作者BaseBlessed (计画老是赶不上变化)
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标题美国FDA狂牛症谘询委员会会议纪录摘要与翻译
时间Tue Nov 3 12:22:32 2009
(欢迎转载本文但请注明FDA原出处网址)
以下摘录并翻译自美国食品药物管制局於2006年9月18日举行之"可传播性海绵状脑症"
谘询委员会会议纪录,详见
http://www.fda.gov/ohrms/dockets/ac/06/transcripts/1006-4240t1.htm
Dr. Lisa Ferguson is employed by USDA in Hyattsville, Maryland.
丽莎弗格森博士是马里兰州海兹维尔市美国农业部之聘雇人员。
Dr. Lisa Ferguson:
丽莎弗格森博士:
As everybody knows, we have been doing active surveillance in
the United States since 1990, and we are targeting the
population where the disease is most likely to be diagnosed.
That is the most efficient way for us to conduct a
surveillance system.
众所皆知,自从1990年以来,在美国,我们一直实施动态监测,针对那些最有可能被诊
断出疾病的群体做检查。对於我们来说,想要施行监测系统,这是最有效率的方法。
The assumption is that if we can't find disease in that
population, then it is even more unlikely for us to find it
in the non-targeted population.
其背後的假设是,如果我们在该群体中找不到疾病,那麽,我们就更不可能在其它未被
锁定的群体中找到。
So, we can use the data that we get from that targeted sampling
to extrapolate information to the broader cattle population.
所以,我们可以使用从那些被锁定样本中得到的资料,来广泛推论其它牛只群体的情况。
...
DR. EPSTEIN: Lisa, my question is, does USDA have information
about food chain controls in non-U.S. countries? Are we in a
position to comment how adequate the food chain controls are
from country to country?
亚培斯坦博士:丽莎,我想问的是,对於美国以外的其它国家的食物链控管,美国农业部
是否有相关的资讯?我们有没有能力评估国与国之间的食物链控管是否得宜?
DR. FERGUSON: I can speak for AFIS per se, since we are not
the food safety group. That is really not part of the
information that we have.
弗格森博士:我只能为动物与食品产业部门发言,因为我们不是食品安全团体。关於那个
部分的资讯,我们真得不了解。
...
MS. KRANITZ: Dr. Ferguson, in the United Kingdom and Japan
they have found cases of BSE in animals that are not
symptomatic. So, I would like to know why the USDA doesn't
consider random sampling of healthy stock.
库朗妮兹小姐:弗格森博士,英国与日本都有在无症状的动物身上发现牛海绵状脑症的
许多案例。因此,我想知道为什麽美国农业部不考虑对健康牲畜进行随机抽样调查?
Dr. Ferguson: ... In the United States, the purpose of our
surveillance program is animal health monitoring, to help us
define either the presence or the absence of disease in the
U.S. cattle population. The purpose is not to identify each
and every individual case of BSE that might be out there.
In fact, that is an impossibility to do with current test
methods that are there.
弗格森博士: ... 在美国,我们的监测作业目的是监测动物的健康情形,以帮助我们
了解美国牛只群体是否存在着疾病。其目的不是去确认每一个可能存在的牛海绵状脑症
个案。事实上,以现有的测量方法,这是不可能做到的事。
...
DR. HOGAN: In terms of identifying your targeted population,
how are those animals being identified? Is it by government
employees or by industry, and what is your sense of the
compliance rate?
侯根博士:在划定你们的目标群体这个方面,这些动物是如何被划分出来的?是由政府
雇员或业者划分的?而你认为实际上被执行的比率有多少?
DR. FERGUSON: We have had very good cooperation with the
industry over the past two years, actually since 1990, since
we have been doing surveillance. As everybody knows, our
surveillance is not mandatory. We do have some regulatory
authority to do that, but we have chosen not to exercise it
at this point in time. We have gotten where we are today with
cooperation with the industry.
弗格森博士:过去这两年来,事实上是从1990年以来,从我们开始实施监测以来,我们
与业者之间皆有非常良好的合作关系。众所皆知,我们的监测并非强制性的。我们的确有
权进行管制,但目前我们选择不展现我们的权力。透过与业者的合作,我们才有今日的成
就。
...
Summary of WHO Consultation on Distribution of Infectivity
in Tissues
世界卫生组织感染传播谘询委员会意见摘要
DR. ASHER: ... Finally, as Dot Scott reviewed for you today,
due to uncertainties in the assumptions -- you will hear more
about that in the next meeting also -- it is very difficult to
offer confident predictions regarding the probability of
variant CJD infections, not to mention illnesses in people
exposed to various blood components and plasma derivatives.
亚瑟博士: ... 最後,如同今天道特史考特为你们评论的,由於各种假设的不确定性--
你们也会在下一场会议听到更多关於此方面的报告--对於变种库贾氏症感染的可能性,
我们很难提出有把握的预测,至於要预测那些接触各种血液成分与血浆制品的人们会引
发的疾病,那就更别提了。
____________________________________________________________________________
(补上:我的感想)
由此可知,美国从未对牛只进行全面普查,也从未进行全面的随机抽样调查。学过基本
统计学的人都知道,在母群体有偏差且抽样方法不恰当的情形下,无法进行有意义的统
计。此外,关於库贾氏症传染的各种可能性,科学家仍在研究当中且尚无定论,更何况
已知人类受感染後至发病的潜伏期可长达十年以上,在不知道有多少人已感染及如何感
染且不知道有多少美国牛已被感染的情形下,根本不可能算出吃美国牛後得病的正确机
率。
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