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

“The FDA has refused to even explore approval of cheap, safe, and effective repurposed drugs for 20 months, despite mounds of evidence from studies vouching for their efficacy and safety. So, naturally, now that the agency is on track to issue an emergency use authorization to the first outpatient drug for COVID, this one must be the greatest thing since penicillin, right? Wrong! In fact, the drug is so dangerous and has so many known and unknown side effects that the FDA advisory committee members basically admitted this was a “difficult” decision and that they could rescind the authorization later on. This decision makes their rejection of ivermectin, fluvoxamine, nitazoxanide, and hydroxychloroquine all the more indefensible.”

By Daniel Horowitz, THE BLAZE

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?

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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.

December 24, 2021 | 8 Comments »

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8 Comments / 8 Comments

  1. @Michael
    I am a big proponent of Melatonin. Also, don’t forget HCQ and Vit. D, especially Vit. D which makes people nearly bulletproof if the levels are optimized to 50-60ng/ml (you should use a doctor to raise levels this hight due to possibility of overdosage FYI).

    Vit D is not really a vitamin, it is a pro-hormone and is responsible for genetic transcription of over 2000 genes and controls 5% of the body’s genome. It is the Master Key to the immune system. It is vital for Tcell activation which is responsible for viral clearance in early infections. If Vit D is present in midrange levels in the body, you can not develop cytokine storm – the fundamental cause of death in Covid. However, 70-80% of Americans are Vit D deficient and this is true in 70% of the world’s population and in 82% of patients in nursing care facilities. 80% of all hospitalized Covid patients have low Vit D and 96% of all Covid patients in ICU are vit D deficient. Above 35th Parallel(draw a line from northern border of AZ thru central Tenn.), sunlight does not stimulate Vit D production from October thru March and so you need supplementation – good rule of thumb is that if your shadow is shorter than your height, you are vit D deficient from Oct – Mar. Flu season is really just a season of low immunity caused by low Vit D, reduced fluid intake and home sequestration. With high Vit D, you are also protected from many other diseases, flu, common cold, etc. Obese people have low Vit D…I could go on about Vit D for a good bit, but you get the idea – it’s not just important, it’s vital for good immune health. Oddly enough, this is never mentioned by Public Health.

    Regarding Melatonin, it is very useful and was among the first compounds promoted. Among the benefits not listed in the summary you listed is its use to lower blood pressure. One disadvantage is that it causes drowsiness, just FYI.

  2. Melatonin works as an antioxidant, antiinflamatory and antiviral. The paper notes:

    As COVID-19 surged to a pandemic with more than 28 million people testing positive worldwide and over half a million deaths in the United State alone, scientists and physicians have been searching for early interventions upon diagnosis.

    COVID-19 develops as SARS-CoV-2 attaches to angiotensin-converting enzyme 2 (ACE2) receptors in airway epithelial cells, triggering a proinflammatory response that often results in a cytokine storm and potential onset of acute respiratory distress syndrome.1 , 2 An additional pro-oxidant response leads to reactive oxygen species (ROS)–mediated damage to the alveoli.3 To avoid severe cases, treatment of COVID-19 should be started upon diagnosis. Compounds that would ameliorate excess inflammation and oxidative damage could lessen morbidity and mortality of infection.4

    The use of melatonin, a naturally occurring tryptophan derivative synthesized in the pineal gland and immune cells, is a potential treatment option to reduce the severity of COVID-19 symptoms due to its known anti-inflammatory, immunomodulatory, and protective antioxidant mechanisms.5 , 6 As a powerful hydroxyl radical scavenger and stimulator of antioxidative enzymes such as glutathione peroxidase (GSH) and superoxide dismutase (SOD), melatonin also provides significant protection against cellular oxidative damage.

  3. Looks like Melatonin, Curcumin and Ivermectin are the best PROVEN options, with 79%, 70% and 52% improvement, respectively. The others appear to be more experimental.

  4. Excellent summary by Dr. Horowitz. Please read this before using Paxlovid, and read this
    https://www.theblaze.com/op-ed/horowitz-mercks-new-covid-drug-molnupiravir-is-dangerous-and-unproven
    before using Molnupiravir.

    These drugs have highly toxic safety profiles. You would use them to treat someone because they have a serious disease that can not be treated with any treatment less toxic. Yet, Covid is a very survivable disease without any treatment to 99.7% of the public, and those who would prefer treatment to rolling the mortality dice, as has been the limit of their care for 2yrs, have plenty of safer generic and brand choices than these toxic products which have very limited drug trial history.

    Good rules to live by:
    1. Always choose early treatment
    2. Always choose the safest treatments with the greatest lab research

    Please do the math and read up on the toxic qualities of these drugs before accepting the risk of their associated side effects.