interventions reported financial associations with trial sponsors, while many did not disclose all of their associations.
Study authors Irbaz Hameed, MD, resident at Yale School of Medicine, and Arnar Geirsson, MD, chief of the division of cardiac surgery at Yale, told Healio that their group had previously analyzed different facets of the quality and methodology of randomized controlled trials in CV medicine and surgery, which revealed significant deficiencies in trial methodology, misinterpretation of trial data and unwanted associations between trial authors and industry sponsors.
“We, consequently, sought to investigate a step further and interrogate the financial associations of ‘experts’ who are invited to comment on published trials as part of journal editorial policy,” they said in an interview. “We hypothesized that the views expressed in these editorials could be biased by declared and undeclared conflicts of interest of their authors.”
Hameed, Geirsson and colleagues used a comprehensive search strategy to identify randomized controlled trials involving coronary, vascular and structural interventional cardiology, and vascular and cardiac surgery procedures published between January 2013 and May 2019. They obtained financial associations via disclosure statements in the articles or accompanying International Committee of Medical Journal Editors online disclosure forms. They acquired additional data from the CMS Open Payments database.
Researchers defined undisclosed financial associations with industry as payments to an author reported on Open Payments but not disclosed in the commentary or the accompanying disclosure forms.
Financial associations prevalent
Overall, the final analysis included 82 editorial commentaries accompanying 79 trials.
Data revealed that 52% of the commentaries were published in The Lancet or The New England Journal of Medicine. Forty percent of commentaries had one author and 60% had two or more, totaling a sample size of 143 authors.
According to the findings, 56% of commentaries had at least one author with a declared financial association with industry, while 20% had at least one author with a declared financial association with the trial sponsor and 48% had at least one author with an Open Payments record.
In addition, 15% of commentary authors reported one financial association with the trial sponsor discussed in their commentary; 6% declared more than one financial association with the trial sponsor; and 34% had Open Payments records.
Among those with Open Payment records, 31% received general payments or research funding from trial sponsors during the year of publication or the prior two calendar years, while 90% received general payments and 52% received research funding from industry during the publication year or the prior two calendar years that were not disclosed with the article.
“The magnitude of these [financial] associations is much worse than we initially hypothesized, and they jeopardize the value of views expressed in these expert commentaries,” Hameed and Geirsson told Healio. “Medical journals are relied on as trusted source of medical information. As the financial associations of authors diminish the value of their work, journal editors of medical journals should strengthen their disclosure requirements, improve compliance and consider once again whether they should allow authors to have such financial associations at all.”
The question of disqualification
In an accompanying editorial, Robert Steinbrook, MD, adjunct professor of internal medicine at the Yale School of Medicine and editor-at-large at JAMA Internal Medicine, and colleagues wrote the study was a wake-up call for authors, readers and journal editors, stating that while improving compliance with disclosure requirements is necessary, focusing only on compliance is an insufficient response.
“Journals should consider once again whether authors of commentaries should be allowed to have any financial associations with trial sponsors (or their competitors) at all,” Steinbrook and colleagues wrote. “Disqualifying more potential authors from writing commentaries because of their financial associations will mean saying no more frequently to colleagues and influential and accomplished researchers, some of whom will have leadership roles in academic medicine. Disqualifying potential editorialists, however, is sometimes the right thing to do.”