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To: E. Pluribus Unum

Neither FDA nor CDC can withhold treatment with licensed drugs.


20 posted on 08/08/2021 12:10:20 PM PDT by Jim Noble (The nation cannot be saved until the GOP is destroyed)
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To: Jim Noble
Neither FDA nor CDC can withhold treatment with licensed drugs.

https://www.fda.gov/media/138946/download

Q. Why was the Emergency Use Authorization (EUA) for hydroxychloroquine sulfate (HCQ) and
chloroquine phosphate (CQ) revoked?
A. FDA has a responsibility to regularly review the appropriateness of an Emergency Use Authorization
(EUA), including review of emerging scientific data associated with the emergency use of an authorized
product. Based on FDA’s continued review of the scientific evidence available for hydroxychloroquine
sulfate (HCQ) and chloroquine phosphate (CQ) to treat COVID-19, FDA has determined that the
statutory criteria for EUA as outlined in Section 564(c)(2) of the Food, Drug, and Cosmetic Act are no
longer met. Specifically, FDA has determined that CQ and HCQ are unlikely to be effective in treating
COVID-19 for the authorized uses in the EUA. Additionally, in light of ongoing serious cardiac adverse
events and other serious side effects, the known and potential benefits of CQ and HCQ no longer
outweigh the known and potential risks for the authorized use. This conclusion warrants revocation of
the EUA for HCQ and CQ for the treatment of COVID-19.
FDA’s review of the available scientific evidence determined:
• The suggested dosing regimens for CQ and HCQ as detailed in the Fact Sheets are unlikely to
produce an antiviral effect.
• Earlier reports of decreased viral shedding with HCQ or CQ treatment have not been
consistently replicated and recent data from a randomized controlled trial assessing probability
of negative conversion showed no difference between HCQ and standard of care alone.
• Current U.S. treatment guidelines do not recommend the use of HCQ or CQ in hospitalized
patients with COVID-19 outside of a clinical trial, and the NIH guidelines now recommend
against such use outside of a clinical trial.
• Recent data from a large randomized controlled trial showed no evidence of benefit of HCQ
treatment in hospitalized patients with COVID-19 for mortality or other outcomes such as
hospital length of stay or need for mechanical ventilation.
The decision to revoke this EUA was made in consultation with the Biomedical Advanced Research and
Development Authority (BARDA) at the U.S. Department of Health and Human Services. BARDA had
originally requested the EUA covering CQ and HCQ. FDA and BARDA are part of a USG-interagency
effort to rapidly respond to this public health emergency and have been communicating as new
scientific data emerged.
For more information, please see the Letter of Revocation. 

22 posted on 08/08/2021 12:22:40 PM PDT by E. Pluribus Unum ("Communism is not love. Communism is a hammer which we use to crush the enemy." ― Mao Zedong)
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To: Jim Noble

“Neither FDA nor CDC can withhold treatment with licensed drugs.”

They don’t need to, the tort system takes care of that. All that’s needed is for a doctor to prescribe Ivermectin to a Covid patient, the patient die anyway, and the doctor (and his medical group) are sued big-time. Now if the FDA said that Ivermectin is ‘approved’ for treating Covid, then the doctor (and medical group) simply say the same and they win...but if the FDA says it’s unapproved, then the doctor is on his own to prove he treated the patient correctly - good luck on that. So, do what the FDA/Fauchi say or risk losing everything...so guess what - they do EXACTLY what the FDA/Fauchi says to do.

Like it or not, it all comes down to Fauchi/CDC - if they’re wrong, big deal, they can’t be sued. If half a million people die because they’re wrong, big deal, they can’t be sued. Sadly, that’s what our medical community has become, a bunch of followers, again, thanks to our tort system and the fact that the ONLY people who can operate with impunity are those in official government positions. It’s true here, and has been true in many other areas of medicine/nutrition...and it’s likely to never change.


27 posted on 08/08/2021 1:42:35 PM PDT by BobL (I shop at Walmart and eat at McDonald's, I just don't tell anyone, like most here.)
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