REVERSE VOXSPLAINING: DRUGS VS.CHAIRS

反向“喔可释”：药品与椅子

【编注：标题中Voxsplaining一词系作者模仿mansplaining一词而生造，由Vox和explaining拼成，Vox是一家美国主流网络媒体，以评论为主，经常发表以“Something blah blah, explained”为标题的真理在握底气十足的评论文章。】

[Content note: this is pretty much a rehash ofthings I’ve said before, and that other people have addressed much moreeloquently. My only excuse for wasting your time with it again is that SOMEHOWTHE MESSAGE STILL HASN’T SUNK IN. Pitching this as “market” vs. “government” is overly simplistic, but maybe if I am overly simplisticsometimes then it will sink in better.]

[内容说明：这差不多是我之前说过事情的重复，其他人也曾经雄辩得多地阐述过。之所以再一次在此问题上浪费你的时间，是因为不知为何我所说的意思还是没有传达到。把这个问题仅仅定义于“市场”和“政府”是过于简单化，但是也许我的简化会令人更容易理解。]

EpiPens,useful medical devices which reverse potentially fatal allergic reactions, haverecently quadrupled in price, putting pressure on allergy sufferers and thosewho care for them. Vox writes that this “tells us a lot about what’s wrong withAmerican health care” – namely that we don’t regulate it enough:

EpiPens的价格最近涨了四倍，作为一个可以有效逆转潜在致命过敏反应的医疗设备，这个涨价给过敏症患者和那些关心他们的人增添了许多压力。Vox网站评论道：“这说明了许多美国医疗卫生状况的问题”——也即我们对它没有足够的监管：

【Thestory of Mylan’s giant EpiPen price increase is, more fundamentally, a storyabout America’s unique drug pricing policies. We are the only developed nationthat lets drugmakers set their own prices, maximizing profits the same waysellers of chairs, mugs, shoes, or any other manufactured goods would.】

【Mylan 公司大幅提高 Epipens 价格的事情从更本质上讲关乎美国独特的药品定价机制。我们是唯一一个允许制药商自主定价的发达国家，让制药商可以像卖椅子、杯子、鞋子或者其它制成品的商家一样追求利润最大化。】

Let me askVox a question: when was the last time that America’s chair industry hiked theprice of chairs 400% and suddenly nobody in the country could afford to sitdown? When was the last time that the mug industry decided to charge $300 percup, and everyone had to drink coffee straight from the pot or face bankruptcy?When was the last time greedy shoe executives forced most Americans to gobarefoot? And why do you think that is?

对此我有个问题：什么时候美国的椅子产业将椅子价格提高到400%然后突然间所有人都买不起椅子坐不下来了？什么时候杯子产业决定每个杯子售价300美元然后所有人都不得不直接从咖啡壶里喝咖啡不然就要破产了？什么时候贪婪的鞋业高管迫使大部分美国人赤脚走路了？为什么你认为制药业就会发生这样的情况呢?

The problemwith the pharmaceutical industry isn’t that they’re unregulated just likechairs and mugs. The problem with the pharmaceutical industry is that they’repart of a highly-regulated cronyist system that works completely differentlyfrom chairs and mugs.

制药业的问题不是他们像椅子或者杯子产业那样不受监管，而是它所处的是一个高度管制的裙带系统。这与椅子和杯子产业完全不同。

If a chaircompany decided to charge $300 for their chairs, somebody else would set up awoodshop, sell their chairs for $250, and make a killing – and so on untilchairs cost normal-chair-prices again. When Mylan decided to sell EpiPens for$300, in any normal system somebody would have made their own EpiPens and soldthem for less. It wouldn’t have been hard. Its active ingredient, epinephrine,is off-patent, was being synthesized as early as 1906, and costs about tencents per EpiPen-load.

如果一个椅子公司决定他们的椅子每张收费300美元，那么其他人就可以开一个木制品店以每张250美元的价格卖椅子，然后大赚一笔——如此这般直到椅子回到正常价格。当Mylan公司决定EpiPens售价300美元时，正常情况下会有其他人生产他们自己的EpiPens 并以较低的价格出售，这并不是很困难，因为EpiPens的有效成分肾上腺素已经过了专利保护期。肾上腺素最早于1906年就开始被合成，现在每剂EpiPen中所含的肾上腺素成本只有10美分。

Why don’tthey? They keep trying, and the FDA keeps refusing to approve them for humanuse. For example, in 2009, a group called Teva Pharmaceuticals announced a planto sell their own EpiPens in the US. The makers of the original EpiPen suedthem, saying that they had patented the idea epinephrine-injecting devices.Teva successfully fended off the challenge and brought its product to the FDA,which rejected it because of “certain major deficiencies”. As far as I know,nobody has ever publicly said what the problem was – we can only hope they atleast told Teva.

那么为什么没人这么做呢？其实别人一直在尝试去做，但是FDA一直拒绝批准他们的产品被应用于人体。例如在2009年，有一个叫Teva制药的企业宣布他们计划在美国售卖自己的EpiPens，然后最早的EpiPen制造商就起诉了他们，声称他们拥有肾上腺素注入设备这个主意的专利。Teva在法庭上胜诉，然后把他们的产品送到了FDA，然而FDA借口由于“某些重大缺陷”驳回了他们的产品。据我所知，从来没有人公开说明过问题是什么——我们只能希望他们至少告诉了Teva。

In 2010,another group, Sandoz, asked for permission to sell a generic EpiPen. Onceagain, the original manufacturers sued for patent infringement. According toWikipedia, “as of July 2016 this litigation was ongoing”.

2010年，另一个集团Sandoz请求允许售卖一个通用类EpiPen，最早的制造商再一次以专利侵权告了他们。根据维基百科，“直到2016年7月该诉讼仍在进行”。

In 2011,Sanoji asked for permission to sell a generic EpiPen called e-cue. This gotheld up for a while because the FDA didn’t like the name (really!), buteventually was approved under the name Auvi-Q, (which if I were a giantgovernment agency that rejected things for having dumb names, would be goingstraight into the wastebasket). But after unconfirmed reports of incorrectdosage delivery, they recalled all their products off the market.

2011年，Sanoji请求允许售卖一个称作e-cue的通用类EpiPen，它一开始被阻挡了一段时间，原因是FDA不喜欢这个名字（千真万确！），但是最终该产品以Auvi-Q的名字被批准了（如果我是一个因其名字愚蠢就拒绝某事物的大型政府机构，那么Auvi-Q会直接进入废纸篓）。但是经过一些未经证实的说他们给药剂量不正确的报道之后，Sanoji从市场上召回了所有产品。

This year, acompany called Adamis decided that in order to get around the patent on devicesthat inject epinephrine, they would just sell pre-filled epinephrine syringesand let patients inject themselves. The FDA rejected it, noting that thecompany involved had done several studies but demanding that they do some more.

同年，一个叫Adamis的公司为了绕开肾上腺素注入设备的专利，决定只售卖预装了肾上腺素的注射器然后让患者自行注射。FDA拒绝了该产品，说该公司虽然已经做了一些研究，但还需要做更多。

Also,throughout all of this a bunch of companies are merging and getting bought outby other companies and making secret deals with each other to retract theirproducts and it’s all really complicated.

与此同时，许多公司开始合并，被其它公司买断出局，或是互相签订一些秘密的协议来撤销自己的产品，这些都很复杂。

None of thisis because EpiPens are just too hard to make correctly. Europe has eightcompeting versions. But aside from the EpiPen itself, only one competitor hasever made it past the FDA and onto the pharmacy shelf – a system calledAdrenaclick.

上述这些无一是因为EpiPens太难生产。欧洲有八个互相竞争的产品，但是除了EpiPen本身，只有一个叫Adrenaclick的竞争品成功通过了FDA的检验进入药店货架。

And of coursethere’s a catch. With ordinary medications, pharmacists are allowed tointerpret prescriptions for a brand name as prescriptions for the genericunless doctors ask them not to. For example, if I write a prescription for“Prozac”, a pharmacist knows that I mean anything containing fluoxetine, the chemicalingredient sold under the Prozac brand. They don’t have to buy it directly fromProzac trademark-holder Eli Lilly. It’s like if someone asks for a Kleenex andyou give them a regular tissue, or if you suggest putting something in aTupperware but actually use a plastic container made by someone other than theTupperware Corporation.

当然这里也存在漏洞。在平常的药物治疗中，除非医生明确告知不能这么做，药剂师可以将药物商标的处方解释为非商标的泛指的处方。例如，如果我开了一个“百忧解”的处方，药剂师知道我指的是任何含有氟西汀这种化学成分的东西，即百忧解品牌含有的化学成分，但他们没有必要直接从百忧解的品牌持有者礼来制药那里买。这就像有人跟你说要克里奈克斯纸巾（Kleenex）而你给他们普通纸巾一样，或者说你想把什么东西放进一个特百惠篮子（Tupperware）里，但实际上你用的却是其他公司而不是特百惠公司生产的塑料容器。

EpiPens areprotected from this substitution. If a doctor writes a prescription for“EpiPen”, the pharmacist must give an EpiPen-brand EpiPen, not anAdrenaclick-brand EpiPen. This is apparently so that children who have learnedhow to use an EpiPen don’t have to relearn how to use an entirely differentdevice (hint: jam the pointy end into your body).

EpiPens并不受这种替换的影响。如果一个医生开了“EpiPen”的处方，药剂师就必须给他们EpiPen牌子的EpiPen而不能是Adrenaclick牌子的EpiPen。很明显如果儿童们学会了如何使用EpiPen他们就不必再重新学习如何使用另一个完全不同的设备（提示：可以将尖端挤扎进你的身体里的东西）。

If you knowanything at all about doctors, you know that they have way too muchinstitutional inertia to change from writing one word on a prescription pad towriting a totally different word on a prescription pad, especially if thesecond word is almost twice as long, and especially especially if it’s just todo something silly like save a patient money. I have an attending who, wheneverwe are dealing with anything other than a life-or-death matter, just dismissesit with “Nobody ever died from X”, and I can totally hear him saying “Nobodyever died from paying extra for an adrenaline injector”. So Adrenaclickcontinues to languish in obscurity.

如果你对医生有任何了解，你就会知道他们有太多的制度惯性，使他们不愿将处方改写成一个跟之前完全不同的词，尤其是当新词差不多长了两倍的时候。更尤其是当这么做只是为了一些比如给病人省钱这样愚蠢的原因的时候，医生就更不愿意了。我有一个主治医生，每当我们面对的是一个并非生死攸关的问题的时候，他总是借口“从来没有人死于某某问题”而不予理会，我完全可以听出他的潜台词是“从来没有人因为给肾上腺素注射器付出额外的钱而死”。因此Adrenaclick依然在默默无闻中止步不前。

So why is thegovernment having so much trouble permitting a usable form of a commonmedication.

那么为什么政府在批准某种普通药物的一种可用的形式上会有这么多麻烦呢？

There are alot of different factors, but let me focus on the most annoying one. EpiPenmanufacturer Mylan Inc spends about a million dollars on lobbying per year. OpenSecrets.orgtells us what bills got all that money. They seem to have given the most todefeat S.214, the “Preserve Access to Affordable Generics Act”. The bill wouldban pharmaceutical companies from bribing generic companies not to creategeneric drugs.

这其中有许多不同的因素，现在我只关注最令人恼火的一个。EpiPen的制造商Mylan公司每年都会花大概一百万美元进行游说。OpenSecrets.org告诉了我们都有哪些法案用到了这些钱，看起来Mylan公司花的最多的是为了打败S.214法案，即“保护可负担非专利药物使用权法案”。这个法案禁止制药公司贿赂收买通用名药物制造商从而让他们不再制造通用名药物。

Did they win?Yup. In fact, various versions of this bill have apparently failed so manytimes that FDA Law Blog notes that “insanity is doing the same thing over andover again and expecting different result”.

他们成功了吗？是的。事实上，这个法案的不同版本显然已经失败了很多次，以至于FDA在他们的法律博客上写道：“一次又一次做相同的事情却期待着会有不同的结果，这就是精神失常”。

So let me tryto make this easier to understand.

那么让我来试着使该问题更容易理解。

Imagine thatthe government creates the Furniture and Desk Association, an agency whichdeclares that only IKEA is allowed to sell chairs. IKEA responds by charging$300 per chair. Other companies try to sell stools or sofas, but get boggeddown for years in litigation over whether these technically count as “chairs”.When a few of them win their court cases, the FDA shoots them down anyway forvague reasons it refuses to share, or because they haven’t done studies showingthat their chairs will not break, or because the studies that showed theirchairs will not break didn’t include a high enough number of morbidly obesepeople so we can’t be sure they won’t break. Finally, Target spends tens ofmillions of dollars on lawyers and gets the okay to compete with IKEA, butpeople can only get Target chairs if they have a note signed by a professionalinterior designer saying that their room needs a “comfort-producing seatingimplement” and which absolutely definitely does not mention “chairs” anywhere,because otherwise a child who was used to sitting on IKEA chairs might sit downon a Target chair the wrong way, get confused, fall off, and break her head.

想象下政府创立了家具和书桌协会，这个机构声称只有宜家可以售卖椅子，宜家相应地给每把椅子定价300美元。其他的公司试着来卖凳子或者沙发，但是他们被诉讼耽搁了许多年，因为不知道这些东西严格意义上算不算是“椅子”。如果他们中有公司侥幸赢了法庭诉讼，FDA又会想方设法以一些它不愿公开的莫名其妙的原因把他们毙掉，或者是因为他们还没有做研究来说明他们的椅子不会坏，或者是在他们用来证明椅子不会坏的研究中没有包括足够多病态肥胖的人因此我们无法确定这些椅子是不是真的不会坏。终于，Target公司在花费了成百上千万美元的律师费之后获得了准许可以和宜家竞争了，但是人们也只能通过专业的室内设计师签署的写明他们需要的是“能产生舒适感可供坐下的工具”的函件来获得Target的椅子，并且这个函件的任何地方都不能提到“椅子”，因为要不然的话一个坐惯了宜家椅子的孩子可能会以错误的方式坐在Target的椅子上，他们可能会困惑，会跌落椅子，会打破他们的头。

(You’re goingto say this is an unfair comparison because drugs are potentially dangerous andchairs aren’t – but 50 people die each year from falling off chairs in Britainalone and as far as I know nobody has ever died from an EpiPen malfunction.)

（你可能会说这个比喻并不恰当，因为药物潜在里具有危险性但是椅子并没有——但是单单在英国每年就有50人因为跌落椅子而死，而据我所知，还没有人曾因为EpiPen故障而死亡。）

Imagine thatthis whole system is going on at the same time that IKEA spends millions ofdollars lobbying senators about chair-related issues, and that these samesenators vote down a bill preventing IKEA from paying off other companies tostay out of the chair industry. Also, suppose that a bunch of people are dyingeach year of exhaustion from having to stand up all the time because chairs aretoo expensive unless you’ve got really good furniture insurance, which istotally a thing and which everybody is legally required to have.

想象下这整个系统都在同时进行：宜家花费数百万美元在椅子相关的问题上游说议员，同时这些议员又投票否决那些可以阻止宜家花钱贿赂其它公司好让他们退出椅子产业的议案。此外，每年都有人因为不得不一直站着而精疲力竭濒临死亡，因为椅子实在是太贵。除非他们有非常好的家具保险。家具保险非常重要，而且也是法律要求每个人都必须取得的。

And nowimagine that a news site responds with an article saying the government doesn’tregulate chairs enough.

现在再想象下有个新闻网站在文章中回应说政府对椅子监管不够。