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The actual cost of developing a successful drug includes failed candidates. If you knew what chemicals would be effective medicines from the start, you wouldn't

by c3534l 9y ago

The actual cost of developing a successful drug includes failed candidates. If you knew what chemicals would be effective medicines from the start, you wouldn't need to do research.

Alex3917 9y ago
> If you knew what chemicals would be effective medicines from the start, you wouldn't need to do research. I mean that's not really accurate, even if you know a drug will be effective you're still legally required to do the research. There are plenty of drugs we know will be effective in advance, but they still need to be tested. Similarly, there are lots of drugs that we know will have maybe only a 5% likely chance of being effective, but it's worth spending money to test them anyway because of the potential profits. So including the costs of failed drug trials doesn't really make any sense.
- c3534l 9y ago
  If you knew it was effective what's the point of the research? The research is what's used to demonstrate efficacy. The FDA requires research because it cannot be known if a drug is safe and effective without research. They don't require you submit all the research that found a drug didn't work. They only require it of the one that did. It doesn't change the fact that you have any number of chemicals that could do any number of things, and you do research to demonstrate which ones have the desirable properties. Not that no one has to constructively invent a process to manufacture a drug, but what a drug patent typically grants is exclusive manufacture for proof of medical utility.
  - 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 ago
      Because 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 ago
      I 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...

by c3534l 9y ago

The actual cost of developing a successful drug includes failed candidates. If you knew what chemicals would be effective medicines from the start, you wouldn't need to do research.

Alex3917 9y ago

> If you knew what chemicals would be effective medicines from the start, you wouldn't need to do research. I mean that's not really accurate, even if you know a drug will be effective you're still legally required to do the research. There are plenty of drugs we know will be effective in advance, but they still need to be tested. Similarly, there are lots of drugs that we know will have maybe only a 5% likely chance of being effective, but it's worth spending money to test them anyway because of the potential profits. So including the costs of failed drug trials doesn't really make any sense.

c3534l 9y ago
If you knew it was effective what's the point of the research? The research is what's used to demonstrate efficacy. The FDA requires research because it cannot be known if a drug is safe and effective without research. They don't require you submit all the research that found a drug didn't work. They only require it of the one that did. It doesn't change the fact that you have any number of chemicals that could do any number of things, and you do research to demonstrate which ones have the desirable properties. Not that no one has to constructively invent a process to manufacture a drug, but what a drug patent typically grants is exclusive manufacture for proof of medical utility.
- 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 ago
    Because 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 ago
    I 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...