您现在的位置: VOA美国之音 >> VOA双语新闻 >> 双语新闻 >> 正文


更新时间:2020-4-10 7:17:54 来源:本站原创 作者:佚名 浏览:

Lapses at Big Drug Factories Add to Shortages and Danger

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.


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.


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。

“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.


Manufacturers reject descriptions of their factories as deteriorating and say they are investing hundreds of millions of dollars to make improvements.


“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.


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.


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.


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.


F.D.A. inspectors cited internal reports of infestations, including a spider and weevils inside vials.


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。”