Achieving greater independence from commercial influence in research

Lexchin, Joel; Bero, Lisa; Davis, Courtney; Gagnon, Marc‐André

doi:10.1136/bmj.n370

Cited by 13 publications

(11 citation statements)

References 53 publications

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“…Although disclosure of FCOI has been increasing over the last decade ( 29 ), disclosure alone is likely insufficient in addressing bias related to FCOI. In particular, overreliance on disclosure may create the perception that a person is relieved of the responsibility of managing their conflict if disclosed ( 29 , 30 ). Furthermore, the high burden of undisclosed FCOI we found may be attributed to our reliance on author self-reporting.…”

Section: Discussionmentioning

confidence: 99%

Financial Conflicts of Interest in Propensity Score-Matched Studies Evaluating Biologics and Biosimilars for Inflammatory Bowel Disease

Elsolh

Tham

Scaffidi

et al. 2022

Journal of the Canadian Association of Gastroenterology

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Background Propensity score matching (PSM), a statistical technique that estimates a treatment effect by accounting for predictor covariates, has been used to evaluate biologics for inflammatory bowel disease (IBD). Financial conflicts of interest are prevalent in the marketing of biologic medications. It is unclear whether this burden of conflicts is present among authors of PSM studies comparing IBD biologics and biosimilars. Objective This study was aimed to determine the prevalence of financial conflicts of interest among authors of PSM studies evaluating IBD biologics and biosimilars. Methods We conducted a systematic search for PSM studies comparing biologics and biosimilars in IBD treatment. We identified 21 eligible studies. Two independent authors extracted self-declared conflicts from the disclosures section. Each participating author was searched on the Centers for Medicare & Medicaid Services Open Payments to identify payment amounts and undisclosed conflicts. Primary outcome was the prevalence of author conflicts. Secondary analyses assessed for an association between conflict prevalence and reporting of positive outcomes. Results Among 283 authors, conflicts were present among 41.0% (116 of 283). Twenty-three per cent (27 of 116) of author conflicts involved undisclosed payments. Studies with positive outcomes were significantly more likely to include conflicted authors than neutral studies (relative risk = 2.34, 95% confidence interval: 1.71 to 3.21, P < 0.001). Conclusions Overall, we found a high burden of undisclosed conflicts among authors of PSM studies comparing IBD biologics and biosimilars. Given the importance of PSM studies as a means for biologic comparison and the potential for undue industry influence from these payments, authors should ensure greater transparency with reporting of industry relationships.

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Section: Discussionmentioning

confidence: 99%

Financial Conflicts of Interest in Propensity Score-Matched Studies Evaluating Biologics and Biosimilars for Inflammatory Bowel Disease

Elsolh

Tham

Scaffidi

et al. 2022

Journal of the Canadian Association of Gastroenterology

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“…Commercial actors can influence scientific processes through mechanisms such as the following: funding research favoring their own interests; attempting to influence scientific editorial decisions; engaging scientists to publish ghost-written articles; stifling or concealing scientific developments; influencing governments in setting research agendas; and personally attacking or buying-out leading researchers in fields of interest [ 30 , 31 ]. For instance, lobbying by the US National Rifle Association (NRA—a recipient of firearms industry funding [ 32 ]) led to a legislative provision (the Dickey Amendment) prohibiting US Centers for Disease Control and Prevention from addressing gun control, deterring their involvement in research on firearms violence [ 33 ].…”

Section: Framework Applicationmentioning

confidence: 99%

The Commercial Determinants of Violence: Identifying Opportunities for Violence Prevention through a Public Health-Based Framework Analysis

Bellis,

McManus,

Hughes

et al. 2024

IJERPH

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Violence has immediate and long-term repercussions for the health of individuals and communities. Recent increases in the understanding of public health approaches to violence prevention have focused on the policies and practices of government, health, and other public sector agencies. However, the roles of commercial bodies in fostering and preventing violence remain largely unaddressed. The wealth and influence of some companies now exceeds that of many countries. Consequently, it is timely to explore the roles of commercial processes in violence. Using a conceptual framework for the commercial determinants of health, we examine seven practices: political; scientific; marketing; supply chain and waste; labor and employment; financial; and reputational management. We include areas directly linked with violence (e.g., firearms) and those that indirectly impact violence through the following: design and promotion of products; employment practices; and impacts on environment, poverty, and local resources. A range of avoidable commercial behaviors are found to increase levels of violence including the following: lobbying practices; distortion of scientific processes; polluting manufacture and supply lines; poor employee protections; financial investment in organizations and regimes associated with violence; and misleading communications and marketing. We conclude commercial actors can take action to ensure their workers, clients, suppliers, and distributors help prevent, not promote, violence. New technologies such as artificial intelligence are transforming corporate processes and products and offer opportunities to implement violence prevention through commercial developments (e.g., monitoring online content). International regulation of commercial behaviors is needed to prevent interpersonal and interstate conflict and harms to health and trade.

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“…There are many potential sources of bias in industry-sponsored trials as well as ways that clinical trials can be manipulated to favour a particular outcome [17]. These include not reporting negative studies as well as reporting only specific subgroups or centres among others [18,19].…”

Section: Industry and Academic Researchmentioning

confidence: 99%

Industry influence in healthcare harms patients: myth or maxim?

Trayer

Rowbotham

Boyle

et al. 2022

Breathe

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Healthcare is a major global industry accounting for a significant proportion of government spending. Drug and medical device manufacturers are publicly traded companies with a responsibility to their shareholders to maximise profits by increasing sales. In order to achieve this, industry exerts influence over every part of healthcare including academic research, medical education, clinical guideline development, physician prescribing and through direct interactions with patients. In contrast, healthcare services seek to provide effective, safe and evidence-based treatments. This article examines interactions with industry across these domains and seeks to identify mutually beneficial relationships and potential conflict leading to patient harms. Case studies are used to illustrate these interactions.There is no single solution for improving healthcare's relationship with industry, although increased transparency has raised awareness of this issue. We briefly discuss some successful interventions that have been tried at national and regulatory level. While industry influence is widespread in healthcare and this has benefits for shareholders, healthcare practitioners have an ethical obligation to prioritise their patients’ best interests. Industry interactions with healthcare professionals have a valid role in product development and distribution, but industry sponsorship of healthcare education and practice, guideline development or regulatory decision-making can have harmful consequences for patients. Healthcare practitioners need to carefully consider these issues when deciding whether to collaborate with industry.Educational aimsTo explore the many areas where industry influences healthcare and the subsequent effects on patient care. Case studies are used to illustrate examples of beneficial and harmful effects of this influence.To raise awareness of the effects of industry influence and for readers to consider their own potential conflicts of interest.To suggest potential ways to improve the current system with a focus on solutions which have successfully been trialled already.

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Achieving greater independence from commercial influence in research

Abstract: As part of The BMJ’s campaign for greater independence from commercial influence in the creation and use of evidence, Joel Lexchin and colleagues outline some approaches to minimise bias in clinical trials

Cited by 13 publications

References 53 publications

Financial Conflicts of Interest in Propensity Score-Matched Studies Evaluating Biologics and Biosimilars for Inflammatory Bowel Disease

Financial Conflicts of Interest in Propensity Score-Matched Studies Evaluating Biologics and Biosimilars for Inflammatory Bowel Disease

The Commercial Determinants of Violence: Identifying Opportunities for Violence Prevention through a Public Health-Based Framework Analysis

Industry influence in healthcare harms patients: myth or maxim?

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