ACC/AHA Guideline Writers’ Disclosures vs Open Payments Don’t Add Up
The gap may not be due to nefarious reporting but could still undermine public confidence in medicine, researchers say.
Close examination of nine recent American College of Cardiology/American Heart Association (ACC/AHA) guideline documents released in 2016 and 2017 shows discrepancies between what their authors disclose about relationships with industry and what the companies report publicly in the Open Payments database, according to a new analysis.
Payments matched in both sources for fewer than one in 10 of the writers, and only half of those who had financial connections listed in Open Payments mentioned these ties in their disclosures for the ACC/AHA recommendations.
“Our findings demonstrate a concerning level of discrepancy between guideline author disclosures and industry-reported payments,” Ramzi Dudum, MD (The Johns Hopkins Hospital, Baltimore, MD), and colleagues note in their paper published online this week in Circulation: Cardiovascular Quality and Outcomes. Whether the fault lies with the process for disclosure or with the veracity of the Open Payments database isn’t clear, they say.
To TCTMD, senior author Brian G. Choi, MD, MBA (George Washington University, Washington, DC), emphasized the same message: that it’s impossible to know the authors’ motivations or whether the financial relationships had any undue influence.
“It’s the appearance that matters, and while there’s no confirmation that there’s ill intent, it just leaves it open to question unless we can all come up with a consistent process to make sure that disclosures are accurate, both from what companies report as well as what physicians report,” he explained.
Open Payments originated from the 2010 Affordable Care Act. Currently, the online repository includes data spanning from 2013 to 2018.
The hope had been that “the sunshine provided by mandatory disclosure would automatically result in physicians accurately reporting relationships with industry,” incentivized by the knowledge that these would be listed on a publicly available data set, Steven E. Nissen, MD (Cleveland Clinic, OH), points out in an accompanying editorial. “Likewise, the ACC and AHA assumed that strict policies regarding conflicts of interest would result in the production of guidelines untainted by allegations of improper industry influence.”
This report, however, “suggests that these efforts have not been entirely successful,” Nissen comments, adding that overall it seems “physicians have not entirely embraced the gravity of disclosures and the seriousness of underreporting.”
Both Nissen and the researchers agree that accurate reporting is required to ensure not only public confidence in the integrity of ACC/AHA guidelines but also patients’ trust in their doctors.
Dudum et al focused on nine ACC/AHA guidelines published in 2016 and 2017 that related to dual antiplatelet therapy in CAD, stroke rehabilitation and recovery, pharmacological therapy for heart failure, lower-extremity PAD, syncope, valvular heart disease, and heart failure management.
Of 696 relationships reported in either the documents or Open Payments, only 8.9% were reported by both sources. Among the 81 US-based physician authors, 65 had self-reported or Open Payments disclosures. Fully 32 of them (49%) had data in Open Payments but lacked corresponding information in the respective ACC/AHA document.
Median payments were greatest for ownership ($101,998) and consulting ($22,497), with lower amounts reported for speaking ($13,644), research ($7,452), and other ($2,591). Authors were most likely to underreport payment size for things in the “other” category (such as meals, gifts, or travel), with amounts disclosed for the guideline process being lower 92% of the time compared with industry data for these payments. Guideline disclosures were also lower for 49% and 34% of company-reported consulting and speaking payments, respectively. In contrast, 46% of authors overreported how much research funding they received.
How Reporting Goes Awry, How to Fix It
Beyond over- or underreporting, there could be multiple explanations for the gap between the two sources, the researchers point out. Among them are incongruent reporting methods, differences in time frames for disclosure, authors not realizing that nonmonetary compensation such as food or travel were considered conflicts, and the fact that the onus is on physicians to dispute errors in the Open Payments database.
It may also be that the companies have reported inaccurate information, Choi said. He himself has experienced errors, thanks to sharing the same name with other physicians in different specialties. These errors are, to his knowledge, quite rare.
Nissen, for his part, offers a few reasons why authors might underreport. “Serving on a guideline committee is highly prestigious and is often considered by promotions committees as a sign of the prominence of the physician within his or her field,” he observes, and industry relationships can disqualify physicians from participating in guideline development. Additionally, he says, “for physicians like myself, with extensive relationships with industry for research, the sheer burden of keeping track of all these activities is challenging.”
Blocking authors who have payments isn’t practical, Nissen argues, stressing, “All conflicts are not created equal.”
Dudum and colleagues agree. That said, both they and Nissen point out that, as reported by TCTMD, research has shown even a single meal can sway physician habits.
“There’s a reason why drug reps buy us meals—it’s because it’s effective. If it was not effective, they wouldn’t do it,” Choi stressed, adding that everyone is vulnerable at some level to being influenced. “In full disclosure, I myself used to work for Pfizer and Medtronic,” he continued, “before I became a physician. I worked in marketing. We do these things because they’re effective.”
Beyond lunches, still more problematic are ties that amount to tens of thousands of dollars, he said.
So what are some immediate solutions? One, says Nissen, is for ACC/AHA staff to cross-check that the relationships mentioned in guidelines are consistent with the Open Payments numbers. Dudum and colleagues urge that it’s “imperative for authors to review the Open Payments data and address any discrepancies that may be incorrectly attributed to them at all times through the guideline development process.” Also, an aligned reporting methodology across platforms “that uses similar categories and expectations is likely to improve transparency and accountability,” they advise.
Nissen says one “central issue” looms: “Can we trust the independence of ACC/AHA guidelines for clinical decision-making?”
For him, “the answer remains uncertain,” despite what he calls “minimal evidence of industry bias” in the recommendations themselves. But damaged credibility from even the appearance of bias “is too steep a price to pay for sloppiness in reporting of relationships,” Nissen concludes, stressing that professional societies and guideline writers must do better.
Dudum R, Sajja A, Amdur RL, Choi BG. Analysis of American College of Cardiology/American Heart Association guideline author self-disclosure compared with Open Payments industry disclosure. Circ Cardiovasc Qual Outcomes. 2019;12:e005613.
Nissen SE. Can we trust the independence of cardiovascular guidelines? Circ Cardiovasc Qual Outcomes. 2019;12:e006225.
- Dudum and Choi report no relevant conflicts of interest.
- Nissen reports that the Cleveland Clinic Center for Clinical Research has received funding to perform clinical trials from Abbvie, AstraZeneca, Amgen, Cerenis, Eli Lilly, Esperion, Medtronic, MyoKardia, Novartis, Pfizer, The Medicines Company, Silence Therapeutics, Takeda, and Orexigen. He is involved in these clinical trials but receives no personal remuneration for his participation. He also consults for many pharmaceutical companies but requires them to donate all honoraria or consulting fees directly to charity so that he receives neither income nor a tax deduction.