How one scientist averted a national health crisis - Andrea Tone

譯者: Thomas Tam 審譯者: Helen Chang

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。

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.

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

雖然凱爾西是新來 FDA 的， 但她並非新手科學家。

After graduating from high school at age 15,

15 歲高中畢業後，

she enrolled at McGill University in Montreal

她進入蒙特婁的麥吉爾大學就讀，

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

並取得藥理學學士和碩士學位。

From there, she applied for a research post

在那裡，她申請芝加哥大學 藥理學系的研究職位，

at the University of Chicago’s pharmacology department.

Her acceptance letter was addressed to Mr. Oldham.

她的接受函上收件人是奧德姆先生。

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

凱爾西後來開玩笑說， 若她的名字是伊麗莎白或瑪麗珍，

her career might have ended there.

她的職業生涯可能會就此完結。

Fortunately, it didn’t.

幸運的是這並沒有發生。

She earned her doctorate in pharmacology

她獲得藥理學的博士學位，

and accepted Chicago’s invitation to stay as faculty,

接受芝加哥大學的邀請留任為教授，

where she undertook pioneering research on drugs and fetal safety.

並展開關於藥物與胎兒 安全的開創性研究。

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

1950 年，凱爾西獲得醫學博士， 是她第四個也是最後一個學位。

By the time she joined the FDA,

當她加入 FDA 時，

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

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。

Yet, as the newest member of the team,

然而，作為團隊的最新成員，

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

她被分配去做 眾人都認為簡單的審核工作：

an application from the US drug company Merrell

審核美國梅里爾製藥公司的申請，

to sell a drug called thalidomide.

出售一種叫做「沙利竇邁」的藥物。

Thalidomide was a sedative developed in Germany

沙利竇邁是德國開發的一種鎮靜劑，

that was already being widely used in dozens of countries

已經在幾十個國家被廣泛使用，

to treat insomnia and workplace stress.

治療失眠和工作壓力。

Thalidomide’s anti-nausea properties

沙利竇邁抗噁心嘔吐的特性，

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

使大量孕婦用作控制孕吐的藥物。

Reviewing Merrell’s application,

在梅里爾藥廠的申請上，

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

凱爾西發現關於沙利竇邁的 吸收和毒性的數據不足。

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

今天 FDA 根據藥物 對胎兒的安全性進行分類。

But in 1960, many experts believed that the placental barrier

但在 1960 年，許多專家相信

胎盤的屏障可保護胎兒不受傷害。

shielded a fetus from harm.

Kelsey's earlier animal-based research

凱爾西早前以動物為基礎的研究結果

demonstrated the opposite:

證明是恰恰相反：

drugs could pass from mother to fetus through the placenta.

藥物能通過胎盤，從母親傳給胎兒。

Like other drug companies at this time,

像那時的其他藥廠一樣，

Merrell had not tested its drug on pregnant animals.

梅里爾尚未在懷孕的動物身上 測試其藥物。

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

凱爾西後來對梅里爾的 沙利竇邁安全性證據的評論︰

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

「 不像縝密的研究報告結果， 更像是推薦書。 」

Kelsey rejected Merrell’s application

凱爾西拒絕了梅里爾的申請，

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

並要求他們提交第二份、 有進一步證據的報告。

Her FDA colleagues supported this decision.

她的 FDA 同事們支持這次決定。

Merrell had expected a quick, affirmative reply

梅里爾藥廠原本期望 一個快速和肯定的答覆，

so it could launch thalidomide for the holiday season,

借鎮靜劑銷售在假期時飆升， 將沙利竇邁推出市場。

when sedative sales soar.

Instead of supplying Kelsey with the data she requested

梅里爾並未提供凱爾西要求的數據，

they first tried to convince her to approve the drug

反而通過多次電話和拜訪， 企圖說服她放行其藥物。

over a series of calls and visits.

When these failed to sway her,

當種種手段未能說服她時，

Merrell executives complained

梅里爾高層抱怨︰

that stubborn and nit-picking Kelsey was the problem,

「 問題的核心不是沙利竇邁， 而是既固執又挑剔的凱爾西 。」

not thalidomide.

FDA 的管理層支持凱爾西，

The FDA backed Kelsey,

forcing Merrell to file another application,

迫使梅里爾藥廠需要提交

and another,

and another.

一份又一份的申請，

As Kelsey reviewed and rejected each new application,

在凱爾西審核、拒絕 每次重新申請的當下，

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

沙利竇邁具有不良 副作用的消息開始浮現。

Doctors reported cases of nerve damage in early 1961,

1961 年醫生初步報告了 導致神經損傷的病例，

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

在秋天他們繼續揭露更多駭人的事實。

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

沙利竇邁廣泛地被孕婦使用後， 導致嚴重的出生缺陷。

Thousands of babies died in utero,

成千上萬的嬰兒在子宮內死亡，

and tens of thousands more were born with extra appendages,

還有數萬人生來就有殘疾， 有較短的四肢或根本沒有。

shorter limbs,

or no limbs at all.

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

1961 年 11 月， 沙利竇邁被迫撤出德國市場。

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

儘管如此，梅里爾藥廠 仍想在美國通過批核程序，

for several months before withdrawing their sixth and final application.

又過了幾個月，才撤銷 第六次、最後一次的申請。

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

雖然凱爾西不是唯一識別 沙利竇邁風險的科學家，

she sounded the alarm

但她敲響警鐘，

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

阻止它在數十億美元的 美國市場上市。

As public awareness of the thalidomide tragedy grew,

隨著公眾意識對沙利竇邁悲劇的增強，

the quiet scientist became a media sensation.

這位實幹的科學家成為媒體的寵兒。

Headlines in newspapers and magazines heralded her heroism

報紙和雜誌在頭條 宣示她的英雄行為，

while a smiling President John F. Kennedy

微笑的甘迺迪總統

presented her an award on the White House lawn.

在白宮草坪上頒獎給她。

After the thalidomide scare,

在沙利竇邁恐慌後，

Congress passed laws that expanded the FDA’s authority

國會通過了擴大 FDA 在法律上的權力，

and toughened requirements for new drug applications.

收緊對新藥申請的政策。

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

凱爾西被任命負責 FDA 的藥物調查部門。

凱爾西在 FDA 擔任不同職位 直到九十多歲。

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

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

她能夠親眼見證 自己的行動所帶來的啟迪。

她的知名度雖然隨時間下降， 但她的遺贈是恆久留存的。

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

Privileging facts over opinions, and patience over shortcuts,

賦予事實特權優於意見， 耐心勝過捷徑，

she made evidence-based medicine the foundation of reforms

她遵循醫學實證作為改革的基礎，

that continue to protect people today.

繼續保護今天的人們。