作为公共卫生工具的基因工程（GE）蚊子的监管：公共卫生伦理分析。
Regulation of genetically engineered (GE) mosquitoes as a public health tool: a public health ethics analysis.
机构信息
Philosophy Department, University of Rhode Island, Kingston, RI, 02881, USA.
出版信息
Global Health. 2022 Feb 21;18(1):21. doi: 10.1186/s12992-021-00760-x.
BACKGROUND
In recent years, genetically engineered (GE) mosquitoes have been proposed as a public health measure against the high incidence of mosquito-borne diseases among the poor in regions of the global South. While uncertainties as well as risks for humans and ecosystems are entailed by the open-release of GE mosquitoes, a powerful global health governance non-state organization is funding the development of and advocating the use of those bio-technologies as public health tools. In August 2016, the US Food and Drug Agency (FDA) approved the uncaged field trial of a GE Aedes aegypti mosquito in Key Haven, Florida. The FDA's decision was based on its assessment of the risks of the proposed experimental public health research project. The FDA is considered a global regulatory standard setter. So, its approval of the uncaged field trial could be used by proponents of GE mosquitoes to urge countries in the global South to permit the use of those bio-technologies.
METHOD
From a public health ethics perspective, this paper evaluates the FDA's 2016 risk assessment of the proposed uncaged field trial of the GE mosquito to determine whether it qualified as a realistic risk evaluation.
RESULTS
The FDA's risk assessment of the proposed uncaged field trial did not proximate the conditions under which the GE mosquitoes would be used in regions of the global South where there is a high prevalence of mosquito-borne diseases.
CONCLUSION
Given that health and disease have political-economic determinants, whether a risk assessment of a product is realistic or not particularly matters with respect to interventions meant for public health problems that disproportionately impact socio-economically marginalized populations. If ineffective public health interventions are adopted based on risk evaluations that do not closely mirror the conditions under which those products would actually be used, there could be public health and ethical costs for those populations.
背景
近年来，基因工程（GE）蚊子被提议作为一种公共卫生措施，以应对全球南方贫困地区蚊媒疾病高发的问题。尽管释放基因工程蚊子存在不确定性和对人类和生态系统的风险，但一个强大的全球卫生治理非政府组织正在资助这些生物技术的开发，并倡导将其用作公共卫生工具。2016 年 8 月，美国食品和药物管理局（FDA）批准在佛罗里达州基霍恩（Key Haven）对一种基因工程埃及伊蚊进行无笼野外试验。FDA 的决定是基于其对拟议的实验性公共卫生研究项目风险的评估。FDA 被认为是全球监管标准制定者。因此，其对无笼野外试验的批准可能被基因工程蚊子的支持者用来敦促全球南方国家允许使用这些生物技术。
方法
从公共卫生伦理的角度出发，本文评估了 FDA 对拟议的无笼野外试验的基因工程蚊子的 2016 年风险评估，以确定其是否符合现实风险评估。
结果
FDA 对拟议的无笼野外试验的风险评估并未接近在蚊媒疾病高发的全球南方地区使用基因工程蚊子的条件。
结论
鉴于健康和疾病具有政治经济决定因素，产品的风险评估是否现实，特别是对于那些不成比例地影响社会经济边缘化人群的公共卫生问题干预措施，尤为重要。如果基于与产品实际使用条件不符的风险评估来采用无效的公共卫生干预措施，这些人群可能会面临公共卫生和伦理方面的代价。
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