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

是美國食品和藥物管理局 新成員之一。

Before the year was out,

在首年工作內，

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

儘管當時無人知道，她展開了 一場拯救萬千人生命的鬥爭。

though no one knew it at the time.

雖然凱爾西是新來 FDA 的， 但她並非新手科學家。

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

15 歲高中畢業後，

After graduating from high school at age 15,

她進入蒙特婁的麥吉爾大學就讀，

she enrolled at McGill University in Montreal

並取得藥理學學士和碩士學位。

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

在那裡，她申請芝加哥大學 藥理學系的研究職位，

From there, she applied for a research post

她的接受函上收件人是奧德姆先生。

at the University of Chicago's pharmacology department.

凱爾西後來開玩笑說， 若她的名字是伊麗莎白或瑪麗珍，

Her acceptance letter was addressed to Mr. Oldham.

她的職業生涯可能會就此完結。

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

幸運的是這並沒有發生。

her career might have ended there.

她獲得藥理學的博士學位，

Fortunately, it didn't.

接受芝加哥大學的邀請留任為教授，

She earned her doctorate in pharmacology

並展開關於藥物與胎兒 安全的開創性研究。

and accepted Chicago's invitation to stay as faculty,

1950 年，凱爾西獲得醫學博士， 是她第四個也是最後一個學位。

where she undertook pioneering research on drugs and fetal safety.

當她加入 FDA 時，

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

凱爾西是世界上受過最多教育 和經驗最豐富的科學家之一。

By the time she joined the FDA,

然而，作為團隊的最新成員，

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

她被分配去做 眾人都認為簡單的審核工作：

Yet, as the newest member of the team,

審核美國梅里爾製藥公司的申請，

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

出售一種叫做「沙利竇邁」的藥物。

an application from the US drug company Merrell

沙利竇邁是德國開發的一種鎮靜劑，

to sell a drug called thalidomide.

已經在幾十個國家被廣泛使用，

Thalidomide was a sedative developed in Germany

治療失眠和工作壓力。

that was already being widely used in dozens of countries

沙利竇邁抗噁心嘔吐的特性，

to treat insomnia and workplace stress.

使大量孕婦用作控制孕吐的藥物。

Thalidomide's anti-nausea properties

在梅里爾藥廠的申請上，

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

凱爾西發現關於沙利竇邁的 吸收和毒性的數據不足。

Reviewing Merrell's application,

今天 FDA 根據藥物 對胎兒的安全性進行分類。

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

但在 1960 年，許多專家相信

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

胎盤的屏障可保護胎兒不受傷害。

But in 1960, many experts believed that the placental barrier

凱爾西早前以動物為基礎的研究結果

shielded a fetus from harm.

證明是恰恰相反：

Kelsey's earlier animal-based research

藥物能通過胎盤，從母親傳給胎兒。

demonstrated the opposite:

像那時的其他藥廠一樣，

drugs could pass from mother to fetus through the placenta.

梅里爾尚未在懷孕的動物身上 測試其藥物。

Like other drug companies at this time,

凱爾西後來對梅里爾的 沙利竇邁安全性證據的評論︰

Merrell had not tested its drug on pregnant animals.

「 不像縝密的研究報告結果， 更像是推薦書。 」

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

凱爾西拒絕了梅里爾的申請，

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

並要求他們提交第二份、 有進一步證據的報告。

Kelsey rejected Merrell's application

她的 FDA 同事們支持這次決定。

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

梅里爾藥廠原本期望 一個快速和肯定的答覆，

Her FDA colleagues supported this decision.

借鎮靜劑銷售在假期時飆升， 將沙利竇邁推出市場。

Merrell had expected a quick, affirmative reply

梅里爾並未提供凱爾西要求的數據，

so it could launch thalidomide for the holiday season,

反而通過多次電話和拜訪， 企圖說服她放行其藥物。

when sedative sales soar.

當種種手段未能說服她時，

Instead of supplying Kelsey with the data she requested

梅里爾高層抱怨︰

they first tried to convince her to approve the drug

「 問題的核心不是沙利竇邁， 而是既固執又挑剔的凱爾西 。」

over a series of calls and visits.

FDA 的管理層支持凱爾西，

When these failed to sway her,

迫使梅里爾藥廠需要提交

Merrell executives complained

一份又一份的申請，

that stubborn and nit-picking Kelsey was the problem,

在凱爾西審核、拒絕 每次重新申請的當下，

not thalidomide.

沙利竇邁具有不良 副作用的消息開始浮現。

The FDA backed Kelsey,

1961 年醫生初步報告了 導致神經損傷的病例，

forcing Merrell to file another application,

在秋天他們繼續揭露更多駭人的事實。

and another,

沙利竇邁廣泛地被孕婦使用後， 導致嚴重的出生缺陷。

and another.

成千上萬的嬰兒在子宮內死亡，

As Kelsey reviewed and rejected each new application,

還有數萬人生來就有殘疾， 有較短的四肢或根本沒有。

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

1961 年 11 月， 沙利竇邁被迫撤出德國市場。

Doctors reported cases of nerve damage in early 1961,

儘管如此，梅里爾藥廠 仍想在美國通過批核程序，

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

又過了幾個月，才撤銷 第六次、最後一次的申請。

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

雖然凱爾西不是唯一識別 沙利竇邁風險的科學家，

Thousands of babies died in utero,

但她敲響警鐘，

and tens of thousands more were born with extra appendages,

阻止它在數十億美元的 美國市場上市。

shorter limbs,

隨著公眾意識對沙利竇邁悲劇的增強，

or no limbs at all.

這位實幹的科學家成為媒體的寵兒。

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

報紙和雜誌在頭條 宣示她的英雄行為，

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

微笑的甘迺迪總統

for several months before withdrawing their sixth and final application.

在白宮草坪上頒獎給她。

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

在沙利竇邁恐慌後，

she sounded the alarm

國會通過了擴大 FDA 在法律上的權力，

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

收緊對新藥申請的政策。

As public awareness of the thalidomide tragedy grew,

凱爾西被任命負責 FDA 的藥物調查部門。

the quiet scientist became a media sensation.

凱爾西在 FDA 擔任不同職位 直到九十多歲。

Headlines in newspapers and magazines heralded her heroism

她能夠親眼見證 自己的行動所帶來的啟迪。

while a smiling President John F. Kennedy

她的知名度雖然隨時間下降， 但她的遺贈是恆久留存的。

presented her an award on the White House lawn.

賦予事實特權優於意見， 耐心勝過捷徑，

After the thalidomide scare,

她遵循醫學實證作為改革的基礎，

Congress passed laws that expanded the FDA's authority

繼續保護今天的人們。

and toughened requirements for new drug applications.

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

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

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

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

Privileging facts over opinions, and patience over shortcuts,

she made evidence-based medicine the foundation of reforms

that continue to protect people today.