Undisclosed Financial Associations with Trial Sponsor Linked to Cardiology Commentary Authors

Arnar Geirsson, MD

Although editorial commentary assists in the interpretation of studies, the value that is provided may be diminished when authors have a relevant financial association.

A recent cross-sectional study explored financial associations of commentary authors on randomized clinical trials (RCTs) of invasive cardiovascular interventions and trial sponsors and if they were disclosed.

Investigators, led by Arnar Geirsson, MD, Division of Cardiac Surgery, Yale School of Medicine, observed 15% of targeted authors in this analysis reported financial associations with trial sponsors, with many of the authors not disclosing all of the financial associations with proper documentation.

Study

Investigators performed a comprehensive search to identify RCTs involving coronary, vascular, and structural interventional cardiology, as well as vascular and cardiac surgery procedures published between January 2013 - May 2019.

In the data search, the team marked the trial sponsor, publication year, and journal as well as identifying accompanying commentary.

They recorded the declarations of all financial associations of all authors, including authors with trial sponsors, obtained through either disclosure statements or an accompanying International Committee of Medical Journal editors online disclosure form.

Financial associations were defined as any report of honoraria, consulting, research support, advisory, speaking fees, affiliation, or employment.

In addition, investigators collected data from the Centers for Medicare & Medicaid Services’ Open Payments database. Any undisclosed financial association with the industry was defined as payment to the author reported on Open Payments, but was not disclosed otherwise.

Results

Investigators identified a total of 82 editorial commentaries accompanying 79 trials. They noted 43 studies (52%) were published in either The Lancet or the New England Journal of Medicine.

Within the total, 143 authors were identified, with 40% of studies including 1 author and 60% of studies including ≥2 authors.

The team observed 46 commentaries (56%) had ≥1 author with a declared financial association with the industry, 16 commentaries (20%) had ≥1 author with a declared financial association with the trial sponsor, and 39 (48%) had ≥1 author with a record in Open Payments.

Further, 21 commentary authors (15%) declared ≥1 financial association with the sponsor discussed in the commentary, 9 authors (6%) declared >1 financial association with the trial sponsor, and 48 authors (34%) had records in Open Payments.

The team noted of those 48 authors, 15 (31%) received general payments or research funding from trial sponsors during the year of publication or prior 2 calendar years.

They also noted 43 (90%) and 25 (52%) of the 48 authors received general payments or research funding from industry, respectively, that were not disclosed.

Conclusion

Investigators noted their concern with both disclosed and undisclosed financial associations with trial sponsors on RCTs involving invasive cardiovascular interventions.

“As the financial associations of authors diminish the value of the commentaries, journal editors should strengthen their disclosure requirements, improve compliance, and consider once again whether they should allow authors to have such financial associations at all,” investigators wrote.

The research letter, “Financial Associations Between Authors of Commentaries on Randomized Clinical Trials of Invasive Cardiovascular Interventions and Trial Sponsors,” was published online by JAMA Internal Medicine.