Horowitz: Sen. Johnson calls out the FDA for not approving promising late-stage COVID drug



Novel gene therapies and therapeutics were approved, marketed, distributed, funded, and in some cases mandated by the government based on nothing more than data by the manufacturers themselves. Yet, to this day, not a single “Right to Try” has been approved even for drugs that are proven safe. This is true of dozens of treatment ideas for early treatment, but is even more poignant for late-stage COVID, where few ideas seem to work when the vicious cytokine storm causing severe lung inflammation sets in. One drug you never heard of is ZYESAMI (off-patent aviptadil), but Sen. Johnson believes people dying of COVID need at least one option.

In a recent letter co-authored by Sen. Ted Cruz and Reps. Andy Biggs and Chip Roy, Sen. Ron Johnson demands answers from the Food and Drug Administration (FDA) and the National Institute of Allergy and Infectious Diseases (NIAID) as to why they have refused to even entertain the emergency use authorization request or even review the data from ZYESAMI manufacturer NRxPharmaceuticals on its efficacy against COVID. Like ivermectin, fluvoxamine, hydroxychloroquine, methylprednisolone, and numerous other drugs tried for COVID, ZYESAMI has an established safety profile and is off patent. Unlike any of the other drugs, though, it has never been fully approved by the FDA. Thus, obviously it’s not going to be a candidate for outpatient treatment. However, it is the only drug that does seem to have some promise for acute stages of cytokine storms because it has been used around the world since the 1970s for acute respiratory distress syndrome (ARDS), COPD, and asthma.

Aviptadil was awarded “orphan drug designation” in 2001 by the FDA for the treatment of ARDS, for pulmonary arterial hypertension in 2005, and for pulmonary sarcoidosis in 2021. Orphan drug designation is granted for products that are intended to treat life-threatening or chronically debilitating conditions affecting less than 200,000 patients.

Sen. Johnson wants to know why the FDA refuses to look at this late-stage drug that already has approval for pulmonary inflammatory disorders when we still have no other options other than the failed remdesivir, which is dangerous and ineffective. Sen. Johnson spoke to a physician who used this drug on 20 patients, and this is what he reported:

According to the physician, more than 20 patients suffering respiratory failure from COVID-19 received ZYESAMI as authorized under Right to Try. It is our understanding the patients received ZYESAMI after prior administration of remdesivir did not improve the patients’ conditions. All the patients were at the very end stage of COVID and were not expected to recover. Upon receiving ZYESAMI, no serious adverse events associated with use were reported and 16 of the 20 patients left the hospital. According to the physician, patients with ARDS normally have a 40 percent mortality rate. With ZYESAMI, the mortality rate decreased to roughly 10 percent.

Well, if the FDA was unwilling to authorize approval of the FDA-approved ivermectin, it’s not surprising the agency would drag its feet on an EUA for something that has not been approved for other conditions, especially if it’s off patent and there is not a lot of money to be made.

In an interview with TheBlaze, Dr. Flavio Cadegiani, a Brazilian endocrinologist who has treated 2,400 COVID patients without losing a single one, was very bullish on the mechanism of action of this drug against the virus. “Aviptadil is a drug that mimics vasoactive intestinal polypeptide (VIP), however, with prolonged effects, compared to the endogenous (produced by the body) VIP,” explained the doctor, who has innovated for two years to save lives. “VIP and aviptadil act in a type of lung cell called alveolar type II (AT-2), that, although representing just as few as 5% of the cells in the lungs, are largely responsible for oxygen transfer and inhibition of dysfunctional hyper inflammatory reaction and cytokine storm, through the inhibition of the activity of one of the main triggers of these reactions, called NMDA-induced caspase-3.”

Dr. Cadegiani, who has co-authored numerous studies exploring several other treatments for COVID, notes that “to date, there is no other molecule capable of working at late stage against COVID-19, and at the same not causing immunosuppression.”

He also believes aviptadil blocks the IL-6, the most dangerous cytokine at the center of the pulmonary dysfunction related to COVID-19. “The importance is that IL-6 is the cytokine that is not effectively blocked by glucocorticoids, even in very high doses. Thus, aviptadil/VIP could confer additional protection when we most need and when we have the fewest resources for.”

He went further to suggest that it is downright malpractice for hospitals not to try this drug at late stage, given the absence of alternatives. “Due to the absence of therapeutic alternatives targeting AT-2 and IL-6, and given the already well-established safety profile, its approval goes beyond the attempt-to-try principle, since it is highly plausible and likely that it works. Therefore, instead of an action of attempt-to-try when giving aviptadil, not providing it when patients fail to respond to other therapies can be considered a medical negligence, from a bioethical perspective.”

A study published in India on the pharmacological effects of aviptadil on COVID concluded as follows: “All the evident data, published based on clinical trials, seem to be very fruitful in defining a pharmacological guideline for COVID care. In recent clinical trials, the overall target result is that there is a tremendous improvement in life expectancy, by optimizing oxygenation and surveilling cytokine storm in COVID-19–induced respiratory failure.”

In the letter, Sen. Johnson notes that already almost a year ago – before the entirety of the deadly Delta wave that resulted in hundreds of thousands of American deaths – Dr. Fauci himself touted the promise of ZYESAMI, but has refused to rush any trial the way he did remdesivir and Merck’s and Pfizer’s drugs, which, as pure antivirals, have zero promise beyond the first few days (if even then).

The letter asks a series of questions of the FDA and NIAID requesting they produce documentation of their work on ZYESEMI, along with an explanation of their recommendation on how to treat late-stage COVID if they refuse to approve any options. The letter also provides testimony from three citizens who had loved ones recover almost immediately after using ZYESAMI, including Marylander Michael Tuttle, whose wife was turned around with the drug after being on a ventilator.

Consider the fact that FOIAed documents now reveal that Pfizer knew of 1,223 reported possible fatalities from the shot early on and continued to go through with a process that made their novel therapeutic the most promoted, and then mandated, product in history for people who are not even sick. Yet, for those already on their deathbeds, our government won’t approve and make available drugs with established safe mechanisms of action. And they have stifled or attacked every single early treatment idea, including simple nasal sprays.

In my practice, the use of nasal/oral rinses with dilute povidone iodine or dilute hydrogen peroxide has been the biggest advance for both prevention and as a adjunct to early treatment. Supported by 12 clinical studies of which 3 are high quality RCT's.pic.twitter.com/ldtTyFI8gh
— Peter McCullough, MD MPH (@Peter McCullough, MD MPH) 1646740851

The most salient question we must explore as U.S. COVID deaths approach 1 million is how many lives could have been saved had our government authorized, much less promoted, safe, established drugs from day one with the same alacrity that it promoted novel, unproven, and ultimately failed therapeutics? It’s not just a matter of justice for the past, but prudence for the next iteration of this virus and others coming down the “pipeline.”

Finally, ask yourselves if you trust this same government to make decisions on war, peace, and energy policy that affect our national security and the lifeblood of our economy, if they were willing to do this to our bodies.

Study finds compounds in hemp may prevent COVID virus from infecting people



Researchers at Oregon State University say that chemical compounds found in hemp can block the virus that causes COVID-19 from entering human cells.

Those findings come from a study published Monday in the Journal of Natural Products, authored by Richard van Breemen, a scientist with Oregon State’s Global Hemp Innovation Center, College of Pharmacy and Linus Pauling Institute.

Van Breeman said that hemp, known by its scientific name as Cannabis sativa, contains a pair of cannabinoid acids that bind to the SARS-CoV-2 spike protein, preventing the virus from infecting people. With the help of his colleagues, van Breeman discovered that two acids, cannabigerolic acid, or CBGA, and cannabidiolic acid, CBDA, target the same spike protein that COVID-19 vaccines and antibody therapy target to prevent and treat the disease.

“These cannabinoid acids are abundant in hemp and in many hemp extracts,” van Breemen said. “They are not controlled substances like THC, the psychoactive ingredient in marijuana, and have a good safety profile in humans. And our research showed the hemp compounds were equally effective against variants of SARS-CoV-2, including variant B.1.1.7, which was first detected in the United Kingdom, and variant B.1.351, first detected in South Africa.”

According to OSU, the variants van Breeman referred to are the alpha and beta variants of COVID-19, respectively.

Van Breeman explained that the SARS-CoV-2 virus has crown-like protrusions on its outer surface, RNA strands that encode its four main structural proteins — spike, envelope, membrane, and nucleocapsid — as well as 16 nonstructural proteins and several "accessory proteins," according to OSU.

“Any part of the infection and replication cycle is a potential target for antiviral intervention, and the connection of the spike protein’s receptor binding domain to the human cell surface receptor ACE2 is a critical step in that cycle,” he said. “That means cell entry inhibitors, like the acids from hemp, could be used to prevent SARS-CoV-2 infection and also to shorten infections by preventing virus particles from infecting human cells. They bind to the spike proteins so those proteins can’t bind to the ACE2 enzyme, which is abundant on the outer membrane of endothelial cells in the lungs and other organs.”

He observed that compounds that block virus-receptor interaction have been used in treatments for other viral infections, including HIV-1 and hepatitis, and could similarly be used to treat COVID-19.

The scientific team at OSU used a mass spectrometry-based screening technique invented in van Breeman's laboratory to discover the compounds. They screened a range of botanical compounds used as a dietary supplement including red clover, wild yam, hops, and three species of licorice, OSU said.

Hemp is a source of fiber, food, and animal feed. Multiple hemp extracts and compounds are used in cosmetics, body lotions, dietary supplements, and food.

“These compounds can be taken orally and have a long history of safe use in humans,” van Breemen said. “They have the potential to prevent as well as treat infection by SARS-CoV-2. CBDA and CBGA are produced by the hemp plant as precursors to CBD and CBG, which are familiar to many consumers. However, they are different from the acids and are not contained in hemp products.”

Horowitz: The blueprint for ending COVID and COVID fascism in 2022



Resolved, that the several states composing the United States of America, are not united on the principle of unlimited submission to their General Government. ~ Thomas Jefferson, Kentucky Resolution

Republicans who maintain robust power in numerous red states need to commence 2022 with a simple New Year’s resolution: that they will actually fight back against federal fascism on all fronts and interpose themselves between the Washington tyrants and the liberties of their citizens. With nearly every legislature getting into session in the coming days, now is the time for the people’s voices to be heard.

If 2020-2021 was the Great Reset for the global elites, 2022 must be the Great Restoration for the ordinary citizens to launch a counterattack against the assault on our way of life. The counterattack begins in the state legislatures. What follows is a non-exclusive list of must-pass items if we are to remain a free and healthy society unshackled by the bio-medical state created in March 2020.

1) The Fight for Treatment of Our Sick

There is no greater liberty than the right to life. With gain-of-function bioweapons unleashed upon us, we should have the right to access, and doctors should have the right to provide, science-based treatment. The war on treatment of COVID has exposed the broken and corrupt government-corporate monopoly over medicine. In order to take back the personal right to remain alive and healthy, we need a bill that will accomplish the following:

a) Doctors must not be penalized with medical licensure threats because they share documented medical information or their own professional experience and observations concerning this or other viruses, treatments, or ailments. Those who speak up against public officials, if done in the public interest, may not suffer undue retaliation in the form of loss of board certification, licensure, or loss of privileges.

b) Doctors must also not be penalized for prescribing any off-label (but FDA-approved) drug that is clinically indicated to treat patients so long as they, unlike the vaccine cult, provide their patients with informed consent.

c) All medical licensing board officials should be subject to removal by the legislature.

d) All pharmacists must fill FDA-approved prescriptions for medications for off-label use so long as they are prescribed by a licensed practitioner. Failure to fill a prescription, absent a conscience objection, would result in a $100,000 fine or revocation of license.

e) All insurance companies operating in the state must cover any prescription written to treat viruses and cannot discriminate. If they can pay $3,000 for the failed and dangerous remdesivir, they can certainly pay for cheap, proven, and safe repurposed drugs.

f) Every state should set up a treatment page similar to what Florida did and encourage, rather than discourage, doctors to prescribe early and often.

g) All hospitalized patients must be allowed always to have one surrogate present in the hospital.

h) All hospitalized patients must be allowed to access FDA-approved drugs off-label prescribed by a doctor at their own expense if they agree to assume liability, along with the right to refuse any hospital-prescribed treatment. A cause of action must be granted to patients to sue hospitals who violate the right-to-try law. All hospitals must be barred from “medical kidnapping,” whereby they prevent a patient from being released or transferred.

i) No patient can be denied an organ transplant on account of injection status.

2) The Fight for Control Over Our Bodies

a) A complete ban on the ability of any private or public-sector official to force an individual to wear a mask or get a shot. We must apply anti-discrimination law, ADA, and OSHA workplace standards evenly. The slate is not clean when it comes to such egregious human rights violations of “the private sector,” and we must not shy away from enforcing against the most inhumane breaches of existing laws and standards.

b) As it relates to public-sector mandates, there must be an effort to place constitutional amendments on the midterm ballots, where feasible, to codify bodily integrity rights into the state constitutions.

c) Prescribe prison time for any local official who forcibly masks children.

d) A ban on all discrimination by insurance companies in terms of coverage for those without the shot; a ban on all discrimination for goods and services in the realm of public accommodation; and a ban on all discrimination or punitive actions taken against any health care provider or patient for opting not to get the shots.

e) Institute a cause of action for citizens to take legal action against those who violate the ban and for anyone injured as a result of getting the shot due to intimidation in the workplace.

3) The Fight to Protect the National Guard

a) The state should assume full control of its National Guard and ensure that the guardsmen are not subject to the same mandate as the entirely federal military.

b) States should create their own non-federalized militias as landing places for soldiers residing within the state from the other branches of the military who are now out of a job.

4) The Fight for Medical Privacy

a) Nobody's vaccination status should be recorded without the affirmative consent of the patient.

b) A provision requiring schools to accept religious exemptions for all other vaccine mandates.

c) A ban on contact tracing or the forced quarantine of any individual who has not been infected with an actual disease that A) has been proven deadly and B) has not already proliferated through large portions of the population.

d) A categorical ban on the authority of any state or county official, including the governor, to issue a stay-at-home order or to shut down businesses carte blanche under the guise of public health.

5) The Fight for Transparency

a) Each state should form a temporary COVID committee to hold hearings and audits of all the current actions taken by the federal and respective state governments predicated on a purported scientific premise regarding the virus, the vaccines, or treatment. Based on the findings, any policy found to be out of sync with evidence of safety and efficacy must be terminated and defunded.

b) State legislative health care committees must conduct full investigations of the treatment of patients in hospitals. The scope of investigation should include an audit and analysis of the therapeutics used, the therapeutics rejected, the deviation from standard and established care for patients in respiratory distress, and any allegations of mistreatment or discriminatory actions taken by hospital staff.

c) Every state should pay for a full audit of every individual who died within the 30-day investigative window of taking the shot.

d) Every state should establish its own vaccine adverse event database and encourage, rather than discourage, doctors to use it.

e) All funding currently used for marketing the shots should be redirected toward funding and marketing proven treatments the committee will study.

6) The Fight for State Sovereignty

a) Every state should pass a law that enables the state legislature, through concurrent resolution, to declare any act of any of the three federal branches unconstitutional, thereby having the effect of criminalizing its enforcement within the state’s boundaries.

b) Legislatures, in accordance with the process to change state constitutions, must make it easier to get back into session immediately to deal with federal usurpations, so the people don’t have to wait 6-12 months for them to get back into session in do the people’s business.

Make sure there is someone in your state’s legislature championing each one of these items. If not now, then when; if not us, then whom? More than ever, we must remember the admonishment of John Adams in the pre-revolutionary times:

Let us contemplate our forefathers, and posterity, and resolve to maintain the rights bequeathed to us from the former, for the sake of the latter. The necessity of the times, more than ever, calls for our utmost circumspection, deliberation, fortitude and perseverance. Let us remember that “if we suffer tamely a lawless attack upon our liberty, we encourage it, and involve others in our doom.” It is a very serious consideration … that millions yet unborn may be the miserable sharers of the event.

Female COVID-19 patient in critical condition given Pfizer's Viagra — and she wakes from month-long coma to go home on Christmas Eve: Report



A U.K. woman was roused from a month-long COVID-19 coma with a round of Pfizer's male erectile dysfunction drug, Viagra, according to reports.

What are the details?

Monica Almeida, a 37-year-old respiratory specialist nurse, contracted COVID-19 in November, and following virus complications including pneumonia, she ended up in the hospital, where she fought for her life.

Her illness, which reportedly became so severe that her parents were told to fly to England in preparation for her final moments, progressed to the point where she was put into an induced coma — a condition in which she remained for a month.

According to the Lincolnite, doctors opted to treat Almeida with Viagra, which helped open her blood vessels, allowing her body to increase oxygen flow.

"Before she was put to sleep, she signed a document saying she was happy to be in a study to try experimental drugs," the outlet reported. "She was also given Viagra around a week after being in a coma, which opened up her airways. Her lungs started responding to it and the oxygen she needed lowered by around 50% as her condition began to improve."

Following the experimental treatment, she awakened and was able to stand up with assistance. Her condition continued to improve, and she was discharged on Christmas Eve.

Almeida, who was fully vaccinated, said that she likely contracted the virus through treating COVID-19 patients.

She told the U.K.'s Sun that she believed the Viagra saved her life.

"Within 48 hours it opened up my [airways] and my lungs started to respond," she said. "If you think how the drug works, it expands your blood vessels,” she told the Sun. “I have asthma and my air [sacs] needed a little help.”

"Mentally I am now as good as ever, but I do get a bit teary and frustrated at times," Almeida told the Lincolnite. "Physically, I am very weak and fragile, but I am determined to recover. I was in the COVID ward and then intensive care and I haven’t got a bad word to say about my treatment. I was listened to and included in everything about my care and I owe my life to those people. From the housekeepers to the nursing staff who showed me care and compassion, to an amazing medical team, I’d like to say a public big thank you."

Almeida said she likely would have died if it hadn't been for her vaccination.

“There are people out there saying the vaccine has killed people," she added. "I’m not denying there are people who react and get poorly with the vaccine, but when we look at the amount of deaths we have in unvaccinated people there is a big message there to have your jab. It does worry me, especially in Lincolnshire, that people are against having the vaccine. I never expected at 37 years of age to get as ill as I did. I never thought this would happen to me and I want people to take it more seriously.”

(H/T: The Daily Wire)

Horowitz: Are hospitals making thousands off this dangerous and ineffective COVID drug?



It simply makes no sense. Hospitals are aggressively using remdesivir months after it has become clear that it is not only ineffective, but causes liver toxicity and kidney failure. Yet despite its astronomical cost, hospital administrators are refusing to pull the treatment from standard protocol. At the same time, they are balking at the use of safe and effective ivermectin (or any other safe repurposed drug) to the point that they are even willing to go to court and appeal if they lose. What gives?

A listener of my podcast who goes by @NC_updipchick on Twitter discovered a little-known fact about the hospital reimbursement scheme for COVID that could possibly explain the genocidal fervor behind doctors blocking lifesaving treatment while sticking with remdesivir until the bitter end. After I had legendary critical care doctor Paul Marik on my podcast to discuss his lawsuit against a Virginia hospital that refused to allow any effective treatments (including vitamin C infusions), @NC_updipchick dug up an important Centers for Medicare & Medicaid Services billing rule from over a year ago that seems to explain everything.

THREAD: Stick with me, I promise it\u2019ll be worth it.\n\nOn Wednesday @RMConservative had Dr. Paul Marik on his podcast to talk about Dr. Marik\u2019s lawsuit against his employer, Sentara Healthcare. Basically, Sentara has told Dr. Marik that he is no longer permitted to treat patients
— Mel #SMILESMATTER \ud83d\ude00 (@Mel #SMILESMATTER \ud83d\ude00) 1637464270

It’s not just the extra 20% bonus the hospitals get for treating patients with remdesivir, which would come out to roughly $600 in extra reimbursements per patient. A report on the CMS compliance rule from last October explains that for hospitals that treat with the approved emergency therapeutics — at the time, remdesivir and convalescent plasma — not only are they eligible for a 20% bonus, but that eligibility triggers access to “a New COVID–19 Treatments Add-on Payment (NCTAP) under the IPPS (inpatient prospective payment system ) for COVID-19 cases that meet certain criteria.”

What is this new payment scheme? Not only do hospitals get hundreds for remdesivir, but they potentially receive thousands for treating that individual patient for his entire course in the hospital. The report explains it as follows:

Normally, Medicare outlier payments, which are extra payments for cases with extraordinarily high costs, only kick in after the hospital has incurred $30,000 in costs above the MS-DRG payment. In other words, under the standard outlier rules, a hospital would only receive 80% of the costs that exceed $30,000 of the IPPS payment, which means that hospitals eat the first $30,000 in losses. Under the IFC, however, when hospitals provide remdesivir or COVID-19 convalescent plasma and the patient has a positive COVID-19 test, Medicare will share in 65% of the first dollar losses that exceed the MS-DRG reimbursement up to the $30,000 outlier threshold.

Hence, the hospital gets reimbursed for 65% of the initial cost as well, which explains why they have been in such a rush to treat patients with remdesivir up front. How big a difference could this make per patient? How about close to $20,000?

For example, if the COVID-19 treatment exceeded the MS-DRG payment by $100,000, based on the outlier payment alone, the hospital would receive $56,000 because Medicare’s formula for outliers is 80% of the cost above the inpatient payment after the hospital eats the $30,000. Under the IFC, however, because Medicare will now share in 65% percent of the first dollar losses up to the $30,000 outlier threshold, Hettich explained that the total Medicare reimbursement would be $75,500—the typical outlier payment of $56,000, plus the add-on payment of $19,500 (65% of the first $30,000 in losses is $19,500). “You would only get $56,000 normally, but because of the add-on payment, you get $75,500,” he said.

Thus, for a hospital system in a given state that treats 5,000 COVID patients over the course of the pandemic, remdesivir alone could be a golden ticket to close to $100 million in federal reimbursements. So while, thanks to the PREP Act, patient families cannot sue Gilead, the maker of remdesivir, for death or organ failure, hospitals are loving every minute of the remdesivir scam.

Perhaps, in a very dark and sinister way, we can now understand the vicious opposition to ivermectin by the hospitals. Ralph Lorigo, the attorney who has litigated most of the ivermectin “right to try” cases against hospital systems, said on my podcast earlier this month that he has gone up against the same hospital attorney in a western New York system who had previously argued against the use of ivermectin and was overruled by the judge, and thanks to that ruling, the patients are now home with their families after being at death’s doorstep. How could that same lawyer possibly argue against him in subsequent cases after seeing the results the first time?

As they say, money makes the world go ’round. Sadly, this greed has likely cost hundreds of thousands of lives.

FDA authorizes pills to treat COVID — but there's a catch



As concern over COVID -19 rises with the spread of the Omicron variant, a new form of treatment for the virus has arrived in the form of oral tablets, but there’s a catch: The medication must be taken quickly to be effective.

The FDA issued an emergency use authorization last week for oral pills made by Pfizer and Merck to treat the virus. Both Pfizer’s Paxlovid and Merck’s molnupiravir are designed to treat people with mild to moderate symptoms who are at risk of hospitalization or death, according to the FDA.

However, the FDA advises that the pills should be taken as soon as possible to be effective.

Both medications should be taken within a five-day window of the initial development of symptoms, according to a report from the Associated Press. Paxlovid comes in three-pill doses that must be taken twice a day for five days. Some pharmacies should be able to test a patient and prescribe the medication in the same visit, according to the AP. Patients hospitalized for COVID after being prescribed Paxlovid should complete the five-day treatment unless otherwise directed by their doctors, according to a fact sheet released by the FDA.

Pfizer's and Merck's treatments are both effective at reducing hospitalization or death as a result of a COVID infection, according to the FDA studies; however, Pfizer's treatment is considered to be far more effective. Pfizer's treatment has shown an 88% effectiveness rate at reducing hospitalization and death, according to the FDA studies. Molnupiravir has not been approved for individuals younger than 18. The FDA expressed concern that molnupiravir may affect bone and cartilage growth in patients under the age of 18. The FDA said that Paxlovid, on the other hand, may be taken by children as young as 12 or who weigh about 88 pounds, according to a statement released Wednesday. Paxlovid is not recommended for patients with kidney or liver problems.

“If you wait until you have started to get breathless, you have already to a large extent missed the window where these drugs will be helpful,” Duke University infectious disease specialist Dr. Cameron Wolfe told the AP, stressing the importance of taking the medication as soon as possible.

Some health professionals have expressed concern that the pills may have serious life-threatening side effects if taken by individuals who are currently taking many common medications, including but not limited to blood thinners; anti-seizure medications; drugs for irregular heart rhythms, high blood pressure, and high cholesterol; and antidepressants, according to NBC.

“Some of these potential interactions are not trivial, and some pairings have to be avoided altogether,” Peter Anderson, professor of pharmaceutical sciences at the University of Colorado Anschutz Medical Campus, told NBC on Sunday.

The Biden administration announced in November that it would purchase 10 million courses of Paxlovid to combat COVID-19. The plan will cost about $5 billion, according to the Washington Post.

Horowitz: The indefensible approval of Pfizer and Merck drugs compared to the snubbing of ivermectin



Later this week, the FDA plans to approve, as the first outpatient COVID drugs, therapeutics that are extremely dangerous and unproven, even as the agency goes to war against cheap, safe, and proven drugs with a track record of no serious adverse events. The approval is as shocking as it is revealing and should serve as a warning to those who don’t believe the FDA would approve vaccines that aren’t safe and effective.

We already know that every drug the FDA has approved so far for inpatient treatment has an FDA “black box warning” for serious adverse events. At present, the only approved drugs in-patient are remdesivir, baricitinib, and tofacitinib. None of them have demonstrated any efficacy over a year of their use, and remdesivir is known to cause liver toxicity and renal failure. Baricitinib (brand name Olumiant) has an FDA black box warning for blood clots, of all things! Tofacitinib (brand name Xeljanz) has a black box warning for “serious infections and malignancy.” Now, let me introduce you to the first candidates for outpatient treatment: Merck’s molnupiravir (brand name Lagevrio) and Pfizer’s Paxlovid.

I’ve already written extensively on molnupiravir. Even the FDA advisory committee admitted that the drug poses a risk of birth defects, is mutagenic, has a dangerous mechanism of action, and was never studied for carcinogenicity, and its second-phase trial showed greater “efficacy” in the placebo group than the trial group. Even the mainstream media has warned that the drug really is not up to snuff, yet shockingly, the FDA is set to give it approval, as if basic safety and efficacy facts no longer matter. This move in itself, in conjunction with what we know about the approved inpatient drugs, should tell you everything you need to know about the juxtaposition of the vaccine approval to the war on ivermectin and hydroxychloroquine and the refusal to approve or encourage the use of numerous other safe and effective drugs.

But what about Pfizer’s Paxlovid? Doesn’t that have a safer mechanism of action, similar to that of ivermectin? And wasn’t it proven 89% effective in reducing mortality and hospitalization?

Efficacy of Pfizer’s Paxlovid

Unlike Merck’s drug, which has a known dangerous mechanism of action as a nucleotide analogue, Paxlovid is more of a defensive drug as a 3CL protease inhibitor. Dr. Ryan Cole, a clinical and anatomic pathologist who has studied the replication process of SARS-CoV-2 and its treatments in more depth than almost anyone on the planet, explains the mechanism as follows:

When COVID replicates inside our cells, part of the process is formation of a long string of amino acids within our cell’s ribosome (hijacked by the virus to use as a protein manufacturing site), forming a chain of proteins called a polyprotein. In order for the proteins to form the parts of the virus, this chain must be clipped and broken down into the viral protein parts. An enzyme called a protease does this cutting and clipping. Paxlovid is a protease inhibitor, meaning it binds to this enzyme “scissors” and keeps the cutting from happening, so the virus cannot reassemble.

Sounds terrific, right?

Here’s the problem. Do you know what else is also the most effective protease inhibitor on the market? Ivermectin. And it also has at least 19 other mechanisms of action, which include anti-coagulant (inhibits CD147 receptor binding) and anti-inflammatory (decreases IL-6 and other inflammatory cytokines) modes of action. Paxlovid has none of these mechanisms. So why would we rely on an expensive drug with one of ivermectin’s 20 mechanisms of action – yes, 20 – that does not have an established safety profile when we can use an off-patent drug with the safest profile imaginable and mechanisms that work even in advanced stages? Also, Cole explains that because Paxlovid only has one mechanism of action, “viruses can eventually mutate around this mechanism.” Dr. John Campbell offers a superb presentation on the similarities and differences, showing why ivermectin is superior to Paxlovid.

Consider that earlier this year, a study in Nature of dozens of potential protease inhibitors against SARS-CoV-2 found ivermectin to be the only one to fully bind the 3LC enzyme. Out of 13 off-target drugs tested, “only ivermectin completely blocked (>80%) the 3CLpro activity at 50 µM concentration.”

So now that we are championing this mode of action, why wouldn’t we exalt the cheaper, more established medicine that is also an anti-coagulant and anti-inflammatory and that has shown the ability to turn around even some patients on ventilators? At best, Paxlovid would likely only work during the first three days of onset of symptoms, which is how the trial was conducted.

Moreover, as anyone who treats this virus will tell you, Delta has been a game changer. This virus is so aggressive and novel in the way it enters the cells and replicates, there is no drug alone without adjuncts that will achieve 89% success against mortality. It’s complete bull. Ivermectin likely achieved that level of success in the original strain, but with Delta, even the most ardent supporters will tell you it needs several adjuncts to keep more people out of the hospital. There is no way Paxlovid with one mechanism of action can achieve 89% success when the king of 3CL protease inhibition can’t do that with several other modes of action.

Now, we all hope that Omicron will completely vanquish Delta and thus will be easier to treat. But why not go with a drug (and more importantly, combo of several drugs) that is safer and has more mechanisms of action? As Cole warns, “A protease inhibitor is only useful when used early when the virus is replicating. We know the Delta and Omicron variants replicate very quickly, so protease inhibitors are only potentially helpful in the first few days of infection.”

Paxlovid contains a dangerous AIDS drug

We haven’t even discussed the safety problems. While the new drug itself in Paxlovid, although unproven, is probably not as dangerous as Merck’s drug, the media has failed to inform the public that it’s combined with AIDS drug, ritonavir.

Why is it combined with the AIDS drug? According to Cole, “In order to work, the protease inhibitor has to last long enough in the body. Another protease inhibitor, ritonavir, usually part of an HIV regimen, is used to prevent the rapid breakdown of Paxlovid.”

Incidentally, in the Nature study of various antiviral drug efficacy against 3CL protease binding, ritonavir had less than 20% success, while ivermectin achieved 85%.

Typically, whenever a pharmaceutical company produces a combo drug, it must conduct separate clinical trials on each component and demonstrate to the FDA why the combination is necessary. But in the pandemic, all rules have been thrown out the window when it comes to Pfizer. No such trial was conducted. Why is this a problem?

According to Cole, “Ritonavir is not without its side effects, which can include life-threatening liver inflammation, pancreatitis, and heart arrhythmias. It may also cause nausea, diarrhea, dizziness, confusion, high cholesterol, high blood sugar, stomach or intestinal bleeding, numb hands and feet, a skin rash, as well as countless other side effects.” The FDA has issued a black box warning for many serious contraindications with ritonavir.

Can you come up with a non-sinister explanation as to how our government will not only approve, but purchase this untested and dangerous product while declaring war on its broader, safer, cheaper, and more established counterpart? If you do, I have some remdesivir to sell you at $3,000 a pop, but unfortunately it won’t cover your kidney transplant.

Horowitz: The new idolatrous utterance: ‘It would have been much worse without the shots.’



It’s become the new holy sacrament. Anyone who gets another shot, after he or she inevitably gets COVID because the shot failed, utters a verse from the COVID cultist “bible” almost verbatim, the same as the next newly infected, boosted deacon of Covidstan’s official church.

Three Democrat politicians put out almost the same statement following their diagnoses with COVID in order to distract from the failures of their three shots:

Sen. Elizabeth Warren tweeted: “Thankfully, I am only experiencing mild symptoms & am grateful for the protection provided against serious illness that comes from being vaccinated & boosted.”

In a press release, Cory Booker said: “I’m beyond grateful to have received two doses of vaccine and, more recently, a booster — I’m certain that without them I would be doing much worse.”

Rep. Jason Crow (D-Colo.), after contracting COVID from a trip in Ukraine, tweeted the following: “I’m thankful to be fully vaccinated and boosted and experiencing only mild symptoms (the vaccine is safe and effective).”

This seems to have become the standard oath of sacrament among boosted politicians getting the virus.

More finds...looks like this propaganda campaign kicked off around mid-August with a test market focus-group at the Mayoral level. Marketing data must have shown good traction so was elevated to the Congressional/Senate level?pic.twitter.com/iguRQDCGwJ
— Chris "Early Treatment" Martenson, PhD (@Chris "Early Treatment" Martenson, PhD) 1640013014

Isn’t it funny how COVID now has a 100% critical illness rate, so that anyone who gets it mildly can always tout the shots as effective? Safe and effective? When was the last time you heard of someone getting the pathogen shortly after having three shots against it? This is not normal.

Every time people like Joe Rogan or Dennis Prager, who didn’t get the shots but used early treatments, assert that they had milder cases because of their choice of therapeutics, they get attacked for not choosing the sacred therapeutic. Yet when the elected officials all coalesce behind the messaging of “it would have been worse” after getting COVID following the third shot, the media accepts that as “science.” I’d love to be a fly on the wall in the homes of these senators to see which therapeutics they are availing themselves of. I doubt they will leave their fate to chance – a diminishing chance that the vaccine works.

These cultist politicians are trying to distract from the broader point. Namely, that it appears those who get the shots are much more likely to get COVID, particularly Omicron, than those who did not get the shots. At least the pagans during the biblical era bowed down to things that simply didn’t respond. In this case, their idol responds, all right. According to data from Denmark, the vaccinated are more than twice as likely to get Omicron as the non-vaccinated. Just 8.5% of Omicron cases are among the unvaccinated, less than half their share of the population. With other variants, it’s approximately on par with their share of the population. What is so shocking is that even those who have gotten the boosters within the past month or two, and are in the bullseye of “vaccine efficacy” before it wanes, are still getting the virus in great numbers.

Maryland Governor Larry Hogan, after testing positive for COVID despite (or perhaps because of) being triple-vaccinated, doubled down by saying Omicron is a reason to get vaccinated! “With the Omicron variant becoming increasingly dominant, I want to again urge Marylanders who haven’t yet to go out and get your booster shot as soon as possible,” said “Lockdown” Larry Hogan in a statement that in itself announced his positive test after having been “boosted.”

We now have entire college campuses that are microcosms of the COVID utopia the public health officials can only dream of. Everyone is vaccinated, most are boosted, and everyone must wear a mask in public. Yet there are huge outbreaks, to the point that Harvard and Cornell have switched to online learning for next semester. What about vaccines passports? Well, cruises full of people who could only sign up with a passport are now coming back full of COVID-positive people. What about states with the highest vaccination rates? Some of them have the highest case rates!

In the USA right now, states with more residents vaccinated are seeing higher rates of infection. \n\nDoes this prove that vaccines have negative efficacy? Nope, it proves that covid waves are driven by regional seasonality, not by human intervention.pic.twitter.com/bOGIzw7Z5j
— PLC (@PLC) 1639814280

As for the question of symptom severity, aside from the fact that this is irrelevant to protecting other people, South Africa is the perfect control group against the theory that Omicron is mild because of the vaccinated. Denmark is ultra-vaccinated, while South Africa only has about a quarter of its population vaccinated. Both countries have experienced a wild Omicron outbreak, yet hospitalizations are low from this variant in both. The hospitalization rate decreased 91% in South Africa. The case fatality rate is estimated to be 19 times lower than during the last Delta wave. Thus, there is no way one can suggest that this variant is only mild for the vaccinated. The White House is warning of a dark, deadly winter from Omicron for those who are unvaccinated. Well, you can hold South Africa’s beer! The country is now getting rid of most restrictions and contact tracing with a recognition that “they are not likely to be successful.”

In other words, they recognize that human interventions have made no difference in this pandemic. The one human intervention that likely would have worked is early treatment. But to this day – no matter how desperate an image they show in public – they will never turn to what actually works. They would rather lead us to hell than follow to heaven.

Horowitz: Now we know why the establishment has always opposed early treatment



The shots don’t work for many people, particularly the elderly. The establishment is blocking every other treatment option available. At this point, with so many people recovering even from late-stage COVID by taking ivermectin, which is infinitely safer than the shots, how could anyone ascribe anything other than very sinister motivations to those declaring war on its use?

The shills for Big Pharma and the “Great Reset” who don’t want to see people survive this virus claim they don’t have enough data on ivermectin, despite dozens of studies and simple reality showing that it works better than anything they have suggested. They demand massive randomized controlled trials, but then refuse to fund any such expensive study. They refuse to follow up on positive signals with off-patent therapeutics the same way they blithely ignore negative signals from the vaccines and refuse to follow up with investigative studies. Well, Brazilian researchers just published something better than a randomized controlled trial. They did a study of reality.

Everyone in the entire southern Brazilian city of Itajai was invited to participate in a preventive study of ivermectin for efficacy against severe COVID-19 symptoms. 133,051 (60.3%) volunteered to take ivermectin for two days every 15-day period between July and December 2020 at a low dose of 0.2mg per kilogram of body weight. 87,466 (39.7%) chose to enroll their information as the control group without taking the treatment. So no complaints can be made about a small sample size. The results? The hospitalization and mortality rate of the trial group was nearly half that of the control group!

However, the results are much more impressive than the top-line numbers suggest. One of the complaints about studies like this that are not randomized is that it’s possible for the healthier, more treatment-conscience individuals to sign up for the trial group, thereby confounding the conclusion of the trial results. But in this case, the opposite is true. The ivermectin group had nearly twice as many people over age 50 enrolled, which also included many more people with hypertension, type 2 diabetes, and pulmonary issues. Thus, the relative risk reduction in mortality rate among those high-risk people taking ivermectin was actually much higher – 71% among those with type 2 diabetes and 67% among those with hypertension. The absolute risk reduction was also even greater among older people who are most at risk.

The overall effect on the city’s population was remarkable. The COVID-19 hospitalization rate decreased from 6.8% before the program with preventive use of ivermectin, to just 1.8% after its beginning (73% reduction). The mortality rate also dropped by 59%, from 3.4% to 1.4%. Most astounding is where the city of Itajai ranked relative to others in the state of Santa Catarina:

“When compared to all other major cities in the State of Santa Catarina, where Itajaí is located, differences in COVID-19 mortality rate between before July 7, 2020 and between July 7, 2020 and December 21, 2020, Itajaí is ranked number one, and far from the second place,” observed the Brazilian researchers in the study manuscript. “These results indicate that medical based optional prescription, citywide covered ivermectin can have a positive impact in the healthcare system.”

In many respects, this is more illuminating than a standard randomized controlled clinical trial. If we actually want to project what the world would look like if everyone would take ivermectin, this is a perfect case study of an entire city and its effect on the hospitals. Contrast these results to the vaccines, where we are seeing no correlation between outcomes and vaccination rates by geography, even though their randomized controlled trials purported to show an unmistakable benefit of 95% reduction in mortality.

Also, another key issue is dosage. FLCCC recommends 0.4-0.6mgs per kilogram of weight, which is 2-3 times the dose used in the trial. Obviously, this was a preventive trial only used for two straight days, but then rather than taking it every week, there was a 15-day gap before the next dose. One has to wonder what the results would be if each one in the trial group ramped up the dosage to 0.4mg every day for five days once they contracted the virus, or at least took the 0.2mg preventive dose twice every week.

Even the most effective drugs need a minimum dose. Ivermectin has demonstrated a strong dose-response relationship in terms of viral clearance; higher doses have not only been required, but have demonstrated clinical efficacy. While critics claim the dose is too high, cancer trials had patients taking ivermectin at a much higher dose for months without any problems.

Moreover, like any other virus, treatment requires a multi-drug approach because the virus has multiple avenues to infect cells. Imagine if every primary doctor treated patients with a mix of ivermectin and several other drugs, along with the appropriate anti-coagulants and steroids in the right patients at the early stage of disease. Imagine if they’d be directed to use Betadine nasal rinse, hydroxychloroquine, azithromycin, and several other proven therapeutics from day one. Imagine if our government had placed as much money, marketing, and logistical facilitation into the monoclonal antibodies as it did the unsafe and ineffective shots.

In a recent presentation, Pr. Million from IHU Marseille has presented their first numbers of Covid mortality by age group in 2021.\n\nHe has highlighted the improved 2021 mortality where patients did not get HCQ+AZ, which he attributed to the discreet introduction of Ivermectin.pic.twitter.com/EOg1JObQKr
— Covid19Crusher (@Covid19Crusher) 1639383575

Well, we already see from doctors in the U.S. who have applied this approach, and their reduction in mortality is near 100%. And all the drugs they use range from safer than over-the-counter medications (in the case of ivermectin) to much safer than anything being administered by the hospital systems, such as remdesivir, baricitinib and tofacitinib.

One thing is certain: Ivermectin is much safer than anything the medical establishment is using, and there definitely is a degree of efficacy. So why would it face such visceral opposition? Had the medical establishment merely talked down its efficacy to a degree, I would probably believe it. But now that they are treating this Nobel Prize-winning drug as if it’s heroin, it actually would appear that it’s super effective. During a pandemic, the FDA is now using resources to collaborate with the post office to hold packages of ivermectin from being delivered.

The FDA is working with the post office to hold packages containing ivermectin. The FDA could better use its resources to, I don\u2019t know, publicly release the docs submitted by Pfizer to license its mandated liability-free V earlier than 75 years from now! http://bit.ly/3oMU53S\u00a0pic.twitter.com/O2d1zgTjAB
— Aaron Siri (@Aaron Siri) 1639353779

Last week, the World Tribune published an article revealing information that indicates the WHO likely knew ivermectin was effective for months, but blocked its use, all for Big Pharma. Dr. Andrew Hill, a senior visiting research fellow in pharmacology at Liverpool University, adviser to the Gates Foundation, and researcher for the WHO, was tasked with conducting an ivermectin trial for the WHO. Based on his preliminary findings, Hill testified enthusiastically about the use of ivermectin before the NIH COVID-19 Treatment Guidelines Panel on Jan. 6, 2021. But then he suddenly changed course and published a study dinging the drug’s efficacy against COVID.

According to the Tribune, Dr. Tess Lawrie, director of the Evidence-based Medicine Consultancy in Bath, England, who was also involved in the ivermectin research, recorded a Zoom call she had with Hill and revealed a remarkable exchange between the two of them.

In a remarkable exchange, Hill admitted his manipulated study would likely delay the uptake of ivermectin in the UK and United States, but said he hoped his doing so would only set the lifesaving drug’s acceptance back by about “six weeks,” after which he was willing to give his support for its use. […]

Four days before publication, Hill’s sponsor Unitaid gave the University of Liverpool, Hill’s employer $40 million. Unitaid, it turns out, was also an author of the conclusions of Hill’s study.

In the call, Lawrie berated Hill’s study as “flawed,” “rushed,” “not properly put together,” and “bad research . . . bad research,” which Hill appears not to have denied.

Instead, when pressed he admitted his sponsor, Unitaid, was an unacknowledged author of conclusions.

“Unitaid has a say in the conclusions of the paper. Yeah,” he told Lawrie.

The exact exchange on the Zoom call, according to the Tribune, went as follows:

Lawrie: I really, really wish, and you’ve explained quite clearly to me, in both what you’ve been saying and in your body language that you’re not entirely comfortable with your conclusions, and that you’re in a tricky position because of whatever influence people are having on you, and including the people who have paid you and who have basically written that conclusion for you.

Hill: You’ve just got to understand I’m in a difficult position. I’m trying to steer a middle ground and it’s extremely hard.

Now, imagine the difficult position that millions of people found themselves in when they were denied access to this treatment early, and many more, even on a ventilator. Imagine how many other promising treatments we know about (and possibly ones we don’t) because research was squelched in order to deny the public a cheap and effective way around the false choice the establishment has created – either confront the bio-weapon virus without treatment or take their bio-weapon injection as the panacea?

It’s not too late for red-state governors and legislatures to correct this mistake by barring all punitive actions taken against doctors for prescribing FDA-approved drugs off label and prohibiting pharmacists from denying those prescriptions. Hospitals must also allow patients to bring in doctors to administer the drug when they are unwilling to save lives themselves. To paraphrase John Kerry about the Vietnam War, how do you ask a man to be the last man to die for a lie?

Horowitz: Even doctors in red states are being punished for saving people from COVID



You are not allowed to treat COVID outpatient. It's not about any one drug. You will be punished if you dare treat patients with anything that works. What began as 15 days to flatten the hospital curve has grown into a ban on all treatment outside the hospital to ensure everyone sick with moderate disease lands in the ER. No, they will not prosecute a doctor, they will just threaten to pull his license, which is why doctors won't even prescribe azithromycin or prednisone, much less ivermectin and other proven antiinflammatories. What if you are part of the 1% of doctors who actually save lives — who run toward the fire rather than away from it? Instead of getting a medal of honor, these national heroes are now losing their licenses.

Idaho is not California. In fact, many Californians are fleeing to Idaho to escape the progressive persecution of the once Golden State. Yet now, with their investigation of Dr. Ryan Cole, the Idaho Medical Board wants to ensure that no doctor will ever treat you for this virus.

If you contract this virus, there is probably nobody in the world you'd want access to more than Dr. Cole. A Mayo Clinic-trained anatomic and clinical pathologist who is licensed in 12 states, Cole knows the mechanisms of pathogens and various medicines as well as you know the streets of your neighborhood. He has lived the COVID pandemic in his Idaho lab since last March, diagnosing over 100,000 cases, and has given up much of his regular work to treat patients on his own time and own dime for months. His record is remarkable, and I have many friends and listeners of my podcast who are alive today because of his brilliance and kindness.

So there will be a ceremony in the Oval Office next week to present Dr. Cole with a medal for treating people in a pandemic while others let their patients die, right? At least the Idaho governor, Brad Little, will offer him some state reward? Nope. Instead, they are threatening to yank his license.

Steven Kohtz, MD, president of the Idaho Medical Association's board of trustees, and Susie Keller, CEO of the association, wrote a letter to the state's board of medicine on Oct. 7, lamenting that "he has treated patients 'from Florida to California'" with ivermectin. The horror! He should have let them die and not treated them at all, like Kohtz and his colleagues have done since last March.

In the letter, they claim Cole's statements have killed people. "Many of those statements have advocated that people not be treated appropriately and undoubtedly have led to and will continue to lead to poor health outcomes as people are encouraged not to be vaccinated against COVID-19 or obtain appropriate treatment for it when such treatment could improve their health."

Well, how could treating pulmonary symptoms with steroids and antiinflammatories be worse than not treating them at all? This is the ultimate exercise in projection. They assuage their own guilt of letting patients die by preventing others from treating people in the critical early days of the virus.

"We understand that as a dermatopathologist Dr. Cole has a laboratory, but we do not believe he has a clinic in which he sees and treats patients."

That is quite rich for people who refuse to treat COVID. In fact, Cole has been performing hands-on clinical treatment of COVID from day one, and there are a lot of people who escaped the grave because of it. Perhaps Kohtz and Keller missed the memo from the FDA stating that physicians can always prescribe off-label FDA-approved drugs "when they judge that it is medically appropriate for their patient." In fact, the FDA has made it clear that there is a particularly strong rationale for prescribing off label if there is no "approved drug to treat your disease or medical condition." If Kohtz and Keller have another treatment option, they should tell us about it; otherwise they should close their mouths.

To suggest the vaccine alone is an alternative is absurd given that thousands of vaccinated people are coming to doctors like Cole for treatment because they are getting clinically ill based on the false promise peddled by people who wrongly suggest that the shots still work. I'm sure people like Colin Powell would have liked to get "unorthodox" treatment from a doctor who didn't tell him to wait at home for a week until his lips turn blue or suggest, "Relax, you can't get seriously ill because you got the shots."

If anything, there needs to be an investigation into the Idaho Board of Medicine for causing the death of countless citizens by discouraging, for the first time in medical history, all outpatient doctors from treating the virus. Perhaps if Dr. Cole had used remdesivir, which causes liver and renal failure, or Olumiant, which has an FDA black box warning for blood clotting, he would have been heralded as a hero.

It's time for the Idaho legislature to step up to the plate. Republicans have 4-1 majorities in the legislature. How can patriot doctors be subjected to this harassment in a state like Idaho? Legislators must immediately pass a bill barring the state medical board from taking actions against any doctor for prescribing FDA-approved drugs, speaking their conscience on all aspects of the virus and its treatment, and choosing not to wear a worthless Chinese face burka. In addition, all members of the board should be subject to termination by the legislature. It's bad enough that blue-state doctors are being forced to follow the political $cience. Do we really need to persecute those who actually follow the life science in red states?