In a new article published in the International Journal of Health Policy and Management, Piotr Ozieranski and colleagues explore drug company payments for research and development (R&D) in Europe. In most countries studied, a self-regulatory, industry-designed approach led to non-uniform reporting of payments, with companies left to decide which payments to report as R&D. This system leaves researchers unable to trace funds from the pharmaceuticals industry to other organizations.
The lack of oversight and reliance on self-reporting of R&D funds makes exploring any conflicts of interest (COI) that may arise from these payments impossible. The current research recommends a uniform reporting system and a central, publicly searchable database that matches industry payments to recipients.
“The lack of full disclosure of R&D payments in countries with industry self-regulation leaves considerable sums of money unaccounted for and potentially many COIs undetected,” the researchers write. “Disclosure mandated by legislation exists in few countries and rarely enhances transparency practically. We recommend a unified European approach to R&D payment disclosure, including clear definitions and a centralized database.”
The pharmaceutical industry has often been accused of creating conflicts of interest in medicine and research. Pharmaceutical industry payments to physicians influence prescribing decisions, with doctors more likely to prescribe the drugs of companies that have offered them compensation. In the United States, these payments lead to increased medicare expenditures.
Sponsorship bias is common in clinical trials, meaning researchers are more likely to reach conclusions favorable for their sponsors. When such trials are included in meta-analyses, they corrupt a new generation of researchers with biased data.
Industry funding has also likely corrupted medical education. For example, researchers have found that industry-funded training encourages physicians to prescribe more opiates without considering the consequences. Similarly, research has found medical education around binge eating disorders includes biased drug promotion.
Conflicts of interest in academic journals have also become a problem for many researchers. Editors of major journals commonly allow authors with clear COIs to write opinion pieces, thereby undermining their credibility. Undisclosed COIs, where a researcher accepts payment from the industry without reporting it, are common in medical research. Psychiatrists disclose fewer COIs than other medical researchers, with psychiatric journals being far less likely to disclose COIs than their general medicine counterparts.
Beyond simply corrupting research, researchers, medical education, and medical journals with financial payments, the pharmaceutical industry has also set up an entire “ghost management” system in which they decide what research gets funded and published. The pharmaceutical industry’s influence over healthcare likely harms patients.
The current research explains that R&D is a large part of bringing new drugs to market. Many drug companies outsource their R&D to other organizations in the modern age. These payments to other research organizations could create COIs.
To detect and avoid COIs, many countries have a system of reporting these payments that require the industry to name precisely where payments go. However, the current model in European countries does not require uniform reporting and leaves many decisions of what to report up to the pharmaceutical companies making the payments. This means COIs are many times impossible to trace.
In 32 of 37 countries analyzed, R&D payments are tracked using an industry-developed self-reporting system in which the company making a payment for R&D does not have to name the recipient. Based on an analysis of UK company methods, the authors conclude that pharmaceutical companies have a great deal of leeway in deciding what payments count as R&D.
In five of the countries analyzed, pharmaceutical companies were required to name the recipients of their R&D payments. However, only two of the five countries with these requirements stored the data in an identifiable and analyzable way. This means in most countries analyzed (35 of 37), the reporting of these payments cannot be scrutinized by researchers.
The amount and number of payments made by pharmaceutical companies for R&D varied wildly from country to country, with R&D payments making up between 19-82% of all payments. However, in countries with self-regulation practices related to payment reporting, R&D made up a significantly larger percentage of overall payments. In other words, when companies are left to decide which payments count as R&D and which do not, they are much more likely to decide in favor of R&D, which comes with fewer regulatory requirements.
The authors conclude that with the industry allowed to determine what counts as R&D and the reporting of these payments happening in a non-uniform way, significant sums of money are entirely unaccounted for. Many of the countries that have mandated the reporting of these payments have done so in such a way as not to increase transparency. This results in COIs likely going undetected.
The authors recommend that Europe adopt a uniform reporting system in which R&D payments have to be made to named recipients and stored in a publicly accessible and searchable database. These steps alone will likely not stop COIs, but they will make them more apparent. The authors conclude:
“The public interest in full transparency of R&D payments over demands for protecting commercial secrecy can be most effectively secured via a new EU regulation or directive mandating disclosure using clear definitions of research activities and payment types. The payments should be disclosed in a centralized database with an accessible interface, allowing for integration with existing and planned EU databases, via funder, recipient, and activity (e.g., clinical trial) identifiers.”
Ozieranski, P., Martinon, L., Jachiet, P. A., & Mulinari, S. (2022). Tip of the Iceberg? Country- and Company-Level Analysis of Drug Company Payments for Research and Development in Europe. International Journal of Health Policy and Management. https://doi.org/10.34172/ijhpm.2022.6575 (Link)