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作者: GETpoint (擲雷爆卦) 看板: Gossiping
標題: [新聞] 美國抗凝血藥物原料因豬瘟告急
時間: Sat Aug 31 21:36:57 2019
1.媒體來源:
彭博社
2.記者署名
By Anna Edney
3.完整新聞標題:
Mass Pig Deaths in China Cause Short Supply of U.S. Blood Thinner
4.完整新聞內文:
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，德國藥廠「費森尤斯」（Fresenius）已經示警，由於中國豬瘟情勢的影響，
可能會在未來某段時間出現原料供給緊張，因此相關藥物的供應將受限制。
“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.
美國食品藥品監督管理局（FDA）則強調，目前抗凝血藥物「整體」供給充足，但也承認
部份原料有短缺狀況，而FDA持續關注中；FDA目前點名「百特」（Baxter International
）及輝瑞（Pfizer）子公司「赫士睿」（Hospira）的抗凝血藥物原料出現短缺，但2間藥
廠不願意承認是否與中國豬瘟有關。
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.
美國抗凝血藥物供給短缺的問題已持續許久，主因是2008年百特在中國的藥廠發生汙染事
件，導致約200名患者死亡，使美國審查外國製造的藥物更加嚴格，而現在業內人士擔憂
由於中國豬瘟疫情影響，短缺問題可能會雪上加霜。
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)
大概編譯由自由時報提供：
https://ec.ltn.com.tw/article/breakingnews/2902010
〔財經頻道／綜合報導〕中國非洲豬瘟疫情肆虐，豬隻大量因病死亡或遭撲殺，影響不僅
只於肉品，甚至全世界其它產業也會受到影響，如美國衛生系統藥師協會（ASHP）示警，
美國甚至全世界的抗凝血藥物，可能會因為大量使用中國豬隻提煉的原料而導致供給危機
。
《彭博》報導，抗凝血劑是心臟病患者的重要藥物，主要用來避免血栓發生，由於部分抗
凝血劑原料主要由豬腸所提煉，ASHP表示，德國藥廠「費森尤斯」（Fresenius）已經示
警，由於中國豬瘟情勢的影響，可能會在未來某段時間出現原料供給緊張，因此相關藥物
的供應將受限制。
美國食品藥品監督管理局（FDA）則強調，目前抗凝血藥物「整體」供給充足，但也承認
部份原料有短缺狀況，而FDA持續關注中；FDA目前點名「百特」（Baxter International
）及輝瑞（Pfizer）子公司「赫士睿」（Hospira）的抗凝血藥物原料出現短缺，但2間藥
廠不願意承認是否與中國豬瘟有關。
費森尤斯則稱多數抗凝血原料來自歐洲及南美，不過也看到了其它藥廠供給短缺而造成的
需求成長。
美國抗凝血藥物供給短缺的問題已持續許久，主因是2008年百特在中國的藥廠發生汙染事
件，導致約200名患者死亡，使美國審查外國製造的藥物更加嚴格，而現在業內人士擔憂
由於中國豬瘟疫情影響，短缺問題可能會雪上加霜。
5.完整新聞連結 (或短網址):
https://is.gd/2drRPn
6.備註:
話說回來WW3可能是減少藥物生產的重大事件。
畢竟沒有辦法也沒有必要讓這麼多人活著。