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In what way would it be legible? It would look identical to exactly what the Montana law is designed to produce: more drugs that aren't known to work being rele

In what way would it be legible? It would look identical to exactly what the Montana law is designed to produce: more drugs that aren't known to work being released to patients. Obviously a large number of those will end up actually not working (which is why trial failure rates are so high to begin with). Producing $5-10MM in revenue with a snake oil drug strikes me as trivial. And keep in mind a substantial portion of the Phase 1 + IND costs are incurred in preparation of actually trying to bring a drug fully to market. If your approach is just to Phase 1, milk consumers, then bail, I'm quite confident you can do this much much much more cheaply. > Also what would be the bad outcomes here? If those drugs end up not being safe (that is prevented by the requirement to not withhold safety data), or being effective? A requirement not to withhold safety data is different (and easier to enforce at Phase 1) than a requirement to produce the relevant safety data in the first place. Again, designing a Phase 1 study with no ambition to succeed in Phase 2 and Phase 3 will both enable and incentivize a lot more "creativity" in study design to not detect a problem early on. Whereas today, all incentives are aligned toward detecting problems as early as possible, because finding out your drug is unsafe at Phase 3 is financially very bad.

niklas_anzinger 10d ago
Is the scheme you describe a risk? Sure. Any new mechanism is, until it has a track record. What I meant by legible: to run it, you'd have to pass FDA's IND review and reporting requirements, IRB review of the Phase 1, and then Montana ETRB review, with public annual outcome reporting and no withholding of safety data from patients. That's a high bar. If your view is that nothing short of full approval is enough of a bar and no alternative should be tried even at small scale, fine. We should agree to disagree here then.
- estearum 8d ago
  No, that’s not my belief and it frankly reads as a little petulant. The risk I’m pointing out has nothing to do with a track record. It’s a design problem. Implementing solutions that are knowably bad is actually really stupid and we shouldn’t do it.

niklas_anzinger 10d ago

Is the scheme you describe a risk? Sure. Any new mechanism is, until it has a track record. What I meant by legible: to run it, you'd have to pass FDA's IND review and reporting requirements, IRB review of the Phase 1, and then Montana ETRB review, with public annual outcome reporting and no withholding of safety data from patients. That's a high bar. If your view is that nothing short of full approval is enough of a bar and no alternative should be tried even at small scale, fine. We should agree to disagree here then.

estearum 8d ago
No, that’s not my belief and it frankly reads as a little petulant. The risk I’m pointing out has nothing to do with a track record. It’s a design problem. Implementing solutions that are knowably bad is actually really stupid and we shouldn’t do it.