Readers may be interested why there is such resistance to alternate treatment therapies for Covid-19. Why you may lose (or have lost) your job if you don't submit. Why loved ones in the hospital for Covid-19 treatment die or have kidney or liver failure.
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| November, 2020 |
The link below
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/214787Orig1s000Sumr.pdf
takes you to a summary review of the Veklury/Remdesivir FDA emergency authorization.
CENTER FOR DRUG EVALUATION AND RESEARCH
APPLICATION NUMBER:
214787Orig1s000
SUMMARY REVIEW
First off, from page 1: "Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care compatible to inpatient hospital care."
This means that treatments like hydroxychloroquine and ivermectin, that can be administered by anyone anywhere, are not acceptable as they eliminate the need for expensive "inpatient hospital care."
On page 2 we see: "Clinical virology data was not submitted for the ACTT-1 trial. ... Clinical virology data was not submitted for either GS-US-540-5773 or GS-US-540-5774."
Hmmm...
And also on page 2: "RDV has an acceptable safety profile for the indicated patient population. The major safety issues identified were hepatotoxicity and hypersensitivity reactions. Hepatotoxicity, manifested as an elevation in transaminase levels, was well-characterized in Phase 1 trials in healthy subjects and appears to be related to both increasing dose and longer duration of administration. In healthy subjects, the transaminase elevations do not demonstrate a clear association with other adverse events, and transaminase values returned to baseline levels after stopping the drug. No clear difference in graded transaminase levels between the RDV and placebo arms was demonstrated in the ACTT-1 trial. Hypersensitivity reactions, including infusion-related and anaphylactic reactions, have been reported during and following administration of RDV. Signs and symptoms included hypotension, hypertension, tachycardia, bradycardia, hypoxia, fever, dyspnea, wheezing, angioedema, rash, nausea, vomiting, diaphoresis, and shivering."
Hepatotoxicity is "chemical damage"to your liver.
But there is apparently no need to worry as "In healthy subjects, the transaminase elevations do not demonstrate a clear association with other adverse events, and transaminase values returned to baseline levels after stopping the drug."
One has to ask: How does this damage get repaired?
Page 3 brings us to this: "There are no FDA-approved drugs for the treatment of COVID-19. On May 1, 2020, the FDA issued an Emergency Use Authorization (EUA) for RDV for the treatment of suspected or laboratory confirmed COVID-19 in adult and pediatric patients hospitalized with severe disease. On August 28, 2020, the FDA expanded the scope of the EUA to include the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adult and pediatric patients irrespective of disease severity."
So if something like ivermectin or hydroxychloroquine were approved or already worked for Covid-19 there would be no need for Veklury/Remdesivir. Seems very clear why these things are taboo ("FSMB: SPREADING COVID-19 VACCINE MISINFORMATION MAY PUT MEDICAL LICENSE AT RISK" fsmb = Federation of State Medical Boards):
"Physicians who generate and spread COVID-19 vaccine misinformation or disinformation are risking disciplinary action by state medical boards, including the suspension or revocation of their medical license. Due to their specialized knowledge and training, licensed physicians possess a high degree of public trust and therefore have a powerful platform in society, whether they recognize it or not."
"Information" - the correct information you must believe - comes, according to the link above, from here: https://www.fsmb.org/advocacy/covid-19/
On page 5: "To date, the Applicant has not conducted a hepatic impairment study, renal impairment study, dedicated QT study, or any clinical drug-drug interaction (DDI) studies" and page 10: "Renal/Hepatic Impairment: There were no dedicated studies conducted in patients with renal or hepatic impairment. Currently, there is insufficient evidence to conclude that hepatic or renal impairment will not affect PK of RDV. Post marketing requirements (PMRs) will be issued to conduct studies in patients with renal and hepatic impairment (see Section 13)."
So, don't worry, someday someone will look into this toxicity problem...
Anyone here of the PMRs listed above?
On page 11 we see why the pushback was so strong on hydroxychloroquine: "Drug-drug interactions (DDIs) The antiviral activity of RDV was antagonized by chloroquine phosphate in a dose-dependent manner when the two drugs were co-incubated at clinically relevant concentrations in HEp-2 cells infected with respiratory syncytial virus (RSV)" and "A warning will be included in the PI to assist in risk mitigation (see Section 12), and a PMR will be issued for the results of the assessment of the effect of chloroquine/hydroxychloroquine on the antiviral activity of RDV against SARS- CoV-2 in human lung cells (see Section 13)."
If you are interested in renal failure, take a look at page 25: "A renal safety signal was identified in nonclinical studies (see Section 4); however, no evidence of renal toxicity was demonstrated in early phase clinical trials in healthy volunteers."
And, apparently, since Covid-19 damages livers (?): "Hepatic safety data from trials in COVID-19 are difficult to evaluate as hepatic injury is a common feature of COVID-19."
Given all this, then, you might no longer wonder why videos like https://rumble.com/vm936v-whistleblower-nurse-destroys-delta-narrative-vaccinated-patients-fill-hospt.html and https://www.bitchute.com/video/IC2LQQpieYl6/?fbclid=IwAR1M_nAdgt-pJU8mu7v3kOWyY0D2UnvKWyB0XIC-FuTtbV4gmz2MWMw41bQ are subject to censorship...
And this link provides an interesting perspective on what testing of this drug did relative to the "endpoint" of testing. Since Covid-19 was not well known or understood at the time of these tests what exactly was being tested in terms of recovery and affects.
You can see that hepatotoxicity, for example, was considered to be something caused by Covid-19. Today, with the millions of cases (if you believe in PCR) that's probably not the case.
So, long before anyone really knew anything about Covid-19 we have this (from a year ago):
“This will be the standard of care,” Fauci, a White House advisor on the pandemic, said during comments from the Oval Office. Fauci said the results, which have not yet been peer-reviewed, prove “that a drug can block this virus.”
Compare that to this data: https://c19early.com/
Understand as well that this drug only makes an improvement, one of perhaps 31%, relative to, at the time, nothing.
Note that before the vaccine was released there was plenty of "alternative" ideas - including ivermectin and hydroxychloroquine (see: https://www.frontiersin.org/articles/10.3389/fmolb.2020.606393/full).
Yet there were not pursued in favor of big pharam...
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