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the entire FDA approval process was heavily gamed before, and is probably even more heavily gamed now. i'm talking about companies specifically starting drug discovery -- without anything in hand -- targeted at diseases where there is the reputation for the FDA playing loose with the approval process for whatever reason. fewer regulatory issues translates cleanly into more profit.

as the author points out, the incentives are always in favor of doing a bad job with regard to efficacy and trial design. a company that can produce a really great and well-proven drug is not going to make more money than a company that produces a shitty drug that is also approved for the same condition.

in fact, with the right marketing efforts, the execs would even see similar sales figures for both of these hypothetical drugs. hence why more is spent on marketing than R&D.




The "whatever reason" is that the level of long-term side effects that can be tolerated depends on the disease being cured. A drug that cures a previously fatal cancer should be approved, even if there are some long-term side-effects, because it's better than death. A drug that treats hair loss or heartburn needs studies to make sure that serious long-term side effects are extremely rare.

Testing for rare long-term effects requires a huge sample size, and billion dollar clinical trial budgets.

Teams do decide, early on, to try to discover drugs for serious diseases or common diseases, depending on how much money they think they can raise. Usually only proven teams can raise the huge amounts, so most pharma startups target serious niche diseases hoping for approval under the orphan drug program.


>"a company that can produce a really great and well-proven drug is not going to make more money than a company that produces a shitty drug that is also approved for the same condition."

Yep, there is only a weak mapping between FDA approval and actual drug usefulness.




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