8 ms·

I was wondering as well... the data was submitted about 3 weeks ago... I understand that it is extensive data (for about 44,000 patients), but taking 3 weeks

I was wondering as well... the data was submitted about 3 weeks ago... I understand that it is extensive data (for about 44,000 patients), but taking 3 weeks to compile/analyze seems excessive. They should have put in an army of analyzers into it... There are about 3,000 people dying every day.... it is like 9/11 every day, or 9 jumbo jets falling.... The FDA should be treating this as a war effort, and not drag their feet into pointless bureaucratic 'safety' theater.

baskire 6y ago
sadly those extra days gained would do little to even put a dent in that figure.
- xyzzyz 6y ago
  Alas, UK managed to approve the same vaccine a week ago. A week of delay means extra 15-20 thousands of lives lost.
  - bigyikes 6y ago
    Also the sooner a vaccine is released, the sooner you can dampen the exponential growth, potentially compounding the lives saved. Not sure how significant of an effect this might be, though.
    - addicted 6y ago
      We still don’t know if the vaccine prevents transmission. So that may not even be true.
      - bigyikes 6y ago
        I didn’t know that, thanks! I guess I need to learn more about how vaccines work. I thought that vaccine implied immunity which implied that transmission is prevented.
      - garmaine 6y ago
        We don’t have gold-standard proof that it prevents transmission, because studying that has not been a priory. There’s no reason to think that it doesn’t prevent transmission when you look at the mechanism involved. It would be very surprising.
  - IfOnlyYouKnew 6y ago
    That's only true in a scenario where you specifically vaccinate exactly the people that were infected that week and later died.
    - xyzzyz 6y ago
      No, that’s wrong. https://marginalrevolution.com/marginalrevolution/2020/12/the-simple-math-of-fda-delay.html https://marginalrevolution.com/marginalrevolution/2020/12/th...
  - chub500 6y ago
    By that same logic why wait for any studies on the vaccine at all? Why not just start administering it as soon as it's developed (en masse)? The rigor is to give the public confidence that we're better off getting the vaccine than not.
    - zaroth 6y ago
      After the Phase 1 data was back, arguably it wouldn’t have been a bad call to give doses for free and gamble on the efficacy even if it turned out to be below 50%.
      - disgruntledphd2 6y ago
        From an ethical viewpoint, this is incredibly wrong, as vaccines given to healthy people which cause problems later are very very dangerous.
        pashamur 6y ago
        > From an ethical viewpoint, this is incredibly wrong, as vaccines given to healthy people which cause problems later are very very dangerous. The first two phases are the safety tests, the third one is efficacy (so we knew the vaccine was "safe" after phase 2, we just didn't know the efficacy - that's what the poster above is alluding to).
    - henrikschroder 6y ago
      It's also the case that if you were to screw up on the first approval, if the first vaccine actually wasn't as safe as it needs to be, then most people will be scared of vaccine #2 or #3, regardless of their safety, regardless of how they were produced. And that would cause a huge setback and prolong all the stupidity for years, potentially.
    - xyzzyz 6y ago
      I hope that extra public confidence is worth hundreds of thousands of deaths resulting from delaying the vaccine by months.
  - mlyle 6y ago
    You get to the same number vaccinated by Jan 15th or whatever no matter what because we're production limited. If you managed to give 5 million doses a week earlier, you save about 200 lives (about 40 deaths per million per week).
    - xyzzyz 6y ago
      We already had millions of doses in April/May. > If you managed to give 5 million doses a week earlier, you save about 200 lives (about 40 deaths per million per week). No, that’s wrong. https://marginalrevolution.com/marginalrevolution/2020/12/the-simple-math-of-fda-delay.html https://marginalrevolution.com/marginalrevolution/2020/12/th...
      - mlyle 6y ago
        > We already had millions of doses in April/May. No we didn't. :P The US has 6.4 million doses of the Pfizer vaccine now. Projections of up to 50M delivered worldwide by the end of the year. We're on a crazy ramp. If you want to complain about a misallocation, a key complaint would be that they're holding slightly more than half the doses back to ensure everyone dosed can get a second dose... but with rolling production such a large holdback isn't necessary. > What could matter is if delay increases the speed at which you can ramp up. All the jurisdictions I know will blow through the entire supply of existing doses allocated to them very quickly. It doesn't go on a slow distribution ramp gated by approval like your ridiculous source suggests. What governs the ramp is production rates, which have been running flat-out irrespective of this decision.
        xyzzyz 6y ago
        > All the jurisdictions I know will blow through the entire supply of existing doses allocated to them very quickly. It doesn't go on a slow distribution ramp gated by approval like your ridiculous source suggests. You misunderstand. "Blowing through entire supply" and being left with nothing is exactly the "slow distribution" Alex Tabarrok, a professor at GMU, talks about in the link I gave. He contrasts it with vaccinating entire population on day 1. Read it carefully. > What governs the ramp is production rates, which have been running flat-out irrespective of this decision. I consider the vaccine production regulation people to be just as incapable at cost-benefit analysis as vaccine approval people, so I assume that most production constraints are just as artificial as the approval constraints.
refurb 6y ago
"They should have put in an army of analyzers into it." You can't make a baby in 1 month with 9 women.
claudeganon 6y ago
> They should have put in an army of analyzers into it I expect that Brook’s law from The Mythical Man Month also applies to these kinds of statistical analysis.
breck 6y ago
> There are about 3,000 people dying every day.... it is like 9/11 every day, or 9 jumbo jets falling This is wrong. Median expected remaining healthy lifespan of a 9/11 deceased was ~35 years, whereas for a COVID decease it's ~3.5 years. So 9/11 is still 10x worse. Don't get me wrong, COVID is still terrible, but it is not a "9/11 every day".
- pixl97 6y ago
  That depends... did covid last over 10 days? Ok, math is off, but covid is going to last for at least 2 more months with death rates like this and that accrues. Also, do you know what they call it when I kill your grandmother 2 days before she was supposed to die of old age? Murder. Just because someone doesn't have much life left makes it no less of a tragedy when they die early.
  - amscanne 6y ago
    > Just because someone doesn't have much life left makes it no less of a tragedy when they die early. At the risk of being cold hearted, isn’t this exactly what it does?
  - remote_phone 6y ago
    In fact, if someone is falling off a building and you shoot them dead midair, that’s also murder.
- rrss 6y ago
  > it's ~3.5 years https://www.pnas.org/content/117/36/22035 https://www.pnas.org/content/117/36/22035 > We calculate, using these same cohort life tables, that the average person dying of COVID-19 had 11.7 y of remaining life expectancy
  - IncRnd 6y ago
    That is taken out of context. The prior sentence pointed out, "we calculate that the 2020 American population of 330 million people has on average..." The calculation you reference was done using all people in the US. Just two sentences later they wrote, "... would on average lose about 0.2 y of remaining life ..." You need to compare to the groups of affected people, which is generally not 100% of people in the US.
creddit 6y ago
"extensive data" is 44K patients!? Wait until I tell you about the extremely extensive data that tech companies at scale deal with every day. I run a large data science organization at a major tech company. If someone told me that it was going to take 3wks to analyze an experiment of this type, I would probably have to start firing people.
- 6gvONxR4sf7o 6y ago
  If someone wanted to take three weeks to analyze an experiment with these kinds of stakes, you’d fire them?! I have to assume you’re being hyperbolic. And are you suggesting that it’s easier because the data isn’t as extensive as what the rest of us deal with? That only makes it harder. Sure if it’s some random A/B test with data from your own systems from an experiment you designed, but this is a vaccine the whole fucking world has been waiting for for most of the year. God forbid people treat it a little more carefully.
  - creddit 6y ago
    > If someone wanted to take three weeks to analyze an experiment with these kinds of stakes, you’d fire them?! I would absolutely need to start a performance improvement process. They are definitionally 1/3 as productive as they should be. Also in terms of stakes, please show me even a modicum of work that suggests the downside risk of approval is greater than the delayed vaccinations. What reason have I to believe there is great risk in approval? Again, the UK approved this over a week ago. > And are you suggesting that it’s easier because the data isn’t as extensive as what the rest of us deal with? That only makes it harder. No, I'm mocking the idea of it being extensive data. It's not. > but this is a vaccine the whole fucking world has been waiting for for most of the year. And that's reason to go slower!? There's no need for this delay!!! https://thedispatch.com/p/fda-career-staff-are-delaying-the https://thedispatch.com/p/fda-career-staff-are-delaying-the
    - 6gvONxR4sf7o 6y ago
      > Also in terms of stakes, please show me even a modicum of work that suggests the downside risk of approval is greater than the delayed vaccinations. What reason have I to believe there is great risk in approval? As I understand it, medical ethics isn’t about utilitarianism, or else we’d skip the rats and monkeys and just go straight to testing on the poor for money. They don’t seem to prioritize minimizing the opportunity cost of avoiding bad outcomes. Their guiding principle seems to be avoiding giving harmful treatment. Meanwhile some healthcare workers at my partner’s facility are skeptical about whether the vaccine was rushed (I think they’re crazy, for the record). But there’s real risk if enough of the public doesn’t trust the vaccine. I’d bet that kind of angle is part of why they focus on “do no harm” instead of “minimize cumulative regret.”
krimpenrik 6y ago
What a weird comparison, every day, 800 children die caus of dirty water. https://www.worldvision.com.au/global-water-crisis-facts#:~:text=Globally%2C%20785%20million%20people%20lack,many%20communities%20around%20the%20world https://www.worldvision.com.au/global-water-crisis-facts#:~:.... No one gives a shit.

baskire 6y ago

sadly those extra days gained would do little to even put a dent in that figure.

xyzzyz 6y ago
Alas, UK managed to approve the same vaccine a week ago. A week of delay means extra 15-20 thousands of lives lost.
- bigyikes 6y ago
  Also the sooner a vaccine is released, the sooner you can dampen the exponential growth, potentially compounding the lives saved. Not sure how significant of an effect this might be, though.
  - addicted 6y ago
    We still don’t know if the vaccine prevents transmission. So that may not even be true.
    - bigyikes 6y ago
      I didn’t know that, thanks! I guess I need to learn more about how vaccines work. I thought that vaccine implied immunity which implied that transmission is prevented.
    - garmaine 6y ago
      We don’t have gold-standard proof that it prevents transmission, because studying that has not been a priory. There’s no reason to think that it doesn’t prevent transmission when you look at the mechanism involved. It would be very surprising.
- IfOnlyYouKnew 6y ago
  That's only true in a scenario where you specifically vaccinate exactly the people that were infected that week and later died.
  - xyzzyz 6y ago
    No, that’s wrong. https://marginalrevolution.com/marginalrevolution/2020/12/the-simple-math-of-fda-delay.html https://marginalrevolution.com/marginalrevolution/2020/12/th...
- chub500 6y ago
  By that same logic why wait for any studies on the vaccine at all? Why not just start administering it as soon as it's developed (en masse)? The rigor is to give the public confidence that we're better off getting the vaccine than not.
  - zaroth 6y ago
    After the Phase 1 data was back, arguably it wouldn’t have been a bad call to give doses for free and gamble on the efficacy even if it turned out to be below 50%.
    - disgruntledphd2 6y ago
      From an ethical viewpoint, this is incredibly wrong, as vaccines given to healthy people which cause problems later are very very dangerous.
      - pashamur 6y ago
        > From an ethical viewpoint, this is incredibly wrong, as vaccines given to healthy people which cause problems later are very very dangerous. The first two phases are the safety tests, the third one is efficacy (so we knew the vaccine was "safe" after phase 2, we just didn't know the efficacy - that's what the poster above is alluding to).
  - henrikschroder 6y ago
    It's also the case that if you were to screw up on the first approval, if the first vaccine actually wasn't as safe as it needs to be, then most people will be scared of vaccine #2 or #3, regardless of their safety, regardless of how they were produced. And that would cause a huge setback and prolong all the stupidity for years, potentially.
  - xyzzyz 6y ago
    I hope that extra public confidence is worth hundreds of thousands of deaths resulting from delaying the vaccine by months.
- mlyle 6y ago
  You get to the same number vaccinated by Jan 15th or whatever no matter what because we're production limited. If you managed to give 5 million doses a week earlier, you save about 200 lives (about 40 deaths per million per week).
  - xyzzyz 6y ago
    We already had millions of doses in April/May. > If you managed to give 5 million doses a week earlier, you save about 200 lives (about 40 deaths per million per week). No, that’s wrong. https://marginalrevolution.com/marginalrevolution/2020/12/the-simple-math-of-fda-delay.html https://marginalrevolution.com/marginalrevolution/2020/12/th...
    - mlyle 6y ago
      > We already had millions of doses in April/May. No we didn't. :P The US has 6.4 million doses of the Pfizer vaccine now. Projections of up to 50M delivered worldwide by the end of the year. We're on a crazy ramp. If you want to complain about a misallocation, a key complaint would be that they're holding slightly more than half the doses back to ensure everyone dosed can get a second dose... but with rolling production such a large holdback isn't necessary. > What could matter is if delay increases the speed at which you can ramp up. All the jurisdictions I know will blow through the entire supply of existing doses allocated to them very quickly. It doesn't go on a slow distribution ramp gated by approval like your ridiculous source suggests. What governs the ramp is production rates, which have been running flat-out irrespective of this decision.
      - xyzzyz 6y ago
        > All the jurisdictions I know will blow through the entire supply of existing doses allocated to them very quickly. It doesn't go on a slow distribution ramp gated by approval like your ridiculous source suggests. You misunderstand. "Blowing through entire supply" and being left with nothing is exactly the "slow distribution" Alex Tabarrok, a professor at GMU, talks about in the link I gave. He contrasts it with vaccinating entire population on day 1. Read it carefully. > What governs the ramp is production rates, which have been running flat-out irrespective of this decision. I consider the vaccine production regulation people to be just as incapable at cost-benefit analysis as vaccine approval people, so I assume that most production constraints are just as artificial as the approval constraints.

refurb 6y ago

"They should have put in an army of analyzers into it." You can't make a baby in 1 month with 9 women.

claudeganon 6y ago

> They should have put in an army of analyzers into it I expect that Brook’s law from The Mythical Man Month also applies to these kinds of statistical analysis.

breck 6y ago

> There are about 3,000 people dying every day.... it is like 9/11 every day, or 9 jumbo jets falling This is wrong. Median expected remaining healthy lifespan of a 9/11 deceased was ~35 years, whereas for a COVID decease it's ~3.5 years. So 9/11 is still 10x worse. Don't get me wrong, COVID is still terrible, but it is not a "9/11 every day".

pixl97 6y ago
That depends... did covid last over 10 days? Ok, math is off, but covid is going to last for at least 2 more months with death rates like this and that accrues. Also, do you know what they call it when I kill your grandmother 2 days before she was supposed to die of old age? Murder. Just because someone doesn't have much life left makes it no less of a tragedy when they die early.
- amscanne 6y ago
  > Just because someone doesn't have much life left makes it no less of a tragedy when they die early. At the risk of being cold hearted, isn’t this exactly what it does?
- remote_phone 6y ago
  In fact, if someone is falling off a building and you shoot them dead midair, that’s also murder.
rrss 6y ago
> it's ~3.5 years https://www.pnas.org/content/117/36/22035 https://www.pnas.org/content/117/36/22035 > We calculate, using these same cohort life tables, that the average person dying of COVID-19 had 11.7 y of remaining life expectancy
- IncRnd 6y ago
  That is taken out of context. The prior sentence pointed out, "we calculate that the 2020 American population of 330 million people has on average..." The calculation you reference was done using all people in the US. Just two sentences later they wrote, "... would on average lose about 0.2 y of remaining life ..." You need to compare to the groups of affected people, which is generally not 100% of people in the US.

creddit 6y ago

"extensive data" is 44K patients!? Wait until I tell you about the extremely extensive data that tech companies at scale deal with every day. I run a large data science organization at a major tech company. If someone told me that it was going to take 3wks to analyze an experiment of this type, I would probably have to start firing people.

6gvONxR4sf7o 6y ago
If someone wanted to take three weeks to analyze an experiment with these kinds of stakes, you’d fire them?! I have to assume you’re being hyperbolic. And are you suggesting that it’s easier because the data isn’t as extensive as what the rest of us deal with? That only makes it harder. Sure if it’s some random A/B test with data from your own systems from an experiment you designed, but this is a vaccine the whole fucking world has been waiting for for most of the year. God forbid people treat it a little more carefully.
- creddit 6y ago
  > If someone wanted to take three weeks to analyze an experiment with these kinds of stakes, you’d fire them?! I would absolutely need to start a performance improvement process. They are definitionally 1/3 as productive as they should be. Also in terms of stakes, please show me even a modicum of work that suggests the downside risk of approval is greater than the delayed vaccinations. What reason have I to believe there is great risk in approval? Again, the UK approved this over a week ago. > And are you suggesting that it’s easier because the data isn’t as extensive as what the rest of us deal with? That only makes it harder. No, I'm mocking the idea of it being extensive data. It's not. > but this is a vaccine the whole fucking world has been waiting for for most of the year. And that's reason to go slower!? There's no need for this delay!!! https://thedispatch.com/p/fda-career-staff-are-delaying-the https://thedispatch.com/p/fda-career-staff-are-delaying-the
  - 6gvONxR4sf7o 6y ago
    > Also in terms of stakes, please show me even a modicum of work that suggests the downside risk of approval is greater than the delayed vaccinations. What reason have I to believe there is great risk in approval? As I understand it, medical ethics isn’t about utilitarianism, or else we’d skip the rats and monkeys and just go straight to testing on the poor for money. They don’t seem to prioritize minimizing the opportunity cost of avoiding bad outcomes. Their guiding principle seems to be avoiding giving harmful treatment. Meanwhile some healthcare workers at my partner’s facility are skeptical about whether the vaccine was rushed (I think they’re crazy, for the record). But there’s real risk if enough of the public doesn’t trust the vaccine. I’d bet that kind of angle is part of why they focus on “do no harm” instead of “minimize cumulative regret.”

krimpenrik 6y ago

What a weird comparison, every day, 800 children die caus of dirty water. https://www.worldvision.com.au/global-water-crisis-facts#:~:text=Globally%2C%20785%20million%20people%20lack,many%20communities%20around%20the%20world https://www.worldvision.com.au/global-water-crisis-facts#:~:.... No one gives a shit.