'Someone should oversee it': patient perspectives on the ethical issues arising with the regulation of probiotics.
'Someone should oversee it': patient perspectives on the ethical issues arising with the regulation of probiotics.
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“应该有人监督”：患者对益生菌监管所产生的伦理问题的看法。
DOI：
10.1111/hex.12027
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发表时间：
2015
期刊：
影响因子：
--
通讯作者：
Sharp,RichardR
中科院分区：
文献类型：
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作者：
Harrison,KristaL;Farrell,RuthM;Brinich,MargaretA;Highland,Janelle;Mercer,MaryBeth;McCormick,JenniferB;Tilburt,Jon;Geller,Gail;Marshall,Patricia;Sharp,RichardR
背景尽管目前在美国（US）许多益生菌产品以酸奶或药丸形式可获得，但围绕这些产品的监管结构存在不确定性。随着越来越多的治疗性益生菌的开发，可能需要改变美国现有的监管程序，以满足人群中患者和使用者的需求。这项研究探讨了慢性胃肠道（GI）疾病患者如何看待益生菌的监管。设计我们进行了一项多中心定性研究，由三家三级医院的慢性胃肠道疾病患者的焦点小组组成：结果我们进行了22个焦点小组，136例患者的主要胃肠道（GI）疾病在2009年3月至8月。参与者不熟悉益生菌产品的现有法规，但希望确保菌株的准确标签以及安全性。与会者表示关切的是，益生菌的监管可能伴随着更高的成本，减少获得和制药公司的参与增加。尽管与会者对政府监管机构表示了极大的怀疑，但他们认为，含有转基因益生菌菌株的产品应该受到与药品类似的监督。讨论和结论如果GI患者的观点表明了美国公众对治疗性益生菌的看法，消费者可能会期望未来更严格的监管，同时希望降低成本，容易获得和低参与制药公司。制造商、转化科学家、临床医生和监管机构在设计、测试和监管新的治疗性益生菌时，应该对消费者的态度保持敏感。
BackgroundAlthough many probiotic products are currently available in yogurt or pill form in the United States (US), there is uncertainty surrounding the structure of regulation of these products. As more therapeutic probiotics are developed, changes to existing regulatory process in the United States may be required to meet the needs of patients and users in the population.ObjectiveThis study examined how patients with chronic gastrointestinal (GI) diseases view the regulation of probiotics.DesignWe conducted a multi‐site qualitative study consisting of focus groups of patients with chronic gastrointestinal diseases at three tertiary hospitals: at [institutions removed for blinded review].ResultsWe conducted 22 focus groups with 136 patients with major gastrointestinal (GI) diseases between March and August 2009. Participants were not familiar with the existing regulation of probiotic products but wanted assurances of accurate labelling of strain as well as safety. Participants raised concerns that regulation of probiotics might be accompanied by greater costs, reduced access and increased involvement of pharmaceutical companies. Although participants voiced significant doubt of government regulators, they felt that products containing genetically modified probiotic strains should have oversight comparable to that of pharmaceutical drugs.Discussion and conclusionIf GI patient perspectives are indicative of public perceptions of therapeutic probiotics in the United States, consumers may expect more rigorous regulation in the future while simultaneously wanting low costs, easy access and low involvement of pharmaceutical companies. Manufacturers, translational scientists, clinicians and regulators should be sensitive to consumer attitudes when designing, testing and regulating new therapeutic probiotics.