FDA Versus NAC 2
As ordered by the courts the FDA must release the data it based it's EUA for the Pfizer shot. The FDA requested the courts to keep this information confidential for no less than 55 YEARS!! The court returned with an order to release 500 documents a month.
the first release of 30+ pages on Adverse Events including death.
(How this product wasn't taken off the shelf within the first month is beyond me!)
1227 deaths by February reported.
These are Pfizer and FDA documents....https://phmpt.org/.../11/5.3.6-postmarketing-experience.pdf
it’s not surprising that the FDA wants to slow-walk the release of the rest. In a November 21, 2021 article, Kyle Becker cites directly from the released documents:
“’It is estimated that approximately [REDACTED] doses of BNT162b2 were shipped worldwide from the receipt of the first temporary authorization for emergency supply on 01 December 2020 through 28 February 2021,’ the document states. ‘Cumulatively, through 28 February 2021, there was a total of 42,086 case reports (25,379 medically confirmed and 16,707 non-medically confirmed) containing 158,893 events ...
Most cases (34,762) were received from United States (13,739), United Kingdom (13,404) Italy (2,578), Germany (1913), France (1506), Portugal (866).’
The chart lists 1,223 fatal outcomes in the Relevant Cases. Interestingly, the age range with the most relevant cases was 31-50 years old, which is not the age group considered to be at high risk from COVID-19.”
It’s worth noting that by redacting the specified number of doses shipped, it becomes more difficult to assess the potential ratio of injury. Still, even without that, 42,086 reports of injury, including 1,223 fatalities, are a significant signal in and of itself, especially when you consider that the 1976 swine flu vaccine was pulled after 50-80 deaths.
Glaring Disregard for Life
It’s even more disturbing when you consider that those 42,086 reports were received by Pfizer in just the first 2.5 months of the shot being rolled out. Pfizer even acknowledges the abnormal rate of injuries, but then sweeps it aside as being of no consequence. As noted by Aaron Siri, in a November 19, 2021 article, he discusses this first batch of documents:
“Pfizer explains, on page 6, that ‘Due to the large numbers of spontaneous adverse event reports received for the product, [Pfizer] has prioritized the processing of serious cases…’
FDA Panel Just Barely Recommends Molnupiravir. Data Show Birth Defects in Rats
Health advisors vote 13 for and 10 against Molnupirivir for COVID-19 Patients. Issues with lack of evidence of efficacy against new variants and birth defects cause doubt.
The FDA may or may not take the weak recommendation by a health advisory committee. With 43% of the health advisors voting against recommendation, and the data on Molnupiravir lacking, the US awaits the decision by FDA on its recommendation position on Merck’s alleged “wonder drug”.
I had written early on the extraordinary hypocrisy of Molnupiravir, given that the press had advanced a press-release (not a peer-reviewed study) on the efficacy and safety of the drug. Even now, the peer-reviewed literature only includes studies with less than 20 patients for first-in-human and dose variation study.
Why Ivermectin Is Superior to Pfizer’s Antiviral Pill
Comedian and political commentator Jimmy Dore discusses a video by John Campbell, Ph.D. where he explains the similarities between Pfizer’s expensive new antiviral drug for COVID and ivermectin, and why ivermectin is better.
…A paper from The Royal Society of Chemistry which showed ivermectin, out of dozens of drugs the researchers experimented with, had the “highest score” when it comes to to stopping viral replication of SARS-CoV-2. Notably, the paper showed that Remdesivir, which is currently patented and approved by the U.S. Food and Drug Administration, had the lowest score out of all of the compounds.
Campbell also pointed to a paper from Frontiers in Microbiology, which he said showed ivermectin not only attacked and bound to COVID’s spike protein which stopped it from infecting the cell, but also bound to the cell receptor.
“So it doesn’t just work one way, but two different ways,” explained Dore. “It double screws it up so you can’t get COVID.”
Campbell put it this way: “Not only does ivermectin bend the COVID key, but it also ruins the lock.”
Campbell told viewers:
“So as far as we’ve been told, the new Pfizer drug is only working against one particular biochemical pathway to stop COVID, and with ivermectin, it’s working against that same biochemical pathway to stop COVID but also several others.”
“Why don’t you know this?” Dore asked. “Because ivermectin is cheap, and we live in a world that is made up of corporate propaganda.”
(Note: In other words, patented drugs make the drug companies lots of money while drugs that are no longer patented like Ivermectin, do not. So top priority is NOT YOUR HEALTH BUT BIG PHARMA PROFITS).
How Dr. Paul Marik Saved a Grandmother & The World (Part 3)
…She (Judy Smentkiewicz) was quite amazed to learn from her children that while she was lying unconscious and near death with COVID-19 she became a front-page story in The Buffalo News and a Joan of Arc figure in a new revolution, the grandmother who won the first legal fight in the battle of ivermectin.
It is an unprecedented civil rights uprising of doctors, nurses, scientists, Nobel-Prize winning biologists, billionaire health philanthropists, civil rights activists, and thousands of ordinary people across Europe, Asia, South America, Africa, Canada, and the United States fighting a global, big-data-driven medical establishment. They’re fighting for the lost little things, the little data—the sanctity of the doctor-patient relationship, the survival of the Hippocratic Oath, and the most important of civil rights, the right to life.
Kory sometimes despairs at the forces against him. “Our little ivermectin has so many big enemies,” he says. “It’s David versus ten Goliaths.” But word is getting out. More than twenty countries representing some 20 percent of the Earth’s population use ivermectin, many in their national protocol. Every day it seems Kory hears from someone like the Toronto doctor, a Bulgarian, who used Kory’s data to convince the health ministers in his home country to sign on. Kory talks every day to his growing base of 17,000 Twitter followers, and his peer-reviewed paper on ivermectin recently exploded online as one of the most-discussed scholarly papers ever posted out of seventeen million tracked by Altmetric.
“This is what being a doctor is,” Dr. Berkowitz said. “It says in the Talmud, if you save one life, you save the entire world.”
Every Wednesday night, Kory stars in an FLCCC webinar hosted by former CBS correspondent Betsy Ashton that is an ivermectin 60 Minutes, with Kory talking to the public and answering their questions. Recently he reported that Mexico, the “light and model of the world,” solved an India-like COVID-19 crisis last fall by testing and treating the population with ivermectin, and now has some of the lowest case and death rates on the globe.
He also posted an interview with a prominent surgeon and hospital owner in Visakhapatnam, India, who treats many COVID-19 patients in the tragic current “COVID tsunami,” and passed on the hopeful news that the All India Institute of Medical Sciences in New Delhi has recently approved ivermectin for early and home treatment, “a game changer for India and for the world,” the surgeon said. Ivermectin “saved India in 2020 after it got official permission in Uttar Pradesh in August followed by many other states,” he wrote, but starting in January with many political changes, it “has been getting BAD propaganda by big pharma and big scientists,” and many doctors stopped using it, collapsing prevention and home treatment and seeding the crisis of overloaded hospitals and many needless deaths.
“We BEG health agencies and mainstream media in other countries,” the Indian doctor wrote, “NOT to give BAD PROPAGANDA of ivermectin. Ivermectin is saving India and Africa.”
As he reported the news that night, Kory expressed disgust with “the physician-scientists in the ivory towers and public health agencies” who are “just not getting it.” It was up to doctors now to save lives as the scientists are “completely disconnected to how to treat this disease and what to do.” His mentor takes the longer view. “The saddest thing for us is we know this can make a difference and save lives,” Marik says, “and it seems like nobody really cares and wants to listen to us.” But “we feel we can’t be silenced, we just can’t be, because you know the truth will ultimately prevail.”
“This is how science always progresses,” says Dr. Berkowitz, who takes hope from the recovery of Judy Smentkiewicz. “This is what being a doctor is,” he said. “It says in the Talmud, if you save one life, you save the entire world.”
Religious Exemption for Jewish people via Rabbinical Council
'We are forced to publicly expose what we believe can only be described as a “disinformation” campaign [against #ivermectin] astonishingly waged with full cooperation of those authorities whose mission is to maintain the integrity of scientific research and protect public health.'
https://covid19criticalcare.com/.../flccc-alliance.../
November 16
First they came for the healthcare workers and I did not speak out - because I was not a healthcare worker.
Then, they came for the federal employees and I did not speak out - because I was not a federal employee.
Then, they came for the workers of companies larger than 100 people and I did not speak out - because I was not a worker of a company larger than 100 people.
Then, they came for me - and there was no one left to speak for me.
https://www.reuters.com/.../austria-orders-non.../
“if the data is not validated, the vaxxxx cannot be mandated!”
FDA asks federal court for 55 years to release the data used to approve the pfizer jabs...
FDA Versus NAC
N-acetylcysteine (NAC) is a precursor to reduced glutathione, which appears to play a crucial role in COVID-19. There’s evidence glutathione deficiency may worsen COVID-19 severity
Patients with glucose 6-phosphate dehydrogenase (G6PD) deficiency are more prone to COVID-19 as it depletes glutathione. Some of these patients are also at increased risk of hemolytic anemia when given the COVID-19 drug hydroxychloroquine
High-dose intravenous NAC may address the chain of events leading to red blood cell hemolysis in these patients, allowing them to recover from severe COVID-19
NAC also inhibits expression of proinflammatory cytokines, improves T cell response, benefits a variety of lung problems, and inhibits the hypercoagulation that can result in stroke and/or blood clots that impair the ability to exchange oxygen in the lungs
As the benefits of NAC against COVID-19 are starting to become known, the U.S. Food and Drug Administration is suddenly cracking down on NAC, claiming it is excluded from the definition of a dietary supplement
N-acetylcysteine (NAC) is a precursor to reduced glutathione, which appears to play a crucial role in COVID-19. According to an April 2020 literature analysis,1 glutathione deficiency may be associated with COVID-19 severity, leading the author to conclude that NAC may be useful both for its prevention and treatment.
NAC has a long history of use as a first-aid remedy for acetaminophen poisoning. It neutralizes the toxic effects of the drug by recharging glutathione, thereby preventing liver damage. But the idea that NAC can also be helpful against viral infections is not new. Previous studies2,3 have found it reduces viral replication of certain viruses, including the influenza virus.
In one such study, the number needed to treat (NNT) was 0.5, which means for every two people treated with NAC, one will be protected against symptomatic influenza. That’s significantly better than influenza vaccines, which have an NNV (number needed to vaccinate) of 71,5 meaning 71 people must be vaccinated to prevent a single case of confirmed influenza. It's even better than vitamin D, which has an NNT of 33.
Previous research has shown NAC inhibits the expression of proinflammatory cytokines in cells infected with highly pathogenic H5N1 influenza virus. Proinflammatory cytokines also play a crucial role in COVID-19 severity.
Researchers have confirmed that in severe COVID-19 cases, cytokines such as interleukin-6 (IL6), interleukin-10 (IL10) and TNF-ɑ are all elevated. Once they reach excessive levels, a so-called cytokine storm develops, causing significant tissue damage. NAC may be able to inhibit this damaging cascade.
…NAC may also protect against other problems associated with COVID-19, including the hypercoagulation that can result in stroke and/or blood clots that impair the ability to exchange oxygen in the lungs.
Many COVID-19 patients experience serious blood clots, and NAC counteracts hypercoagulation, as it has both anticoagulant and platelet-inhibiting properties. A 2017 paper also found NAC has potent thrombolytic effects, meaning it breaks down blood clots once they've formed.
This is largely thanks to the sulfur in NAC (from cysteine).
High-dose intravenous NAC may be expected to play an adjuvant role in the treatment of severe COVID-19 cases and in the control of its lethal complications … including pulmonary and cardiovascular adverse events. ~ FASEB Journal August 11, 2020
…Importantly, NAC’s mechanism of action does not appear to increase bleeding disorders like heparin does, so it would likely be a safer alternative to the heparin used in the MATH+ protocol.
…Studies have also demonstrated that NAC helps improve a variety of lung-related problems, including pneumonia and ARDS, both of which are common characteristics of COVID-19.
…Standard of Care for COVID-19 Should Include NAC
Considering many COVID-19 cases involve blood clots in addition to excessive oxidative stress, and NAC effectively addresses both…
…FDA Cracks Down on NAC and Wants to Prevent You From Using It
At present, 11 studies involving NAC for COVID-19 are listed on Clinicaltrials.gov. Ironically, just as we're starting to realize its benefits against this pandemic virus, the U.S. Food and Drug Administration is suddenly cracking down on NAC, claiming it is excluded from the definition of a dietary supplement.
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The U.S. Food and Drug Administration is suddenly cracking down on N-acetylcysteine (NAC), claiming it is excluded from the definition of a dietary supplement. As a result, Amazon has removed all listings featuring NAC-containing supplements
The trade group for the supplement industry, the Council for Responsible Nutrition, is challenging the FDA’s position, calling it “legally invalid,” and is urging its members to continue selling NAC supplements
NAC supplements have been sold for 57 years, and the FDA has never taken action against it — until now, when 16 clinical trials are investigating its usefulness against COVID-19
NAC is a precursor to reduced glutathione, which appears to play a crucial role in COVID-19. There’s evidence glutathione deficiency may worsen COVID-19 severity
NAC inhibits expression of proinflammatory cytokines that can trigger a cytokine storm, improves T cell response, benefits a variety of lung problems, and inhibits the hypercoagulation that can result in stroke and/or blood clots that impair the ability to exchange oxygen in the lungs
N-acetylcysteine (NAC), a precursor to reduced glutathione, appears to play an important role in COVID-19. According to an April 2020 literature analysis, glutathione deficiency may be associated with COVID-19 severity, leading the author to conclude that NAC may be useful both for its prevention and treatment.
NAC has a long history of use as a poison control remedy for acetaminophen poisoning in the emergency room. It neutralizes the toxic effects of the drug by recharging glutathione, thereby preventing liver damage. But the idea that NAC can also be helpful against viral infections is not new. Previous studies have found it reduces viral replication of certain viruses, including the influenza virus.
Early At-Home Treatment Is Crucial
MedCram producer and cofounder Kyle Allred interviews Dr. Roger Seheult, a pulmonologist who has been treating COVID-19 patients since the beginning of the pandemic in 2020, about strategies that can significantly reduce your need for hospitalization should you contract this infection.
Among those strategies is the use of NAC, which used to be readily available over the counter and online. Disturbingly, as more information is coming out about the usefulness of NAC, the U.S. Food and Drug Administration is now clamping down on sales.
Since the beginning of this pandemic, global and national health authorities have done everything in their power, it seems, to discourage and prevent people from accessing any treatment that competes with the COVID jab. This appears to be yet another shameful attempt to prevent patients from helping themselves and boost the risk of infections progressing into more serious cases.
Should you come down with symptoms of COVID-19, early treatment is crucial. Not only can it significantly reduce the length of time that you’re sick, early treatment will also minimize your risk of long-hauler syndrome. A summary of the treatment strategies Seheult reviews in more detail in the video is as follows:
Monitor your oxygen saturation status using a pulse oximeter. If your oxygen saturation drops below 94% at rest, you should seek medical treatment. Below 90%, you are hypoxic and need supplemental oxygen
Use vitamins and other immune-boosting supplements, including vitamins C and D, quercetin, zinc and NAC, and/or medication
In December 2020, the trade group for the supplement industry, the Council for Responsible Nutrition (CRN), challenged the FDA’s position, calling it “legally invalid.”11 CRN argued that FDA records fail to prove that the FDCA section in question actually applies to NAC.
NAC has the ability to reduce mucus secretions and phlegm, as well as to reduce coughing, wheezing and trouble breathing. This makes it helpful in treating conditions including chronic bronchitis (defined as the presence of chronic productive coughs for more than three months in two consecutive years), as well as colds and the flu.
In addition, there’s evidence that it can be an adjunct treatment for chronic obstructive pulmonary disease (the fourth-leading cause of death in the United States) and emphysema.
NAC improves insulin sensitivity and can help those who are susceptible to developing metabolic disorders.
Between 600–1,800 milligrams of NAC daily seems to be effective against many conditions; 600-milligram capsules taken two to three times a day is the recommended dosage to start with.
There’s evidence that 2,000 milligrams is safe for most adults.
Higher doses may be needed to treat certain chronic and degenerative diseases, including COPD, impaired glucose control and cancer. For example, doses of about 2,800 milligrams per day for up to three months seem to be effective for adults with COPD, according to some studies.
In response to a Freedom of Information Act (FOIA) request to the FDA for information proving NAC was investigated as a drug in 1963, all they received was a handwritten letter containing “what appears to be a handwritten approval date of 1963” for an inhaled drug.
An inhaled substance cannot be treated the same as an orally ingested product, hence the NAC drug approved in 1963, if valid, still would not apply to oral supplements. The FDA did approve an NAC drug for oral-only use in 2016, but by then dietary supplement companies had already been marketing NAC supplements for several decades, and therefore cannot be canceled by a new drug approval.
Amazon has apparently decided to side with the FDA, despite the ongoing legal controversy and, as of this writing, has already removed all NAC product listings. Since Amazon owns Whole Foods Market, NAC products may be removed from brick and mortar stores as well. But that doesn’t mean you can’t find NAC elsewhere.
At present, ClinicalTrials.gov lists 16 clinical studies underway or completed involving NAC against COVID-19.14 That’s five more than there were in November 2020.
This includes a still-ongoing Phase 2 trial looking at NAC in patients with severe COVID-19..
Researchers have confirmed that in severe COVID-19 cases, cytokines such as interleukin-6 (IL6), interleukin-10 (IL10) and TNF-ɑ are all elevated. Once they reach excessive levels, a cytokine storm develops, causing significant tissue damage. NAC may be able to inhibit this damaging cascade.
Previous research has shown NAC inhibits the expression of proinflammatory cytokines in cells infected with highly pathogenic H5N1 influenza virus. Proinflammatory cytokines also play a crucial role in COVID-19 severity.
Researchers have confirmed that in severe COVID-19 cases, cytokines such as interleukin-6 (IL6), interleukin-10 (IL10) and TNF-ɑ are all elevated.18 Once they reach excessive levels, a so-called cytokine storm develops, causing significant tissue damage. NAC may be able to inhibit this damaging cascade.
A recent paper published on the preprint server ChemRxiv.org, June 1, 2021, hypothesizes NAC may be used to perturb the spike protein by reducing its solvent accessible disulfide bond, “thereby disintegrating its structural architecture.” By so doing, the virus loses its capacity to infect your cells.
Analyses have shown NAC causes a threefold weakening of the spike protein’s binding affinity with the ACE2 receptor. Other experiments have shown NAC inhibited SARS-CoV-2 replication in VEroE6 cells by 54.3%. According to the authors, “Our observed results open avenues for exploring in vivo pharmaco-preventive and therapeutic potential of NAC for COVID-19.”
NAC Shown to Improve Variety of Lung-Related Problems
Studies have also demonstrated that NAC helps improve a variety of lung-related problems, including pneumonia and ARDS,25 both of which are common characteristics of COVID-19.
NAC Also Protects Against Blood Clots
NAC may also protect against hypercoagulation that can result in stroke and/or blood clots that impair the ability to exchange oxygen in the lungs. Many COVID-19 patients experience serious blood clots, and NAC counteracts hypercoagulation, as it has both anticoagulant and platelet-inhibiting properties.
A 2017 paper also found NAC has potent thrombolytic effects, meaning it breaks down blood clots once they’ve formed. This is largely thanks to the sulfur in NAC (from cysteine). The sulfur reduces the intrachain disulfide bonds by von Willebrand factors that have polymerized by dissociating the sulfur bonds holding them together, thus contributing to the clot.
Once von Willebrand factor sulfur bonds are broken, the clots start to dissolve and the blood vessels open up again allowing for exchange of oxygen and carbon dioxide.
Two additional papers show the same thing. Importantly, NAC’s mechanism of action does not appear to increase bleeding disorders like heparin does, so it would likely be a safer alternative to the heparin used in the MATH+ protocol.