To Health and Human Services: Why Do You Fail to Utilize Broad-Spectrum Antiviral Drugs?

Dear Assistant Secretary of Health and Human Services Dawn O’Connell,

             When speaking to his general staff in World War Two General George S. Patton said, “If everyone is thinking alike, then somebody isn’t thinking.” Unfortunately, during the recent War on Covid the NIH and CDC thought too much about new drug development and vaccines and not enough about novel targets for pharmacologic interventions, early therapy, broad-spectrum antivirals, and late therapy. The NIH missed two obvious targets for pharmaceutical interventions to save lives. That omission more than doubled the mortality rate of Americans compared to what would have been achieved if those interventions had been used.  

            A much less famous quote than General Patton’s is from Dr John Fahey the first Director of the UCLA arm of the Multi-centered AIDS Cohort Study - MACS. Chairing a plenary session at an AIDS Clinical Trials Group (ACTG) Conference in Washington DC in 1992 Dr Fahey pleaded to hundreds of university researchers, “If we could just find something to inhibit NF-kB!” After Dr Fahey issued that plea I moved to the microphone and said, “Dr Fahey, aspirin can inhibit NF-kB.” The room fell silent. In 1989 Dr Donald Kotler of Columbia University proved that asacol (5-ASA) could inhibit viral replication almost as well as AZT. Years later in Zimbabwe I helped show aspirin could more than double the increase in CD4 count compared to AZT. Thus cheap, safe aspirin proved more effective against HIV than expensive, toxic AZT. “Believe it or nots” happen in science. Ignoring basic scientific principles doubled pandemic deaths in the United States during Covid-19.      

            In 1995, sitting in a meeting of the UCLA AIDS Institute’s Community Advisory Board, Dr. Ronald Mitsuyasu, Director of the UCLA  AIDS Institute finally admitted to me, “Howard, we know aspirin inhibits HIV, BUT WE ARE NOT GOING TO STUDY IT!” Twenty-five years later in June 2020 scientists determined that a strong NF-kB inhibitor, dexamethasone, could reduce deaths from Covid-19 by between one-fifth and one-third. What took so long? We could have used NF-kBI drugs since 1990 to help save lives from HIV/AIDS by inhibiting that same NF-kB protein, but we did not. We also failed to use NF-kBIs against Ebola, Zika, or other viruses like West Nile. Over a dozen steroid and non-steroid anti-inflammatory NF-kBI drugs exist with a wide range of strengths ranging from aspirin (1x) to dexamethasone (210x) that is two hundred and ten times as strong as aspirin. We have failed to use a range of both weaker ones like diclofenac (15x) and the most powerful one like tamoxifen (567x) against viral disease. This is one of the greatest oversights in modern medical history. It contributed to the death of over one million Americans from Covid-19, and millions more worldwide. That oversight is the failure to realize that all drugs that inhibit NF-kB not only inhibit inflammation but also inhibit viral replication at a similar rate. Thus all anti-inflammatory drugs also work as broad-spectrum antiviral drugs. It is past time to acknowledge and apply that basic fact to save lives. Ignoring it costs too much.

            While it is fine to spend five billion dollars to try to develop new drugs to treat unknowable future viruses, why do we fail to test existing, approved, safe, affordable, obviously effective anti-inflammatory/ antiviral NSAID and steroid drugs? Is that five billion dollars just corporate welfare for the pharmaceutical industry or does the Administration of Strategic Preparedness and Response – ASPR - really focus on preparing to save American lives? While NF-kBI drugs have an extremely wide range of strengths and can be used as interventions from day one of infection of a pandemic, and at all stages of disease progression, they also can be combined with other drugs working via other mechanisms such as Paxlovid. ASPR should arrange to conduct randomized, controlled clinical trials of these safe drugs rather than only pursuing less cost-effective new drug discovery for drugs to treat unknown future viruses. If ASPR ignores existing broad-spectrum antiviral drugs, what kind of specific drugs will it focus on for future viruses? While vaccine development was critical for Covid-19, by using a new vaccine development platform, that proved surprisingly quick. Although vaccines did not fully live up to all initial expectations during the pandemic, the critical preparedness failure was having no effective, early therapies to treat people from the start, and failing to recognize the easily remedied rapid depletion of selenium in terminal stage disease. Will Paxlovid be effective against the next XYZ virus? No one knows. But broad-spectrum selenium and NF-kBIs will be.   

            Reviewing the development of a therapy for Ebola in the 2010s presents a case study of corporate welfare where profits come first and saving lives come last, with few follow-on benefits. 

            Working with the Ministry of Health of Liberia in 2014 Dr Jerry Brown took the selenium the ministry had asked me to bring from South Africa and used 1.2mg daily on his Ebola patients at ELWA-2 Ebola treatment unit in Monrovia. We showed that adding 1.2mg of selenium to the WHO standard of care reduced the mortality rate of Ebola by 42.8%. If Dr Brown had used the 2.0mg daily dose I had recommended, the mortality rate should have fallen by approximately 65%. This greatly exceeded dexamethasone’s comparative benefits against Covid-19. Yet when Dr Brown took this impressive result to the representatives of the NIH and CDC who had recently arrived in Monrovia, they were not interested. This was because the NIH had four candidate Ebola drugs in development and obviously did not want competition from a cheap, safe, effective nutritional supplement. Three years later the NIH conducted their clinical trials of those four potential Ebola drugs in Kivu Province, Congo. They found that one of the four, Remdesivir, was effective. A course of Remdesivir costs more than a hundred times as much as selenium and must be administered intravenously through an IV requiring additional clinical care compared to easy to take selenium tablets. The other three candidate drugs that were tested showed no benefit. When SARS-CoV-2 arrived, Remdesivir was tested against Covid-19. It was not effective. Selenium is effective because it gets to the core of how SARS-CoV-2 and most other viruses cause disease and death. That is by attacking the cellular antioxidants that contain selenium and depleting the immune system of the selenium it needs to function. Most antiviral drugs are virus specific and are not effective against other viruses. As broad-spectrum antivirals, selenium and NF-kBIs are the exceptions. Working by inhibiting a cellular protein, not a viral enzyme, they are effective against most viruses. Why do we fail to use them?             

             Next is an even bigger gap in scientific common knowledge than failing to understand that all drugs that inhibit NF-kB are anti-inflammatory and also act as antiviral drugs. That is the failure to understand what a critical role selenium depletion plays in how enveloped viruses such as HIV, Ebola, influenza, and Covid-19 cause disease and death. That relates directly to how many selenoproteins each viral genomes encodes and therefore how rapidly viruses deplete selenium from cells and the immune system as they replicate.  

            Just as the NF-kB protein stimulates both inflammation and viral replication, selenium helps fuel the immune system. All aspects of immune function require selenium. In fact, the level of selenium in the body is the primary determinate of whether the thymus gland produces more CD4 helper cells or more CD8 suppressor cells. The higher the selenium level in the body, the more CD4 cells are produced and the fewer CD8 cells are produced. Selenium is the strongest immune booster because it is the strongest medicinal agent to increase CD4 count, the basic measure of immune system strength.

            Besides being the most important element to support immune function, selenium is a key to cellular health. All cells contain antioxidants to protect them from oxidative stress and structural damage and to help eliminate toxins. Most antioxidants contain selenium at their “active site”, the part that accomplishes that work. As a minimally available trace element, if selenium levels are depleted, there is not enough left to form antioxidants. Then the prooxidant/antioxidant balance in cells is disrupted. That damages cellular health. Supplementing selenium restores the body’s oxidative balance and the health of cells, tissues, and organs.

            Normally it takes years for pharmaceutical companies working with the assistance of the NIH to develop and test new effective antiviral drugs. With HIV it took fifteen years to develop protease inhibitors. With Ebola it took an additional three years to develop Remdesivir after the NIH chose not to save lives using selenium. Did anyone develop a therapy against the Zika virus that attacks nerve cells to obtain the selenium that is concentrated in the developing nervous system and brain? How can ASPR possibly spend five billion dollars developing drugs to fight zoonotic viruses that have not yet emerged from the biome? When the next highly pathogenic virus emerges, perhaps from a 20,000-year-old animal carcass unfrozen by the melting permafrost of the Siberian tundra, how many years will it take to develop new drugs, then test, approve, manufacture, distribute and administer them worldwide? How many will die in the first, second and third wave of the next pandemic before newly developed drugs finally start to save lives? It took two years for Paxlovid. Would it not be better to have an array of broad-spectrum antiviral drugs to use from day one, choosing a strength tailored to the severity of a patient’s symptoms?  That option exists. That is real preparedness. New drugs can always be added to the base therapy of NF-kBIs and selenium. Is that too simple? Too cheap? Or too prepared?  

            Covid-19 initially had a case mortality rate in the US exceeding 1.0%, and a final estimated case fatality rate of approximately 0.5%. SARS-1 had a case fatality rate of approximately 9.6% and MERS has a rate of about 37%. The lowest case fatality rate for H5N1 avian influenza currently cited by reliable sources is 40%, although other reliable sources have quoted 50% and 55%. Who is prepared? Certainly not the WHO or ASPR.      

When viruses mutate to become transmissible from person-to-person, they often become less deadly. However this may take time and can never be taken for granted. If H5N1 did become the next pandemic to strike the US and it retained a 40% case fatality rate, given a 40% infection rate in the first year, 53 million Americans would die. 330 million population x 40% infection rate x 40% case fatality rate = 53 million deaths. There is zero certainty in this number because the virus may mutate to become less pathogenic. Since H5N1 currently appears to be trying to jump the species barrier from many bird species into many mammal species, there is a 10-20% chance H5N1 could be the next pandemic to strike worldwide. Considering the potential advent of this viral Armageddon, should ASPR try to understand more clearly how viruses interact with our cells and immune systems? That has been the focus of my research for the last thirty-three years. How will ASPR and the CDC treat H5N1 flu from the start? With stockpiles of ineffective Tamiflu? What else? Although N5N1 vaccines are in development, flu vaccines are usually only 65-80% effective in preventing infection.                        

            Putting the prognostication shoe on the other foot, what would you predict might be the next highly pathogenic virus to cause a deadly global pandemic? Another novel Corona virus? A more contagious or deadly mutation of the current SARS-CoV-2 omicron variant? A mosquito-borne virus like West Nile or Zika? An H1N1 influenza related to the1918 Spanish-flu type? Or an infectious virus like Ebola or HIV that recombines with an airborne virus exchanging genetic material and becoming airborne? Immunocompromised HIV patients who are not receiving antiviral medications in some Southern African country have been mixing bowls for viral mutations, as has India. But new viruses can emerge anywhere, including from a chicken or turkey farm in Iowa. Is ASPR prepared? No. Will it be prepared? Only partially. While the NIH, the CDC and ASPR fail to think outside the box and ignore safe effective broad-spectrum antiviral medicines, you will never fully be prepared. You will always be behind the curve. What intelligent government ever fought a war without using all the weapons in its armamentarium? Only the losing side - as the US did with Covid. Then why ignore life-saving selenium and NF-kBIs? Since selenium is also effective against heavy metal and radiation poisoning, does ASPR have a strategic stockpile of selenium for that? Why not? Do not be blindsided again!       

            People sometimes say, “What Howard Armistead writes is not peer reviewed! Do not read his paper!” That is true. My book is not peer reviewed and my letters to you and Congress are not peer reviewed. But what I write is 100% based on scores of peer reviewed articles that are listed and excerpted in my two books and the over 3,000 other peer reviewed medical journal articles I have read since 1990 on virology, immunology, NF-kB, selenium, hemorrhagic viruses, and related subjects. Although I have only read a dozen books on virology, a dozen on immunology, and a dozen on the history of medicine, science, and disease, that should be enough for a fundamental understanding. I have attended over fifty-seven AIDS and virology conferences worldwide, and although I am not a clinical physician nor a PhD, I have been a member of the International AIDS Society and have worked with several doctors to design clinical trials in Africa. In 2007 the Zambian Ministry of Health, asked me to organize the Technical Working Group on Selenium, and I wrote the report of that working group. In 2014 I advised the Liberian Ministry of Health on the quick informal clinical trial conducted by Dr Jerry Brown – Time Magazine’s Person of the Year for 2014. That trial provided the only effective therapy for Ebola discovered during the entire 2014-16 Ebola epidemic in West Africa. Since I started participating in AIDS research with the Multi-centered AIDS Cohort Study in April 1984 and started experimenting on myself in 1989, like Anthony Fauci, one might say I have previous pandemic experience. In 1990 I became an autodidactic AIDS researcher to save my own life. Unfortunately the United States was not prepared for SARS-CoV-2 because it failed to research and then use NF-kB inhibitors against HIV/AIDS even after this approach was so presciently pled for by one of the leaders in AIDS research at the time, Dr John Fahey at the 1992 ACTG Conference. The US again failed to grasp the therapeutic brass ring when the NIH and CDC failed to accept that selenium showed great effect saving lives from Ebola in Liberia. One must ask how inefficient a government can be when it plans to spend five billion dollars on research to protect us from unknown XYZ viruses while continuing to ignore highly effective, broad-spectrum, antiviral NF-kB inhibitors and selenium. That is not warped speed. That is warped science that ends up warping preparedness.  

            In the end, the way viruses like HIV, Ebola, and SARS-CoV-2 kill people is by genetically encoding selenoproteins and depleting selenium from cells, the immune system, and the body. When 20% of a person’s selenium is lost, they suffer immune deficiency. When 30% is gone, they perish. Adequate selenium levels are as essential to life as adequate oxygen and water levels are. My thorough understanding of this is based on uncovering the few golden needles hidden in the haystacks of scientific knowledge contained in three thousand medical journal articles and then putting two and two together. When did modern science ban logic? Was it the same time some told others not to read scientific essays not because they were wrong or thought provoking but because they were not “peer reviewed” when they were not even in the form that requires peer review? Institutionally and intellectually introverted bureaucratic agendas do not save people’s lives. Testing, then using proven therapies based on solid scientific principles and evidence do. Obviously, early therapy is the best therapy, but Paxlovid can only be taken for five days. Some physicians do not prescribe it for some patients due to its numerous contraindications. Effective combination therapy is always better than monotherapy. Complementary therapy with selenium should also reduce the side effects from Paxlovid, as it does with many other drugs. To the contrary, selenium and various strength NF-kBIs can be taken from day one of a pandemic or infection until the last day of recovery.     

NF-kB is a replication factor - the primary stimulant to viral replication. It seems a crime to use only one of a dozen NF-kB inhibitors to save lives, ignoring all the rest. If you ignore scientific facts, you also ignore potential scientific solutions. Why would ASPR do that? How long will it continue to do that? How many future millions will die due to scientific neglect? How many more billions need to be spent inefficiently instead of refining our clinical knowledge about how to use NF-kBI drugs and selenium? How many trillion dollars will the next pandemic cost the American taxpayers as the NIH and the CDC again fail to save the lives of so many who could have been saved? So many questions. So much scientific inefficiency. So much corporate welfare. So little wisdom. So little therapeutic preparedness. Where are the pandemic heroes when we need them most? I suppose they are lamenting the millions who died due to past bureaucratic neglect and scientific obfuscation.                     

            I have enclosed a copy of my recent books, Understanding Covid-19, How 500,000 American Lives Could Have Been Saved and Dear Bill Gates, How to End Serial Pandemic Failure, HIV-1 to Covid-19. While Understanding Covid-19 has been reedited,  Dear Bill Gates is in its rough, first self-published draft. I am currently reediting and updating it. Please excuse its imperfections and turn to page 48 for a list of NF-kBIs and their relative strengths.  

            I do not have the answers to all the pandemic questions - only a few critical life-saving ones. In 2006 AIDS journal published a large study showing that just one 200mcg tablet of selenium daily can slow HIV progression by 43.6%. It can slow Covid too. Remarkably, AIDS is the acquired immune deficiency of selenium. That is how HIV kills, by depleting selenium from the immune system. Once 20% of a person’s selenium is lost, one has AIDS. When 30% is depleted, a person perishes. The same thing happens with Ebola, just a hundred times faster. Medical journals report that every single person who is hospitalized with Covid is seriously deficient in selenium. As SARS-Cov-2 genetically encodes and depletes this essential trace element, those who can maintain enough selenium survive. Those who cannot expire. It is the same as when one loses 30% of their water or oxygen. No one should be surprised at this uncommon knowledge. Selenium depletion is also the key to understanding the blood clotting in Covid - DIC – distributed intravascular coagulation.       

            If ASPR needs someone to consult on this as they obviously do, I am available. Unlike many people, Covid was not my first pandemic. Given the conceptual void on the issue of effective broad-spectrum anti-viral interventions, you need someone to think outside the bureaucratic box. As General Patton would have noted, you are “all thinking alike, so somebody is not thinking.” You need help from the Viral Intelligence Agency.  

            No one can predict when the next pandemic may strike nor how pathogenic it will be. Thinking outside the box is not a bureaucratic forte. As an autodidactic AIDS, Ebola, and Covid researcher, I humbly offer my services. It is the least I can do to help save the lives of my fellow citizens and humanity.

Scientifically yours,

Howard Steel Armistead