21st Century CURES Act by FDA: section 3022 outlines framework for FDA to consider NOT only randomized controlled trials (RCTs) but real world evidence e.g. observational studies! why don't THEY??
Why did the FDA demand only RCTs) and this precluded good HCQ and IVM & other key tools for COVID responding, when they had a duty and actual ACTs saying use RWE & observational studies?
RWE: REAL WORLD EVIDENCE
SOURCE:
https://www.hhs.gov/sites/default/files/Gruber_16x9_Comments%20from%20FDA_Remediated.pdf
SOURCE:
https://www.congress.gov/114/plaws/publ255/PLAW-114publ255.pdf
See Lee Mueller’s substack, great scholarship on this, hence I add:
I am proud to announce my affiliation with The Wellness Company. My dear and esteemed colleagues Dr. Peter McCullough and Dr. Harvey Risch as well as Dr. Richard Amerling and Dr. Heather Gessling are also with The Wellness Company which provides telemedicine services for long-haul COVID, vaccine injury, and medical exemptions along with great all natural supplements and products that are fully aligned with our values. We are talking about scientifically researched supplements designed by leading physicians like Dr Peter McCullough. This support for The Wellness Company stems from the sub-optimal medical care and response that we experienced throughout the pandemic. It became apparent that there are many glaring gaps in our healthcare system and people were not properly treated. Thus, the pivot by us to support The Wellness Company. Take a stand against a broken healthcare delivery system and purchase a membership with the The Wellness Company, which directly funds our fight against medical tyranny. Click here The Wellness Company for more information.Â
Congress needs to do their part to fix this legislation and prevent it from ever occurring again.
The shots were/are experimental; therefore, risk is unknown. Minimal risk could not have been known, and people were NOT given informed consent with the omnipresent script of "safe and effective" reiterated over and over everywhere we went.
Congress needs to fix the laws, protect our freedoms, and hold those that pushed the "safe and effective" narrative accountable.
https://leemuller.substack.com/p/the-elephant-in-the-room-hr34-21st
https://leemuller.substack.com/p/focus-on-forward-the-righting-the
https://leemuller.substack.com/p/the-proposed-cures-20-act-2021-2022
Dr. Alexander, we are going to have to fight a physical war to extricate all of the calls to reason you properly make. At the moment, we are dominated by people who despise reason, and natural law. They are monsters, and have neatly tipped large swaths of the lower tail of the Normal Curve in their favor. At the expense of our blood, health, wealth and sanity.
Give us two weeks to remove the vermin vector, then a return to logic. They MUST fear us.