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Just Because a Product Is FDA Approved Does NOT Mean It is Not Experimental
The Nuremberg Standard Still Matters
The Nuremberg Code was adopted in 1949 to establish that it was an internationally recognized war crime to conduct experiments on subjects without their informed consent. The definition of informed consent was quite broad:
The voluntary consent of the human subject is absolutely essential.
This means that the person involved should have legal capacity to give consent;
should be so situated as to be able to exercise free power of choice, without the
intervention of any element of force, fraud, deceit, duress, over-reaching, or other
ulterior form of constraint or coercion; and should have sufficient knowledge and
comprehension of the elements of the subject matter involved, as to enable him to
make an understanding and enlightened decision. This latter element requires that,
before the acceptance of an affirmative decision by the experimental subject, there
should be made known to him the nature, duration, and purpose of the
experiment; the method and means by which it is to be conducted; all
inconveniences and hazards reasonably to be expected; and the effects upon his
health or person, which may possibly come from his participation in the
The duty and responsibility for ascertaining the quality of the consent rests upon
each individual who initiates, directs or engages in the experiment. It is a personal
duty and responsibility which may not be delegated to another with impunity.
Note the words “force, fraud, deceit, duress, over-reaching, and ulterior form of constraint or coercion.” The adoption of any sort of vaccine passport system is an over-reaching government measure providing an artificial constraint on people (inability to live a normal life) to coerce them into taking an experimental vaccine.
Any politician, public official, or boots on the ground officer who participates in a vaccine passport system is thus guilty of an internationally recognized war crime and should be tried and convicted in a court of law of these same war crimes.
The fact this is even a debate shows us how corrupted many modern officials and the “Bagdad Bob” media are. But they cannot hide behind the laws of their nation. The people have a right to dissolve any government that commits such war crimes and hold them accountable to the standard set forth at Nuremburg, whatever laws their politicans have passed. That dissolution should come about through peaceful means - nonviolent demonstrations, work stoppages, tax strikes, etc. if at all possible. No one benefits from civil war unless an oppressed minority has no other option because the majority has become deaf to their cries for help (think the Jews in Nazi Germany - I don’t think anyone would disagree they had a right to violently resist being sent to camps).
My main point is that governments do not have unlimited authority and it is the substance of their actions that matters relative to the internationally recognized moral standard, not their domestic laws. Those who tortured Jews in Nazi Germany were held legally accountable despite those war crimes being authorized by the German government.
None of these statements should be controversial. Informed consent has long been recognized an international human right along with the right of the people to dissolve the shackles of a tyrannical government. This is how most existing governments came into being. To this very day nations like the US unjustly send troops to remove governments through force they find “tyrannical,” even when they are not (ask the people of Libya about that). Should they not hold themselves to the same standard?
What About the BLA Approval? - Isn’t This Drug No Longer Experimental?
Yes, the BLA has been rubbered stamped by the FDA. That does not mean it is magically not experimental.
Imagine that Adolph Hilter passed a law that said “We approve of these drugs were are injecting are safe and effective. We have a panel of doctors led by Dr. Mengela who has certified it.” Do you honestly think that would get the personelle at the camps out of being tried for war crimes after the Nazi regime fell?
Again, it is the substance of the matter, not a declaration by the government that matters. Based on the data we have, the FDA clearly rubber stamped this review without sufficiently inspecting the data. The fact they allowed Pfizer to get away with classifying a death as not ”severe COVID-19” on its label, on a secondary endpoint no less, clearly shows that as clearly as you can.
The FDA also failed to inform patients on the label of the at least 262 severe adverse events on the label or apparently consider that those severe adverse events drove a 41.6% increased risk of severe adverse outcome even when you include severe COVID-19 prevented.
Most importantly of all, the registration study was designed to include 2 years of follow up as part of its safety monitoring plan. Do not believe me blindly; here it is spelled out in their briefing document to the FDA panel on December 10th, 2020:
Source: VRBPAC 12/10/2020 Briefing Document, page 15, Figure 1
Now let me ask you this question. If 4.5 months of data, the average length of follow up prior to unblinding in the vaccine arm, is sufficient to demonstrate something is safe, why on earth would you need two years of follow up post dose 2?
You do not run a study for twoo years if you are not concerned for safety. And there is nothing you can learn in 4.5 months that can tell you anything about data in two years.
How can you tell a treatment is “safe and effective” if the original experiment designed to prove that hypothesis has not been carried out to completion? How can anyone say this has long-term safety, when time has not even passed.
The fact is, you cannot. Any scientist who tells you that he knows that this will be safe for use long term, when there is no two year data, is lying to your face.
Trials are done for a reason. Without long term followup data in a blinded study (which we will never get now since Pfizer crossed patients over and unblinded the data) the vaccine is by definition experimental, regardless of what the obviously corrupt FDA says.
The FDA was in such a hurry to rubber stamp this before people realized how bad the risk reward ratio was, they did not even hold the customary VRBPAC panel meeting to review the existing data before approval. Why would you hold a panel meeeting for a EUA, and not for a full approval? Because it was rubber stamped and they did not want the scrunity! God help them if someone during the public comment period pointed out obvious errors in the data like the misclassified death I mentioned earlier.
This is also a very new type of vaccine. Vaccines that work via injection of RNA or DNA into cells to generate the production of pathogenic immune targets inside the body have never been used on large numbers of healhty people. I worked on the predecessors to this technology over 25 years ago. At the time we thought this was the future of cancer medicine, and medicine in general. But until now you have not heard much about the technology.
Why? Well it turned out, the scientists underestimated the toxicity of the treatments. In 1999, you had a kid Jesse Gelsinger killed by a genetically modified adenovirus, the same type of vector I published a paper on and that is now used in some of the COVID-19 vaccines.
This was unexpected. It set back the field of gene therapy decades because people began to appreciate the risks of such acute reactions to genetic manipulation in real human subjects. Without the data you just do not know.
Now the technologies have been tweaked no doubt to make them safer over the years. But we still do not have much data in otherwise healthy patients because these technology have been confined to the most desperate patients due to events like the Gelsinger death. For example, cancer patients tend to have suppressed immune systems and are less likely to have autoimmune reactions. These are not normal patients that have received this type of technolgoy in experiments.
To be honest, I was absolutely shocked and horrified knowing the history of this technology that they just rushed this into humans without animal studies and appropriately tiered human studies. When I found out that Johnson and Johnson and AstraZeneca were using adenoviral vectors in large numbers of people, my jaw dropped. The first report I saw, I actually did not believe it! I thought it was another half baked internet rumor. I had to double check it.
We have no idea what the long term ramifications of using these novel types of vaccines in healthy people over time, and that is on top of the risks particular to any individual vaccine that is even a normal technology. A FDA panel member stated at the December 2020 meeting, “I have never seen side effects in vaccines past 6 weeks.” But those were different types of vaccines! How do you know these new vaccines behave the same way? There is no way of knowing.
To make things worse, many government officials are now demanding people get additional jabs of the same vaccine. There has been no randomized clinical testing of this at all for safety or efficacy. Remember, the short term reactogenicity went up markedly from the first dose to the second dose. For example, an excess of 11.5% had to use pain medicines or antipyretics after the first dose, with that rate tripling to 31.0% after the second dose. There is no way of isolating the effect of each shot individually on the total serious adverse events from the data we have. We just know the short term 7-day reaction is much worse.
What on earth will be the effect of a third, fourth, or fifth shot? Given the data we have, there is good reason to believe that the reaction might get prospectively worse each time. And this may or may not increase the rate of adverse events after the shot as well.
At the same time we have no evidence that a third jab of the same vaccine would increase efficacy. In fact we have good reason to believe it might not since “breakthrough cases” are much more likely to be a result of a mismatch between the existing vaccines and the current strains in circulation as normally happens with respiratory viruses like the flu. The only way I can even contemplate that a 6 month booster would help would be to theoretically counter some sort of antibody dependent enhancement since this phenomenon usually happens when the initial antibody titers after antigen challenge normalize. But if this is the case, that is even more reason not to get a vaccine!
This third jab is simply not a recommendation founded in good science. There is no evidence that this is safe or effective, and we have more basic science reasons to believe the opposite on both. This would be an “off label” use, not approved by the FDA through the BLA. By every definition of the word “experimental,” jabs after jab two would be experimental.
This is the largest mass experiment carried out in history, and it is being done with reckless abandon. Yes, all these vaccines are experimental even if the FDA gives permission to Pfizer to peddle this experiment on people.
When government fears the people, there is liberty. When the people fear the government, there is tyranny. (Thomas Jefferson)
And how we burned in the camps later, thinking: What would things have been like if every security operative, when he went out at night to make an arrest, had been uncertain whether he would return alive and had to say good-bye to his family? Or if, during periods of mass arrests, as for example in Leningrad, when they arrested a quarter of the entire city, people had not simply sat there in their lairs, paling with terror at every bang of the downstairs door and at every step on the staircase, but had understood they had nothing left to lose and had boldly set up in the downstairs hall an ambush of half a dozen people with axes, hammers, pokers, or whatever else was at hand? After all, you knew ahead of time that those bluecaps were out at night for no good purpose. And you could be sure ahead of time that you’d be cracking the skull of a cutthroat. (Aleksandr Solzhenitsyn)
Governments overestimate their power. They cannot imprison all of us. They cannot make us all comply with their dictates. We are free men and they should be afraid of us, not the other way around.
The Nuremberg code thus still applies. Refuse any coercion to force you to get the vaccine. Stand your ground and do not have your children condemned to a lifetime of medical tyranny. Even if vaccinated, refuse any coercive vaccine passport on principle. If society stands together in non-violent resistances to tyranny and demands justice, they will get it.