I remember reading somewhere that Andreas Novak/Noak, a German chemist, identified the irregular liquid that Ms Jackson saw as Graphene hydroxide. He was assassinated in front of his pregnant wife three days later.
It is our duty to remember all whistle-blowers who paid with their lives.
One thing and one thing only needs to be understood: we have entered a completely lawless age in which the powerful feel free to act just as they wish, even to poisoning and killing at will.
References to protocols, established industry standards, the law, etc, are redundant, they belong to the pre- 'pandemic' time. That world died in 2020.
You are right of course, Xabier, given what we now know. However, those standards have not gone away. In the US, they are written into Law since the Food, Drug and Cosmetics Act, 1938, and the Code of Federal Regulations, Title 21, FDA portion of the CFRs. Same in Europe, under EU Directive Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use: https://eur-lex.europa.eu/eli/dir/2001/83/oj/eng - if they had been repealed in some way, it would be a different story, but they have not. All that needs to happen is to admit that the world has been taken for a fool, and go back to where we were...can explain more if you like, thanks for the comment...
Hearing Trump praise Albert Bourla as a great businessman at a recent event, and not batting an eyelid at the, deserved, jeers from the crowd, demonstrates that nothing good is going to come of the new administration.
JFK jr is completelycompromised, if he was ever honest in the first place.
And Trump played his role to the satisfaction of his superiors in authorising OWS, which he has never disowned.
More crimes to come, I'm afraid, and the thing now is to prepare for evil times.
Originally the concept of outsourcing research, development and manufacturing was to exploit the knowledge resources within the academia and academic medical centres for reducing the time of discovery and development. And strengthen the value of innovation and remove the conflict of interests. But unfortunately it increased the number of stakeholders in the value chain and non accountability (reflected in poor data integrity) .
To add fuel to the fire, the regulatory capabilities in terms of personnel strength and timely corrective preventive actions failed to meet the increasing stakeholders and their quantum of activities.
As a result the market was flooded with substandard and therapeutically suboptimal products. Often their failure gets exposed at the very end of their life cycle
To those reading this, Kannan is the real deal. He and I have had long discussions over the years on the topic of big pharma putting patents ahead of patients in the pursuit of $$$$$$R
With secretive groups like the JASON advisory group—"elite" scientists who have been steering government decisions since the Cold War—what role did they play in the whole "COVID" debacle? They were deeply involved in the anthrax agenda and countless other schemes, with figures like Joshua Lederberg leading the charge. If this administration actually cares about the people, every bit of their work needs to be declassified.
And ICON outsourced the clinical trial site work to Ventavia. By law, Pfizer is responsible for the work of ICON and Ventavia. In practice, Pfizer was asleep at the wheel. This is the story of the industry - all the work is carried out by contractors with little or no oversight…
Indeed, Brook Jackson’s evidence should have stopped the “development” of the “vaccine”, if in fact it was an investigational medical product under the regulation of FDA.
Nothing happened.
Either the FDA and others are corrupt, or FDA wasn’t regulating the material in question.
Both are true. FDA is party to the pantomime that they’re regulating these materials.
However, the legal position is clear, as Katherine Watt and Sasha Latypova have patiently demonstrated, repeatedly.
They are “countermeasures”, for use under the discretion of the HHS Secretary, given the prior declaration of a Public Health Emergency, and immunity from prosecution for liability from harms is provided by the PREP Act. These agents are legally & explicitly defined as “non-investigational”, and “their administration to humans explicitly does not constitute a clinical trial”.
Thus, in the clear wording of the regulations under which this operation proceeded and still proceeds, they are not regulated by FDA.
This is why Brook Jackson’s attempt to bring Pfizer to book failed in court. The defence Pfizer advanced, so I read, was that the government was wholly aware of everything that was happening, so no fraud could have taken place. I doubt these words were used, but a summary of the situation was given: “Pfizer delivered the fraud that the government ordered!”
The judge considered the wording and implications of all the laws and regulations & concluded that this was legally correct and that Pfizer had done nothing wrong in the terms of the action brought against them.
There is a difference between legal and lawful. It might all match up with and be consistent with what the law says, but it’s unquestionably unlawful.
You cannot deliberately injure & kill people, lawfully. And that’s what’s happened & is still happening.
Ps: I’m doing my best to represent the position as best I can. To the best of my knowledge, I have faithfully summarized the position. Please check yourself by reference to the Substack writings of Katherine Watt and separately of Sasha Latypova.
Dr. Yeadon - Here are the links to The PREP Act and the FDA EUAs for Pfizer and Moderna. Conflating EUAs with Prep is creating confusion. For clarity see below.
PREP Act, see link, was extended for the 12th time December 2024. ✔PREP authorizes the Secretary of Health and Human Servies to issue a Declaration to provide liability immunity to certain individuals and entities against claims of loss arising from the manufacture, distribution, administration except for claims involving willful negligence. So, MDs, Pharmacists, nurses are protected should they kill and injure a patient due to the administration of the Covid vaccines. The Brook Jackson case confirms it is challenging to sue Pfizer under the circumstances.
✔You stated above the vaccines don't constitute a clinical trial. The FDA EUAs confirm otherwise. Stated in the EUAS - FDA reviewed safety and efficacy from an ongoing 44,000 participants for the Pfizer trial and reviewed 30,351 for the Moderna trial. ✔ You stated above the vaccines are non-investigational. According to the FDA the vaccines are investigational because Pfizer had to submit safety reports based on their investigational New Drug application (IND) number 19736 and Moderna for 19745.
Conclusion - Because the vaccines are FDA regulated; they can also be withdrawn. Confusing Prep with the EUAs is keeping these vaccines on the market. Keeping vaccines on market generates profits for pharma but continues to put people and especially children at risk of injury or death.
When I read your explanations I either think of a word salad or pretzel talk.
Then there are claims involving “wilful negligence” highlighted in Alison’s work above. There are at least 5 FDA inspections of facilities producing either drug substance or drug product for the ‘vaccines’ that demonstrate gross negligence, with inspectors names included in the FDA 483. A case for wilful negligence could be advanced by lawyers for those impacted by the potentially misbranded drugs…
The research you have carried out here, Alison, is exemplary. A few points to reinforce. An investigational new drug (IND) application was submitted to FDA for Pfizer and Moderna. Why would that be required if the were to bypass FDAs established procedures? Then there are the conditions attached to the EUA, which explicitly required Pfizer and Moderna’s compliance with current Good Manufacturing Practice. To be continued….
Hedley, is Latypova correct to say that there are four _mutually _exclusive ways to get a therapeutic or preventative medication approved? (Not sure of the accurate way to say it.)
Now since an Emergncy Use Authorization EUA can only be appllied when there is a Public Health Emergency PHE, and since the entire mRNA platform has only EUA approval, then if Kennedy repeals the PHE for covid then automatically all covid transfections become illegal immediately.
If the routes are mutually exclusive then they would have to start all over looking for approval again.
I would bet all $4.7 trillion in fraud the DOGE has thus far discovered on the idea that most big pharma drug trials, studies and testing is purely bogus, fake and manipulated.
the above article when taken with multiple ex-editors from the big peer reviewed journals disparaging peer review and the fealty journals pay to big pharma (their main customers/funders) - one begins to pierce the illusion of modern medicine.
from Grok / twitter/x's AI:
Marcia Angell, a former editor-in-chief of the New England Journal of Medicine (NEJM), wrote the book "The Truth About the Drug Companies: How They Deceive Us and What to Do About It" (2004). In her writings, she has highlighted how the pharmaceutical industry has influenced medical research, particularly through financial ties to researchers and institutions.
Jerome Kassirer, also a former editor of the NEJM, authored "On the Take: How Medicine's Complicity with Big Business Can Endanger Your Health" (2005). He discusses how financial conflicts of interest have led to biases in medical research and publication.
Richard Smith, who was the editor of the British Medical Journal (BMJ), has written extensively on the corruption within medical publishing. In an article titled "Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies," he describes how the journals can be compromised by the financial interests of pharmaceutical companies.
while not a peer reviewed journal editor, John Abramson has been on the faculty at Harvard Medical School, where he taught health care policy. He is known for his critique of the pharmaceutical industry's practices, particularly how these practices impact medical research and patient care.
He authored "Sickening: How Big Pharma Broke American Health Care and How We Can Repair It" (2022), where he discusses the pharmaceutical industry's control over medical research and how it misleads doctors and harms patient health. His earlier book, "Overdosed America: The Broken Promise of American Medicine" (2004), also touches on similar themes, highlighting the corruption of medical knowledge by industry interests.
I remember reading somewhere that Andreas Novak/Noak, a German chemist, identified the irregular liquid that Ms Jackson saw as Graphene hydroxide. He was assassinated in front of his pregnant wife three days later.
It is our duty to remember all whistle-blowers who paid with their lives.
It really is. Many people have woken up painfully to how the world is really run.
One thing and one thing only needs to be understood: we have entered a completely lawless age in which the powerful feel free to act just as they wish, even to poisoning and killing at will.
References to protocols, established industry standards, the law, etc, are redundant, they belong to the pre- 'pandemic' time. That world died in 2020.
You are right of course, Xabier, given what we now know. However, those standards have not gone away. In the US, they are written into Law since the Food, Drug and Cosmetics Act, 1938, and the Code of Federal Regulations, Title 21, FDA portion of the CFRs. Same in Europe, under EU Directive Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use: https://eur-lex.europa.eu/eli/dir/2001/83/oj/eng - if they had been repealed in some way, it would be a different story, but they have not. All that needs to happen is to admit that the world has been taken for a fool, and go back to where we were...can explain more if you like, thanks for the comment...
Hearing Trump praise Albert Bourla as a great businessman at a recent event, and not batting an eyelid at the, deserved, jeers from the crowd, demonstrates that nothing good is going to come of the new administration.
JFK jr is completelycompromised, if he was ever honest in the first place.
And Trump played his role to the satisfaction of his superiors in authorising OWS, which he has never disowned.
More crimes to come, I'm afraid, and the thing now is to prepare for evil times.
Hope you are not right...I didn't know about the Bourla comment....
Originally the concept of outsourcing research, development and manufacturing was to exploit the knowledge resources within the academia and academic medical centres for reducing the time of discovery and development. And strengthen the value of innovation and remove the conflict of interests. But unfortunately it increased the number of stakeholders in the value chain and non accountability (reflected in poor data integrity) .
To add fuel to the fire, the regulatory capabilities in terms of personnel strength and timely corrective preventive actions failed to meet the increasing stakeholders and their quantum of activities.
As a result the market was flooded with substandard and therapeutically suboptimal products. Often their failure gets exposed at the very end of their life cycle
To those reading this, Kannan is the real deal. He and I have had long discussions over the years on the topic of big pharma putting patents ahead of patients in the pursuit of $$$$$$R
With secretive groups like the JASON advisory group—"elite" scientists who have been steering government decisions since the Cold War—what role did they play in the whole "COVID" debacle? They were deeply involved in the anthrax agenda and countless other schemes, with figures like Joshua Lederberg leading the charge. If this administration actually cares about the people, every bit of their work needs to be declassified.
Hedley, Did Ventavia do all the clinical work for Pfizer or were other CROs involved? A few good signs from Trump/Kennedy team;-). Fingers crossed!
https://www.pbs.org/newshour/politics/watch-trump-signs-orders-targeting-covid-vaccine-mandates-and-creating-energy-dominance-council
https://www.dailymail.co.uk/health/article-14174091/Covid-vaccine-faces-ban-Americans-radical-U-turn-Trump-team.html
Pfizer outsourced the clinical component to ICON: https://www.iconplc.com/
And ICON outsourced the clinical trial site work to Ventavia. By law, Pfizer is responsible for the work of ICON and Ventavia. In practice, Pfizer was asleep at the wheel. This is the story of the industry - all the work is carried out by contractors with little or no oversight…
Indeed, Brook Jackson’s evidence should have stopped the “development” of the “vaccine”, if in fact it was an investigational medical product under the regulation of FDA.
Nothing happened.
Either the FDA and others are corrupt, or FDA wasn’t regulating the material in question.
Both are true. FDA is party to the pantomime that they’re regulating these materials.
However, the legal position is clear, as Katherine Watt and Sasha Latypova have patiently demonstrated, repeatedly.
They are “countermeasures”, for use under the discretion of the HHS Secretary, given the prior declaration of a Public Health Emergency, and immunity from prosecution for liability from harms is provided by the PREP Act. These agents are legally & explicitly defined as “non-investigational”, and “their administration to humans explicitly does not constitute a clinical trial”.
Thus, in the clear wording of the regulations under which this operation proceeded and still proceeds, they are not regulated by FDA.
This is why Brook Jackson’s attempt to bring Pfizer to book failed in court. The defence Pfizer advanced, so I read, was that the government was wholly aware of everything that was happening, so no fraud could have taken place. I doubt these words were used, but a summary of the situation was given: “Pfizer delivered the fraud that the government ordered!”
The judge considered the wording and implications of all the laws and regulations & concluded that this was legally correct and that Pfizer had done nothing wrong in the terms of the action brought against them.
There is a difference between legal and lawful. It might all match up with and be consistent with what the law says, but it’s unquestionably unlawful.
You cannot deliberately injure & kill people, lawfully. And that’s what’s happened & is still happening.
Ps: I’m doing my best to represent the position as best I can. To the best of my knowledge, I have faithfully summarized the position. Please check yourself by reference to the Substack writings of Katherine Watt and separately of Sasha Latypova.
Dr. Yeadon - Here are the links to The PREP Act and the FDA EUAs for Pfizer and Moderna. Conflating EUAs with Prep is creating confusion. For clarity see below.
PREP Act, see link, was extended for the 12th time December 2024. ✔PREP authorizes the Secretary of Health and Human Servies to issue a Declaration to provide liability immunity to certain individuals and entities against claims of loss arising from the manufacture, distribution, administration except for claims involving willful negligence. So, MDs, Pharmacists, nurses are protected should they kill and injure a patient due to the administration of the Covid vaccines. The Brook Jackson case confirms it is challenging to sue Pfizer under the circumstances.
https://www.federalregister.gov/documents/2024/12/11/2024-29108/12th-amendment-to-declaration-under-the-public-readiness-and-emergency-preparedness-act-for-medical
✔You stated above the vaccines don't constitute a clinical trial. The FDA EUAs confirm otherwise. Stated in the EUAS - FDA reviewed safety and efficacy from an ongoing 44,000 participants for the Pfizer trial and reviewed 30,351 for the Moderna trial. ✔ You stated above the vaccines are non-investigational. According to the FDA the vaccines are investigational because Pfizer had to submit safety reports based on their investigational New Drug application (IND) number 19736 and Moderna for 19745.
https://www.federalregister.gov/documents/2021/01/19/2021-01022/authorizations-of-emergency-use-of-two-biological-products-during-the-covid-19-pandemic-availability
Conclusion - Because the vaccines are FDA regulated; they can also be withdrawn. Confusing Prep with the EUAs is keeping these vaccines on the market. Keeping vaccines on market generates profits for pharma but continues to put people and especially children at risk of injury or death.
When I read your explanations I either think of a word salad or pretzel talk.
Then there are claims involving “wilful negligence” highlighted in Alison’s work above. There are at least 5 FDA inspections of facilities producing either drug substance or drug product for the ‘vaccines’ that demonstrate gross negligence, with inspectors names included in the FDA 483. A case for wilful negligence could be advanced by lawyers for those impacted by the potentially misbranded drugs…
The research you have carried out here, Alison, is exemplary. A few points to reinforce. An investigational new drug (IND) application was submitted to FDA for Pfizer and Moderna. Why would that be required if the were to bypass FDAs established procedures? Then there are the conditions attached to the EUA, which explicitly required Pfizer and Moderna’s compliance with current Good Manufacturing Practice. To be continued….
Hedley, is Latypova correct to say that there are four _mutually _exclusive ways to get a therapeutic or preventative medication approved? (Not sure of the accurate way to say it.)
Now since an Emergncy Use Authorization EUA can only be appllied when there is a Public Health Emergency PHE, and since the entire mRNA platform has only EUA approval, then if Kennedy repeals the PHE for covid then automatically all covid transfections become illegal immediately.
If the routes are mutually exclusive then they would have to start all over looking for approval again.
I would bet all $4.7 trillion in fraud the DOGE has thus far discovered on the idea that most big pharma drug trials, studies and testing is purely bogus, fake and manipulated.
what you say about fraud & manipulation exists somewhere on the spectrum btw common knowledge and inside info...
72% of biomedical researchers think field is facing a reproducibility crisis: survey
November 2024
https://www.fiercebiotech.com/research/72-biomedical-researchers-think-field-facing-reproducibility-crisis-survey
the above article when taken with multiple ex-editors from the big peer reviewed journals disparaging peer review and the fealty journals pay to big pharma (their main customers/funders) - one begins to pierce the illusion of modern medicine.
from Grok / twitter/x's AI:
Marcia Angell, a former editor-in-chief of the New England Journal of Medicine (NEJM), wrote the book "The Truth About the Drug Companies: How They Deceive Us and What to Do About It" (2004). In her writings, she has highlighted how the pharmaceutical industry has influenced medical research, particularly through financial ties to researchers and institutions.
Jerome Kassirer, also a former editor of the NEJM, authored "On the Take: How Medicine's Complicity with Big Business Can Endanger Your Health" (2005). He discusses how financial conflicts of interest have led to biases in medical research and publication.
Richard Smith, who was the editor of the British Medical Journal (BMJ), has written extensively on the corruption within medical publishing. In an article titled "Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies," he describes how the journals can be compromised by the financial interests of pharmaceutical companies.
while not a peer reviewed journal editor, John Abramson has been on the faculty at Harvard Medical School, where he taught health care policy. He is known for his critique of the pharmaceutical industry's practices, particularly how these practices impact medical research and patient care.
He authored "Sickening: How Big Pharma Broke American Health Care and How We Can Repair It" (2022), where he discusses the pharmaceutical industry's control over medical research and how it misleads doctors and harms patient health. His earlier book, "Overdosed America: The Broken Promise of American Medicine" (2004), also touches on similar themes, highlighting the corruption of medical knowledge by industry interests.
Shut down all the gain of function labs