I will reiterate it was definitely not the CDC or FDA doing this, it came from higher up. No idea HOW high but it was above the CDC, I am not comfortable saying anymore than that. The only reason I can think of for doing this is they wanted to keep the numbers low in hopes that it would fizzle out. An idea which dovetails with what Trump has been saying about it being "no big deal".
After this became a big story, the FDA has since allowed other sources for Coronavirus testing. I have no idea if the administration caved to the pressure or if someone else made a different decision but this change is very good. I know both Quest and LabCorp are now in the process of developing/deploying their own test kits. Once they get online, then we should have much more realistic numbers because these companies have the capacity to perform hundreds of millions of tests a month if the reagents and need are there.
I have limited interaction with the CDC but in my limited interaction they have been VERY intelligent and try to be proactive. That being said, they are notably underfunded and as a result overworked. I remember hearing issues about sample storage at some CDC labs a while back. That kinda of failure is symptomatic of either 1)a lax safety culture or 2) people so overworked and exhausted that they are making mistakes. Considering the few people I know at the CDC are hardcore about safety (any safety failure could mean their death) and are notably overworked, then I would view it as the latter.
As for the FDA, since I work in an FDA regulated industry, I have loads of experience with them. I truly have nothing but the utmost respect for the FDA; every single company in the industry fears them and that's how it should be. They are frustrating at times and scary at others, but much like OSHA almost every rule they make was first "written in blood". They are the sole reason that we did not experience the tragedy of thalidomide babies that Europe experienced. Their model of evidence-driven risk-based decision making was a breakthrough in medical/pharmaceutical safety and efficacy; this is a model the rest of the world has followed. Personal anecdote: I had the fun of being in front of an auditor for multiple days at a surprise audit a few months ago and I don't think I have ever been more stressed in my life. They are experts at picking at little threads and seeing what they can unravel; it is truly remarkable how good they are at it. I had to defend almost every single decision I made in my investigations. He questioned not only my scientific decisions but my assignments of risk, the data I used to make my decisions, the systematic framework through which the decisions were approved, etc. This was all to ensure that we had the systems and people in place to properly ensure patient safety. Say what you will about the government but the FDA is a remarkable department and one that we are VERY lucky to have. If anything, I would like to see them take a MORE aggressive regulatory role. Soapbox: Now if they would just add supplements to their domain so that they can close that loophole.
Edit:
Just a quick update for those that don't think this is serious. These are the stats from 07MAR2020 for the nursing home which is the epicenter of the outbreak up here in Kirkland:
On 2/19 the center had 120 patients, they now have 63. Since 2/19, 26 have died (far above the normal rate for the facility of 3-7/month). Of the deaths, 13 of the 15 who died in hospitals tested positive for COVID-19. They do not have COVID-19 status information on the 11 who died at the nursing home. 6 of the remaining 63 residents and 70 staff were showing symptoms of COVID-19. They received some test kits for testing patients. As per the update yesterday (09MAR2020) the current testing results are:
- 31 positive
- 1 negative
- 3 indeterminate
- 20 tests still pending
Keep in mind, these results are for the patients only (because they were the most at risk) and do not include the previous confirmed cases/deaths at local hospitals. It also doesn't include the staff,
which means the number will rise dramatically when they test the staff (since 70 staff were showing symptoms).
EDIT2: Just saw that they have added three more COVID-19 deaths related to the facility and the facility has less the 60 patients at this point.
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Originally Posted by UKHistory
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