Authors commenting on RCTs of invasive cardiovascular interventions often have financial conflicts

Reuters Health - 16/08/2021 - Over a six-and-a-half year period, nearly one in six authors of commentaries on randomized controlled trials of invasive cardiovascular interventions reported financial associations with trial sponsors, a new study finds.

The analysis of 82 editorial commentaries accompanying 79 trials found that 46 commentaries (56%) had at least one author with a declared financial association with the trial sponsor. And many authors had undisclosed general payments or research funding from industry during the year of publication or the prior two calendar years, the study team reports in JAMA Internal Medicine.

"The take-home from this study is that commentators on these randomized controlled clinical trials were not always forthcoming about their conflicts of interest," said senior author Dr. Arnar Geirsson, a professor of surgery and chief of cardiac surgery at the Yale University School of Medicine in New Haven, Connecticut. "It's important to know about these conflicts. It's certainly important for the advancement of medicine."

The danger is the possibility of biased interpretation of the data from the trials, said the study's first author, Dr. Irbaz Hameed, a resident physician in the Yale University School of Medicine cardiothoracic training program.

"Unfortunately, the results of clinical trials can easily be misinterpreted," Dr. Hameed said. "In fact, we recently found in another study that this occurs in over 60% of cardiovascular trials. This can become particularly dangerous when done by influential commentators with financial interests."

To take a closer look at the issue, Dr. Geirsson and his colleagues identified randomized controlled trials (RCTs) involving coronary, vascular and structural interventional cardiology as well as vascular and cardiac surgery procedures that were published between January 1, 2013 and May 31, 2019.

For each commentary accompanying a RCT, the researchers recorded the declared associations of all the authors, including links with the trial sponsors. They obtained that information from the disclosure statements in the articles or the accompanying International Committee of Medical Journal Editors online disclosure forms.

The researchers defined a financial association with a trial sponsor as any report of honoraria, consulting, research support, advisory, speaking fees, affiliation or employment. The researchers also obtained information from the Centers for Medicare and Medicaid Open Payments database.

In the Open Payments database, "Companies are required to disclose what they pay to physicians or anyone in the medical field," Dr. Geirsson explained. "If a company takes a physician out to dinner it is required to disclose the name of the physician and what the dinner cost."

The researchers defined undisclosed associations with industry as payments to an author reported on Open Payments but not disclosed with the commentary, nor in the accompanying disclosure forms.

The researchers identified 82 editorial commentaries accompanying 79 trials during the study period; of these, 43 (52%) commentaries were published in The Lancet or The New England Journal of Medicine. Thirty-three commentaries (40%) had one author and 49 (60%) had at least two authors, for a total of 143 authors.

Forty-six commentaries (56%) had at least one author with a declared financial association with industry, 16 (20%) had at least one author with a declared financial association with the trial sponsor, and 39 (48%) had at least one author with a record in Open Payments.

Of the commentary authors, 21 (15%) declared at least one financial association with the sponsor of the trial discussed in the commentary, 9 (6%) declared more than one financial association with the trial sponsor, and 48 (34%) had Open Payments records.

Of the 48 authors with Open Payments records, 15 (31%) received general payments or research funding from trial sponsors during the year of publication or the prior two calendar years. Moreover, 43 (90%) of these authors received general payments, and 25 (52%) received research funding, from industry during the year of publication or the prior two calendar years that were not disclosed with the article.

The new study is "troubling" and important because the findings from studies "are not always clear cut, leaving substantial room for interpretation and communication of the study's findings," said Dr. Peter Muennig, a professor of health policy and management at the Columbia University Mailman School of Public Health in New York City. "For example, a study can show that a drug or device produces some improvement in outcome, but is otherwise expensive or potentially even harmful to patients."

"Financial incentives can nudge even the best scientists to emphasize the upside or overlook the downsides of medical interventions," Dr. Muennig said in an email. "Doctors and providers do not have a good deal of statistical training or research training, and must rely heavily on commentaries to help them decide how to treat patients."

"We should not see any commentaries by authors with financial ties to industry," Dr. Muennig said.

Knowing whether conflict of interest had improper influence on commentary authors is difficult if not impossible, said Dr. Joseph Carrese, a professor of medicine and core faculty at the Johns Hopkins Berman Institute of Bioethics at Johns Hopkins University in Baltimore.

In the end, the issue isn't just an issue of an appearance of conflict of interest (COI), Dr. Carrese said in an email. "The 'illusion of unique invulnerability' in this context is the view that others will be influenced by COI, 'but not me,'" he added. "But the data say otherwise: no one is invulnerable. The 2009 IOM report on COI is replete with examples of COI transgressions."

Dr. Carrese agrees that the best policy is to not allow anyone with a COI to write a commentary "even if that means forgoing the most prominent experts in the field; given the very deep bench nationally in every area of medicine with respect to expertise and knowledge, this approach would seem to have very little downside."

SOURCE: https://bit.ly/3yRxXrR and https://bit.ly/3D2P2Se JAMA Internal Medicine, online August 16, 2021.

By Linda Carroll



Posted on 16 August 202124 August 2021