继炮轰美国食药监管局后 特朗普宣布了这一“重大突破”

当地时间23日，美国总统特朗普宣布紧急授权使用血浆疗法治疗新冠病毒肺炎。

美国食品药品监督管理局（FDA）在发布的声明中表示，“这种疗法已知和潜在益处超过了其潜在风险”，对治疗新冠病毒肺炎可能有效。另据FDA介绍，截至目前美国已有超6万人接受了恢复期血浆治疗。

尽管特朗普将此举吹捧为一项“历史性的突破”，却没能振奋人心。

包括美国传染病专家福奇在内的多名公共卫生专家都认为，该疗法相关数据仍显薄弱，缺乏有力的随机试验结果作为支撑。哈佛全球卫生研究所所长阿希什•贾更发出提醒，认为发布紧急使用授权（EUA）会使得此类试验变得更加困难， FDA的可信度也将进一步降低。

由于此前FDA曾因暂缓批准血浆疗法为新冠治疗方案遭到特朗普的猛烈抨击，不少美国媒体猜测，此次FDA转变口径的原因，可能受到特朗普政府的施压。

The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) on Sunday for investigational convalescent plasma for the treatment of COVID-19 in hospitalized patients.

It is part of the agency's ongoing efforts to fight COVID-19. Based on scientific evidence available, the FDA concluded this product may be effective in treating COVID-19 and that the known and potential benefits of the product outweigh the known and potential risks of the product, said a release of the agency.

The EUA authorizes the distribution of COVID-19 convalescent plasma in the United States and its administration by health care providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in hospitalized patients with COVID-19, said the FDA.

随着2020年美国大选日渐临近，新冠疫情的发展成为影响选民判断的重要变数之一。

寻求连任的特朗普近日更“火力全开”，他不仅用一则禁令剥夺了FDA监管实验室检测的资格，更在社交媒体上接连“发飙”，指责FDA为阻碍自己连任拖延疫苗试验导致疫苗“难产”。

在8月22日的推文中，特朗普点名FDA局长斯蒂芬•哈恩，称"'深层政府'或是FDA内部的一些人，让制药公司难以找到疫苗和疗法试验对象”，并指责哈恩的做法意在把疫苗发布推迟到11月3日以后。

此前哈恩一再强调，FDA致力于以科学为指导而不是服从于政治需要，不会在疫苗批核上走捷径。

各界人士担忧，将新冠疫苗视作政治筹码的特朗普政府，会在大选前把安全有效性未经证实的新冠疫苗投入使用。

众议院院长南希•佩洛西批评特朗普发表了“危险言论”。她强调，FDA审核药物必须基于其安全性和效用，而非白宫的声明，特朗普强行干预FDA做出科学决策的做法“将危及所有美国人的健康和福祉”。

The topic of the trade war between China and the U.S. has extended from the 2018 U.S. midterm elections to the context in which Trump is preparing to run for re-election in 2020.

U.S. President Donald Trump on Saturday sent a tweet in which he accused members of the "deep state" at the Food and Drug Administration of delaying the development of COVID-19 vaccines and drug therapies to thwart his re-election, Reuters reported.

"Obviously, they are hoping to delay the answer until after November 3. Must focus on speed, and saving lives!" Trump wrote, tagging FDA Commissioner Stephen Hahn in the tweet.

U.S. House Speaker Nancy Pelosi said it was a "dangerous statement" and that the president was "beyond the pale" for accusing the FDA of playing politics.

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