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. (shrink)

Conflicts of interest have been reduced to financial conflicts. The National Institutes of Health’s new rules for managing conflicts of interest in medical research, the first major change to the regulations in over 15 years, address only financial ties. Although several commentators urged that the regulations also cover non-financial interests, the Department of Health and Human Services declined to do so. Similarly, the Institute of Medicine’s influential 2009 Conflict of Interest Report focuses almost exclusively on financial conflicts. Institutional policies at (...) academic medical centers and guidance from professional bodies and medical journals also primarily emphasize financial ties. Even broadly worded rules are applied more readily to financial ties than non-financial interests, such as the regulations that restrict institutional review board members with conflicting interests from participating in protocol reviews. (shrink)

The pharmaceutical industry plays an increasingly dominant role in healthcare, raising concerns about “conflicts of interest” on the part of the medical professionals who interact with the industry. However, there is considerable disagreement over the extent to which COI is a problem and how it should be managed. Participants in debates about COI have become entrenched in their views, which is both unproductive and deeply confusing for the majority of medical professionals trying to work in an increasingly commercialized environment. We (...) used a modified meta-narrative review method to analyse debates about COI in the academic and grey literature. We found two Discourse Models: The Critical Discourse Model sees COI in health and biomedicine as a major problem that both can and should be addressed, while the Defensive Discourse Model argues that current efforts to control COIs are at best unnecessary and at worst harmful. Each model is underpinned by profoundly differing views about how society should be organized—in particular whether market forces should be encouraged or curtailed—and how the dangers associated with market forces should be managed. In order to make any headway, academics and policymakers must recognize that these debates are underpinned by profoundly differing worldviews. (shrink)

Informed consent mandates for abortion providers may infringe the First Amendment's freedom of speech. On the other hand, they may reinforce the physician's duty to obtain informed consent. Courts can promote both doctrines by ensuring that compelled physician speech pertains to medical facts about abortion rather than abortion ideology and that compelled speech is truthful and not misleading.

ABSTRACT The UK Supreme Court ruling of Montgomery v Lanarkshire clarified that in obtaining informed consent to treatment, practitioners are under a duty to inform patients of material risks. Traditionally such risk has pertained to the clinical risks inherent to treatment. In examining empirical and judicial evidence, this paper makes the case for disclosure of potent financial interests; with potency relating to those interests likely to have greatest influence over practice. The paper explores how financial interests may detrimentally influence practice (...) patterns and how non-disclosure of such interests may be linked to the erosion of patient trust and subsequent disinclination to consent to treatment. Judicial notions of material risk are explored, and the conclusion reached that they offer a broader interpretation of disclosable risk compared to current UK GMC guidance. It is anticipated that empirical evidence could be used by the courts in determining questions of both materiality and causation in cases of negligent non-disclosure of potent financial interests. The paper concludes that there is sufficient reason to surmise that a test case could successfully apply the principles identified therein to establish the materiality of conflict of interest in informed consent to medical treatment. (shrink)

Well-designed pragmatic clinical trials (PCTs) are critical for improving healthcare delivery and patient outcomes (Haff and Choudhry 2018), and the article written by Garland et al. (2023) advance...

How can we ensure that players in the National Football League receive excellent health care they can trust from providers who are as free from conflicts of interest as realistically possible? NFL players typically receive care from the club's own medical staff. Club doctors are clearly important stakeholders in player health. They diagnose and treat players for a variety of ailments, physical and mental, while making recommendations to the player concerning those ailments. At the same time, club doctors have obligations (...) to the club, namely to inform and advise clubs about the health status of players. While players and clubs share an interest in player health—both of them want players to be healthy so they can play at peak performance—there are several areas where their interests can diverge, and the divergence presents legal and ethical challenges. The current structure forces club doctors to have obligations to two parties—the club and the player—and to make difficult judgments about when one party's interests must yield to another's. None of the three parties involved should prefer this conflicted approach. We propose to resolve the problem of dual loyalty by largely severing the club doctor's ties with the club and refashioning that role into one of singular loyalty to the player-patient. The main idea is to separate the roles of serving the player and serving the club and replace them with two distinct sets of medical professionals: the Players' Medical Staff and the Club Evaluation Doctor. We begin by explaining the broad ethical principles that guide us and that help shape our recommendation. We then provide a description of the role of the club doctor in the current system. After explaining the concern about the current NFL player health care structure, we provide a recommendation for improving this structure. We then discuss how the club medical staff fits into the broader microenvironment affecting player health. (shrink)

Our article “NFL Player Health Care: Addressing Club Doctors’ Conflicts of Interests and Promoting Player Trust” focused on an inherent structural conflict that faces club doctors in the National Football League. The conflict stems from club doctors’ dual role of providing medical care to players and providing strategic advice to clubs. We recommended assigning these roles to different individuals, with the medical staff members who are responsible for providing player care being chosen and subject to review and termination by a (...) committee of medical experts selected equally by the NFL and the NFL Players Association. Recognizing that the problem of structural conflict of interest is deeply entrenched and that our recommendation is a significant departure from the status quo, we invited comment from a diverse and highly qualified group of experts. There is considerable common ground among the commentators. All but one agreed with us that, despite the best intentions of upstanding professionals, there is a structural conflict of interest in the club doctors’ relationship with players, and the commentaries were generally supportive of our recommendation for change. There are also meaningful disagreements, however. Some commentators think that the proposal is on the right track but does not go far enough to reduce the structural conflict of interest, and one commentary wholly disagrees with our analysis and recommendations. (shrink)

The Physician Payments Sunshine Act requires health care product manufacturers to report to the federal government payments more than $10 to physicians. Bringing unprecedented transparency to medicine, PPSA holds great potential for enabling medical stakeholders to manage conflicts of interest and build patient trust—crucial responsibilities of medical professionalism. The authors conducted six focus groups with 42 physicians in Chicago, IL, San Francisco, CA, and Washington, DC, to explore attitudes and experiences around PPSA. Participants valued the concept of transparency but were (...) wary of the law's design and consequences. They downplayed PPSA's potential and felt it undermined public trust. Showing broad unawareness of COI, they dismissed the notion of industry influence and welcomed company “perks.” Misapprehensions may leave physicians unprepared to advance the opportunities PPSA holds for professionalism. The authors offer recommendations for government and medicine to improve physicians' and other stakeholders' understandings and use of the data. (shrink)

Volume 20, Issue 4, May 2020, Page 59-61.

A conflict of interest is a situation in which a person has competing loyalties or interests that make it difficult to fulfil his or her duties impartially. Conflict of interest is not categorically improper in itself but requires proper management. A SCOPUS literature search was performed for publications on the efficacy/safety of Phospho-Di-Esterase Inhibitors for treating erectile dysfunction. A categorization tool was used to review and classify the publications as supportive/not-supportive for the discussed active ingredient and reporting or not reporting (...) a COI for that specific drug or for the remaining PDEIs. Multivariable binary logistic regression was performed. In the 419 selected records the prevalence of supportive opinions was higher when a COI for the index label was declared. The CoOpCaT showed good internal consistency, discriminative validity and intra/inter-rater agreement. The strongest predictor for a supportive opinion was the total number of financial COIs for the index label. A mild protective effect of the total number of financial COIs for any competitor label was noted. Financial COIs have frequently been associated with bias, and the measures currently adopted to restrain it lack effectiveness. Some evidence for monitoring and/or compensating this bias is reported here, but the ultimate solution remains distant. (shrink)