Posted on 08/08/2021 10:23:24 AM PDT by E. Pluribus Unum
No respect for you liberal trolls!!! = You don’t agree with me, so I will call you a liberal troll!!!
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.
No licensed drug (hydroxychloroquine, for example, licensed since 1955) requires EUA for any purpose.
Any licensed physician can prescribe any licensed drug for any purpose, and it has nothing to do with the FDA.
We had hydroxychloroquine + azithromycin on our standard COVID orders from March 2020 until July 2020 as preferred, and as an option until August 2020. We treated >150 COVID patients with those (licensed) drugs, and not only did we not hear from the FDA, it would have been shocking had that happened.
The issuance of an EUA for HCQ by FDA was surprising, precisely because it was meaningless.
It was for the purpose of discouraging its use when the EUA was revoked.
“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.
There use to be a Saturday show bout a horse named "Fury." You must be the rear end of that equine!
Ahhhhh. So we see the group think talking points today. I have been vaccinated so therefore I have lost my mind.
Bull crap. You sre throwing yourself in with the naturopathic quack who likes to hang out with puppies and good souls and whose institute states you have to love and heal yourself first then you can help others by eating mud and engaging nature
Why don’t you go listen to some souls music with Dr Ealy and enjoy his altered perspective.
Nice try. But miserable fail.
"The sky is falling, the sky is falling...."
YOU not ME got into the "jab" line right away.....on the say so of that congenital liar Fouchi (masks don't work....no, no masks work, no, no it's double masks that we need) and to Rand Paul, he says, "I did not promote gain of function experiments."
dr_gas your liberal gas is smelln' up the place!!!
how does one withhold vitamins from people?
starting Feb 2020, at Trump’s insistence, drug trials flew into gear - testing everything you mentioned and more. Ivermectin trials were begun somewhere around June, by a Dr. Caly, and some 60 trials were continuing through Dec 2020.
Are people now crying that they waited for testing? But how does that mesh with the same people stomping their feet that the vaccine wasn’t tested enough?
Seems a Panda red herring argument to me - one not backed by reality
You seem to be confabulating. I make no secret that I chose to be vaccinated early on. As a front line physician, all of my colleagues did the same. Even the FLCCC states very clearly that vaccines are important.
Your perverse use of the “jab” language marks you as the one who has to repeat talking points and cannot formulate an original thought. If you had actually researched, I think Fauci is an idiot. He has very few bona fides that would make me thing anything about him beside he is a complete disaster. I made the decision to get vaccinated understanding basic biology and immunology, and weighting the risks and benefits for me and my family.
Probably an answer that does to satisfy you as it does not achieve your narrative, Just like 170 Million other Americans, I have elected to be vaccinated. And of those 170 M Americans — where are all the complications? VAERS is a joke it is a self reported database that itself states has implicit bias and cannot be used for scientific data — the very same database those opposed to vaccines take as gospel truth.
When viewed from the side, many of the arguments you and those opposed to vaccination make are incredibly thin. But of course, you cannot counter that — all you can do is engage in name calling.
Be well,
You misdirected a FReeper in dire need of help by demanding your so-called medical degree override all other considerations, while insisting she get bamlanivimab/etesevimab treatment within 24 hours, even though the FDA halted the administration of that treatment over a month prior.
Someone else on the thread had to tell you and cite the FDA notice stating it was halted in June.
You replied back that you still ordered it 'based on disease' the prior week, but that treatment was for Covid only and halted administration a month earlier. You could not have ordered it. It's that simple.
Worse still, bamlanivimab/etesevimab never had a proven record of success but was given an investigational EUA to see if it worked. It was not a success and is no longer available.
You and others convinced you are a doctor coached that FREeper to get treatment routinely denied others, and ultimately denied to her. You urged her not to risk more Ivermectin and instead she more of nothing.
You're not a doctor. You're causing more harm than those who aren't claiming to be doctors. You're on threads flailing around ridiculing people who give better advice and share their successful personal experiences.
Why is it you just don't know that Dr. McCullough, Dr. Zelenko and others created drug protocols because the ERs and hospitals just offer oxygen? You warn people not to be pro-active and urge them time and again to seek treatments they can't get?
You're harming, not helping. Here's the thread in which you established your 'credentials' by convincing someone you knew what you were talking about when you didn't.
https://freerepublic.com/focus/news/3981474/posts?page=109#109
Re: 33 - You’re being intellectually dishonest.
ASPR halted the DISTRIBUTION. The rest of the advisory is a recommendation on the use of monoclonal antibody therapies.
Results of trials cited, both human and animal, were tepid.
Bamlanivimab has been studied in several trials. While some initial results on bamlanivimab seemed promising, further results have not shown any clinically-relevant benefit.[12][19]
It was only prescribed for mild to moderate Covid in those at risk of becoming severely ill/hospitalized.
It was only developed for, and had an EUA for, Covid.
~~~~~Links and background information
"Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. Bamlanivimab is authorized for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kilograms (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization."
Bamlanivimab is a monoclonal antibody developed as a treatment for Covid-19.[6] The drug was granted an EUA by the FDA in November 2020,[7][8][9] .] In April 2021, the EUA was revoked.[11]
Bamlanivimab is also used as part of the bamlanivimab/etesevimab combination that was granted an EUA by the FDA.[13][14][15]
In June 2021, the US Office of the Assistant Secretary for Preparedness and Response (ASPR) paused distribution of bamlanivimab and etesevimab together, due to the increase of circulating variants.[16][17][18]
Bamlanivimab EUA - Mild to Moderate at risk of becoming severe
Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibody for Treatment of COVID-19 | FDA
The administration was not halted. Please re-read https://www.phe.gov/emergency/events/COVID19/investigation-MCM/Bamlanivimab-etesevimab/Pages/bamlanivimab-etesevimab-distribution-pause.aspx
Words mean things - understand what words such as “administration”, “distribution”, etc. mean in the context of what ASPR posted.
Re: 35 - Looks like we’re talking past each other. Oh well.
Re: 28 - LOL!!!
Well you need not concern yourself with it being fake. Must be nice to have nothing to contribute except sitting at your keyboard all day saying the same things over and over again.
Your incorrect judgments notwithstanding, for some reason you seem to think you are the oracle of Delphi. Simply proclaiming makes it the truth.
Whatever — Have a good night.
Watching 2011 movie “Contagion” on Hulu. Wow mi forgot how this film predicted a virus and the incompetence of government agencies to respond to it.
Trailer: https://youtu.be/4sYSyuuLk5g
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