505: Use Only as Directed - This American Life
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00:00 00:00 Transcript Share This American Life Life Partners How to Listen Episodes Recommended About Overview Staff Announcements Fellowships Jobs Music Make Radio On The Road FAQ Submissions Merch Contact Us Our Other Shows Merch Follow Us Life Partners Subscribe to our newsletter Full episode Toggle Audio and Transcript Sync Transcript | Episode #505 | September 20, 2013 505: Use Only as Directed Note: This American Life is produced for the ear and designed to be heard.
00:00 00:00 文字记录 分享此 美国生活 生活伙伴 如何收听 剧集 推荐 关于 概述 员工公告 奖学金 工作 音乐 在路上制作电台 常见问题解答 提交 商品 联系我们 我们的其他节目 商品 关注我们 生活伙伴 订阅我们的时事通讯 整集 切换音频和文字记录同步 文字记录 | 内容第 505 集 | 2013 年 9 月 20 日 505:仅按指示使用 注意:This American Life 专为耳朵而设计,旨在让人们听到。
If you are able, we strongly encourage you to listen to the audio, which includes emotion and emphasis that's not on the page.
如果可以的话,我们强烈建议您收听音频,其中包括页面上没有的情感和重点。
Transcripts are generated using a combination of speech recognition software and human transcribers, and may contain errors.
文字记录是使用语音识别软件和人工转录员结合生成的,可能包含错误。
Please check the corresponding audio before quoting in print.
请在印刷版引用前检查相应的音频。
Prologue Ira Glass Sarah Erush was a pharmacist and head of the Drug Information Center at the Hospital at the University of Pennsylvania.
序言 Ira Glass Sarah Erush 是一名药剂师,也是宾夕法尼亚大学医院药物信息中心的负责人。
And in that job, she had to do one of those tasks that you never heard of, but then when you hear that this job exists, you think, oh right, of course.
在那份工作中,她必须完成其中一项您从未听说过的任务,但是当您听说有这份工作时,您会想,哦,当然,是的。
Somebody's got to do that.
必须有人这么做。
Namely, when patients had a bad reaction, a surprising reaction, to the drugs that they were on, Sarah Erush was the person who was supposed to make sure that the Food and Drug Administration was notified about it.
也就是说,当患者对所服用的药物产生不良反应、令人惊讶的反应时,莎拉·埃鲁什(Sarah Erush)应该确保将此事通知美国食品和药物管理局。
The FDA keeps track of these things, drug injuries.
FDA 跟踪这些事情,药物伤害。
It's part of monitoring whether drugs are safe.
这是监测药物是否安全的一部分。
And so one day in 2002, she got this unusual call from somebody at the FDA about one of the most popular drugs in the country-- acetaminophen.
2002 年的一天,她接到 FDA 工作人员打来的一通不同寻常的电话,询问该国最受欢迎的药物之一——对乙酰氨基酚。
Acetaminophen is the active ingredient in Tylenol.
对乙酰氨基酚是泰诺的活性成分。
And every now and then, Erush had sent in a report about some patient reacting to acetaminophen.
埃鲁什时不时地发来一份报告,称一些病人对乙酰氨基酚有反应。
And they said, we were looking at your reports on acetaminophen, and we were wondering if you had ever really sat and collated this data.
他们说,我们正在查看您关于对乙酰氨基酚的报告,我们想知道您是否曾经真正坐下来整理过这些数据。
And we said, no, not really.
我们说,不,不是真的。
We've been reporting it all along, and we look at it when we report it.
我们一直在报道,报道的时候我们也会看。
But we never really looked at it in aggregate.
但我们从未真正从总体上看待它。
"In aggregate"-- they never looked at all the cases together as a group.
“总的来说”——他们从来没有把所有的案例作为一个整体来看待。
And they said, well, we have been looking at it in aggregate, and we think it's really interesting.
他们说,好吧,我们一直在综合考虑它,我们认为这真的很有趣。
And we think you might want to do that.
我们认为您可能想这样做。
And we thought that was kind of an odd request.
我们认为这是一个奇怪的要求。
And so I said, well, why would we do that?
所以我说,好吧,我们为什么要这么做?
What are you seeing?
你看到什么了?
And they said, well, we don't really want to tell you that.
他们说,好吧,我们真的不想告诉你这个。
We want to see if you think it's compelling as well.
我们想看看您是否也认为它具有说服力。
So they sort of opened the door and said, you should go look, but they didn't tell us what to look for.
所以他们打开门说,你应该去看看,但他们没有告诉我们要寻找什么。
Which was a really good scientific method, because they didn't tell us what we should go find, which would have biased us towards the data.
这是一个非常好的科学方法,因为他们没有告诉我们应该去寻找什么,这会让我们对数据产生偏见。
They just said, you should go look.
他们只是说,你应该去看看。
It's interesting.
这很有趣。
Sarah got off the phone and told her office-mate, the FDA wants us to look at our acetaminophen cases.
莎拉挂断电话告诉她的同事,FDA 希望我们检查我们的对乙酰氨基酚病例。
And her co-worker was all, why?
而她的同事就是全部,为什么?
They had no idea.
他们不知道。
Not a clue.
没有任何线索。
We really didn't.
我们真的没有。
Till we started looking at it, and then this little light bulb kind of went on in the back of our heads, where we said, hey, we do remember that one odd case.
直到我们开始观察它,然后这个小灯泡就在我们的脑后亮了起来,我们说,嘿,我们确实记得那个奇怪的案例。
Oh, we do remember that other odd case.
哦,我们确实记得另一个奇怪的案例。
Oh, we do remember that third odd case.
哦,我们确实记得第三个奇怪的案例。
And then it started to occur to us, we have a lot of odd cases.
然后我们开始意识到,我们有很多奇怪的案例。
Sarah Erush found 23 people in four years at just one hospital who said they took just a little extra, just a few more pills than recommended for a few more days, and severely damaged their livers.
萨拉·埃鲁什 (Sarah Erush) 发现,四年内,仅一家医院就有 23 名患者表示,他们只是多服用了一点,只是比建议多服用了几天药片,结果导致肝脏严重受损。
Three of them died.
其中三人死亡。
Two had transplants.
其中两人接受了移植手术。
Now most of these 23 were either chronic heavy drinkers or had a lot of alcohol around the time they were taking the pills, which makes acetaminophen more dangerous.
现在,这 23 人中的大多数要么是长期酗酒者,要么是在服药期间喝了很多酒,这使得对乙酰氨基酚更加危险。
But it wasn't every case.
但并非所有情况都是如此。
Some didn't report any drinking.
有些人没有报告任何饮酒行为。
And what surprised Sarah Erush most of all was the amounts-- just how easy it was to take too much acetaminophen.
最让莎拉·埃鲁什感到惊讶的是剂量——服用过量对乙酰氨基酚是多么容易。
It used to be touted as the safest pain reliever you can buy.
它曾经被吹捧为您可以买到的最安全的止痛药。
I mean, that was the big push on selling Tylenol.
我的意思是,这是泰诺销售的巨大推动力。
It's the safest pain reliever you can buy.
这是您能买到的最安全的止痛药。
And in fact, when we would interview the patients and say, you know, the label says how much to take.
事实上,当我们采访患者并说,你知道,标签上写了服用多少。
Why did you take more than that?
为什么你拿的比这个多?
And the answers were always, because it always says it's the safest thing you could buy.
答案总是如此,因为它总是说这是你能买到的最安全的东西。
I figure if two were OK, then I would take three.
我想如果两个都可以的话我就选三个。
When we would say, you know, you realize you're here because here you have a high acetaminophen level and that's affected your liver, And they would be aghast.
当我们说,你知道,你意识到你在这里是因为这里的对乙酰氨基酚水平很高,这会影响你的肝脏,他们会感到震惊。
They would say, from Tylenol?
他们会说,来自泰诺?
This is from Tylenol?
这是泰诺的吗?
How could it be from Tylenol?
怎么可能是泰诺呢?
I thought that was harmless, or it was so safe, it couldn't possibly happen.
我认为那是无害的,或者说它是如此安全,它不可能发生。
I didn't take that much.
我没拿那么多。
That would be the first thing they would all say.
这将是他们所有人都会说的第一句话。
I didn't take that much.
我没拿那么多。
And when you'd ask how much, it was more than the recommended dose, but they really didn't take that much more.
当你问多少时,它超过了推荐剂量,但他们实际上并没有服用更多。
Erush says she's also surprised how many doctors she meets who don't know this kind of reaction can happen if a patient takes just a little bit too much acetaminophen.
埃鲁什说,她还感到惊讶的是,她遇到的许多医生不知道如果患者服用过多的对乙酰氨基酚,就会发生这种反应。
I am stunned and amazed, still, how physicians will almost routinely throw in Tylenol when they're treating pain.
我仍然感到震惊和惊讶,医生在治疗疼痛时几乎经常使用泰诺。
Well, here, why don't you take this on top of everything else, because it's only Tylenol.
好吧,在这里,你为什么不把它放在其他一切之上,因为它只是泰诺。
It's fine.
没关系。
It's safe.
很安全。
My own mother, she had bone pain from cancer, and they had her on lots of big painkillers.
我自己的母亲,她因癌症而患有骨痛,他们让她服用大量止痛药。
And they said, oh, and we're going to give her 4 grams of Tylenol a day, too.
他们说,哦,我们还要每天给她 4 克泰诺。
And I said, why?
我说,为什么?
And they said, oh, it's good for bone pain.
他们说,哦,这对骨痛有好处。
I said, no, it's not.
我说,不,不是。
[LAUGHS] A, it's not, and B, I don't want my mother taking 4 grams of Tylenol a day for no good reason whatsoever.
[笑] A,不是,B,我不希望我的母亲无缘无故地每天服用 4 克泰诺。
She's also on morphine, and I think that'll probably do it.
她还服用吗啡,我想这可能会起作用。
Over the last nine months, our radio show has worked alongside the investigative reporting organization ProPublica-- who's been at this even longer-- looking into acetaminophen and Tylenol, interviewing dozens of doctors and scientists.
在过去的九个月里,我们的广播节目与调查报道组织 ProPublica 合作(该组织从事这方面的工作时间更长),调查对乙酰氨基酚和泰诺,采访了数十名医生和科学家。
ProPublica went through hundreds of documents.
ProPublica 查阅了数百份文件。
And what we've concluded is that while Tylenol has built its reputation on the idea that it is safer than other over-the-counter painkillers, it is less safe than many of us believe.
我们得出的结论是,虽然泰诺因其比其他非处方止痛药更安全而享有盛誉,但它的安全性却没有我们许多人认为的那么高。
Now I want to be very clear about what I'm saying here.
现在我想非常清楚地说明我在这里所说的内容。
Taken as recommended, Tylenol-- or any drug containing the active ingredient in Tylenol, acetaminophen-- is considered safe by most doctors and experts.
按照建议,大多数医生和专家认为泰诺或任何含有泰诺活性成分对乙酰氨基酚的药物是安全的。
The problems that we're talking about with the drug probably affect much less than 1% of all the people taking acetaminophen and Tylenol.
我们所讨论的药物问题可能影响到所有服用对乙酰氨基酚和泰诺的人中不到 1%。
After all, one out of six Americans take acetaminophen in any given week-- 50 million people, according to Tylenol's manufacturer.
毕竟,据泰诺 (Tylenol) 制造商称,六分之一的美国人在任何一周内都会服用对乙酰氨基酚,即 5000 万人。
And as a pharmacist, Sarah Erush says, sure, we should keep it on the market.
作为一名药剂师,莎拉·埃鲁什说,当然,我们应该将其留在市场上。
No question.
毫无疑问。
It's the best medicine out there for lots of situations.
对于很多情况来说,这是最好的药物。
Mild chronic pain, like for geriatric patients, two Tylenol a day.
轻度慢性疼痛,例如老年患者,每天两颗泰诺。
They can take that for a lot longer than they might be able to take two Motrin or Advil a day because of the risk of GI ulceration.
由于存在胃肠道溃疡的风险,他们服用该药物的时间可能比每天服用两片美林或布洛芬的时间要长得多。
In a pediatric hospital, she says, it's the best thing to give a kid for fever.
她说,在儿科医院,给发烧的孩子吃药是最好的。
Won't upset a stomach.
不会伤胃。
It won't interact with other drugs.
它不会与其他药物相互作用。
It doesn't put them at risk for Reye syndrome, the way that aspirin would.
它不会像阿司匹林那样使他们面临雷氏综合症的风险。
But all that said, it is very easy overdose on acetaminophen.
但话虽如此,对乙酰氨基酚很容易过量。
Over 150 people in the United States die on average every year from accidentally taking too much of the drug.
美国平均每年有超过 150 人因意外服用过量药物而死亡。
150 people.
150人。
That data comes from the federal government, from the Centers for Disease Control and Prevention.
这些数据来自联邦政府、疾病控制和预防中心。
Federal government data also shows that every year, 78,000 people land in the emergency room and over 33,000 people are hospitalized either from intentional or unintentional overdoses of the drug.
联邦政府数据还显示,每年有 78,000 人进入急诊室,超过 33,000 人因有意或无意过量服用该药物而住院。
Will Lee is one of the liver specialists and researchers who's been calling attention to the dangers of acetaminophen.
威尔·李(Will Lee)是肝脏专家和研究人员之一,他一直呼吁人们关注对乙酰氨基酚的危险。
He is at the University of Texas Southwestern Medical Center and talked to reporter Sean Cole.
他在德克萨斯大学西南医学中心接受了记者肖恩·科尔的采访。
In one of the articles, we actually printed up the little coupon that I got with my Zocor prescription that says, $2 off on your next acetaminophen bottle.
在其中一篇文章中,我们实际上打印了我通过 Zocor 处方获得的小优惠券,上面写着,下一瓶对乙酰氨基酚可优惠 2 美元。
And one of the things on the coupon, it says safest.
优惠券上的一件事是,它说最安全。
Not safer, or not safe, but safest.
不是更安全,也不是不安全,而是最安全。
Well, this is the number-one drug killing Americans every year.
嗯,这是每年杀死美国人的第一大毒品。
Over-the-counter drug killing Americans.
非处方药杀死了美国人。
Over-the-counter drug.
非处方药。
Sean Cole Not the safest.
肖恩·科尔 不是最安全的。
Not the safest, for sure.
当然不是最安全的。
So I guess that's-- if you think I have a bee in my bonnet, that's probably where it came from.
所以我想——如果你认为我的帽子里有一只蜜蜂,那它可能就是从那里来的。
That assessment, that acetaminophen kills more Americans than any other over-the-counter pain reliever, comes from two big databases, the Centers for Disease Control and Prevention-- that's part of the federal government-- and the American Association of Poison Control Centers.
这项评估认为,对乙酰氨基酚比任何其他非处方止痛药杀死的美国人都多,这一评估来自两个大型数据库:美国疾病控制与预防中心(隶属于联邦政府)和美国毒物控制中心协会。
The company that makes Tylenol, McNeil Consumer Healthcare, does not agree with that assessment.
生产泰诺 (Tylenol) 的公司 McNeil Consumer Healthcare 并不同意这一评估。
A spokesperson said in an email that in their view, we here at This American Life cannot responsibly say on the radio that acetaminophen kills more people, because those two databases, quote, "simply do not contain the information needed," end quote.
一位发言人在一封电子邮件中表示,在他们看来,我们《美国生活》不能负责任地在广播中说对乙酰氨基酚杀死了更多的人,因为这两个数据库“根本不包含所需的信息”,引用结束。
And in fact, it's true that epidemiologists have pointed out that those databases might not accurately count all of the people who die as a result of taking other over-the-counter pain relievers.
事实上,流行病学家确实指出,这些数据库可能无法准确统计所有因服用其他非处方止痛药而死亡的人数。
But that is a theoretical possibility, that lots of people may be dying from those other over-the-counter painkillers.
但这是一种理论上的可能性,即很多人可能会死于其他非处方止痛药。
There aren't studies-- or anyway, we couldn't find any-- which locate real people who died this way and find more of them dying from over-the-counter aspirin or ibuprofen or any of the others than die from acetaminophen.
没有研究——或者无论如何,我们找不到任何研究——找到真正以这种方式死亡的人,并发现死于非处方阿司匹林或布洛芬或任何其他药物的人比死于对乙酰氨基酚的人更多。
We asked McNeil for studies like that, and they did not send any.
我们向麦克尼尔索要这样的研究报告,但他们没有寄出任何报告。
Just last month, McNeil, the maker of Tylenol, and its parent company Johnson & Johnson, announced that they're putting a new warning onto the caps of Extra Strength Tylenol saying, in bright red letters, "Contains acetaminophen," and "Always read the label." The new warning does not go so far as to say that a relatively small overdose can kill you.
就在上个月,泰诺的制造商麦克尼尔及其母公司强生公司宣布,他们将在特强泰诺的瓶盖上加上新的警告,用鲜红色的字母写着“含有对乙酰氨基酚”和“务必阅读标签”。新的警告并没有说相对少量的过量服用就可能致命。
Most people already know that acetaminophen can be dangerous.
大多数人已经知道对乙酰氨基酚可能很危险。
According to a national poll commissioned by ProPublica and our radio program, 86% of Americans know that Tylenol can cause severe liver damage, and 2/3 of the public knows that it can kill you.
根据 ProPublica 和我们的广播节目委托进行的一项全国民意调查,86% 的美国人知道泰诺会导致严重的肝损伤,2/3 的公众知道它会致命。
But I think that many people do not know just how little extra it takes to be dangerous or to kill you.
但我认为很多人不知道需要多少额外的努力才会造成危险或杀死你。
Certainly, I have say none of us who worked on this story, here at our radio show, knew this before.
当然,我说过,我们在广播节目中参与这个故事的人以前都不知道这一点。
And why not?
为什么不呢?
Well, today we explain how we got to this point, how one of the most widely-used over-the-counter painkillers in the country, acetaminophen, also kills so many people.
好吧,今天我们解释一下我们是如何走到这一步的,对乙酰氨基酚是该国最广泛使用的非处方止痛药之一,如何也导致如此多的人死亡。
And many of us had no idea.
我们很多人都不知道。
And so even though a lot of you already know that acetaminophen can be dangerous, we're going to spend an hour on this today.
因此,尽管你们很多人已经知道对乙酰氨基酚可能很危险,但今天我们仍将花一个小时来讨论这个问题。
Because number one, over 150 people are dying every year.
因为第一,每年有超过 150 人死亡。
It seems completely unnecessary.
这似乎完全没有必要。
And number two, the story of how this drug has been regulated by the Food and Drug Administration-- when we heard it, I have to say we were shocked at the government's behavior, and we think that you will be shocked.
第二,关于这种药物如何受到食品和药物管理局监管的故事——当我们听到这个消息时,我不得不说我们对政府的行为感到震惊,我们认为你们也会感到震惊。
And so from WBEZ Chicago, it's This American Life, distributed by Public Radio International.
这是芝加哥 WBEZ 的《This American Life》,由国际公共广播电台发行。
I'm Ira Glass.
我是艾拉·格拉斯。
Our show today on all of these things.
我们今天的节目涉及所有这些事情。
Stay with us.
留在我们身边。
And I turn things over now to the reporter who's been looking into this for our radio show, Sean Cole.
我现在把事情交给一直在为我们的广播节目调查此事的记者肖恩·科尔。
So here's a little drug regulation lingo for you.
这里有一些药物监管术语供您参考。
I know that's why a lot of you tune into this show.
我知道这就是你们很多人收看这个节目的原因。
That small margin of error between a safe dose and a potentially harmful dose of acetaminophen?
对乙酰氨基酚的安全剂量和潜在有害剂量之间的误差幅度这么小?
That's what the FDA would call a narrow therapeutic index.
这就是 FDA 所说的窄治疗指数。
And the other over-the-counter painkillers don't have it.
而其他非处方止痛药则没有。
I'll let T.
我会让T。
Miller explain this part.
米勒解释了这部分。
He's one of the ProPublica reporters who spent a long time on this story.
他是 ProPublica 的记者之一,花了很长时间报道这个故事。
So with a drug like ibuprofen, Advil, it can cause stomach and gastric problems at the recommended dose.
因此,像布洛芬、布洛芬这样的药物,在推荐剂量下可能会引起胃部和胃部问题。
Aspirin, same thing.
阿司匹林,同样的东西。
But it takes a lot of ibuprofen to kill yourself.
但需要大量布洛芬才能自杀。
In fact, there's not a lot of cases on record of anybody dying from ibuprofen toxicity.
事实上,据记录,因布洛芬中毒而死亡的病例并不多。
In the only case he could find, it took 20 times the recommended dose to kill someone.
在他能找到的唯一一个案例中,需要 20 倍推荐剂量才能杀死一个人。
Same with aspirin.
与阿司匹林相同。
You have to take six or eight times the maximum recommended dose for it to become toxic to your system.
您必须服用最大推荐剂量的六到八倍,它才会对您的系统产生毒性。
With acetaminophen, just twice the maximum safe dose, or even less, taken over several days could possibly get you into serious trouble.
对于对乙酰氨基酚,只要是最大安全剂量的两倍,甚至更少,连续几天服用,就可能会给你带来严重的麻烦。
Now I should be clear that there's no hard and fast number for this.
现在我应该明确的是,这没有硬性的数字。
Nobody knows for sure.
没有人确切知道。
One of the most prominent doctors researching right now is Will Lee, who you heard from earlier.
目前最著名的研究医生之一是威尔·李(Will Lee),您之前曾听说过他。
His data shows if you take twice the maximum safe dose-- maximum safe dose printed on the bottle is 4 grams-- if you take twice that amount, you're in the danger zone.
他的数据显示,如果您服用最大安全剂量的两倍(瓶子上印有的最大安全剂量是 4 克),那么您就处于危险区域。
McNeil, who makes Tylenol, said pretty much the same thing in an email, but later changed their estimate to at least 10 grams a day for at least two to three days.
泰诺 (Tylenol) 的生产商麦克尼尔 (McNeil) 在一封电子邮件中说了几乎同样的话,但后来将他们的估计改为每天至少 10 克,持续至少两到三天。
10 grams a day is 2 and 1/2 times the maximum safe dose.
每天10克是最大安全剂量的2又1/2倍。
But the danger zone might start at a much smaller dose.
但危险区域可能从较小的剂量开始。
The FDA has said that just 5 grams a day could hurt your liver.
FDA 表示,每天仅 5 克就会损害肝脏。
That's just one gram more than the safety limit listed on the bottle.
这仅比瓶子上列出的安全限值多了一克。
A gram.
一克。
That would mean the difference between a safe dose and a dangerous dose is two Extra Strength Tylenol tablets.
这意味着安全剂量和危险剂量之间的差异是两片特强泰诺片。
Just two tablets.
只需两片。
That number comes from the FDA's national database of adverse drug events.
该数字来自 FDA 的国家药物不良事件数据库。
That is, cases of people who were injured by medicinal drugs.
也就是人被药物伤害的案例。
The agency cites it in a report prepared in 2008.
该机构在 2008 年编写的一份报告中引用了这一点。
But now here's a caveat-- not everyone who takes a little more than they should will get into trouble.
但现在有一个警告——并不是每个多吃一点的人都会遇到麻烦。
It seems that some people are more susceptible to liver damage from acetaminophen than others.
似乎有些人比其他人更容易受到对乙酰氨基酚的肝脏损害。
Some people can take twice the safe dose, or even more than that amount, and be fine.
有些人服用两倍于安全剂量,甚至更多的剂量,就没有问题。
This is all according to the FDA, and Will Lee and Sarah Erush told us this as well.
这一切都是根据 FDA 的说法,Will Lee 和 Sarah Erush 也告诉了我们这一点。
But the science is still really preliminary.
但科学仍处于初步阶段。
And truthfully, this wouldn't be as much of a problem if it wasn't for you.
说实话,如果不是你的话,这不会是一个大问题。
And me, before I started working on this story.
而我,在我开始写这个故事之前。
A lot of us just take too much of this stuff, thinking that if two pills work fine, three must work better.
我们很多人服用了太多这种东西,认为如果两片药效果很好,那么三片效果一定更好。
We found five separate surveys, including one performed by McNeil, that show about a quarter of us take more than the recommended dose of over-the-counter drugs.
我们发现五项独立的调查(包括麦克尼尔进行的一项调查)显示,大约四分之一的人服用的非处方药超过了推荐剂量。
That would mean because acetaminophen is taken by 50 million people every week, a quarter would be 12 million of us routinely taking more than the recommended dose.
这意味着,由于每周有 5000 万人服用对乙酰氨基酚,四分之一的人会经常服用超过推荐剂量的剂量。
I talked with Dr. Mel Wilcox about these surveys.
我与梅尔·威尔考克斯博士讨论了这些调查。
He's a gastroenterologist and liver doctor at the University of Alabama at Birmingham.
他是阿拉巴马大学伯明翰分校的胃肠病学家和肝脏医生。
He and a couple of other researchers published a paper analyzing two of the surveys, 9,000 patients in all.
他和其他几位研究人员发表了一篇论文,分析了两项调查,总共涉及 9,000 名患者。
And he says the numbers confirm what he sees in his practice all the time with over-the-counter painkillers.
他说这些数字证实了他在使用非处方止痛药的实践中一直看到的情况。
Just in talking to people, oftentimes people would take it two to four times higher dose than on the instructions.
仅在与人交谈时,人们通常会服用比说明上高两到四倍的剂量。
Two or four times?
两次还是四次?
Dr. Mel Wilcox Yeah.
梅尔·威尔科克斯博士 是的。
Yes.
是的。
So not insignificant.
所以并非微不足道。
Remember, two to four times, with acetaminophen, could put you in the danger zone.
请记住,使用对乙酰氨基酚两到四次可能会让您处于危险区域。
Well, we saw one here probably, I don't know, six months ago or so.
嗯,我不知道,大概六个月前我们在这里见过一个。
I happened to be covering on the weekend, and it was a young woman who came in with liver failure.
周末我碰巧去报道,是一位患有肝功能衰竭的年轻女性。
I can't remember the exact reason for the Tylenol, but it was something related to pain-- back pain, headache, something-- and clearly taking more than the standard dose.
我不记得服用泰诺的确切原因,但它与疼痛有关——背痛、头痛等等——而且显然服用的剂量超过了标准剂量。
And died.
然后死了。
Do you know how much more she was taking than the--
你知道她服用的药物比——
No, the family didn't really know, other than she was taking more.
不,家人并不真正知道,只知道她拿了更多。
She was comatose, essentially, when I evaluated her.
当我评估她时,她基本上处于昏迷状态。
Generally suicides on the medication is pretty obvious, and the family would tell you.
一般来说,药物引起的自杀是很明显的,家人会告诉你。
It's the ones like this young lady, that really were taking it more for a pain issue, that are more troublesome.
就是像这位小姐姐这样的人,确实是因为疼痛的问题,才比较麻烦。
The connection between acetaminophen and liver damage-- this is not news.
对乙酰氨基酚和肝损伤之间的联系——这不是新闻。
Case reports started showing up more than four decades ago.
病例报告在四十多年前就开始出现。
As long ago as 1975, the British medical publication The Lancet said, quote, "Liver damage has been observed after absorption of as little as 6.2 grams." 6 grams a day would be the equivalent of four extra strength Tylenol beyond the maximum safe dose on the bottle.
早在1975年,英国医学刊物《柳叶刀》就曾报道称,“仅吸收6.2克就观察到肝脏损害”。每天 6 克相当于超过瓶子上最大安全剂量的四颗额外强度的泰诺。
Those cases started appearing at the exact same time that acetaminophen was getting more and more popular.
这些病例开始出现的同时,对乙酰氨基酚变得越来越流行。
Tylenol went on the market in the 1950s, but it really started taking off in the '70s, largely based on the fact that it was better than the alternatives because it didn't upset your stomach or make it bleed, like aspirin can.
泰诺 (Tylenol) 于 20 世纪 50 年代上市,但它真正开始起飞是在 70 年代,很大程度上是因为它比其他替代品更好,因为它不会像阿司匹林那样使胃部不适或导致出血。
Acetaminophen really did seem like the safest of all possible painkillers.
对乙酰氨基酚确实看起来是所有可能的止痛药中最安全的。
And then in the '80s, aspirin was linked to a rare but possibly fatal disease in children called Reye's syndrome, which gave Tylenol even more of a marketing edge.
然后在 80 年代,阿司匹林与一种罕见但可能致命的儿童疾病有关,即雷氏综合症,这给泰诺带来了更多的营销优势。
In fact, the fight over our pain medicine dollars got so heated and expensive that it came to be known as the Aspirin Wars.
事实上,围绕止痛药费用的斗争变得如此激烈和昂贵,以至于后来被称为“阿司匹林战争”。
This Aspirin Wars thing was something I'd never even heard of, but it turned out that was something that the McNeil Consumer Products Company was obsessed by.
我从来没有听说过“阿司匹林战争”这件事,但事实证明麦克尼尔消费品公司对此很着迷。
Pat Malone is a lawyer in DC.
帕特·马龙是华盛顿特区的一名律师。
He has represented plaintiffs in about a dozen lawsuits against McNeil, so he's had to bone up on a lot of this history.
他曾在十几起针对麦克尼尔的诉讼中代表原告,因此他必须深入了解这段历史。
And they quickly developed their competitive advantage over aspirin, not based on working better for your headaches and your aches and pains, but just because supposedly, this stuff is safe.
他们很快就形成了相对于阿司匹林的竞争优势,并不是因为它能更好地治疗你的头痛和疼痛,而是因为据说这种东西是安全的。
Because if you remember, back then, the television was just constantly bombarded with--
因为如果你还记得的话,那时候电视上不断地充斥着——
[TYLENOL ADVERTISEMENT PLAYS IN BACKGROUND]
[背景播放泰诺广告]
"Recommended the most by doctors," "Used most by hospitals."
“医生推荐最多”、“医院使用最多”。
Look.
看。
Last year, hospitals dispensed 10 times as much Tylenol as the next four brands combined.
去年,医院发放的泰诺 (Tylenol) 数量是紧随其后的四个品牌总和的 10 倍。
Hospitals can trust Tylenol to give effective relief without the stomach irritation possible with aspirin or any other type of pain reliever.
医院可以相信泰诺能够有效缓解疼痛,而不会像阿司匹林或任何其他类型的止痛药那样刺激胃部。
And it worked very well.
而且效果非常好。
And any time one of these reports would percolate up in the medical journals about somebody taking Tylenol for therapeutic purposes and winding up with their liver wiped out, that was a threat to McNeil's image.
每当医学期刊上出现这样的报道,称有人服用泰诺进行治疗,结果肝脏被毁掉,这对麦克尼尔的形象就构成了威胁。
McNeil Consumer Healthcare declined, after many requests, to let us interview someone there.
在多次请求后,麦克尼尔消费者保健公司拒绝让我们采访那里的某人。
And when we emailed them this quote from Malone, the company wrote back and reminded us that Malone has represented people who've sued McNeil, and that he, quote, "Therefore represents a particular point of view." The company goes on.
当我们通过电子邮件向他们发送马龙的这句话时,该公司回信并提醒我们,马龙代表了起诉麦克尼尔的人,并且他引用了“因此代表了一种特定的观点”。公司还在继续。
"The fact is that doctors still recommend Tylenol more than any other brand of pain reliever and do so based on their knowledge, training, and experience," end quote.
“事实是,医生仍然比任何其他品牌的止痛药更推荐泰诺,并且是根据他们的知识、培训和经验这样做的,”引用结尾。
The federal government got involved with all of this in the 1970s, with the risks of acetaminophen.
联邦政府在 20 世纪 70 年代介入了这一切,并考虑到了对乙酰氨基酚的风险。
Back in 1977, a panel of scientists convened by the Food and Drug Administration said the potential harm from an overdose is so severe that it should have a much stronger warning label on the box.
早在 1977 年,美国食品和药物管理局召集的一个科学家小组就表示,服用过量的潜在危害非常严重,因此应该在盒子上贴上更强烈的警告标签。
And the warning should state, quote, "Do not exceed recommended dosage because severe liver damage may occur."
警告应注明:“不要超过推荐剂量,因为可能会发生严重的肝损伤。”
Ninfa Redmond was one of the people who came up with that wording.
宁法·雷德蒙德是提出这个措辞的人之一。
She's a toxicologist, one of seven members on the panel.
她是一名毒理学家,是该小组的七名成员之一。
She says her group met every two months for three or four years, poring over reports and studies about 50 different ingredients in over-the-counter painkillers-- acetaminophen, but also aspirin, caffeine, which is in some drugs-- lots of things.
她说,她的小组每两个月开一次会,持续了三四年,仔细研究报告并研究非处方止痛药中大约 50 种不同的成分——对乙酰氨基酚,还有阿司匹林、咖啡因(某些药物中含有咖啡因)——很多东西。
The result was a 1,200-page report with recommendations about each ingredient.
结果是一份 1,200 页的报告,其中包含有关每种成分的建议。
But they didn't just recommend this warning label for acetaminophen.
但他们不仅仅推荐对乙酰氨基酚这个警告标签。
They added an extra special emphasis.
他们特别强调了这一点。
We used the word that it was terribly important, or-- I'm trying to think of the word that we used.
我们用了“这非常重要”这个词,或者——我正在努力思考我们用的这个词。
Um-- mandatory-- obligatory is the word.
嗯——强制性——这个词就是强制性的。
And the only time in the whole report that I can remember that we used the word obligatory was in the warnings for acetaminophen.
在整个报告中,我记得我们唯一一次使用“强制”一词是在对乙酰氨基酚的警告中。
And I remember there was a total unanimity on this opinion.
我记得这个观点得到了完全一致的同意。
The panel was well aware of all the advertising about how safe acetaminophen was.
该小组非常了解所有有关对乙酰氨基酚安全性的广告。
In fact, in their recommendation, they say, quote, "Some advertising for acetaminophen gives the impression that it is much safer than aspirin and implies that the toxic effects of the drug are less than those encountered in aspirin." To be clear, the report said that at recommended doses, acetaminophen was, quote, "Relatively free of adverse effects." But Ninfa Redmond says she was troubled by the reports the panel was reading.
事实上,在他们的建议中,他们引用了这样的话:“一些对乙酰氨基酚的广告给人的印象是它比阿司匹林安全得多,并暗示该药物的毒性作用比阿司匹林要小。”需要明确的是,该报告称,在推荐剂量下,对乙酰氨基酚“相对没有不良反应”。但宁法·雷德蒙德表示,她对小组正在阅读的报告感到不安。
About suicidal intentions and overdose by accident.
关于自杀意图和意外服药过量。
And they were just so numerous and so easy to have an overdose, for either one of two reasons.
由于两个原因之一,它们的数量如此之多,而且很容易过量服用。
Either because the person has not calculated how many milligrams he should have taken, or takes much more because the headache persists.
要么是因为该人没有计算出他应该服用多少毫克,要么是因为头痛持续而服用了更多毫克。
Of course, as we mentioned before, a lot of people disregard over-the-counter drug labels or just don't read them.
当然,正如我们之前提到的,很多人忽视非处方药标签或根本不阅读它们。
But a lot of people do read them, and warning labels are still the FDA's main tool to deal with problems like this.
但很多人确实阅读了它们,警告标签仍然是 FDA 处理此类问题的主要工具。
But when it came to printing what was supposed to be obligatory language onto an actual box of acetaminophen, the process broke down.
但当把本应是强制性语言的内容打印到一个实际的对乙酰氨基酚盒子上时,这个过程就崩溃了。
The next action the FDA takes on issuing a warning isn't for 11 years.
FDA 发出警告后采取的下一次行动是 11 年后的事。
In 1988, the FDA declares that yes, a warning label is needed for acetaminophen products.
1988 年,FDA 宣布对乙酰氨基酚产品需要贴有警告标签。
And they did put one on acetaminophen products, but they didn't go as far as Ninfa Redmond and the panel said was necessary.
他们确实在对乙酰氨基酚产品上添加了一种药物,但没有达到 Ninfa Redmond 的程度,专家组认为这是必要的。
Nothing about the liver at all.
完全没有关于肝脏的事情。
And then another 14 years went by.
又过了14年。
2002, the FDA convenes another advisory committee-- just for a couple days this time-- and that panel recommended, basically, the original warning again, the same one that Ninfa Redmond's group insisted upon 25 years earlier.
2002 年,FDA 召集了另一个咨询委员会(这次只召开了几天),该小组基本上再次提出了最初的警告,这与 Ninfa Redmond 的小组 25 年前坚持的警告相同。
And again, no action by the FDA.
FDA 再次没有采取任何行动。
It took seven years-- so 2009, we're talking now-- for the agency to finally require that liver warning.
该机构花了七年时间——也就是我们现在所说的 2009 年——最终要求发出肝脏警告。
We asked Ninfa Redmond what could have taken the FDA 32 years to mandate her warning language.
我们询问 Ninfa Redmond,FDA 花了 32 年才强制使用她的警告语言。
But she said her involvement with the process ended in 1977, when they submitted the report.
但她表示,她对这一过程的参与在 1977 年他们提交报告时就结束了。
In fact, Redmond didn't even know it took that long for the FDA to take action.
事实上,雷德蒙德甚至不知道 FDA 花了这么长时间才采取行动。
She only found out when she got a call for this story.
她是在接到报道这个故事的电话后才知道的。
Sad?
伤心?
Why?
为什么?
Ninfa Redmond How many people may have died as a result of that.
宁法·雷德蒙德 可能有多少人因此而死亡。
It's only a hypothetical question.
这只是一个假设问题。
It's a question to myself that has no answer.
这是对我自己的一个没有答案的问题。
Have you been asking yourself that since finding out that it took that long?
自从发现花了这么长时间后,你是否一直在问自己这个问题?
Yes.
是的。
Dr. Kennedy, the FDA commissioner at that time, on the 8th of July, said, it will take two years.
时任FDA局长肯尼迪博士7月8日表示,这需要两年时间。
It's in the press.
这是在媒体上。
It's either in The New York Times or The Washington Post, and that he hypothesized it.
要么是在《纽约时报》或《华盛顿邮报》上,要么是他的假设。
Let's double, let's triple that-- so six years would have been enough.
让我们加倍,让我们三倍——所以六年就足够了。
Nothing that I can hypothesize will explain the 32 years.
我无法做出任何假设来解释这 32 年。
So why did it take that long?
那么为什么花了那么长时间呢?
This American Life and ProPublica have been asking that question of pretty much everyone we can get our hands on for the last nine months, and no one has a simple explanation.
在过去的九个月里,《美国生活》和《ProPublica》一直在向几乎所有我们能接触到的人提出这个问题,但没有人能给出简单的解释。
But after all of the reporting that we've done, the main answer that has risen to the top is that acetaminophen was just one little drug ingredient competing for the attention of an enormous, inefficient bureaucracy.
但在我们完成所有报告之后,得到的主要答案是,对乙酰氨基酚只是一种小药物成分,正在争夺庞大而低效的官僚机构的注意力。
Beginning in 1972, the FDA actually set up 17 panels of experts-- Ninfa Redmond's was just one of them-- to look at all of the over-the-counter drugs that went on the market before drug review laws tightened up.
从 1972 年开始,FDA 实际上设立了 17 个专家小组(Ninfa Redmond 的专家小组只是其中之一),负责审查在药物审查法收紧之前上市的所有非处方药。
So these were all of the drugs the FDA had never formally approved as both safe and effective.
因此,这些都是 FDA 从未正式批准安全有效的药物。
There were two or three hundred thousand of them.
足足有二三十万人。
But they all boiled down to just 731 ingredients.
但归根结底,它们都只有 731 种成分。
They would decide whether the drug was safe and effective and appropriate for over-the-counter use, and in what quantities, and at what frequency, and for what duration.
他们将决定该药物是否安全、有效、是否适合非处方药使用、剂量、频率和持续时间。
This is Thomas Garvey.
这是托马斯·加维。
He's a doctor.
他是一名医生。
These days, he consults with drug companies about their products, and he's testified on the side of people suing McNeil over acetaminophen poisoning.
如今,他向制药公司咨询他们的产品,并为起诉麦克尼尔的对乙酰氨基酚中毒案的人们作证。
But in the late '70s and very early '80s, he supervised drug reviewers at the FDA.
但在 70 年代末和 80 年代初,他负责监督 FDA 的药物审评员。
And he says the process of getting to the final list of rules-- or a monograph, as it's called-- on a given drug at the FDA?
他还提到了 FDA 就特定药物制定最终规则清单(或者所谓的专着)的过程?
He says it's byzantine.
他说这是拜占庭式的。
And then there was a tentative final monograph, and where comments were collected, and then a reappraisal, and a rebroadcast of the revised tentative, and on and on and on.
然后是暂定的最终专着,收集评论,然后重新评估,并重播修订后的暂定专着,如此周而复始。
And you know, people would send in voluminous responses, which had to be understood and addressed and responded to.
你知道,人们会发送大量的回复,这些回复必须得到理解、处理和回应。
And that took a lot of time.
这花了很多时间。
That was one reason for the delay.
这是延误的原因之一。
All this vetting and opining and drafting up rules and synthesizing comments and everything, that all was supposed to take five years.
所有这些审查、意见、起草规则、综合意见等等,所有这些都应该需要五年的时间。
10 years in, the job was still only 1/16 of the way done.
10 年过去了,这项工作仍然只完成了 1/16。
Things were going so slowly that another government agency, the General Accounting Office, stepped in to do a review of the review to see what was taking such a, quote, "inordinate amount of time." And looking through it, there was a lot of dysfunction at the agency at the time.
事情进展得如此缓慢,以至于另一个政府机构——总审计局介入,对审查进行了审查,看看到底是什么花了如此多的时间,引用的话,“过多的时间”。纵观全局,当时该机构存在很多功能障碍。
"Priorities have little meaning," the review says.
“优先事项没有什么意义,”评论说。
"The OTC division is not using its staff efficiently." Stuff like that.
“OTC 部门没有有效地利用其员工。”诸如此类的事情。
But in the end, the review of the review found that the FDA's strategy was reasonable.
但最终审评结果发现FDA的策略是合理的。
It was just a crazy huge job.
这真是一项疯狂的巨大工作。
The 2008 FDA report cited, quote, "limited financial resources and large workloads" as obstacles.
2008 年 FDA 报告引用“有限的财政资源和大量的工作量”作为障碍。
The FDA also refused, after multiple requests, to give us a recorded interview for this story.
在多次请求后,FDA 也拒绝为我们提供有关这个故事的录音采访。
But ProPublica did an off-tape interview with Dr. Sandra Kweder, one of the FDA's experts on acetaminophen.
但 ProPublica 对 FDA 的对乙酰氨基酚专家之一 Sandra Kweder 博士进行了录音采访。
And she acknowledged that the agency moved too slowly getting the final rules written for dosage and labeling and all that.
她承认,该机构在制定剂量和标签等最终规则方面行动过于缓慢。
The rules for acetaminophen are still only at the tentative stage.
对乙酰氨基酚的规定仍处于暂定阶段。
The drug approval process is usually slow, but not usually this slow.
药物审批过程通常很慢,但通常不会这么慢。
The FDA began with acetaminophen over 40 years ago, in 1972.
FDA 于 40 多年前(即 1972 年)开始使用对乙酰氨基酚。
In that time, science has mapped the human genome, eradicated smallpox.
那时,科学已经绘制了人类基因组图谱,消灭了天花。
We've cloned a sheep-- and yet we still have not come up with rules for safe usage and labeling of one of the most popular drugs in the country, of which more than 20 billion doses are sold each year.
我们已经克隆了一只羊,但我们仍然没有制定出该国最受欢迎的药物之一的安全使用和标签规则,该药物每年售出超过 200 亿剂。
Former FDA official Tom Garvey.
前 FDA 官员汤姆·加维。
Now I must admit this one is remarkable for its duration of gestation.
现在我必须承认,这一次的孕育时间非常长。
It's like a vastly overdue child.
就像一个迟到的孩子。
I mean, this is remarkable and unusual.
我的意思是,这是非凡且不寻常的。
There's no question about that.
毫无疑问。
During the early years of this long process, the maker of Tylenol, McNeil, was understandably not so thrilled with the idea of a liver damage warning label.
在这个漫长过程的最初几年,泰诺的制造商麦克尼尔对肝损伤警告标签的想法并不那么兴奋,这是可以理解的。
The brand finally had a significant piece of the painkiller market, and the company did surveys that showed the warning label would scare people away from the drug.
该品牌最终在止痛药市场占据了重要份额,该公司进行的调查显示,警告标签会吓跑人们远离该药物。
Not only that, but when the 1,200-page report from Ninfa Redmond's group came out in 1977, it became a weapon in the Aspirin Wars.
不仅如此,当 1977 年 Ninfa Redmond 小组的 1200 页报告发表时,它成为阿司匹林战争中的武器。
Bayer Aspirin cited the report in a full-page magazine ad.
拜耳阿司匹林在整版杂志广告中引用了该报告。
It said, quote, "Leading medical experts have expressed great concern about the occurrence of liver damage with acetaminophen, the chemical name for the ingredient in all Tylenol products." And then it quotes the obligatory severe liver damage language.
引用称,“领先的医学专家对对乙酰氨基酚(所有泰诺产品中该成分的化学名称)对肝脏造成的损害表示了极大的担忧。”然后它引用了强制性的严重肝损伤语言。
And then-- big finish-- "Now, makers of Tylenol," it says, "let's look at your advertising again.
然后——最后——“现在,泰诺的制造商,”它说,“让我们再看看你们的广告。
Safer than aspirin?
比阿司匹林更安全?
Just as effective?
同样有效吗?
Shame on you." Losses, McNeil told the FDA, are already in the millions of dollars.
真为你感到羞耻。”麦克尼尔告诉 FDA,损失已经达到数百万美元。
That was just one point McNeil made in a lengthy response it sent to the FDA about the report from Redmond's panel.
这只是麦克尼尔在向 FDA 发送的关于雷德蒙德小组报告的冗长答复中提出的一点。
Here's another-- McNeil said that the proposed warning label was unfair, that acetaminophen was being singled now, since aspirin can also hurt you.
这是另一个——麦克尼尔说,提议的警告标签是不公平的,现在单独对乙酰氨基酚进行了分类,因为阿司匹林也会伤害你。
So if that kind of, "If you take too much, then this bad thing might happen" language is appropriate for acetaminophen, the company wrote, then it's appropriate for aspirin, too.
因此,该公司写道,如果这种“如果你服用太多,那么这种坏事可能会发生”的语言适用于对乙酰氨基酚,那么它也适用于阿司匹林。
McNeil went as far as to suggest several hypothetical warning labels for its aspirin competitors.
麦克尼尔甚至为其阿司匹林竞争对手提出了几个假设的警告标签。
One of them read, quote, "Do not exceed recommended dosage because serious potentially life-threatening changes in body chemistry, respiratory failure, coma, convulsions, and cardiovascular collapse may occur," end quote.
其中一篇写道,“不要超过推荐剂量,因为可能会发生严重的、可能危及生命的身体化学变化、呼吸衰竭、昏迷、抽搐和心血管衰竭,”最后引用。
Again, Tom Garvey, who was at the FDA back then.
汤姆·加维(Tom Garvey)还是当时在 FDA 工作的人。
It was kind of a, why are you doing this to us when you're not doing it to the others?
有点像,为什么你不对其他人这样做,却对我们这样做?
And what did you make of it?
你对此有何看法?
Thomas Garvey I thought it was nonsense.
托马斯·加维 我认为这是无稽之谈。
That's not their job.
那不是他们的工作。
Their job is not to make sure that the other drugs are labeled correctly.
他们的工作不是确保其他药物的标签正确。
Their job is to make sure their drug is labeled correctly.
他们的工作是确保他们的药物标签正确。
And they weren't doing that.
但他们并没有这样做。
They were instead saying you should label the other guys too.
相反,他们说你也应该给其他人贴上标签。
Intentionally, do you think?
你觉得是故意的吗?
Or was it--
或者是——
And I guess I keep trying to get at why.
我想我一直在努力找出原因。
Well, I don't think we need to dig very deep about that, that the most transparent of motives can be adduced.
嗯,我认为我们不需要对此进行深入挖掘,可以引出最透明的动机。
Well, to do God's work.
好吧,做上帝的工作。
No, you nitwit!
不,你这个白痴!
To make money.
为了赚钱。
To make money.
为了赚钱。
Thomas Garvey Well, I mean, isn't it the job of these firms to make money and to maximize profits for the shareholders?
托马斯·加维 嗯,我的意思是,这些公司的工作不就是赚钱并为股东实现利润最大化吗?
Isn't that what they're supposed to do?
这不是他们应该做的吗?
Here's McNeil's version of all of this.
这是麦克尼尔对这一切的版本。
First, to Garvey's point, the company writes, quote, "Thomas Garvey has been a paid witness for individuals who have filed lawsuits against McNeil, and his statements do not accurately reflect our conversations with the regulatory agency regarding label changes.
首先,针对加维的观点,该公司写道,“托马斯·加维一直是对麦克尼尔提起诉讼的个人的付费证人,他的声明并不能准确反映我们与监管机构就标签变更问题进行的对话。
We are a company of caring people who believe deeply that our first responsibility is to the families and health care professionals who rely on our products.
我们是一家充满爱心的公司,我们坚信我们的首要责任是对依赖我们产品的家庭和医疗保健专业人员。
We stand behind the safety profile of acetaminophen when taken as directed, and over the years we have led the efforts to educate and warn consumers of the dangers of acetaminophen overdose," end quote.
我们支持按指示服用对乙酰氨基酚的安全性,多年来我们一直在努力教育和警告消费者过量服用对乙酰氨基酚的危险。”
But the way McNeil would tell the story of the last four decades of regulation is that the scientific research wasn't always so clear-cut.
但麦克尼尔讲述过去四十年监管故事的方式是,科学研究并不总是那么明确。
For instance, all of the studies that measure how many pills lead to liver failure-- well, when people overdose, they sometimes misremember how many pills they took.
例如,所有测量服用多少药物会导致肝功能衰竭的研究——好吧,当人们服药过量时,他们有时会记错服用了多少药物。
Or they lie.
或者他们撒谎。
And for years, McNeil officials, and the scientists and doctors who testified on the company's behalf, argued that most if not all cases of acetaminophen overdose were suicides, people intentionally swallowing lots more of the drug than anybody would take for pain relief.
多年来,麦克尼尔的官员以及代表该公司作证的科学家和医生都认为,大多数(如果不是全部)对乙酰氨基酚过量服用的病例都是自杀,人们故意吞下的药物比任何人为缓解疼痛而服用的药物要多得多。
McNeil itself has funded studies of acetaminophen that back up its point of view.
麦克尼尔本身资助了对乙酰氨基酚的研究来支持其观点。
Again, McNeil declined to give us an interview on tape, and it objected to the tone of the written questions that ProPublica and the show submitted to them.
麦克尼尔再次拒绝接受我们的录音采访,并且对 ProPublica 和节目提交给他们的书面问题的语气表示反对。
In a letter back to us, it said our questions were, quote, "inflammatory, misleading, and unwarranted."
在给我们的回信中,它说我们的问题是“煽动性的、误导性的和毫无根据的”。
And along with the written responses to our questions, we received an eight-minute recording of a statement read by Ed Kuffner, the vice president of Over-the-Counter Medical Affairs and Clinical Research.
除了对我们问题的书面答复外,我们还收到了非处方药医疗事务和临床研究副总裁埃德·库夫纳 (Ed Kuffner) 宣读的一份长达八分钟的声明录音。
He says as more data piled up, the company's position evolved in the way it should, according to the science.
他表示,随着更多数据的积累,该公司的地位按照科学的方式发展。
Opinions about medicine labels, they've changed over time, as have the labels.
关于药品标签的看法随着时间的推移而发生了变化,标签也是如此。
We believe that any label change should be medically accurate, and it should be based on research.
我们认为任何标签变更都应该在医学上准确,并且应该基于研究。
And this is from slightly later in the tape.
这是磁带稍后的内容。
After careful consultation with the FDA, over the years, we've made changes to the labels of Tylenol in an effort to help consumers understand how to use the medicine safely.
多年来,在与 FDA 仔细协商后,我们对泰诺的标签进行了更改,以帮助消费者了解如何安全使用该药物。
The FDA recognizes that labels will change over time and that a label change does not mean that a prior label was inadequate.
FDA 认识到标签会随着时间的推移而改变,标签的改变并不意味着之前的标签不充分。
In fact, label changes are an indication that our medical understanding is evolving and that the public health system really is working.
事实上,标签的变化表明我们的医学理解正在不断发展,公共卫生系统确实在发挥作用。
But while McNeil says it always took new data into account as it emerged, here's how that looked in practice.
不过,尽管麦克尼尔表示,它总是在新数据出现时就将其考虑在内,但实际情况是这样的。
OK, please take your seats.
好的,请入座。
Please take your seats.
请就座。
This is the 2002 FDA advisory meeting where McNeil, to its credit, got in front of the warning label issue, after many years, and called on the FDA to mandate a specific liver damage warning for acetaminophen.
值得赞扬的是,在 2002 年 FDA 咨询会议上,麦克尼尔在多年之后才提出了警告标签问题,并呼吁 FDA 强制对乙酰氨基酚发出特定的肝损伤警告。
Today we are recommending an organ-specific overdose warning.
今天,我们建议针对特定器官的药物过量警告。
These labeling and education--
这些标签和教育——
This was the company's VP of Research and Development at the time, Debra Bowen.
这是该公司当时的研发副总裁黛布拉·鲍文 (Debra Bowen)。
This meeting was convened after more evidence started showing up of people accidentally overdosing on acetaminophen.
这次会议是在更多证据表明人们意外服用过量对乙酰氨基酚后召开的。
There was a big 1997 paper by researcher Will Lee and the numbers from Sarah Erush, who you heard from earlier.
研究员 Will Lee 于 1997 年发表了一篇重要论文,还有您之前听过的 Sarah Erush 提供的数据。
In fact, this whole day was devoted to the problem of accidental overdoses.
事实上,这一整天都在讨论意外服药过量的问题。
And even at this meeting, McNeil still held that most acetaminophen overdoses in adults were not accidental, but suicides.
即使在这次会议上,麦克尼尔仍然认为,大多数成年人服用对乙酰氨基酚过量并非意外,而是自杀。
Harm is rare and is caused by overdose.
危害很少见,是由过量服用引起的。
Serious harm caused by inadvertent misuse is very rare.
因无意误用而造成严重伤害的情况非常罕见。
Sarah Erush, the University of Pennsylvania pharmacist who got the call from the FDA, she was at this meeting presenting her findings, that half of the overdose cases she saw were accidental.
接到FDA电话的宾夕法尼亚大学药剂师莎拉·埃鲁什(Sarah Erush)在这次会议上介绍了她的发现,她看到的用药过量案例中有一半是意外的。
And she says, yes, it's a drug company's job to defend its product, but she wishes McNeil had shown more interest in the data that she and some of the other scientists and doctors were there presenting.
她说,是的,捍卫其产品是制药公司的工作,但她希望麦克尼尔对她和其他一些科学家和医生在那里展示的数据表现出更多的兴趣。
So they really seemed to me to try to be bulldozing over what we were just-- we had a crack in the door open, and saying, hey, there's something over there.
所以在我看来,他们确实试图用推土机推倒我们——我们的门开着一条缝,然后说,嘿,那边有东西。
You should take a look at it.
你应该看看它。
And they were just trying to keep that door shut as tight as they could.
他们只是想尽可能地把那扇门关得严严实实。
So I think that's all I got out of that meeting, was I thought, you're not even listening.
所以我认为这就是我从那次会议中得到的全部,我想,你根本没有在听。
You need to listen.
你需要倾听。
There's some interesting stuff here.
这里有一些有趣的东西。
I think that was the thing that bothered me the most, is it was still-- you must have it wrong, was their attitude, as opposed to, wow, this is really interesting.
我认为这是最让我困扰的事情,他们的态度仍然是——你一定搞错了,而不是,哇,这真的很有趣。
Can we take a closer look and see if we can figure this out together?
我们可以仔细看看,看看我们是否可以一起解决这个问题吗?
I have partnered with the pharmaceutical industry in my past life to do research and things, and have encountered companies, or facets of companies, that are very much like that.
我过去的生活中曾与制药行业合作进行研究和工作,并且遇到过非常类似的公司或公司的各个方面。
So it was very offensive to me that they didn't want to take that tact.
所以他们不想采取这种策略,这对我来说是非常冒犯的。
I ran this quote by McNeil officials.
我引用了麦克尼尔官员的这句话。
They pointed out that they did in fact reach out to Erush for more information when they learned of her findings, and she didn't give it to them.
他们指出,当他们得知埃拉什的发现时,他们确实联系了她以获取更多信息,但她没有提供给他们。
She told me she wanted to protect the patient's identities and didn't feel like the company needed to root around in their case files.
她告诉我,她想保护患者的身份,并且认为公司不需要深入调查他们的案件档案。
McNeil also said, quote, "We are constantly assessing information on overdoses and today use databases and web searches to seek out information and further improve our reporting systems." In other words, they say they're on top of this.
麦克尼尔还表示,“我们不断评估有关用药过量的信息,今天使用数据库和网络搜索来寻找信息并进一步改进我们的报告系统。”换句话说,他们说他们掌握了这一切。
They look for any problems related to their drug and actively try to reduce the number of overdoses.
他们寻找与药物相关的任何问题,并积极尝试减少用药过量的次数。
Sean Cole.
肖恩·科尔.
Coming up, kids and babies and problems in acetaminophen labeling-- for me, I have to say the most disturbing part of this story, we haven't even gotten to yet.
接下来,孩子和婴儿以及对乙酰氨基酚标签的问题——对我来说,我不得不说这个故事中最令人不安的部分,我们甚至还没有讲到。
That's in a minute, from Chicago Public Radio and Public Radio International, when our program continues.
稍后,芝加哥公共广播电台和国际公共广播电台将继续我们的节目。
It's This American Life.
这就是美国生活。
I'm Ira Glass.
我是艾拉·格拉斯。
Today's program, "Use Only As Directed." Today's show reported alongside the investigative reporting team at ProPublica.
今天的节目“仅按指示使用”。今天的节目与 ProPublica 的调查报道团队一起进行了报道。
And we're bringing you the story of one of the most popular drugs in the country, acetaminophen, the active ingredient in Tylenol.
我们将为您带来该国最受欢迎的药物之一对乙酰氨基酚(泰诺的活性成分)的故事。
It also, according to federal data, causes more deaths than any other over-the-counter pain medication.
根据联邦数据,它造成的死亡人数也比任何其他非处方止痛药都要多。
Each year, on average, over 150 people died of accidental overdose, 78,000 people land in the emergency room, 33,000 people are hospitalized-- again, this is all based on data from the federal government.
每年平均有超过 150 人因意外服药过量死亡,78,000 人进入急诊室,33,000 人住院治疗——同样,这一切都是基于联邦政府的数据。
McNeil Consumer Healthcare, the maker of Tylenol, as I said earlier in the show, disputes that its product is the deadliest over-the-counter pain medication.
正如我在节目早些时候所说,泰诺的制造商麦克尼尔消费保健公司质疑其产品是最致命的非处方止痛药。
And in the first half of the show, you heard about the FDA delaying action on labelling acetaminophen to a degree that was unusual, even for the FDA-- and, in fact, kind of mind-boggling.
在节目的前半部分,你听说 FDA 推迟了对乙酰氨基酚标签的行动,其程度是不寻常的,即使对 FDA 来说也是如此——事实上,有点令人难以置信。
A panel recommended a warning about liver damage in 1977.
1977 年,一个专家小组建议对肝损伤发出警告。
It took 32 years for the agency to rule on that.
该机构花了 32 年才做出裁决。
But you know, in a certain way, that pales compared to the confusion and delay surrounding infants' and children's acetaminophen.
但你知道,在某种程度上,与婴儿和儿童对乙酰氨基酚的混乱和延误相比,这显得相形见绌。
What's interesting about these products and this situation is that this is a situation where the maker of Tylenol, McNeil, did not oppose a new label on the packages.
这些产品和这种情况的有趣之处在于,泰诺的制造商麦克尼尔并不反对在包装上使用新标签。
In fact, it was the opposite.
事实上,事实恰恰相反。
McNeil wanted the change.
麦克尼尔想要改变。
It actively urged the FDA to get clearer, better labeling on those products for years, saying that would make the product safer.
多年来,它积极敦促 FDA 在这些产品上贴上更清晰、更好的标签,称这将使产品更安全。
And for years, the FDA did not fix the problem.
多年来,FDA 一直没有解决这个问题。
And McNeil didn't step in and fix the problem-- which, as you'll hear, it could have taken steps to do.
麦克尼尔没有介入并解决问题——正如你所听到的,它本可以采取措施来解决这个问题。
And the problem lingered in a way that's kind of stunning.
这个问题以一种令人震惊的方式持续存在。
Again, here's reporter Sean Cole.
记者肖恩·科尔再次报道。
Again, this all has to do with the nature of acetaminophen and how relatively easy it is to overdose.
同样,这一切都与对乙酰氨基酚的性质以及相对容易过量服用有关。
In this case, there's the added complicating factor of parents giving the drug to their kids.
在这种情况下,还有一个额外的复杂因素,那就是父母给孩子服用药物。
And these two formulas, Infants' Tylenol and Children's Tylenol, they're different.
婴儿泰诺和儿童泰诺这两种配方是不同的。
Infants' is actually for kids up to three years of age, and Children's is for kids up to 11 years of age.
婴儿实际上是针对 3 岁以下的儿童,儿童是针对 11 岁以下的儿童。
And this next part is going to sound really counter-intuitive, so I'll say it slowly.
下一部分听起来确实违反直觉,所以我会慢慢地说。
For the longest time, Infants' Tylenol was three times stronger, three times more concentrated, than Children's Tylenol, the rationale being that it's harder to make a very young child, and especially a baby, swallow medicine.
在最长的时间里,婴儿泰诺的浓度是儿童泰诺的三倍,其理由是让很小的孩子,尤其是婴儿,吞咽药物比较困难。
So if you make the medicine stronger, the parents will have an easier time of it.
所以,如果你的药力更强,父母就会更容易接受。
Makes sense on one level.
在某一层面上是有道理的。
But if you ask toxicologist Barry Rumack, who's done research funded by McNeil and has testified as an expert witness on the company's behalf, there's a big problem, again with the labeling.
但如果你问毒理学家巴里·鲁马克(Barry Rumack),他在麦克尼尔资助下进行了研究,并作为专家证人代表该公司作证,就会发现标签存在一个大问题。
Confusingly, he says, there aren't any dosing instructions for children under two on either product.
他说,令人困惑的是,这两种产品都没有针对两岁以下儿童的剂量说明。
All it says on the box is, "Ask a doctor." And for years, McNeil has been urging the FDA to change that.
盒子上只写着“询问医生”。多年来,麦克尼尔一直敦促 FDA 改变这一现状。
Here's Rumack.
这是鲁马克。
I've been trying, and Tony Temple's been trying--
我一直在努力,托尼·坦普尔也一直在努力——
Tony Temple is a former McNeil executive.
托尼·坦普尔 (Tony Temple) 是麦克尼尔公司的前高管。
And everybody else has been trying since at least 1983 to get a dose on these labels that goes down preferably to two months of age.
至少从 1983 年起,其他人就一直在尝试获得这些标签上的剂量,最好能降低到两个月大。
Because for one thing, if a baby's feverish and irritable at 3:00 in the morning, and there's no doctor around--
因为一方面,如果婴儿在凌晨 3:00 发烧、烦躁,而且周围没有医生——
The mother or father want to give the Tylenol, and it says, under two years, ask a doctor.
母亲或父亲想要给予泰诺,它说,两岁以下,请咨询医生。
What are they going to do?
他们要做什么?
They're going to guess at a dose.
他们会猜测剂量。
And they're going to say, you know, he's a little big for his age.
他们会说,你知道,对于他的年龄来说,他有点大了。
You know, maybe I'll give him half of this.
你知道,也许我会给他一半。
Half a dropperful.
半滴。
Dr. Barry Rumack Maybe I'll give him the whole thing.
巴里·鲁马克博士也许我会把整个事情交给他。
That's one scenario.
这是一种情况。
Another is that parents might get the two different formulas mixed up, give their child the stronger medicine based on the instructions for the weaker medicine.
另一个原因是,父母可能会混淆两种不同的配方,根据较弱药物的说明给孩子服用较强的药物。
It can happen.
它有可能发生。
And it has.
确实如此。
Christina Hoyt She's about three, four months there.
克里斯蒂娜·霍伊特 她在那里大约三四个月了。
She was a very, very big baby.
她是一个非常非常大的婴儿。
Very big.
很大。
Christina Hoyt had her first baby, Brianna, when she was 17 years old.
克里斯蒂娜·霍伊特 (Christina Hoyt) 17 岁时生下了她的第一个孩子布丽安娜 (Brianna)。
Her then-husband Eric Hutto was 18.
她当时的丈夫埃里克·赫托 (Eric Hutto) 18 岁。
This was about 10 years ago, back in Louisiana, where they're from.
那是大约十年前,回到他们的家乡路易斯安那州。
Christina lives near Denver now.
克里斯蒂娜现在住在丹佛附近。
Eric flew into town so we could talk to them both together.
埃里克飞到城里,这样我们就可以和他们一起交谈。
Both of them kept mentioning how big Brianna was when she was born.
他们俩都不停地提到布丽安娜出生时有多大。
And it wasn't just that she was fat, but she was long, too.
而且她不仅胖,而且还长。
She would hang outside of her infant seat.
她会挂在婴儿座椅外面。
It was just awkward.
实在是太尴尬了。
Yes, if you walked behind, you could see her feet sticking up.
是的,如果你走在后面,你可以看到她的脚伸出来。
[LAUGHS] Yeah.
[笑]是的。
Sean Cole And she was pretty healthy.
肖恩·科尔 她很健康。
Yes.
是的。
Sean Cole But then when she was about five months old--
肖恩·科尔但是当她大约五个月大时——
She got a cold.
她感冒了。
Chest congestion.
胸部充血。
She wasn't eating.
她没有吃饭。
She was extremely fussy.
她非常挑剔。
Fever?
发烧?
Christina Hoyt Mm-hm.
克里斯蒂娜·霍伊特 嗯嗯。
So they gave her Tylenol at the triage.
所以他们在分诊时给了她泰诺。
The emergency room.
急诊室。
Christina's mother came along, too.
克里斯蒂娜的母亲也来了。
Now Christina had already started Brianna on Infants' Tylenol, and she says she showed the folks at the hospital the type she was using.
现在克里斯蒂娜已经开始让布丽安娜使用婴儿泰诺,她说她向医院的人们展示了她正在使用的类型。
And it came in a little bitty bottle, and the purple kind is what we gave her.
它装在一个小瓶子里,紫色的就是我们给她的。
I even pulled out the dropper, showed them how much I was giving her, and it was the first line on the dropper.
我什至拉出了滴管,向他们展示了我给她的剂量,这是滴管上的第一行。
Because we didn't know how much to give her.
因为我们不知道该给她多少钱。
It says to consult a physician.
上面说要咨询医生。
So without knowing how much to give her, we just gave her the lesser of the doses of the Infants' Tylenol.
因此,在不知道该给她多少剂量的情况下,我们只给了她婴儿泰诺剂量中较小的剂量。
So they wrapped her in warm towels, broke her fever.
于是他们用温暖的毛巾包裹着她,给她退烧。
The doctor came back in, said she just had a virus and that it would pass.
医生回来后说她只是感染了病毒,很快就会过去。
So he gave us a script, wrote on a piece of paper, "3/4 teaspoon of Tylenol every four to six hours for pain, as needed."
所以他给了我们一个脚本,在一张纸上写道:“根据需要,每四到六个小时服用 3/4 茶匙泰诺止痛。”
So my mom questioned it and said, don't you think that's a little much for a baby of her size?
于是我妈妈就质疑说,你不觉得这对她这么大的婴儿来说有点过分了吗?
And so the doctor gave it back to the nurse, the nurse went away, came back, scratched it out, and says 1 teaspoon of Tylenol.
于是医生把它还给护士,护士走开,回来,把它刮掉,并说一茶匙泰诺。
Nowhere does it say--
没有任何地方说——
Wait, she said, don't you think that's a little much?
等等,她说,你不觉得这有点过分了吗?
And he scratches it out and writes more?
然后他把它划掉并写更多?
Yes.
是的。
And he says because of her weight, that's how much she needs to be given.
他说由于她的体重,这就是她需要给予的量。
The hospital was going off a dosing chart it got from McNeil.
医院正在使用从麦克尼尔那里得到的剂量表。
McNeil had sent the chart around to doctors and hospitals as a kind of stop-gap until it was able to convince the FDA to put more specific dosing instructions on the boxes of Infants' and Children's Tylenol.
麦克尼尔已将该图表发送给医生和医院,作为一种权宜之计,直到它能够说服 FDA 在婴儿和儿童泰诺的盒子上放置更具体的剂量说明。
Now the FDA held its first public meetings about all this label confusion eight years earlier, in 1995.
现在,FDA 在八年前(即 1995 年)召开了第一次公开会议,讨论所有这些标签混乱问题。
Christina and Eric were still in middle school when that happened.
事情发生时克里斯蒂娜和埃里克还在上中学。
When Brianna arrived at the ER, it was 2003, and the problem still wasn't fixed.
当布丽安娜 (Brianna) 到达急诊室时,那是 2003 年,问题仍然没有得到解决。
In fact, 2003 was the year that the FDA finally said, OK, now we're going to address this issue.
事实上,FDA 终于在 2003 年表示:“好吧,现在我们要解决这个问题了”。
And said the same thing in 2004, in 2005, 2006, 2007, and 2008.
并在2004年、2005年、2006年、2007年和2008年也说过同样的话。
And they actually put on their calendar for the year that we're going to address this this year, and then they just don't.
他们实际上把我们今年要解决这个问题的那一年的日历放在了日历上,然后他们就没有这样做。
And it just goes by and by and by, year after year after year.
就这么过去了,又过去了,年复一年。
The FDA's response was, it's a public health issue.
FDA 的回应是,这是一个公共卫生问题。
Again, Barry Rumack, the toxicologist who argued for the dosing label.
毒理学家巴里·鲁马克(Barry Rumack)再次提出了剂量标签的主张。
If this says, call a doctor under age two, then the parents are going to be required to call a physician, and they will get into the health care system.
如果这说,给两岁以下的医生打电话,那么父母将被要求打电话给医生,并且他们将进入医疗保健系统。
And that would be safer and better than trying to treat them by themselves.
这比尝试自行治疗更安全、更好。
Yes.
是的。
Sean Cole The thing is, the Huttos did see a doctor.
肖恩·科尔 事实是,胡托人确实看过医生。
They had instructions from a doctor in their hands.
他们手里拿着医生的指示。
So we gave her Infants' Tylenol, what we had given her before, a teaspoonful every six hours.
所以我们给了她婴儿泰诺,就像我们之前给她的那样,每六个小时一茶匙。
And it was too much.
这太过分了。
As it turned out, the 1-teaspoon dose the doctor recommended was for the less-concentrated Children's formula.
事实证明,医生建议的 1 茶匙剂量适用于浓度较低的儿童配方奶粉。
The hospital didn't normally use Infants' Tylenol.
医院通常不使用婴儿泰诺。
They didn't tell us to give Children's or Infants' Tylenol, either of them.
他们没有告诉我们要给儿童或婴儿泰诺,无论是哪一种。
They just said Tylenol?
他们只是说泰诺?
Eric Hutto Right.
埃里克·赫托 对。
So being that she was an infant child, you know, it was Infants' Tylenol.
因为她还是个婴儿,所以你知道,那是婴儿泰诺。
Because you wouldn't think to give a child Children's Tylenol at an infant's age, because you can't give a child adult Tylenol, you know?
因为您不会考虑在婴儿时期给孩子服用儿童泰诺,因为您不能给孩子服用成人泰诺,您知道吗?
Eric and Christina said they followed the directions to the letter.
埃里克和克里斯蒂娜说,他们按照信中的指示进行操作。
Soon, Brianna Hutto wasn't fussy anymore.
很快,Brianna Hutto 就不再挑剔了。
She was listless.
她无精打采。
Eric said it was like she was there, but not there, and her stomach felt hard.
埃里克说,她就像在那里,但又不在那儿,她的胃感觉很硬。
Eric and his father took Brianna back to the hospital.
埃里克和他的父亲带着布丽安娜回了医院。
Then they said, well, is she on any kind of medication?
然后他们说,好吧,她正在服用任何药物吗?
And I actually said, yeah, the Tylenol y'all prescribed her.
我实际上说,是的,你们都给她开了泰诺。
When the doctors figured out she'd overdosed on Tylenol, Brianna was airlifted to New Orleans Children's Hospital, and then to a transplant center in Omaha a day and a half later.
当医生发现她服用了过量的泰诺时,布丽安娜被空运到新奥尔良儿童医院,一天半后又被送往奥马哈的移植中心。
She just kept getting worse-- went into a coma, had tubes and wires all over her.
她的情况越来越糟——陷入昏迷,身上布满了管子和电线。
The plan was to give her part of her mother Christina's liver, but first, Brianna would have to start breathing on her own again.
计划是给她母亲克里斯蒂娜的一部分肝脏,但首先,布里安娜必须重新开始自主呼吸。
The Omaha hospital put up Eric and Christine in a room down the hall from their daughter's.
奥马哈医院将埃里克和克里斯汀安排在他们女儿住的房间楼下的一个房间里。
I walked down there to go see here.
我走到那里去看看这里。
And when I was walking down to go see here, they had a bunch of doctors running to her room, and they turned me around.
当我走下来去看这里时,他们有一群医生跑到她的房间,他们把我转了过来。
And not long after that, they had a priest come walk in, and-- there was a couple people.
不久之后,他们有一位牧师走进来,然后——有几个人。
Priest and a preacher.
牧师和传教士。
Eric Hutto Priest and a preacher.
埃里克·赫托 (Eric Hutto) 牧师和传教士。
And they had a doctor or someone.
他们有医生或其他人。
They had a couple people came in, started talking to us, telling us what was going on, that her kidneys had shut down, her heart failed and everything, and that she had passed away.
他们有几个人进来,开始与我们交谈,告诉我们发生了什么事,她的肾脏已经关闭,她的心脏衰竭等等一切,并且她已经去世了。
That's so awful.
那太可怕了。
Christina Hoyt I don't really remember much after that.
克里斯蒂娜·霍伊特 在那之后我不太记得了。
The Huttos ultimately filed suit against the doctor and the hospital, but also against McNeil.
胡托人最终对医生和医院提起诉讼,同时也对麦克尼尔提起诉讼。
Their lawyer made the case that there should have been better dosing on the box, plus a severe liver damage warning.
他们的律师认为,盒子上应该有更好的剂量,加上严重肝损伤警告。
All of this happened about two years before McNeil put the liver warning on the Tylenol label.
所有这一切都发生在麦克尼尔将肝脏警告放在泰诺标签上的两年前。
The hospital admitted fault almost immediately, but McNeil fought.
医院几乎立即承认了错误,但麦克尼尔进行了抗争。
In the end-- this is just how the court system works in Louisiana-- the jury divvied up the blame, saying the hospital was 70% at fault, McNeil was 23% at fault, and Christina and her mother together were 7% at fault.
最后——这正是路易斯安那州法院系统的运作方式——陪审团对责任进行了分配,称医院有 70% 的过错,麦克尼尔有 23% 的过错,克里斯蒂娜和她的母亲合计有 7% 的过错。
McNeil was ordered to pay $1.1 million, but the company appealed.
麦克尼尔被责令支付 110 万美元,但该公司提出上诉。
And appealed, all the way up to the Supreme Court.
并提出上诉,一直上诉至最高法院。
Just last October, the Supreme Court refused to hear McNeil's case.
就在去年十月,最高法院拒绝审理麦克尼尔的案件。
Christina and Eric broke up after that.
此后克里斯蒂娜和埃里克分手了。
Both got remarried.
两人都再婚了。
Christina went on to have three more kids with her new husband.
克里斯蒂娜和她的新丈夫又生了三个孩子。
She says living with Eric would have been a constant reminder of what happened.
她说和埃里克住在一起会不断提醒我们发生过什么。
And given the three-year appeals process, she already had to think about it too much.
而且经过三年的上诉过程,她已经不得不考虑太多了。
From the reporting we've done, it seems clear that McNeil genuinely tried to make dosing infants and children less confusing for families like the Huttos.
从我们所做的报告来看,麦克尼尔似乎很清楚地真诚地试图让像胡托人这样的家庭不再对婴儿和儿童的用药感到困惑。
It argued for better instructions.
它主张更好的指示。
It gave caregivers the dosing chart.
它为护理人员提供了剂量表。
Here's former McNeil executive Tony Temple at an FDA hearing in 2009.
这是 McNeil 前高管 Tony Temple 在 2009 年 FDA 听证会上的照片。
I believe the most important labeling improvement that could be made now would be to add dosing instructions for children less than two years of age to the label.
我认为现在可以进行的最重要的标签改进是在标签中添加针对两岁以下儿童的剂量说明。
If that had already been done, the other pediatric issues would be of much less concern.
如果这已经完成了,那么其他儿科问题就不会那么令人担忧了。
This is at the heart of the product confusion and misdosing issue we've heard so much about.
这是我们经常听到的产品混乱和剂量错误问题的核心。
When we asked the FDA about this, it said in a written statement basically that dosing instructions for babies, quote, "pose a number of challenges." They said parents might not know the weight of a child unless they've been to their pediatrician recently, so they should just go to the pediatrician.
当我们向 FDA 询问此事时,它在一份书面声明中表示,婴儿的剂量说明“带来了许多挑战”。他们说,除非最近去过儿科医生,否则父母可能不知道孩子的体重,所以他们应该去看儿科医生。
We asked, if weight- and age-based dosing present such a problem, why infants' and children's ibuprofen has it.
我们询问,如果基于体重和年龄的剂量存在这样的问题,为什么婴儿和儿童的布洛芬会出现这种问题。
The agency said, because it's a newer drug and went through a different drug approval process.
该机构表示,因为这是一种较新的药物,并且经历了不同的药物审批程序。
But where McNeil was arguing for clearer instructions, there's another strategy they could have taken, one that would have ended the confusion between the two products, and it wouldn't have had to have asked the FDA.
但是,当麦克尼尔主张更清晰的说明时,他们可以采取另一种策略,该策略可以结束两种产品之间的混淆,而且不必询问 FDA。
The company could have just yanked the stronger-concentration product off the market.
该公司本可以将浓度较高的产品撤出市场。
That's what PeterMax Miller says he would have done.
彼得马克斯·米勒说他会这么做。
He used to be involved in decisions like this-- whether to pull products from the market-- when he worked in the industry years ago, when he was at Bristol-Myers Squibb and at GD Searle.
几年前,当他在百时美施贵宝和 GD Searle 工作时,他曾参与过类似的决策——是否从市场上撤回产品。
Now he teaches marketing ethics at the University of Colorado.
现在他在科罗拉多大学教授营销伦理学。
So I would not have had any hesitation at all about yanking it off the shelf overnight everywhere.
所以我会毫不犹豫地在一夜之间把它从架子上拉下来。
And Johnson & Johnson knows how to do that.
强生公司知道如何做到这一点。
Johnson & Johnson, again, is McNeil's parent company.
强生公司也是麦克尼尔的母公司。
You might remember it pulled a ton of Tylenol off the market in the '80s due to a tampering scare in which some capsules were laced with cyanide.
您可能还记得,在 80 年代,由于一些胶囊中掺有氰化物的篡改恐慌,该公司将大量泰诺从市场上撤下。
And having said that, overnight is not fast enough either.
话虽如此,一夜之间也不够快。
But that's as fast as we can get.
但这是我们能达到的最快速度。
What would the trigger be?
触发因素是什么?
Petermax Miller If there was an infant death due to confusion, that's the time to pull it.
彼得马克斯·米勒(Petermax Miller) 如果有婴儿因混乱而死亡,那就是时候把它拉下来了。
One infant death?
一名婴儿死亡?
Petermax Miller Just one infant death.
彼得马克斯·米勒 (Petermax Miller) 仅有一名婴儿死亡。
That is-- I want to say more than a trigger.
那就是——我想说的不仅仅是一个触发因素。
That is a huge cannon.
那是一门巨大的大炮。
And ultimately, McNeil did pull the stronger concentration off the market, in 2011.
最终,麦克尼尔确实在 2011 年将更强的集中度撤出了市场。
Now when you go into a drugstore, you'll see both Infants' and Children's Tylenol, but it's the same stuff in two different packages.
现在,当你走进药店时,你会看到婴儿泰诺和儿童泰诺,但它们是相同的东西,但有两个不同的包装。
Of course, more than one child died in the 18 years McNeil was asking the FDA to let it include better dosing instructions on the box.
当然,在 McNeil 要求 FDA 在盒子上添加更好的剂量说明的 18 年间,不止一名儿童死亡。
Tony Temple was asked about this on the witness stand during the Huttos' lawsuit.
在胡托人诉讼期间,托尼·坦普尔在证人席上被问及此事。
Again, he's the former McNeil exec who'd been vying for weight-based dosing.
再说一遍,他是麦克尼尔公司的前高管,一直在争取基于体重的剂量。
Temple testified that you might go two, three, or four years without any death reports, and then there might be one in a given year.
坦普尔作证说,你可能会在两年、三年或四年内没有任何死亡报告,然后在某一年可能会出现死亡报告。
The attorney questioning him said, "And rather than pull the products off the shelf, that's sort of the cost of doing business?" Tony Temple-- "McNeil felt that the benefit as-- really, it's the FDA, because it hasn't pulled it off either.
询问他的律师说:“这不是把产品下架,而是做生意的成本吗?”托尼·坦普尔——“麦克尼尔认为,真正的好处是 FDA,因为它也没有成功。
But the benefit to children having the product available was appropriate to keep it in the marketplace, yes."
但是,将产品留在市场上对儿童来说是有好处的,是的。”
I read that excerpt to PeterMax Miller.
我把这段摘录读给彼得马克斯·米勒听。
He said Temple's argument doesn't really make sense to him, because McNeil didn't need to wait for the FDA to take action with Infant Tylenol.
他说坦普尔的论点对他来说实际上没有意义,因为麦克尼尔不需要等待 FDA 对婴儿泰诺采取行动。
You know, from an industry standpoint, we know it's going to be slow at the FDA.
你知道,从行业的角度来看,我们知道 FDA 的进展会很慢。
So I cannot-- if I have a drug that's causing problems, or labeling that's causing problems with confusion, I cannot blame the FDA for being slow.
所以我不能——如果我的药物引起了问题,或者标签引起了混乱,我不能责怪 FDA 行动迟缓。
The FDA does not care if you take something off the market, that I know of.
据我所知,FDA 并不关心你是否将某些东西从市场上撤下。
You can do it overnight.
你可以在一夜之间完成。
We asked McNeil why it didn't move to a single concentration sooner, among other questions about this part of the story.
我们问麦克尼尔为什么不早点转向单一集中,以及关于这部分故事的其他问题。
The response said the company has a long history of being a responsible health care partner with regard to pediatrics.
回应称,该公司长期以来一直是儿科方面负责任的医疗保健合作伙伴。
Then McNeil laid out a brief history of Infants' and Children's Tylenol, including the 2011 decision to take the stronger concentration off the market, which it said was not just something McNeil did, but all acetaminophen manufacturers.
然后,麦克尼尔简要介绍了婴儿和儿童泰诺的历史,包括 2011 年决定将浓度较高的泰诺从市场上撤出,据称这不仅是麦克尼尔的做法,也是所有对乙酰氨基酚制造商的做法。
The company also said it made the dosing devices themselves safer for kids.
该公司还表示,它使剂量装置本身对儿童来说更安全。
The company didn't send us any comments specifically about the Hutto case or any of the specific lawsuits we asked about.
该公司没有向我们发送任何有关 Hutto 案件或我们询问的任何具体诉讼的具体评论。
But it did address those cases more generally in that recorded statement from Medical Affairs VP Ed Kuffner.
但在医疗事务副总裁埃德·库夫纳 (Ed Kuffner) 的记录声明中,它确实更广泛地解决了这些案例。
We're committed to preventing acetaminophen overdose.
我们致力于防止对乙酰氨基酚过量。
Even one patient who takes a significant overdose is one too many.
即使一名患者服用了严重过量的药物,也已经是太多了。
Our hearts go out to those who've overdosed and gotten sick, and to the families and loved ones of those who've died.
我们的心与那些吸毒过量和生病的人以及死者的家人和亲人同在。
So let's run down what McNeil has done to try to prevent acetaminophen overdose.
那么,让我们回顾一下麦克尼尔为防止对乙酰氨基酚过量服用所做的努力。
Again, there are now both alcohol and severe liver warnings on Tylenol, and the company has taken the stronger Infants' concentration off the market.
同样,泰诺现在同时存在酒精和严重肝脏警告,并且该公司已将更强的婴儿浓度从市场上撤下。
The company put the alcohol and liver warnings on its products before it was required to by the FDA-- though after FDA advisory panels recommended them.
该公司在 FDA 要求之前就在其产品上添加了酒精和肝脏警告 - 尽管是在 FDA 顾问小组推荐之后。
Also, as we mentioned at the beginning, the words, "contains acetaminophen-- always read the label," are going onto the cap of every Extra Strength Tylenol bottle.
此外,正如我们在开头提到的,每个特强泰诺瓶子的瓶盖上都印有“含有对乙酰氨基酚——请务必阅读标签”的字样。
In addition, McNeil has done a bunch of its own public outreach on the issue, especially in the last few years, including a public service campaign called "Get Relief Responsibly." Plus McNeil was the one who funded the development of an antidote for acetaminophen poisoning, which surely has saved thousands of lives.
此外,麦克尼尔自己也针对这一问题开展了一系列公共宣传活动,尤其是在过去几年中,其中包括一项名为“负责任地获得救济”的公共服务活动。此外,麦克尼尔还资助开发了一种对乙酰氨基酚中毒的解毒剂,这无疑挽救了数千人的生命。
But despite its efforts, right now McNeil faces more than 85 lawsuits related to acetaminophen, many of them saying the company failed to warn the public about the true risks of the drug, and particularly the narrow margin between a safe dose and a toxic dose.
但尽管做出了努力,麦克尼尔目前仍面临超过 85 起与对乙酰氨基酚相关的诉讼,其中许多诉讼称该公司未能警告公众该药物的真正风险,特别是安全剂量和有毒剂量之间的狭窄差距。
At least 10 other countries have taken steps the US hasn't to try to prevent acetaminophen overdose.
至少还有其他 10 个国家已经采取了美国没有采取的措施,试图防止对乙酰氨基酚过量服用。
According to a 2008 FDA report, Australia, France, the UK, New Zealand, Germany, Finland, Denmark, Sweden, and Switzerland have limited how much of the drug you can buy at one time.
根据 2008 年 FDA 的一份报告,澳大利亚、法国、英国、新西兰、德国、芬兰、丹麦、瑞典和瑞士限制了您一次可以购买的药物数量。
Or they say you can only buy it from a pharmacy.
或者他们说你只能从药房购买。
In the UK, for instance, they simply limited the package sizes.
例如,在英国,他们只是限制了包装尺寸。
A lot of times it comes in those little blister packs, those little plastic-and-foil chewing-gum-looking packages, so you have to pop them out one at a time.
很多时候,它都是装在那些小泡罩包装中,那些塑料和铝箔看起来像口香糖的小包装,所以你必须一次把它们拿出来。
Those rules went into place in 1998.
这些规则于 1998 年生效。
Since then, deaths from acetaminophen poisoning have dropped by more than 40%.
自那时以来,对乙酰氨基酚中毒造成的死亡人数下降了 40% 以上。
That's all deaths, including suicides, and it's only for England and Wales.
这是所有死亡人数,包括自杀,而且仅适用于英格兰和威尔士。
Scotland didn't see a decrease in deaths, for some reason.
由于某种原因,苏格兰的死亡人数并没有减少。
In Canada, the package warnings say an overdose can be fatal.
在加拿大,包装警告称服药过量可能致命。
That word is not on over-the-counter acetaminophen products here.
这里的非处方对乙酰氨基酚产品上没有这个词。
I also noticed, last time I was in Canada, that the stronger Infants' formula of liquid Tylenol is still on the shelf, but weight- and age-based dosing is on both Infants' and Children's Tylenol packages.
上次我在加拿大时,我还注意到,更强效的婴儿配方液体泰诺仍在货架上,但婴儿和儿童泰诺包装上都注明了基于体重和年龄的剂量。
Here in the States, you could argue acetaminophen labeling has gotten a little more confusing lately.
在美国,您可能会说对乙酰氨基酚的标签最近变得更加混乱。
In 2009, an FDA advisory panel suggested that the recommended daily dose drop from 4 grams a day to 3 grams a day, hoping fewer people would end up overdosing.
2009 年,FDA 的一个咨询小组建议将推荐的每日剂量从每天 4 克降至每天 3 克,希望减少过量服用的人。
The FDA still hasn't taken action on that recommendation.
FDA 尚未对该建议采取行动。
But in 2011, McNeil did.
但2011年,麦克尼尔做到了。
It lowered the recommended dose on the label to 3 grams a day.
它将标签上的推荐剂量降低至每天 3 克。
But the company still says 4 grams a day is a safe dose, so now this is what the label says.
但该公司仍然表示每天 4 克是安全剂量,所以现在标签上是这么说的。
"The maximum daily dose of this product is 3,000 milligrams in 24 hours.
“该产品的每日最大剂量为 24 小时内 3,000 毫克。
Severe liver damage may occur if you take more than 4,000 milligrams of acetaminophen in 24 hours."
如果你在 24 小时内服用超过 4000 毫克的对乙酰氨基酚,可能会出现严重的肝损伤。”
With so many people already buying acetaminophen, one of the ways companies can still boost sales is to put it in more and more products.
由于已经有这么多人购买对乙酰氨基酚,公司仍然可以提高销量的方法之一是将其添加到越来越多的产品中。
More than 600 products contain acetaminophen now, including Excedrin, Theraflu Dristan Tablets, Sudafed Cold and Cough, Robitussin Cold and Flu, Alka Seltzer Plus Cold and Sinus, several types of Mucinex and Midol, most kinds of NyQuil, and stronger prescription painkillers like Percocet and Vicodin.
现在有超过600种产品含有对乙酰氨基酚,包括Excedrin、Theraflu Dristan Tablets、Sudafed Cold and Cough、Robitussin Cold and Flu、Alka Seltzer Plus Cold and Sinus、几种类型的Mucinex和Midol、大多数种类的NyQuil以及更强效的处方止痛药,如Percocet和Vicodin。
The problem is, having it in so many products means that it's that much easier to accidentally take two drugs with acetaminophen in them at the same time-- say, Tylenol and NyQuil-- and inadvertently overdose yourself.
问题是,如此多的产品中都含有它,这意味着您很容易不小心同时服用两种含有对乙酰氨基酚的药物(例如泰诺和奈奎尔),从而无意中服用过量。
McNeil, responsibly, makes a big point of this in its outreach these days.
麦克尼尔负责任地在最近的外展活动中强调了这一点。
Nonetheless, an independent national poll commissioned by ProPublica and This American Life shows a third of the public thinks it's safe to take the maximum recommended dose of Extra Strength Tylenol together with NyQuil.
尽管如此,由 ProPublica 和 This American Life 委托进行的一项独立全国民意调查显示,三分之一的公众认为将最大推荐剂量的特强泰诺与奈奎尔一起服用是安全的。
It's not.
它不是。
And a third say it's OK to give your kid the maximum recommended dose of Children's Tylenol along with Children's Tylenol Plus Multi-Symptom Cold Medicine.
第三个人表示,可以给孩子服用最大推荐剂量的儿童泰诺以及儿童泰诺加多症状感冒药。
That's not OK either.
那也不行。
The proliferation of products, just how easy it is to double up, might be one reason why deaths from acetaminophen toxicity are much higher now than they were 20 years ago.
产品的激增,以及很容易加倍,可能是现在因对乙酰氨基酚中毒而死亡的人数比 20 年前高得多的原因之一。
An FDA report in 2008 noted that acetaminophen poisoning quadrupled and deaths went up seven-fold between 1995 and 2005.
FDA 2008 年的一份报告指出,1995 年至 2005 年间,对乙酰氨基酚中毒人数增加了四倍,死亡人数增加了七倍。
They're even higher today.
今天它们甚至更高。
Sean Cole.
肖恩·科尔.
ProPublica has its own version of today's story, with all kinds of videos and graphs and charts and pictures and interactive stuff.
ProPublica 对今天的故事有自己的版本,包括各种视频、图表、图片和互动内容。
You can find that at propublica.org.
您可以在 propublica.org 上找到该信息。
Special thanks today to the two ProPublica reporters who did the heavy lifting in researching acetaminophen, finding documents and scientific studies and sources-- Jeff Gerth and T.
今天特别感谢两位 ProPublica 记者 Jeff Gerth 和 T.
Christian Miller.
克里斯蒂安·米勒.
Also, editors Mark Schoofs, Robin Fields, and Stephen Engelberg.
还有编辑马克·斯科夫斯 (Mark Schoofs)、罗宾·菲尔兹 (Robin Fields) 和斯蒂芬·恩格伯格 (Stephen Engelberg)。
[MUSIC - BO DIDDLEY, "PILLS"] Credits Ira Glass Well, our program was produced today by Ben Calhoun and myself, with Alex Blumberg, Sarah Koenig, Miki Meek, Jonathan Menjivar, Lisa Pollak, Brian Reed, Robyn Semien, Alissa Shipp, and Nancy Updike.
[音乐 - BO DIDDLEY,“PILLS”] 鸣谢 Ira Glass 好吧,我们今天的节目由 Ben Calhoun 和我自己制作,还有 Alex Blumberg、Sarah Koenig、Miki Meek、Jonathan Menjivar、Lisa Pollak、Brian Reed、Robyn Semien、Alissa Shipp 和 Nancy Updike。
Our senior producer is Julie Snyder.
我们的高级制片人是朱莉·斯奈德。
Production help from Dana Chivvis.
Dana Chivvis 提供制作帮助。
Elliot Stapleton is filling in as our operations director.
埃利奥特·斯泰普尔顿 (Elliot Stapleton) 将担任我们的运营总监。
Emily Condon is our production manager.
艾米丽·康登 (Emily Condon) 是我们的生产经理。
Elise Bergerson's our administrative assistant.
埃莉斯·伯格森是我们的行政助理。
Adrienne Mathiowetz runs our website.
艾德丽安·马修维茨 (Adrienne Mathiowetz) 负责运营我们的网站。
Research help today from Julie Beer.
今天朱莉·比尔提供了研究帮助。
Music help from Damien Graef and Rob Geddes.
Damien Graef 和 Rob Geddes 提供音乐帮助。
Special thanks today to Antonio Benedi, Kate Trunk, Willis Maddrey, Raymond Woosley, Sameer Thapar, Sidney Wolfe, Lisa Swersky, Lisa Gill, and Missy Adams.
今天特别感谢 Antonio Benedi、Kate Trunk、Willis Maddrey、Raymond Woosley、Sameer Thapar、Sidney Wolfe、Lisa Swersky、Lisa Gill 和 Missy Adams。
Our website-- thisamericanlife.org.
我们的网站——thisamericanlife.org。
This American Life is distributed by Public Radio International.
《美国生活》由国际公共广播电台发行。
Thanks as always to our program's co-founder, Torey Malatia, who does not always make the choices that others would.
一如既往地感谢我们项目的联合创始人托里·马拉蒂亚 (Torey Malatia),他并不总是做出其他人会做出的选择。
For example, the reason that he got into public broadcasting?
例如,他进入公共广播行业的原因是什么?
Well, to do God's work.
好吧,做上帝的工作。
No, you nitwit.
不,你这个白痴。
To make money.
为了赚钱。
I'm Ira Glass.
我是艾拉·格拉斯。
Back next week with more stories of This American Life.
下周我们将带来更多《美国生活》的故事。
[MUSIC - BO DIDDLEY, "PILLS"] Announcer PRI, Public Radio International.
[音乐 - BO DIDDLEY,“PILLS”] 国际公共广播电台 PRI 播音员。
This American Life is produced in collaboration with WBEZ Chicago and delivered to stations by PRX The Public Radio Exchange.
《This American Life》与 WBEZ Chicago 合作制作,并由 PRX 公共广播电台传送到各电台。