ASCO: ‘Substantial discordance’ in financial disclosures highlights need for ‘harmonized’ approach
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ASCO identified significant discordance between company-reported and self-disclosed financial relationships among authors of clinical oncology research studies, according to study results published in Journal of Clinical Oncology.
The low concordance may be due in part to differences between ASCO disclosure requirements for manuscripts and abstracts and Open Payments reporting requirements for pharmaceutical companies.
“ASCO believes disclosure of relationships with companies is critical to maintaining both professional and public trust and has extensive policies that require authors and presenters to disclose relationships with industry,” Clifford A. Hudis, MD, FACP, FASCO, CEO of ASCO, told Healio. “Today, physicians must disclose to a wide range of publications, meetings and organizations all with differing disclosure requirements and criteria, increasing the likelihood of inaccuracies and inconsistencies.”
Hudis and colleagues sought to identify sources of discrepancies and inform recommendations on ways to improve transparency in financial disclosures by comparing disclosures reported to ASCO with transactions in the Open Payments database. The Open Payments program gathers and publishes data on financial relationships between the health care industry and providers.
The investigators matched financial disclosures reported by 163 authors of studies published in Journal of Clinical Oncology and presenters at the 2018 ASCO Annual Meeting with Open Payments data. Overall, 148 physicians had at least one disclosure to ASCO or transaction in Open Payments, which corresponded to an average of 7.5 disclosures to ASCO vs. 8.6 in Open Payments.
Financial disclosure categories included ownership, research, consulting/services, honoraria, expenses, royalty/patent/intellectual property and other disclosures. Researchers calculated measures of concordance and discordance based on matches on both company and category of disclosure and matches on company.
Results showed overall concordance between disclosures reported to ASCO and Open Payments data of 16% for company and category matching and 24% for matching on the basis of company only.
A mean 37% of disclosures reported to ASCO were not reported to Open Payments, whereas a mean 47% of payments reported to Open Payments were not reported to ASCO.
In addition, 35 authors/presenters disclosed ownership, including stock, to ASCO; however, no payments were categorized as ownership in Open Payments.
“Our paper highlights why we need a single, standard, harmonized approach to disclosure,” Hudis told Healio. “The substantial discordance between disclosures to ASCO and to Open Payments confirms the need for consistent, simpler conflict disclosure systems in medicine.”
More work is needed to facilitate disclosure in accordance with ASCO’s policies, Hudis added.
“Until then, it is a reminder for everyone in medicine to approach disclosure rigorously,” he said. “Our findings also demonstrate that Open Payments should not be considered a comprehensive database and should not be used as the sole basis for comparison when examining disclosures. We may take on additional research in the future, but ASCO’s focus right now is working with leaders in the medical community to standardize disclosure requirements across the field, to make compliance simpler for authors and decrease the likelihood of unintended errors in disclosure.” – by Jennifer Southall
For more information:
Clifford A. Hudis, MD, FACP, FASCO, can be reached at American Society for Clinical Oncology, 2318 Mill Road, Suite 800, Alexandria, VA 22314.
Disclosures: Hudis reports employment by ASCO and uncompensated relationships with Alliance Foundation and Columbia University External Scientific Advisory Board. Please see the study for all other authors’ relevant financial disclosures.
Perspective
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Cole Wayant, DO
This important study by Garrett-Mayer and colleagues examines physician financial conflicts of interest (COI) disclosures in oncology research, particularly the discordance between physician-reported and pharmaceutical company-reported payments. Physician COI disclosures often do not match what is recorded in Open Payments database. Whether physicians, policies or the Open Payments database are to blame is unclear, and an answer may guide future efforts to strengthen COI policies.
The study examined physician disclosures for submissions to the 2018 ASCO Annual Meeting or to the premier ASCO journal, Journal of Clinical Oncology. Unsurprisingly, given what is known about physician disclosure, the investigators found very low concordance (16%) between physician disclosure and pharmaceutical company reporting in the Open Payments database.
The investigators suggest that the reason for the low concordance is the lack of standardization between ASCO disclosure requirements for authors and Open Payments reporting requirements for companies. This may very well be true, as the ASCO policy includes many categories not captured by Open Payments. The breadth of ASCO’s disclosure policy far exceeds what is standard in medical research and should be praised. However, there are serious concerns about the inability to reconcile physician-disclosed payments and those reported by companies.
Moving forward, there are two key takeaways from this paper. The first is that the self-disclosure system is splintered and somewhat ineffective. The investigators conclude that a standardized disclosure system is needed across medical research. This would be a massive undertaking, albeit necessary. The second takeaway is a reminder that disclosure is not the endgame in promoting unbiased medical research. A payment disclosed and a payment not disclosed are equally capable of invoking bias, as each is a payment received. Disclosure often happens after the trial is completed, upon journal submission or conference presentation, long after the trial design, conduct, analysis and interpretation.
Disclosure does not absolve one of bias, nor does it correct past effects of bias. Any corrections to the self-disclosure system should parallel efforts to incentivize conflict-free physicians.
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