On December 22, 2021, the Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for Pfizer’s Paxlovid, an oral medication regimen for early “treatment” of mild to moderate COVID-19. Paxlovid is a combination drug therapy consisting of Pfizer’s Nirmatrelvir co-packaged with Ritonavir (Norvir), a drug used in the treatment of HIV. According to the FDA’s authorization letter, “PAXLOVID is comprised of nirmatrelvir, a SARS-CoV-2 main protease (Mpro; also referred to as 3CLpro or nsp5 protease) inhibitor, co-packaged with ritonavir, an HIV-1 protease inhibitor and CYP3A inhibitor. Ritonavir, which has no activity against SARS-CoV-2 on its own, is included to inhibit CYP3A-mediated metabolism of nirmatrelvir and consequently increase nirmatrelvir plasma concentrations to levels anticipated to inhibit SARS-CoV-2 replication. PAXLOVID is not approved for any use, including for the treatment of COVID-19.”
This is another experimental medication regime fast-tracked (Pfizer used the term “light speed” as will be covered later) for use by the public.
Before continuing, a review is necessary to understand all of this. SARS-CoV-2, the “virus” that supposedly causes the illness COVID-19, has never been isolated, purified, or proven to exist, nor proven to cause disease or illness in humans or animals. The genome for SARS-CoV-2 was created in silico meaning on a computer and a “consensus” of individuals determined which genome created was SARS-CoV-2. None of the studies claiming isolation and purification met Koch’s or Rivers’ postulates, the medical science gold standard of bacterial/viral verification. Without the isolation, purification, or proof of disease causation with an original strain, no determination can be made for “variants”. Moreover, without an isolated, purified viral particle, testing using any mechanism is moot and fraudulent. Using an RT-PCR test is inappropriate for use as a diagnostic tool according to its inventor, Kary Mullis. Armed with this knowledge, the Pub Med studies cited in the series will show in silico modeling being used for determination of findings. Remember, all the information is based on the theory that viruses exist despite the lack of proof of such and lack of isolation of any virus or proof viruses cause illness in humans.
A brief review of some of the terms is necessary to understand the mechanisms of PAXLOVID.
CYP3A is also known as cytochrome P450 family 3 subclass A. It is responsible for drug metabolism in the liver and intestines. When CYP3A is inhibited, it increases the amount of medication or drug in the blood stream also known as plasma concentrations.
RdRP is known as RNA dependent RNA polymerase. These are proteins involved in the replication of RNA viruses.
According to the FDA EUA letter to Pfizer, PAXLOVID “may be effective for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, as described in the Scope of Authorization (Section II), and when used under the conditions described in this authorization, the known and potential benefits of PAXLOVID outweigh the known and potential risks of each product.”
The letter references the clinical trial EPIC-HR (NCT04960202). Clinicaltrials.gov indicates the status is “recruiting”. When accessing the data, the study start date was July 16, 2021, and the completion date is expected April 21, 2022. This is not even one year of investigation and means the trials are in phase 3 in a matter of months. In looking at the eligibility criteria for the study, it indicates the ages eligible are 18 years and older. There are no studies involving PAXLOVID for children less than 18 years of age, but the FDA has approved this regimen for ages 12 and older. Moreover, pregnant and lactating women were excluded from the study. Yet, the EUA letter does not indicate an exclusion for pregnant and lactating women. As will be shown later, both the patient fact sheet and health care provider fact sheets claim there is no data for treating pregnant and lactating women with PAXLOVID. Both of these can be found at www.COVID19oralRX.com. The clinical trials for PAXLOVID have 359 locations. Only one location has an “active, not recruiting” status – Atella Clinical Research in Long Beach California. The remaining 358 have statuses of “recruiting” or “not yet recruiting”. The indicated last update was on December 2, 2021.
It is known that is takes years and billions of dollars to develop medications for any type of disease or illness. Yet, Pfizer’s “light speed” development and production of nirmatrelvir took place in the span of a year before starting a trial in July 2021. Does anyone think “light speed” is coincidental? It sounds very similar to “warp speed”. If you watched the TV series Star Trek, you would know that warp speed means a hypothetical speed faster than the speed of light. It appears Pfizer is taking “Operation Warp Speed” to new levels – drug development (injections and oral) at an unreasonable speed while comprising safety and skipping steps.
There is plenty of controversy surrounding Pfizer’s PAXLOVID. Bloomberg Law reported there was a “row” concerning skipping a step in the approval process. “The FDA authorized Pfizer Inc.’s pill to treat Covid-19 without first getting input from a panel of clinical advisers, a move public health professionals say could further undermine trust in an agency already facing scrutiny over its rapid decision-making during the pandemic.” It is usually standard for the FDA to convene a panel of advisors to review information before “authorizing” a therapeutic for use. However, what we have come to expect from this agency is a “warp speed” authorization of anything that would benefit stakeholders in these pharmaceutical companies at the expense of the people.
In the next series, we’ll look at recent history to see how this treatment regimen of PAXLOVID could have come into development through previous studies on combination drug therapy. In the meantime, remember, when taking any therapeutic authorized for emergency use only, it is considered experimental, and you are the test subject. As always, buyer beware of EUA experimental therapeutics. You are literally out on a limb alone.
This is part one of a three-part series.
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