Deaths in Blood-Thinner Patients Bring Calls for Answers

Deaths in Blood-Thinner Patients Bring Calls for Answers
Why did some supplies of heparin contain a chemical that should not have been there? A U.S. drug maker and a Chinese supplier face questions. Transcript of radio broadcast?
29 April 2008

This is the VOA Special English Health Report.

Heparin is a blood-thinning medicine made from pig intestines, which often come from small farms in China. The drug is often used to prevent blockages during kidney dialysis treatment and different operations.

But in February, a major producer, Baxter International, recalled almost all of its heparin. Tests showed the presence of a chemical called oversulfated chondroitin sulfate. This is chemically similar to heparin but should not have been used. Who added it, and why, remains unclear.


Officials in the United States have received hundreds of reports of severe reactions, including deaths.
On April twenty-first, the Food and Drug Administration released a warning letter to a Chinese supplier for the Baxter heparin. The letter said Changzhou SPL had received material from an unacceptable supplier, and could not purify the materials used to make the drug. F.D.A. inspectors found that the company did not follow good manufacturing practice.

Chinese officials have suggested that the contaminant entered the heparin during the finishing process in the United States. Baxter disagreed. A Chinese delegation visited a Baxter factory in New Jersey last week.

Scientists have offered explanations for how the chemical could have caused the allergic reactions and low blood pressure seen in patients.

Reports from two teams were published online last week in the New England Journal of Medicine and Nature Biotechnology. Both teams were led by Professor Ram Sasisekharan at the Massachusetts Institute of Technology.

Officials in the United States are investigating eighty-one deaths in heparin patients with signs of allergic reactions or low blood pressure. Most of these deaths happened between November of last year and February of this year. But F.D.A. officials say the reactions may not have been the cause of death in all cases.

China says there is no proof of a connection between the contaminant and the deaths. The chemical has been found in heparin supplies in other countries. But Chinese officials note that the United States and Germany are the only countries that have reported any health problems.

The widespread use of foreign drug suppliers has led American lawmakers to call for at least five hundred additional F.D.A. inspectors. Also, a House subcommittee held a hearing Tuesday called "The Heparin Disaster: Chinese Counterfeits and American Failures."

And that’s the VOA Special English Health Report written by Caty Weaver. I’m Barbara Klein.

----------------------------Google Translate

死亡的血液稀释剂的病人带来呼吁答案
为什么有些用品肝素含有一种化学品不应该已经有？美国药物制造商和中国供应商面对的问题。全文电台广播？
2008年4月29日

这是美国之音特别英语卫生报告。

肝素是一种血液间伐中医药从猪肠子，这往往来自小农场在中国。药物往往是用来防止淤塞在肾脏透析治疗和不同的行动。

但在2月，一个主要的生产者， Baxter国际公司，回顾了几乎所有的肝素。测试结果显示，存在一个化学所谓oversulfated硫酸软骨素。这是化学类似肝素，但不应有被使用。世卫组织说，它的，为什么，仍不清楚。

官员在美国已收到数以百计的报道严重的反应，包括死亡。
4月20 -首先，美国食品和药物管理局发表了一份警告信，向中国供应商为巴克斯特肝素。信中说，常州市规划地政局局长已收到材料从一个不可接受的供应商，并不能净化材料可用来制造毒品。 f.d.a.检查人员发现该公司没有按照优良制造规范。

中国官员曾建议，污染物进入肝素在整理过程是在美国。巴克斯特同意。中国代表团参观了工厂巴克斯特在新泽西州上星期。

科学家们提供的解释如何化学可能会引起过敏性反应和血压低的压力，看到在病人。

报告从两个小组发表的线上上周，在新英格兰医学杂志和性质，生物技术。两个小组分别由教授的RAM sasisekharan在麻省理工学院技术。

官员在美国现正调查81人死亡，在肝素迹象的病人过敏反应或血压低的压力。这些死亡中的大多数之间发生于去年十一月和今年二月。但f.d.a.官员说，反应可能尚未死亡的原因在所有案件中。

中国说，有没有证据证明之间的连接，污染物和死亡。化学已发现在肝素用品，在其他国家。但中国官员指出，美国和德国是目前仅有的国家报告，任何健康问题。

广泛使用的外国药物的供应商已导致美国国会议员要求至少500额外林业局督察。此外，众议院小组委员会举行听证会周二的所谓“肝素灾害：中国冒牌货和美国的失败” 。

这是该美国之音特别英语健康的书面报告，由caty维夫。我芭芭拉克莱因。