The unintended consequence of the onerous FDA approval process is that only a few extremely large players have the resources to develop and bring new drugs to the market. Therefore they need to make a lot of money back to cover their costs.
On the other hand, in earlier times we had a lot of drugs that were in the "snake oil" category, making a lot of claims but doing nothing at all (or that were actually harmful).
But in a bid to mitigate risk (from their shareholders) big pharma effectively outsources lots of compound discovery to biotechs. This has helped create a large pool of biotech startups that never intend to run a phase 1 study but instead prepare for acquisition upon promising preclinical.
Re:The truth about ‘breakthrough’ drugs
by beenBoutIT on Monday August 20, 2018 @08:39PM
(#17805681)
IMO the only criteria should be safety. Medicine doesn't have to work for everyone to be useful for a lot of people.
Re:The truth about ‘breakthrough’ drugs
by rincebrain on Tuesday August 21, 2018 @03:03AM
(#17807640)
A great many drugs are grossly unsafe if you even minorly exceed the clinical dosage threshold, but are still regularly used by people because we haven't found better replacements.
A much larger set of drugs fall into a gradient of "as far as we can tell you'll just excrete it if you take too much" to "it's probably not _good_ if you unnecessarily take it, but it won't really be detectable in 4 weeks" to "oh god why would you ever prescribe that".
So if we were purely grading on safety, we'd be out quite a lot of pharmacology.
[0] https://en.wikipedia.org/wiki/Drotrecogin_alfa#Marketing_con...
[1] https://en.wikipedia.org/wiki/Celecoxib#Fabricated_efficacy_...