Origin of safe and effective and we can’t figure it out

https://bailiwicknews.substack.com/p/exemptions-for-biologics-all-vaccines

2) we [manufacturers and regulators] can’t do controlled studies because biologics can’t be standardized and we can’t figure out which parts of biological materials are the “active components” or the ones having the effect, or if any effect is caused. And we can’t figure out how to account for the wide variability in response in humans from person to person, and from time to time within the same person. We can’t figure out dosing. We can’t figure out clinical endpoints. We don’t really know anything about biologics, what’s in them, or what they do. But we think that partially-controlled, uncontrolled studies, with case reports, with post-marketing (aka “real world”) reports and with “pertinent medical and scientific literature” (aka Enders and other scientific misconduct papers) are good enough to keep making and using biologics.