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博主胡德良:邢台学院外语系英语教授,中国译协专家会员,河北省译协常务理事,邢台市译协副会长。爱好翻译,内容涉及宇宙探秘、医疗卫生、家庭保健、生命科学、能源科学、地球科学、环境科学、散文小说和纪实文学等领域。所译文章曾见于《光明日报》、《科技日报》、《健康时报》、《健康报》、《英语世界》、《英语知识》、《科技英语学习》、《科学之友》、《科学与文化》、《世界科学》、《生命世界》等全国各大报刊。博客特色:英汉对照、图文并茂,融趣味性、科学性、知识性为一体。

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国会对一个生物医学创新议案投票表决(图)   

2017-05-06 16:17:43|  分类: 医疗保健 |  标签: |举报 |字号 订阅

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国会对一个生物医学创新议案投票表决(图) - 月亮飞船 - 欢迎光临月亮飞船的博客

国会对一个生物医学创新议案投票表决

胡德良   译

Congress is poised to begin voting on a sweeping biomedical innovation bill that includes nearly $5 billion in dedicated funding for a trio of major research initiatives at the National Institutes of Health (NIH). The bill also includes measures to speed the approval of new drugs and medical devices by the Food and Drug Administration (FDA), and it would create a mechanism for catalyzing efforts to streamline federal regulations that universities and academic researchers regard as burdensome. 

 国会做好准备,开始对一个全面性生物医学创新议案投票表决。该议案包括国家卫生研究院(NIH)的三项研究计划,涉及专门资助金额将近50亿美元。该议案还包括针对美国食品及药物管理局(FDA)提出的加快新药和新医疗器械审批的措施。该议案将会创建一种机制,加大努力精简那些被大学和学术人员当成负担的联邦法规。

 The bipartisan bill, known as the 21st Century Cures Act, is the culmination of more than 2 years of lobbying by research, patient, and industry groups, and extensive negotiations between members of the Senate and the House of Representatives. The House is expected to approve the bill Wednesday. Its fate in the Senate is unclear, with some Senators objecting to funding mechanisms and other provisions. But late on Tuesday lawmakers announced changes to the bill designed to win over skeptics. Senate Majority Leader Mitch McConnell (R–KY) has said completing Cures and sending it to President Barack Obama for signing is one of his highest priorities before Congress adjourns for the year, and the White House has said it supports the bill.

 这项代表两党的议案被称为《21世纪医疗议案》,是研究团体、病人团体、和产业团体经过两年多游说,在参议院与众议院成员之间经过广泛协商之后形成的。该议案有望在星期三获得众议院的审批,但是否能够通过参议院的审批并不明朗,因为有些参议员反对其中的资助机制和其他条款。但是,立法机构于星期二宣布,该议案有所改动,意在争取怀疑者的支持。参议院多数党领导人米奇·麦康奈尔说过:完善医疗议案,将其提交给奥巴马总统签署,是他在今年国会休会之前最期望做到的事情,而白宫方面称支持该议案。

 Biomedical research groups are cautiously optimistic that Cures will finally cross the finish line. The bill includes a long list of largely uncontroversial provisions, including calls for NIH to produce a comprehensive strategic plan, set up a special initiative for young scientists, establish a prize to incentivize certain kinds of research, and take new steps to encourage data sharing and ensure the reproducibility of NIH-funded research. And research lobbyists are delighted with provisions that set aside $4.8 billion over the next 10 years for three NIH initiatives: $1.4 billion for Obama’s Precision Medicine Initiative, $1.8 billion for Vice President Joe Biden’s cancer moonshot, and $1.6 billion for the White House’s Brain Research through Advancing Innovative Neurotechnologies initiative. The bill also provides $30 million over 3 years for regenerative medicine research using adult stem cells.

 对于该医疗议案最终是否能够审批通过,生物医学研究团体持有谨慎乐观的态度。该议案包含一个大体没有争议的条款列单,这些条款中包括要求国家卫生研究院出台一个全面的战略计划,为年轻科学家发起一个特别的倡议行动,设立奖金激励某些种类的研究,采取新的措施鼓励数据共享,确保国家卫生研究院资助的研究具有重现性。研究团体的游说人员对于下列条款感到满意:在接下来的10年中,拨出48亿美元支持国家卫生研究院的三项计划——14亿美元支持奥巴马总统的精准医疗计划,18亿美元支持副总统副总统乔·拜登的癌症登月计划,16亿美元通过推进创新神经技术支持白宫的大脑研究计划。该议案还提出:在三年之内提供3,000万美元,支持利用成体干细胞进行再生医学研究。

 Funding concerns

 资助问题

 The NIH total is less than the $8.8 billion envisioned in earlier versions, but research advocates aren’t complaining. They say Cures would put Congress on record as supporting sustained funding for key research areas at NIH, which currently spends more than $30 billion annually, and specifies how the spending boost would be paid for. “We’re absolutely thrilled,” says Jon Retzlaff, director of science policy in the Washington, D.C., office of the American Association for Cancer Research, which has lobbied for Biden’s cancer moonshot.

 国家卫生研究院需要的资助总额少于早期设想的88亿美元,但是,倡导研究的人士并没有抱怨,他们说该医疗议案会使国会的支持力度达到创纪录的水平,因为国会要持续地为国家卫生研究院的关键研究领域提供资金支持,目前这笔花费为每年300亿美元,而且国会也明确指出了这些增加的资金该如何支出。美国癌症研究协会办公室华盛顿哥伦比亚特区科学政策主任乔恩·莱茨拉夫说:“我感到异常激动!”该协会办公室曾经为拜登的癌症登月计划进行游说。

 A 25 November Cures draft calls for raising the money by selling oil from the U.S. Strategic Petroleum Reserve and redirecting funds from a public health fund established by the Affordable Care Act (Obamacare). The money would flow into a new NIH Innovation Account that congressional appropriators would control. But that plan has drawn opposition from some Senators, including those concerned about the public health programs, and is a source of angst in the biomedical research community. The arrangement disappoints those who sought a dedicated stream of money for NIH not subject to the vagaries of the annual appropriations process, but satisfies some lawmakers’ desire to keep Congress in control of spending.

 1125,《21世纪医疗议案》草案要求通过销售美国战略石油储备的石油来筹集资金,并且重新启用奥巴马医改方案中《评价医疗法案》设立的公共卫生基金。这些资金将注入国家卫生研究院新开的创新账户中,由国会拨款机构控制。但是该计划引来某些参议员的反对,其中包括那些关心公共卫生计划的参议员,这些反对之声引起了生物医学研究界的焦虑。对于那些为国家卫生研究院争取专属资金、不受每年拨款过程变化影响的人士来说,草案中的计划令人失望,但是这种计划满足了一些立法机构的愿望——让国会控制资金的支出。

 “Our hope is that this fund will add a layer of security” for NIH’s budget, says Tannaz Rasouli, a policy specialist at the Association of American Medical Colleges in Washington, D.C. But “there are no guarantees,” warns Howard Garrison, a policy expert at the Federation of American Societies for Experimental Biology (FASEB) in Bethesda, Maryland. He and others want Congress to use the fund as a supplement to NIH’s regular budget, but fear it could become an excuse to curb spending in other parts of the agency. Garrison also worries about other provisions that could burden NIH. In a bid to boost accountability, for instance, Congress wants the director of each institute to personally review and sign off on grants. “It’s awkward, it’s unnecessary, and it’s burdensome,” Garrison says. And FASEB worries a plan to impose renewable, 5-year term limits on institute directors could make it harder for NIH to recruit talent.

 华盛顿哥伦比亚特区美国医学院协会的政策专家坦纳兹·拉苏里说:“我们希望这些资金能够为国家卫生研究院的预算添加一层安全保障。”但是,马里兰州贝塞斯达美国实验生物学会联合会(FASEB)政策专家霍华德·加里森说:“不存在什么保障。”加里森和其他专家希望能够将这些资金当作国家卫生研究院正常预算的补充资金来使用,但是他们又担心这会可能会成为限制研究院其他部门支出的一个借口。例如:为了加强问责制,国会希望每个学术机构的领导对拨款都要亲自审查并进行签署。加里森说:“这是令人难堪的事情,这没有必要,而且是一种负担。”此外,FASEB担心:对研究院院长实行可再续五年任期的限制性计划,可能会使国家卫生研究院更加难以招聘到人才。

 New Research Policy Board

 新成立的政策研究委员会

 Getting a warmer welcome are provisions aimed at reducing the regulatory burden on institutions that get federal research dollars. Reporting requirements on grants have grown over the past few decades, for instance, as have rules meant to safeguard research subjects. The bill creates a Research Policy Board within the White House Office of Management and Budget. The board, which would be made up of representatives from up to 10 federal agencies and a similar number of research institutions, would study emerging regulatory problems as well as recommend how to harmonize existing policies.(For more on the research board, read this ScienceInsider story.) The idea came from a 2015 report by a committee of the National Academies of Sciences, Engineering, and Medicine. Another provision calls for a review of 5-year-old rules that tightened conflict of interest reporting by NIH-funded researchers. Institutions complain the rules have imposed big costs with little benefit.

 对于获得联邦研究经费的机构来说,旨在减轻监管负担的条款受到更加热烈的欢迎。例如:据报道,在过去的几十年中,获得拨款的必要条件有所增加,用于确保研究项目正常进行的规则也增加了。根据该议案,要在白宫管理和预算办公室内创建一个政策研究委员会,该委员会由来自十个联邦机构和十个研究机构的代表组成,除了就如何协调现有政策提供建议之外,还要研究新出现的监管问题。这个主意来自2015年的一个报告,该报告是由国家科学、工程和医学研究院下属的一个委员会撰写的。另外一个条款要求审查实行了五年之久的规章制度,因为据国家卫生研究院资助的研究人员报告说,这些制度激化了各方的利益冲突。研究机构抱怨说,这些制度已经造成了巨额花费,但收效甚微。

 The bill’s FDA provisions aim to accelerate the agency’s review of some new drugs and medical devices. In certain cases, FDA would allow companies to run smaller clinical trials or rely on evidence collected outside of trials to support approval. In an apparent bid to boost stem cell and other experimental therapies, the current draft also directs FDA to give special attention to treatments designated as “regenerative advanced therapy.” If a treatment meets the criteria—for example, if it is based on stem cells or other tissues and addresses an unmet medical need—regulators can offer a company faster review, or more flexibility in setting trial endpoints.

 针对FDA的规定,该议案的目的在于加快该局对一些新药和新型医疗器械的审批。在某些情况下,FDA将允许公司进行较小规模的临床试验,或者依靠在试验之外收集的证据来支持批准。很明显,在努力促进干细胞疗法和其他疗法时,目前的草案指示FDA要特别关注被称为“再生性先进疗法”的治疗方案。如果一个治疗方案符合标准——例如,如果该治疗方案基于干细胞或其他组织,能够处理以前未能满足的医疗需求,那么监管机构可以对其进行加快审查,或者在设置试验终点时可以更加灵活地掌握。

 A set of potentially controversial provisions would expand FDA’s priority review system, which attempts to create an incentive for companies to develop drugs for neglected tropical and pediatric diseases by doling out tradeable vouchers that entitle the companies to speedier agency reviews. Cures would add medical countermeasures—designed to respond to a chemical or biological attack, for example—to the treatments that would win vouchers for their developers. But critics say there is little evidence the vouchers have worked, and worry that creating even more of them will only reduce their potential value.

 一套具有潜在争议的条款有可能会扩大FDA的优先审查系统,该系统试图通过推出可交易凭证创建一种激励机制,激励制药公司研发药品,用于治疗被忽视的热带疾病和儿科疾病。这些可交易凭证可以使公司获得FDA较为快速的审查。对于为公司赢得凭证的那些治疗方案,该医疗议案会增加一些医疗应对措施,目的是为化学药品或生物药品之类的治疗所造成的攻击做出反应。但是,持有批评态度的人士称没有证据显示凭证会起作用,他们担心推出更多的凭证只会降低凭证的潜在价值。

 If Cures stalls in the Senate, where critics have argued it gives too much leeway to the drug industry, backers fear it could be a lengthy wait for another chance to lock in NIH funding and tweak FDA rules. The bill, says Representative Fred Upton (R–MI), a leading sponsor, is a “once-in-a-generation, transformational opportunity to change the way we treat disease.

 该医疗议案在参议院是否会受阻,尚不清楚。参议院持有批评态度的人士认为,该议案为制药企业提供了太大的回旋余地;支持者担心,错过此次机会,再想锁定国家卫生研究院的资金,再想调整FDA的规则,将会经历漫长的等待。主要赞助商众议员弗雷德·厄普顿说:“该议案是几十年不遇的一次转型机会,能够改变我们治疗疾病的方式。”

译自:美国《科学》杂志官网(http://www.sciencemag.org/news/

原著:Jocelyn Kaiser   

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