I doubt the FDA's decision had anything to do with the Gates connection, but most study rejections don't get articles in the NYT. His backing is why it's "news," he spend/gives millions to the press to ensure it.
I doubt the FDA's decision had anything to do with the Gates connection, but most study rejections don't get articles in the NYT. His backing is why it's "news," he spend/gives millions to the press to ensure it.
No, it's news because the FDA is haulting COVID testing over utterly stupid bureaucracy when we need massively ramped up COVID testing and SCAN/Seattle Flu Study are actually providing quality home tests at scale.
This stands in stark contrast to the hundreds of poor quality home antibody tests the FDA has approved with almost no oversight. It seems inconsistent with the need to cut red tape to fight COVID.
https://marginalrevolution.com/marginalrevolution/2020/03/em...
“By Feb. 25, Dr. Chu and her colleagues could not bear to wait any longer. They began performing coronavirus tests, without government approval.
What came back confirmed their worst fear. They quickly had a positive test from a local teenager with no recent travel history. The coronavirus had already established itself on American soil without anybody realizing it.”
Combined with symptoms taking about a week to present, this was in community spread for a while. Yet, here in WA, the deaths figure is still 92% over sixty years old. I don't know the percent from long term care facilities. (I would love that stat.)
Then the question is at what point did it break into long term care facilities? And could we have done something to strengthen their protection?
With a further question of what, exactly, causes it to go severe.
It's not utterly stupid, diagnostic testing adds some amount of bias in the results. The quality of these home tests needs to be proven.
How does it add bias? Also, this is not the FDA's stated concern.
> The quality of these home tests needs to be proven.
They have been. That data has been submitted to the FDA a month ago.
Source https://www.king5.com/mobile/article/news/health/coronavirus...
Both sides would have notably different biases that would need to be accounted for, and would have different guidelines for FDA approval. Pausing the project when you discover there was a miscommunication over what kind of testing was being done makes sense. You need to keep the potentially tricky data separate from further results.
>Regardless, it has nothing to do with the TFA and the FDA's actions.
It's the actual reason they gave for their actions, and their request for more information on tests done to people not showing symptoms would be one of the main things they need to determine what bias is present.
Edit: to say "halted".
I don't really see the point of most of the stories about various ongoing tests. Until something is shown to be effective, what benefit do we get from learning all these details?