14 Apr High Rates of Financial Conflict-of-Interest Non-Disclosure in High-Impact US Medical Journals
MedicalResearch.com Interview with:
James H. Baraldi
University of Pittsburgh
MedicalResearch.com: What is the background for this study?
Response: Researchers investigating pharmaceuticals and medical devices in randomized controlled trials (RCTs) often receive payments from the manufacturers of these investigational products. In many cases these payments are not dedicated to the express purpose of research, but rather consist of consulting fees and compensation for travel and lodging and food and beverage. As part of the 2010 Affordable Care Act, the US government passed the Physician Payment Sunshine Act to increase transparency of this type of funding. The law required manufacturers reimbursed by Medicare, Medicaid, or the Children’s Health Insurance Program to disclose to the Centers for Medicare and Medicaid Services information regarding investigator payments. This information became freely and publicly available on the Open Payments website with the earliest data from 2013. Not only have the pharmaceutical and medical device manufacturers disclosed the investigators’ payment information, but the investigators themselves have had to do so in accordance with the requirements of the journals in which they publish their findings or in accordance with the requirements of the International Committee of Medical Journal Editors (ICMJE).
The objective of this study1 was to find out how accurate these self-reported disclosures were for physician-authors publishing the results of RCT’s in the two highest-impact general medical journals of the United States, the New England Journal of Medicine and the Journal of the American Medical Association. What were the physician-authors’ disclosure rates? How much did they receive in industry payments that they disclosed and that they did not disclose? This study is the first effort at a systematic evaluation of financial COI disclosures in these two journals over the requisite 36-month period prior to article publication. The study compares self-disclosures with industry-reported disclosures in the earliest 36-month period following the inception of Open Payments.
MedicalResearch.com: What are the main findings?
Response: One hundred eighteen physician-authors met inclusion criteria as authors of 31 articles per journal for a total of 62 articles. The physician-authors received a combined total of $7.48 million in industry payments not dedicated specifically for research; we and Open Payments called these “general payments.” One hundred six of the 118 (89.8%) received payments, so this $7.48 million was divided amongst 106 individuals. Of these 106, 86 (81.1%) received undisclosed payments. There was a lot of variation in the amount that the individual physician-authors received, ranging from a minimum of $6.36 for one individual to a maximum of $1.49 million for the most highly paid physician-author. Looking more closely at the distribution, we found 23 statistical outliers, defined as upper-end earners, not those with low or no amounts. The total amount of money that the outliers as a group received in general payments was $6.32 million or 84.5% of all of the money received by the entire group of 106. There were similar payment distributions by journal, and there were no statistically significant differences in how much was disclosed versus undisclosed between the two journals. Fifty-five of the 106 physician-authors (51.9%) made disclosures that amounted to at least half of the total payment amounts that they had received according to the companies’ reporting to Open Payments. Twenty of these individuals actually did disclose 100% of their payments. Fifty-one individuals out of the 106 (48.1%) disclosed less than half of their payment amounts; 33 of these authors disclosed 0% of the payments that they received. Finally, 101 of the 118 physician-authors (85.6%) were males, and the remaining seventeen (14.4%) were females.
MedicalResearch.com: What should readers take away from your report?
Response: There is a disconnect between self-reported and industry-reported disclosure of industry payments to physician-authors of RCT results. This is concerning because these payments may comprise conflicts of interest that may bias the study results. The combination of mandated reporting by industry to Open Payments with self-reporting rules, such as those of the ICMJE, does not appear adequate to address this disconnect and, therefore, the bias that may be inherent in the research publications in question.
MedicalResearch.com: Is there anything else you would like to add?
Response: This study examined financial COIs, not possible intellectual or emotional explanations for why research publications might be biased. Financial COIs are relatively easily quantifiable, although the process of determining precisely what constitutes a financial COI might not be so straightforward. In addition to “disclosed” and “undisclosed,” we had two other categories that we assessed: “indeterminate” and “unrelated,” in both of which the relevant payment amounts were very small compared to the first two categories. Factors contributing to an inability to identify a financial COI included a physician-author’s identification of a subsidiary rather than parent company, or vice versa, and a researcher studying type I diabetes while the industry payments came from a company that sponsors type II diabetes research. Additionally, we did perform subgroup and sensitivity analyses that did not make it into the final report due to a possible lack of statistical power, although they are in the publicly available preprint.2 From these data we found, tentatively, that there was no difference in COI disclosure rate in terms of payment amount. The possible implication is that targeting for correction those who earned the highest amounts would not address the fundamental issue of financial COI non-disclosure. This question would be interesting to pursue in the future. So would the financial COI disclosure landscape of mid-level healthcare providers, whose data have become available from January 2021 following implementation of the SUPPORT Act.
- Baraldi JH, et al. Cross-sectional examination of conflict-of-interest disclosures of physician-authors publishing in high-impact US medical journals. BMJ Open 2022, https://bmjopen.bmj.com/content/12/4/e057598.
- Baraldi JH, et al. A cross-sectional examination of conflict-of-interest disclosures of physician-authors publishing in high-impact US medical journals. MedRxiv 2022; https://www.medrxiv.org/content/10.1101/2021.09.12.21263468v2
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