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【drug-news】FDA顾问评审委员会质疑回顾性遗传分
FDA advisers skeptical of retrospective genetic analysis
An FDA advisory committee took a dim view of two prominent developers' attempt to use a retrospective look at drug data to make a case that cancer drugs should be reserved for a specific population of patients based on genetics. In a significant verdict for developers forging a path to more personalized medicines, the advisers say that drug companies will need to do more studies and gather more data before they can win their case for targeting patients based on genetics.
ImClone and Amgen had argued that they have the data needed to prove that Erbitux and Vectibix are most effective in patients with a normal K-RAS gene. "The data are... nothing less than transformational," said Hagop Youssoufian, a senior vice president at ImClone.
Not so, say the advisers, who are looking for more evidence.
"It's going to make life more complicated, costly... it's going to require larger clinical trials," said panel member Richard Simon of the National Cancer Institute. And that means that developers with drugs in the pipeline are going to have to consider genetics when they're designing trials.
- read the article from The Guardian 要点：吃力不讨好？ 不成熟的一点想法：
1. 侵犯病人隐私，可能因为资料泄漏引发基因歧视的问题。
2. 一旦此项要求写入法律，会造成临床实验成本上升，小制药公司无力负担，给大制药公司并购小公司提供机会。破坏行业竞争。
3. 数据可信度和实际价值值得怀疑。 [标签:content1][标签:content2]
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作者:admin@医学,生命科学 2011-02-28 05:11
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