4 ms·

> This is evidence of what I call magical thinking–an undue focus on the clinical trial design as having incantatory power. This isn't complicated. Once we ha

> This is evidence of what I call magical thinking–an undue focus on the clinical trial design as having incantatory power. This isn't complicated. Once we have clinical trial evidence, the protocols tested form the standard of care. With no standards of care (i.e. no tested vaccine, here), then we can only guess about what might be better than nothing. It's fair to make that decision on a balance of probabilities -- try something if it's 51% likely to help (absent negative side-effects, anyway). But once we have such a standard, the very deliberate conservatism of our medical science means we need compelling evidence before supplanting it. I think it's very likely that a single dose of Pfizer/Moderna is adequately protective in the medium term (weeks to months), but this was not fully tested. It's not appropriate to start experimenting on the general population based on a hunch. This community is IT-centric, so think of it like experimenting on a production system. Even if you are 80% sure that something's likely to work out, the risk of failure is so catastrophically high that you don't do it when any other option is open to you.

baggy_trough 6y ago
The deliberate conservatism of medical science may be appropriate in "peacetime", but it is murderous in "wartime" (a pandemic).
- ridaj 6y ago
  The "what have you got to lose" approach doesn't have a great track record either... Even wartime medics take time to disinfect their tools
  - baggy_trough 6y ago
    Certainly one could go too far in either direction, but there's little doubt we are too far in the status quo / conservative direction at the moment.
    - nojokes 6y ago
      I think that the most murderous conservative decision was to not allow early human challenge trials on the ethical grounds while hundred thousands of people were dying.
      - baggy_trough 6y ago
        There are certainly many to choose from, but no single dose first is up there as well.
monkeypizza 6y ago
> It's not appropriate to start experimenting on the general population based on a hunch. By varying the parameters of the situation, could you be induced to change your view? i.e. vary CFR up to 1%, 10%, 50% - given that you acknowledge that the natural experiments we are observing from single-dose administration suggest most of the immunity granted by a vaccine is in the first dose - at what point do you budge? If you admit that for a 50% CFR, you would not insist on following the established standard of care, then the question is where is the border for you, where your recommendation flips, and you consider early end to quarantine, reduced life loss, to be worth moral hazard of ad-hoc decisions, or not following the standard of care would bring?
- Majromax 6y ago
  > at what point do you budge? Around the same time that you dispense with phase 3 trials entirely. It was more likely than not that the Pfizer/Moderna vaccines were effective by the time they'd completed phase 2 studies. If that is our standard, then we ought to have begun vaccinating at-risk individuals on a volunteer basis then -- in Fall of 2020. To me, it's inconsistent to both say we need a full phase 3 clinical trial to grant authorization to a vaccine, but then to ignore the protocol of that phase 3 trial when distributing it.
  - nojokes 6y ago
    Alternative is to have a more detailed and parameterized protocol. Regardless, the real solution should have been early human challenge trials and we would have had the vaccine already in the beginning of the summer most likely.
- dalbasal 6y ago
  Here's the thing... they did budge. Alex is so caught up in dunking on the FDA that you might miss the fact they just approved a one-shot... within days of hsi last article dunking on them for not doing it. Presumably, that approach was being studied all along (in the three months that it's even been a decision. Everyone assumes the FDA are being rigid and bureaucratic regardless of what they actually do. How do you write an article ripping them for magical thinking as they do the thing you're saying they should do? The fact that the FDA didn't pull a u-turn on the same day a"maybe this" thought occurs to a welfare economics professor is enough to accuse them of negligence every week. Now, it doesn't even seem like even doing what he thinks they should do is enough. They're still caught up in "magical thinking." What for, giving any weight to clinical trial design at all.

baggy_trough 6y ago

The deliberate conservatism of medical science may be appropriate in "peacetime", but it is murderous in "wartime" (a pandemic).

ridaj 6y ago
The "what have you got to lose" approach doesn't have a great track record either... Even wartime medics take time to disinfect their tools
- baggy_trough 6y ago
  Certainly one could go too far in either direction, but there's little doubt we are too far in the status quo / conservative direction at the moment.
  - nojokes 6y ago
    I think that the most murderous conservative decision was to not allow early human challenge trials on the ethical grounds while hundred thousands of people were dying.
    - baggy_trough 6y ago
      There are certainly many to choose from, but no single dose first is up there as well.

monkeypizza 6y ago

> It's not appropriate to start experimenting on the general population based on a hunch. By varying the parameters of the situation, could you be induced to change your view? i.e. vary CFR up to 1%, 10%, 50% - given that you acknowledge that the natural experiments we are observing from single-dose administration suggest most of the immunity granted by a vaccine is in the first dose - at what point do you budge? If you admit that for a 50% CFR, you would not insist on following the established standard of care, then the question is where is the border for you, where your recommendation flips, and you consider early end to quarantine, reduced life loss, to be worth moral hazard of ad-hoc decisions, or not following the standard of care would bring?

Majromax 6y ago
> at what point do you budge? Around the same time that you dispense with phase 3 trials entirely. It was more likely than not that the Pfizer/Moderna vaccines were effective by the time they'd completed phase 2 studies. If that is our standard, then we ought to have begun vaccinating at-risk individuals on a volunteer basis then -- in Fall of 2020. To me, it's inconsistent to both say we need a full phase 3 clinical trial to grant authorization to a vaccine, but then to ignore the protocol of that phase 3 trial when distributing it.
- nojokes 6y ago
  Alternative is to have a more detailed and parameterized protocol. Regardless, the real solution should have been early human challenge trials and we would have had the vaccine already in the beginning of the summer most likely.
dalbasal 6y ago
Here's the thing... they did budge. Alex is so caught up in dunking on the FDA that you might miss the fact they just approved a one-shot... within days of hsi last article dunking on them for not doing it. Presumably, that approach was being studied all along (in the three months that it's even been a decision. Everyone assumes the FDA are being rigid and bureaucratic regardless of what they actually do. How do you write an article ripping them for magical thinking as they do the thing you're saying they should do? The fact that the FDA didn't pull a u-turn on the same day a"maybe this" thought occurs to a welfare economics professor is enough to accuse them of negligence every week. Now, it doesn't even seem like even doing what he thinks they should do is enough. They're still caught up in "magical thinking." What for, giving any weight to clinical trial design at all.