There appears to be no pattern or bias as it relates to reporting to one entity or the other, however. “Despite quantification of concordance and causes of discordance, one cannot determine the level of under- or over-reporting to ASCO or OP,” the authors wrote.
The authors of the analysis also pointed out that the way payments are reported could provide a loophole, ultimately having the potential to be gamed. “Free-text reporting of company names, large companies with many subsidiaries, and payments made by third-party entities challenged the matching of companies within individual physicians’ records,” they explained. For example, the naming of pharmaceutical company subsidiaries that were making payments to physicians created obfuscation in some instances. The investigators specifically called attention to Bristol-Myers Squibb, for which they found 163 global subsidiaries listed with the US Securities and Exchange Commission — and while many of these affiliated companies have names that resemble Bristol-Myers Squibb’s brand, “at least 50 have names that bear no obvious resemblance” to the company.
Thus, the authors called for the synchronization of self-disclosure across sources, but also called OP reporting “complementary” to ASCO disclosures. “ASCO has encouraged [United States] authors to examine their reported payments to OP, to find information responsive to ASCO disclosure, or to identify erroneous information.” To show support for this notion, in the disclosure section of the JCO article, the direct links to OP records for coauthors Clifford A. Hudis, MD, FACP, FASCO, chief executive officer of ASCO, and Richard L. Schilsky, MD, FACP, FSCT, FASCO, chief medical officer and executive vice president of ASCO, were listed and linked.
Continue Reading
For Dr Hudis, specifically, no data were available for review for 2017 and 2018. ASCO’s senior communications manager confirmed that the information in OP is accurate for Dr Hudis. “In Dr Hudis’ case, as CEO of ASCO, he does not accept payments from companies,” the spokesperson wrote to Cancer Therapy Advisor. “He assumed his role as CEO in 2016, which would explain why there are no payments reported to him by companies in Open Payments for 2017 and 2018.”
But even for those who support stronger disclosure policies and believe strengthening these policies would be a positive step toward better transparency, there is still the issue of how such disclosures should be policed or corrected.
To illustrate the complexity of COI disclosure, Cancer Therapy Advisor looked up information in OP on general payments supposedly paid to Howard Burris III, MD, FACP, FASCO, who serves as the current president of ASCO. In 2018, Dr Burris was listed as getting a $3200 general payment from Pfizer for “compensation for services other than consulting, including serving as faculty or as a speaker at a venue other than a continuing education program.” However, this same payment from Pfizer was not included in the disclosure section of an opinion paper by Dr Burris and colleagues on the value of phase 1 clinical trials in oncology that was recently published in Nature Reviews Clinical Oncology.2 Similarly, in another recent Journal of Oncology Practice article for which Dr Burris is listed as an author,3 Pfizer is not listed as making any kind of payment to Dr Burris, either for consulting or advisory services, or in the form of research funding to his institution.
ASCO’s spokesperson, speaking on behalf of Dr Burris, explained that this 2018 general payment in OP that is listed as coming from Pfizer was specifically for publication support fees.
“These publication fees are assessed/allocated by the sponsor, in this case Pfizer, to offset some of the costs it incurs in preparing a study for submission/publication,” ASCO’s communications professional stated. “Authors must agree to ‘accept’ this allocation as a condition of being an author. To be clear, no money exchanged hands — so Dr Burris wasn’t ‘paid’ a fee — he was actually assessed that fee.”
When Cancer Therapy Advisor asked Pfizer why it categorized this publication fee as a general payment, Jessica Smith from the corporate affairs department replied that “CMS has not provided specific direction on how manufacturers should report publication fees. Publication fees are generally fair market value payments for editorial or medical writing services paid to third parties who assist authors in the development of a publication. Publication fees do not go directly to the author. There is no publication fee category on the Open Payments website and we have chosen to report payments under the ‘general template’. There is no industry standard, and other companies may report differently.”
“The above information illustrates one reason why ASCO conducted the research it did,” the ASCO spokesperson emphasized. “A key takeaway from the JCO article is that there is no single source of truth when it comes to disclosure; comparing different sources of disclosure is like comparing apples to oranges, given differing disclosure requirements and timeframes,” she said. “This can easily lead to inaccurate assumptions, misinterpretation, and wrongful conclusions. This is why ASCO has been calling for consistent, simpler financial disclosure systems in medicine.”
Disclosures: Please refer to the original study for a full list of author disclosures.
References
- Garrett-Mayer E, Kaltenbaugh MW, Spence RJ, et al. Discrepancies in financial self-disclosures and Open Payments reporting among authors of clinical oncology research studies [published online December 9, 2019]. J Clin Oncol. doi: 10.1200/JCO.19.02467
- Burris HA 3rd. Correcting the ASCO position on phase I clinical trials in cancer [published online December 19, 2019]. Nat Rev Clin Oncol. doi: 10.1038/s41571-019-0311-4
- Kline RM, Rocque GB, Rohan EA, et al. Patient navigation in cancer: the business case to support clinical needs. J Oncol Pract. 2019;15(11):585-590.
