"“A bunch of laboratories, universities, and health care groups came up with COVID tests before the virus was even in the US, and were 100% ready to deploy them. But when the US declared that the coronavirus was a “public health emergency”, the FDA announced that the emergency was so grave that they were banning all coronavirus testing, so that nobody could take advantage of the emergency to peddle shoddy tests. Perhaps you might feel like this is exactly the opposite of what you should do during an emergency? This is a sure sign that you will never work for the FDA.
The FDA supposedly had some plan in place to get non-shoddy coronavirus tests. For a while, this plan was “send your samples to the CDC in Atlanta, we’ll allow it if and only if they do it directly in their headquarters”. But the CDC headquarters wasn’t set up for large-scale testing, and the turnaround time to send samples to Atlanta meant that people had days to go around spreading the virus before results got back. After this proved inadequate, the FDA allowed various other things. They told labs that they would offer emergency approval for their kits - but placed such onerous requirements on getting the approval that almost no labs could achieve it (for example, you needed to prove you’d tested it against many different coronavirus samples, but it was so early in the pandemic that most people didn’t have access to that many). Then they approved a CDC kit which that the CDC could send to places other than their headquarters, but this kit contained a defective component and returned “positive” every time. The defective component was easy to replace, but if you used your own copy like a cowboy then the test wouldn’t be FDA-approved anymore and you could lose your license for administering it.
A group called the Association of Public Health Laboratories literally begged the FDA to be allowed to deploy the COVID tests they had sitting on the shelf ready for use. The head of the APHL went to the head of the FDA and begged him, in what they described as “an extraordinary and rare request”, to be allowed to test for the coronavirus. The FDA head just wrote back saying that “false diagnostic test results can lead to significant adverse public health consequences”.
So everyone sat on their defective FDA-approved coronavirus tests, and their excellent high-quality non-FDA approved coronavirus tests that they were banned from using, and didn’t test anyone for coronavirus.”
https://astralcodexten.substack.com/p/adumbrations-of-aducanumab
The FDA supposedly had some plan in place to get non-shoddy coronavirus tests. For a while, this plan was “send your samples to the CDC in Atlanta, we’ll allow it if and only if they do it directly in their headquarters”. But the CDC headquarters wasn’t set up for large-scale testing, and the turnaround time to send samples to Atlanta meant that people had days to go around spreading the virus before results got back. After this proved inadequate, the FDA allowed various other things. They told labs that they would offer emergency approval for their kits - but placed such onerous requirements on getting the approval that almost no labs could achieve it (for example, you needed to prove you’d tested it against many different coronavirus samples, but it was so early in the pandemic that most people didn’t have access to that many). Then they approved a CDC kit which that the CDC could send to places other than their headquarters, but this kit contained a defective component and returned “positive” every time. The defective component was easy to replace, but if you used your own copy like a cowboy then the test wouldn’t be FDA-approved anymore and you could lose your license for administering it.
A group called the Association of Public Health Laboratories literally begged the FDA to be allowed to deploy the COVID tests they had sitting on the shelf ready for use. The head of the APHL went to the head of the FDA and begged him, in what they described as “an extraordinary and rare request”, to be allowed to test for the coronavirus. The FDA head just wrote back saying that “false diagnostic test results can lead to significant adverse public health consequences”.
So everyone sat on their defective FDA-approved coronavirus tests, and their excellent high-quality non-FDA approved coronavirus tests that they were banned from using, and didn’t test anyone for coronavirus.”
https://astralcodexten.substack.com/p/adumbrations-of-aducanumab