A new open-access study evaluates the reliability of self-disclosure as a method for identifying researchers’ financial conflicts of interest (COI) in leading US medical journals. The results of the cross-sectional investigation, which compares COI self-disclosures by researchers with public financial records of payments from producers of related medical goods, indicate serious inconsistencies in reported COIs.
The researchers, led by James H. Baraldi of the Department of Neuroscience at the University of Pittsburgh, emphasize the breadth of potential repercussions of conflicts of interest interference with medical research integrity, writing:
“Physician researchers who receive industry payments are more likely to demonstrate results favorable to the companies funding them; are more likely to prescribe drugs and use of medical devices produced by these companies…; and they may unduly influence other physicians by contributing to research that others use to guide their own clinical practice.”
“Industry payments to physicians, therefore, may bias healthcare providers’ delivery of evidence-based medicine and interfere with their responsibilities to their patients.”
Given these risks, conflicts of interest need to be reported transparently in disclosures that are accurate. While Baraldi and his colleagues indicate this is generally recognized throughout the medical research community, they also note that “COI disclosure opacity has persisted across a diversity of specialties, forms of compensation, and investigational products of clinical trials.”
In an attempt to combat this problem, the International Committee of Medical Journal Editors (ICMJE) created a document for reporting COIs. Researchers seeking publication by member journals must complete and submit the form. They are supposed to acknowledge any payments received from companies whose products relate to the subject of their work within the three years before publication.
Attempts to address COI disclosures have also come from outside the medical research community. Passed into law in 2010 as part of the ACA, the Physician Payment Sunshine Act requires producers of drugs and medical devices who receive reimbursements from federal health care plans (Medicare, Medicaid, or CHIP) to declare any payments they make physicians. These reports are submitted to the Centers for Medicare and Medicaid Services (CMS), which publicly release the data annually on their Open Payments website.
To determine the effectiveness of self-reporting for uncovering COIs, the authors of the new study assess disclosures made by medical researchers who published original research containing results of randomized clinical trials in the New England Journal of Medicine (NEJM) and the Journal of the American Medical Association (JAMA), both of which utilize the ICMJE form.
They judge the accuracy of the self-disclosures by comparing them against the reports from the companies paying them listed on Open Payments. The scope of this study was limited to articles published in 2017, as this was the first year in which sufficiently comprehensive records were released on Open Payments to perform a systematic analysis.
The researchers identified thirty-one publications in each journal that met their inclusion criteria, with 118 total researchers credited across all the articles, finding that “within their respective 36-month disclosure windows, the 118 authors received $7,476,049.87 in general payments combined.”
Analyzing the data in terms of COI disclosures, the authors of this study coded all payments into one of four categories. Payments self-reported by the medical researchers were labeled “disclosed.” For payments omitted from the self-reports, when coming from companies with products relevant to the given study, were labeled “undisclosed”; otherwise, they were classified as “unrelated.” If it was unclear whether the company offered related products at the time of the study, the payments were labeled “indeterminate.”
In terms of the overall distribution of payments, 0.4% were found to be indeterminate, 2.8% unrelated, 51.3% disclosed, and 45.6% undisclosed. Comparing the results across the sample of medical researchers, the authors of this study state, “Of the 118 authors, twelve (10.2%) received no payments. Of the 106 (89.8%) who did…86 of the[m] (81.1%) received undisclosed payments.”
Delineating the distribution of disclosures, they continue:
“Of the 106 authors who received payments, 55 made disclosures of which the disclosed companies reported dollar amounts that summed to at least half of the authors’ total payment amounts. Twenty had a three-year disclosure rate of 100%. … Of the 51 authors who disclosed less than half of their payment amounts[, 33] disclosed 0%, or no amount, of their payments received.”
Finding that almost half of the medical researchers’ payments were not reported to the journals publishing their works, the authors of this study conclude that the self-disclosure method is drastically ineffective for identifying potential conflicts of interest. They also note, with some surprise, the trends they uncovered held true for researchers across a wide range of compensation rates.
Additionally, they found the trends were highly similar in both the NEJM and JAMA, although the two journals differ procedurally in their handling of the self-disclosures. Given these findings:
“The authors of this study take no position on the physician-authors’ intentions in non-disclosure of their COIs; we characterize the issue as a ‘process problem’ rather than a ‘people problem,’ especially in light of the patterns observed in COI disclosure rates regardless of the journal’s disclosure process and regardless of payment amount.”
The authors’ overall conclusion is that requiring self-disclosure by medical researchers is an insufficient mechanism for identifying financial conflicts of interest that can bias their studies. While they do not propose any specific new plan for addressing this issue, they affirm the value of mandating companies provide public reports to the Open Payments website.
The institution of this legal requirement is the only reason they had access to the resources needed to perform this study in the first place. For the future, they hope ubiquitous reporting to Open Payments will bolster COI disclosure transparency, noting its impact may become stronger thanks to a new development:
“The SUPPORT Act has expanded the range of researchers whose data are collected by Open Payments. As of January 2021, physician assistants, clinical nurse specialists, certified nurse midwives, certified registered nurse anesthetists, and anesthesiologist assistants have entries on the Open Payments website.”
Ideally, then, as payments received by more members of the medical research community become matters of public record, it will become easier to recognize when these constitute financial conflicts of interest and thus to identify potentially biased publications.
Baraldi, J.H., Picozzo, S.A., Arnold, J.C., Volarich, K., Gionfriddo, M.R., & Piper, B.J. (2022). A cross-sectional examination of conflict-of-interest disclosures of physician-authors publishing in high-impact US medical journals [Unpublished manuscript]. medRxiv. https://doi.org/10.1101/2021.09.12.21263468 (Link)