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How you treat a case like decision making to achieve certain extra-scientific outcomes vs. rigor of evidence. The way accelerated approvals work for approving novel therapies falls into this and I would argue implicitly results in values rightly influencing thresholds of decision-making. 1/2
It can and should be the case that we apply different thresholds to the causal and statistical evidence for surrogate endpoints, incorporating non-epistemic concerns like enabling future innovation, consequences of delaying a plausibly effective treatment matter.
Up until now we actually had a system where medical and statistical reviewers very rigorously weighed the evidence and told drug developers, no your evidence isn't good enough. But the decision makers look at the full picture can still make the call to conditionally approve a drug. 3/n
Value-laden decision making didn't hampered the ability of the FDA to ruthlessly weighing the evidence. On the other hand, this was not true for drug developers who often present the same evidence in much better light, or even the best medical journals like NEJM who fail to find the problems 4/n
May 2, 2025 21:15
