Coronavirus Cases Have Surged, But The US Is Refusing To Take The World’s Most Available Masks
As hospitals around the country desperately seek N95 respirator masks to protect health care workers treating COVID-19 patients, the federal government has blocked imports of what might be the world’s most abundant alternative.
That mask is designed to filter out at least 95% of particles that are 0.3 microns or larger in size — the same measure used for the scarce N95 mask. Like the N95, it fits closely around the nose and mouth, creating a seal that decreases the risk of infection. And the Centers for Disease Control has said it’s as effective as N95, which is certified under US testing standards. But this second type of mask, called the KN95, complies with slightly different norms and is made in factories that have not been certified by the US government.
By law, masks, along with most medical devices, can’t be imported or sold in the United States without the Food and Drug Administration’s say-so. Last week, to ease the national shortfall of protective gear, the FDA issued an emergency authorization for non-N95 respirators that had been certified by five foreign countries as well as the European Union. It conspicuously left the KN95 masks out of the emergency authorization.
The omission was all the more startling because in late February the Centers for Disease Control and Prevention said that KN95 masks were one of numerous “suitable alternatives” to N95 masks “when supplies are short.”
The FDA did not respond to multiple requests for comment.
A significant majority of all respirator masks, including both the N95 and KN95, are manufactured in China. During the height of that country’s outbreak, China restricted exports of virtually all respirator masks, keeping them for domestic use. As that country’s infection numbers have slowed it has eased those restrictions, but now the US must compete with dozens of other countries desperate to acquire masks.
Allowing the importation and use of KN95 could help to greatly alleviate the scarcity.
“The KN95 masks are far more readily available,” said Bob Tilton, who owns a New Jersey–based cosmetics packaging importer and earlier this month decided to use his familiarity with Chinese supply chains to bring in masks and other personal protective equipment to sell to hospitals. “The N95s are much harder to grab.”
Yet without the FDA’s seal of approval, importers are hesitant to order KN95 masks because they worry they’ll get held up at customs. Many hospitals are refusing to accept them, even as free donations, because they fear legal liability should a health care worker get ill while using a nonpermitted device.
Under ordinary circumstances, N95 masks — which are certified by the National Institute for Occupational Safety and Health — are abundant, available at hardware stores and pharmacies for around $1 apiece and for as little as 35 cents apiece wholesale. But in just two months, the coronavirus pandemic has depleted the world’s supply, creating a gray market that has driven prices for a single mask as high as $12 or more. That, in turn, has opened the door to unscrupulous actors running internet scams that take payment for N95 masks they never deliver, and to others selling counterfeit or mislabeled N95 masks, which could put health care workers at serious risk of infection.
Meanwhile, masks made under the newly permitted US standards — Australia, Brazil, Japan, Korea, Mexico, and the EU — are not made in as great quantities as the N95 or KN95, according to industry experts.
Tilton is one of a growing number of entrepreneurs and do-gooders who have rushed to find ways to bring respirators into the country to meet the urgent national need. The federal government recently estimated that the US would require 3.5 billion masks over the next year to address COVID-19.
Earlier this month Tilton applied for and received a medical device importer’s license from the FDA and soon thereafter inked a deal to sell 111,000 masks to a large hospital group in New Jersey. Because of the scarcity and high cost of the N95 masks, he split the order between those and KN95 masks and worries that some may get held up. “You don’t want to risk $500,000 or $1 million on a shipment of masks in hopes the customs people look away,” said Tilton. “I’m not going to take any more orders until I know we can get everything through.” A spokesperson for Customs and Border Patrol, which oversees all imports, said that the agency had recently intercepted various COVID-19-related products coming into the country because they were either counterfeit or not permitted, but could not elaborate on whether any were KN95 masks. An advisory paper published by law firm Covington and Burling last week predicted “increased screening, examination, and sampling at ports” of medical devices. Some believe that the FDA’s omission may be motivated by rising tensions between the US and China during the outbreak. Earlier this month, President Donald Trump made a point of referring to the pathogen as the “Chinese virus,” while last week Secretary of State Mike Pompeo’s insistence on calling it the “Wuhan virus” led to the spiking of a G7 joint communiqué on the pandemic. “It seems like this is happening for political reasons,” said Byron Walker, who owns SurivalFrog.com, an online store that focuses on survival gear. After noticing a month ago that his own small inventory of N95 masks had sold out overnight, he decided to try to import many more. He reached out to the Colorado Department of Human Services and agreed to sell it 50,000 masks at cost, and plans to donate an additional 10,000 masks to hospitals in Denver, where he lives. After considerable effort, Walker was able to source the masks at a cost of more than $3 and is awaiting the first shipments early this week. But he says he could have ordered at least twice as many KN95 masks if they were permitted. Vernessa Pollard, an attorney at McDermott Will & Emery whose practice focuses on FDA law and who formerly worked at the agency, dismisses such concerns. She said she was aware of several health care providers that had been inquiring about authorization from the FDA to import KN95 masks, and understood that the agency was reviewing scientific data to determine that the respirators were truly equivalent. “My belief is the FDA is looking at the KN95 to be allowed to be imported,” Pollard said. “It’s science-based. I don’t believe there is anything political at all.” In the meantime, however, prices for the US-approved N95 masks continue to surge. One survey of offers from China on Friday showed KN95 masks averaged significantly less than half the price — roughly $1.44 compared to $3.60 apiece. Although some hospitals flat-out reject KN95 masks at any price on advice of their lawyers, people rounding up masks to give to hospitals have found that individual doctors or nurses will often accept the donations, given the dire need. On March 17, the CDC issued guidance saying that health care personnel could use bandanas, scarves, or other “homemade masks” as “a last resort.” Despite the import restrictions, some KN95 masks are trickling through. The FDA has set up several special email addresses for inquiries about shortages, and several importers said that prior to the EUA issued last week, they had received guidance from agency officials that small shipments of KN95 would likely not be stopped at the border. Some of those masks are already working their way into the consumer marketplace. Although N95 masks have been sold out for at least a month, KN95s have begun appearing in retail stores.
The Farms, a neighborhood market in Santa Monica, California, had masks labeled “KN95” for sale at $8.99 for a two-pack, or close to $5 apiece with tax, on Saturday evening. According to an employee who answered the phone, they were sold out by the next morning. “We should have more tomorrow,” the employee said. Karen Conway, an executive at GHX, which provides technological solutions to supply chain management for the health care industry, said that given the extreme shortages, “the most important thing is to get health care workers what they need.”
文章中谈到50个在这个病毒工作组里的成员的评论。不要说这个媒体左啦右了，读一下关于事实描述的部分再做评判。
建议读英文全文，就是比较长。下面是Google 机器翻译的，当然翻译得不咋地。
Original article: The Lost Month: How a Failure to TestBlinded the U.S. to Covid-19
https://www.nytimes.com/2020/03/28/us/testing-coronavirus-pandemic.html
早些时候，负责捍卫美国抵抗冠状病毒的十几名联邦官员日复一日地聚集在白宫局势室，被危机所消耗。他们努力解决如何撤离在中国武汉的美国领事馆，禁止中国旅行者和从钻石公主号和其他游轮中解救美国人的问题。
几名参与者回忆说，冠状病毒工作队的成员通常只花五到十分钟（通常是在有争议的会议结束时）谈论测试。领导们向其他人保证，疾病控制与预防中心已经开发出一种诊断模型，并将其作为第一步迅速推出。
但是，由于致命病毒从1月下旬至3月初在中国以凶猛的方式从中国传播开来，因此并未对可能感染者进行大规模测试-由于技术缺陷，监管障碍，日常事务官僚主义根据对50多名现任和前任公共卫生官员，行政官员，高级科学家和公司高管的采访，他们缺乏多层领导能力。
结果是一个月的损失，当时世界上最富裕的国家（配备了一些训练有素的科学家和传染病专家）浪费了控制病毒传播的最佳机会。相反，美国人对即将来临的公共卫生灾难的规模视而不见。
前C.D.C.托马斯·弗里登（Thomas Frieden）博士说，在进行“太迟”之前，没有进行有力的筛查表明整个政府都失败了。导向器。约翰·霍普金斯大学的流行病学家詹妮弗·纳佐（Jennifer Nuzzo）说，特朗普政府对病原体潜在影响的看法“极为有限”。美国食品药品监督管理局前局长玛格丽特·汉堡博士说，这一失误使“病例呈指数增长”。
参与抗击该病毒的高级政府科学家安东尼·福西博士（Anthony S. Fauci）告诉国会议员，早期无法测试是政府对致命的全球性大流行的反应的“失败”。他在随后的一次杂志采访中问：“为什么？我们无法进行更大范围的动员吗？”
他们说，在整个政府中，负责检测和应对冠状病毒等威胁的三个机构未能足够迅速地做好准备。甚至当科学家们看着中国并发出警报时，这些机构的负责人都没有传达出敦促不设防的防御措施的紧迫性。
现年68岁的罗伯特·雷德菲尔德（Robert R. Redfield）博士曾经是一名军事医生，是著名的艾滋病研究人员，领导着美国疾病预防与控制中心（C.D.C.）。他信任他的资深科学家为这一冠状病毒创建了世界上最精确的测试方法，并与州实验室共享。当测试中的缺陷在2月变得明显时，他承诺会迅速解决，尽管解决方案花了数周的时间。
C.D.C.还严格限制了可以接受测试的人，并且对进行“基于社区的监视”（这种基于社区的监视）的速度很慢，这是一种检测病毒可及范围的标准筛选方法。如果美国能够追踪其最早的动向并找出隐藏的热点，那么当地的隔离可能会限制这种疾病。
美国食品药品监督管理局（FDA）局长60岁的斯蒂芬·哈恩（Stephen Hahn）实施的法规反常使医院，私人诊所和公司在紧急情况下进行诊断测试变得更加困难。动员企业的其他国家/地区每天要进行数万次检测，而在美国，平均水平不到100次，这使当地的卫生官员，议员和绝望的美国人感到沮丧。
领导卫生和公共服务部的亚历克斯·M·阿扎尔二世（Alex M. Azar II）负责监督其他两个机构，并协调政府对大流行的公共卫生应对措施。当公众对测试问题的批评加剧时，他感到沮丧，但他无法推动任何一家机构加快或改变方向。
52岁的阿扎尔先生一直担任冠状病毒特别工作组的主席，直到2月下旬由副总统迈克·彭斯（Mike Pence）负责。该工作队与总统的首席联络人是代理白宫办公厅主任米克·穆尔瓦尼（Mick Mulvaney），他被特朗普先生驱逐出境。没有高层的关注或行动的要求，测试问题就恶化了。
在那关键的损失月份开始之初，当他的政府可能会集结时，总统因弹imp和疏忽对公众健康或国家经济的威胁而分心。到本月底，特朗普先生声称该病毒即将在美国消散，他说：“它将消失。有一天，这就像奇迹，它将消失。”
到3月初，联邦官员终于宣布对扩大测试范围进行更改之后，为时已晚。随着时间的流逝，遏制不再是一种选择。流行病学的工具包将转移—封锁，社会破坏，强化治疗—希望减轻危害。现在，美国有超过100,000例冠状病毒病例，在世界上任何国家中最多。死亡人数在上升，城市被关闭，经济在飞速发展，日常生活得到了改善。仍然，许多因病毒而生病的美国人无法接受检查。
白宫发言人贾德·迪尔（Judd Deere）在一份声明中说：“任何关于特朗普总统没有认真对待Covid-19威胁或美国未做好准备的建议都是错误的。”他补充说，在特朗普先生的领导下，政府“扩大了测试能力。”
世界卫生组织高级顾问布鲁斯·艾尔沃德博士上个月率领专家组前往中国，研究这种神秘的新病毒。他说，测试对于理解如何战胜某种疾病“绝对至关重要”，这是一种区别于其他疾病，疾病范围以及最重要的是其通过人群的途径。
艾尔沃德博士说：“你想知道你是否有它。” “您想知道周围的人是否拥有它。因为你知道吗？然后，您可以停止它。”
他警告说：“你无法阻止它，如果你看不到它。”
令人震惊的挫折
罗伯特·雷德菲尔德（Robert Redfield）博士是在元旦前后与家人度假时，第一次从中国同行那里得知这种病毒的严重性。他在电话上花费了太多时间，以至于他们几乎看不到他。他所听到的使他不安。几天后，在一场关于病毒的严峻谈话中，中国疾病预防控制中心主任乔治·F·高哭了起来。
长期担任爱滋病研究人员的雷德菲尔德（Redfield）博士在被任命为C.D.C.领导人之前从未经营过政府机构。在2018年之前，他的首要任务一直是抗击阿片类药物的流行和艾滋病毒的传播。突然之间，一个在海地或非洲偏爱于治疗患者而不是在公共场所刺眼的男人正面临着新的大流行威胁。
最初，雷德菲尔德博士的代理机构迅速采取行动。
1月7日，为冠状病毒建立了“事件管理系统”，并建议前往武汉的旅行者采取预防措施。到1月20日，也就是中国科学家共享该病毒的基因序列后的两周，C.D.C。像往常一样已经开发了自己的测试，并将其部署到该国的第一例冠状病毒病例中。
雷德菲尔德博士在随后的一次采访中说：“这是我们的首要任务，着眼于这件事。”
评估病毒具有挑战性。它太新了，科学家几乎没有信息可以使用。中国提供的数据有限，并拒绝了阿扎尔先生和雷德菲尔德博士的早期尝试，将C.D.C.那里的专家了解更多。该病毒不会引起任何症状，但仍会传播-最初尚不为人所知-使它变得更加难以理解。
为了识别病毒，请使用C.D.C.该测试使用了三个小的遗传序列，以与从拭子中提取的一部分病毒基因组相匹配。德国开发的一项测试在分发给其他国家/地区时仅使用了两个，可能会使其准确性降低。
但是在F.D.A.之后不久清除了C.D.C.与州卫生部门实验室共享其测试套件时，有些发现了问题。第三个序列或“探针”给出了不确定的结果。而C.D.C.探索了原因-污染或设计问题-它告诉那些国家实验室停止测试。
令人震惊的挫折阻止了C.D.C.在最重要的时候追踪该病毒的努力。根据C.D.C.的网站，到2月中旬，美国每天仅检测约100个样本。
几名政府官员说，雷德菲尔德博士在与阿扎尔先生的工作组会议和对话中淡化了这个问题，并确保他将很快得到解决。
由于容量有限，因此C.D.C.的受检者标准在接下来的几周内仍然非常狭窄：只有最近来过中国或与感染该病毒的人接触过的人。
各州缺乏检测手段也意味着当地公共卫生官员不能使用另一种基本的流行病学工具：监测检测。为了了解病毒可能隐藏在何处，还将对从筛查普通流感的人的鼻拭子样本中检查冠状病毒。
C.D.C. 2月14日宣布了一项计划，在纽约，芝加哥，洛杉矶，旧金山和西雅图这五个高风险城市进行放映。一位机构官员说，它可能会提供“预警信号，以触发我们应对策略的改变。”但是大多数城市无法执行。
约翰·霍普金斯大学（Johns Hopkins）的纳佐（Nuzzo）博士说：“如果从一开始我们就进行了更多的测试，并且较早地发现了案件，那么我们将处在截然不同的地方。”
到2月底，后果变得显而易见。在西雅图地区，第一次没有人接触该病毒或有旅行史的人检测为阳性，一个多月前在美国发现了第一例。研究人员后来得出结论，该病毒可能已经在那里和其他地方传播了数周。如果没有更完整的感染者资料，公共卫生工作者就无法进行“接触追踪”，即找到所有具有传染性的人与之互动的人，然后隔离他们以阻止进一步的传播。
C.D.C.几乎没有考虑采用W.H.O.使用的测试C.D.C.的测试正在其自己的实验室中进行-仍在处理各州的样品-使机构官员充满信心。该机构的主要副主任安妮·舒卡特（Anne Schuchat）博士稍后会说，认为“我们需要别人的测试”。
还有德国设计的W.H.O.测试尚未通过美国监管机构的批准程序，这需要时间。
整个2月，雷德菲尔德博士在美国哥伦比亚特区的亚特兰大之间穿梭。总部设在华盛顿，华盛顿每天与Azar先生打多次电话，并参加冠状病毒工作队。
阿扎尔先生的负责任风格与雷德菲尔德博士的审慎态度形成鲜明对比，雷德菲尔德博士缺乏令特朗普印象深刻的那种指挥电视台。正如一位同事所描述的那样，他是“一个共识的人”，他努力避免冲突。他在很大程度上依赖C.D.C.的职业科学家，例如该机构国家免疫与呼吸疾病中心主任Schuchat博士和Nancy Messonnier博士。
在国会的审查下，雷德菲尔德博士表示放心。他在2月24日回应49名国会议员关于在美国进行测试的必要性的信时说，“疾病预防控制中心的积极反应使我们能够及早发现潜在案件并确保妥善处理。”
几天后，他的机构提供了一种解决方法，告诉州和地方卫生部门的实验室他们终于可以开始测试了。他们应该等待C.D.C.测试工具包，省去有问题的第三个探针。
同时，随着该病毒在韩国和意大利传播，该机构的流行病学家越来越担心。 2月25日，Messonnier博士作了简报，警告比平常大得多。她说：“破坏日常生活可能会很严重。”
据高级政府官员称，特朗普先生从印度之旅返回时感到非常愤怒。那天晚些时候，阿扎尔先生似乎正在降低关切的程度。他在新闻发布会上说，梅森尼尔博士的全部意思是，人们应该“开始思考自己的生活中可能涉及的问题。”
“可能。”阿扎尔先生强调地说。 “可能涉及。”
测试的障碍
斯蒂芬·哈恩（Stephen Hahn）博士担任F.D.A.的第一天专员是在阿扎尔先生于1月31日宣布突发公共卫生事件仅仅六周前到来的。一名放射肿瘤学家和研究员帮助扭转了美国主要癌症中心之一的休斯顿的MD安德森病，哈恩博士来到华盛顿进行监督一个庞大的联邦机构，负责监管从救生疗法到狗食的所有事务。
但是一夜之间，他的使命-以精确和谨慎定义的文化来管理15,000名员工-被推翻了。特朗普后来称其为“无形的敌人”的病原体正在向美国蔓延。这将由新来的哈恩博士来帮助建立一个庞大的国家能力，以进行学术和私人实验室的测试。
相反，在他的领导下，联邦军据现任和前任官员以及全国实验室的研究人员和医生称，这已成为一个重要的障碍。
私人部门的测试应该是继C.D.C.履行了在公共实验室开始筛查的义务。在其他受到冠状病毒打击严重的国家，政府迅速采取行动，加快了对其人口的检测速度。例如，在韩国，监管机构于2月初召集了20家医疗制造商的高管，他们放宽了要求测试的规定。
但是哈恩博士采取了谨慎的态度。遵循F.D.A.通常批准医疗检查的繁琐方法后，他没有主动与制造商联系，而是顺服了他的科学家。
甚至美国的公共卫生实验室都在寻求F.D.A.的帮助。 “我们现在已经有数周的回复时间了，在C.D.C.之外仍然没有可用的诊断或监视测试。对于我们绝大多数会员实验室而言，”公共卫生实验室协会首席执行官斯科特·贝克尔（Scott Becker）在2月下旬给哈恩先生写信。 “我们认为目前需要一条更快捷的路线。”
具有讽刺意味的是，正是阿扎尔先生的紧急声明确立了哈恩博士坚持遵循的规则。这样的声明旨在使制药商在危机期间更容易进行疫苗和其他疗法的治疗，该声明使F.D.A.快速批准，否则可能需要一年或更长时间。
但是，紧急公告为想要创建自己的测试以诊断冠状病毒的医院和实验室创造了新的障碍。通常，他们面临的联邦法规极少。但是，一旦阿扎尔先生采取行动，他们就必须接受F.D.A.此过程称为“紧急使用授权”。
尽管全国各地的研究人员很快开始创建可以诊断Covid-19的测试，但许多人表示，他们受到联邦调查局（F.D.A.）批准程序的阻碍。新测试未在全国各地的实验室使用。
斯坦福大学就是其中之一。根据世界卫生组织（W.H.O）发布的协议，这所世界知名大学的研究人员已于2月进行了工作测试。该组织已经向全球70个实验室提供了超过25万个德国设计的测试，斯坦福实验室的医生希望为大流行做好准备。
实验室的医学主管本杰明·平斯基（Benjamin Pinsky）博士说：“即使没有来，也要比不准备好。”
但是面对平时在外交部所说的“相对严格”的规则，平斯基博士和他的同事们决定甚至拒绝争取许可。斯坦福大学的临床实验室直到3月初才开始测试冠状病毒样品，当时哈恩博士终于放宽了规定。
法国诊断公司bioMérieux的高管也有类似的经历。该公司制造了一个台面测试系统BioFire，该系统通常用于检查全国1700所医院的流感和其他呼吸道疾病。
“我们很多人都说过，您典型的E.U.A.要求太高了，”该公司首席医疗官马克·米勒（Mark Miller）提到紧急批准时说。 “这将花费太多时间。你不能做些什么来缩短它吗？”
F.D.A.的官员米勒博士说，试图做出回应。但是，该机构并没有抛出规则，只是修改了监管要求，仍然需要数周的讨论和谈判。
与F.D.A.交谈后2月中旬，该公司于3月24日获得了BioFire测试的紧急批准。（该公司还于1月开始与FDA讨论另一种测试类型，但决定暂时不在美国进行。）米勒说，尽管他最终对FDA的行动感到满意，但政府的总体反应太慢，尤其是在后勤问题上，例如为需要的人提供足够的测试用品。
他说：“您有其他国家-很抱歉，不幸的是，美国是其中一个国家-那里的发展缓慢，混乱。” “那里仍然没有足够的测试来测试每个需要它的人。”
在通过电子邮件发送的声明中，哈恩博士坚称，他的代理机构已尽其所能安全地尽快行动，以确保测试准确无误。他说：“自大流行之初以来，联邦调查局的大门一直而且仍然向测试开发人员开放。”
缺乏信任
一月底，亚历克斯·阿扎尔（Alex Azar）表现出自信。在笨拙的H.H.S.新闻发布会上他说，他已经控制了政府对新的冠状病毒的反应，并指出他在2003年SARS爆发期间曾在部门中担任的高级职务和其他传染性威胁。
他告诉记者：“我非常了解这本剧本。”
阿扎尔（Azar）曾是耶鲁大学（Yale）培训过的律师，曾担任卫生部门的高级律师，在全球最大的制药公司之一礼来公司（Eli Lilly）担任高级行政官已有十年之久。但他之所以引起特朗普的注意，部分原因是他还拥有其他资格：在法学院毕业后，阿扎尔（Azar）是美国一些最保守的法官的书记员，其中包括最高法院法官安东宁·斯卡利亚（Antonin Scalia）。两年来，他担任肯·斯塔尔（Ken Starr）的克林顿·怀特沃特（Clinton Whitewater）调查副手。
正如特朗普第二任卫生部长在2018年初确认的那样，阿扎尔先生迅速称赞总统，并专注于他关心的问题：降低药品价格和打击阿片类药物成瘾。 2月6日-即使是W.H.O.宣布全球范围内有超过28,000例冠状病毒病例-阿扎尔先生在白宫东厅的第二排，表明了他对总统的忠诚，因为特朗普先生声称前一天因弹each无罪而被平反并遭到抨击反对“邪恶”的立法者和联邦调查局的“败类”。
据知情机构内部对病毒的反应的知情人士说，随着一月和二月公众对病毒威胁的关注日益增强，阿扎尔先生对其部门和向他报告的机构负责人的严厉关注日益感到沮丧。
阿扎尔被一些政府官员形容为多刺的老板，长期以来一直与医疗保险和医疗补助计划负责人西玛·维尔玛（Seema Verma）发生争执，他最近在特朗普先生关于大流行的电视简报中成为常任理事国。尽管有一些F.D.A.专员的助手参加了H.H.S.关于这个问题的会议。
随着测试问题的持续存在，秘书与雷德菲尔德博士之间的紧张关系日益加剧。阿扎尔（Azar）先生和雷德菲尔德（Redfield）博士每天至少打六遍电话。但整个2月，以C.D.C.据几位政府官员称，阿扎尔先生坚信测试工作步履蹒跚，雷德菲尔德博士的代理机构正在向他提供有关秘书公开重复进行的测试的不准确信息。
有一次，阿扎尔先生出现在周日早上的新闻节目中，并说已经对3,600多人进行了这种病毒的检测。实际上，实际数字要小得多，因为许多患者已经过多次测试，因此C.D.C.那个星期不得不纠正国会的证词。一位卫生部门官员说，阿扎尔先生一再向人们保证，将在一周或十天之内广泛使用C.D.C.C.的测试，而一周后才得到同样的承诺。
当被问及对其机构对大流行病反应的批评时，雷德菲尔德博士说：“我个人并没有关注他们是在这里还是那里指责。我们致力于尽一切可能尽快解决这场爆发并确保美国安全。”
阿扎尔先生的盟友说，雷德菲尔德博士和福西博士告诉他说C.D.C.拥有所需的资源，没有理由相信该病毒正在人与人之间传播，并且仅对符合特定条件的人进行检测非常重要。
但是，即使面对全国各地医生和卫生保健研究人员的抱怨越来越多的情况，阿扎尔先生也未能迫使他领导下的人做一件事可能会有所帮助：扩大检测范围。
阿扎尔（Azar）的女发言人凯特琳·奥克利（Caitlin Oakley）在一份声明中说，秘书在测试问题上“授权并遵循了世界知名的美国科学家的指导”。她说：“任何暗示阿扎尔秘书都没有对紧急响应或测试工作采取紧急措施的暗示，这完全是错误的，事实不成立。”
到2月26日，Fauci博士担心停滞的测试已成为迫切需要解决的问题。他给阿扎尔（Azar）的参谋长布莱恩·哈里森（Brian Harrison）打电话，并要求他召集监督甄选工作的官员小组。
2月27日中午左右，哈恩（Hahn）博士，雷德菲尔德（Redfield）博士和美国外交部的高级助手和H.H.S.拨入电话会议。哈里森先生的最后通：是：直到我们解决测试的滞后性，没人离开。一位高级政府官员回忆说，我们没有答案，我们需要答案。完成它。
到一天结束时，该小组同意F.D.A.应该放宽法规，以便医院和独立实验室可以通过自己的测试快速前进。
但是在前一天晚上，当特朗普先生突然将彭斯先生接管时，阿扎尔先生已被免职，担任特遣队负责人。这一决定如此刻骨铭心，以至于白宫最高卫生官员都知道了这一点。在观看公告时。
默许
前任总统迅速采取行动，通过安装“沙皇”来管理白宫内部的疾病威胁。
在2014年埃博拉病毒爆发期间，总统巴拉克·奥巴马（Barack Obama）聘请了他的副总统前参谋长罗恩·克莱恩（Ron Klain）指导西翼行动。奥巴马先生随后在国家安全委员会内部设立了全球健康安全办公室，以协调未来的危机。
“如果从历史上看，在美国遇到诸如此类的挑战时，无论是H.I.V.危机，不管是大流行，还是其他问题-伙计们，他们全力以赴地阻止了整个系统，并使它们发挥作用，” W.H.O。Aylward博士说。流行病学家。
但面对冠状病毒，特朗普先生选择在计划开始后近两个月才让白宫领导该计划。奥巴马先生的全球卫生办公室已于一年前解散。而且在彭斯先生接管之前，工作队还没有一名白宫官员有权采取行动。
从那时起，测试迅速增加，医院和其他地方的近100个实验室进行了测试。上周五，医疗保健巨头雅培公司（Abbott）表示已获得一项便携式测试的紧急批准，该测试可在五分钟内检测出该病毒。
总统星期二吹嘘说，美国“创建了一个新系统，现在我们正在做令人难以置信的大量测试”。他说，过去八天美国对韩国的冠状病毒检测工作比韩国八周内进行的检测更多。
然而，全国各地的医院和诊所仍必须拒绝对症状较轻的人进行检查，以挽救最严重的情况，而且他们通常要等待一周才能得到结果。特朗普默契地承认了短缺，周一要求韩国总统从那里每天生产的10万个中发送尽可能多的测试包，超出韩国的需求。
公共卫生专家对增加的能力作出了积极反应。但是，在中国首次披露该病三个月后，就具有诊断这种疾病的能力，并不能说明为什么美国未能尽早做到这一点，因为这可能有助于减轻大流行病的人数。
波士顿大学医学院特殊病原学小组医学主任纳希德·巴德里亚博士说：“测试是将所有其他问题联系在一起的裂缝，它将其余的响应分开。”
她说：“它渗透到我们回应的其他各个方面，触动了我们所有人。” “测试的延迟影响了整体响应。”
Coronavirus Cases Have Surged, But The US Is Refusing To Take The World’s Most Available Masks
As hospitals around the country desperately seek N95 respirator masks to protect health care workers treating COVID-19 patients, the federal government has blocked imports of what might be the world’s most abundant alternative.
That mask is designed to filter out at least 95% of particles that are 0.3 microns or larger in size — the same measure used for the scarce N95 mask. Like the N95, it fits closely around the nose and mouth, creating a seal that decreases the risk of infection. And the Centers for Disease Control has said it’s as effective as N95, which is certified under US testing standards. But this second type of mask, called the KN95, complies with slightly different norms and is made in factories that have not been certified by the US government.
By law, masks, along with most medical devices, can’t be imported or sold in the United States without the Food and Drug Administration’s say-so. Last week, to ease the national shortfall of protective gear, the FDA issued an emergency authorization for non-N95 respirators that had been certified by five foreign countries as well as the European Union. It conspicuously left the KN95 masks out of the emergency authorization.
The omission was all the more startling because in late February the Centers for Disease Control and Prevention said that KN95 masks were one of numerous “suitable alternatives” to N95 masks “when supplies are short.”
The FDA did not respond to multiple requests for comment.
A significant majority of all respirator masks, including both the N95 and KN95, are manufactured in China. During the height of that country’s outbreak, China restricted exports of virtually all respirator masks, keeping them for domestic use. As that country’s infection numbers have slowed it has eased those restrictions, but now the US must compete with dozens of other countries desperate to acquire masks.
Allowing the importation and use of KN95 could help to greatly alleviate the scarcity.
“The KN95 masks are far more readily available,” said Bob Tilton, who owns a New Jersey–based cosmetics packaging importer and earlier this month decided to use his familiarity with Chinese supply chains to bring in masks and other personal protective equipment to sell to hospitals. “The N95s are much harder to grab.”
Yet without the FDA’s seal of approval, importers are hesitant to order KN95 masks because they worry they’ll get held up at customs. Many hospitals are refusing to accept them, even as free donations, because they fear legal liability should a health care worker get ill while using a nonpermitted device.
Under ordinary circumstances, N95 masks — which are certified by the National Institute for Occupational Safety and Health — are abundant, available at hardware stores and pharmacies for around $1 apiece and for as little as 35 cents apiece wholesale. But in just two months, the coronavirus pandemic has depleted the world’s supply, creating a gray market that has driven prices for a single mask as high as $12 or more. That, in turn, has opened the door to unscrupulous actors running internet scams that take payment for N95 masks they never deliver, and to others selling counterfeit or mislabeled N95 masks, which could put health care workers at serious risk of infection.
Meanwhile, masks made under the newly permitted US standards — Australia, Brazil, Japan, Korea, Mexico, and the EU — are not made in as great quantities as the N95 or KN95, according to industry experts.
According to 3M, the world’s largest mask manufacturer, the KN95 is “equivalent” and “can be expected to function very similar” to the N95 mask. That opinion was echoed on Feb. 29 by the CDC, which said the KN95 is one of seven foreign-certified respirators “expected to provide protection to workers.”
Tilton is one of a growing number of entrepreneurs and do-gooders who have rushed to find ways to bring respirators into the country to meet the urgent national need. The federal government recently estimated that the US would require 3.5 billion masks over the next year to address COVID-19.
Earlier this month Tilton applied for and received a medical device importer’s license from the FDA and soon thereafter inked a deal to sell 111,000 masks to a large hospital group in New Jersey. Because of the scarcity and high cost of the N95 masks, he split the order between those and KN95 masks and worries that some may get held up. “You don’t want to risk $500,000 or $1 million on a shipment of masks in hopes the customs people look away,” said Tilton. “I’m not going to take any more orders until I know we can get everything through.” A spokesperson for Customs and Border Patrol, which oversees all imports, said that the agency had recently intercepted various COVID-19-related products coming into the country because they were either counterfeit or not permitted, but could not elaborate on whether any were KN95 masks. An advisory paper published by law firm Covington and Burling last week predicted “increased screening, examination, and sampling at ports” of medical devices. Some believe that the FDA’s omission may be motivated by rising tensions between the US and China during the outbreak. Earlier this month, President Donald Trump made a point of referring to the pathogen as the “Chinese virus,” while last week Secretary of State Mike Pompeo’s insistence on calling it the “Wuhan virus” led to the spiking of a G7 joint communiqué on the pandemic. “It seems like this is happening for political reasons,” said Byron Walker, who owns SurivalFrog.com, an online store that focuses on survival gear. After noticing a month ago that his own small inventory of N95 masks had sold out overnight, he decided to try to import many more. He reached out to the Colorado Department of Human Services and agreed to sell it 50,000 masks at cost, and plans to donate an additional 10,000 masks to hospitals in Denver, where he lives. After considerable effort, Walker was able to source the masks at a cost of more than $3 and is awaiting the first shipments early this week. But he says he could have ordered at least twice as many KN95 masks if they were permitted. Vernessa Pollard, an attorney at McDermott Will & Emery whose practice focuses on FDA law and who formerly worked at the agency, dismisses such concerns. She said she was aware of several health care providers that had been inquiring about authorization from the FDA to import KN95 masks, and understood that the agency was reviewing scientific data to determine that the respirators were truly equivalent. “My belief is the FDA is looking at the KN95 to be allowed to be imported,” Pollard said. “It’s science-based. I don’t believe there is anything political at all.” In the meantime, however, prices for the US-approved N95 masks continue to surge. One survey of offers from China on Friday showed KN95 masks averaged significantly less than half the price — roughly $1.44 compared to $3.60 apiece. Although some hospitals flat-out reject KN95 masks at any price on advice of their lawyers, people rounding up masks to give to hospitals have found that individual doctors or nurses will often accept the donations, given the dire need. On March 17, the CDC issued guidance saying that health care personnel could use bandanas, scarves, or other “homemade masks” as “a last resort.” Despite the import restrictions, some KN95 masks are trickling through. The FDA has set up several special email addresses for inquiries about shortages, and several importers said that prior to the EUA issued last week, they had received guidance from agency officials that small shipments of KN95 would likely not be stopped at the border. Some of those masks are already working their way into the consumer marketplace. Although N95 masks have been sold out for at least a month, KN95s have begun appearing in retail stores.
The Farms, a neighborhood market in Santa Monica, California, had masks labeled “KN95” for sale at $8.99 for a two-pack, or close to $5 apiece with tax, on Saturday evening. According to an employee who answered the phone, they were sold out by the next morning. “We should have more tomorrow,” the employee said. Karen Conway, an executive at GHX, which provides technological solutions to supply chain management for the health care industry, said that given the extreme shortages, “the most important thing is to get health care workers what they need.”
https://www.buzzfeednews.com/article/kenbensinger/coronavirus-kn95-masks-us-wont-import-china
1月3号开始的每天通报WHO、美国，当然数字你可以不信。现在回想起来，湖北省政府（最起码也是那个湖北副书记的武汉书记）应该是最想捂盖子的，因为前两批人光靠武汉市自己是唬弄不住的。美国这边一直看笑话，还有最初那个不传白人的谣言应该也有影响，因为我确实在一些媒体及自媒体上看到过一些白人、黑人都这样表达过。当时有数据指出ACE2在不同人种上的区别，数字看上去像那么回事。当时有些声音提及这种区别在被感染时影响不大，但都被淹没了。
一月二月的时候，骂了太多中国政府。
想不到三月四月，会看到美国这副样子。
二月底三月初的时候，看到台湾一个节目，里面的卫生局官员就说了，
美国一个月后会很惨，会比欧洲惨，因为他们不承认，当做流感对待。
我觉得美国跟中国要赔偿，真的特别让人无语。 一个伟大的国家，沦落成这样。
就算真的被中国“骗”了，美国情报局，CDC，病毒研究所，各路科学家，都没有人能察觉吗？
就是傲慢，特别自大。
当初取笑亚洲人带口罩，结果亚洲国家好几个控制住了。
台湾香港和新加坡，得到的讯息跟美国不会差太多，但人家意识到了。
出乎意料的没有爆发，挺过第一波。