HOW A SAFE NASAL SPRAY HAS THE POTENTIAL TO HELP AMERICA FUNCTION NORMALLY DURING THE NEXT COVID-19 (SAR-Cov-2), ITS VARIANTS OR MUTANTS OR OTHER RESPIRATORY VIRUS PANDEMICS

HOW A SAFE NASAL SPRAY HAS THE POTENTIAL TO HELP AMERICA FUNCTION NORMALLY DURING THE NEXT COVID-19 (SAR-Cov-2), ITS VARIANTS OR MUTANTS  OR OTHER RESPIRATORY VIRUS PANDEMICS 

                                     Stephen L. DeFelice, M.D.

    FIM, The Foundation for Innovation in Medicine

The enormous physical, social and personal devastation spawned by the Covid pandemic has tangibly weakened us almost bringing our nation to its knees. Not yet recognized is that the pandemic occurred during the disruptive cultural- transforming technological revolution where the stabilizing forces of family, religion and tradition have markedly and speedily diminished.  Thus kids in kindergarten are not only are forced to wear masks and bear their mentally destructive consequences, but also taught to question their natural genitals.

What really struck me was that people suddenly lost contact with people resulting in massive individual isolation. Going to work or the store or to the movie or to a family gathering among other get-togethers virtually came to a halt. This destabilizing  phenomenon our greatest enemy would employ to splinter and weaken our country creating an epidemic of hate and insecurity robbing it of its clear thinking and will to survive.

Though we have been lulled into believing that the worst is over, this is not true, not at all! As we shall see, there is little doubt that the possibility of another soon to arrive more devastating Covid pandemic is real and can weaken our nation to an even greater degree than our ongoing one.

It is also proposed that this simple nasal spray may be the national solution in preventing this catastrophic possibility. All, as we shall see, that is needed is an unencumbered leader to pursue this opportunity.

        The Nasal Spray: How it Works,  How Effective and How Safe  

To help understand why this nasal spray should be immediately available to the general public, it’s first necessary to consider its mechanism of action, or how it works. Drugs or pharmaceuticals such as aspirin or anti-Covid agents must undergo multiple steps such as intestinal absorption into the body, proper distribution to where it’s supposed to be clinically effective and then be metabolized in order be eliminated from the body. In addition, it must be shown to be acceptably safe. Because of this highly complicated multi-step path, most drugs in laboratory research fail to be proven clinically effective and safe.

But the nasal spray does not go through these multiple steps for it, by one single act, simply kills bacteria, viruses and fungi on the surface of things like chlorine on a kitchen counter making its predictability of effectiveness on any surface, including human nasal cells, almost one hundred percent.

                                              Laboratory Studies 

The nasal spray works by preventing Covid, its variants and certain other respiratory virus by attaching to them on their surfaces preventing their absorption through the nasal cavity mucosa or cells  into the body. Regarding Covid and its variants, there are a number of published sophisticated laboratory studies, some of which were conducted by the National Cancer Institute, which demonstrate that the way it blocks the Covid virus is by attaching to its surface spike proteins. 

Other studies report that it also blocks the Covid virus from dividing or replicating, also by acting on its surface preventing it from entering the nasal mucosa of laboratory animals which is the most predictable model regarding whether it would do the same in humans. It also blocks the Delta and Omicron variants. The latter, at this moment, remains stubbornly with us.

Conclusion: Based on laboratory studies it is reasonable to assume that the nasal spray will prevent Covid viruses from penetrating nasal mucosa cells and thereby entering the human body.

                                                   Clinical Study

 It’s important to keep in mind that the nasal spray is designed for the prevention of viral infections and not for treatment, so you would think that the only clinical study conducted was so designed. Unfortunately, it was a treatment design where patients were already Covid infected. It was a double-blind study conducted in 30 patients, 15 on the nasal spray and 15 on placebo where a number of measurements were made. Both groups were treated for only 6 days. The results between the groups were not significant. Not to be ignored, however, and which, to repeat, is the most important clinical endpoint was that 7 patients in the nasal spray group were completely free of the virus compared to only 2 in the placebo group. More about this later on.

You may be scratching your head and wondering why this apparent clinical treatment design error. It’s simple. Generally speaking, to conduct a preventive study it would, as with the vaccines, require evaluating thousands of patients at an enormous cost which only large pharmaceutical companies and the government can afford. This was not economically doable by the small company funding the study 

In conclusion, no prevention clinical study has yet been done with the nasal spray. 

                                                Human Safety

The very good news is that, unlike drugs and vaccines, the nasal spray ingredients are extremely safe and officially classified by our government as GRAS, or Generally Recognized as Safe, and generally available to the public in foods and other edible substances to suppress microorganisms.  

                                  Theoretical King  Veritas Takes Command

Our experience with Covid leaders has and continues to be characterized by multiple competing parties within and without government with conflicting opinions and controversial policies. Succinctly put, it is a heated political battle with no captain of the ship.  So I found it  necessary to call upon the all-powerful, rational, unhindered sovereign, King Veritas, as its commander. He ordered respected physician, Dr. Silvio Saggio, to form the Nasal Spray Covid Committee of Seven entitled Where We Are and Where We Should Go where it would, without human interfering forces such as politics and media, analyze the available nasal spray data and other critical factors to finalize a nasal spray national policy. The following is Dr. Saggio’s committee summary:

Dear King Veritas,

During the pandemic we have had a plethora of  experts voicing and  implementing  a variety and oftentimes contradictory approaches to containing Covid’s spread none of which, with the exception of vaccines, has been substantially effective.  

The following is our very concise Covid summary — we know that you’re a fan of Occam’s Razor and wanted us to cut through the ever exploding and voluminous confusing information in order to arrive at the facts — of where we are and our strategic recommendations where we should go regarding the role of the nasal spray.

                                          Where We Currently Are 

  1. Covid, at this point, is no longer considered a pandemic but an endemic one perhaps becoming a permanent public health threat.
  2. Our country must face the fact that our best experts haven’t the slightest idea what’s coming next, but all agree something devastating may be  lurking in Covid’s viral genomes awaiting its debut. 
  3. Also, Your Highness, none of the committee members, most of us are doctors and scientists, would be surprised if one of these lurking ones would arrive tomorrow morning or the day after, even more devastating than the original ones. Your people, as indicated by various surveys, have been lulled by our plethora of  leaders into believing that the worst is over.  
  4. If this pandemic occurs, we will lack effective vaccines and  pharmaceuticals to counter it.  Even if such potential therapies existed somewhere in our marvelous research systems, it would take much time to be both discovered, developed and produced in large enough quantities to be successfully distributed nationally. It’s important to note that even with an enormous effort, only a little over one-half of our population has been Covid vaccinated. In fact, the current worldwide vaccination effort has not succeeded.   
  5. One alarming puzzling under-reported scientific breakthrough is that exploding genetic technology and relatively inexpensive ways to create lethal, devastating bacteria, viruses and fungi are becoming readily available to powerful evil men and women including those in, let’s say, unfriendly governments. The optimistic political belief that the Western  policy of establishing worldwide globalization where countries would become economically connected broadly benefitting from this interdependence would lead to the rejection of war, as judging by current events and, let’s not forget, human nature, cannot be relied upon.
  6. Masks and social distancing, whose effectiveness were largely overrated based more on desperate hope and not clinical studies, may be all that we have during the early phases of the next lethal pandemic.
  7. The men and women of our country are exhausted and cannot now emotionally handle the truth of this threat let alone endure another lethal pandemic. The latter is an alarming probability in your kingdom.
  8. And finally, we recommend  that you order that a survey be conducted asking the simple question  whether, if available, people would or would not take the nasal spray during the next pandemic under the conditions that we just presented.

Your Highness, hopefully we have covered the ground that you commanded us to cover.

Your humble servant,

Silvio Saggio, M.D.

—————–

The King paused, reflected a moment and then asked, “Dr. Saggio, has your distinguished group framed the  survey question? ”

“Yes, we have, Your Highness.”

“Well, let’s hear it. I’m all ears!”

The doctor reached for his spectacles in the inside pocket of his ultra- suede jacket along with a folded, plain 8 x 10 sheet of paper which he slowly unfolded. He then read, 

“Make the assumption that there is an extremely safe nasal spray available to you that many sophisticated laboratory scientific studies, some even conducted by our National Cancer Institute, demonstrate that by physically attaching to Covid viruses it can prevent them from passing through your nasal membrane into your body. As a result it will help you during the pandemic to function normally instead of in isolation wearing a mask and social distancing. You can go to work, school, restaurants or other places you would normally go to in your daily life until the pandemic is controlled or gone.

“Also, make the assumption that medical experts who have evaluated the data believe that, though a clinical study to test whether it can prevent the virus from entering the body has not yet started, because the way it works, there is a reasonable probability that it will be clinically effective.

If the next pandemic arrives where vaccines and drugs are not generally  available, would you take this safe nasal spray? 

Please check Yes, No or Not Sure.

King Veritas, obviously pleased, smiled and then commanded, “Dr. Saggio, there are seven members in your committee who are obviously connected to people in all walks of life. I want them to each contact ten of their colleagues or friends or whomever and ask them that question and then get back to me within a week with the results.”

A week passed and all gathered in the King’s spacious chamber. After all were seated, the King asked, “Dr. Saggio, what are the survey results?”

“Your Highness, the response exceeded our expectations. People even took it upon themselves to contact their own contacts, and we’ve come up with a total of 193 responders. The group composed of 31 doctors, 32 scientists and 130 others. A total of 167 said Yes; 18 said No and 8, Not Sure.”

The King paused and then asked, “Dr. Saggio, who were the folks in the No group.”

“There were 8 scientists and the others mixed.”

The King, increasingly curious,  asked, “How long would it take to conduct a small clinical trial to determine if the nasal pray actually prevents Covid infection? We all know that it took many thousands of patients at an enormous cost to demonstrate the prevention effectiveness of vaccines. Though I am king, my princes still have enough power to try to block me from spending  tons of money for this project, but I could overrule them, if I had to.“

Dr. Saggio smiled and replied, “Fortunately, Your Highness, in our group is physician, Maurice Pascal, who has had a vast, unequaled experience planning and managing clinical trials for all types of diseases and disabilities. So let’s ask him.”

Dr. Pascal replied, “Less than six-months and at minimal costs.” And he said no more.

The King, taken somewhat off guard by such brevity, asked, “ Dr. Pascal, could your elaborate?”

“Well, Your Highness, the creativity of our medical system is mainly in the laboratory studies where bright men and women can test their ideas much, much more freely than in clinical studies where they are overwhelmingly controlled by laws and regulation. Clinical studies therefore, are generally not innovative. Also, our culture is obsessively concerned with safety. If an unexpected toxic effect occurs, the media, like sharks surrounding an injured blue whale, will feast on it. Take my word for it, this is a huge concern of clinical investigators which negatively impacts their attempts at creativity, and they are also fearful of losing their reputations and being sued. Look how many sharks are now out there are searching for vaccine toxicity. Fortunately, with your power, you can silence the sharks.”

 “Well, Dr. Pascal, how then would you proceed?”

“The way I always do usually with a group of seven experts such as those in this room. Also, I would add a probability statistician — and this is critical — who is more expert in the field of probability than a regular biostatistician. For example, I would not be surprised that such an expert may have found the differences in the 7 virus versus the 2 virus free patients in the nasal spray treatment study statistically significant which would have led to its further vigorous development. 

“Before I forget, Your Highness; this must be an independent group with no interference from anyone, not even from you. Then give me about 90 days and the probability that the group will come up with a doable, relatively inexpensive short -term clinical study design or designs is very high. But, of course, there is no guarantee. Not to be forgotten, the project will need sufficient funding.”

 

       The Nasal Spray Plan of King Veritas: His Two Commands

In order to digest the information, The King requested a lunch break after                 which he would return with his proposed plan for discussion. He surprisingly requested that Dr. Pascal join him.

 After he returned all observed a curious man transformed into an energized, determined one.

“Members of the Committee of Seven, with respect to Covid and future variant or mutants, you have concluded that the future is unknown and  it would not be surprising if a new, even more lethal variant or different respiratory virus suddenly invaded our country when we would lack  sufficient vaccines or drugs to combat it.  We have forgotten that the original virus could be man-made and unnatural whose future behavior remains to be seen. My beloved  America was almost brought to its knees during the past two pandemic years and cannot withstand another similar or more devastating attack. It may destroy the very fabric of our society and also, let us not forget, open the doors to our enemies.

“What is also disturbing is that polls report that my people, influenced by understandable but false hope, have been lulled into the false belief that the worst is over and it would, even for a king, be political suicide to aggressively set the record straight which would backfire leading to an epidemic of national fear and anger. But I as king, have the responsibility to take charge and take immediate action.

“Our discussions have led to the clear conclusion that we must, as national insurance, always, and I mean always, have available some type of therapy available to keep my country functioning socially and economically during these attacks until we have available effective vaccines and drugs or it naturally ends. The nasal spray is a perfect example of such therapy.

“Given this urgent need, I will immediately command the following:

First: there is no time to lose for the virus may come before the next full moon. We will produce multimillion nasal spray devices to create a national stockpile to be distributed to each of my states and for each state to employ according to its judgement.

Dr. Pascal has informed me that in the past, former Senate Majority Leader and physician, Bill Frist, had the vision to recommend the stockpile approach of then available therapies to President George Bush, wisely anticipating future microorganism pandemics.

Second: I command the Committee of Seven to design a clinical research plan within 90 days and, if acceptable to me, manage its execution which is to be completed within a six-month period.

“And finally, I want to motivate you by thinking about how much mental and physical suffering, let alone the loss of life, could have been avoided if an effective nasal spray were available at the beginning of our Covid pandemic.”

A moment of palpable silence followed after which the King asked, “Any comments or suggestions?”

Dr. Saggio responded by noting that there would be much concern by certain authorities  that people would prefer the spray over vaccines discouraging their discovery.”

The King smiled broadly and replied, “What then am I to do? Withhold an effective nasal spray from my people and let them suffer?

“Any other points?”

None was made and the die was cast.

The nasal spray, under the brand name, Covixyl, is being developed by Salvacion, a very small New Jersey based corporation. The GRAS active ingredient is Ethyl lauroyl arginate. The inventor is the respected  scientist and my colleague, Abdul Gaffar, Ph.D.. A yet to be peered reviewed review article.

View the article here in PDF format.

No financial connection.