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2021-07-16

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Cleveland Clinic, Mount Sinai and Providence Won’t Give Biogen’s New Alzheimer’s Drug<blockquote>克利夫兰诊所、西奈山和普罗维登斯不会提供百健(Biogen)的阿尔茨海默病新药</blockquote>

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Three large hospitals are declining to administerBiogenInc.’sBIIB-6.79%new Alzheimer’s treatment, Aduhelm, the latest rupture to emerge from the Food and Drug Administration’s controversial approval of the drug last month.<blockquote>由于对Aduhelm有效性的争论，这三家医院运营商推迟了Aduhelm的使用。三家大型医院拒绝使用BiogenInc.的sBIIB-6.79%新的阿尔茨海默病治疗药物Aduhelm，这是美国食品和药物管理局上个月有争议地批准该药物后出现的最新破裂。</blockquote> The Cleveland Clinic, Mount Sinai Health System in New York and Providence in Renton, Wash., said they wouldn’t administer Aduhelm, which is also called aducanumab, to patients amid a debate about the drug’s effectiveness and whether the FDA lowered its standards in approving the medicine.<blockquote>克利夫兰诊所、纽约西奈山卫生系统和华盛顿州伦顿的普罗维登斯。，表示他们不会给患者服用Aduhelm，也称为aducanumab，因为人们正在争论该药物的有效性以及FDA是否降低了批准该药物的标准。</blockquote> The hospitals’ moves come as some health insurers also restrict access to the therapy—unusual pushback against a drug targeting a devastating disease like Alzheimer’s that has few effective treatments.<blockquote>医院采取这一举措之际，一些健康保险公司也限制了这种疗法的使用——这是对针对阿尔茨海默氏症等毁灭性疾病的药物的不同寻常的抵制，这种疾病几乎没有有效的治疗方法。</blockquote> While some doctors have been eager to start prescribing the newly approved drug, others have criticized the FDA for clearing the drug before studies proved it works. The critics have also expressed concerns about whether the drug’s benefits, which appeared to be modest in studies, are worth the risks of side effects such as brain bleeding that require regular monitoring by physicians.<blockquote>虽然一些医生渴望开始开这种新批准的药物，但其他人批评FDA在研究证明该药物有效之前就批准了该药物。批评者还对该药物的益处（在研究中似乎不大）是否值得冒脑出血等副作用的风险表示担忧，这些副作用需要医生定期监测。</blockquote> “Clinical studies failed to demonstrate the effectiveness of Aduhelm…while documenting significant risks, like brain swelling and bleeding,” said a spokeswoman for Blue Cross and Blue Shield of North Carolina, which won’t cover the drug for its commercially insured patients.<blockquote>北卡罗来纳州蓝十字和蓝盾公司的发言人表示：“临床研究未能证明Aduhelm的有效性……同时记录了脑肿胀和出血等重大风险。”该公司不会为其商业保险患者承保该药物。</blockquote> Federal officials recently began a monthslong review of whether Medicare will cover Aduhelm and under what circumstances. The vast majority of patients expected to get the drug are on Medicare, the federal insurance program for the elderly and disabled.<blockquote>联邦官员最近开始了为期数月的审查，审查医疗保险是否会覆盖Aduhelm以及在什么情况下覆盖。预计获得该药物的绝大多数患者都参加了联邦老年人和残疾人保险计划Medicare。</blockquote> The Cleveland Clinic won’t carry the drug in its pharmacy or provide infusions of it to patients following a review of available scientific evidence by a multidisciplinary panel of experts, a hospital spokeswoman said.<blockquote>医院发言人表示，在多学科专家小组审查现有科学证据后，克利夫兰诊所不会在其药房出售该药物，也不会向患者提供输液。</blockquote> Cleveland Clinic doctors, the spokeswoman said, can still prescribe the medicine, but patients will have to receive their infusions at an outside facility.<blockquote>这位发言人说，克利夫兰诊所的医生仍然可以开药，但患者必须在外部机构接受输液。</blockquote> Aduhelm is given with a monthly infusion, typically at an outpatient medical center. Biogenpriced the drug at $56,000 a year, though one health researcher said it will probably cost more for a typical patient.<blockquote>Aduhelm通常在门诊医疗中心每月输注一次。Biogen将该药物定价为每年56,000美元，不过one health研究人员表示，对于典型患者来说，该药物的价格可能会更高。</blockquote> “Based on the current data regarding its safety and efficacy, we have decided not to carry Aducanumab at this time,” the Cleveland Clinic said. The hospital said it will reconsider the decision when more data are available.<blockquote>克利夫兰诊所表示：“根据目前有关其安全性和有效性的数据，我们决定目前不携带Aducanumab。”医院表示，当有更多数据时，将重新考虑这一决定。</blockquote> Mount Sinai said it won’t infuse Aduhelm until it sees the findings of a U.S. government investigation into interactions between FDA staff and Biogen during the review process. The investigation, which was requested last week by FDA Acting Commissioner Janet Woodcock,has raised concernsabout the integrity of the approval process, Mount Sinai said.<blockquote>西奈山表示，在看到美国政府对FDA工作人员与Biogen在审查过程中互动的调查结果之前，不会注入Aduhelm。西奈山表示，FDA代理专员珍妮特·伍德库克(Janet Woodcock)上周要求进行的调查引发了人们对审批过程完整性的担忧。</blockquote> “Medical decisions should be based on science and data, so it is disappointing that patients living with Alzheimer’s disease may reportedly not be able to access Aduhelm at some facilities,” a Biogen spokeswoman said. “Biogen continues to stand 100% behind Aduhelm and the clinical data that supported approval.”<blockquote>百健(Biogen)发言人表示：“医疗决策应基于科学和数据，因此据报道，阿尔茨海默病患者可能无法在某些机构获得Aduhelm，这令人失望。”“Biogen继续100%支持Aduhelm以及支持批准的临床数据。”</blockquote> ‘We still want to do what’s best for our patients, but we simply don’t want to make a decision we can’t sustain.’ — Dr. Sam Gandy, Alzheimer’s disease expert at Mount Sinai Jason Karlawish, an Alzheimer’s specialist at the University of Pennsylvania, said the decision of some health systems to not give Aduhelm suggests an erosion of trust in the FDA’s decision making.<blockquote>“我们仍然想做对患者最有利的事情，但我们只是不想做出我们无法维持的决定。”—Sam Gandy博士，西奈山阿尔茨海默病专家宾夕法尼亚大学阿尔茨海默氏症专家Jason Karlawish表示，一些卫生系统不给予Aduhelm的决定表明人们对FDA决策的信任受到侵蚀。</blockquote> “It’s very disturbing that we’re starting to hear health systems that rely on the FDA sending signals that they don’t trust the FDA,” Dr. Karlawish said in an interview. “I have to trust the system that puts drugs into the pharmacy so that I can prescribe them with confidence.”<blockquote>Karlawish博士在接受采访时表示：“非常令人不安的是，我们开始听到依赖FDA的卫生系统发出不信任FDA的信号。”“我必须信任将药物放入药房的系统，这样我才能放心地开药。”</blockquote> The New York Times earlier reported that Cleveland Clinic and Mount Sinai weren’t going to administer Aduhelm to patients.<blockquote>《纽约时报》早些时候报道称，克利夫兰诊所和西奈山不会给患者服用Aduhelm。</blockquote> In June, theFDA approved Aduhelmbased on two large but inconclusive studies of its effect in slowing cognitive decline in people with mild Alzheimer’s symptoms.<blockquote>6月，FDA批准了Aduhel，这是基于两项大型但尚无定论的研究，研究其在减缓轻度阿尔茨海默病症状患者认知能力下降方面的作用。</blockquote> The agency issued the approval using a regulatory mechanism that allows for drugs to be cleared before they are definitively proven effective, saying the Aduhelm was reasonably likely to provide a benefit by reducing levels of a sticky protein called amyloid from the brain.<blockquote>该机构使用一种监管机制发布了批准，该机制允许药物在最终证明有效之前获得批准，并表示Aduhelm很可能通过降低大脑中一种称为淀粉样蛋白的粘性蛋白的水平来提供益处。</blockquote> The FDA approval wasmade over the objectionsof some of its own statisticians and members of an outside committee of experts convened by the agency to provide advice on the drug. Three of theoutside advisers resignedfrom the committee in protest of the FDA’s decision.<blockquote>FDA不顾一些自己的统计学家和该机构召集的外部专家委员会成员的反对，批准了该药物。三名外部顾问从委员会辞职，以抗议FDA的决定。</blockquote> The FDA subsequentlynarrowed its recommendationfor who should get the drug, to Alzheimer’s patients in the early stage of the disease.<blockquote>FDA随后将谁应该获得该药物的建议范围缩小到疾病早期阶段的阿尔茨海默病患者。</blockquote> Dr. Woodcock’s request for an investigation last week prompted Mount Sinai to hold off on treating patients with Aduhelm.<blockquote>伍德库克博士上周要求进行调查，这促使西奈山推迟了对Aduhelm患者的治疗。</blockquote> A Mount Sinai spokeswoman said that in addition to completion of the investigation, the hospital is awaiting the writing of “best practices” guidelines for Aduhelm by its own experts, as well as a standard review necessary for adding Aduhelm to its formulary of available drugs.<blockquote>西奈山发言人表示，除了完成调查外，医院还在等待自己的专家为Aduhelm撰写“最佳实践”指南，以及将Aduhelm添加到其可用药物处方集所需的标准审查。</blockquote> Sam Gandy, a Mount Sinai professor of Alzheimer’s disease research, said he and his colleagues, who are setting guidelines for Aduhelm, were open to prescribing the drug for certain patients, although only one of Biogen’s two clinical studies appeared to show the drug worked.<blockquote>西奈山阿尔茨海默病研究教授萨姆·甘迪(Sam Gandy)表示，他和正在为Aduhelm制定指南的同事愿意为某些患者开出该药物，尽管百健(Biogen)的两项临床研究中似乎只有一项表明该药物有效。</blockquote> Dr. Woodcock’s request for an investigation, however, threw into question whether the drug was appropriately evaluated and approved in the first place, Dr. Gandy said. Over the following days, the group decided they would wait for the investigation’s conclusion before considering infusions.<blockquote>然而，甘迪博士说，伍德库克博士的调查请求引发了人们对该药物最初是否经过适当评估和批准的质疑。在接下来的几天里，该小组决定在考虑输液之前等待调查结论。</blockquote> “I’m willing to allow for the possibility that the FDA may have the latitude to approve [Aduhelm] along this accelerated approval pathway, but not if I can’t trust the integrity of the process,” Dr. Gandy said in an interview. “We still want to do what’s best for our patients, but we simply don’t want to make a decision we can’t sustain.”<blockquote>甘迪博士在接受采访时表示：“我愿意考虑FDA可能有权通过这种加速批准途径批准[Aduhelm]，但如果我不能相信该过程的完整性，就不会这样做。”“我们仍然想做对患者最有利的事情，但我们只是不想做出我们无法维持的决定。”</blockquote> Washington neurologist Nancy Isenberg, one of the Providence doctors involved in the decision to not administer Aduhelm, cited the drug’s potential for serious side effects, lack of clear benefit and high cost as reasons behind the policy. Providence, whose system includes 52 hospitals and more than 1,000 outpatient clinics, is also wary of prescribing the drug before investigators return results of an investigation of Aduhelm’s regulatory approval, she said.<blockquote>华盛顿神经科医生南希·伊森伯格（Nancy Isenberg）是参与决定不使用Aduhelm的普罗维登斯医生之一，她指出该药物可能产生严重副作用、缺乏明确的益处和高昂的成本是该政策背后的原因。她说，普罗维登斯的系统包括52家医院和1,000多家门诊诊所，在调查人员返回Aduhelm监管批准的调查结果之前，普罗维登斯也对开这种药物持谨慎态度。</blockquote> “I wish and I hope we can offer safe, effective and affordable treatments” for Alzheimer’s patients, Dr. Isenberg said. “At the same time, this is not that.”<blockquote>伊森伯格博士说：“我希望我们能够为阿尔茨海默氏症患者提供安全、有效和负担得起的治疗方法”。“同时，这个不是那个。”</blockquote> Resistance to Aduhelm from some hospitals and insurers may not affect Biogen, which analysts project could eventually ring up billions of dollars in sales from the drug.<blockquote>一些医院和保险公司对Aduhelm的耐药性可能不会影响Biogen，分析师预计该药物最终可能会带来数十亿美元的销售额。</blockquote> A fair number “of academic medical centers etc. can stay on sidelines and [the] math may still work,” Evercore ISI analyst Umer Raffat said in a research note.<blockquote>Evercore ISI分析师Umer Raffat在一份研究报告中表示，相当多的“学术医疗中心等可以保持观望，数学可能仍然有效”。</blockquote> Some skeptical doctors, he added, have said they won’t deny Aduhelm to interested patients.<blockquote>他补充说，一些持怀疑态度的医生表示，他们不会拒绝向感兴趣的患者提供Aduhelm。</blockquote>","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>Cleveland Clinic, Mount Sinai and Providence Won’t Give Biogen’s New Alzheimer’s Drug<blockquote>克利夫兰诊所、西奈山和普罗维登斯不会提供百健(Biogen)的阿尔茨海默病新药</blockquote></title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 12.5px; color: #7E829C; margin: 0;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nCleveland Clinic, Mount Sinai and Providence Won’t Give Biogen’s New Alzheimer’s Drug<blockquote>克利夫兰诊所、西奈山和普罗维登斯不会提供百健(Biogen)的阿尔茨海默病新药</blockquote>\n</h2>\n<h4 class=\"meta\">\n\nThe Wall Street Journal2021-07-16 08:15\n\n</h4>\n</header>\n<article>\n The three hospital operators are holding off on administering Aduhelm amid a debate over its effectiveness. Three large hospitals are declining to administerBiogenInc.’sBIIB-6.79%new Alzheimer’s treatment, Aduhelm, the latest rupture to emerge from the Food and Drug Administration’s controversial approval of the drug last month.<blockquote>由于对Aduhelm有效性的争论，这三家医院运营商推迟了Aduhelm的使用。三家大型医院拒绝使用BiogenInc.的sBIIB-6.79%新的阿尔茨海默病治疗药物Aduhelm，这是美国食品和药物管理局上个月有争议地批准该药物后出现的最新破裂。</blockquote> The Cleveland Clinic, Mount Sinai Health System in New York and Providence in Renton, Wash., said they wouldn’t administer Aduhelm, which is also called aducanumab, to patients amid a debate about the drug’s effectiveness and whether the FDA lowered its standards in approving the medicine.<blockquote>克利夫兰诊所、纽约西奈山卫生系统和华盛顿州伦顿的普罗维登斯。，表示他们不会给患者服用Aduhelm，也称为aducanumab，因为人们正在争论该药物的有效性以及FDA是否降低了批准该药物的标准。</blockquote> The hospitals’ moves come as some health insurers also restrict access to the therapy—unusual pushback against a drug targeting a devastating disease like Alzheimer’s that has few effective treatments.<blockquote>医院采取这一举措之际，一些健康保险公司也限制了这种疗法的使用——这是对针对阿尔茨海默氏症等毁灭性疾病的药物的不同寻常的抵制，这种疾病几乎没有有效的治疗方法。</blockquote> While some doctors have been eager to start prescribing the newly approved drug, others have criticized the FDA for clearing the drug before studies proved it works. The critics have also expressed concerns about whether the drug’s benefits, which appeared to be modest in studies, are worth the risks of side effects such as brain bleeding that require regular monitoring by physicians.<blockquote>虽然一些医生渴望开始开这种新批准的药物，但其他人批评FDA在研究证明该药物有效之前就批准了该药物。批评者还对该药物的益处（在研究中似乎不大）是否值得冒脑出血等副作用的风险表示担忧，这些副作用需要医生定期监测。</blockquote> “Clinical studies failed to demonstrate the effectiveness of Aduhelm…while documenting significant risks, like brain swelling and bleeding,” said a spokeswoman for Blue Cross and Blue Shield of North Carolina, which won’t cover the drug for its commercially insured patients.<blockquote>北卡罗来纳州蓝十字和蓝盾公司的发言人表示：“临床研究未能证明Aduhelm的有效性……同时记录了脑肿胀和出血等重大风险。”该公司不会为其商业保险患者承保该药物。</blockquote> Federal officials recently began a monthslong review of whether Medicare will cover Aduhelm and under what circumstances. The vast majority of patients expected to get the drug are on Medicare, the federal insurance program for the elderly and disabled.<blockquote>联邦官员最近开始了为期数月的审查，审查医疗保险是否会覆盖Aduhelm以及在什么情况下覆盖。预计获得该药物的绝大多数患者都参加了联邦老年人和残疾人保险计划Medicare。</blockquote> The Cleveland Clinic won’t carry the drug in its pharmacy or provide infusions of it to patients following a review of available scientific evidence by a multidisciplinary panel of experts, a hospital spokeswoman said.<blockquote>医院发言人表示，在多学科专家小组审查现有科学证据后，克利夫兰诊所不会在其药房出售该药物，也不会向患者提供输液。</blockquote> Cleveland Clinic doctors, the spokeswoman said, can still prescribe the medicine, but patients will have to receive their infusions at an outside facility.<blockquote>这位发言人说，克利夫兰诊所的医生仍然可以开药，但患者必须在外部机构接受输液。</blockquote> Aduhelm is given with a monthly infusion, typically at an outpatient medical center. Biogenpriced the drug at $56,000 a year, though one health researcher said it will probably cost more for a typical patient.<blockquote>Aduhelm通常在门诊医疗中心每月输注一次。Biogen将该药物定价为每年56,000美元，不过one health研究人员表示，对于典型患者来说，该药物的价格可能会更高。</blockquote> “Based on the current data regarding its safety and efficacy, we have decided not to carry Aducanumab at this time,” the Cleveland Clinic said. The hospital said it will reconsider the decision when more data are available.<blockquote>克利夫兰诊所表示：“根据目前有关其安全性和有效性的数据，我们决定目前不携带Aducanumab。”医院表示，当有更多数据时，将重新考虑这一决定。</blockquote> Mount Sinai said it won’t infuse Aduhelm until it sees the findings of a U.S. government investigation into interactions between FDA staff and Biogen during the review process. The investigation, which was requested last week by FDA Acting Commissioner Janet Woodcock,has raised concernsabout the integrity of the approval process, Mount Sinai said.<blockquote>西奈山表示，在看到美国政府对FDA工作人员与Biogen在审查过程中互动的调查结果之前，不会注入Aduhelm。西奈山表示，FDA代理专员珍妮特·伍德库克(Janet Woodcock)上周要求进行的调查引发了人们对审批过程完整性的担忧。</blockquote> “Medical decisions should be based on science and data, so it is disappointing that patients living with Alzheimer’s disease may reportedly not be able to access Aduhelm at some facilities,” a Biogen spokeswoman said. “Biogen continues to stand 100% behind Aduhelm and the clinical data that supported approval.”<blockquote>百健(Biogen)发言人表示：“医疗决策应基于科学和数据，因此据报道，阿尔茨海默病患者可能无法在某些机构获得Aduhelm，这令人失望。”“Biogen继续100%支持Aduhelm以及支持批准的临床数据。”</blockquote> ‘We still want to do what’s best for our patients, but we simply don’t want to make a decision we can’t sustain.’ — Dr. Sam Gandy, Alzheimer’s disease expert at Mount Sinai Jason Karlawish, an Alzheimer’s specialist at the University of Pennsylvania, said the decision of some health systems to not give Aduhelm suggests an erosion of trust in the FDA’s decision making.<blockquote>“我们仍然想做对患者最有利的事情，但我们只是不想做出我们无法维持的决定。”—Sam Gandy博士，西奈山阿尔茨海默病专家宾夕法尼亚大学阿尔茨海默氏症专家Jason Karlawish表示，一些卫生系统不给予Aduhelm的决定表明人们对FDA决策的信任受到侵蚀。</blockquote> “It’s very disturbing that we’re starting to hear health systems that rely on the FDA sending signals that they don’t trust the FDA,” Dr. Karlawish said in an interview. “I have to trust the system that puts drugs into the pharmacy so that I can prescribe them with confidence.”<blockquote>Karlawish博士在接受采访时表示：“非常令人不安的是，我们开始听到依赖FDA的卫生系统发出不信任FDA的信号。”“我必须信任将药物放入药房的系统，这样我才能放心地开药。”</blockquote> The New York Times earlier reported that Cleveland Clinic and Mount Sinai weren’t going to administer Aduhelm to patients.<blockquote>《纽约时报》早些时候报道称，克利夫兰诊所和西奈山不会给患者服用Aduhelm。</blockquote> In June, theFDA approved Aduhelmbased on two large but inconclusive studies of its effect in slowing cognitive decline in people with mild Alzheimer’s symptoms.<blockquote>6月，FDA批准了Aduhel，这是基于两项大型但尚无定论的研究，研究其在减缓轻度阿尔茨海默病症状患者认知能力下降方面的作用。</blockquote> The agency issued the approval using a regulatory mechanism that allows for drugs to be cleared before they are definitively proven effective, saying the Aduhelm was reasonably likely to provide a benefit by reducing levels of a sticky protein called amyloid from the brain.<blockquote>该机构使用一种监管机制发布了批准，该机制允许药物在最终证明有效之前获得批准，并表示Aduhelm很可能通过降低大脑中一种称为淀粉样蛋白的粘性蛋白的水平来提供益处。</blockquote> The FDA approval wasmade over the objectionsof some of its own statisticians and members of an outside committee of experts convened by the agency to provide advice on the drug. Three of theoutside advisers resignedfrom the committee in protest of the FDA’s decision.<blockquote>FDA不顾一些自己的统计学家和该机构召集的外部专家委员会成员的反对，批准了该药物。三名外部顾问从委员会辞职，以抗议FDA的决定。</blockquote> The FDA subsequentlynarrowed its recommendationfor who should get the drug, to Alzheimer’s patients in the early stage of the disease.<blockquote>FDA随后将谁应该获得该药物的建议范围缩小到疾病早期阶段的阿尔茨海默病患者。</blockquote> Dr. Woodcock’s request for an investigation last week prompted Mount Sinai to hold off on treating patients with Aduhelm.<blockquote>伍德库克博士上周要求进行调查，这促使西奈山推迟了对Aduhelm患者的治疗。</blockquote> A Mount Sinai spokeswoman said that in addition to completion of the investigation, the hospital is awaiting the writing of “best practices” guidelines for Aduhelm by its own experts, as well as a standard review necessary for adding Aduhelm to its formulary of available drugs.<blockquote>西奈山发言人表示，除了完成调查外，医院还在等待自己的专家为Aduhelm撰写“最佳实践”指南，以及将Aduhelm添加到其可用药物处方集所需的标准审查。</blockquote> Sam Gandy, a Mount Sinai professor of Alzheimer’s disease research, said he and his colleagues, who are setting guidelines for Aduhelm, were open to prescribing the drug for certain patients, although only one of Biogen’s two clinical studies appeared to show the drug worked.<blockquote>西奈山阿尔茨海默病研究教授萨姆·甘迪(Sam Gandy)表示，他和正在为Aduhelm制定指南的同事愿意为某些患者开出该药物，尽管百健(Biogen)的两项临床研究中似乎只有一项表明该药物有效。</blockquote> Dr. Woodcock’s request for an investigation, however, threw into question whether the drug was appropriately evaluated and approved in the first place, Dr. Gandy said. Over the following days, the group decided they would wait for the investigation’s conclusion before considering infusions.<blockquote>然而，甘迪博士说，伍德库克博士的调查请求引发了人们对该药物最初是否经过适当评估和批准的质疑。在接下来的几天里，该小组决定在考虑输液之前等待调查结论。</blockquote> “I’m willing to allow for the possibility that the FDA may have the latitude to approve [Aduhelm] along this accelerated approval pathway, but not if I can’t trust the integrity of the process,” Dr. Gandy said in an interview. “We still want to do what’s best for our patients, but we simply don’t want to make a decision we can’t sustain.”<blockquote>甘迪博士在接受采访时表示：“我愿意考虑FDA可能有权通过这种加速批准途径批准[Aduhelm]，但如果我不能相信该过程的完整性，就不会这样做。”“我们仍然想做对患者最有利的事情，但我们只是不想做出我们无法维持的决定。”</blockquote> Washington neurologist Nancy Isenberg, one of the Providence doctors involved in the decision to not administer Aduhelm, cited the drug’s potential for serious side effects, lack of clear benefit and high cost as reasons behind the policy. Providence, whose system includes 52 hospitals and more than 1,000 outpatient clinics, is also wary of prescribing the drug before investigators return results of an investigation of Aduhelm’s regulatory approval, she said.<blockquote>华盛顿神经科医生南希·伊森伯格（Nancy Isenberg）是参与决定不使用Aduhelm的普罗维登斯医生之一，她指出该药物可能产生严重副作用、缺乏明确的益处和高昂的成本是该政策背后的原因。她说，普罗维登斯的系统包括52家医院和1,000多家门诊诊所，在调查人员返回Aduhelm监管批准的调查结果之前，普罗维登斯也对开这种药物持谨慎态度。</blockquote> “I wish and I hope we can offer safe, effective and affordable treatments” for Alzheimer’s patients, Dr. Isenberg said. “At the same time, this is not that.”<blockquote>伊森伯格博士说：“我希望我们能够为阿尔茨海默氏症患者提供安全、有效和负担得起的治疗方法”。“同时，这个不是那个。”</blockquote> Resistance to Aduhelm from some hospitals and insurers may not affect Biogen, which analysts project could eventually ring up billions of dollars in sales from the drug.<blockquote>一些医院和保险公司对Aduhelm的耐药性可能不会影响Biogen，分析师预计该药物最终可能会带来数十亿美元的销售额。</blockquote> A fair number “of academic medical centers etc. can stay on sidelines and [the] math may still work,” Evercore ISI analyst Umer Raffat said in a research note.<blockquote>Evercore ISI分析师Umer Raffat在一份研究报告中表示，相当多的“学术医疗中心等可以保持观望，数学可能仍然有效”。</blockquote> Some skeptical doctors, he added, have said they won’t deny Aduhelm to interested patients.<blockquote>他补充说，一些持怀疑态度的医生表示，他们不会拒绝向感兴趣的患者提供Aduhelm。</blockquote>\n<div class=\"bt-text\">\n\n\n 来源：<a href=\"https://www.wsj.com/articles/cleveland-clinic-mount-sinai-wont-give-biogens-new-alzheimers-drug-11626366968?mod=hp_lead_pos2\">The Wall Street Journal</a>\n为提升您的阅读体验，我们对本页面进行了排版优化\n\n\n</div>\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"BIIB":"渤健公司"},"source_url":"https://www.wsj.com/articles/cleveland-clinic-mount-sinai-wont-give-biogens-new-alzheimers-drug-11626366968?mod=hp_lead_pos2","is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1153640468","content_text":"The three hospital operators are holding off on administering Aduhelm amid a debate over its effectiveness.\n\nThree large hospitals are declining to administerBiogenInc.’sBIIB-6.79%new Alzheimer’s treatment, Aduhelm, the latest rupture to emerge from the Food and Drug Administration’s controversial approval of the drug last month.\nThe Cleveland Clinic, Mount Sinai Health System in New York and Providence in Renton, Wash., said they wouldn’t administer Aduhelm, which is also called aducanumab, to patients amid a debate about the drug’s effectiveness and whether the FDA lowered its standards in approving the medicine.\nThe hospitals’ moves come as some health insurers also restrict access to the therapy—unusual pushback against a drug targeting a devastating disease like Alzheimer’s that has few effective treatments.\nWhile some doctors have been eager to start prescribing the newly approved drug, others have criticized the FDA for clearing the drug before studies proved it works. The critics have also expressed concerns about whether the drug’s benefits, which appeared to be modest in studies, are worth the risks of side effects such as brain bleeding that require regular monitoring by physicians.\n“Clinical studies failed to demonstrate the effectiveness of Aduhelm…while documenting significant risks, like brain swelling and bleeding,” said a spokeswoman for Blue Cross and Blue Shield of North Carolina, which won’t cover the drug for its commercially insured patients.\nFederal officials recently began a monthslong review of whether Medicare will cover Aduhelm and under what circumstances. The vast majority of patients expected to get the drug are on Medicare, the federal insurance program for the elderly and disabled.\nThe Cleveland Clinic won’t carry the drug in its pharmacy or provide infusions of it to patients following a review of available scientific evidence by a multidisciplinary panel of experts, a hospital spokeswoman said.\nCleveland Clinic doctors, the spokeswoman said, can still prescribe the medicine, but patients will have to receive their infusions at an outside facility.\nAduhelm is given with a monthly infusion, typically at an outpatient medical center. Biogenpriced the drug at $56,000 a year, though one health researcher said it will probably cost more for a typical patient.\n“Based on the current data regarding its safety and efficacy, we have decided not to carry Aducanumab at this time,” the Cleveland Clinic said. The hospital said it will reconsider the decision when more data are available.\nMount Sinai said it won’t infuse Aduhelm until it sees the findings of a U.S. government investigation into interactions between FDA staff and Biogen during the review process. The investigation, which was requested last week by FDA Acting Commissioner Janet Woodcock,has raised concernsabout the integrity of the approval process, Mount Sinai said.\n“Medical decisions should be based on science and data, so it is disappointing that patients living with Alzheimer’s disease may reportedly not be able to access Aduhelm at some facilities,” a Biogen spokeswoman said. “Biogen continues to stand 100% behind Aduhelm and the clinical data that supported approval.”\n\n‘We still want to do what’s best for our patients, but we simply don’t want to make a decision we can’t sustain.’\n— \nDr. Sam Gandy, Alzheimer’s disease expert at Mount Sinai\n\nJason Karlawish, an Alzheimer’s specialist at the University of Pennsylvania, said the decision of some health systems to not give Aduhelm suggests an erosion of trust in the FDA’s decision making.\n“It’s very disturbing that we’re starting to hear health systems that rely on the FDA sending signals that they don’t trust the FDA,” Dr. Karlawish said in an interview. “I have to trust the system that puts drugs into the pharmacy so that I can prescribe them with confidence.”\nThe New York Times earlier reported that Cleveland Clinic and Mount Sinai weren’t going to administer Aduhelm to patients.\nIn June, theFDA approved Aduhelmbased on two large but inconclusive studies of its effect in slowing cognitive decline in people with mild Alzheimer’s symptoms.\nThe agency issued the approval using a regulatory mechanism that allows for drugs to be cleared before they are definitively proven effective, saying the Aduhelm was reasonably likely to provide a benefit by reducing levels of a sticky protein called amyloid from the brain.\nThe FDA approval wasmade over the objectionsof some of its own statisticians and members of an outside committee of experts convened by the agency to provide advice on the drug. Three of theoutside advisers resignedfrom the committee in protest of the FDA’s decision.\nThe FDA subsequentlynarrowed its recommendationfor who should get the drug, to Alzheimer’s patients in the early stage of the disease.\nDr. Woodcock’s request for an investigation last week prompted Mount Sinai to hold off on treating patients with Aduhelm.\nA Mount Sinai spokeswoman said that in addition to completion of the investigation, the hospital is awaiting the writing of “best practices” guidelines for Aduhelm by its own experts, as well as a standard review necessary for adding Aduhelm to its formulary of available drugs.\nSam Gandy, a Mount Sinai professor of Alzheimer’s disease research, said he and his colleagues, who are setting guidelines for Aduhelm, were open to prescribing the drug for certain patients, although only one of Biogen’s two clinical studies appeared to show the drug worked.\nDr. Woodcock’s request for an investigation, however, threw into question whether the drug was appropriately evaluated and approved in the first place, Dr. Gandy said. Over the following days, the group decided they would wait for the investigation’s conclusion before considering infusions.\n“I’m willing to allow for the possibility that the FDA may have the latitude to approve [Aduhelm] along this accelerated approval pathway, but not if I can’t trust the integrity of the process,” Dr. Gandy said in an interview. “We still want to do what’s best for our patients, but we simply don’t want to make a decision we can’t sustain.”\nWashington neurologist Nancy Isenberg, one of the Providence doctors involved in the decision to not administer Aduhelm, cited the drug’s potential for serious side effects, lack of clear benefit and high cost as reasons behind the policy. Providence, whose system includes 52 hospitals and more than 1,000 outpatient clinics, is also wary of prescribing the drug before investigators return results of an investigation of Aduhelm’s regulatory approval, she said.\n“I wish and I hope we can offer safe, effective and affordable treatments” for Alzheimer’s patients, Dr. Isenberg said. “At the same time, this is not that.”\nResistance to Aduhelm from some hospitals and insurers may not affect Biogen, which analysts project could eventually ring up billions of dollars in sales from the drug.\nA fair number “of academic medical centers etc. can stay on sidelines and [the] math may still work,” Evercore ISI analyst Umer Raffat said in a research note.\nSome skeptical doctors, he added, have said they won’t deny Aduhelm to interested patients.","news_type":1,"symbols_score_info":{"BIIB":0.9}},"isVote":1,"tweetType":1,"viewCount":695,"commentLimit":10,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"symbols":[],"verified":2,"subType":0,"readableState":1,"langContent":"EN","currentLanguage":"EN","warmUpFlag":false,"orderFlag":false,"shareable":true,"causeOfNotShareable":"","featuresForAnalytics":[],"commentAndTweetFlag":false,"andRepostAutoSelectedFlag":false,"upFlag":false,"length":3,"xxTargetLangEnum":"ORIG"},"commentList":[],"isCommentEnd":true,"isTiger":false,"isWeiXinMini":false,"url":"/m/post/170011513"}