The SARS-CoV-2 coronavirus and COVID-19: the literature, the data, and public policy
The effort to develop public policy about the SARS-CoV-2 coronavirus and the COVID-19 disease based on rational science should begin with searching the published scientific literature.
Search the “Literature”
The Internet now makes it much easier and certainly less expensive than it ever has been. In addition to the ease of finding literature published about the SARS-CoV-2 coronavirus and the COVID-19 disease, the recent change in publication policy by the major scientific journals which now permits authors to publish online with or without peer review, as well as the requirement to publish all of the raw data upon which the conclusions presented in a paper are based make it possible for the reader to make a preliminary evaluation concerning the conclusions of the paper at the time they read it.
Evaluate the “Literature”
However, the search for accurate scientific information upon which to base public policy only begins with identifying and actually reading the published literature. What has been published must then be evaluated and the data published with papers must be validated in some fashion. In recent decades a number of papers in the life sciences have been retracted because of “improprieties” in the research upon which the paper was based and purported to report. The improprieties ranged from fabricated data to unverifiable results. Nevertheless, the papers were published in peer-reviewed and otherwise reputable scientific journals.
Fortunately, open publication on the World Wide Web has encouraged other scientists interested in the results published in these papers to immediately attempt to replicate or otherwise validate the data. This Internet-based effort has established a level of peer review unknown and essentially unavailable to the scientific community in the past. After a scientific paper has been subject to Internet-based review whether by credentialed “peers” or just concerned citizens with some understanding of the scientific method and the basics of modern statistics, it can be considered reasonably reliable. Nevertheless, the conclusions of the paper and the study it reports must be checked for consistency with the data upon which they are based.
The purpose of the research reported
The SARS COV-2 coronavirus and the COVID-19 disease raise another somewhat unique issue with respect to evaluating the value of the published literature about them. Before relying upon the literature to make an informed judgment sufficient to base public policy upon, the purpose of the researchers and their research has to be considered in sufficient detail to determine whether the conclusions of the paper are “relevant” and “material,” —in the legal sense of those words— to the public policy under consideration.
Virus and pandemic epidemiology
The next step is to consider the epidemiology of the SARS-CoV-2 coronavirus and then the epidemiology of the COVID-19 disease. They are not necessarily be the same. Although somehow linked, each requires an independent investigation because the causal relationship between the infectious agent and the disease are not unequivocal.
It is with the epidemiological data that lack of public confidence in government-supplied information has its origin. In the minds of a large number of American citizens including a number of knowledgeable and reputable members of the scientific community, the Centers for Disease Control (CDC) has lost much of its former credibility and is now actively distrusted by many scientists in the United States and throughout the world.
It is imperative to provide the general public with independently verifiable data concerning the actual number of SARS-CoV-2 coronavirus infections, the rate of those infections, and the morbidity and mortality from the COVID-19 disease directly attributable to those infections. At the present time the data is not readily available, and much of the data which is available is questionable for a variety of reasons.
Honesty, integrity, and transparency
It is a basic principle of Anglo-American jurisprudence derived from natural law concepts of “Justice” at least as old as Cicero that government officials have a nondelegable duty of honesty, integrity, and transparency particularly with respect to the public health, safety, and welfare. This is especially true of those who work for public health agencies such as the CDC and FDA.
It is becoming more evident that, at least during the early days of the COVID-19 pandemic, many of the management level employees at the CDC and FDA poorly presented and may have even misrepresented the epidemiological evidence associated with transmission of the SARS-CoV-2 coronavirus and the morbidity and mortality of the COVID-19 disease.
Institutional bias
There is significant bias inherent in the operation of healthcare institutions from small clinics through large teaching hospitals to report as the “cause of death” on death certificates the most obvious immediate cause of death rather than the primary cause of death established on autopsy.
Historically through the 1960s, it was not unusual to see as the cause of death on the death certificates of elderly people, just the word, “pneumonia.” In cases where the physician who signed the death certificate had been treating the patient for some time or the hospital admission diagnosis was otherwise, the official death certificate might list as a secondary cause of death, the underlying disease for which the patient was being treated prior to the pneumonia which actually killed them.
Gathering meaningful and reliable epidemiological data
If our elected representatives intend to promulgate legislation mandating proof of vaccination as a condition precedent to entering public spaces or performing personal services for a large number of people, the public is entitled to demand that government agencies under the jurisdiction and control of our elected representatives gather statistical information about vaccinations, the comorbidities of those vaccinated, and the health of the individuals who receive vaccinations for at least 2 to 5 calendar years after the vaccination and make sure that data becomes available to the general public as soon as it has been verified.
There is no other way to even begin evaluating the safety and effectiveness of a vaccines consistent with the well-established scientific method for evaluating scientific theories which has been generally accepted since the time of Francis Bacon in 17th-century England.
Worldwide interactive communication on the Internet and the ease of tracking human behavior and accumulating data about such behavior has been well-established by most businesses which market and sell consumer products. There is no reason why the CDC and the FDA cannot use the same well-established techniques to gather meaningful epidemiological evidence concerning infectious diseases, their prevention through vaccination, and their treatment when required.
Obtaining and presenting the epidemiological evidence
Obtaining and presenting the epidemiological evidence about the SARS COV coronavirus and the COVID-19 disease is relatively uncomplicated. All that is required is to encode the required information into some kind of device similar to the key card required to open electronic locks in modern hotels and then swiping that card on each subsequent visit to any healthcare provider already required by federal law to use and participate in some kind of electronic medical records (EMR) program.
The CDC is uniquely situated to collect, organize, and publish this kind of data, coordinate the epidemiological research, and report regularly to the general public by posting the information on their website.
Whether to update and publish the data on a daily, weekly, or monthly basis will depend upon the current rates of SARS-CoV-2 coronavirus transmission and the morbidity and mortality rates attributable to the COVID-19 disease at the time. With meaningful verified and verifiable information readily available and accessible, elected officials and legislative bodies at the state and federal level could promulgate short-term public health legislation with well-defined sunset provisions. Should the data justify interference with personal freedom and individual liberty, temporary emergency executive mandates could also be a reasonable exercise of the police power of representative government.
Morbidity and mortality rates are already sufficiently high and in many areas rising at a sufficiently rapid rate to demand immediate commitment by Congress and the several state legislatures to a proper program of retrospective epidemiological evaluation of the existing vaccination programs and an immediate start on the epidemiological evaluation of any proposed ongoing or new vaccination programs.
Unfortunately, no responsible public official, or CDC and the FDA management, has yet suggested this kind of effort. The reaction we see from many of our elected officials and politically appointed public health management leaders has been, “When in trouble or in doubt; run in circles, scream and shout”
The ultimate disincentive
The ultimate disincentive driving the lack of reliable and verifiable public information concerning treatment for the SARS-CoV-2 coronavirus infection and reasonable actions to prevent its spread as well as treatment of the COVID-19 disease is the immunity afforded vaccine manufacturers by the Congress during the questionable swine flu epidemic/pandemic.
Upon discovery of a new recombinant strain of the influenza virus which later became known as the swine flu, the vaccine manufacturing segment of the pharmaceutical industry threatened that no vaccines would be produced unless Congress provided assurance that no individual suffering from a vaccine related disease, disability, or death could bring legal action against the manufacturer under the common law (court imposed) or statutory (legislatively promulgated) products liability law of any State. Congress capitulated to the vaccine manufacturers not once but twice— The Public Readiness and Emergency Preparedness Act (PREP) and the National Vaccine Injury Compensation Program (VICP) which covers claims for 16 routine vaccines but excludes those related to COVID-19. As a result, the SARS-CoV-2 coronavirus vaccine manufacturers have total immunity from legal liability for side effects associated with the vaccines they manufacture unless the victim can establish there has been “willful misconduct” by the company.
The PREP Act established a Countermeasures Injury Compensation Program (CICP) which provides some benefits to eligible individuals who suffer serious injury from the side effects of only two vaccines, one for the H1N1 strain of flu and anthrax, neither of which are diseases for which most of the American people are at risk.
Hidden data
According to CDC, the FDA is responsible for making the legal determination of whether a vaccine proposed for use by human beings is both “safe and effective” for the use intended. The FDA relies upon the recommendation of a committee of “experts,” many of whom have well-established economic and academic relationships with vaccine manufacturers.
To inspire even less public confidence in FDA determinations, the evidence upon which FDA relies in order to make their determination, is provided almost exclusively by the vaccine manufacturers themselves and is not independently verified by the FDA or, because of proprietary economic considerations, any independent reviewers, much less the general academic community or ordinary citizens.
Unless and until there is accurate epidemiological evidence subject to independent verification, mandating compulsory vaccination raises troubling questions of constitutional law in the law Courts and personal freedom and individual liberty in the court of public opinion. The last hope of the average citizen seeking sufficient reliable information upon which to base their personal decision whether to be vaccinated is for the United States government by the appropriate agencies to collect the raw data and then present it in a form which can be analyzed by independent scientists and the concerned public.
It should disturb and enrage every American citizen that those government officials who have access to the public through the mass media and those who provide them with access to the public through the mass media have not targeted this issue for meaningful discussion, Isn’t it obvious that we must do it now; sooner rather than later, because later may be too late.