Name: 【TED-Ed】一個科學家如何扭轉國家級健康危機 (How one scientist averted a national health crisis - Andrea Tone)
Uploaded: 2018-08-06T05:02:12.000Z
Duration: 5 min 32 s

In the fall of 1960, Frances Oldham Kelsey

1960 年秋天， 弗朗西絲‧奧德姆‧凱爾西

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。

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。

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.

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,

接受芝加哥大學的邀請留任為教授，

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.

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。

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：

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，

已經在幾十個國家被廣泛使用，

Thalidomide was a sedative  developed in Germany

that was already being widely used  in dozens of countries

使大量孕婦用作控制孕吐的藥物。

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。

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.

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

藥物能通過胎盤，從母親傳給胎兒。

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。

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

“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。

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。

Instead of supplying Kelsey with the data she requested

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 。」

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，

沙利竇邁具有不良 副作用的消息開始浮現。

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。

沙利竇邁廣泛地被孕婦使用後， 導致嚴重的出生缺陷。

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，

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。

隨著公眾意識對沙利竇邁悲劇的增強，

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

for several months before withdrawing  their sixth and final application.

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

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.

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，

她遵循醫學實證作為改革的基礎，

Congress passed laws that expanded  the FDA's authority

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

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【TED-Ed】一個科學家如何扭轉國家級健康危機 (How one scientist averted a national health crisis - Andrea Tone)

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