4 ms·

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 wee

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.
dcolkitt 6y ago
The application was submitted on November 22 and the review meeting was not scheduled until December 10. The UK, not exactly a country known for taking reckless medical risks, approved the Pfizer vaccine eight days earlier than the US despite receiving the application at the same time. While nearly ten thousand Americans died, I guess the FDA was “catching up on its sleep”. Eight long days of glorious sleep!

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.

dcolkitt 6y ago

The application was submitted on November 22 and the review meeting was not scheduled until December 10. The UK, not exactly a country known for taking reckless medical risks, approved the Pfizer vaccine eight days earlier than the US despite receiving the application at the same time. While nearly ten thousand Americans died, I guess the FDA was “catching up on its sleep”. Eight long days of glorious sleep!