Concern about financial conflicts crowds out sufficient consideration of other interests that may bias research conduct. Regulations, institutional policies, and guidance from professional bodies and medical journals all primarily focus on financial ties. But why? Economic gain is not the only powerful influence. This article argues that we under-prioritize non-financial interests in the regulation of medical research. It critiques the usual reasons given for regulating financial and non-financial interests differently - that the interests contrast in terms of tangibility, that financial interests are optional, and that financial interests can be efficiently carved out as a discrete area of focus. Moreover, disparate regulatory treatment seems inattentive to the very similar social and psychological forces that animate the bias effect of both financial and non-financial interests and fails to account for how financial and non-financial interests synergistically interact. Under-prioritization of non-financial interests threatens to erode public trust and creates negative spillover effects that weaken financial conflicts regulation. Optimal regulation requires a more integrated, balanced, and proportionate response to secondary interests in medical research.
The 21 Century Cures Act ("Cures Act") relies on the concept of real-world evidence ("RWE") to improve the Food and Drug Administration ("FDA") approval process. This has amplified interest and furthered momentum in applying RWE more broadly, beyond FDA regulation. In this article, we discuss the understandable appeal of RWE's pragmatic application and its many potential benefits. But we also caution that claims about RWE's wide-ranging, ameliorative impact on the health care system are likely overstated. The real world of RWE is messy and uncertain. Successfully incorporating RWE into regular health care system decision-making, beyond the FDA, faces considerable obstacles and limitations. We review the reasons to be wary about RWE as a game-changer. These concerns including data reliability, insufficient incentives for stakeholders to generate and engage with high-quality RWE, and lack of comprehensive regulatory oversight. In addition, the push for RWE may impact the enforcement of the health care fraud and abuse laws, perhaps not in necessarily positive ways. Increased reliance on RWE may have significant implications for off-label fraud enforcement, further conflating the distinction between claims that are false for reimbursement rather than for scientific purposes.
The Physician Payments Sunshine Act ("Sunshine Act"), enacted to address financial conflicts in health care, is the first comprehensive federal legislation mandating public reporting of payments between drug companies, device manufacturers, and medicine. This article analyzes the Sunshine Act's uneven record, exploring how the law serves as an intriguing example of the uncertain case for transparency regulation in health care. The Sunshine Act's bumpy rollout demonstrates that commanding transparency through legislation can be arduous because of considerable implementation challenges. Capturing all the relevant information about financial relationships and reporting it with sufficient contextual and comparative data has proven disappointingly difficult. In addition, the law suffers from uncertainty and poor design as to the intended audience. Indeed, there is strong reason to believe that it will not significantly impact decision-making of primary recipients like patients. Yet the Sunshine Act nonetheless retains important and perhaps underappreciated value. From the almost four years of information generated, we have learned that industry-medicine financial ties vary significantly by physician specialty, and somewhat by physician gender. In many medical fields the distribution of top dollar payments tends to be heavily skewed to a few recipients, all of which have important implications for optimal management of financial conflicts and for health policy more generally. Accordingly, the Sunshine Act's greatest potential is not guiding decisions of individual patients or physicians, but its downstream effects. This Article traces how secondary audiences, such as regulators, watchdogs, and counsel are already starting to make productive use of Sunshine Act information. Public reporting has, for example, made more feasible linking industry payment information with Medicare reimbursement data. As a result, policymakers can more closely examine correlations between industry spending directed at individual physicians and their prescribing and referral decisions. Moreover, savvy counsel are recognizing that Sunshine Act information provides explosive evidence in private civil litigation and this Article explores the first wave of cases.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.