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> The FDA requires research because it cannot be known if a drug is safe and effective without research. Why not? AstroZeneca knew the safety and efficacy of N
by Alex3917 9y ago
> The FDA requires research because it cannot be known if a drug is safe and effective without research.
Why not? AstroZeneca knew the safety and efficacy of Nexium without doing any research, but they were still required by law to run a couple studies.
- c3534l 9y agoBecause doing controlled trials is how you come about that knowledge. Otherwise you're just guessing. You can guess something is safe, but until you try it for real in a systematic way, that's all it is, a guess. That's not knowledge.
- deleted 9y ago[deleted]
- aaavl2821 9y agoI don't know the details of the nexium approval but for novel drugs you don't know it's effective until you test it The biggest driver of the high cost of drug development are failed late stage (phase 2 and 3) studies. Things look effective in the lab, then look effective in animals, then look potentially effective in exploratory human studies, then when you test rigorously for effectiveness in humans, they often fail. And these late stage human studies are the most expensive For generic drugs where you "know" it is safe and effective, there's an expedited pathway with fewer / smaller studies. And for slight tweaks to approved drugs there is another process that's more burdensome than the generics approval process but not as bad as a full new chemical entity path
- Alex3917 9y ago> I don't know the details of the nexium approval The story is written up in a lot of different books, but also here is a blog post on it: http://www.chemistry-blog.com/2010/10/18/nexiums-dirty-little-secret/ http://www.chemistry-blog.com/2010/10/18/nexiums-dirty-littl...