※ [本文转录自 Gossiping 看板 #1TQdVzG9 ]
作者: GETpoint (掷雷爆卦) 看板: Gossiping
标题: [新闻] 美国抗凝血药物原料因猪瘟告急
时间: Sat Aug 31 21:36:57 2019
1.媒体来源:
彭博社
2.记者署名
By Anna Edney
3.完整新闻标题:
Mass Pig Deaths in China Cause Short Supply of U.S. Blood Thinner
4.完整新闻内文:
Mass Pig Deaths in China Cause Short Supply of U.S. Blood Thinner
By Anna Edney
2019年8月31日 上午4:37 [GMT+8] Updated on 2019年8月31日 上午5:21 [GMT+8]
A Chinese outbreak of African swine fever that has killed millions of pigs in
the country has also led to falling U.S. supplies of a widely used drug
derived from the animals, the anti-clotting drug heparin.
Heparin’s active ingredient is derived from pig intestines. It’s a critical
drug for heart attack patients and is used in surgery to stop clots. Much of
the world’s supply of active pharmaceutical ingredient, or API, for the
blood thinner comes from China, a byproduct of the nation’s massive pork
consumption.
One major producer of heparin, a subsidiary of Germany’s Fresenius SE, said
it has started limiting allocations of the drug “due to a potential shortage
of raw ingredient,” according to the American Society of Health-System
Pharmacists, a trade organization that tracks drug shortages.
ASHP表示，德国药厂“费森尤斯”（Fresenius）已经示警，由于中国猪瘟情势的影响，
可能会在未来某段时间出现原料供给紧张，因此相关药物的供应将受限制。
“We source from multiple suppliers and geographies to serve our customers,
but the situation in China is expected to cause API supply constraints
globally for an unknown period,” Fresenius Kabi said in a July letter posted
by the pharmacist group.
Supply Available
The U.S. Food and Drug Administration, which tracks and officially declares
product shortfalls, said that while there were shortages of some heparin
products, there was sufficient overall supply.
“FDA has been monitoring this issue since last year and has followed up with
heparin suppliers,” Nathan Arnold, a spokesman for the agency, said in an
email Friday. “Although certain presentations of heparin have been in
shortage, the overall supply continues to meet demand.”
The global drug supply chain relies on raw ingredients made around the world
and shipped to drugmakers and finishers in other countries. That complex
system has created challenges for regulators and health-care system reliant
on far-flung economies to provide ingredients and medicine.
China has lost an as many as 150 million to 200 million animals to the
contagious and deadly disease, according to one estimate, a dire example of
how problems can ripple around the world.
The FDA has listed two companies, Baxter International Inc. and Pfizer Inc.’
s Hospira, that have shortages of heparin going back to November 2017. The
agency hasn’t declared an official shortage of Fresenius’s product, though
the pharmacists group often sends notice of a shortage before the FDA
officially declares one.
Pfizer and Baxter haven’t said whether their shortages have been exacerbated
by the situation in China, and didn’t immediately respond to requests for
comment Friday. Baxter has previously blamed its shortage on hurricane damage
in Puerto Rico, where it has manufacturing.
美国食品药品监督管理局（FDA）则强调，目前抗凝血药物“整体”供给充足，但也承认
部份原料有短缺状况，而FDA持续关注中；FDA目前点名“百特”（Baxter International
）及辉瑞（Pfizer）子公司“赫士睿”（Hospira）的抗凝血药物原料出现短缺，但2间药
厂不愿意承认是否与中国猪瘟有关。
The Fresenius subsidiary, Fresenius Kabi, “has seen a significant increase
in demand for certain heparin presentations as other manufacturers have
experienced supply interruptions,” Matthew Kuhn, a company spokesman, said
in an email.
Fresenius Kabi sources most of its heparin active ingredient outside of Asia,
including in Europe and South America, Kuhn said. He also said the FDA has
recently approved additional manufacturing space at one of the company’s
U.S. plants to help mitigate a shortage.
Prior Crisis
The ongoing heparin shortage carries echoes of a crisis more than a decade
ago, when tainted raw materials for heparin made their way into the U.S. drug
supply. The contamination resulted in the deaths of more than 200 patients,
and a congressional committee has raised concerns that shortages could lead
suppliers to cut corners again, putting patients at risk.
The FDA found during a 2008 inspection of Baxter’s supplier in Changzhou,
China, that it hadn’t established a process to remove impurities and had
used crude heparin material from a supplier it had previously deemed
unacceptable.
美国抗凝血药物供给短缺的问题已持续许久，主因是2008年百特在中国的药厂发生污染事
件，导致约200名患者死亡，使美国审查外国制造的药物更加严格，而现在业内人士担忧
由于中国猪瘟疫情影响，短缺问题可能会雪上加霜。
The heparin crisis led U.S. lawmakers to boost the FDA’s ability to inspect
foreign drugmakers. The House Energy and Commerce Committee investigated and
held hearings on the contaminated blood thinner. Representatives Frank
Pallone and Greg Walden, the chairman and top Republican on the panel
respectively, wrote the FDA in July about the potential for a shortage linked
to China’s swine fever outbreak..
Pharmaceutical researchers are concerned the outbreak could cause an “
unprecedented shortage,” Pallone and Walden wrote last month to Acting FDA
Commissioner Ned Sharpless.
In 2018, the FDA encouraged development of heparin using cow lungs instead of
pigs. Heparin manufacturers used bovine materials up until the 1990s but
stopped given concerns over mad cow disease.
“The FDA has been in contact with several companies, both domestic and
foreign, regarding reintroduction of bovine heparin to the U.S. market,”
Arnold, the FDA spokesman, said. “The details of those conversations are
confidential.”
(Updates with Fresenius response in 11th paragraph)
大概编译由自由时报提供：
https://ec.ltn.com.tw/article/breakingnews/2902010
〔财经频道／综合报导〕中国非洲猪瘟疫情肆虐，猪只大量因病死亡或遭扑杀，影响不仅
只于肉品，甚至全世界其它产业也会受到影响，如美国卫生系统药师协会（ASHP）示警，
美国甚至全世界的抗凝血药物，可能会因为大量使用中国猪只提炼的原料而导致供给危机
。
《彭博》报导，抗凝血剂是心脏病患者的重要药物，主要用来避免血栓发生，由于部分抗
凝血剂原料主要由猪肠所提炼，ASHP表示，德国药厂“费森尤斯”（Fresenius）已经示
警，由于中国猪瘟情势的影响，可能会在未来某段时间出现原料供给紧张，因此相关药物
的供应将受限制。
美国食品药品监督管理局（FDA）则强调，目前抗凝血药物“整体”供给充足，但也承认
部份原料有短缺状况，而FDA持续关注中；FDA目前点名“百特”（Baxter International
）及辉瑞（Pfizer）子公司“赫士睿”（Hospira）的抗凝血药物原料出现短缺，但2间药
厂不愿意承认是否与中国猪瘟有关。
费森尤斯则称多数抗凝血原料来自欧洲及南美，不过也看到了其它药厂供给短缺而造成的
需求成长。
美国抗凝血药物供给短缺的问题已持续许久，主因是2008年百特在中国的药厂发生污染事
件，导致约200名患者死亡，使美国审查外国制造的药物更加严格，而现在业内人士担忧
由于中国猪瘟疫情影响，短缺问题可能会雪上加霜。
5.完整新闻连结 (或短网址):
https://is.gd/2drRPn
6.备注:
话说回来WW3可能是减少药物生产的重大事件。
毕竟没有办法也没有必要让这么多人活着。