双语新闻：美国食品药品监督管理局健康顾问投票反对，对ALS疾病进行实验性治疗
United States health advisers voted against an experimental treatment for ALS disease last week. The vote came after years of efforts by ALS patients and their families in support of the unproven medical treatment.
上周，美国健康顾问投票反对对ALS疾病进行实验性治疗。这次投票是在ALS患者及其家人多年来努力支持这种未经证实的医疗方法之后进行的。
ALS, or amyotrophic lateral sclerosis, is also known as Lou Gehrig's disease. Patients with ALS slowly lose the ability to control muscle movements, the ability to speak, eat, move and breathe. The U.S. National Institutes of Health says people can get the disease at any age. It most commonly develops between the ages of 55 and 75.
ALS，或称肌萎缩侧索硬化症，也被称为Lou Gehrig病。ALS患者慢慢失去控制肌肉运动的能力，失去说话、进食、移动和呼吸的能力。美国国立卫生研究院表示，人们在任何年龄都可能感染这种疾病。它最常见于55岁至75岁之间。
Last Wednesday, a group of health advisors for the U.S. Food and Drug Administration (FDA) voted 17 to one against the treatment from BrainStorm Cell Therapeutics. The Israel-based company's treatment, NurOwn, uses stem cells. These are cells that can develop into many kinds of body cells. The group found the treatment was not effective for patients with ALS. A member of the group representing ALS patients was the only vote in favor. One expert did not register a vote.
上周三，美国食品药品监督管理局（FDA）的一组健康顾问以17票对1票反对BrainStorm Cell Therapeutics的治疗方法。这家总部位于以色列的NurOwn公司的治疗方法使用干细胞。这些细胞可以发育成多种身体细胞。研究小组发现，这种治疗方法对ALS患者无效。代表ALS患者的小组成员是唯一投赞成票的人。一位专家没有登记投票。
Lisa Lee, a health expert from Virginia Tech University voted against the treatment. She said, "Creating false hope can be considered a moral injury and the use of statistical magic or manipulation to provide false hope is problematic."
弗吉尼亚理工大学的健康专家Lisa Lee投票反对这种治疗方法。她说：“制造虚假的希望可以被视为一种道德伤害，使用统计魔术或操纵来提供虚假的希望是有问题的。”
The FDA is not required to accept the group's vote. However, the agency's own scientists said earlier in the week that BrainStorm's treatment was "scientifically incomplete."
美国食品药品监督管理局不需要接受该组织的投票。然而，该机构自己的科学家在本周早些时候表示，BrainStorm的治疗“在科学上是不完整的”。
Brainstorm and the ALS community wanted to use the meeting to change the FDA's thinking about the NurOwn treatment.
头脑风暴和ALS社区希望利用这次会议来改变美国食品药品监督管理局对NurOwn治疗的想法。
Brainstorm's 200-patient study failed to show that NurOwn extended life, slowed the disease, or improved patients' ability to move. But the FDA agreed to bring outside advisers together after ALS patients and supporters submitted 30,000 signatures seeking a public meeting.
Brainstorm对200名患者的研究未能表明NurOwn延长了生命，减缓了疾病，或提高了患者的行动能力。但在ALS患者和支持者提交了30000个签名寻求公开会议后，美国食品药品监督管理局同意召集外部顾问。
In the last year, the FDA has approved two new experimental drugs for ALS, Relyvrio and Qalsody. The approvals followed intense campaigns from the ALS community although there have been a limited number of scientific studies of the treatments.
去年，美国食品药品监督管理局批准了两种治疗ALS的新实验药物，Relyvrio和Qalsody。尽管对ALS治疗方法的科学研究数量有限，但在ALS社区的激烈运动之后，批准了这些治疗方法。
The FDA has used the term "regulatory flexibility" when considering experimental treatments for some conditions, including ALS and Alzheimer's. But the agency appears unwilling to overlook the results of BrainStorm's approval effort. Important information about manufacturing and quality control was missing.
美国食品药品监督管理局在考虑对某些疾病的实验治疗时使用了“监管灵活性”一词，包括ALS和阿尔茨海默氏症。但该机构似乎不愿忽视BrainStorm审批工作的结果。缺少有关制造和质量控制的重要信息。
Dr. Kenneth Fischbeck of the National Institutes of Health said, "It really is a disease that needs a safe and effective treatment and there are a lot of other prospects out there that we need to encourage. Approving one like this would get in the way of that."
美国国立卫生研究院的Kenneth Fischbeck博士说：“这确实是一种需要安全有效治疗的疾病，我们需要鼓励很多其他前景。批准这样的治疗会阻碍这一点。”
At last week's meeting, ALS patients, their family members and doctors spoke in support of BrainStorm's treatment. Several presented before-and-after videos that showed patients who had taken part in BrainStorm's study. The videos showed the patients walking, climbing stairs and doing other activities.
在上周的会议上，ALS患者、他们的家人和医生发言支持BrainStorm的治疗。一些人在视频前后展示了参与BrainStorm研究的患者。视频显示病人走路、爬楼梯和做其他活动。
Mitze Klingenberg spoke for her son Matt Klingenberg who doctors found to have ALS in 2018. She said, "When Matt is on NurOwn it helps him, when he's off of it he gets worse."
Mitze Klingenberg为她的儿子Matt Klingenbeerg代言，医生在2018年发现他患有ALS。她说：“当马特在NurOwn时，这对他有帮助，当他离开时，情况会变得更糟。”
上周，美国健康顾问投票反对对ALS疾病进行实验性治疗。这次投票是在ALS患者及其家人多年来努力支持这种未经证实的医疗方法之后进行的。
ALS, or amyotrophic lateral sclerosis, is also known as Lou Gehrig's disease. Patients with ALS slowly lose the ability to control muscle movements, the ability to speak, eat, move and breathe. The U.S. National Institutes of Health says people can get the disease at any age. It most commonly develops between the ages of 55 and 75.
ALS，或称肌萎缩侧索硬化症，也被称为Lou Gehrig病。ALS患者慢慢失去控制肌肉运动的能力，失去说话、进食、移动和呼吸的能力。美国国立卫生研究院表示，人们在任何年龄都可能感染这种疾病。它最常见于55岁至75岁之间。
Last Wednesday, a group of health advisors for the U.S. Food and Drug Administration (FDA) voted 17 to one against the treatment from BrainStorm Cell Therapeutics. The Israel-based company's treatment, NurOwn, uses stem cells. These are cells that can develop into many kinds of body cells. The group found the treatment was not effective for patients with ALS. A member of the group representing ALS patients was the only vote in favor. One expert did not register a vote.
上周三，美国食品药品监督管理局（FDA）的一组健康顾问以17票对1票反对BrainStorm Cell Therapeutics的治疗方法。这家总部位于以色列的NurOwn公司的治疗方法使用干细胞。这些细胞可以发育成多种身体细胞。研究小组发现，这种治疗方法对ALS患者无效。代表ALS患者的小组成员是唯一投赞成票的人。一位专家没有登记投票。
Lisa Lee, a health expert from Virginia Tech University voted against the treatment. She said, "Creating false hope can be considered a moral injury and the use of statistical magic or manipulation to provide false hope is problematic."
弗吉尼亚理工大学的健康专家Lisa Lee投票反对这种治疗方法。她说：“制造虚假的希望可以被视为一种道德伤害，使用统计魔术或操纵来提供虚假的希望是有问题的。”
The FDA is not required to accept the group's vote. However, the agency's own scientists said earlier in the week that BrainStorm's treatment was "scientifically incomplete."
美国食品药品监督管理局不需要接受该组织的投票。然而，该机构自己的科学家在本周早些时候表示，BrainStorm的治疗“在科学上是不完整的”。
Brainstorm and the ALS community wanted to use the meeting to change the FDA's thinking about the NurOwn treatment.
头脑风暴和ALS社区希望利用这次会议来改变美国食品药品监督管理局对NurOwn治疗的想法。
Brainstorm's 200-patient study failed to show that NurOwn extended life, slowed the disease, or improved patients' ability to move. But the FDA agreed to bring outside advisers together after ALS patients and supporters submitted 30,000 signatures seeking a public meeting.
Brainstorm对200名患者的研究未能表明NurOwn延长了生命，减缓了疾病，或提高了患者的行动能力。但在ALS患者和支持者提交了30000个签名寻求公开会议后，美国食品药品监督管理局同意召集外部顾问。
In the last year, the FDA has approved two new experimental drugs for ALS, Relyvrio and Qalsody. The approvals followed intense campaigns from the ALS community although there have been a limited number of scientific studies of the treatments.
去年，美国食品药品监督管理局批准了两种治疗ALS的新实验药物，Relyvrio和Qalsody。尽管对ALS治疗方法的科学研究数量有限，但在ALS社区的激烈运动之后，批准了这些治疗方法。
The FDA has used the term "regulatory flexibility" when considering experimental treatments for some conditions, including ALS and Alzheimer's. But the agency appears unwilling to overlook the results of BrainStorm's approval effort. Important information about manufacturing and quality control was missing.
美国食品药品监督管理局在考虑对某些疾病的实验治疗时使用了“监管灵活性”一词，包括ALS和阿尔茨海默氏症。但该机构似乎不愿忽视BrainStorm审批工作的结果。缺少有关制造和质量控制的重要信息。
Dr. Kenneth Fischbeck of the National Institutes of Health said, "It really is a disease that needs a safe and effective treatment and there are a lot of other prospects out there that we need to encourage. Approving one like this would get in the way of that."
美国国立卫生研究院的Kenneth Fischbeck博士说：“这确实是一种需要安全有效治疗的疾病，我们需要鼓励很多其他前景。批准这样的治疗会阻碍这一点。”
At last week's meeting, ALS patients, their family members and doctors spoke in support of BrainStorm's treatment. Several presented before-and-after videos that showed patients who had taken part in BrainStorm's study. The videos showed the patients walking, climbing stairs and doing other activities.
在上周的会议上，ALS患者、他们的家人和医生发言支持BrainStorm的治疗。一些人在视频前后展示了参与BrainStorm研究的患者。视频显示病人走路、爬楼梯和做其他活动。
Mitze Klingenberg spoke for her son Matt Klingenberg who doctors found to have ALS in 2018. She said, "When Matt is on NurOwn it helps him, when he's off of it he gets worse."
Mitze Klingenberg为她的儿子Matt Klingenbeerg代言，医生在2018年发现他患有ALS。她说：“当马特在NurOwn时，这对他有帮助，当他离开时，情况会变得更糟。”
