本文选自《经济学人》10月26日文章。阿尔兹海默病，俗称老年痴呆，很多人认为它距自己很远，实际上它与每个人都息息相关。现在阿尔兹海默病已成为威胁人类尤其是老年人健康的主要病症，至今人类仍未揭开它的神秘面纱，更没有有效药物治疗这种疾病。近日Biogen（渤健）和卫材宣布，在与美国食药品监局（FDA）协商后，计划提交阿尔茨海默病治疗药物Aducanumab的生物制品许可上市申请，如果获得批准，Aducanumab将成为首个能改善阿尔茨海默病临床症状的药物。Aducanumab曾因临床数据呈现无效性被宣布终止，但渤健对临床数据进行细致分析后，将Aducanumab从死亡线上拉回来，并宣布将向FDA提交上市申请。本文认为，能治疗阿尔兹海默症的药物对广大患者来说是福音，对生产药企来说是摇钱树，在尚未确定其是否有效时，仍需谨慎对待。
选文精讲
Claims about a treatment for Alzheimer’s should be met with caution
- Alzheimer's disease: 阿尔茨海默病，简称AD，俗称老年痴呆病
More trials would be a good ideaA DRUG THAT slowed the progress of Alzheimer’s disease would be both a boon to humanity and a cash cow for the firm that developed it. Hence the rollercoaster ride enjoyed by the shares of Biogen, a biotechnology company based in Cambridge, Massachusetts, which hopes to be the firm in question. The recent surge in its share price (see chart) followed its announcement, on October 22nd, that it would soon seek approval in America for aducanumab, a molecule it believes will fit the bill.
一种能够延缓阿尔茨海默病病情恶化的药物，对人类来说是福音，对研发它的公司来说，也是摇钱树。总部位于马萨诸塞州剑桥市的生物科技公司渤健有望成为这样的公司，它的股价也因此经历了过山车式的波动。10月22日，该公司宣布将很快在美国申请对aducanumab(一种它认为能治疗阿尔茨海默病的分子)的批准，其股价随之飙升(见图表)。
Aducanumab is a type of drug known as a monoclonal antibody. Antibodies are specialised protein molecules that form part of the immune system. They include so-called hypervariable regions, the exact chemistry of which differs from one type of antibody to another. The specifics of the hypervariable region cause it to bind with great fidelity to some other molecule, usually part of a pathogen, stopping that molecule working and marking it for destruction by other parts of the immune system.
- monoclonal antibody: 单克隆抗体
- fidelity: 忠诚、保真度，这里指紧密结合在一起
Aducanumab是一种被称为单克隆抗体的药物。抗体是形成部分免疫系统的特殊蛋白质分子，涉及所谓的高变区，其确切的化学性质因抗体的不同而不同。高变区的特性使其与其他分子(通常是病原体的一部分)紧密结合，让这些细胞失效，并标记其被免疫系统的其他部分破坏。
America’s Food and Drug Administration, which will decide whether to give aducanumab the go-ahead, will of course be aware of the conventions concerning statistical power, and will make its decision in light of that awareness. There must, though, be a temptation, given the magnitude of the problem of Alzheimer’s (in America alone there are almost 6m cases), and the absence of alternative treatments, to give a green light to something that might work, in the hope that it does work. Which will make heroes out of everyone involved if it turns out to be correct—and villains if it does not.
美国食品药品监督管理局将决定是否批准aducanumab的使用，当然，它会弄明白有关统计强度的惯例，并将根据这种认知做出决定。然而，考虑到阿尔茨海默病的严重性(仅在美国就有近600万病例)，以及缺乏替代疗法，肯定存在一些诱惑让（FDA）给那些可能起作用的药物开绿灯，寄希望于它真的奏效。如果事实证明是正确的，那么每个人都会成为英雄；如果不是，那么每个人都会成为恶棍。
