FDA批准阿兹海默症药後 最少3名顾问小组成员请辞
《CNBC》报道,美国食品及药物管理局(FDA)顾问小组自批准渤健(Biogen)(BIIB.US)阿兹海默症(Alzheimer)药物使用後,最少已有3名委员请辞。
最新请辞委员为哈佛医学院药物教授Aaron Kesselheim,他在请辞信中批评,准许使用该药为美国近代史上最糟糕的药物批准许可。他又指摘当局基於具争议性的前提,最後一刻转为快速审批。他认为当局目前不能适当地因应委员会的科学建议作出审批,损害对病人的护理及公众信任。当局决定与独立专家小组的建议相违,小组去年秋季未有支持该药使用,认为数据欠缺说服力。
其余已请辞的委员为Mayo Clinic神经病学家David Knopman及华盛顿大学神经病学家Joel Perlmutter。
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