6 ms·

Propose to the companies to conduct a trial to test your hypothesis on the effectiveness of a single dose? Until then the FDA policy is clearly data based and t

by s0rce 6y ago

Propose to the companies to conduct a trial to test your hypothesis on the effectiveness of a single dose? Until then the FDA policy is clearly data based and they are saying to follow the tested dose schedule from the clinical trial and not to deviate.

dcolkitt 6y ago
Hypothetical question. Imagine if for some reason everyone in the trial received the vaccine on a rainy day (maybe it occured in Seattle during a bad patch of weather). The vaccine shows immunity, but we can only be sure for a population that got it on a rainy day. Now we're distributing the vaccine, but the bottleneck is that we have to keep waiting for rainy days. It's especially bad in Arizona and Nevada. Is your contention that we keep the rainy day requirement? Even when all are scientific and empirical priors tell us that the effect is de minims. The example is kind of silly, but it makes my point. There's literally countless number of factors that go into any trial. There's no possible way that the way treatment is deployed in the field will exactly match the way it was tested. Yet doctors, scientists and public health experts use judgement and empirical priors to determine when and where we can relax the requirements.
- s0rce 6y ago
  I think the analogy to your example is to have conducted a larger trial where the dose was given under different weather conditions, or in the case of the real vaccine vary the timing of the 2nd dose. I agree, if experts agree the likelihood that 1 dose is effective and the likelihood of it being ineffective is low, we should do what will save the most lives. This is an emergency.
  - hcknwscommenter 6y ago
    " if experts agree the likelihood that 1 dose is effective and the likelihood of it being ineffective is low" Experts do not agree.
- abduhl 6y ago
  > Yet doctors, scientists and public health experts use judgement and empirical priors to determine when and where we can relax the requirements. They certainly do. And the FDA, a collection of the leading doctors, scientists, and public health experts, just told you that two doses is the regimen. Is there something that you know that these experts don't?
  - dcolkitt 6y ago
    Considering that the FDA let thousands of Americans needlessly die because they delayed the approval hearing to enjoy a relaxing Thanksgiving weekend... Yes, I don’t trust their judgement. As for more general critiques, there’s mountains of evidence that the FDA is too risk averse, even before Covid. https://www.hoover.org/research/fdas-risky-risk-aversion https://www.hoover.org/research/fdas-risky-risk-aversion
    - jschwartzi 6y ago
      Setting aside my deep visceral reaction to what you're suggesting, how is it safe or productive to conduct a review on a Friday evening at the end of a long week and not sleep or eat until it is done? Do you have any reason to believe they would make more or fewer mistakes doing so? And what's your personal policy on making really important decisions while sleep deprived? Would you, for example, get some sleep before signing a contract on a house?
      - 1stcity3rdcoast 6y ago
        If anyone only ever made decisions while they were perfectly fed and rested, this would be a sad, slow, boring world, because nothing would ever get done or decided. There is such a thing as urgency, and people do work beyond a 35 hour work week with evenly spaced meals, and especially during a global pandemic. Specific to this instance, this FDA meeting was a formality -- they had already had the data for two weeks to review. The efficacy was well-known. They chose to take a 4-day holiday (Thursday, Friday, Saturday, Sunday). People don't all of a sudden sign house contracts. They've germinated the idea, spent weeks or months working through the pros and cons, talking to their life partners and family and agent and mortgage broker. The decision is made well in advance of the actual contract signing, and all the red lines are done before you get to the actual meeting to sign on the line. Similarly with the FDA regulators, they weren't meeting to review the data for the first time and come up with a decision on the spot. This was one final step in a very long process.
deleted 6y ago
[deleted]

by s0rce 6y ago

dcolkitt 6y ago

Hypothetical question. Imagine if for some reason everyone in the trial received the vaccine on a rainy day (maybe it occured in Seattle during a bad patch of weather). The vaccine shows immunity, but we can only be sure for a population that got it on a rainy day. Now we're distributing the vaccine, but the bottleneck is that we have to keep waiting for rainy days. It's especially bad in Arizona and Nevada. Is your contention that we keep the rainy day requirement? Even when all are scientific and empirical priors tell us that the effect is de minims. The example is kind of silly, but it makes my point. There's literally countless number of factors that go into any trial. There's no possible way that the way treatment is deployed in the field will exactly match the way it was tested. Yet doctors, scientists and public health experts use judgement and empirical priors to determine when and where we can relax the requirements.

s0rce 6y ago
I think the analogy to your example is to have conducted a larger trial where the dose was given under different weather conditions, or in the case of the real vaccine vary the timing of the 2nd dose. I agree, if experts agree the likelihood that 1 dose is effective and the likelihood of it being ineffective is low, we should do what will save the most lives. This is an emergency.
- hcknwscommenter 6y ago
  " if experts agree the likelihood that 1 dose is effective and the likelihood of it being ineffective is low" Experts do not agree.
abduhl 6y ago
> Yet doctors, scientists and public health experts use judgement and empirical priors to determine when and where we can relax the requirements. They certainly do. And the FDA, a collection of the leading doctors, scientists, and public health experts, just told you that two doses is the regimen. Is there something that you know that these experts don't?
- dcolkitt 6y ago
  Considering that the FDA let thousands of Americans needlessly die because they delayed the approval hearing to enjoy a relaxing Thanksgiving weekend... Yes, I don’t trust their judgement. As for more general critiques, there’s mountains of evidence that the FDA is too risk averse, even before Covid. https://www.hoover.org/research/fdas-risky-risk-aversion https://www.hoover.org/research/fdas-risky-risk-aversion
  - jschwartzi 6y ago
    Setting aside my deep visceral reaction to what you're suggesting, how is it safe or productive to conduct a review on a Friday evening at the end of a long week and not sleep or eat until it is done? Do you have any reason to believe they would make more or fewer mistakes doing so? And what's your personal policy on making really important decisions while sleep deprived? Would you, for example, get some sleep before signing a contract on a house?
    - 1stcity3rdcoast 6y ago
      If anyone only ever made decisions while they were perfectly fed and rested, this would be a sad, slow, boring world, because nothing would ever get done or decided. There is such a thing as urgency, and people do work beyond a 35 hour work week with evenly spaced meals, and especially during a global pandemic. Specific to this instance, this FDA meeting was a formality -- they had already had the data for two weeks to review. The efficacy was well-known. They chose to take a 4-day holiday (Thursday, Friday, Saturday, Sunday). People don't all of a sudden sign house contracts. They've germinated the idea, spent weeks or months working through the pros and cons, talking to their life partners and family and agent and mortgage broker. The decision is made well in advance of the actual contract signing, and all the red lines are done before you get to the actual meeting to sign on the line. Similarly with the FDA regulators, they weren't meeting to review the data for the first time and come up with a decision on the spot. This was one final step in a very long process.

deleted 6y ago

[deleted]