by Mike Critelli
We must demand great science, not simply passively follow what others tell us is “the science.”
Great scientists developed and deployed Covid 19 vaccines, which have been effective in reducing hospitalization and death risks in every age cohort and in every subpopulation of comparable health risk. They also understood that the virus would evolve and that what we believed at the beginning of the crisis would change.
The certainty and rigidity emanating from politicians, the media, and many health advocates are the opposite of great science. When we truly use and demand rigorous scientific analysis, additional solutions will emerge.
What has gone wrong?
We relied on incomplete data and made basic statistical errors in believing that mandatory vaccinations, mask wearing and other non-pharmaceutical interventions could contain this virus.
A randomized clinical trial process enables us to conclude that being vaccinated is better than not being vaccinated, all other factors being equal. But many other risk factors come into play and they skew health outcome data considerably from what a pure focus on vaccination would yield.
We have failed to make good decisions as to who is at risk because we have not developed the best data or made best use of the data we have. Based on ample data of all kinds, including clinical trials and studies, we know that the virus has differential effects based on
Underlying health conditions
Vitamin D levels
Clinical studies have not focused on combinations of risk factors to enable decision makers to assess individual or population subsegment risk. To design trials and studies in which every permutation and combination of these risk factors is tested would require data we do not assemble anywhere.
Those who draw conclusions about the different outcomes of vaccinated vs. unvaccinated populations based on that single variable lack adequate understanding of statistics. “All other things” are not equal.
Let’s use a population of roughly 500,000, the approximate number of people who have died since vaccines were available in early 2021. The CDC calculation would suggest that unvaccinated people would account for 475,000 of this total; vaccinated people account for 25,000.
But this is only the beginning of the analysis. At least five different variables have been isolated in risk assessment:
Presence of chronic diseases or auto-immune conditions
Natural immunity from having been infected previously
Vitamin D levels.
Given what we know, the 475,000 is highly likely to encompass an exceptional range of risk percentages based on the following:
CDC data shows that an 85-year-old is 85x as likely to die from Covid as a 35-year-old and 340x as likely to die as a teenager. I am 73 years old. In fact, those who are 85 or older are 6x as likely to die from Covid as I am. Since the beginning of the pandemic, people over 75 and over, who constitute 10% of the population, have accounted for 48% of Covid deaths.
By contrast 35-year-olds are in an age group that accounts for 22.8% of the population, but account for only 2.5% of all Covid deaths. Even 65-74-year-olds, who have accounted for 23% of all Covid deaths, account for 15% of the US population.
Protecting those over 75, especially those in congregate living or individuals who need 24-hour care in their residences, has to be the highest priority in reducing death rates.
The next variable is underlying health status. The CDC has concluded that Americans with 2 or more diseases or comorbidities (e.g. obesity, Type 2 diabetes, heart failure) have a 2.6x risk of death compared with people with no underlying health conditions. Official CDC and state health data has determined that the American adult population averages 2.23 co-morbidities,
The vast majority of adults hospitalized with or because of Covid have co-morbidities, whether or not they are vaccinated.
When we focus on vaccinations, versus reversing chronic disease progression, we are missing the best long-term opportunity within our control to strengthen our immune system against this and all future viruses and bacterial pandemics.
We need a concentrated effort to attack all root causes of these preventable chronic diseases, particularly obesity from excess food intake, stress, inadequate physical activity and sleep. This pandemic is not a randomly distributed infectious disease crisis. It is an acceleration of a pre-existing chronic disease crisis.
Vitamin D Levels
People with Vitamin D deficiencies or unusually high levels of Vitamin D have very different Covid risk profiles.
We need to get everyone focused on increasing their Vitamin D levels.
Multiple studies have shown that people with O blood types are ⅓ less likely to be infected or to be hospitalized from Covid. We need to look at a variety of genetic and other biomarkers to do a better job at risk assessment.
We need to identify biometric factors that either cause or correlate with different health outcomes. We eventually need individualized risk scoring, even for unchangeable attributes like blood type.
The CDC has concluded that natural immunity diminishes significantly after six months, but the Israeli national health authority undertook the largest study anywhere and concluded that natural immunity is 13x more effective in preventing a serious recurrence of Covid than taking vaccines.
Great scientists must take a deeper look at why the Israeli study produces such radically different results from the studies on which the CDC has relied. They do not leave conflicting clinical study results unexplained.
If we compared two individuals, one who has been vaccinated and one who is unvaccinated and every other variable were identical, the unvaccinated person would be many times more likely to be hospitalized. The CDC claims that the percentage is about 20x, although this multiple declines over time as vaccines and boosters lose some effectiveness.
However, if we adjusted both individuals by age, health status, blood type, Vitamin D levels and whether they had been infected previously, and what vaccine they took and how much time had elapsed since vaccination, it is probable that, in many combinations and scenarios, much of that risk differential would disappear.
Adverse Consequences From Vaccinations
The CDC has acknowledged that four serious adverse effects have been demonstrated from Covid vaccines: anaphylaxis (a severe allergic reaction), thrombosis (blood clotting), myocarditis and pericarditis (inflammation of the heart muscle), and Guillain-Barre syndrome (serious nerve damage).
But it asserts that these conditions are “rare” over an entire population. The implication is that, because of their overall rarity, we can safely ignore them.
When I led an industry-wide task force to address the anthrax threat in 2001, I learned that general government reassurances are insufficient when people are afraid. As an industry spokesperson, I never told the public that mail was perfectly safe. I simply said that the odds of receiving a piece of anthrax-laced mail were equivalent to “getting struck by lightning while being eaten by a shark.” The CDC needs to frame the adverse event risk more concretely for each population segment.
What Does This Mean?
For me, a 73-year-old male with above average risk based on age, and little, if any, downside risk of being vaccinated, or for anyone in high risk age (over 65), health status, blood type, and Vitamin D level population cohorts, regardless of age, the case for vaccinations is compelling.
The data to support the proposition that, but for universal vaccination, unvaccinated individuals will be hospitalized and die does not exist, because none of the studies have looked at the aggregate of all relevant risk factors.
The more fundamental issue this data raises is why we are so single-mindedly focused on vaccinations as the solution to this crisis. These are incontrovertible facts:
We need a better strategy for protecting vulnerable populations, especially individuals in nursing homes over 75 years of age. This population is vulnerable, even if vaccinated ,
Too many Americans have preventable chronic diseases and auto-immune conditions that increase their odds of infection, hospitalization and death. We need to focus on better nutrition, more physical activity, less stress, and more sleep, all those areas of focus our parents drilled into us.
We need much more rigorous research and thoughtful discussion about risk. All of the data we collect from clinical trials and studies is inherently imperfect and incomplete.
We should be humbler in our assertions about what is settled and certain. This SARS Cov-2 virus has mutated multiple times and confounded the predictions of even the best scientists.