促成药品安全监管的致命失误
日期:2018-01-19 10:34

(单词翻译:单击)

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The history of medicine is full of some huge triumphs, but also some pretty terrible mistakes.
医药历史载满巨大的胜利但也有些相当糟糕的失误kT^@t)a&9jetcj
Like how, in the 1930s, a company out to make a quick buck took a safe, effective drug and managed to make it a killer.
比如1930年代,一家公司想要挣快钱,他们设法将安全有效的药物制造成了毒药=s|ezHvMqrz0EupT[7
But surrounding that tragedy are some pretty fascinating stories: how a dye became a wonder drug,
但围绕这个悲剧周围的却是一些相当吸引人的故事:染色剂是如何变身成一种特效药的、
how the US Food and Drug Administration became what it is today, and how one scientist walked home with a Nobel Prize.
美国食品药品监督管理局是如何演变成今日面貌的以及一名科学家是如何带着诺贝尔奖走回家的+I%yt%y,Y%*S4
The drug in question is called elixir sulfanilamide, and it was briefly manufactured and sold by the S. E. Massengill Company of Tennessee in 1937.
问题中的这种药被称为磺胺酏剂,1937年暂由美国制药商SE麦森吉尔公司生产和销售b3-e0cebvf|
But before this deadly elixir was concocted, sulfanilamide had a good rep as an effective drug all on its own.
但在这种致命酏剂调制之前,磺胺本身就是一种有效良药的代表#Lk%6|J|O4,Z
Sulfanilamide is an antibiotic, so it's used to fight bacterial infections.
磺胺是一种抗生素,所以它被用于对抗细菌感染]=],WO,&Fhhn;w
It works by interfering with bacteria's ability to make folic acid, which they need to reproduce.
通过干扰细菌产生叶酸的能力而起作用,细菌需要通过叶酸进行繁殖EU#boh4eG_8bRrCB+=d
It was derived from an earlier drug called Prontosil, which had a vivid red color and was actually developed by the dye industry.
磺胺源于一种早期药物—百浪多息,百浪多息是亮红色的且由染料工厂生产E@Mo[kS(ojiU5,%;W_
In 1932, chemist Gerhard Domagk found that this molecule wasn't just pretty, it could cure bacterial infections in mice.
1932年,药剂师格哈德·多马克(Gerhard Domagk)发现这种分子不仅漂亮,而且还能治愈老鼠身上的细菌感染*3PzOMIrV+i
And once Prontosil hit the market in 1935, it quickly grew popular and saved a lot of lives.
1935年百浪多息一打入市场就迅速流行且拯救了很多生命#c_9;3mC&i4V]
In fact, Prontosil and related compounds were some of the earliest widespread antibiotics.
事实上,百浪多息和相关化合物都是一些最早期的抗生素kS=T5@OFV4q[K08~1*
Penicillin had already been discovered, but wasn't easily available yet.
百浪多息虽然已经被发现,但还不能轻易获得B~pWp!po[9
Now, further research showed that there were two parts to the Prontosil molecule. One part was the dye, and the other was the antibiotic.
现在进一步的研究显示百浪多息分子有两个部分JL*KTLR8f8])M~;uf5X。一个部分是染料,另一部分是抗生素VVWzg18z~+&#R~lmfP
The antibiotic half was sulfanilamide, which researchers found could be used on its own, mostly in powder or pill form.
抗生素一半是磺胺,而研究员发现这部分磺胺自身就能被使用,大多数是粉末或药片状mdkbyfj;VBU=GL
While it had potential side effects, it was generally safe.
虽然有潜在的副作用,但基本还是安全的~V;XWNgWlP9^e4]#NN4U
We actually still use sulfanilamide to treat vaginal infections, though not very often because there are other antimicrobials out there nowadays.
事实上我们仍在使用磺胺治疗阴道感染,虽然不常用,因为当下还有其他抗菌剂可用Xj8zYj&yf@cKtEq
But the problem was that sulfanilamide had already been synthesized by chemists, and the patent had expired. So anybody could make and sell variants of it.
但问题是磺胺已被药剂师们进行了合成,而专利已经过期了0|C9DXNuVR^mt。所以任何人都可以制造且售卖其变体yesq__c%=3s&
Enter the Massengill company, who found that their customers liked their drugs in syrup form.
回到麦森吉尔公司,他们发现他们的客户喜欢糖浆状的药BWb=O%#aUJid*LTl5&8
They set out to make a liquid version of sulfanilamide, and their researchers eventually found that the powder would dissolve in diethylene glycol.
他们开始制造磺胺液体版本,并且他们的研究员最终发现这种粉末能够在二甘醇中分解Lvx4KOrZ&8UIw8e3T4
At the time, diethylene glycol was known as a solvent.
在那时二甘醇被认为是一种溶剂A64j_WHPxkw#glC*Ok)
It has a sweet taste and smell, and once the lab added some caramel and raspberry flavoring,
它有一种甜甜的味道和气味,一旦加入一些焦糖覆盆子调味剂,
they figured they had a nice medicine and released it as an antibiotic elixir.
他们发现他们就得到了一种漂亮的药品且将其作为一种抗菌药物上架m35Tv2*@mLV^=)fnCl;
Frankly, it sounds tastier than some cough syrups I've had.
说实话,这种药听起来比一些咳嗽糖浆更美味v^vGS]YzKCTD#,wL
Except for one thing: diethylene glycol is super poisonous.
除了一件事之外:二甘醇毒性超猛Ou5UNgI=Bm%#-^
Back then, there were one or two scientific studies about its toxicity, but they weren't widely known.
那时候对其毒性的科学研究有一两项,但还不为大众所知4uimlt_sLt#;+h%Hoa6

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促成药品安全监管的致命失误

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These days it's used as antifreeze, among other things, and we know it's not a sweet treat.
如今这种药被用作防冻剂,除了其他方面之外,我们知道这不是一种甜点GfGCH#Ld9qKI4es2yQed
Inside your body, diethylene glycol takes time to do its dirty work. At first, the symptoms resemble drunkenness. But after several hours, the poisoning gets worse.
二甘醇需要些时间才能在你体内捣鬼Y6eDvI0VdxA。首先,其症状像是醉酒_avKHBL]edY*e。但几小时之后,中毒开始越来越糟糕N%+p_E7q#Prs
While scientists aren't exactly sure how it kills, we do know it gets broken down by your liver into a nastier form.
虽然科学家并不确定它是如何致命的,但我们确实知道它会将身体内的肝脏分解成令人作呕的形式]|)m.F4DV|lj=
From there, it shuts down the kidneys and can affect the nervous system too.
从那里起,它会让肾脏停工并影响神经系统deS=q@yFL|VFBz
The instructions that shipped with the deadly elixir sulfanilamide said to keep giving it to patients until they got better.
据说致命磺胺酏剂使用方法是一直给病人服用这种药,直到病人好转为止4EB2A|dK]%uv2veq7O
Which means that some people were poisoned by well-meaning loved ones who fed them antifreeze for days or weeks until they succumbed, usually from kidney failure.
这就意味着一些人是被好心的挚爱之人一直喂食防冻剂,几周或是几星期,直到他们死去,通常死于肾衰竭FXgjF]%aM@vOQT^u|ehY
In total, at least 105 people died.
总计至少造成105人死亡aG6%qmvty9GbxyF
And if Massengill had just fed it to a handful of mice before shipping a bunch of it out, this tragedy might have been prevented.
如果在装船前,麦森吉尔公司能够用试验老鼠做一次实验,或许这场悲剧早已被避免WrQZu3ZgEUkuwiGx
Before 1938, the United States FDA only had the power to prevent adulteration and mislabeling.
1938年以前,美国食品药品监督管理局仅有权预防假药和贴错标签~,,btXT@Z@bKK8
You couldn't, for example, sell tablets of flour and say it was medicine. That was against the law.
例如,你不能把面粉制成的片剂当药卖Z39KsueW.;UY;M=。这是违法的aV|Tvc,gYg6(v
But you could sell something that was poison with zero safety testing beforehand — as long as it was what you said on the label.
但你可以售卖没有进行过安全测试的有毒物—只要你没贴错标签ux|qKiBzaXZ7
The Massengill company's elixir contained exactly what they said it did: sulfanilamide and diethylene glycol, with some water and flavoring.
麦森吉尔公司的酏剂就含有他们标签所说的物质:磺胺和二甘醇,以及一些水和调味剂nz=rz#1gBRe*9=Q5z
But they did technically break the law.
但他们在技术上确实违法了bPMzaAR9iY6J|P3.;=
They called the stuff an elixir, but that word was only supposed to be used for products that contained ethyl alcohol and Massengill's syrup had none.
他们称这种物质为酏剂,但这个词只用于那些含有乙醇的产品,但麦森吉尔公司的这种糖浆中却没有乙醇8)tSb|_(m!)Yc
The FDA seized on this technicality. They used it to track down the tainted medicine and slap Massengill with an unprecedented fine.
美国食品药品监督管理局正是抓住了这一点5ZA+LMt&5(r9u!Et_T(4。他们利用这一点查找那些污染药物并甩给麦森吉尔公司一张史无前例的罚单w!9ShV(3F#n~&xW
If not for the fine print, they would have been helpless, and many more people could have died.
如果不是因为标签极小的字体,他们也会束手无策,并造成更多人死亡I-t4CcFa9z&p
But a new law was rushed through Congress in 1938, giving the FDA increased power over drug safety.
但1938年快速通过的一项新法律赋予了美国食品药品监督管理局管理药品安全更大的权利8!1M7hHfwRBeF1~7[
That law is credited with preventing the infamous drug thalidomide, which was found to cause severe birth defects, from hitting US shelves many years later.
该法案成功阻止了一种臭名昭著的药物—萨力多胺一种导致严重的先天畸形药物的火爆销售4%g_JLkWFu
In the aftermath of this tragedy and new legislation, the chemist responsible for the antifreeze elixir committed suicide.
在悲剧和新监管之后,该防冻剂酏剂的负责药剂师自杀身亡e7X-)#]k=^0TDE2@*;;O
The senator who sponsored the 1938 drug law died shortly after it passed, reportedly of exhaustion.
1938年赞助药品法的参议员在法案通过之后没多久就因力竭而死亡6CfTtc2#KX|d8uVS9#d;
Powder and pill forms of sulfanilamide were still being made in labs and widely used as antibiotics by American soldiers in World War II.
粉末及药片磺胺仍在实验室中制作并在二战中被美军广泛用作抗生剂K2d)5!PfpD2!tM^ax2
As for Gerhard Domagk, developer of Prontosil, he won the 1939 Nobel prize in physiology and medicine for helping to usher in the antibiotic era.
至于格哈德·多马克,百浪多息的开发者,因协助引入抗生素时代而获1939年生理学和药物学诺贝尔奖Y9&QbN(2OHq.y
Because, really, prontosil, sulfanilamide, and related compounds were used a lot at the time, and can be safe and effective antibiotics.
因为百浪多息、磺胺以及相关物质是当时的常用药,并且也是安全有效的抗生素47Y0lfcdGy4aYM
You know, as long as you don't take them with antifreeze.
只要不和防冻剂一同食用(=H)fZA[O2qw0]
Thanks for watching this episode of SciShow! If you want to learn more about health-related science and policy,
感谢收看本期科学秀!如果你想知道更多关于健康的科学和政策,
you can check out videos with Dr. Aaron Carroll on our sister channel Healthcare Triage at youtube.com/healthcaretriage.
可以登录youtube.com/healthcaretriage和Aaron Carroll 博士一起观看我们的姊妹频道Healthcare Triage_)G0Q#XwF[-@bfQj~p

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