They're using the phantasm of a horrible new plague to wipe out national sovereignty & human rights—not for a finite lockdown, as in 2020, but forever, with dissidence an outright criminal offense
Because the WHO and affiliates are not leaders. They are parasites who suck energy, life force, data, and money from humanity. They want to weaken their host.
Yes, that seems to be the M.O. Listening to their lies and deceptions is exhausting however I feel it is necessary in order to see through it on behalf of humanity.
Regrettably, with over 5 BILLION people receiving their first poisonous injection, these people have already furthered their depopulation agenda right under our noses. Why do you think people are "dying suddenly" all over the world? The damage is done; sit back and watch your family and friends drop dead at increasing rates. Who can stop this?
They've made too many mistakes. First and foremost they've left their dirty fingerprints all over the murder weapon, as well as the 'virus'. Altering the modRNA protein to make it easily differentiable from the 'natural' protein, means the mRNA damage is easily provable via proper autopsies/biopsies. They also patented parts of the 'virus' spike protein, using a scissoring technique to alter. This again is easily proven. They had not silenced/captured alternative/social media to nearly the required extent. Same with politicians. Same with the Laws.
Reiner Fuellmich has noted that the original plans were decades in the future - they brought it forward. Likely, because the doddering old farts know they do not have long, and really want to see their 'vision' brought to fruition. They are toast.
Hello Mark - heartening information here re: illegal agreements with WHO
"New research has revealed that the UK is unlawfully part of WHO! Based on this discovery, a group known as The People’s Lawyers are launching a legal action for an Injunction to reject the IHR and proposed amendments, any ‘Pandemic Treaty’, and all dictates from WHO, both now and in the future. They are also seeking to halt UK Government funding of WHO and related organisations, and to have the UK exit WHO on the basis that its Membership has been unlawful from the start."
"How did this situation arise?
The fundamental concern is that significant fraud was committed during the establishment of WHO. Documents, including diary entries, prove that the ‘official story’ is a highly sanitised version of the actual events. You can read the details of the whole intriguing story here, but for a quick overview, here are the essential points that illustrate the fraudulent nature of WHO’s origins, and give hope that this may aid the UK’s withdrawal."
Nass says that, if this passes, we will be subject to vaccines developed in only 100 days. What's her point? That, if they were developed in a longer timeframe that we might be okay with it?
I think most free people want total control over what goes into their bodies, regardless of any vax development timelines. Period. Framing it as she did is odd. Furthermore, videos allowed on the YouTube platform must be viewed with suspicion, in my opinion.
Her point, I think, is that they're not even paying lip service to safety concerns. If you want to use that to question her integrity, one has to ask what YOUR game is. (YouTube often takes down perfectly innocuous videos while leaving critical pieces be. They've left up some of mine, deleting other stuff that's very similar; so using it as any kind of measure is unwise.)
My 'game', so to speak, is simply to question everything. I think that's both fair and wise. Though, I also believe we need to find connections with like-minded, justice-seeking people. It's hart to not be suspicious. Controlled opposition is often very subtle.
What I notice occurring very frequently is people in comments putting aspects of any presentation under a microscope and taking issue with them or casting suspicion upon them. Now perhaps this is routine online behavior, a product of the culture of incessant critique that we live in, but I find it really peculiar that people do not immediately try to get as much knowledge and information about something or someone as they can before commenting or forming an opinion. Some people, AI puppets or trolls or underpaid lackeys of the censorship industrial complex just spend their online time casting suspicion, making people guilty by association (the fact of proximity to creepy people tainting them, a logical fallacy) or pecking some fragment or speech to death or distorting it. This is epidemic. If you genuinely want to understand Dr. Nass, you should look up her history, read her substack and her analyses of documents, it seems to me.
It never fails to astound me how valuable people think their uneducated opinions are. There are topics I would never presume to spout opinions about because I know how uneducated I am with regard to them. Maybe this is just the cognitive zeitgeist these days, but, maybe it is tactical.
First off, I'm not uneducated, generally, nor am I ignorant of Dr. Nass' viewpoints on various issues. What I have noticed, from time to time, is that her stance seems to fall short in certain, important regards. To be honest, I do need to spend some time reading more of her work so as to glean a more thorough assessment. It's something on my to-do list.
Secondly, and more to your own commentary, I feel I have fairly good intuition when it comes to discerning automated A.I. responses (on Substack and elsewhere). There's a kind of 'staidness' to it. It's just a sense I have. Perhaps I am wrong, but I seem to detect that very quality in your particular style of writing. Can I ask: Are you A.I.?
Josh Blunt. Oh to be perfect. Question of course, but to question until all help is lost? Awake too late? Have any other warriors keeping tabs, speaking out, offering the warnings so many are ignoring?
Cynthia, what I also have thought about since late 2020, don’t you find it at all odd (some call it a coincidence—I don’t) that AI has suddenly emerged (I get it that it has been worked on for decades) but for it to come out during this bio weaponry epidemic makes me think they deployed it to sway people and have many think, all this news is auto generated and fake.
Cynthia, you hit the nail on its head. Very well articulated. This critique happens in everything today. It’s an epidemic and is engrained in culture and done strategically by the evils they are.
A person might also ask why not focus on the legislation in each country that allowed civil liberties to be thrown aside, untested pharmaceuticals to be injected, lockdowns to be introduced and for those that spoke against these measures to be censored, marginalised, lose their means of income and in some countries their personal freedom. But hey let’s not focus on this…look over there a WHO squirrel.
It’s all part of their plan. Why do you think the EU was formed. Divide cultures up and throw them under one hood. Now, illegals crossing everywhere. On and on it goes
You're right. There are so many obvious cues that ought to work to wake people up. But, I'm not sure what this has to do with my comment about controlled opposition.
As you said controlled opposition is very subtle therefore if you want to focus attention away from a particular area why not promote another area which can be the focus of attention so leaving, in my example, the underlying legal framework in place all ready for the next time.
So, you're saying that it's not the unelected WHO conspirators working to undermine our freedoms that are the problem, but rather loopholes in the legislation that allows them to do so?
Sorry, but this sounds like more A.I. gobbledegook.
I can't help but notice that neither of the previous commenters answered my question as to whether they are, in fact, A.I. So, I'll ask you the same question: Are you A.I.?
It is only a clipped video. I don't think she is doing any more than making a statement. Nevertheless as all vaccines are pointless at best, harmful or deadly at worst it is academic how long they take.
It might possibly indicate that they intend to inject all those they can at ever increasing intervals.
The truth has been staring us in the face for years now, but most people refuse to see it.
It's so easy to blame everything on "THEM" and absolve ourselves and our friends and family.
Remember that when you hear WEF, WHO, Govt, Corporations, Universities etc - these are not alien monsters come to eat you. They are people just like you that pay taxes, do their job well and believe they are the good guys.
The Nuremberg trials were a joke. Out of millions of SS soldiers, concentration camp guards and doctors and nurses that happily murdered people, the winners (pretended to) kill 17. AFAIK none of those 17 ever killed someone by their own hand - just like Fauci.
You have two choices now: continue to be a spineless hypocrite "good German" or admit you are part of the problem and take a good long look at yourself.
For those few that selected the second option, your life won't be easy. You cannot continue working knowing that your taxes and work help the nazis. You cannot continue talking to your family members that are nazi supporters. Your only choice is becoming "a voice crying in the wilderness".
Who am I kidding: you have no choice since most people are soulless NPCS with no free will. Go back to your programming.
Thats why its critical to use our voice to share the only message of importance. The final warning of the everlasting gospel contained in Revelation 14:6-12 before the Sunday mark is upon us.
Josh Blunt. Meryl Nass has proven her worth. Has been a warrior and given up much. there is no reason to doubt her IMO---better to heed her warning. People not paying enough attention to this possible catastrophe. Research
This Base is at the Al-Tanf US Military Base in Syria, not Jordan. The World Government/Healthcare Dictatorship is about to go down and force you to take these Experimental Gene Therapy injections on 7 Billion People.
Purpose: Clarify the legal status of EUA Medical Countermeasures (MCMs)
Pursuant to Section 564 of the FD&C Act, as amended by PAHPRA, 2013, and the Supremacy Clause of the United States Constitution (Article VI, Clause 2), EUA MCMs have potentially been exempted from testing using Good Laboratory Practices, Good Clinical Practice, including informed consent, and from being assessed to determine if Risk Evaluation and Mitigation Strategies (REMS) are necessary.
Safety regulations governing the manufacture, shipment, holding, dispensing, administration and labeling do not necessarily apply to MCMs, rather, they are subject to an opinion by FDA and HHS officials without proper Congressional or judicial review for the duration of HHS-declared emergency. The declaration of emergency is likewise without properly defined stopping criteria, nor Congressional or judicial review.
Under federal law, FDA must approve any new drug product prior to a manufacturer introducing it into interstate commerce.[1] This process requires manufacturer to open an Investigational New Drug application and obtain an exemption from the FDA for its use in regulated investigational clinical research (trials). This normal regulated process is therefore referred to as an “investigational” regulatory pathway. It requires a manufacturer to conduct regulated clinical research (trials) under the IND, obtaining Institutional Review Board’s (IRB) approval for clinical trial protocols, independent safety monitoring oversight, and properly executed informed consent from clinical trial volunteers. In addition, manufacture of the drugs and biologics subject to the investigational status is regulated by the current Good Manufacturing practices (cGMP)[2]
EUA Medical Countermeasures are a radically different, defined in law as non-investigational drugs, biologics and devices deployed under FDA’s authorization power known as the “Emergency Use Authorization” (EUA) process[3].
The EUA process is used only when the United States Secretary of Health and Human Services declares an emergency[4].
By law, the EUA process is non-investigational[5]: while the manufacturers may choose and FDA may ask to undertake some of the activities typically expected from an investigational clinical trial and manufacturing validation process, none of the typical regulatory standards are applicable in an enforceable way.
FDA has the discretion to issue an EUA if the applicant shows that its product “may be effective” in treating the relevant disease or condition[6]. It is important to emphasize the no other criteria for approval apply in an enforceable way.
FDA will approve EUA products on incomplete information so long as the applicant shows that the “known and potential benefit of the product” merely “outweigh[s] the known and potential risks”[7] and considers it unlikely that “comprehensive effectiveness data” will be available before an EUA grant. In contrast, for an investigational drug (under normal regulatory approval process) the FDA “shall” deny approval if the applicant “do[es] not show that such drug is safe.”[8]
Therefore, the EUA status of an MCM precludes collection of the investigational (subject to IRB and informed consent) clinical trial data and thus precludes reliable, valid scientific knowledge of risks and benefits associated with the EUA Countermeasure.
The EUA process precludes meaningful informed consent from the recipients of the product: while Congress mandated that FDA directly inform health care professionals and product recipients of any “significant known and potential benefits and risks,”[9] formal regulated clinical trials are neither required nor possible for a non-investigational EUA product. Thus, there is no reliable and scientifically valid information on risks and benefits of an EUA, especially for extremely novel technologies such as mRNA shots.
Furthermore, there are no required standards for quality-control in manufacturing; no inspections of manufacturing procedures; no lot-release testing and no prohibition on wide variability among lots; no prohibition on adulteration; and no required compliance with Current Good Manufacturing Practices (cGMP). EUA products, even though unregulated and non-standardized, “shall not be deemed adulterated or misbranded.”[10]
In summary, the process through which the EUA products enter interstate commerce and claims about their safety, efficacy or contents are based solely on the HHS Secretary opinion, which requires no supporting scientific evidence. Misrepresentation of safety, efficacy or contents of EUA products is allowed by federal law. Thus, claims provided by the federal health authorities or manufacturers cannot be considered reliable sources of information.
The Global Oligarchs are really trying to destroy the US and EU. The WHO Plandemic Treaty will destroy our national sovereignty and individual bodily autonomy. The mass immigration will destroy our economies. Time to rise up.
I just updated the essay today: 01/28/2024 at 2 PM. So if you read an earlier version there is much more that has been added. Included in the update: After Covid migrants took more US jobs than American workers lost. What happens when all 16 million get work permits? How long do we put up with this?
Please share widely. This is probably the most comprehensive essay you will find, when it comes to Biden Open Border treachery against the American people. I would recommend you read through it and then start watching the videos and accessing the links. I’m quite confident that, by the time you assimilate all of the information that you are going to want to see Biden impeached, tried for treason and locked up for the rest of his life.
The Anti-Globalist Revolution may begin in Eagle Pass/Shelby Park, Texas, where Biden is demanding Gov. Abbot allow federal agents to cut the razor wire in order to accelerate the Illegal Alien Invasion. Mass migration has been pushed by the UN for decades. Up until 2023 many democrat cities supported sanctuary cities while most republicans opposed them. But as the reality of mass migration stressed out the resources of sanctuary cities this is no longer a bipartisan issue. Now the majority of Americans favor a policy of Catch and Deport.
Meanwhile the WEF just met in January 2024 and has determined that the greatest threat to the world (e.g., to the globalist agenda) is “misinformation.” In other words they are appalled that journalists, such as myself, are exposing their agenda. Those that censor free speech are never the good guys.
The Escalating Globalist Clusterfuck of Mass Immigration and Censorship in the EU and US
Could the standoff at Eagle Pass result in the mass deportation of Illegal Aliens?
Be careful: Greg Abbott is also a WEFer (https://www.weforum.org/people/greg-abbott/). For all we know, this whole coming 'civil war' thing could be staged just to get rid of all the Americans who didn't take the vax.
Thank you for helping James Roguski break the silence barrier. He's been quietly doing great work, for a long time.
He had a great website, prior to the Covid censorship spree, call The Ultimate Guide to Health... It suddenly got "cancelled" by its ISP - along with hundreds of articles - at least one of which was about Ivermectin, early in 2020.
If Trump gets in and investigates what really happened in 2020 and they can't sweep it under the rug, they will be swinging by the neck from lamp posts.
They MUST cheat. They HAVE to cheat.
They're ALREADY cheating.
That's what these absurd, Banana Republic lawfare suits are about.
Is he clever? Or just playing a role to convince us he's on our side?
If he is clever, he ought to have known they would be out to steal the last election, and he would have had plenty of observers in place to ensure it could not happen. He didn't. Why not?
If these people are so intent on wiping out a large portion of the world's population, why don't they lead by example and just kill themselves first?
Because the WHO and affiliates are not leaders. They are parasites who suck energy, life force, data, and money from humanity. They want to weaken their host.
Parasites funded by satan.
Of the worst and lowest caliber.
Yes, that seems to be the M.O. Listening to their lies and deceptions is exhausting however I feel it is necessary in order to see through it on behalf of humanity.
Regrettably, with over 5 BILLION people receiving their first poisonous injection, these people have already furthered their depopulation agenda right under our noses. Why do you think people are "dying suddenly" all over the world? The damage is done; sit back and watch your family and friends drop dead at increasing rates. Who can stop this?
You have to have 'balls' to kill yourself. The genociders would not know balls if they smacked them in the face. Metaphorically, of course.
Ah, but they are glow-ball-ists. They think the sun shines out of their proverbial if you understand me! :)
https://alphaandomegacloud.wordpress.com/2023/02/08/globalism-and-globalist-globalization-or-globalisation-whats-in-the-words/
The best idea yet! Their first member just died of old age (HK)! I hope we all can!
He didn’t die young, although he looked old in the 70’s too. What’s the opposite of clean living?
No, he didn't die young but he was the first Globalist that openly called for killing the useless eaters.
That's been my question since day one. Billy Gates should lead the pack. And if he thinks his bucks will buy him a ticket? Thats a huge LOL!
Here is the latest...
https://jamesroguski.substack.com/p/enforcearticle55
They've made too many mistakes. First and foremost they've left their dirty fingerprints all over the murder weapon, as well as the 'virus'. Altering the modRNA protein to make it easily differentiable from the 'natural' protein, means the mRNA damage is easily provable via proper autopsies/biopsies. They also patented parts of the 'virus' spike protein, using a scissoring technique to alter. This again is easily proven. They had not silenced/captured alternative/social media to nearly the required extent. Same with politicians. Same with the Laws.
Reiner Fuellmich has noted that the original plans were decades in the future - they brought it forward. Likely, because the doddering old farts know they do not have long, and really want to see their 'vision' brought to fruition. They are toast.
Hello Mark - heartening information here re: illegal agreements with WHO
"New research has revealed that the UK is unlawfully part of WHO! Based on this discovery, a group known as The People’s Lawyers are launching a legal action for an Injunction to reject the IHR and proposed amendments, any ‘Pandemic Treaty’, and all dictates from WHO, both now and in the future. They are also seeking to halt UK Government funding of WHO and related organisations, and to have the UK exit WHO on the basis that its Membership has been unlawful from the start."
"How did this situation arise?
The fundamental concern is that significant fraud was committed during the establishment of WHO. Documents, including diary entries, prove that the ‘official story’ is a highly sanitised version of the actual events. You can read the details of the whole intriguing story here, but for a quick overview, here are the essential points that illustrate the fraudulent nature of WHO’s origins, and give hope that this may aid the UK’s withdrawal."
https://drtesslawrie.substack.com/p/is-the-uk-unlawfully-a-member-of?utm_campaign=email-half-post&r=12vcal&utm_source=substack&utm_medium=email
Thank you !
you're welcome! ... any heartening developments are helpful. :)
Nass says that, if this passes, we will be subject to vaccines developed in only 100 days. What's her point? That, if they were developed in a longer timeframe that we might be okay with it?
I think most free people want total control over what goes into their bodies, regardless of any vax development timelines. Period. Framing it as she did is odd. Furthermore, videos allowed on the YouTube platform must be viewed with suspicion, in my opinion.
Her point, I think, is that they're not even paying lip service to safety concerns. If you want to use that to question her integrity, one has to ask what YOUR game is. (YouTube often takes down perfectly innocuous videos while leaving critical pieces be. They've left up some of mine, deleting other stuff that's very similar; so using it as any kind of measure is unwise.)
My 'game', so to speak, is simply to question everything. I think that's both fair and wise. Though, I also believe we need to find connections with like-minded, justice-seeking people. It's hart to not be suspicious. Controlled opposition is often very subtle.
What I notice occurring very frequently is people in comments putting aspects of any presentation under a microscope and taking issue with them or casting suspicion upon them. Now perhaps this is routine online behavior, a product of the culture of incessant critique that we live in, but I find it really peculiar that people do not immediately try to get as much knowledge and information about something or someone as they can before commenting or forming an opinion. Some people, AI puppets or trolls or underpaid lackeys of the censorship industrial complex just spend their online time casting suspicion, making people guilty by association (the fact of proximity to creepy people tainting them, a logical fallacy) or pecking some fragment or speech to death or distorting it. This is epidemic. If you genuinely want to understand Dr. Nass, you should look up her history, read her substack and her analyses of documents, it seems to me.
It never fails to astound me how valuable people think their uneducated opinions are. There are topics I would never presume to spout opinions about because I know how uneducated I am with regard to them. Maybe this is just the cognitive zeitgeist these days, but, maybe it is tactical.
First off, I'm not uneducated, generally, nor am I ignorant of Dr. Nass' viewpoints on various issues. What I have noticed, from time to time, is that her stance seems to fall short in certain, important regards. To be honest, I do need to spend some time reading more of her work so as to glean a more thorough assessment. It's something on my to-do list.
Secondly, and more to your own commentary, I feel I have fairly good intuition when it comes to discerning automated A.I. responses (on Substack and elsewhere). There's a kind of 'staidness' to it. It's just a sense I have. Perhaps I am wrong, but I seem to detect that very quality in your particular style of writing. Can I ask: Are you A.I.?
Josh Blunt. Oh to be perfect. Question of course, but to question until all help is lost? Awake too late? Have any other warriors keeping tabs, speaking out, offering the warnings so many are ignoring?
Is this more A.I. gobbledegook?
Cynthia, what I also have thought about since late 2020, don’t you find it at all odd (some call it a coincidence—I don’t) that AI has suddenly emerged (I get it that it has been worked on for decades) but for it to come out during this bio weaponry epidemic makes me think they deployed it to sway people and have many think, all this news is auto generated and fake.
Cynthia, you hit the nail on its head. Very well articulated. This critique happens in everything today. It’s an epidemic and is engrained in culture and done strategically by the evils they are.
A person might also ask why not focus on the legislation in each country that allowed civil liberties to be thrown aside, untested pharmaceuticals to be injected, lockdowns to be introduced and for those that spoke against these measures to be censored, marginalised, lose their means of income and in some countries their personal freedom. But hey let’s not focus on this…look over there a WHO squirrel.
It’s all part of their plan. Why do you think the EU was formed. Divide cultures up and throw them under one hood. Now, illegals crossing everywhere. On and on it goes
You're right. There are so many obvious cues that ought to work to wake people up. But, I'm not sure what this has to do with my comment about controlled opposition.
As you said controlled opposition is very subtle therefore if you want to focus attention away from a particular area why not promote another area which can be the focus of attention so leaving, in my example, the underlying legal framework in place all ready for the next time.
So, you're saying that it's not the unelected WHO conspirators working to undermine our freedoms that are the problem, but rather loopholes in the legislation that allows them to do so?
Sorry, but this sounds like more A.I. gobbledegook.
I can't help but notice that neither of the previous commenters answered my question as to whether they are, in fact, A.I. So, I'll ask you the same question: Are you A.I.?
It is only a clipped video. I don't think she is doing any more than making a statement. Nevertheless as all vaccines are pointless at best, harmful or deadly at worst it is academic how long they take.
It might possibly indicate that they intend to inject all those they can at ever increasing intervals.
https://baldmichael.substack.com/p/what-is-the-flu-aka-covid-19-and
So glad you are posting about the WHO attempting a COUP, Mark! Just posted a cartoon about their shameless power grab: https://open.substack.com/pub/annecantstandit/p/who-coup-what-to-do?r=qowdg&utm_campaign=post&utm_medium=web
The comments here are so funny, in a dark way.
The truth has been staring us in the face for years now, but most people refuse to see it.
It's so easy to blame everything on "THEM" and absolve ourselves and our friends and family.
Remember that when you hear WEF, WHO, Govt, Corporations, Universities etc - these are not alien monsters come to eat you. They are people just like you that pay taxes, do their job well and believe they are the good guys.
The Nuremberg trials were a joke. Out of millions of SS soldiers, concentration camp guards and doctors and nurses that happily murdered people, the winners (pretended to) kill 17. AFAIK none of those 17 ever killed someone by their own hand - just like Fauci.
You have two choices now: continue to be a spineless hypocrite "good German" or admit you are part of the problem and take a good long look at yourself.
For those few that selected the second option, your life won't be easy. You cannot continue working knowing that your taxes and work help the nazis. You cannot continue talking to your family members that are nazi supporters. Your only choice is becoming "a voice crying in the wilderness".
Who am I kidding: you have no choice since most people are soulless NPCS with no free will. Go back to your programming.
Thats why its critical to use our voice to share the only message of importance. The final warning of the everlasting gospel contained in Revelation 14:6-12 before the Sunday mark is upon us.
Josh Blunt. Meryl Nass has proven her worth. Has been a warrior and given up much. there is no reason to doubt her IMO---better to heed her warning. People not paying enough attention to this possible catastrophe. Research
This Base is at the Al-Tanf US Military Base in Syria, not Jordan. The World Government/Healthcare Dictatorship is about to go down and force you to take these Experimental Gene Therapy injections on 7 Billion People.
https://markcrispinmiller.substack.com/p/who-do-they-think-they-are-meryl?utm_source=post-email-title&publication_id=383085&post_id=141173015&utm_campaign=email-post-title&isFreemail=false&r=8ksrz&utm_medium=email
https://www.youtube.com/watch?v=RxM5c30-1gs&t=285s
We must share with everyone. We are at war!!!!
Josh I'm not an A.I.
Did the WHO implement this? You decide.
Purpose: Clarify the legal status of EUA Medical Countermeasures (MCMs)
Pursuant to Section 564 of the FD&C Act, as amended by PAHPRA, 2013, and the Supremacy Clause of the United States Constitution (Article VI, Clause 2), EUA MCMs have potentially been exempted from testing using Good Laboratory Practices, Good Clinical Practice, including informed consent, and from being assessed to determine if Risk Evaluation and Mitigation Strategies (REMS) are necessary.
Safety regulations governing the manufacture, shipment, holding, dispensing, administration and labeling do not necessarily apply to MCMs, rather, they are subject to an opinion by FDA and HHS officials without proper Congressional or judicial review for the duration of HHS-declared emergency. The declaration of emergency is likewise without properly defined stopping criteria, nor Congressional or judicial review.
Under federal law, FDA must approve any new drug product prior to a manufacturer introducing it into interstate commerce.[1] This process requires manufacturer to open an Investigational New Drug application and obtain an exemption from the FDA for its use in regulated investigational clinical research (trials). This normal regulated process is therefore referred to as an “investigational” regulatory pathway. It requires a manufacturer to conduct regulated clinical research (trials) under the IND, obtaining Institutional Review Board’s (IRB) approval for clinical trial protocols, independent safety monitoring oversight, and properly executed informed consent from clinical trial volunteers. In addition, manufacture of the drugs and biologics subject to the investigational status is regulated by the current Good Manufacturing practices (cGMP)[2]
EUA Medical Countermeasures are a radically different, defined in law as non-investigational drugs, biologics and devices deployed under FDA’s authorization power known as the “Emergency Use Authorization” (EUA) process[3].
The EUA process is used only when the United States Secretary of Health and Human Services declares an emergency[4].
By law, the EUA process is non-investigational[5]: while the manufacturers may choose and FDA may ask to undertake some of the activities typically expected from an investigational clinical trial and manufacturing validation process, none of the typical regulatory standards are applicable in an enforceable way.
FDA has the discretion to issue an EUA if the applicant shows that its product “may be effective” in treating the relevant disease or condition[6]. It is important to emphasize the no other criteria for approval apply in an enforceable way.
FDA will approve EUA products on incomplete information so long as the applicant shows that the “known and potential benefit of the product” merely “outweigh[s] the known and potential risks”[7] and considers it unlikely that “comprehensive effectiveness data” will be available before an EUA grant. In contrast, for an investigational drug (under normal regulatory approval process) the FDA “shall” deny approval if the applicant “do[es] not show that such drug is safe.”[8]
Therefore, the EUA status of an MCM precludes collection of the investigational (subject to IRB and informed consent) clinical trial data and thus precludes reliable, valid scientific knowledge of risks and benefits associated with the EUA Countermeasure.
The EUA process precludes meaningful informed consent from the recipients of the product: while Congress mandated that FDA directly inform health care professionals and product recipients of any “significant known and potential benefits and risks,”[9] formal regulated clinical trials are neither required nor possible for a non-investigational EUA product. Thus, there is no reliable and scientifically valid information on risks and benefits of an EUA, especially for extremely novel technologies such as mRNA shots.
Furthermore, there are no required standards for quality-control in manufacturing; no inspections of manufacturing procedures; no lot-release testing and no prohibition on wide variability among lots; no prohibition on adulteration; and no required compliance with Current Good Manufacturing Practices (cGMP). EUA products, even though unregulated and non-standardized, “shall not be deemed adulterated or misbranded.”[10]
In summary, the process through which the EUA products enter interstate commerce and claims about their safety, efficacy or contents are based solely on the HHS Secretary opinion, which requires no supporting scientific evidence. Misrepresentation of safety, efficacy or contents of EUA products is allowed by federal law. Thus, claims provided by the federal health authorities or manufacturers cannot be considered reliable sources of information.
The Global Oligarchs are really trying to destroy the US and EU. The WHO Plandemic Treaty will destroy our national sovereignty and individual bodily autonomy. The mass immigration will destroy our economies. Time to rise up.
I just updated the essay today: 01/28/2024 at 2 PM. So if you read an earlier version there is much more that has been added. Included in the update: After Covid migrants took more US jobs than American workers lost. What happens when all 16 million get work permits? How long do we put up with this?
Please share widely. This is probably the most comprehensive essay you will find, when it comes to Biden Open Border treachery against the American people. I would recommend you read through it and then start watching the videos and accessing the links. I’m quite confident that, by the time you assimilate all of the information that you are going to want to see Biden impeached, tried for treason and locked up for the rest of his life.
The Anti-Globalist Revolution may begin in Eagle Pass/Shelby Park, Texas, where Biden is demanding Gov. Abbot allow federal agents to cut the razor wire in order to accelerate the Illegal Alien Invasion. Mass migration has been pushed by the UN for decades. Up until 2023 many democrat cities supported sanctuary cities while most republicans opposed them. But as the reality of mass migration stressed out the resources of sanctuary cities this is no longer a bipartisan issue. Now the majority of Americans favor a policy of Catch and Deport.
Meanwhile the WEF just met in January 2024 and has determined that the greatest threat to the world (e.g., to the globalist agenda) is “misinformation.” In other words they are appalled that journalists, such as myself, are exposing their agenda. Those that censor free speech are never the good guys.
The Escalating Globalist Clusterfuck of Mass Immigration and Censorship in the EU and US
Could the standoff at Eagle Pass result in the mass deportation of Illegal Aliens?
https://brucecain.substack.com/p/the-escalating-globalist-clusterfuck
Be careful: Greg Abbott is also a WEFer (https://www.weforum.org/people/greg-abbott/). For all we know, this whole coming 'civil war' thing could be staged just to get rid of all the Americans who didn't take the vax.
Thank you for helping James Roguski break the silence barrier. He's been quietly doing great work, for a long time.
He had a great website, prior to the Covid censorship spree, call The Ultimate Guide to Health... It suddenly got "cancelled" by its ISP - along with hundreds of articles - at least one of which was about Ivermectin, early in 2020.
One good thing, when Trump is president, he'll just pull us out, like he did before. If it's DeSantis or Halley, I think they would pull us out also.
If he really plans to pull us out, he'll never win, no matter how many votes he gets.
He'll never win if they cheat like they did in 2020
And why would they not cheat?
If Trump gets in and investigates what really happened in 2020 and they can't sweep it under the rug, they will be swinging by the neck from lamp posts.
They MUST cheat. They HAVE to cheat.
They're ALREADY cheating.
That's what these absurd, Banana Republic lawfare suits are about.
He’s very very clever. Have hope in that fact
You never know Trump is very clever !
Is he clever? Or just playing a role to convince us he's on our side?
If he is clever, he ought to have known they would be out to steal the last election, and he would have had plenty of observers in place to ensure it could not happen. He didn't. Why not?
Cat. Hope and prayers. Prayers and hope
Char. Prayer is always answered. Give charity too. And ask God to SAVE OUR COUNTRY AND ALL GOOD PEOPLE ON EARTH. He hears heartfelt appeals.
Faith and Trust with the prayer
The UN is in NYC🪱🐀🕷️🕸️
Who do they think they are? Look at the reaction to the ICJ decision for helpful insights