Woman's Death in Drug Study Probed
药物实验妇女死亡案已查明
By CARLA K. JOHNSON
The Associated Press
Saturday, August 11, 2007; 8:00 PM
CHICAGO -- A woman whose death in a gene therapy study shut it down and prompted a review of the safety of 28 other studies was experiencing multiple organ failure when she got to the hospital, a spokesman said.
芝加哥—一位妇女的死于基因治疗研究，并促使对其他28项研究回顾性调查。她去医院后死于多器官衰竭，一位发言人说。
Jolee Mohr, 36, died July 24, 22 days after receiving her second injection of an experimental drug made of genetically engineered viruses she hoped would help her arthritis.
Jolee Mohr，36岁，在第二次接受实验药注射22天后，死于7月24日，她原以为这种基因工程病病毒药能治疗关节炎。
Robb Mohr said he believes his wife thought the drug would help her, even though the research was to determine the drug's safety, rather than its effectiveness. The University of Chicago Medical Center, where Jolee Mohr died, is investigating the cause of death.
Robb Mohr坚信妻子认为药物能治疗疾病，即使研究目的是考察药物安全性而不是疗效。芝加哥医学中心（Jolee Mohr死亡的地方）正在调查死因。
\"By the time she got to us, she was in liver failure and kidney failure, she was on a ventilator and she was septic\" or responding to severe infection, hospital spokesman John Easton told The Associated Press. The hospital will send tissue samples to multiple labs for testing.
“她来就诊时已有肝衰、肾衰、脓毒症（严重感染后反应）”，医院发言人John Easton说。医院传送组织样本到各个实验室，进行进一步检查。
Targeted Genetics Corp. of Seattle has halted the study, and more than 100 patients involved are being evaluated, said company spokeswoman Stacie Byars. The company believes it's too early to speculate on the woman's cause of death, Byars said.
丑闻主角Genetics Corp.已停止研究，并检查研究中其他100多位患者，公司发言人Stacie Byars说。公司认为推测此妇女的死因为时尚早。
Alan Milstein, a New Jersey attorney who is representing Robb Mohr in a possible civil lawsuit, said Jolee Mohr believed the experimental therapy would be in her best interests.
新泽西州律师Alan Milstein代表Robb Mohr提出诉讼，他说：“Jolee Mohr一直相信实验性治疗是其最选择。”
\"She wasn't going to risk her life for science or medicine or the profits of some company,\" Milstein told The Associated Press on Saturday. \"She had mild rheumatoid arthritis.\"
“她不会冒生命危险参加某些公司的科学、医学甚或赢利性研究，” Milstein对美联社说，“她仅患轻微关节炎。”
Milstein also represented 18-year-old Jesse Gelsinger, who died in 1999 in his fourth day of a gene therapy experiment at the University of Pennsylvania. Gelsinger had suffered from an inherited disorder that blocks the body from properly processing nitrogen. The Food and Drug Administration concluded that the gene therapy injection intended to try to cure him instead killed him.
Milstein也提到18岁的Jesse Gelsinger，1999年，他在宾西法尼亚州大学基因研究的第四天死亡。Gelsinger患遗传性疾病，不能代谢氮类物质。FDA的结论是，基因注射治疗是试图治疗疾病而不是杀他。
Milstein said he's not sure who's to blame for Jolee Mohr's death, but \"we certainly believe the death was connected to the research trial she was in.\"
Milstein不知道谁该为Jolee Mohr的死亡负责，但“我们坚信死亡与实验本身有关。”
The experimental drug uses a virus to try and block a substance that fuels the joint inflammation behind crippling forms of arthritis.
实验药物是一种病毒，可阻滞引发关节炎的物质，从而防止本病的致畸作用。
Twenty-eight other gene therapy studies have been reported to the FDA that used, or are using, the same virus, called adeno-associated virus or AAV.
FDA报道，另有28项基因治疗研究应用相同病毒――adeno-associated virus（AAV）
The FDA has said that it was not aware of any serious side effects in any of the AAV studies but that as a precaution, officials are reviewing the ones still actively treating patients.
FDA不知道AVV研究有严重副作用，但曾发出警告。官员们正调查仍积极进行研究的人员。
In addition, the National Institutes of Health's advisory committee on gene therapy will meet in September to discuss the potential scientific implications of Mohr's death.
而且，NIH基因治疗顾问委员会将于9月聚会，讨论Mohr死亡事件可能带来的科学启示。 |
发表于 2007-9-20 01:10:11
