What if you have two drugs, one that saves 1000 lives per year, and the other that costs 1000 per year? I think you’re saying that it’s a wash whether you approve both or ban both. But if you approve both and eventually ban the deadly drug, it’s a net win. The expected value of approving a drug is higher than the expected value of using it indefinitely. (I see that you address this in the comments. But I don’t think this is “an additional complication” but a huge bias to this methodology.)
The continual push for “higher standards” leads to fewer drug approvals. It is hard to assess the quality of the marginally rejected drugs, but the other effect is to delay approval. It is easy to retrospectively measure the effect of delay. Gieringer showed that in the 50s, 60s, and 70s when the US and Europe had different standards, the lives lost to delays on one side of the Atlantic swamped the lives lost to drugs that were eventually banned. That’s all drugs that were eventually banned, not just drugs that were not approved because of “higher standards.” In fact, the most famous differential rejection, thalidomide, was rejected on a US whim, when the US generally had laxer standards at the time.
What if you have two drugs, one that saves 1000 lives per year, and the other that costs 1000 per year? I think you’re saying that it’s a wash whether you approve both or ban both. But if you approve both and eventually ban the deadly drug, it’s a net win. The expected value of approving a drug is higher than the expected value of using it indefinitely. (I see that you address this in the comments. But I don’t think this is “an additional complication” but a huge bias to this methodology.)
The continual push for “higher standards” leads to fewer drug approvals. It is hard to assess the quality of the marginally rejected drugs, but the other effect is to delay approval. It is easy to retrospectively measure the effect of delay. Gieringer showed that in the 50s, 60s, and 70s when the US and Europe had different standards, the lives lost to delays on one side of the Atlantic swamped the lives lost to drugs that were eventually banned. That’s all drugs that were eventually banned, not just drugs that were not approved because of “higher standards.” In fact, the most famous differential rejection, thalidomide, was rejected on a US whim, when the US generally had laxer standards at the time.