好英语网美国药品质量问题触目惊心
Weevils floating in vials of heparin. Morphine cartridges that contain up to twice the labeled dose. Manufacturing plants with rusty tools, mold in production areas and — in one memorable case — a barrel of urine.
肝素药瓶里漂浮着象鼻虫。药盒里的吗啡剂量几乎是标签规定的两倍。生产车间放着生锈的工具，生产区里有霉菌，在一个令人印象深刻的案例中，检查人员发现了一桶尿液。
These recent quality lapses at big drug companies show that contamination and shoddy practices extend well beyond the loosely regulated compounding pharmacies that have attracted attention because of their link to an outbreak of meningitis.
最近大型制药公司出现的这些质量问题表明，药品污染、操作不规范已经不仅仅局限于那些监管疏松的复方药店。这些药店因与脑膜炎发病关联而引起关注。
In the last three years, six of the major manufacturers of sterile injectable drugs — which are subject to rigorous inspections by the federal government, as opposed to compounding pharmacies, which are generally overseen by the states — have been warned by the Food and Drug Administration about serious violations of manufacturing rules. Four of them have closed factories or significantly slowed production to fix the problems. Nearly a third of the industry’s manufacturing capacity is off line because of quality issues, according to a Congressional report.
过去三年中，六家生产无菌注射类药物的大型药厂已因严重违反生产条例而遭到美国食品与药品管理局（Food and Drug Administration，简称FDA）的警告。与那些通常属于各州监管的复方药店不同，这些大型制药厂都受到联邦政府严密的直接监管。其中有四家或关闭工厂，或者通过大幅降低产量来解决问题。一份国会报告显示，因质量问题，制药行业的产能已经减少了几乎三分之一。
Ben Venue在俄亥俄州贝德福德的工厂正在改建。该公司已经投入了超过3亿美元来升级改造这个生产基地。
“In the industry, everyone knows that all of the factories are in terrible shape,” said Erin Fox, manager of the Drug Information Service at the University of Utah, which tracks drug shortages. But the public, she said, is still in the dark. “I think people think this is a foreign outsourcing problem, but these factories are in our own country.”
“行业内每个人都知道，所有的工厂都存在严重的问题，”犹他大学药品信息服务部(Drug Information Service at the University of Utah)的经理埃琳·福克斯(Erin Fox)说。该部门跟踪药品短缺问题。但她表示，公众却被蒙在鼓里。“我想人们普遍认为这是外包到国外才会出现的问题，但这却是我们自己国家内的工厂。”
The shutdowns have contributed to a shortage of critical drugs, and compounding pharmacies have stepped into the gap as medical professionals scramble for alternative sources. But several serious health scares have been traced to compounding pharmacies in recent years. Authorities said 19 people had died from meningitis in an outbreak traced to a contaminated steroid made by the New England Compounding Center in Massachusetts.
工厂关闭引起主要药品短缺。就在医疗专业人士慌忙寻找其他途径解决问题的档口，复方药店趁势而上。但是近年来，这些复方药店却引发了数起严重的医疗恐慌事件。官方称，最近爆发的脑膜炎疫情已导致19人丧生，经过调查，他们都接触过马赛诸塞州新英格兰复方药物中心(New England Compounding Center)制造的受到污染的类固醇。
Regulators and manufacturers note that most sterile injectable drugs — products like chemotherapy drugs and anti-seizure drugs like diazepam — sold in the United States are safe and of high quality. Still, several industry observers and former plant employees said that the recent quality issues were troubling and that manufacturers had been reluctant to fix problems because stopping production was simply too costly in a business where profits were driven by volume. Many basic drugs sell for less than a dollar a vial and are made in batches of tens of thousands of vials, run on lines that can operate up to 24 hours at a time.
监管人员和制造厂商表示，在美国出售的大部分无菌注射类药物，比如化疗类药物和像安定这样的癫痫类药物都很安全、质量可靠。但一些行业观察者和制药厂的前员工表示，最近的制药行业质量问题很严重，而且制药厂不愿解决问题，因为在这个靠销售量盈利的行业中，停产的成本太高。很多基础药物一瓶的售价还不到1美元，24小时不停地大批量生产，一个批次就达数万瓶。
Manufacturers reject descriptions of their factories as deteriorating and say they are investing hundreds of millions of dollars to make improvements.
制药厂驳斥了那些宣称工厂情况正在日益恶化的报道，他们称，正投入数亿美元改善情况。
“When you read and or hear different people in the industry saying that these are old, dilapidated, rundown facilities — absolutely not true,” said David Gaugh, a senior vice president for the Generic Pharmaceutical Association, an industry trade group.
“如果你读到或者听到这个行业里不同的人说车间设备陈旧、破烂、简陋，这绝对不是真相，”行业组织仿制药协会(Generic Pharmaceutical Association)的高级副总裁戴维·高(David Gaugh)称。
The manufacturing process garnered more attention in 2009, when Dr. Margaret Hamburg took over as commissioner of the F.D.A. and pledged to get tougher on plant inspections.
在2009年，制药流程曾引发很多关注，当时玛格丽特·汉堡(Margaret Hamburg)博士出任FDA局长，发誓要对制药厂采取更严格的检查。
Hospira, the leading manufacturer of injectable drugs, has been a major target of quality complaints. Since 2009, federal regulators have outlined failures in quality control at its plants in North Carolina, California and Costa Rica, leading to several major recalls of products as diverse as faulty infusion pumps and overfilled morphine vials. The company has slowed production at its largest factory in Rocky Mount, N.C., which had the most extensive problems.
全球领先的注射药物生产商赫士睿(Hospira)已成为质量投诉的焦点。自从2009年以来，联邦监管机构已经公布了该公司在北卡罗来纳、加利福尼亚以及哥斯达黎加的多家药厂在质量监控上的漏洞。这直接导致几次大范围集中召回，其中有质量不合格的输液泵、装得过满的吗啡瓶。赫士睿在北卡罗来纳洛基山城的药厂已经开始减产。这里是它最大的生产基地，它的问题也是最多的。
Hospira’s manufacturing issues became public months after the company began in 2009 a two-year initiative called Project Fuel, designed to save more than $100 million a year by, for example, shrinking the work force 10 percent.
2009年，赫士睿公布了一项为期两年的重组计划，名为“能源计划”(Project Fuel)，此后它不断爆出生产问题。该计划目标是每年节约成本超过1个亿，其中一个方法是裁员10%。
Critics, including a group of shareholders who have filed a lawsuit against Hospira, claim that Project Fuel led to deep cuts in quality control, including the dismissal of seasoned employees and the failure to maintain equipment.
各方批评纷沓至来，其中还包括一些正与赫士睿打官司的股东。他们认为“能源计划”大幅削减了质控人员，其中包括一些经验丰富的雇员，导致了设备维护上的漏洞。
Stacey Eisen, a Hospira spokeswoman, said the company supported the F.D.A.’s recent focus on manufacturing quality. “We support the agency in this respect, as we, too, consider the quality of our products to be of paramount importance, and we’re working closely with the agency on all aspects of our quality efforts,” Ms. Eisen said. She said Project Fuel was not about cost-cutting but about reducing complexity across the company and improving productivity.
赫士睿的新闻发言人斯泰茜·艾森(Stacey Eisen)说，公司支持FDA近期对生产质量的关注。“我们完全赞同FDA在此方面的决定，并认同产品质量是重中之重，我们正与FDA紧密合作，在质量方面开展全方位的努力，”艾森女士说到。她说“能源计划”不是为了削减开支，而是为了简化公司流程，提高生产效率。
Late last year, Ben Venue, a division of the German drug maker Boehringer Ingelheim, shut its plant in Bedford, Ohio, after the F.D.A. visited the facility. Agency inspectors reported rusty tools, mold and a barrel of an “unknown liquid” later determined to be urine; the report did not make it clear what the barrel was doing there. Three other companies that make injectable drugs — Sandoz, Luitpold Pharmaceuticals and A.P.P. Pharmaceuticals — have also received warning letters. Earlier this year, Sandoz slowed production at a plant in Quebec to fix problems identified by the agency. All the companies said they took quality seriously and were either working with the agency to address its concerns or had already resolved the issues.
去年年底，FDA拜访了Ben Venue在俄亥俄州贝德福德的药厂，之后该厂关闭。Ben Venue是德国制药商勃林格殷格翰(Boehringer Ingelheim)的下属企业。FDA的检查人员在厂里发现了生锈的器具、霉菌以及一桶不明液体，后经鉴定为尿液。报告中并未说明该桶的用途。山德士(Sandoz)、路特普制药有限公司(Luitpold Pharmaceuticals)、美国药品伙伴公司(APP Pharmaceuticals)这三家注射药生产商也先后收到了警告信。今年年初，山德士在魁北克的生产基地减产以针对FDA提出的问题进行改进。这几家公司都声称他们对质量问题很重视，或者正在配合FDA改进，或者问题已经解决。
In a particularly vivid lapse, agency inspectors cited the failure to investigate a number of reported problems at A.P.P.’s plant outside of Buffalo, including complaints of human hair and fungal growth in vials.
在检查人员提到的一个明显的玩忽职守案例里，美国药品伙伴公司接到几个有关该公司在布法罗(Buffalo)城外生产基地的投诉，但未能进行检查。投诉内容包括药瓶内发现头发和霉菌。
One former supervisor at the plant said his managers were reluctant to stop the production lines. “It’s like trying to fix your car when you’re driving down the Thruway,” said the former employee, who was recently terminated and said he did not want to be identified because he feared retaliation. Managers ordered shortcuts that compromised quality, he said, and skimped on cleaning to shorten the turnaround time between batches. Afterward, centipedes and spiders were spotted in manufacturing areas, he said.
该厂的一位前监察员表示，经理们都不愿意停产。“这就好比是一边在高速路上行驶，一边修车，”这位前雇员说到。他最近被解雇，由于害怕报复，不愿透露姓名。他还说，经理们会下令节省工序，虽然这样会导致质量下降。他们会跳过清理的步骤，以缩短生产批次之间的周转时间。之后，人们曾在生产区域内看到蜈蚣和蜘蛛。
F.D.A. inspectors cited internal reports of infestations, including a spider and weevils inside vials.
FDA检查人员说，工厂的内部报告就提到过虫类出没，包括在药瓶里发现一只蜘蛛和象鼻虫。
Matthias Link, a spokesman for Fresenius Kabi, the German drug maker that owns A.P.P., said the company was committed to making high-quality medicines and was addressing the inspectors’ concerns. He said Fresenius Kabi had already planned to spend $38 million on improving and expanding the plant before the agency’s warning letter.
美国药品伙伴公司的母公司德国制药公司费森尤斯卡比(Fresenius Kabi)的新闻发言人马赛厄斯·林克(Matthias Link)说，公司致力于制造高品质的药品，非常重视检查员提出的问题 。他说，早在收到警告信之前，费森尤斯卡比已计划投资3800万美元改进和扩大该厂规模。
The investments are real, said Dr. Sandra Kweder, deputy director of the F.D.A.’s Office of New Drugs. “I would say we are encouraged,” she said. “But we also know it takes three to five years to get one of these plants up and running.”
FDA新药办公室副主任桑德拉·奎韦德(Sandra Kweder)说投资确有其事。“可以说，我们很受鼓舞，”她说，“但是，我们也知道要彻底改进一个厂，就得三到五年的时间。”