August 23, 2020 Dr. Vladimir Zelenko
Rationale:
The Coronavirus, also known as Covid-19, or Sars-CoV-2, is reported in the news as “novel,” or new. However it shares 80% similarity to Sars-CoV-1, the Sars virus, and it’s cousin, the Mers virus, so there is really nothing all that “novel” about the current pandemic virus, except that in this pandemic, like never before, the response of GOVERNMENT has been completely, “novel.”
Like everything else about the Coronavirus, it is surrounded by a complex web of intentional lies. Lies about its origin. Lies about its character. Lies about its severity. Lies about its very existence. Lies told through models. Lies about the actual death counts and case counts. Lies reported on the news. Lies from our own government. Lies that have resulted in countless deaths because a known treatment that works, the Dr. Zelenko Protocol, has been systematically demonized, discredited, and banned, and another treatment that makes far more money for the CDC/NIH/FDA/Big Pharma Cabal, the drug Remdesivir, has been substituted in its place. This was done at the altar of greed, corruption, and obsession, by a Technocracy of alleged “experts,” headed up by the always media dominating, Dr. Anthony Fauci. They did this by using the FDA procedure for bypassing the regular procedures for approving a new drug, treatment or therapy, the “Emergency Use Authorization,” or EUA, to substitute “their” drug choice, Remdesivir, which is still “experimental,” very expensive at $3,200, and very profitable, for the Zelenko Protocol, which if used in the early stages of the Coronavirus, works, and costs about $20.
Dr. Zelenko, Dr. Gold, and other pioneering and life saving doctors can document the whole story when they testify in open hearings before Congress, to counter the never ending stream of lies from Dr. Anthony Fauci, and other key players at NIH, CDC, and FDA, all to enrich themselves and their benefactors at the companies known as “Big Pharma.” Dr. Zelenko reported to Action Radio in an extended interview that in his judgment this is a crime against humanity, where potentially 84% of all those lost to the Coronavirus, could have been saved, if the Zelenko Protocol of Hydroxychloroquine, zinc sulfate, and azithromycin, drugs that have been around, and government approved, for decades, had the Emergency Use Authorization from the FDA so the Zelenko Protocol could have been implemented immediately, instead of, or in addition to, Remdesivir.
This evil was made possible by the specific use of this one provision of the section in Title 21 we are amending.
“(3) that there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such disease or condition;”
This is the clause that has allowed the FDA to grant an EUA for Remdesivir, and block the Zelenko Protocol, when the FDA declared that there was no alternative to Remdesivir, despite obvious evidence, proof, and loud testimony to the contrary. To sell this travesty to the President, the Congress, the States, the Governors, the Mayors, and everyone else, Hydroxychloroquine (HCQ) in particular, has been denied an EUA, and has been demonized and discredited as described above, in an effort to prove it is not an alternative. Our legislation deletes this provision.
Please note that our new language of this section does not limit viable therapies in their number, nor in the stage of any pandemic disease when they may be implemented, because it is in the public interest to use the best available therapies, be they several in number, at the stage of any disease where they will be the most effective. This will also prevent the government / pharmaceutical / industrial complex, from gaming the system for their profit, at the cost of hundreds of thousands of American lives, depending on the severity of this, and future pandemics.
Please note also that this legislation breaks the dominance of the CDC/NIH/FDA agencies, from effectively running the entire government effort dealing with the current pandemic, and running virtually everything else in the country as well. To do this, a separation of powers and authority, modeled on the Constitution, has been brought into the process of granting a letter of Emergency Use Authorization, such that no one unit of government can concentrate all power within themselves. This is especially valuable because the current government health agency cabal is without any specific delegation of power to the Federal Government in the Constitution to create them in the first place. The FDA has no such delegation at all, and the CDC as stated on their own website, that they derive their power and authority from the Commerce Clause.
There are still huge problems to be investigated that are beyond the scope of this citizen legislation. For example: why did Dr. Fauci announce a week before President Trump was inaugurated, that he would most likely face a pandemic during his Administration? What did he know then? Why did the CDC change the Pandemic Guidelines a mere three months after President Trump took office, deleting the Pandemic Severity Index from the 2007 Guidelines which called for a graduated response to a pandemic, with five categories that reflected an increasing death rate and separate recommendations for each category, and substituted new Guidelines, April 21, 2017, that allowed for recommending full lockdowns, house arrest procedures, social distancing mandates, and mandatory mask wearing, all without actual mandates, just “recommendations,” based only on models that turned out to be hopelessly wrong, and before the pandemic had actively begun? Why did so many State Governors turn those recommended mandates into actual mandates, completely violating a long list of constitutional rights? Was it the work of Dr.Fauci who admitted in one press briefing that he “talks to the Governors all the time?” For this a genuine, public, televised, national oversight hearing from Congress, must be initiated as soon as possible.
These and other crises will be addressed in subsequent citizen legislation which shall be submitted to Congress. But for this citizen legislation, and for the lives it will save as soon as it goes into effect, Congress has to override the current FDA Commissioner, and mandate that the Secretary of Health and Human Services, grant an immediate letter of Emergency Use Authorization to the Dr. Zelenko Protocol. To accomplish and facilitate that, we submit for your consideration, this citizen written legislation to change the “Criteria for Issuance of Authorization.” The citation in the US Code is:
LII U.S. Code Title 21. FOOD AND DRUGS Chapter 9. FEDERAL FOOD, DRUG, AND COSMETIC ACT Subchapter V. DRUGS AND DEVICES Part E. General Provisions Relating to Drugs and Devices Section 360bbb–3. Authorization for medical products for use in emergencies.
Our proposed amendments:
360bbb-3 (c) Criteria for issuance of authorization: Is hereby amended by striking the current language, and inserting in its place, the following:
The Secretary (of Health and Human Services) may issue an authorization under this section with respect to the emergency use of a product in consultation with the Assistant Secretary for Preparedness and Response, the Director of the National Institutes of Health, and the Director of the Centers for Disease Control and Prevention.
The President may issue an authorization under this section in consultation with the Surgeon General in the form of an Executive Order directing the Secretary to issue the authorization.
Congress may direct the Secretary to issue the authorization under this section through legislation, signed by the President, or through override of a veto.
Congress shall also, through open hearings, take testimony from private doctors seeking an Emergency Use Authorization, who have independently tested a drug or combination of drugs, or therapies, or technologies, and have evidence or testimony to present to the Senate Committee on Health, Education, Labor and Pensions, and/or the House Energy and Commerce Committee, regarding the efficacy or potential of their findings, trials, other clinical study, or actual results with patients.
(to the extent feasible and appropriate given the applicable circumstances described in subsection (b)(1)), the Secretary, the President, or the Congress concludes—
(1) that an agent referred to in a declaration under subsection (b) can cause a serious or life-threatening disease or condition;
(2) that, based on the totality of scientific and medical evidence available, it is reasonable to believe that;
(A) the product may be effective in diagnosing, treating, or preventing— such disease or condition that has caused the emergency declaration or pandemic.
(B) the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product, taking into consideration the material threat posed by the agent or agents identified in a declaration under subsection (b)(1)(D), if applicable;
(3) Given the extreme emergency nature of a pandemic or epidemic, the death toll that can accumulate rapidly, such that there is no time for extended or even regular clinical trials, particularly randomized controlled trials (RCT), during an emergency declaration, and as such shall not be required for an EUA authorization.
(A) There can not be a specific limit to the number or type of lifesaving drugs, therapies or technologies that can be considered for an EUA during a declared emergency, nor a restriction on their source, such as private, corporate, academic, or government, so long as they meet the conditions and criteria of (c), (1) and (2) (A)&(B).
(B) EUA’s may also be issued for different stages of a pandemic, epidemic, or disease emergency using different drugs, treatments or therapies for individual or multiple stages. Dividing treatments into three stages for a disease will allow for different drugs, therapies and technologies, to be administered at the most opportune time, or times. Stage One shall be the Incubation period. Stage Two shall be the Symptomatic period. Stage Three shall be the Hospital or Critical period.
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