x****e
发帖数: 1773 | 1 【 以下文字转载自 Military 讨论区 】
发信人: softknife (软刀), 信区: Military
标 题: FDA 关于在中国儿童身上做转基因实验给我的回执 (转载)
发信站: BBS 未名空间站 (Thu Sep 6 13:55:52 2012, 美东)
发信人: softknife (软刀), 信区: Biology
标 题: FDA 关于在中国儿童身上做转基因实验给我的回执
发信站: BBS 未名空间站 (Thu Sep 6 12:39:56 2012, 美东)
我：(这是我的信的摘要，全文太长）I write this letter to raise the
possibility of misconducts in a clinical trial recently published in Am J
Clin Nutr September 2012 vol. 96 no. 3 658-664, entitled “ β-Carotene in
Golden Rice is as good as β-carotene in oil at providing vitamin A to
children”. In the abstract http://ajcn.nutrition.org/content/96/3/658.abstract#fn-1, the authors mentioned that “This trial was registered at www.clinicaltrials.gov as NCT00680212.” The location mentioned in this trial, United States, Massachusetts didn't match what's in the paper (CHINA), and the claim of having approval from Ethics Review Committee of Zhejiang Academy of Medical Sciences is false because that was removed from the registry on 7/16/2008.
----------
FDA： since the study was conducted outside of the U.S. you need to contact
the Country that hosted the trial for their requirements. You can also
express your concerns to the publishers of the study.
-------------
我：If the trial was conducted outside of the U.S., what sense does it make
to register in US? Could you let me know what kind of monitoring, if any,
provided by FDA or her institutional IRB to this trial?
Allowing this trial registered in US gives people， especially her subjects,
a false impression that this trial
conducted in foreign country is approved and monitored by FDA. This loop
hole allows someone to conduct unethical trials in foreign country, but
still easily publish them in top US journals. I strongly urge FDA ask the Dr
. Tang to remove the statement “This trial was registered at www.
clinicaltrials.gov as NCT00680212.” from the paper because what registered
by Dr. Tang has nothing to do with the trial.
---------------------------------------------------------------
舟子说的有两国ethics委员会批准是自己意淫。汤广文干的是挂羊头卖狗肉的勾当骗中
国人。看来这个实验既没有美国批准也没有中国批准（根据现在的调查结果）。希望大
家写信给杂志要求retract这篇文章，向中国方面施压要他们跟杂志交涉不能发没有经
过批准的人体实验。杂志retract这篇文章让这些没有良知‘科学家’竹篮打水一场空
是他们应该得到的后果。这不光是针对这个事件，也是警示其他没有得到审批，或和中
国腐败官僚勾结拿中国人做医学实验的无良科学家。
----------------------------------------
update： 经hellozero 提示给SFDA（国家食品药品监督管理局）发信了。
问他们这个trial他们批准了没有。如果没有要求他们出面撤销这篇文章。
局领导们都有在线信箱
http://www.sfda.gov.cn/WS01/CL0039/#wuzhen
好像用Internet Explorer 才能行 | s******s
发帖数: 505 | 2
这个应该找Tufts University的IRB。
【在 x****e 的大作中提到】
: 【 以下文字转载自 Military 讨论区 】
: 发信人: softknife (软刀), 信区: Military
: 标 题: FDA 关于在中国儿童身上做转基因实验给我的回执 (转载)
: 发信站: BBS 未名空间站 (Thu Sep 6 13:55:52 2012, 美东)
: 发信人: softknife (软刀), 信区: Biology
: 标 题: FDA 关于在中国儿童身上做转基因实验给我的回执
: 发信站: BBS 未名空间站 (Thu Sep 6 12:39:56 2012, 美东)
: 我：(这是我的信的摘要，全文太长）I write this letter to raise the
: possibility of misconducts in a clinical trial recently published in Am J
: Clin Nutr September 2012 vol. 96 no. 3 658-664, entitled “ β-Carotene in
|
|
