A nurse from Texas brought to my attention the FDA’s Emergency Use Authorization page. Here you’ll find pages and pages of letters written by the agency giving companies permission to sell and/or use PCR tests to diagnosis COVID-19 — even though the FDA admits the tests are unproven, limited, have known risks and don’t meet quality assurance standards.
One such letter, to Connecticut’s Wren Laboratories LLC, states:
“…it is reasonable to believe that your product may be effective in diagnosing COVID-19, and that the known and potential benefits of your product when used for diagnosing COVID-19, outweigh the known and potential risks of your product.”
In other words, the PCR test may not work and has “known” risks, but we “believe” it “may” provide some benefit… so you’re approved!
The letter justifies such reckless approval because the USA is apparently in a “public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad…”
Being such an emergency, the letter also waives “good manufacturing practice requirements, including the quality system requirements…” In other words, you can make shoddy testing kits and we’ll look the other way.
Furthermore, the letter admits that there “is no adequate, approved, and available alternative…” . Hmmm… would not that mean that the PCR test is inadequate and unapproved?
In Corona, False Alarm?, Drs. Karina Reiss PhD and Sucharit Bakdi MD came to the same conclusion:
“Diagnostic PCR tests must normally undergo stringent quality assessment and be approved by regulatory agencies before use. This is important because no laboratory test can ever give 100% correct results. The quality control requirements were essentially shelved in the case of SAR-CoV-2, because of declared international urgency. Consequently, nothing was really known regarding test reliability, specificity and sensitivity.”
It sure looks like we don’t have a viral pandemic; we have a PCR pandemic of false tests detecting who-knows-what.
About the Author: John C. A. Manley is the author of the full-length novel, Much Ado About Corona: Dystopian Love Story. He is currently working on the sequel, Brave New Normal, while living in Stratford Ontario, with his wife Nicole and son Jonah. You can 