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美国加强对干细胞疗法的监管

2017-08-29 11:30:45   新华网

新华社华盛顿8月28日电(记者林小春)美国卫生当局正在加强对干细胞疗法的监管和执法行动,清理可能破坏整个再生医疗行业健康发展的“坏角色”诊所和公司。

美国食品和药物管理局28日宣布,已经查抄加利福尼亚州一家公司的干细胞产品,并向佛罗里达州一家干细胞诊所发出警告信,接下来还将很快出台对干细胞疗法进行监管的政策文件。

美药管局局长斯科特·戈特利布当天发表一份声明说,大多数干细胞疗法尚处于早期研发阶段,它们拥有巨大的前景,有可能帮助治疗最麻烦、最棘手的人类疾病。但“少数肆无忌惮者”利用这一点,欺骗性地向患者推广“未经证实、在某些案例中甚至疑似危险的产品”。

“这使整个领域处于危险之中,”戈特利布写道,“如果‘坏角色’能做出虚假的声明,并推广不安全的科学,那么可靠和精心研发的(干细胞)产品将更难推进。”

美药管局同日还宣布,联邦官员本月25日采取执法行动,查抄了加利福尼亚州干细胞免疫公司5瓶牛痘疫苗。这种疫苗原本仅供天花高风险人群使用,但该公司把疫苗和干细胞混合生产了一种未经批准的干细胞产品,在没有任何证据证明它有效的情况下,通过静脉直接注射入肿瘤,用于治疗免疫系统受损的癌症患者。

与此同时,美药管局向一家位于佛罗里达州的干细胞诊所发出了警告信,原因是这个诊所向患者推广未经评审和批准的干细胞疗法。美药管局表示,这家诊所至少在生产256批干细胞产品时没有遵循现有生产规范,比如没有建立和遵循旨在防止微生物污染的书面流程,还试图阻止美药管局的调查,要求调查人员预约才允许进入,而拒绝药管局调查人员进入是违反联邦法律的。

戈特利布说,为加强对干细胞疗法的监管,美药管局将在今秋发布一份全面的政策框架文件,为干细胞疗法这一新领域制定更明确的规则。

他举例说,有一些干细胞疗法从患者自身提取细胞或组织,然后在没有重大修改的情况下再植入患者体内履行相同的基本功能,这些疗法的利弊已经研究得很清楚,就可能不再需要接受上市前评审;而一旦干细胞疗法对提取的细胞或组织修改较大,或改变细胞或组织的基本功能,那么就需要进行上市前评审。

干细胞在理论上可以分化成任何一种成体细胞,因而被认为具有医疗价值,特别是可用于再生医疗领域。但美国《科学》杂志曾发表一篇专家评论文章警告,当前干细胞研究与治疗存在“炒作”现象,对科研进展及潜在应用夸大其词,存在误导公众的风险。

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