A Rapid Way to Keep Our Country Functioning Normally During a Covid-Respiratory Virus Pandemic
It’s In the Nose and Understanding the Lessons of Nasal Steroids
Attached is a timely proposal by physician, Stephen L. DeFelice, regarding a rapid
and doable way to keep our country functioning normally during future Covid or
other respiratory pandemics. You will note that his proposal is new and has not yet
been reviewed by medical experts so below are some facts about his history
including comments from his colleagues.
In this attachment, Dr. DeFelice describes how the history of anti-allergic nasal
sprays during the allergy season led him to the idea of the use of anti-Covid nasal
sprays during a Covid pandemic which would permit our country to function
normally. And he also warns, as other authorities do, that a destabilizing Covid
mutant or variant may be just around the corner.
Unlike with nasal vaccines, the problem is that there are substantial financial and
other barriers which would discourage innovative innovators to enter this medical
sector such as those that he encountered during his doctornaut crusade. But
because of the urgency and public fear of this potential national threat, he offers a
path to encourage innovators, be they individuals or various organizations, to lead
the way. And he asks for your help in finding such innovators.
During his active 60-year career he has been widely respected by both domestic and international leaders for his longtime efforts to speed up the discovery of medical breakthroughs. He personally brought carnitine into the United States and guided it through FDA approval for Primary Carnitine Deficiency, a potentially fatal disease in children.
He has worn many hats. He founded FIM, The Foundation for Innovation in Medicine in 1976, as his personal pro-bono platform to educate and persuade our leaders on his innovative proposals. His major proposal was expressed in his first book, Drug Discovery The Pending Crisis, published in 1972. The major theme was that we had created multiple financial and legal barriers to conduct clinical studies, the critical step in discovering a medical breakthrough. For example, you can’t discover insulin unless it’s clinically tested in diabetic patients.
As a solution his core proposal was to permit physicians or Doctornauts, a word that he coined, to take greater risks in volunteering for clinical research. More potential therapies would then be tested and, therefore, discovered. This could be legally accomplished by his proposed Doctornaut Act. Physician and then Senate Majority Leader of Congress, Bill Frist, readily agreed with him and circulated a draft of the Doctornaut Act for review but, unfortunately, had few major supporters.
Nevertheless, Dr. DeFelice’s message eventually led to a national awareness of the vital importance of clinical research, and today it is now a thriving sector of American medicine.
I’ve been by his side for 48 years helping him manage FIM and knew and interacted with many of the large personalities around the world with whom he dealt. Below is a selected list of their impressions of this man which support his well-earned credibility and recognize his passion to accelerate medical research and discovery.
Louis Lasagna, M.D.
Dean, Tufts University School of Graduate Biomedical Sciences
Founder and Chairman
The Center for the Study of Drug Development
Member of FIM Board
(In the past he was the recognized worldwide authority on the public policy issues
impacting the productivity of the dynamics of our medical discovery system).
“I have never run across anyone like Dr. DeFelice with such broad and intense
personal involvement for so many years in all aspects of medical innovation in his
great quest to bring much needed new therapies to all those in need. He has
passionately lived and toiled within the system for almost 40 years and he, perhaps
more than any other, understands its strengths and weaknesses and what remedies
are appropriate. There is none like him.”
Former Managing Editor and Vice President, The New York Times
Member of FIM Board
(Spoken to Dr. DeFelice at a FIM Board meeting. Unfortunately, it didn’t happen).
“Steve, I’ll bet that my media colleagues will embrace your concept of the
Aram Chobanian, M.D.
Former President of Boston University
Dean of Boston University Medical School
Member of FIM Board
(Comments made to an interviewer in a piece written about Dr. DeFelice).
“Steve stirs up the pot when it comes to speeding up medical discovery like no one
I’ve ever met.”
William J. Curran, J.D., LL.M, S.M.Hyg.
Frances Glessner Lee Professor of Legal Medicine
Harvard Medical School
Noted authority on medical legal issues and regular contributor to the
prestigious New England Journal of Medicine.
Member of FIM Board
(Spoken by Dr. Curran at a FIM conference. This effort was also largely made
possible by Italy’s most famous and distinguished physician, Silvio Garattini,
Director of the Mario Negri Institute and FIM Board Member).
“One of my best decisions was to have Dr. DeFelice join our Harvard faculty. It
was particularly gratifying when he arranged for our faculty to teach the Italian
researchers how to manage biomedical research. He loves Italy and his enthusiasm
was infectious to both our faculty and students.”
Joseph R. DiPalma, M.D.
Hahnemann University Medical School Member of FIM Board
(Taken from a review of one of Dr. DeFelice’s books dealing with the importance of
encouraging clinical research on natural substances).
“A brilliant and readable analysis of the forces which hinder the delivery of
nature’s medical promise. When DeFelice speaks, I listen. When he writes, I read.”
Senator Bill Frist, M.D.
Physician and Senate Majority Leader under George W. Bush.
(From a telephone call regarding his decision to pursue the Doctornaut Act.
Unfortunately, even with his powerful legislative power there was no interest from any
“Steve, it’s a go! I’ve instructed my staff to write and circulate a draft”
Sheldon S. Gilgore, M.D.
Past Chairman, G.D. Searle
Past Chairman, Pharmaceutical Research and Manufacturers of America,
Member of FIM Board
“Dr. DeFelice is the most extraordinary visionary that I’ve ever encountered and
sees things that others do not.”
D. Ted Lewers, M.D.
Past Chair, Board of Trustees
American Medical Association, AMA
Member of FIM Board
(Spoken at a FIM Board meeting. Unfortunately, it didn’t happen. He was once
declared dead after an accident but luckily someone then discovered that he was
still alive before he was placed in the morgue).
“Steve, I’ll bet you that my medical colleagues at the AMA will love your concept
behind the Doctornaut Act, and I’ll do my best to convince them.”
Jay Skyler, M.D.
Past President, the American Diabetes Association
(One of the world’s highly respected and dynamic authorities on diabetes).
(A quote from a book written about Dr. DeFelice).
“I think doctornauts should be mandatory for clinical research physicians. They
provide a wonderful opportunity for doctors to serve their patients.”
Mark Hallett, M.D.
Chief of NINDS Medical Neurology Branch and Human Motor Control Section
(Dr. DeFelice considers him one of the most brilliant physicians that he has
collaborated with in clinical trials. Dr. Hallett became one of the world’s most
respected neurologists. Though many disagreed with Dr. DeFelice’s ideas
practically all, like Dr. Hallett, appreciated his love of life).
“Steve thinks outside the box, and that is often the way progress is made. He truly
enjoys life, and we had good times together.”
William F. Buckley Jr.
Founder and Editor, National Review
America’s most famous and highly influential Conservative writer, educator
and adviser to President Reagan.
(Said by Mr. Buckley to Dr. DeFelice during a private dinner regarding his Drug
Discovery book. Unfortunately, he was right. He called him after he reviewed his book
and said that the response to his column about the book was one of the lowest).
“Dr. DeFelice, I believe you’re too optimistic that your fellow physicians, media
and companies will be willing to support your Doctornaut concept. But I will give
you and your mission a plug of your book in one of my columns.”
Senator Tom Harkin
Former major force in the United States Senate and U.S. Presidential
candidate. Also a good and generous man.
“Dr. DeFelice is a national leader and innovator in the health field and leading
advocate for clinical research on nutraceuticals, a term which he coined.”
Joseph M. Valenzano, Jr.
Founder and Former CEO and Publisher
Exceptional Parent Magazine, Global Communications
Member of FIM Board
(In the past this visionary man recognized that many parents of children with
disabilities were lost having no place to go regarding information of their conditions and where to go for help. Exceptional Parent Magazine provided such critical information helping untold numbers of parents, children and their families).
“Dr. DeFelice approaches the crisis of health care in a radically different manner.
He is not introducing new complicated policies or bureaucratic programs, but
instead, a practical program of action to be carried out by brave women and men
physicians he calls “Doctornauts.”
And now, to his National Spray Approach.
Patricia Park, Director
FIM, The Foundation for Innovation in Medicine
A Rapid Way— on Short Notice— to Keep America Functioning Normally on a Day-to-Day Basis During the Next Covid or Respiratory Virus Pandemic: It’s Through the Nose and Implementing the Lessons Learned of Nasal Spray Steroids on Allergic Rhinitis and Sinusitis
Stephen L. DeFelice, M.D., Founder The Foundation for Innovation in Medicine, FIM, 1976 www.fimdefelice.org
The Nasal Spray Rationale
During a Covid or respiratory virus pandemic the primary medical objective is to eliminate or at least control the disease with effective vaccines and pharmaceuticals and substantially diminish the devastating mental, physical and economic damages.
But there is another critical yet little-mentioned national objective that recently dawned on me. It’s a way to counteract or control such damage until effective vaccines and pharmaceuticals are available to do their job or the pandemic naturally dissipates. And the good news is that such a possibility does exist and which it, unlike vaccines and drugs, can be rapidly developed and distributed. It’s by the use of nasal sprays which prevent viruses from attaching to the nasal mucosa and entering the body or by any other mechanism. So with a few squirts in the morning and maybe at night, a teacher can safely go to class, doctors and nurses to their hospitals and many millions to their jobs. As a result, our country’s devastating social-economic impact would be substantially reduced.
This piece deals with how I stumbled upon this hopefully doable opportunity and the need to somehow establish a national nasal spray approach— rapidly.
A Call for a National Spray Approach
The Covid pandemic had effectively destabilized our nation bringing it perilously close to its knees. Though we may be on the mend, there is little doubt that a future Covid pandemic where effective vaccines or drugs will not be available may be on its way leaving us only with masks and distancing to protect us. Many knowledgeable physicians and scientists would not be surprised that such a new Covid mutant or variant will indeed abruptly appear and mightily strike us leaving us defenseless.
So where do we look for a type of therapy that will keep our country functioning during future pandemics? It’s in the Nose and understanding the broad positive cultural impact of nasal spray steroids on allergic rhinitis and sinusitis.
During the dreaded allergy season, millions of Americans experience the debilitating signs and symptoms of allergic rhinitis and sinusitis. Such suffering includes a relentless runny nose, pressure headaches, insomnia, fatigue, feeling miserable and diminished mental acuity all of which lead to a substantial reduction of our national work productivity such as in the family, schools, government, business, military and religion, as well as other sectors. And also let’s not forget that, despite years of intensive research efforts, there are no general drugs, vaccines or any other type of cures available during the allergy seasons. So another medical approach was needed to keep our country functioning as normally as possible on a day-to-day basis during these seasons. The steroid nasal spray is such a therapy. It’s highly effective in reducing the debilitating allergic clinical manifestations making it possible for men, women and children to function more normally. So it makes compelling sense to take a similar medical approach to Covid and other respiratory viruses. And for some inexplicable reason we currently lack such a sensible and unquestionably uncomplicated doable approach in the face of potential oncoming Covid and other respiratory viruses.
You may be wondering how I came upon this approach. An old colleague and well-respected scientist contacted me asking my advice regarding his discovery of a nasal spray that was shown in multiple laboratory studies to block the entry of the Covid virus through the nasal mucosa or cells preventing it from entering at the point of its entry to the body.
To my surprise, there are indeed a number of such highly promising laboratory studies, including those conducted by a division of the National Institutes of Health, which confirm this effect.
Now I’m going to stick my head out on a limb because the critical need for such a national weapon against respiratory viruses mandates taking risks, even personal ones. For the record, I’ve had an extensive career in evaluating laboratory studies which are necessary to help me design clinical studies, place and oversee the actual studies and, after completion, evaluate their results. I instituted the Peer Group concept selecting a group of creative, independent physicians and scientists to help guide every step of the process. I managed a substantial number of clinical studies in the capacity of medical director of pharmaceutical company divisions, chief of certain clinical studies for the Department of Defense during the Vietnam War and establishing the first CRO or private Clinical Research Organization which plans and manages clinical studies for domestic and international pharmaceutical companies.
Based on such broad personal experience, I believe that it is reasonable to be optimistic that this nasal spray has a good chance to be clinically effective as a prevention weapon.
Drugs or pharmaceuticals such as aspirin or anti-Covid ones must in clinical studies undergo multiple biological steps such as intestinal absorption, proper distribution to the site where it’s supposed to be effective and then metabolized in order to be eliminated from the body. In addition, they must be shown to be acceptably safe. Because of this highly complicated, multi-step path, most promising drugs discovered in laboratory research fail to be proven to be both clinically effective and/or safe.
But this nasal spray, like certain others, does not go through these multiple steps for it, by just a single act, simply kills or immobilizes bacteria, viruses and fungi by acting on their surfaces like the disinfectant chlorine on a kitchen counter and antiseptic alcohol in hand sanitizers making its predictability of activity on any surface such as human nasal mucosa cells extremely high.
And, before I forget, the ingredients of my colleague’s nasal spray are extremely safe. So I said to myself, that because of the aforementioned facts and taking into account the urgency of maintaining national security, promising treatments such as this should be immediately and aggressively pursued with creatively designed clinical studies backed by sufficient financial support. If you’re going to do something this important, do it right!
The intended objective of the nasal spray clinical study was to prevent the attachment of the Covid virus to the nasal mucosa and not to treat an already infected nasal cavity such as is done with oral pharmaceuticals. But the cost of conducting a prevention study is prohibitively high. The pharmaceutical industry evaluated tens of thousands of volunteers spending multi- millions of dollars in order to demonstrate the preventative effects of their vaccines.
The sponsor of this study did not have such deep pockets and, therefore, supported a very small yet well-designed study in patients who were already infected with Covid as determined by presence of the virus in the nasal cavity. In other words, it was a treatment study.
The study results were not statistically significant, but I thought that if the number of volunteers were much larger, there may have been a highly significant clinical effect on the most important measurement—the disappearance of the virus from the nasal cavity. If so, it may signal a significant breakthrough. Maybe this statistical exercise should still be done.
(A colleague just informed me of a double-blind study conducted in a large Asian country evaluating a nasal spray that prevents the Covid virus from entering the nasal mucosa. Though the results were reported as positive, they were, for a number of reasons, not conclusive. More details are needed. But the good news is that it may be a sign of growing interest in this approach).
What Would You Do if You Were in My shoes? Here’s What I’m Going to Try.
Here’s how I view the situation and decided what to try to do: Though the results of the laboratory studies on the U.S. nasal spray, also including animals, are highly promising, significant support and enthusiasm from academic sectors is lacking which presents a credibility problem. But I have no reason not to accept their results, particularly since the NIH participated in such studies. And, based on my experience, I believe that there’s a high probability that the nasal spray will be clinically effective in preventing Covid viruses from passing through the nasal mucosa. Yet, to my knowledge, no preventive clinical study is planned and a golden opportunity will be lost to our country.
Now with the current surge of B.4, B.5 and God knows what other mutants could be on their way —soon!— I must make the assumption that our vaccines and drugs may not be sufficiently effective when they strike.
So I’m thinking where does that leave us? It’s in an already vulnerable country where our day-to-day operations will immediately be crippled and the inevitable destructive consequences will be enormous. And I concluded that an energetic national nasal spray approach is a compelling logical and short- term solution, and I’ll try to spread the word by my foundation in an attempt to find influential others who can move the ball. At age 86, I lack the necessary ATP levels.
That’s what I plan to do. So what would you do if you were in my shoes? Do nothing?
A National General Nasal Spray Approach
As with vaccines and drugs the establishment of a national research and development effort is urgently needed. The very good news is that, unlike vaccines and drugs, the costs of discovery and development of a nasal spray is far, far, far less as well as the time required to conduct the clinical trials and achieve adequate national distribution.
In addition, there is a cornucopia of generally available potential nasal spray candidates such as hydrogen peroxide, hypochlorous acid, nitric oxide and even saline, if, however, delivered properly. Another NIH division is evaluating a promising candidate with a different mechanism of action. The frequent administration necessary during prolonged pandemics, however, would require long-term safety studies. And, for the record, I believe a high percentage will inevitably fail this requirement.
There are, unfortunately, real world economic and social considerations that can stand in the way of nasal spray pursuits. Many of the active ingredient candidates may not be supported by a strong enough proprietary position such as a patent to justify financial investments by pharmaceutical companies or other potential sources. Also, understandable concern already has been raised that effective alternative therapies such as the nasal spray would discourage large segments of our population from taking effective vaccines and drugs.
On the other hand, despite such barriers the compelling urgent national need combined with the large market potential will inevitably lead to innovative organizations or individuals who will take the chance and invest in highly promising nasal spray research.
The Need to Establish a Nasal Spray National Stockpile and When to Begin
Because of the magnitude of the threat to our national security and well- being, when it’s determined that the initial clinical study data are unequivocally positive, even before the study is completed, a commitment to expeditiously establish a national stockpile of the nasal spray should be placed into motion with the capability of rapid expansion depending on further clinical data on its efficacy and safety. When produced in sufficient quantities, it should be distributed to individual States to maximize efficient national distribution.
A Call to Potential Leaders
I’ve been asked what specific organizations or even wealthy individuals such as Jeff Bezos, Bill Gates and Elon Musk would invest in the anti-Covid nasal spray effort in order to avoid the possibility of the crippling and weakening of America. And, let’s not forget, leaving us particularly vulnerable to unfriendly powers. Or, even a capable charismatic political leader. Or, how about a creative international source? This remains to be seen. What is critical at this point in time, however, is that the message of the Nose opportunity and the lessons learned of the anti-allergic steroid nasal sprays be rapidly first understood and appreciated.
And, hopefully, this post will help lead to such an awareness followed by some type of highly productive national nasal spray approach.