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

Op-ed
Pavlo Gonchar/SOPA/LightRocket/Getty Images

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.

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.
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