Redman Barbara K
Division of Medical Ethics, Grossman School of Medicine, New York University, New York, NY, United States.
Front Med (Lausanne). 2023 Sep 22;10:1247258. doi: 10.3389/fmed.2023.1247258. eCollection 2023.
Biomedical research is intended to benefit human beings and their health. Toward that end, scientific norms involve examining and criticizing the work of others and prioritizing questions that should be studied. Yet, in areas of health research where industry is active, it has often utilized well-honed strategies aimed at evading scientific standards and at dominating the research agenda, largely through its financial support and lack of transparency of its research practices. These tactics have now been documented to uniformly support industry products. Commercial entities are aided in this pursuit by public policy that has significantly embedded commercial interests and agendas into federal research funding and infrastructure. Therefore, to understand the resulting landscape and its effect on priority in health research agendas, traditional definitions of individual conflicts of interest (COI) and the less well developed institutional COI must be supplemented by a new construct of structural COI, largely operating as intellectual monopolies, in support of industry. These arrangements often result in financial and reputational resources that assure dominance of commercial priorities in research agendas, crowding out any other interests and ignoring justified returns to the public from investment of its tax dollars. There is no sustained attention to mechanisms by which public interests can be heard, normative issues raised, and then balanced with commercial interests which are transparently reported. Focus on research supporting approval of commercial products ignores social and environmental determinants of health. Commercial bias can invalidate regulatory research protections through obscuring valid risk-benefit ratios considered by IRBs.
生物医学研究旨在造福人类及其健康。为此,科学规范包括审视和批评他人的工作,并对应该研究的问题进行优先级排序。然而,在制药行业活跃的健康研究领域,该行业常常采用精心打磨的策略,旨在规避科学标准并主导研究议程,这在很大程度上是通过其资金支持以及研究行为缺乏透明度来实现的。现已证明,这些策略一概是为了支持制药行业的产品。公共政策在这一追求过程中起到了助力作用,它已将商业利益和议程大量植入联邦研究资金和基础设施之中。因此,为了理解由此产生的局面及其对健康研究议程优先级的影响,必须用一种新的结构性利益冲突概念来补充个人利益冲突(COI)的传统定义以及发展尚不充分的机构利益冲突定义,这种结构性利益冲突在很大程度上如同知识垄断一般运作,以支持制药行业。这些安排往往会产生资金和声誉资源,确保商业优先事项在研究议程中占据主导地位,排挤任何其他利益,并忽视公众因纳税投资而应得的合理回报。对于能够听取公众利益、提出规范性问题并与透明报告的商业利益进行平衡的机制,没有持续的关注。专注于支持商业产品获批的研究忽视了健康的社会和环境决定因素。商业偏见可能会通过模糊机构审查委员会(IRB)所考虑的有效风险效益比,使监管研究保护失效。