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Related: Editorials & Other Articles, Issue Forums, Alliance Forums, Region ForumsInfectious Disease Expert: FDA Has 'All But Given Up' Oversight On Antibody Testing
The Food and Drug Administration has all but given up its oversight responsibility on coronavirus antibody tests, one the countrys top infectious disease experts said Sunday.
We have the wild, wild West for testing right now, Dr. Michael Osterholm, the director of the Center for Infectious Disease Research and Policy at the University of Minnesota, told NBCs Meet The Press.
The FDA has all but given up its oversight responsibility for the tests we have on the market, he added. Many of them are nothing short of a disaster.
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Newest Reality
(12,712 posts)Let's run this country like a business and do the budget like a family would at home. That's what has been missing.
Wild West? Isn't that a fun thing? Shoot 'em out at the OK Corral? There are more important things than living.
Disasters are good. Really. Disaster capitalism will just switch into high gear and, you know, PROFIT! YAY! There is much money to be made. Count on it.
Vulture capitalism rides along side of it to pick the bones clean before they they are ground down into a salable powder. Then, the rubble gets value and is sold, too. Then you go back to the beginning and start all over in several million years. It's a great plan. Invest now.
Takket
(21,425 posts)this administration's incompetence has been nothing less than criminal.
Igel
(35,197 posts)CDC test didn't work.
FDA was slow in approving, even granting just emergency approval took forever. Tests were ready, but held up because of lack of data.
In fact, they finally granted emergency approve, even without independent data. That could take a month or two to produce. It was bad for them to treat this as business as usual.
But that would also mean less oversight. It's a trade off.
CDC didn't authorize other labs to do testing because it was concerned maybe it would go wrong. That meant the limited number of CDC labs were the *only* places to get test kits processed. A couple thousand per day. For the country.
I like a bit more time taken for diagnostic tests. But as it became clear that the diagnosis wasn't medically important, I stopped caring. Antibody tests aren't diagnostic.
That some kits are being falsely labeled is a problem and they should be shut down. Some kits probably are a mess. Some aren't. I'm assuming that data collection's proceeding a pace.
The FDA's thinking is about 1/2 of the way down at
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-serological-test-validation-and-education-efforts
Speed and completeness are enemies.
Medical folk will be interested in accuracy. So with academics. If it takes two months of total shutdown to produce something that saves lives--their highest ranked priority--so be it. Others can have other priorities, and democracy isn't serial autocracy as different groups take absolute power for 3 days.
stillcool
(32,626 posts)is no more. Ossifying before our eyes.