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Re: Coronavirus
https://www.forbes.com/sites/william...h=5ee8655a2c81
FDA Turns Down Fluvoxamine Emergency Use Authorization Request
William A. HaseltineContributor
May 19, 2022
forbes.com
FDA Turns Down Fluvoxamine Emergency Use Authorization Request
William A. Haseltine
8-10 minutes
Tennis ball hitting to net on blur court background
Tennis ball hitting to net on blur court background
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The Food and Drug Administration denied an emergency use authorization for fluvoxamine as a SARS-CoV-2 antiviral. Fluvoxamine was proposed as a possible antiviral in 2021 due to its mechanisms of action for treating obsessive-compulsive disorder. These same mechanisms were suspected to inhibit SARS-CoV-2, leading to four trials testing the efficacy of the drug.
In December 2021, Dr. David R Boulware requested an emergency use authorization for the outpatient treatment of adults testing positive for SARS-CoV-2 to prevent progression to severe symptoms based on early efficacy data from the fluvoxamine trials. The Food and Drug Administration denied his request, listing concerns such as insufficient data. Here we will discuss the FDA’s decision and reasoning.
Trials
The FDA’s main concern was the lack of conclusive evidence from four trials that were below emergency use authorization standards. The largest of the four trials, the TOGETHER trial, was a randomized, double-blind, placebo-controlled trial of high-risk patients in Brazil. The primary endpoints of the trial were (1) emergency room visits lasting greater than six hours and (2) hospitalization due to progression of Covid-19.
The FDA found that the success of the trial was fueled by the six-hour threshold, which they found to be arbitrary. A patient remaining in the emergency room for 5.9 hours after taking fluvoxamine was considered a positive data point, whereas 6.1 hours was considered a negative. In the FDA’s words, “there are uncertainties about…whether the 6-hour timepoint represents a clinically meaningful threshold.”
The other three trials were found to be inconclusive as well. The FDA noted that the STOP COVID trial had several damaging design flaws, including a lack of randomization, a small sample size, and only a single testing center. The STOP COVID 2 trial and the COVID-OUT trial both failed to demonstrate a positive efficacy for fluvoxamine and were terminated early for futility.
While the TOGETHER trial did achieve a positive efficacy based on its trial design, the FDA ultimately concluded that the four trials failed to provide sufficient data to conclude that fluvoxamine may be an effective treatment for nonhospitalized Covid-19 patients.
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Mechanisms of Action
Among fluvoxamine’s mechanisms of action, which we discussed in a previous article, are binding to sigma-1 receptors on immune cells, reduced expression of inflammatory genes in human endothelial cells, and mediation of lysosomotropic properties. These factors were theorized to reduce the immune impacts following SARS-CoV-2 infection, including cytokine storms, hyperinflation, and coagulation.
While some in-vitro data supported the claim that fluvoxamine’s mechanisms of action could work against SARS-CoV-2, no in vivo animal or human studies have been conducted to confirm this hypothesis. The FDA notes that the lacking evidence and lack of detailed characterization for fluvoxamine in a Covid-context is a primary data point for their rejection of the emergency use.
Alternate Treatments
The FDA’s notice of emergency use rejection for fluvoxamine was concluded with currently available and approved treatments for Covid-19. We have detailed each of these and encourage their use whenever applicable. These include Paxlovid, Remdesivir, Bebtelovimab, and convalescent plasma. We note that Molnupiravir is listed among these as well, but we discourage the use of this drug due to concerns about mutagenesis and cytotoxicity.
Many further treatments are currently in development, including a number of monoclonal antibody treatments that aim to broadly neutralize all variants of SARS-CoV-2, which is an ongoing concern two years into the pandemic.
Full coverage and live updates on the Coronavirus
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Re: Coronavirus
https://blog.nomorefakenews.com/2022...-human-events/
Quiet apocalypse at the school board: when in the course of human events…
Jun
20
by Jon Rappoport
by Jon Rappoport
June 20, 2022
In OhMyGod, Ohio, on a slow Thursday afternoon, Dr. Helmet Von Suit, a career bureaucrat, the president of the school board, held a meeting to discuss budget allocations for the coming year. Sixty parents sat in the room.
Margo Smith stood up and said:
I have two young boys in elementary school. One of them brought me a book from the library which contains pictures and descriptions of oral sex and other sexual practices. I’m going to read a graphic passage from the book now—
That won’t be possible. To read it would be obscene, and we can’t have that at a public meeting.
Dr. Suit, as I said, this is a book from—
I don’t care where it’s from. I refuse to allow—
All right. I’ve copied pages from the book and sent them to a hundred parents in the District. I’m sure you’ll be hearing from them. Now, as to the matter of Critical Race Theory, I have a video taken in a sixth grade class two weeks ago. The teacher is telling nine-year olds that all white people are evil racists, and that would include children. I’ll play you the audio.
No you won’t. What goes on in our classrooms is private and privileged. Taping is a crime.
I see. It’s all right for a teacher to tell nine-year olds that all white people are racists, but it’s not all right for anyone to document the teacher saying that. Good, Dr. Suit. We now have you on the record. So I’ll move on. Four teachers in the District are teaching very young children they can choose their gender. Not only that—and we have audio and video—but the teachers are telling the kids they can take puberty blocking drugs that will help them make a choice about gender. In this folder, I have eight published studies describing the VERY serious adverse effects of the drugs. I want to read a passage from one of the studies.
Out of order. We don’t permit casual reading of scientific literature. Our District public health people make all medical decisions—
Then I’ll say this. I have another folder here with studies documenting the ineffectiveness of masks, and the negative consequences of children wearing them. On top of that, I have 40 studies—
Not permitted—
—That conclude the COVID vaccines are unnecessary for children and carry considerable risks.
You don’t get to decide that.
Oh but I do. A month ago, I started a Zoom group of school parents in the District. We now have 85 parents attending our sessions. The number expands every week. You can either hold real discussions with us or you can suffer the consequences.
That sounds like a threat. It borders on terrorism.
We’re aware the US Attorney General has tasked the FBI with investigating parents like us, all across the country, who are rising up in rebellion against oppressive school boards. We don’t care. We’re willing to deal with whatever comes our way.
Even if it means being thrown in jail?
Especially if it means that. We want the vaccine mandate eradicated. We’re not sending our kids to school if they have to take the shot. We’ll pull our kids out. Actually, we’re in the process of starting our own home school. Free from people like you.
What do mean, people like me?
Bureaucrats who pick up a paycheck on our tax dime and harm our children. By the way, we know your teachers aren’t teaching our children how to read and write. Certainly not at their grade levels. Your teachers are faking grades to make it seem education is going on in the classrooms.
This is outrageous.
I agree. And we’ve had enough. This is a 1776 moment, Doctor.
Another threat of insurrection.
You bet. That’s exactly what it is. Without guns. Without a shot being fired. You’re a bureaucrat who does evil, who passes along evil, who permits evil. You think we serve you, but we don’t. You’re OURS.
I won’t stand for this.
You’ll stand for it or sit for it. Our numbers are growing every day. We won’t back down. No matter what.
Trump is behind all this!
Who? Oh, you mean the former President who keeps flogging his wondrous COVID vaccine that’s caused, by a VERY conservative estimate, more than 800,000 injuries in America? But listen, keep trying to sell that line. Sell anything you want to.
Who are you anyway? Who’s behind you? Who’s funding you? Everything you’re saying is just code for white racism.
Keep telling yourself that, as more and more black parents join our group.
We have hundreds of thousands of people on social media who will drown you out.
Do you seriously think we care about those bobble heads? We’re parents. PARENTS. We would do anything for our children. You’re fronting for an agenda of destruction. We see that clearly. You want to control our kids’ minds. We want to make them free and strong and independent. Those are the terms of the war. Now, seriously, who do you think is on the side of the angels?
Don’t give me that garbage. Children live under the protection of the State. They’re part of the State.
Glad to get that on the record, too, DOCTOR.
You don’t have final say over your children. We can intercede.
You’ve been interceding for a long time. We were asleep. Not anymore.
We’re a duly instituted public school board. You have no license to change what we do.
We’re raising our children. That’s duly instituted on levels you’re apparently unaware of.
The school system and the government behind it are stronger than you are.
We’ll see about that. Ever hear of the phrase, “consent of the governed?”
That consent was given to us a long time ago.
We’re in the process of taking it back. You’re a figurehead, Dr. Suit. As classrooms in your schools empty out, and more and more parents put their kids into home schooling, you’ll see that. When our Union of Concerned Parents starts picketing your—
Union of what?!
Did I forget to mention that? We’re forming a Union of the Dissenters.
You have no power to do that.
Of course we do. That’s what our lawyers tell us.
Your lawyers?
Yes. It turns out that some parents are also practicing attorneys.
Don’t get sarcastic with me.
This is just the beginning of your nightmare. We’re going to squeeze you in every possible way. We no longer recognize your authority. Nor do we accept your judgments.
I’ll have you thrown in jail.
You already said that. We’re ready. We have six local police officers in our parent group. If we’re arrested, they’ll be making video statements which, by the way, will mention you by name. Those videos will be spread all over the world.
That’s illegal.
By what law? Has the 1st Amendment been recently revoked? And how do you think jailing dozens of parents is going to play? Talk to your PR people. Ask them.
You pay us to babysit your children.
Thank you again, Doctor. Another nice statement for the record. Actually, no. We pay you to teach our children to think for themselves, to use their imaginations. To learn the basics. You’re failing on all counts.
I’m warning you.
Warning us about what?
You’ve gone too far.
We’re just getting started. Our theater group—
Your what?
—Will be putting on little sketches all over town. You’re the featured character. Doctor Suit Enforces Mask Mandates on Our Children, But He Doesn’t Wear a Mask in Public. That’s the first one. We’ll be reading passages describing raw sex acts from the book in the school library. That should provoke some interesting reactions. You know—“Here’s how your tax dollars are being spent.”
Sit down.
I am sitting down, Doctor. I’ve been sitting down for a few minutes. You’re the one standing up.
You’re a devil.
I refer you to the members of my church. I’m the head of the choir. On the other hand, your provenance is questionable.
You’re a…Republican.
My status is Independent. I cast my votes in elections on a case by case basis. You…not so much. We have your record during your term as city councilman. We know who donated to your campaign. For example, that “financier for the people,” who lobbied against the bill that would have ordered a clean-up of the lead and other heavy metals in the drinking water.
I’m calling the police now.
We already have, Doctor. We’ve informed them this is a legal and peaceful meeting, and we’re happy to answer any questions they may have. You see, Doctor, we’re prepared. We’re not bumpkins. We try to think things through and anticipate. We want to provide a workable template for other parent groups, so they can do the same. Of course, we’re outraged at what you’ve been doing to our children. But that doesn’t mean we’re flying by the seat of our pants. By the way, we have a request. Your brother-in-law owns a piece of empty land on the edge of the city. Some of our parents who live out there want to turn it into an urban farm. People in the community would grow food for themselves and sell the excess to local markets. We’d like you to help us get permission.
I can’t do that.
Why not?
There is an ongoing negotiation with the city to—
Turn it into a landfill for garbage. Yes, we’re aware. But which would you rather see? People living next door to a toxic dump, or those people growing clean, nutritious, free food for themselves and their families?
This is a PR stunt.
Since when is food a stunt?
I refuse to knuckle under to pressure.
Because you’re bent on control. In your mind, giving people an inch is letting them take a mile. You need basic re-education.
You’re lecturing me about education?
Your PhD is in social psychology. Aside from teaching one semester of plane geometry and algebra in a private junior high school, you’ve never dealt with students face to face. After the school let you go, you flew out to California and convinced a rich friend from college to cut you in on a winery he was launching. You’ve been serving as an administrative assistant in that operation for many years. As far as we can tell, your job involves studying in-house reports and liaising with a law firm. Recently, you spoke with your friend about bankrolling your run for mayor of our city. You have your eye on that office, as a stepping-stone to the governorship. We don’t think that’s going to happen for you. We think you’re dead in the water, Doctor.
You’re…you’re…
I’m what, Doctor? My name is Margo Smith, and I have two young children in public school in your District. Today, I pulled them out of school. They’re never going back. The perverse show you and your board members are running, which you call education, is a blight. It’s a disgrace and a crime. You’re a grifter with a degree next to your name, that’s all.
You’re making this personal. You’re digging into my private life. That’s out of bounds. It’s illegal.
Really? If you’re going to throw your hat in the political arena, Doctor, you’d better get used to it. It’s called opposition research. I’m trying to prepare you. You should be thanking me. For instance, remember the cute beagle your family used to have? Sonny? For some reason, you gave Sonny away. But not to another family. Not even to a shelter. You donated him to your old friend, Jim Murdock. Jim owns an animal testing lab. Sonny went into a cage. To test an experimental antibiotic, lab techs cut away pieces of Sonny’s body, leaving open wounds, to study “infection rate and treatment.” The experimental drug, used for bacterial infections, was redundant. There were a dozen antibiotics just like it on the market.
I never knew about that until it was too late!
We don’t think that’s true. We’ve been talking to Jim Murdock.
That son of a bitch!
A few years ago, you gave him advice about a biotech stock. You told him you had inside information. He bought shares, and it tanked. He wasn’t very happy about that. —I see the police are arriving. A bunch of us are leaving now, Doctor, to chat with them. Carry on. Discuss how you’re going to spend our tax dollars. We’ll see you around. Soon and often. We’ll pass along your regards to your ex-wife. A few of us are having tea with her later this afternoon. Should be an interesting conversation.
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Re: Coronavirus
This video contains good clear exposure and explanation of the Comirnaty trick.
7:34 video runtime
https://www.youtube.com/watch?v=A5vVhfXHkvw
https://www.youtube.com/watch?v=A5vVhfXHkvw
News | 22-Year Naval Enlisted LT Opting Out of COVID-19 Vaccine Wins in Naval Board Hearing
TrialSite News
112K subscribers
Join The Conversation! | https://trialsitenews.com/
A scientist and expert witness shared with TrialSite News a recent legal case involving a 22-year Navy enlisted LT. The winning law firm, R Davis Younts Esquire, reports that on May 20, 2022, a Board composed of three Navy officers found that the firm’s client, LT Bill Moseley, did not commit misconduct by refusing a COVID-19 injection and found unanimously that LT Moseley should be retained in the United States Navy.
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Re: Coronavirus
https://www.youtube.com/watch?v=HkLVnvN-Sb8
https://www.youtube.com/watch?v=HkLVnvN-Sb8
News Roundup | U.S. Poison Control Ivermectin Data Analyzed by TrialSite – Some Surprises
234,645 views
Sep 14, 2021
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TrialSite News
112K subscribers
10:20 video runtime
Join The Conversation! | https://trialsitenews.com/
U.S. Poison Control Ivermectin Data Analyzed by TrialSite – Some Surprises
he U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and prominent physician and pharmacy societies have stepped up and intensified warnings about the use of ivermectin across mass media. While a recent American Medical Association warning press release cites a huge rise in ivermectin prescriptions and a 3-Fold increase in calls to poison control centers associated with the misuse of the generic drug.
Article Link | https://trialsitenews.com/u-s-poison-...
2,465 Comments
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Re: Coronavirus
https://prodimage.images-bn.com/lf?s...oduct.chain%5D
Resisting Medical Tyranny: Why the COVID-19 Mandates Are Criminal
by Francis A. Boyle
Starting with the outbreak of the COVID-19 pandemic, the American people have been continually subjected to an endless stream of totalitarian medical orders by the highest level officials of the United States government and state governments from both political parties; by federal, state, and local public health authorities; by life scientists; and by doctors. This book debunks the scientific basis for their edicts. This book proves that the COVID vaccines and their related mandates violate the Nuremberg Code on Medical Experimentation that the United States government used to prosecute, convict, and execute Nazi doctors at Nuremberg. The COVID vaccines and their related mandates are a Nuremberg Crime against Humanity under international criminal law. This book sets forth legal strategies and arguments for the American people and their lawyers to fight back against this medical tyranny that is being ruthlessly imposed upon us by these scientific and medical elites by using criminal law, constitutional law, and international law. This book is essential reading for any concerned citizen who wants to stop dead in its tracks this developing American medical police state and to hold legally accountable those responsible for the COVID-19 pandemic and its lethal consequences for now one million of their fellow Americans.
https://www.barnesandnoble.com/w/res...yle/1141416491
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Re: Coronavirus
https://rwmalonemd.substack.com/p/mo...scientifically
Most Journalists are Scientifically Unqualified
Why does anyone rely on reporters to interpret scientific articles?
Robert W Malone MD, MS
8 hr ago
We don't have many investigative journalists left. Most are following their leadership who determines the tone and message of events for hidden agendas. Whether it is covid, Mass shootings, Border issues Ukraine Crisis or the Green Agenda, the messages are carefully honed to re-educate the masses. About 40 years ago, it was reported that ABC, NBC, and CBS executives meet for breakfast in New York at 5 AM and they would all agree on what events to broadcast for the day! Now we are down to 6 Corporations that control over 90% of the Mass media, for profit. The 6 Billion they receive from Big Pharma makes sure they don't bite the hand that feeds them and the Covid crisis continues ad nauseum!
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Re: Coronavirus
This show is broadcasting LIVE now but this url should work for free access to replay as well..
...https://www.theepochtimes.com/sudden...ent=06-21-2022...
https://ecp.yusercontent.com/mail?ur...lFYsSpLlIQ--~D
https://www.theepochtimes.com/sudden...ent=06-21-2022
https://ecp.yusercontent.com/mail?ur...zPFI_VCfTg--~D
Sudden Adult Death Syndrome, Mad Cow Disease, and Bizarre Blood Clots Raise Questions About Vaccines
A phenomenon of strange deaths has fallen under the label of Sudden Adult Death Syndrome (SADS). The real cause of the deaths is unknown, but is affecting young people primarily in their sleep. The Spectator reports, “They simply do not wake up after going to bed, or collapse during the day,” and claims cases have been increasing.
Meanwhile, there are new phenomena of fatal conditions, including the brain disorder commonly known as Mad Cow Disease, a sudden increase in myocarditis and heart failure,
Quality reporting here.
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Re: Coronavirus
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Re: Coronavirus
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Re: Coronavirus
New VAERS Data as of June 10, 2022 (posted June 17, 2022)
31,352 Total Deaths and 1,390,560 Total Adverse Events
28,859 Pfizer/Moderna and 2,493 J&J Deaths
1,301,356 Pfizer / Moderna and 89,204 J&J Adverse Events
Source: https://drtenpenny.com/wednesday-newsletter/
