> It costs $5 Billion Dollars now to bring a new drug to market.
It costs more like $35M. Look at the last 20 years of MAPS budgets.
It costs more like $35M. Look at the last 20 years of MAPS budgets.
http://csdd.tufts.edu/news/complete_story/pr_tufts_csdd_2014...
which arrives at $2.6B. And if you are interested in keeping up with some of these studies from someone in the industry, I highly recommend Derek Lowe's blog -- he's a medicinal chemist. For example, http://blogs.sciencemag.org/pipeline/archives/2017/09/12/it-...
In some indications however one phase 3 study can be $300M+
The upper bound is actually very relevant. Those $300M studies are cardiovascular outcomes studies, which are required for many diabetes / cardiovascular drugs, and those expensive studies have basically stifled innovation in those areas because the cost of developing those drugs is too high compared to the expected profits
Not sure I understand the statement that the only thing that matters is how much the least expensive drug approvals cost?
I mentioned the cash costs for developing an approved drug as an additional data point to that illustrate GPs $35M is too low even excluding cost of failure
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.
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.
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
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-littl...
It seemed to hardly count as verifiable academic research. The raw data was seemingly made available privately to the researchers by way of their close relationship with the companies they're studying, the raw data is not made available by reproduction of their analysis, and there's no way for others to acquire similar data for comparison.
They may be honest, and the data and analysis may be accurate, and it may not be trying to paint a picture that favors its benefactors, but I did not conclude any of those things.