When randomized clinical trials (RCTs) focus on invasive cardiovascular interventions and include a separate editorial, that editorial is often written by someone with financial ties to one of the RCT's sponsors. This finding, published in JAMA: Internal Medicine, included another key detail: that financial connections were not disclosed to the public.
The researchers identified 79 RCTs involving coronary, vascular, and structural interventional cardiology and vascular and cardiac surgery procedures published from January 2013 to May 2019. A total of 82 editorials accompanied those trials, and they were written by a 143 authors in all. Fifty-two percent of the editorials were published in either The Lancet or The New England Journal of Medicine.
The authors defined financial associations as any reports of honoraria, consulting, research support, advisory, speaking fees, affiliation or employment. They reviewed various disclosure statements and forms for their research, turning to the CMS Open Payments database when necessary.
Overall, 56% of the commentaries had at least one author with a declared financial link within the industry. Twenty percent, meanwhile, had at least one author with a declared financial connection with a trial sponsor.
“The disclosed and undisclosed financial associations with trial sponsors for a substantial number of editorial commentaries on RCTs of invasive cardiovascular interventions are concerning, all the more so because of the attention focused on the issue since the 1990s,” wrote lead author Irbaz Hameed, MD, with the division of cardiac surgery at Yale School of Medicine, and colleagues. “Many of the authors with general payments or research funding reported on Open Payments did not disclose all of these financial associations in the commentary nor the accompanying disclosure forms.”
Hameed et al. also noted that some of these financial associations were not properly shared with the public.
"Many of the authors with general payments or research funding reported on Open Payments did not disclose all of these financial associations in the commentary nor the accompanying disclosure forms," they wrote.
This practice can "diminish the value of the commentaries," the authors added. They suggested that journal editors "strengthen their disclosure requirements, improve compliance, and consider once again whether they should allow authors to have such financial associations at all."
In an accompanying editorial, the study by Hameed et al. is viewed as a wake-up call for authors, readers and journal editors.
“Although improving compliance with disclosure requirements is necessary, focusing only on compliance is an insufficient response," wrote Robert Steinbrook, MD, of the department of internal medicine at Yale School of Medicine, and colleagues. "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."
Read the entire research letter here.