An investigation published in the European Journal of Radiology (EJR) on 17 August looks set to focus attention on the payments made to medical doctors by device manufacturers.
"Medical professionals should continuously and critically examine and address the influence of financial relationships with industry to ensure the highest standard of evidence-based care, protect professional integrity, and maintain public trust in the specialty," noted a team led by Dr. Satoru Yanagaki, PhD, of the Department of Diagnostic Radiology at Tohoku Medical Pharmaceutical University Hospital, Sendai, Japan.
In the EJR article, Yanagaki and colleagues studied the payments made to medical providers in Japan by companies selling intravascular embolization devices. They found that payments reached a peak in 2019 before dropping sharply in 2020 and then increasing steadily each year since then. Also, they found that the voluntary payment disclosures made by the companies were not consistently transparent or accessible.
The total amount of each device company's declared payments and the breakdown of the payments into items by year (2019-2023).Courtesy of Dr. Satoru Yanagaki et al and the EJR.
In the evaluation, the researchers evaluated the payments disclosed by 18 companies selling intravascular embolization devices to medical institutions and providers. They reviewed publicly disclosed payment data from all companies manufacturing and marketing vascular embolization devices approved by the Pharmaceuticals and Medical Devices Agency (PMDA).
The payment amounts were stratified according to the following categories defined in the country's transparency guidelines: research and development expenses, academic research grants, manuscript writing and lecturer fees, information provision-related expenses, and other expenses.
Additionally, they evaluated the disclosures themselves, assessing them for both accessibility and quality of payment information. They used five metrics for accessibility: database format, database structure, database searchability, customizable summary statistics, and downloadability.
For payment information quality, they used the following five metrics: spectrum of disclosed characteristics (i.e., characteristics of donors, recipients, and payments), aggregation of payments (e.g., were the payments itemized or aggregated?), inclusion of taxes, unique identifiers, and year limit (i.e., if disclosures were only available for a limited time period).
Payments from the companies peaked in 2019, totaling €169.1 million, or €12 million per company. They were lowest in 2020 during the height of the COVID-19 pandemic (€8.37 million per company). They increased annually thereafter, reaching €9.7 million in 2023.
For the accessibility metrics of the disclosures, over half scored high for database structure; however, all of the companies had low scores for customizable summary statistics and downloadability. The company disclosures fared better on the quality of payment information: More than half received high scores for four measures. However, all companies received low scores on the “unique identifiers” metric.
Are tighter controls needed?
The authors noted that many medical doctors in Japan oppose regulatory restrictions on such industry payments because they do not believe that such financial relationships have an influence on clinical decision-making. Furthermore, the collaborative nature of the relationship between manufacturers of interventional devices and healthcare providers is beneficial and "not invariably prone to unethical practices or corruption," according to Yanagaki and colleagues.
However, the team also wrote that studies in other countries have shown that industry payments can and do create conflicts of interest, and “even modest payments, such as industry-sponsored meals, increase the prescriptions of the drug promoted by the company.” This has been an ongoing issue of concern in Japan, as shown by a May 2024 study about bribery in Japan's medical device sector.
Overall, the analysis highlighted gaps in both full transparency (in the quality of information given) and accessibility of that information, suggesting a need for standardized reporting requirements, the authors concluded.
Read the full EJR article here.
