From bench to bedside
从实验台到临床(来源:经济学人)
A reform of American regulation would mean better drugs for everybody
一项美国药品监管规则的改革将对研发更好的药品产生积极意义。
THE notorious red tape at a government agency like America's Food and Drug Administration (FDA) is, in the words of Milton Friedman, “a consequence of its constitution in precisely the same way that a meow is related to the constitution of a cat.” Friedman often argued that the agency's heavy-handed, overcautious
approach to drug approval did more harm than good by stifling innovation and delaying the arrival of life-saving new medicines on the market .Few are likely to agree with his conclusion that the FDA is unreformable and must be abolished outright—therein lies a tort lawyer's paradise. But signs that the industry is beginning to shift away from a few blockbuster drugs towards a larger number of products targeted at less common diseases or particular patient groups (see article) strengthens the argument for lightening the regulatory burden and shifting
the balance away from guarding public safety and towards encouraging innovation.
一个声名狼籍的官僚机构，这是米尔顿. 弗里德曼（注：20世纪最伟大的经济学家之一）对美国食品药品监督管理局的评价，他说：“他的地位就好象猫的叫声对猫的地位一样（注：指FDA的作用有名无实）”弗里德曼经常批评FDA用过于严厉，过于谨慎的手段来对待药品的审批，窒息了制药行业的创新，推迟了许多可以拯救生命的新药的上市时间。当然很少有人同意弗里德曼的结论即FDA已经无可救药必须被彻底废除（他说FDA给那些靠知识产权案件吃饭的律师提供了天堂）。但是有迹象表明制药行业正在实现从依靠少数拳头产品到生产大量治疗少数特殊疾病和面向特殊病人群体的药物的转变。这使得放松管制的呼声进一步高涨，维护公众用药安全和鼓励创新之间的微妙平衡正在被打破。
Faster and better
更快、更好
The number of new drugs securing regulators' approval is dropping as the cost and length of clinical trials grow. The launches of a string of blockbuster drugs—including Avandia, a diabetes drug made by GlaxoSmithKline, and Zimulti, an obesity drug by Sanofi-Aventis—have recently gone awry. Studies have
suggested that the costs of the FDA's regulations may outweigh the benefits (see article). All this explains why America's Congress is now considering an FDA reform bill. Because the FDA is the world's principal drugs regulator, everyone has a stake in what happens. The starting point is that the FDA and its counterparts across the world need to move from a risk obsessed, “one size fits all” approach to a more flexible system that considers the risks and benefits of new therapies. Rather than asking drugs to undergo many years of costly trials in the vain pursuit of medicines that are safe for all in all circumstances, regulators should allow speedier conditional
approvals. This is especially true for the growing number of targeted therapies, such as several excellent new cancer treatments, made possible by advances in genomics—a science that identifies which genetic groups will benefit from a drug.
If initial tests and sophisticated computer modelling show promise, innovative new drugs should proceed to small human trials. Ultimately, the drug could be approved for use by a wider part of the general population deemed (through genetic testing and other screening methods) to be at relatively low risk or more likely to benefit from the therapy.
随着成本增加和临床实验的延长，药品监管部门批准的新药的数量在减少。最近一系列投放市场的拳头产品-包括Avandia（葛兰素史克的治疗糖尿病的新药）、Zimulti（赛诺菲-安万特的新型减肥药）都被查出有强烈的负作用。有研究表明FDA的烦琐规定造成的成本大于它所带来的收益。所有这一切解释了美国国会现在为什么要讨论一项关于FDA改革的法案。因为FDA是世界上最重要的药品监管机构，无论它发生什么变化，和每个人都有利害关系。这个问题的出发点是FDA和世界其他国家的类似机构应当从一门心思控制风险的模式中摆脱出来。从采用一成不变的方法进行控制到建立既考虑风险又考虑新药收益的灵活体系。而不是像现在这样要求所有药品都必须进行很多年的高成本的临床实验以保证这些药品在任何情况下都是安全的。监管者应当允许特定条件下快速审批的存在。这对那些数量日益增长的以特定病症为目标的药品而言是特别重要的，例如几个非常优秀的抗癌新药，可能通过基因组研究来确定这些药物对哪种遗传群体有效。如果通过最初的试验和复杂的电脑模拟显示这些药物是有前途的，这些创新药物就应当进行小规模的人体临床试验。最终，这种药将被批准用于更广泛的人群（通过遗传学的试验和其他筛选研究方法），这种做法被认为会将风险控制在较低的范围内并且能够获得新药所带来的收益。
Safeguards can counterbalance this relaxation. Faster approval of new drugs in humans should be matched by more rigorous post-launch testing and surveillance. At the moment, the FDA does not have the money or authority to do this properly. Scores of post-launch studies of drugs safety have been requested by regulators, but remain undone or ignored by firms. And yet there is reason to think such
post-launch surveillance, if bolstered by the use of electronic records and “data mining” techniques, could save many lives. When Vioxx, a blockbuster pain remedy made by Merck, turned out to be dangerous for some patients, private health-management organisations with excellent electronic patient records
spotted the problem months before the FDA did. The second safeguard is for all drugs trials done anywhere in the world—failed or successful—to be made public and the data published online. Consumers would have the information they need to choose whether to take a drug, weighing benefit against risk. Companies would benefit from a cheaper and faster approvals process, and a lower risk of litigation.
一些新的防护措施可以平衡由于放松对某些新药的审批而带来的风险。与更快速的人用新药审批相适应的应当是对上市后的新药进行更严密的检验和监督。目前，FDA还没有足够的资金和权力来做好这方面的工作。监管者所要求的对上市后新药的大量安全性研究被许多制药企业所忽视，许多企业都没有做。因此现在有理由重新考虑对上市后新药的监管方法，是否可以使用电子记录和其他数据库技术来保护更多的生命。当Vioxx（一种默克公司生产的重要拳头产品）被查出对某些病人是有危险的时，一些私人健康管理机构因为有非常好的病人电子档案而比FDA早几个月发现这个问题。第二个安全措施就是对世界上任何地方进行的药品试验（无论成功与否）都必须将数据在网络上公布。消费者将获得他们挑选药品所需要的信息以此来权衡服用某种药品的收益和风险。制药企业可以从较快的、成本较低的审批程序中受益，并且减少法律诉讼的风险。
By cutting the costs of approval, lighter regulation should help move the industry away from blockbusters towards niche products. A reformed FDA might thus speed the arrival of the long-promised age of personalised medicine. Even if it survived, Friedman would surely approve.
通过降低审批成本，放松管制将会帮助制药行业实现从依赖少数拳头产品到针对特殊病症的小范围产品的转变。改革后的FDA可能会加速个性化药品时代的到来。如果真能如此，相信弗里德曼教授也会允许它继续存在的。
本人拜读完上述文章,jl917921翻译功力可见一斑,不过有两处值得商榷地方!!!
1.The number of new drugs securing regulators' approval is dropping as the cost and length of clinical trials grow. The launches of a string of blockbuster drugs—including Avandia, a diabetes drug made by GlaxoSmithKline, and Zimulti, an obesity drug by Sanofi-Aventis—have recently gone awry.
随着临床实验成本增加和试验时限延长,能够最终获批的新药数量呈下降趋势.据报道,最近一系列投放市场的拳头产品-包括Avandia（葛兰素史克的治疗糖尿病的新药）、Zimulti（赛诺菲-安万特的新型减肥药）已经出现重大风险
2.By cutting the costs of approval, lighter regulation should help move the industry away from blockbusters towards niche products. A reformed FDA might thus speed the arrival of the long-promised age of personalised medicine. Even if it survived, Friedman would surely approve.
通过降低审批成本，放松管制将会帮助制药行业实现从依赖少数拳头产品到针对特殊病症的小范围产品的转变。改革后的FDA可能会加速批准一些人们企盼已久的特色药品。如果情况稍作改观，弗里德曼教授也许会乐见其成.
上述译文与楼住商榷,不吝赐教
我希望SFDA能够和FDA一样这样的“声名狼藉”。
harrisonzhang的帮助,希望以后有机会多交流.
从实验台到临床(来源:经济学人)
A reform of American regulation would mean better drugs for everybody
一项美国药品监管规则的改革将对研发更好的药品产生积极意义。
THE notorious red tape at a government agency like America's Food and Drug Administration (FDA) is, in the words of Milton Friedman, “a consequence of its constitution in precisely the same way that a meow is related to the constitution of a cat.” Friedman often argued that the agency's heavy-handed, overcautious
approach to drug approval did more harm than good by stifling innovation and delaying the arrival of life-saving new medicines on the market .Few are likely to agree with his conclusion that the FDA is unreformable and must be abolished outright—therein lies a tort lawyer's paradise. But signs that the industry is beginning to shift away from a few blockbuster drugs towards a larger number of products targeted at less common diseases or particular patient groups (see article) strengthens the argument for lightening the regulatory burden and shifting
the balance away from guarding public safety and towards encouraging innovation.
一个声名狼籍的官僚机构，这是米尔顿. 弗里德曼（注：20世纪最伟大的经济学家之一）对美国食品药品监督管理局的评价，他说：“他的地位就好象猫的叫声对猫的地位一样（注：指FDA的作用有名无实）”弗里德曼经常批评FDA用过于严厉，过于谨慎的手段来对待药品的审批，窒息了制药行业的创新，推迟了许多可以拯救生命的新药的上市时间。当然很少有人同意弗里德曼的结论即FDA已经无可救药必须被彻底废除（他说FDA给那些靠知识产权案件吃饭的律师提供了天堂）。但是有迹象表明制药行业正在实现从依靠少数拳头产品到生产大量治疗少数特殊疾病和面向特殊病人群体的药物的转变。这使得放松管制的呼声进一步高涨，维护公众用药安全和鼓励创新之间的微妙平衡正在被打破。
Faster and better
更快、更好
The number of new drugs securing regulators' approval is dropping as the cost and length of clinical trials grow. The launches of a string of blockbuster drugs—including Avandia, a diabetes drug made by GlaxoSmithKline, and Zimulti, an obesity drug by Sanofi-Aventis—have recently gone awry. Studies have
suggested that the costs of the FDA's regulations may outweigh the benefits (see article). All this explains why America's Congress is now considering an FDA reform bill. Because the FDA is the world's principal drugs regulator, everyone has a stake in what happens. The starting point is that the FDA and its counterparts across the world need to move from a risk obsessed, “one size fits all” approach to a more flexible system that considers the risks and benefits of new therapies. Rather than asking drugs to undergo many years of costly trials in the vain pursuit of medicines that are safe for all in all circumstances, regulators should allow speedier conditional
approvals. This is especially true for the growing number of targeted therapies, such as several excellent new cancer treatments, made possible by advances in genomics—a science that identifies which genetic groups will benefit from a drug.
If initial tests and sophisticated computer modelling show promise, innovative new drugs should proceed to small human trials. Ultimately, the drug could be approved for use by a wider part of the general population deemed (through genetic testing and other screening methods) to be at relatively low risk or more likely to benefit from the therapy.
随着成本增加和临床实验的延长，药品监管部门批准的新药的数量在减少。最近一系列投放市场的拳头产品-包括Avandia（葛兰素史克的治疗糖尿病的新药）、Zimulti（赛诺菲-安万特的新型减肥药）都被查出有强烈的负作用。有研究表明FDA的烦琐规定造成的成本大于它所带来的收益。所有这一切解释了美国国会现在为什么要讨论一项关于FDA改革的法案。因为FDA是世界上最重要的药品监管机构，无论它发生什么变化，和每个人都有利害关系。这个问题的出发点是FDA和世界其他国家的类似机构应当从一门心思控制风险的模式中摆脱出来。从采用一成不变的方法进行控制到建立既考虑风险又考虑新药收益的灵活体系。而不是像现在这样要求所有药品都必须进行很多年的高成本的临床实验以保证这些药品在任何情况下都是安全的。监管者应当允许特定条件下快速审批的存在。这对那些数量日益增长的以特定病症为目标的药品而言是特别重要的，例如几个非常优秀的抗癌新药，可能通过基因组研究来确定这些药物对哪种遗传群体有效。如果通过最初的试验和复杂的电脑模拟显示这些药物是有前途的，这些创新药物就应当进行小规模的人体临床试验。最终，这种药将被批准用于更广泛的人群（通过遗传学的试验和其他筛选研究方法），这种做法被认为会将风险控制在较低的范围内并且能够获得新药所带来的收益。
Safeguards can counterbalance this relaxation. Faster approval of new drugs in humans should be matched by more rigorous post-launch testing and surveillance. At the moment, the FDA does not have the money or authority to do this properly. Scores of post-launch studies of drugs safety have been requested by regulators, but remain undone or ignored by firms. And yet there is reason to think such
post-launch surveillance, if bolstered by the use of electronic records and “data mining” techniques, could save many lives. When Vioxx, a blockbuster pain remedy made by Merck, turned out to be dangerous for some patients, private health-management organisations with excellent electronic patient records
spotted the problem months before the FDA did. The second safeguard is for all drugs trials done anywhere in the world—failed or successful—to be made public and the data published online. Consumers would have the information they need to choose whether to take a drug, weighing benefit against risk. Companies would benefit from a cheaper and faster approvals process, and a lower risk of litigation.
一些新的防护措施可以平衡由于放松对某些新药的审批而带来的风险。与更快速的人用新药审批相适应的应当是对上市后的新药进行更严密的检验和监督。目前，FDA还没有足够的资金和权力来做好这方面的工作。监管者所要求的对上市后新药的大量安全性研究被许多制药企业所忽视，许多企业都没有做。因此现在有理由重新考虑对上市后新药的监管方法，是否可以使用电子记录和其他数据库技术来保护更多的生命。当Vioxx（一种默克公司生产的重要拳头产品）被查出对某些病人是有危险的时，一些私人健康管理机构因为有非常好的病人电子档案而比FDA早几个月发现这个问题。第二个安全措施就是对世界上任何地方进行的药品试验（无论成功与否）都必须将数据在网络上公布。消费者将获得他们挑选药品所需要的信息以此来权衡服用某种药品的收益和风险。制药企业可以从较快的、成本较低的审批程序中受益，并且减少法律诉讼的风险。
By cutting the costs of approval, lighter regulation should help move the industry away from blockbusters towards niche products. A reformed FDA might thus speed the arrival of the long-promised age of personalised medicine. Even if it survived, Friedman would surely approve.
通过降低审批成本，放松管制将会帮助制药行业实现从依赖少数拳头产品到针对特殊病症的小范围产品的转变。改革后的FDA可能会加速个性化药品时代的到来。如果真能如此，相信弗里德曼教授也会允许它继续存在的。
本人拜读完上述文章,jl917921翻译功力可见一斑,不过有两处值得商榷地方!!!
1.The number of new drugs securing regulators' approval is dropping as the cost and length of clinical trials grow. The launches of a string of blockbuster drugs—including Avandia, a diabetes drug made by GlaxoSmithKline, and Zimulti, an obesity drug by Sanofi-Aventis—have recently gone awry.
随着临床实验成本增加和试验时限延长,能够最终获批的新药数量呈下降趋势.据报道,最近一系列投放市场的拳头产品-包括Avandia（葛兰素史克的治疗糖尿病的新药）、Zimulti（赛诺菲-安万特的新型减肥药）已经出现重大风险
2.By cutting the costs of approval, lighter regulation should help move the industry away from blockbusters towards niche products. A reformed FDA might thus speed the arrival of the long-promised age of personalised medicine. Even if it survived, Friedman would surely approve.
通过降低审批成本，放松管制将会帮助制药行业实现从依赖少数拳头产品到针对特殊病症的小范围产品的转变。改革后的FDA可能会加速批准一些人们企盼已久的特色药品。如果情况稍作改观，弗里德曼教授也许会乐见其成.
上述译文与楼住商榷,不吝赐教
我希望SFDA能够和FDA一样这样的“声名狼藉”。
harrisonzhang的帮助,希望以后有机会多交流.