2020 is a year when many things besides people have died, or at least placed on indefinite life support. Music and most arts and culture (at least audience-based), education, a person`s livelihood, social trust and interaction, common sense and common decency, debate, and we can include responsible journalism to the list.
In fact, responsible journalism was one of the first casualties of 2020 and bears responsibility for much of the rest.
My path to 2020 was unusual, to say the least, but it prepared me to deal with the events that have transpired.
Each step of my career as a scientist I chose a path which led me to 2020.
Here are some examples:
- My two leading choices for the Ph.D. program in chemistry were at the University of Southern California (USC), where I had interviewed with Professor George A. Olah (Nobel Prize in Chemistry, 1992), and the University of California, Riverside (UCR). I chose UCR and Professor M. Mark Midland, who had earned his degree with Professor Herbert C. Brown (Nobel Prize in Chemistry, 1979) and was young, enthusiastic, and broad-based in his interests . If I had chosen and been able to study with Dr. Olah, my career would have been set but much more narrowly focused. I chose Dr. Midland and I have never regretted the choice.
- With the Ph.D. in hand, I had a choice of academia (the expected route) or industry. I chose industry, specifically, the pharmaceutical industry since I had always been interested in medicinal applications and medicine in general.
- In industry, I chose development over research based upon the unique challenges.
- Later, I chose to move out of direct scientific work and into Quality Assurance. Part of this choice was the opportunity to learn new things.
- Still later, I chose to move into Biopharmaceuticals and vaccines in particular. This afforded me a new opportunity at learning.
- Finally, I moved into consulting to try and use my experience to assist others in the industry.
The last company I worked for was a vaccine company, as Director of QA. For those that do not understand, being responsible for Quality Assurance is an immense task. You have to be both an expert and a judge.
The company was founded in an attempt at development of an HIV vaccine. After 9/11, the company expanded into Biodefense and was pursuing the development of vaccines for anthrax and smallpox for the US National Stockpile as part of the newly formed Dept. of Homeland Security. I joined the company at that time and I became the project leader on a new smallpox vaccine being developed in collaboration with a Japanese company.
I had studied virology and infectious diseases in college, but I needed to expand my knowledge. So, it was immersion time. This also coincided with the original SARS outbreak in Hong Kong. In fact, I visited Hong Kong in 2003 during SARS (no lockdowns, distancing, etc.; some people wore masks but it was mainly because of the very poor air quality in Hong Kong, not due to SARS). I had become interested in Upper Respiratory Infections (URI) long before, mainly as a result of my occasional personal battles with the cold, flu, sinusitis, bronchitis, etc. but SARS was a new opportunity.
As a project leader for smallpox, I had the opportunity to meet and talk with Dr. D.A. Henderson, a leading person during the WHO smallpox eradication effort during the 1960s and 1970s and involved with the Dept. of Homeland Security on the Biodefense initiative under the G.W. Bush administration.
An hour or two with Dr. Henderson was worth a whole semester of classroom learning. I learned much about infectious disease control, strategy, management, etc. Of course, Dr. Henderson would be opposed, to put it mildly, to the current “policies” being used, such as lockdowns, closures, masking, etc.
However, at the time that I met him, much of the concern was directed towards the aging U.S. vaccine stockpile, particularly for infectious diseases that were being considered as possible bioterrorism weapons (e.g. anthrax and smallpox).
After “retiring”, I had hoped that I was “riding off into the sunset” on a Harley (figuratively, since I do not yet own one) as far as my career was concerned. But,as a scientist, with expertise in infectious diseases, PPE, antiviral medicines, vaccines, etc., this year thrust me back into thinking mode, instinctively at first. But, I soon discovered that we were in trouble, not from the virus but from ourselves.
As if a switch had been thrown, the light went out on responsible journalism EVERYWHERE! Power has not yet been restored.
I came upon an article recently on Yahoo from Zacks that caught my attention . The opening sentence really got me going and I quote it now (emphasis added):
Biotech firms and drugmakers across the globe are pumping in millions of dollars to develop a vaccine to wipe out the deadly coronavirus, with many already ramping up production of their vaccine candidates if one gets an approval.
With this one sentence and a simple phrase in it, the hammer was hit right on the head of irresponsible and misinformed journalism. Normal journalism would have written simply “…a vaccine for coronavirus…”; but hyperbole won out.
There are two aspects to that phrase that are worth examining, i.e. the idea of a vaccine wiping out a virus and the concept of a deadly virus. I have heard the term “wiping out” before (Nancy Pelosi?). But, I want to first deal with the deadly virus hyperbole and get to the vaccine part later.
How “deadly” is coronavirus? NOT VERY and that is based on data, medical reports, and general knowledge of URI.
It is interesting to review the first confirmed case in the US. Fortunately, this case history has been published. This person, a male in his 30s, had returned from Wuhan in mid-January after visiting family and had developed a cough and nausea. He was in a suburb north of Seattle, Washington.
As it so happened, I was visiting that area at the same time. He happened to have seen a CDC alert about Wuhan and went to a clinic. At the time, his main symptoms were cough and nausea and only intermittent low fever. His initial examination presented with no fever and his chest x-ray and lab tests were all normal. Even the clinicians recognized the implications as evidenced by the following statement from the case study:
These nonspecific signs and symptoms of mild illness early in the clinical course of 2019-nCoV infection may be indistinguishable clinically from many other common infectious diseases, particularly during the winter respiratory virus season.
He was admitted into isolation as he was being tested for the new strain of coronavirus (there have been 4 known strains prior to this: HKU1, NL63, 229E, and OC43). Once confirmed as having the new strain, he received only supportive care. It should be noted that besides nasal swabs containing virus, his feces also tested positive (which was tested since he was experiencing some gastrointestinal symptoms).
After several days, he developed pneumonia, which the staff feared was hospital-acquired pneumonia. This pneumonia is a serious problem because they tend to be antibiotic resistant strains. As a result, he was started on vancomycin (the only effective antibiotic against resistant strains) and also was given remdesivir. He recovered quickly and eventually was released.
The source of his infection was never traceable since he reported no contact with ill people while in Wuhan. It is not known if he picked up the virus while in Wuhan, or in transit, or even after returning to the US. At the end of the case study report, January 30, no secondary transmissions had been identified as known contacts had not yet become sick. This case does not mirror the panic that has been imposed concerning this disease.
After reading this, I have considered what would have happened had this person NOT reported to a clinic. It is hard to say. Eventually, there would have been a first confirmed case, but when and where? How many cases would have gone unnoticed in the meantime? Would this person’s disease have faded without experiencing pneumonia? He responded quickly to medical intervention, which was mainly to fight a BACTERIAL infection (pneumonia) that was possibly acquired in the hospital setting. He did quite well against the virus.
The media hype over this case at the time focused heavily on his Wuhan trip. How many people experienced the same symptoms and dismissed them because they had no Wuhan connection?
But, soon the media was all about the most serious symptoms, high fever, serious fatigue, difficulty breathing. If one went to the medical sites, as I did, you would find the same general advice, i.e. treat it like you would the flu but if it starts becoming worse, call or go see a doctor.
So, most people were probably paying attention to the media reports and not recognizing the actual medical reports. How many people were experiencing the mild form and dismissed it because it did not fit the serious symptoms reported by the media?
To this day, little has changed. The vast majority of people experience mild symptoms. Higher risk individuals sometimes experienced the more serious symptoms. Symptoms vary depending on the individual, their immune system, viral load, etc.
Meanwhile, around the world, more cases were becoming known as was the relatively benign nature of the virus by most people who experienced it. It was known early on in China that the high risk group for serious disease was the same as influenza; that is, elderly with serious health problems, but this was not being communicated. Even so, we had plenty of other data as well.
In February, the virus was discovered on a cruise ship in Japan. A ship mostly carrying retired, elderly people. It was an opportune situation to observe this virus. About half of the people on the ship tested positive (672 positive) and remained quarantined on the ship. There were a few deaths (13 in total), but most people experienced mild disease and eventually were released from the ship or hospital. Some Americans were returned to the US despite the travel bans. Still, it was clear that the virus was not deadly and it was clear who was at risk.
We all know what happened in March. The virus did not change nor did the data, bad modeling was pushed and governments panicked. There is little need to go into detail about the time since March.
So, now that several months have elapsed, what do we know about the mortality? First, it is becoming clearer that the mortality rate of Covid is consistent with influenza. There is nothing so different about it. This is based on serology studies to try and define a baseline number of people who have experienced the virus, not on testing since the testing numbers have little value. Far more people have experienced the disease than the numbers indicate. But the mortality is not so much due to the virus, but rather the susceptible population.
The national average on mortality rate, all causes, is running about 110-111% of expected. This number has actually risen over the last month or two even though the Covid death rate has declined. The top 5 highest values are for NYC (176%, note: the CDC reports NY state separately), New Jersey (134%), Arizona (124%), NY State (121%) and D.C (129%). There are seven states/territories that are below the 100% level (Puerto Rico, West Virginia, North Dakota, North Carolina, Montana, Hawaii, and Alaska). The Non-lockdown states are Arkansas (108%), Iowa (105%), Nebraska (102%), North Dakota (99%), South Dakota (100%), Utah (108%), and Wyoming (107%). A few other states worth noting are California (110%), Michigan (113%), Massachusetts (117%), Florida (114%), and Texas (115%).
What do these numbers mean? The CDC calculates expected mortality. They do this looking at the populations, age of population, health characteristics, recent historical trends, averages across various diseases and conditions, etc. Yes, it is computer modeling. People might expect that given the hype on Covid the mortality rates should be high. Well, let’s see.
The current number of reported deaths related to Covid is about 180,000, although that number is maybe meaningless because there is no consistency in reporting and we do not know how deaths are being recorded. Just because a person dies and maybe they have the virus does NOT mean that the virus or even a complication was the cause of death. Nationally, we know that deaths related to Covid have been accounting for about 5-6% of overall mortality and while that number was slightly higher earlier during lockdowns, it has been drifting downwards for some time. But, those deaths are probably not contributing significantly to the excess mortality figures.
Why? Because, the vast majority of deaths are in the elderly, age 70+, with serious health issues. These people have already been mostly calculated into 2020 mortality. In other words, they are at high risk of death from many things, not just coronavirus. They would experience the same outcome if it were influenza, maybe even rhinovirus. Certainly, bacterial infections would cause the outcome (and in the majority it has been pneumonia causing death, not Covid). Their life expectancy before coronavirus was already short – they were probably not expected to make it into 2021. That has been calculated into the expected mortality. Remember, the life expectancy in the US is about 78 years.
I know some people cringe when this kind of analysis is done. But, like a medical examiner doing an autopsy, in order to adequately understand what you are doing, you need to put aside the emotional aspects and focus on learning what you can learn. I especially feel for the elderly in care facilities and the poor in the inner cities who had this virus thrust upon them by horrible policies. They had no choice. Hopefully, by being honest with analysis, we can avoid the same mistakes in the future.
In fact it was the latter segment of society that may have an impact on the mortality number since the poorer communities were the ones to have been hit hard by the lockdown orders and virus. Minorities between the ages of 50-65 tend to have a higher death rate than would be normal course. Certainly, it is higher than their, shall we say, suburban counterparts.
So, where do mortality increases actually come from? The news media is paying little attention to this question. One source is collateral damage from another war started by our government decades ago. The “War on Drugs” was started in the 1980s. The following chart shows deaths by overdose (OD) in the US since that time. In 2019, 71,000 people died from OD in the US.
Recently, the American Medical Association (AMA) issued an emergency alert for an alarming increase observed in OD deaths in over 40 states in 2020. They predicted 2020 was going to be worse than 2019! They consider it a state of National Emergency.
While the data is hard to find at this point, there are reports that suicides are also increasing in 2020. This should not be surprising given the huge emotional and mental strains imposed on people during 2020 by their governments.
OD and suicide deaths tend to be mostly in younger, healthier people under the age of 50 who ARE NOT calculated significantly into the mortality rate. OD and suicides are calculated into the expected mortality but based upon past history so if there are sudden surges upward, it will reflect in the overall mortality.
Other diseases are also contributing simply because of the restrictions placed on receiving medical care during the pandemic, something which violates the Hippocratic Oath. Pneumonia deaths with no connection to either influenza or coronavirus are more prevalent than pneumonia deaths related to either viral infection.
So, is coronavirus deadly? Not really; in fact, most viruses are not truly deadly. The outcome may be death, but that is different than actually being deadly. A bite from a black mamba snake is deadly due to the potent venom. Viruses are parasites, unlike bacteria. Viruses depend on the support of their host. If a virus is to survive, it needs the host to survive. What kills most people with viruses is their own immune system weakness, but sometimes the immune overreaction can kill. That weakness is taken advantage of by bacterial infections. Also, generally poor health conditions can lead to organ failure.
During this pandemic, the vast majority of deaths have occurred in elderly people with serious health issues. These people would experience the same result if they had acquired influenza. As a matter of fact, it is quite likely that they would have the same result if the virus was rhinovirus. They would likely have the same result if they had bronchitis, sinusitis, pancreatitis, gastritis, bladder infection, etc. Their system simply was not able to fight the disease. Period.
To the vast majority of people who have experienced this disease, it is not even close to “deadly.”
“A Vaccine to wipe out the deadly coronavirus”
Well, the coronavirus is not deadly. But, what about the “vaccine” part of the statement?
No vaccine “wipes” out a virus. Vaccines are not cures. Vaccines are not preventatives. Vaccines do not seek out and destroy. As an example, we have had vaccines for influenza for decades (since the 1940s) and each year influenza exacts a toll on humans, including sometimes those who have been vaccinated. Influenza is not even close to being “wiped out.” We manage it at best.
Here is a short list of infectious diseases that are a part of our natural existence and any of these have the potential to cause death in any given individual..
1. Bacterial Infections. (Cocci) Pneumonia, Staphylococcal, Streptococcal, Enterococcal, Toxic Shock; (Gram Positive Bacilli) Diphtheria, Anthrax, Listeriosis; (Gram Negative Bacilli) Cholera, Trench Fever, E. Coli, Plague, Salmonella
2. Spirochetes Infections. Lyme disease, Yaws, Leptospirosis
3. Anaerobic Bacterial Infections. Botulism, Tetanus, Clostridium
4. Rickettsiae Infections. Murine Typhus, Rocky Mountain Spotted Fever
5. Mycobacteria. Tuberculosis, Leprosy
6. Fungal Diseases. Aspergillosis, Candidiasis, Histoplasmosis
7. Parasitic Infections. Nematodes (roundworms), Trematodes (flukes), Cestodes (tapeworms)
8. Protozoan Infections. Amebiasis, Giardiasis, Malaria, Encephalitis, Toxoplasmosis
9. Respiratory Viruses. Influenza/Parainfluenza, Adenovirus, Rhinovirus, Coronavirus
10. Herpes Viruses. Chickenpox, Mononucleosis, Cytomegalovirus, Herpes Zoster
11. Enteroviruses. Polio, Hand-Foot-Mouth Disease (not the same as the politician’s “foot-in-mouth” disease)
12. Various Viradae Viruses. Dengue, Hanta, Lassa, Ebola, Marburg, Yellow Fever
13. Immunodeficiency Virus. HIV
14. Misc. Viruses. Measles, Mumps, Rubella, Smallpox
15. Sexually Transmitted Diseases. Syphilis, Gonorrhea
Many of these diseases have vaccines available, many do not. Some vaccines are more effective than others. But there has been only one that we have eradicated naturally, i.e. “wiped out,” and that is smallpox.
Smallpox has been known as long as human existence. There is evidence from archeological studies that ancient Egyptians suffered from smallpox based upon descriptions and artistry. Many historically famous people experienced smallpox and survived (Mozart and Lincoln are two notable examples). Finally, in the mid-20th century, it took a worldwide effort lasting over a decade to do it. Here are some of the main reasons why it was possible:
1. Smallpox was entirely a human disease. It did not “toggle” back and forth between other mammalian species.
2. The symptoms of smallpox were unique and quite recognizable. This meant that it was easy to identify a person who was sick with smallpox and quarantine them. It was just as easy to identify contacts and observe them.
3. The vaccine was quite effective. As far as vaccines go, it was very effective, probably because of #1 above. However, the vaccine also had serious side effects. A small percentage of people experienced these very bad effects, sometimes fatal. In fact, one of the reasons for the new initiative after 9/11 was the concern over the safety of the old vaccine. During the eradication effort, the safety profile was accepted against the goal of eradication. But, in today’s world, the serious side effect potential was considered too great. We could now do better.
4. A massive effort was undertaken to go to every place on Earth to try and eliminate the disease. This effort was started several years before the WHO eradication effort. The vaccine had been used in most non-third world countries and there was little incidence of the disease. Usually, the disease was brought back by an aid worker going into some part of a third world country where the virus was still prevalent.
What exactly does a vaccine do?
Under the best of circumstances, a vaccine acts as a primer to the immune system. That is, it “inspires” the immune system to respond as if a true infection has occurred, albeit at a reduced scale. That is, to produce antibodies specific to the virus or surrogate used in the vaccine (antigen). The idea is that if a person is exposed to the real virus (true antigen) at a later time, the immune system will recognize it and respond quicker and more efficiently than normal. This may allow the immune system to gain control of the viral load before it can go to a threshold where disease symptoms are exhibited.
The vaccine usually is some weakened form of the original virus, maybe even inactivated, or it may be a chemical or structural surrogate, i.e. similar in composition but not active.
It is not a preventative! The vaccine does not somehow block the entry of the virus into your body. The vaccine only acts to initiate maybe a quicker more efficient immune response once infection has occurred.
It does not wipe out the virus! In fact, it does nothing to directly interact with a virus either in or out of the body.
The vaccine does not actually do any damage to the virus in your body; it is not a therapy or “antiviral” medicine. If your body has produced antibodies that are effective, they will seek out the virus. The antibodies are your weapon. The vaccine does not play any direct role against the virus.
The vaccine does nothing to the virus molecule that exists outside of your body. You could spray vaccine everywhere in the environment and it would have ZERO effect. Disinfecting agents like bleach, UV radiation, low or high pH solutions, etc. will break the virus molecule down but not the vaccine.
After decades of vaccines for influenza, we have not been able to eradicate influenza, why? It goes to the reasons why we were able to eradicate smallpox. First, URI such as influenza and coronavirus are carried by other mammalian species besides humans. Birds, pigs, and even domestic cats can carry the virus. So, in order to eradicate the virus, we would have to start by eradicating all of the birds, pigs, and cats in the world, maybe all mammals because we maybe do not yet know all of the species that may be capable of carrying the virus. Maybe then we could begin to deplete the molecule and eventually eradicate it.
It is this very reason that we tend to have a low effectiveness of URI vaccines. For this, we need to make clear certain definitions. Let’s use influenza as an example (the same applies to coronavirus). When a person receives an influenza vaccination, given in the muscle of the tricep or back of the arm, within some period of time they usually experience swelling, tenderness, pain, maybe some redness, etc. This is usually an indication that the vaccine has elicited some form of immune response, or a “take”. With influenza vaccines, this has been typically around 90%. Sometimes a second injection will give a take, and sometimes it just doesn’t happen.
For people who may remember the smallpox vaccine, the vaccine was given by stabbing a series of small punctures on the skin of your arm. After a period of time, a sort of blister developed followed by a scab. This was a take of the smallpox vaccine. After the scab fell off, you had a dimpled scar. I still have a scar but it has almost faded out. Under certain conditions I can still see it.
When a vaccine is tested for approval, it cannot be actually tested against the virus. That is, medical ethics do not permit exposing a healthy person to a live virus. So, the logical experiment of giving a vaccine to people and then exposing them to the virus is not performed. In old times it was done that way. The original smallpox vaccine, derived from cowpox serum by William Jenner, was first used on a small boy who was intentionally exposed to smallpox. Fortunately for Jenner, the boy lived and did not develop the disease but that was over 200 years ago and the medical ethics then were nonexistent.
In modern times clinical signs are evaluated, such as take, and serological signs, such as antibodies (that are tested for). The presence of all of these is enough to accept the vaccine as “effective.” However, that does NOT mean that it actually will be effective under normal use.
The other consideration is safety. If the vaccine does not cause disease and does not cause serious side effects, it is considered safe. This can be tested on healthy volunteers.
If both of these are met, it will be approved for use.
Vaccine effectiveness can actually only be inferred after an infectious epidemic/pandemic season. It is determined based upon the number of individuals vaccinated, prevalence of disease, etc. It is a complicated evaluation but one which is performed each year by infectious disease agencies such as the CDC and WHO.
To use influenza as an example, while the influenza vaccine generally has a take rate of about 90%, the effectiveness rate can vary widely depending on the flu season and strain(s) for that season. The following table shows data since 2004 on the calculated “effectiveness” of influenza vaccine.
Most of the time, the effectiveness is below 50%. There are many factors which can determine the effective rate but the health of the individual is always the most important. In the elderly, it is recommended that a double dose be administered. But, there is no data that supports that this is actually beneficial.
What Determines Effectiveness?
The answer comes down to individuality. The factors that will determine the outcome of a person with a viral infection are:
1. General Health. The healthier the person and their immune system, the better.
2. Age. Elderly people, even if healthy, will experience weakening immune systems. It is questionable whether the vaccine even gives any boost to their immune system since it is already weakening due to age. To give a double dose when the immune system is not capable of responding to a single dose is maybe futile.
3. Viral Load. This goes to exposure. For any individual, the more virus you are exposed to and infected with initially, the more difficult the fight against the virus. A large initial viral load, even in a healthy person, could mean stronger symptoms. Conversely, elderly people may still be able to deal with a lighter initial viral load, even though they are old and even if they have health problems.
4. Genetics. Genetics plays a central role in health and immune response. Some people are just more disposed to suffer from infections than others. Just like some people are more prone to certain types of cancers.
5. Environment. Those who require hospitalization, while getting more constant care, also are in an environment of increasing danger, especially from acquired antibiotic resistant infections (as seen above with the first confirmed case). The environment can also come into play with viral load. With any person who is battling an infectious disease, trying to minimize other possible sources of infection is very important. It seems contradictory, but hospitals are oftentimes not the optimal place for treatment.
So, it is difficult to really evaluate how effective vaccines truly are with most diseases. However, if a vaccine is proven safe and it may do some good, it should be considered. Perhaps the vaccine can give enough of a boost to an individual’s immune system to prevent reaching a threshold of viral load that is dangerous.
On a personal note, and this is not meant to be an endorsement of vaccines, I choose to get the influenza vaccine each year. I believe that it is not really necessary as I tend to have a good immune system. However, my philosophy on the immune system is that it needs constant exercise to remain healthy, just like the rest of your body and mind. As long as the vaccine is safe, I reason it to be an additional exercise of my immune system. It maybe will have little effect if I encounter influenza, but, maybe the general strength of the immune system is more enhanced, ever so slightly. But, this is my personal choice; I cannot impose this choice on others.
Here is the flip side of the coin. This applies to anyone who has experienced disease.
1. People who have developed immunity do not need a vaccine. So, any person who experienced Covid in 2020 does not require a vaccine so soon (they also do not need to wear any face coverings).
2. These same people have demonstrated that their immune system is quite capable of handling the disease. That means for over 99% of the population, this virus is not deadly.
3. Even in the highest risk population, between 75-90% of those infected survived.
If coronavirus is like influenza, your naturally acquired immunity may not last if the virus mutates. We do not know enough yet to know if or when that may occur. The timing also varies from individual to individual. Still, it is important for people to keep a healthy immune system.
If a vaccine is developed and if a person has had this virus, they will have to make the decision for themselves whether a vaccine is appropriate, perhaps with their personal physician.
It is a personal health choice. The Government should not be making that decision.
Take Home Message
1. The coronavirus, SARS-COV-2, is not “deadly.” It can lead to death in very well-identified segments of the population, e.g. the infirmed elderly or poor, but it is very rarely death by the virus. It may be death by bacteria or other causes, yes, but very rarely, if ever, by virus. This is exactly the same as other URI and many other infectious diseases.
2. The mortality that is associated with Covid has little impact on the expected mortality rate since the population that was most at risk also had a very low life expectancy.
3. Increases in mortality in the US are more likely associated with increases in drug OD and suicides, which are collateral damage due to the policies imposed during 2020.
4. Any vaccine that may be developed and approved for coronavirus is at best a boost to the immune system. It will not prevent infection or wipe out the virus. The degree of effectiveness will only be determined over time.
5. People who have experienced Covid or are otherwise healthy do not need a vaccine. But it should be their choice, as it should be for all.
We have gone most of 2020 without responsible journalism, except in a few places that have refused to go the ugly route. Has it been lost forever or can we recover?