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美一医学中心忽视临床试验失误
来源:中国科学报      作者:宗华      时间:2016-10-12 17:55      关键词:美国,医学,中心,忽视,临床,试验,失误
摘要:当美国国立卫生研究院(NIH)院长Francis Collins于5年前提出在NIH成立一个新的转化医学中心时,他遭到了足够多的质疑。默克公司前首席执行官Roy Vagelos告诉一个国会委员会,NIH耗资6亿美元的努力能克服业界无法解决的问题——这个想法就像是相信“有精灵存在一样”。



美国国立卫生研究院临床中心是一项NPC临床试验的所在地。不过,当并发症出现时,该试验被叫停。图片来源:美国国立卫生研究院

当美国国立卫生研究院(NIH)院长Francis Collins于5年前提出在NIH成立一个新的转化医学中心时,他遭到了足够多的质疑。默克公司前首席执行官Roy Vagelos告诉一个国会委员会,NIH耗资6亿美元的努力能克服业界无法解决的问题——这个想法就像是相信“有精灵存在一样”。

因此,在该计划启动后不久,Collins的得意门生、掌管美国国家转化科学促进中心(NCATS)的Chris Austin便面临着拿出成功例子的巨大压力。目前,NCATS已经有了一些成功案例,比如发现一种名为氯环嗪的现有抗组胺剂会阻碍丙肝病毒感染细胞的能力。在2014年埃博拉疫情肆虐期间,通过采用强力手段筛选化学物质,NCATS研究人员还辨别出53种阻止该病毒进入细胞的化合物。

不过,没有哪项发现像VTS-270这样成功。VTS-270是一种针对无法治愈的罕见遗传性疾病——C型尼曼匹克氏症(NPC)的治疗方法。该疗法的早期研发由NCATS协调成立的协作组开展,并在随后移交给位于马里兰州盖瑟斯堡市的小型公司Vtesse负责。然而,这个成功故事里的早期篇章如今正在被重写,因为它引发了关于协作组参与者是否对一个关键挫折给予了轻描淡写的问题。

目前,Vtesse正在进行药物的后期临床试验。这是一种名为环糊精的大型糖分子,通过腰椎穿刺被注射进NPC儿童患者的脊髓液内。不过,在通往当前试验的道路上存在一个很大的障碍。当时,由NCATS召集的团队在其首次尝试中利用通常被用于注射脑癌化疗药物的植入式“储液器”,将该药物直接注射进存放脑脊液的脑室。在3名儿童中,有两人的脑室很快被感染,而试验于2013年4月30日被暂停。

这项被称为侧脑室药物注射ICV试验的研究之所以重新回到聚光灯下,是因为一位母亲最近要求对一篇出现在《医药化学当前论题》期刊上的文章进行修正。这位母亲有两个受到NPC折磨的孩子。该文章由25位作者撰写,描述了政府、学术研究人员和倡导团队之间的合作。它使得ICV试验成为团队合作的榜样,即令药物加速通过早期研发阶段并且提高被商业化的几率。试验在临床上被叫停的9天后,该文章被提交至《医药化学当前论题》期刊,并在2个月后被修改,然后直到2014年才被发表。不过,它并未提及上述试验的失败以及对直接大脑给药路径的放弃。

Chris Hempel有一对目前已经12岁但患有NPC的双胞胎女孩,并且是倡导研发NPC疗法的知名人士。近日,她向《医药化学当前论题》期刊编辑Allen Reitz指出了上述疏忽。Reitz则表示,他正在准备发布一个纠错。(宗华)


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