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凭一人之力反转了国家健康危机的科学家 – 译学馆
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凭一人之力反转了国家健康危机的科学家

How one scientist averted a national health crisis - Andrea Tone

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“她非凡的判断力……阻止了一场大悲剧”——美国总统约翰·F·肯尼迪
在1960年的秋天 弗朗西斯•奥尔德姆•凯尔希
In the fall of 1960,Frances Oldham Kelsey
成为了美国食品及药物管理局的新成员之一
was one of the Foodand Drug Administration’s newest recruits.
在这一年结束之前
Before the year was out,
尽管无人知晓 她开始了一场
she would begin a fight that would save thousands of lives,
拯救成千上万的生命的战斗
though no one knew it at the time.
虽然她刚来美国食品及药物管理局
Although she was new to the FDA,
但她不是一名新手科学家
Kelsey was no novice as a scientist.
在她15岁高中毕业后
After graduatingfrom high school at age 15,
她被蒙特利尔的麦吉尔大学录取
she enrolledat McGill University in Montreal
并获得药理学的学士和硕士学位
and earned both undergraduateand master’s degrees in pharmacology.
从那开始 她就在芝加哥大学的药理学系
From there, she applied for a research post
申请了一个研究职位
at the University of Chicago ’ s pharmacology department.
她录取通知书的名字是奥尔德姆先生
Her acceptance letter was addressedto Mr. Oldham.
凯尔希后来开玩笑说
Kelsey later joked
如果她名叫伊丽莎白或是玛丽•简
that had her name been Elizabeth or Mary Jane,
她的职业生涯可能就此结束
her career might have ended there.
幸运的是 这没发生
Fortunately, it didn’t.
她获得了药理学博士学位
She earned her doctorate
并收到了芝加哥大学留校任教的邀请
in pharmacology and accepted Chicago ’ s invitation to stay as faculty,
她在那进行了药物和胎儿安全的研究 这是开拓性的
where she undertook pioneeringresearch on drugs and fetal safety.
在1950年 她获得了医学博士学位 这是她的第四个 也是最后一个学位
In 1950, she earned an MD,her fourth and final degree.
在她加入美国食品及药物管理局时
By the time she joined the FDA,
弗朗西斯•凯尔希是那里受教育程度最高 最有经验的科学家之一
Frances Kelsey was one of the most educated, experienced scientists around. Yet,
作为团队的最新成员
as the newest member of the team,
凯尔希被指派了一个大家认为很轻松的复审
Kelsey was assigned what everyone thought would be an easy review:
一个来自美国的制药公司Merrell的申请
an application from theUS drug company Merrell
他们申请售卖一种叫萨力多胺的药
to sell a drug called thalidomide.
萨力多胺是一种在德国很成熟的镇静剂
Thalidomide was a sedativedeveloped in Germany
它已经在很多国家被广泛使用
that was already being widely usedin dozens of countries
它用来治疗失眠和缓解工作压力
to treat insomnia and workplace stress.
萨力多胺的抗恶心功能
Thalidomide’s anti-nausea properties
也让它流行于治疗孕妇晨吐
also made it a popular remedy for pregnant women with morning sickness.
收到Merrell公司的申请
Reviewing Merrell ’ s application,
凯尔希发现萨力多胺有关吸收和毒性的数据不足
Kelsey found its data on thalidomide ’ s absorption and toxicity inadequate. Today,
当今 美国食品及药物管理局依据对胎儿的安全性给药物分等
the FDA classifies drugs based on their safety for a fetus.
但在1960年 许多专家相信胎盘屏障
But in 1960, many experts believedthat the placental barrier
能保护胎儿免受伤害
shielded a fetus from harm.
而早期凯尔希基于动物的研究却呈现出相反的结果
Kelsey’s earlier animal-based research demonstrated the opposite:
药物能通过胎盘从母亲传给胎儿
drugs could pass from mother to fetus through the placenta.
像其他制药公司一样
Like other drug companies at this time,
Merrell公司没有在怀孕的动物身上测试他们的药物
Merrell had not tested its drugon pregnant animals.
凯尔希后来说Merrell关于萨力多胺的安全的证据看起来
Kelsey later said Merrell’s evidencefor thalidomide’s safety seemed
“更像证明书 而不像精心设计的研究成果”
“more like testimonials thanthe results of well-designed studies.”
凯尔希驳回了Merrell公司的申请
Kelsey rejected Merrell’s application
并要求他们提交另一个更好的证据
and asked them to submit a secondbacked by better evidence.
她的同事们都支持这一决定
Her FDA colleaguessupported this decision.
Merrell公司正期待着一个快速而肯定的答复
Merrell had expected a quick,affirmative reply
这样就能在镇静剂销量飙升的假期
so it could launch thalidomidefor the holiday season,
推出萨力多胺
when sedative sales soar.
Merrell公司没有提供凯尔希要求的数据
Instead of supplying Kelseywith the data she requested
而是想尝试在连续的电话和拜访中
they first tried to convince herto approve the drug
说服她批准这个药物
over a series of calls and visits.
在他们失败后
When these failed to sway her,
Merrell公司的高管们抱怨问题在于凯尔希的固执和挑剔
Merrell executives complained that stubborn and nit-picking Kelsey was the problem,
而不在于萨力多胺
not thalidomide.
美国食品及药物管理局支持凯尔希 并强迫Merrell公司提出另一个申请
The FDA backed Kelsey, forcing Merrell to fileanother application,
接着是另一个 另一个
and another, and another.
随着凯尔希审核并驳回了每一个申请
As Kelsey reviewedand rejected each new application,
萨力多胺的副作用开始浮出水面
news of thalidomide’s adverseside effects began to surface.
医生在1961年初报告了一例神经损伤
Doctors reported cases of nerve damagein early 1961,
到了秋季 他们揭露了一个更加可怕的真相
and by fall,they’d unmasked a more horrible truth. Thalidomide,
萨力多胺 这种被孕妇广泛使用的药物 造成了严重的先天缺陷
widely used by pregnantwomen, caused severe birth defects.
成千上万的婴儿在子宫内死去
Thousands of babies died in utero,
并且超过上万名婴儿出生时带有额外的肢体
and tens of thousands morewere born with extra appendages,
有的四肢短小 有的甚至没有四肢
shorter limbs, or no limbs at all.
在1961年11月 萨力多胺在德国市场下架
In November 1961, thalidomidewas pulled from the German market. Nonetheless,
尽管如此 Merrell公司在被撤回第六个 也是他们最后一个申请前
Merrell continued tryingto get it approved in the US
仍努力了好几个月想使其在美国得到批准
for several months before withdrawingtheir sixth and final application.
虽然凯尔希不是
While Kelsey wasn ’ t the
唯一识别出萨力多胺的危险的科学家
only scientist to identify the risks of thalidomide,
但她敲响了警钟 使它远离了几十亿美元的美国药物市场
she sounded the alarm that kept it off the multi-billion-dollar American drug market.
由于公众渐渐认识到了萨力多胺引发的悲剧
As public awarenessof the thalidomide tragedy grew,
这位安静的科学家轰动了媒体
the quiet scientistbecame a media sensation.
报纸和杂志上的头条新闻报道了她的勇敢行为
Headlines in newspapersand magazines heralded her heroism
并且美国总统约翰·F·肯尼迪微笑着
while a smiling President John F. Kennedy
在白宫前的草地上给她颁发了一个奖项
presented her an awardon the White House lawn.
在经历萨力多胺恐慌后
After the thalidomide scare,
国会通过了一项法律 这项法律扩大了美国食品及药物管理局的权力
Congress passed laws that expanded the FDA ’ s authority
并且使新药的申请变得更加困难
and toughened requirementsfor new drug applications.
凯尔希被挖去当药物代理调查机构的领导人
Kelsey was tapped to headthe agency’s drug investigation branch.
她一生在美国食药局担任过许多职位 直到她90多岁
Working at the FDA indifferent capacities into her 90s,
凯尔希能够见证她的行为给别人带来的鼓舞
Kelsey was able to witness the changesher actions helped inspire.
她的知名度可能变低 但她的遗产将永存
Her visibility may have dimmed since,but her legacy endures.
那就是:事实先于观点 耐心胜过捷径
Privileging facts over opinions,and patience over shortcuts,
她确立了循证医学 医药改革制度的基础
she made evidence-based medicinethe foundation of reforms
这种制度至今仍在保护人们
that continue to protect people today.
我们受弗朗西斯·凯尔希的故事的鼓舞
We are inspired by Francis Kelsey’s story.
并且我们希望你也是这样
And we hope you are too.
但在1930年代
But Doctor Kelsey’s life saving work
凯尔希博士的生命拯救工作得到了普遍的性别偏见
was almost thoughted by the pervasive gender biases of 1930s.
她在芝加哥大学得到工作时
When offered her job at University of Chicago,
她感到很有压力 害怕被拒绝
she felt pressure to refuse it.
因为据凯尔希博士所说
Because according to Doctor Kelsey,
“当一个女人在那时找到了一份工作
“When a woman took a job in those days,
她会感觉到仿佛是她剥夺了一个男人供养他的妻子和孩子的能力”
she was made to feel as if she was depriving a man of the ability to support his wife and child”.
当今 妇女占据了全世界40%的有偿工作职位
Today women make up almost 40% of the world’s pay work force.
但是她们仍然不能代表科学 技术 机械 数学领域
But they are still dispropotionally on reprent the stem field.
为什么呢? TED-ED俱乐部项目的学生也在问相同的问题
Why? These students on TED-ED Clubs program are asking the same question.
并且很多人在利用这个平台分享他们对世界科学的想法 探索和希望
And many are using the platform to share their scitific ideas, discoveries and hopes with the world.
要为你的激情树立信心 并加入这个活动来宣传工作室的想法
makes faith for your passion and join the movement to promote studio ideas.
想了解更多 逛逛“ED.TED.COM/CLUBS”
with ED. TED. COM/CLUBS to learn more.

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