认真读了一下FDA的文字,From Test Tube To Patient,对比了颖河和方舟子的文字,也看了浙大某教授的文章。笔者得出的结论是:方舟子确实抄袭了颖河的文章。
下面,我准备按确定抄袭难度从易到难分五个级别,对方舟子抄袭颖河这个问题进行分析。
难度一级:文字分段相同
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对比颖河和方舟子的文字,可以看出他们在介绍三期临床实验时,同样都用了三段文字。这确实会引起读者的怀疑。但是,经过那位浙江大学教授的实验,某位博士生也在叙述表格内容时,进行了相同的分段。所以,可以认为仅仅用相同的文字分段,还不足以确证方舟子抄袭了颖河的文章。
方舟子通过了难度一级的检验。
例如,对I期临床试验的介绍,颖河称其“初步观察新药的安全性并确定合
适的给药剂量”,我则更精确地说“其主要目的是观察新药是否会出现急性毒副
作用,检验合适的安全给药剂量”,我根据的就是FDA文的说法,“These phase
1 studies assess the most common acute adverse effects and examine the
size of doses that patients can take safely without a high incidence
of side effects.”所以出现了颖河用“安全性”而我用“急性毒副作用”,颖
河用“确定”而我用“检验”的差异。我的这部分介绍中还有一句话为颖河所无:
“如果没有严重的问题,例如不可接受的毒副作用,就可进入II临床试验。”这
也是根据的FDA文:“If phase 1 studies don’t reveal major problems,
such as unacceptable toxicity,...”
该例子依据的原文(见后)没有提到临床试验天数,在另一处有“Zidovudinewas approved in 107 days”的说法,经仔细核对,天数(第107天,即106天后)应该指的是批准时间,而非临床试验时间。之所以出现这个误读,是因为以前读过颖河《认识药物》介绍的同一个例子提到临床试验只进行了106天,留下的印象导致先入为主的误读。实际上整个临床试验进行了大约一年,到II期临床试验时发现显著提高了艾滋病患者的存活率,即提前终止。
特此更正。
In any trial in which a possible effect on survival is being assessed,
it’s important to monitor results as they emerge. That way, if a major
effect is seen—positive or negative—the trial can be stopped. This
happened in the first clinical study of the AIDS drug zidovudine (AZT),
when a clear survival advantage for patients receiving zidovudine was
seen well before the trial was scheduled to end. The trial was then ended
early, and within a week FDA authorized a protocol allowing more than
4,000 patients to receive zidovudine before it was approved for marketing.
…These are examples of the ethical principle that if a lifesaving or
life-extending treatment for a disease does exist, patients cannot be denied.