A quick hypo: assume a glass vial manufacturer has a production issue and a charge of 10.000 of its vials is contaminated. The vial is used for vaccines. The contamination leads to an increased frequency of heart attacks. How does the regulator find out?
Another hypo: assume one of the chemicals used in producing a vaccine is not up to the normal standard of the company. Despite using the adequate standard of diligence they do not detect it, because it wasn't detectable. How does the regulator find out?
The answer is: the regulator gets tons and tons of data on problems. From "I felt like I had to drink alcohol after taking the drug, which is why I had to drive drunk" (well, dubious) to "I could not sleep" to "X died, no idea why".
The regulator now has to filter the raw data. What is relevant? Is there a pattern? To get at problems that range from "no problem" to "a bad charge" to "people in centre X have a doctor who is bad at injecting" to "the vaccine is bad".
THAT'S A TOUGH JOB.
THAT'S A TOUGH JOB.
Now I won't pretend I know how that works. I took the time to read up on the database and the reporting system. But that's it.
What worries me is to find how many pseudo-experts have not even done that.
What worries me is to find how many pseudo-experts have not even done that.
"I found in the data of event reporting that in the last months there were X occurrences of" Yeah. Irrelevant. You don't even claim to know what pattern was spotted. You can read numbers. You don't understand them.
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