3 ms·
Remember when the CDC was considered the world’s absolutely top infectious disease center? Remember when they couldn’t even ship COVID test kits with uncontamin
by zaroth 6y ago
Remember when the CDC was considered the world’s absolutely top infectious disease center? Remember when they couldn’t even ship COVID test kits with uncontaminated distilled water?
Remember when the FDA wouldn’t let public or private labs run their own COVID tests and everything was being shipped to CDC headquarters to PCR?
The CDC and the FDA essentially guaranteed through extraordinary ineptitude that the US would not fend off COVID back in January/February. They deserve zero benefit of the doubt.
The FDA’s 70 years of process likely worked against them here. What I can say for certain is that there was a t-minus one, the day before the results were unblinded, and there was a t-zero, the day results were unblinded. On that day t-zero they uncovered which of the patient IDs got the vaccine versus which got placebo.
No expense should have been spared in preloading the analysis, verification, whatever could have been done, it should have been done up until t-minus-1. On day t-zero you get 15,000 patient IDs in column A and 15,000 in column B, that’s the only new thing you learn that day. There should be nothing new to talk about or discuss, the approval criteria should already be set in stone. Check the IDs and launch.
- loopz 6y agoDon't forget who is the Chief in command responsible for this outcome.
- brian_cloutier 6y agoI'm sorry you're being downvoted. The testing disaster killed far more than this vaccine approval delay has killed and it's infuriating that nobody seems to care. They shut down testing back when we needed it most, allowing us to pretend there was no spread in the US for far too long: https://www.statnews.com/2020/05/27/coronavirus-testing-seattle-bill-gates-fda/ https://www.statnews.com/2020/05/27/coronavirus-testing-seat... They spent far too long before approving any kind of at-home testing and to this day have not approved most rapid testing. Three weeks ago the EUA was submitted, so three weeks ago there was an entire team of people at pfizer who had reviewed all the data and were confident FDA would approve the application, but somehow nobody at FDA was part of that set of people. In any reasonable process that application would have contained no new information, if it contained any new information they were not communicating closely enough. I understand spending a few days doing some final checks on the data before approving. Three weeks, however, is suspiciously long. It's possible they were in fact doing important work which could not possibly have been done before the application was submitted, but nobody seems able to articulate what that important work actually was.
- refurb 6y agoA shitty test with 60% accuracy can make things worse than they already are.. People are making decisions based on results that are right barely half the time. I don’t blame the FDA for saying “no”. I love HN who is normally vehemently anti-business (with good reason) suddenly flips and says “well Pfizer said the vaccine was ok, isn’t that good enough?” No. It’s not good enough. The reason we spend billions per year on the FDA is because we want an independent, critical and evidence based body making decisions on drugs given to hundreds of millions of Americans. I mean, hell, Trump was bullying the FDA (which was stupid) and HN seems to be arguing for that exact thing.
- brian_cloutier 6y agoThere probably exist universes where a shitty test would make things worse. How are you so sure we're in that universe? And how are you so sure that the unapproved tests are so shitty that you're not at all curious whether the FDA made the right choice? Nowhere in my comment did I say the FDA should just take Pfizer's word for anything. I'm also not sure why you're trying to use Trump's actions as evidence here. "Trump did a thing and therefore doing that thing was the correct action" is an argument which requires some justification.