It has been more than a decade since lawmakers enacted the Physician Payments Sunshine Act, requiring disclosure of payments of more than $10 from manufacturers of drugs, medical devices, biologics, and medical supplies. “We haven’t seen a significant impact in terms of patient awareness of physician financial conflicts. At the same time, we continue to see significant kickback cases involving the pharmaceutical and medical device industries,” asserts Jacob T. Elberg, JD, director of the Center for Health & Pharmaceutical Law at Seton Hall University School of Law, who recently authored a recent paper on this topic.1
Elberg and colleagues argued it is time to consider another approach to transparency on financial conflicts. “There may be changed rules requiring direct disclosure to patients, as California has recently considered,” Elberg notes. There also is a broader question of trust in the doctor-patient relationship, and whether clinicians should consider affirmative disclosures. In California, that approach received a lukewarm reception.2 “Clinicians might consider whether they should instead welcome a move to direct disclosure,” Elberg says.
Another group of researchers focused on conflict of interest (COI) declarations by physicians receiving the highest payments. Those researchers identified the highest-compensated clinicians from 10 vascular device companies.3 “Our study is unique in that it only looks at the highest-paid individuals. Our hypothesis is that the higher the payment, the more likely it would be that you will declare the conflict,” says Mehraneh Dorna Jafari, MD, FACS, FASCRS, one of the study’s authors and chief of colorectal surgery at NewYork-Presbyterian Brooklyn Methodist Hospital.
The physicians earned a median of $92,500 in payments in 2017. Relevant COI was identified in 74% of the articles published. Only half the relevant articles included a COI declaration. The study demonstrates clear inconsistencies between self-declared COI and COI that were actually declared on relevant articles published by the highest-compensated clinicians.
To make it easier for people to know about a clinician’s COI, the authors proposed journals add a link to each author’s Open Payments page for published studies. “Our overarching goal is to standardize reporting of conflict within medical journals and meetings,” Jafari explains. “Currently, there is no standard, and the rules differ for each journal.”
The International Committee of Medical Journal Editors (ICMJE) mandates COI reporting. “But the effectiveness of this practice is unclear,” says Carl Berdahl, MD, a physician policy researcher at RAND Corporation and a research scientist in the departments of medicine and emergency medicine at Cedars-Sinai Medical Center.
Berdahl and colleagues sought to learn how disclosing COI affects the editorial decision to publish. The objective was to produce evidence that would cause journal editors to realize current reporting practices may not adequately protect the integrity of the scientific process. The researchers analyzed 1,312 manuscripts submitted to a leading journal from 2014-2018, using data from previous research on author COI for those same manuscripts.4
Methodology for COI reporting “is inherently and notably weak, because no specific process is identified that a reader or researcher could follow and thereby replicate the results. Such lack of detail would not be tolerated if submitted as part of medical research in any scientific journal,” offers Michael Callaham, MD, the study’s principal investigator and founding chair of the department of emergency medicine at the University of California, San Francisco Medical Center. “It seems odd that this important aspect of scientific integrity has been largely ignored and little discussed.”
Manuscripts with reported COI were more likely to be accepted (26.9% were published) than those without COI (13.5% were published). Researchers suggested articles by authors with COI might be higher quality because the authors are more experienced, thus overcoming editors’ hesitancy. Most papers (65.1%) did not include COI declarations, and 34.9% included at least one. One-third of articles with government COI were published, compared to 19.8% of articles with commercial COI only.
“Current COI disclosure practices are burdensome, but they may also be inadequate at protecting the integrity of the scientific process,” Berdahl says.
Clinicians should encourage journal editors to explore innovative COI disclosure practices that could be more effective than the current ICMJE standard. Berdahl and colleagues suggested temporarily relaxing COI requirements so investigators can perform large-scale randomized, controlled studies on the effects of mandated COI disclosure. In any case, says Berdahl, “clinicians should exercise healthy skepticism when reviewing articles written by authors with COI that would be expected to bias study results.”
REFERENCES
1. Adashi EY, Cohen IG, Elberg JT. Transparency and the doctor-patient relationship - Rethinking conflict-of-interest disclosures. N Engl J Med 2022;386:300-302.
2. Ibarra A. California’s medical board declares neutrality on proposed doctor disclosure law. California Healthline. May 9, 2016.
3. Al-Khouja F, Nyam A, Sheehan B, et al. Conflict of interest disclosure among the highest earning physicians receiving compensation from vascular device companies. Am Surg 2022 May 23;31348221103650. doi: 10.1177/00031348221103650. [Online ahead of print].
4. Berdahl CT, Addo N, Callaham ML. The impact of mandatory conflict of interest disclosures on editors’ manuscript acceptance decisions: A cross-sectional observational study. J Am Coll Emerg Physicians Open 2022;3:e12680.
It might be time to consider another approach to transparency on financial conflicts.
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