Most of that cost is driven by the increasing difficulty of doing basic research and discovering anything that actually works (plus accounting for the many failures).
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It can't possibly be the FDA. The FDA isn't stricter now than in the past (quite the opposite with so many accelerated approvals of various types). Indeed, most cancer drugs barely extend lifespan at all (jamanetwork.com/journals/jaman). It would be hard to lower the bar more than that.
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Here’s what the Eroom’s Law paper says about “low-hanging fruit.” Prove them wrong and you’ll get a Nature publication.
And the initial efficacy requirement was added in 1962. Hard to believe that had no effect on approvals cost!
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“It would be hard to lower the bar more than that.”
Hypothetically, what if we said all treatments were allowed until shown to be unsafe? That would be a significantly lower bar and would bring many more treatments onto the market.
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Most treatments by themselves are inherently unsafe. Psych drugs, cancer drugs...mostly toxic with terrible side effects. Only reason to take them is if someone verifies that they actually have some benefit.
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I agree, but that doesn’t mean that the best way to get there is to impose a regulatory barrier. It simply doesn’t follow.
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Without regulation, we'd have many equivalents of Bayer marketing heroin to children.
But yes, payers could serve the role of demanding hard evidence that a drug's benefit exceeds cost. But if they actually did that properly, it would be a far more onerous process than the FDA!
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All the FDA expects is some evidence (often not even very good evidence) of some benefit (often not a clinically relevant benefit). It doesn't expect cost-benefit analysis, and isn't even allowed to do so. Payers could be much more stringent than that, if they behave rationally.
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I'm on Stuart's side here. Biology is hard, it's not the FDA. But those crispr therapies and partial reprogramming are on the way, they'll just take their time.
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Paul Janssen sides with Eli in this interview (jump to 12:50): vimeo.com/195216394. (According to Wikipedia, "Altogether Janssen and his cadre of scientists discovered more than eighty new medications, four of which are on the WHO list of essential medicines.")
I certainly agree that if we had little toxicological testing, or animal testing, etc., the timeline would be shorter and cheaper . . . and there are almost certainly ways to streamline all of that.
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Also, when he says that penicillin was "rediscovered" and made available at the front lines of WWII "within one year" . . . I thought Howard Florey started isolating and testing in 1938, and it wasn't on the front lines until 1943-44?
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Janssen, of course, also developed fentanyl, to Stuart's point.
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