How one scientist averted a national health crisis - Andrea Tone

翻译人员: Riley WANG 校对人员: Lipeng Chen

In the fall of 1960, Frances Oldham Kelsey

1960年秋天，

Frances Oldham Kelsey 刚刚加入 美国食品药品监督管理局 (FDA)。

was one of the Food and Drug Administration’s newest recruits.

Before the year was out,

在这年年末，

she would begin a fight that would save thousands of lives,

她即将开始一场拯救数千生命的斗争，

though no one knew it at the time.

但在当时却无人知晓。

Although she was new to the FDA, Kelsey was no novice as a scientist.

虽然凯尔西刚刚进入FDA， 但她并非新人科学家。

After graduating from high school at age 15,

15岁从高中毕业之后，

she enrolled at McGill University in Montreal

她在加拿大蒙特利尔的麦吉尔大学就读，

and earned both undergraduate and master’s degrees in pharmacology.

在此获得了药理学的学士和硕士学位。

From there, she applied for a research post

此后，她向芝加哥大学的药理学系

at the University of Chicago’s pharmacology department.

申请了研究员一职。

Her acceptance letter was addressed to Mr. Oldham.

她的录取信发给了 Oldham 先生。

Kelsey later joked that had her name been Elizabeth or Mary Jane,

Kelsey 后来开玩笑说 如果她的名字是 Elizabeth 或 Mary Jane，

her career might have ended there.

她的职业生涯可能会就此结束。

Fortunately, it didn’t.

幸运的是，这并未发生。

She earned her doctorate in pharmacology

她获得了药理学博士学位，

and accepted Chicago’s invitation to stay as faculty,

并接受了芝加哥大学的邀请成为教员，

where she undertook pioneering research on drugs and fetal safety.

她在药物和胎儿安全方面进行了开创性的实验。

In 1950, she earned an MD, her fourth and final degree.

1950年，她获得了医学博士学位， 这是她获得的第四个也是最后一个学位。

By the time she joined the FDA,

她加入FDA时，

Frances Kelsey was one of the most educated, experienced scientists around.

Frances Kelsey 是其中受教育程度最高、 经验最丰富的科学家之一。

Yet, as the newest member of the team,

但作为团队最新的一员，

Kelsey was assigned what everyone thought would be an easy review:

分派给 Kelsey 的是公认的简单工作：

an application from the US drug company Merrell

审查美国梅里尔制药公司的提起的申请，

to sell a drug called thalidomide.

这项申请请求批准名为沙利度胺的药品上市。

Thalidomide was a sedative developed in Germany

沙利度胺是德国开发的镇静剂，

that was already being widely used in dozens of countries

已经在数十个国家广泛使用，

to treat insomnia and workplace stress.

用来治疗失眠和职场压力。

Thalidomide’s anti-nausea properties

沙利度胺具有抑制恶心的特性，

also made it a popular remedy for pregnant women with morning sickness.

使得它也广泛用于缓解孕妇晨吐。

Reviewing Merrell’s application,

在审核梅里尔的材料时，

Kelsey found its data on thalidomide’s absorption and toxicity inadequate.

Kelsey 发现，关于沙利度胺 药品吸收和毒性的数据并不充分。

Today, the FDA classifies drugs based on their safety for a fetus.

如今，FDA按照对胎儿的安全程度 进行药品分级。

But in 1960, many experts believed that the placental barrier

但在1969年时，许多专家认为

胎盘屏障可以保护胎儿免受药物伤害。

shielded a fetus from harm.

Kelsey's earlier animal-based research

Kelsey 进行的早期动物测试

demonstrated the opposite:

推翻了这一结论：

drugs could pass from mother to fetus through the placenta.

药物可以通过胎盘由母体传递给胎儿。

Like other drug companies at this time,

如同当时其他的制药公司，

Merrell had not tested its drug on pregnant animals.

梅里尔并未在孕期动物身上进行测试。

Kelsey later said Merrell’s evidence for thalidomide’s safety seemed

Kelsey 后来表示 梅里尔给出的沙利度胺安全性的证据

“more like testimonials than the results of well-designed studies.”

“更像是引用证词而不是精确研究得出的结果。”

Kelsey rejected Merrell’s application

Kelsey 否决了梅里尔的申请，

and asked them to submit a second backed by better evidence.

并要求公司再次提交更有效的证据。

Her FDA colleagues supported this decision.

这个决定也得到了FDA同事的支持。

Merrell had expected a quick, affirmative reply

梅里尔原本期待快速通过批准，

so it could launch thalidomide for the holiday season,

以便在假期前发售沙利度胺药品，

when sedative sales soar.

因为镇静药物销量在假期时往往大增。

Instead of supplying Kelsey with the data she requested

梅里尔公司并未提供 Kelsey 要求的数据，

they first tried to convince her to approve the drug

而是先通过不断打电话和上门会面，

over a series of calls and visits.

试图说服 Kelsey 批准药物上市。

When these failed to sway her,

当这些都无法动摇 Kelsey 时，

Merrell executives complained

梅里尔的高层主管怨声载道，

that stubborn and nit-picking Kelsey was the problem,

认为沙利度胺没有问题，

顽固不堪、吹毛求疵的 Kelsey 才是最大的问题。

not thalidomide.

The FDA backed Kelsey,

FDA支持 Kelsey，

forcing Merrell to file another application,

迫使梅里尔公司重新提交申请，

and another,

and another.

再一次提交，

又一次提交。

As Kelsey reviewed and rejected each new application,

这些申请都经过 Kelsey 的审核及回绝，

news of thalidomide’s adverse side effects began to surface.

此时有关沙利度胺副作用 的新闻也开始出现。

Doctors reported cases of nerve damage in early 1961,

1961年初，有医生发表神经损伤的病例，

and by fall, they’d unmasked a more horrible truth.

秋天时，医生揭露出一个更可怕的事实。

Thalidomide, widely used by pregnant women, caused severe birth defects.

广泛作为孕妇用药的沙利度胺 导致了严重的婴儿出生缺陷。

Thousands of babies died in utero,

数千名婴儿在子宫中死去，

and tens of thousands more were born with extra appendages,

上万名婴儿出生时伴有多余附器，

shorter limbs,

更短的四肢，

or no limbs at all.

甚至完全没有四肢。

In November 1961, thalidomide was pulled from the German market.

1961年11月，沙利度胺在德国市场下架。

Nonetheless, Merrell continued trying to get it approved in the US

尽管如此，梅里尔仍进行了数月的尝试，

共提交了六次申请， 希望药品在美国通过审批。

for several months before withdrawing their sixth and final application.

While Kelsey wasn’t the only scientist to identify the risks of thalidomide,

虽然发现沙利度胺具有风险的 不止 Kelsey 一人，

she sounded the alarm

却是她敲响了警钟，

that kept it off the multi-billion-dollar American drug market.

阻止该药品进入 规模达到数十亿的美国药品市场。

As public awareness of the thalidomide tragedy grew,

随着公众对沙利度胺惨案的意识提高，

the quiet scientist became a media sensation.

默默无闻的科学家成为了媒体聚焦点。

Headlines in newspapers and magazines heralded her heroism

报纸杂志头条宣传 Kelsey 的英雄事迹，

while a smiling President John F. Kennedy

约翰·肯尼迪总统在白宫的草坪

presented her an award on the White House lawn.

颁发给 Kelsey 一枚奖章。

After the thalidomide scare,

沙利度胺恐慌之后，

Congress passed laws that expanded the FDA’s authority

议会通过法案提高FDA的权力，

and toughened requirements for new drug applications.

加强了新药申请的要求。

Kelsey was tapped to head the agency’s drug investigation branch.

Kelsey 被任命领导药品审查部分的工作。

Working at the FDA in different capacities into her 90s,

她在FDA不同职位工作直到90岁高龄，

Kelsey was able to witness the changes her actions helped inspire.

Kelsey 见证了 她的行为促进了改变。

Her visibility may have dimmed since, but her legacy endures.

虽然之后人们对她的关注度不如以往， 但她的事迹仍在流传。

Privileging facts over opinions, and patience over shortcuts,

事实高于观点，耐心胜于捷径，

she made evidence-based medicine the foundation of reforms

她将以证据为基础的药品作为改革的基础，

that continue to protect people today.

而这仍继续保护着如今的我们。