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INTRODUCTION and SUMMARY

INTRODUCTION and SUMMARY

Careful Examination of the COVID-19 Pandemic

Robert M Rennebohm, MD

The articles listed below are intended to contribute to a deeper public examination and understanding of the COVID-19 pandemic. Most importantly, these articles offer new, positive, practical, public-honoring recommendations for successful resolution of the pandemic:

  1. INTRODUCTION and SUMMARY: Careful Examination of the COVID-19 Pandemic
  2. A Middle Narrative
  3. The Importance of Knowing the Ct Value at which a COVID PCR Test is Positive
  4. Critically Examining COVID Data
  5. Treatment of Severe COVID Illness
  6. Vaccine Concerns
  7. An Interview with the Human Immune System
  8. Spiritual Appreciation of the Human Immune System
  9. Hypotheses Regarding New COVID strains
  10. Lessons the Human Immune System Teaches
  11. Marek’s Disease—A Cautionary Tale?
  12. Che—the Rebel Chicken
  13. COVID Analysis—The Big Picture
  14. Treatment of Severe COVID-19 Illness—LONG VERSION
  15. The Importance of Knowing the Ct Value at which COVID PCR Tests are Positive—LONG VERSION
  16. Critically Examining COVID-19 Data—LONG VERSION
  17. Analysis of COVID-19: An Additional Narrative; An Alternative Response—LONG VERSION
  18. The Nature of Epidemics
  19. Analysis of COVID-19: Geo-political Aspects
  20. The Corporate Consortium
  21. Letter to Dr. Anthony Fauci

These 21 articles are posted in full on a Social Clinic website, which may be accessed by googling: notesfromthesocialclinic.org

The above articles simply represent one pediatric rheumatologist’s assessment and recommendations, regarding the COVID-19 Pandemic. I am a pediatric rheumatologist, which means I have specialized in the study and clinical care of children with autoimmune and autoinflammatory diseases—such as juvenile idiopathic arthritis (formerly called juvenile rheumatoid arthritis), childhood lupus, juvenile dermatomyositis, Kawasaki disease, Susac syndrome, and many other diseases, all of which are due to disorders of immune regulation. I do not want to speak for all pediatric rheumatologists, but I do want to explain how I imagine a COVID Task Force comprised of excellent, experienced, caring pediatric rheumatologists might have guided the public through the COVID pandemic. The purpose of doing so is to explain how and why a new approach, which is outlined at the end of the article, could bring about a successful resolution of the COVID-19 pandemic.

How an imagined COVID Task force comprised of pediatric rheumatologists might have guided the country through the COVID pandemic:

Below are the most important steps such a Task Force might have taken:

  1. Quality of COVID-19 PCR Test Kits: A first step would have been to develop a COVID PCR test of indisputably proven excellence. The test would need to be proven to be specific for detection of the SARS-CoV-2 virus—i.e., it must be positive only in the presence the SARS-CoV-2 virus and not positive because of cross-reactivity with other coronaviruses or other viruses. The test would need to be optimally sensitive. The test would also need to have a very low false positivity rate, both in the setting of clinical illness and when used to screen people who are asymptomatic. (Please see articles #3 and #15 for more information about COVID PCR tests, including published peer-reviewed references.)
  2. Disclosure of the Ct value at which a COVID PCR test is positive: Great attention would be paid to the Ct value at which a COVID PCR test is positive. A COVID PCR test would be declared “definitely positive” only if it were positive after 30 or fewer cycles of amplification (i.e., at a Ct value of 30 or less). If a test became positive only after 31-35 cycles of amplification, it would be labeled “possibly positive.” If a test became positive only after 36-40 cycles, it would be declared uninterpretable (for research and epidemiological purposes) and considered negative for clinical purposes. If a test were negative after 40 cycles, it would be declared “definitely negative.” Testing would not continue beyond 40 cycles of amplification. It would be made clear that data on people whose test was positive between 31-40 cycles were being collected primarily for research purposes, out of an abundance of caution. A strong argument could be made, however, to cease amplification after 30 cycles and declare all tests that are negative after 30 cycles to be “definitely negative.” (Please see articles #3 and #15 for more about the Ct values of COVID PCR tests, including published peer-reviewed references.)
  3. Public education regarding Ct values: From the beginning of the epidemic, the public would have been thoroughly educated about the importance of knowing the Ct value at which a COVID PCR test is positive. This would include explaining that if a person’s test is positive, for example, at a Ct value of 18 (i.e., after 18 cycles of amplification), this means the person is carrying a very high viral load and is very contagious; but if a person’s test is positive only at a Ct of 37 (only after 37 cycles of amplification), the result is uninterpretable and even if that test were accurately detecting a tiny amount of SARS-CoV-2 virus (as opposed to being a false positive), it would almost surely be detecting just a tiny quantity of remnants of dead virus, and the person would not be contagious. It would also be explained, however, that in a very rare instance a test that is positive at 31-35 is detecting a person who has very recently entered a pre-symptomatic phase of infection—in which case the person should be retested in 2-5 days (to see if the Ct value drops below 30) and monitored for COVID symptoms.

The Task Force would have felt strongly that the public is perfectly capable of understanding the practical aspects and importance of knowing Ct values. The public would have been taught that If a person’s COVID PCR test comes back “positive,” that person and their physician need to know how strongly the test was positive, and they need to ask the lab, “At what Ct value was the test positive?” The public would easily understand that asking this question makes common sense. (Please see articles #3 and #15 for further details.)

It would also be explained to the public and physicians that there are limitations to the accuracy of Ct values, and that these limitations need to be taken into account. The COVID PCR test is a qualitative test, not a quantitative test, and the Ct value at which a test is positive is only an indirect and imperfect estimate of viral load. Furthermore, the Ct value at which a given test is positive can vary modestly from one lab to another, though not to a practical, clinically significant degree. Despite these limitations, the Ct value provides a very good estimate of how strongly positive a test is. A very good estimate is far more valuable than no estimate at all. Reporting a test as “positive at a Ct of 45” (as opposed to being positive at a Ct of 18) is far more helpful than simply reporting the test as “positive,” with no information about the Ct value at which it was positive.

  1. Establishment of strict diagnostic and classification criteria: A next step would have been to establish uniform, accurate, strict criteria for diagnosis of a “definite COVID case,” a “definite COVID hospitalization,” and a “definite COVID death.” In addition to clinical features, these criteria would take into account the Ct value at which a person’s PCR test was positive. Included in this classification scheme would be specific criteria for designation as a “probable” or “possible” COVID case/hospitalization/death, and criteria for designation of “not COVID (even if a person has had a ‘positive’ PCR test).” Uniform data record forms would be accurately and fully completed for all persons reported to state health departments and the CDC. Those forms would indicate which criteria were fulfilled, the Ct values at which the person’s PCR test was positive, and what the basis was for the person’s ultimate classification/diagnosis. (Please see articles #4 and #16 for more details about quality data collection.)
  2. Quality epidemiologic data: The above steps would have resulted in epidemiologic data of high scientific quality. These epidemiologic data would be broken down into “definite,” “probable,” and “possible” categories. Public health officials and the general public would, thereby, have accurate, scientifically sound information regarding the true number of definite new and cumulative COVID cases, COVID hospitalizations, and COVID deaths—as well as numbers of probable and possible cases, hospitalizations, and deaths. Public health officials and the general public would also know what percentage of cumulative and recent (during a given week of screening) COVID PCR tests were positive at a Ct of 30 or less, and what percentage were positive at higher, far less worrisome Ct values. Steps 1-4 not only make scientific sense, but also common sense.

 

  1. Prompt, appropriately aggressive treatment of patients with severe COVID illness: Pediatric rheumatologists have had many years of experience with the clinical study and treatment of life-threatening hyperimmune disorders, including spontaneous and infection-triggered “cytokine storm.” An early step would have been to apply that knowledge and experience, including the results of past clinical trials, to the new COVID situation. We would have immediately developed nationwide protocols that would make it possible to offer prompt, appropriately aggressive treatment to all patients with severe COVID illness, and, simultaneously, make it possible to learn maximally from each of those patients. Those protocols would have included use of Ct values of COVID PCR tests for guidance in interpreting whether a given patient’s primary problem (at a given point in time) was out-of-control active viral infection (in need of anti-viral treatments) or an excessive out-of-control hyperimmune reaction (in need of immunosuppression). (Please see articles #5 and #14 for further discussion of treatment of patients with severe COVID illness, including a specific and detailed protocol for such treatment, as well as published peer-reviewed references.)

 

  1. Early preventive treatment of mild-moderate COVID illness: In an effort to prevent outpatients with early mild-moderate COVID illness from progressing towards severe illness and need for hospitalization, we would have developed, implemented, and studied large-scale nationwide protocols for treatment of such outpatients. Each and every outpatient diagnosed with definite COVID (based on proper use of the COVID PCR test and proper use of diagnostic criteria) would have been eligible to participate in one of several outpatient preventative treatment protocols that involved various combinations of drugs such as remdesivir, other anti-viral therapies, monoclonal antibodies, and/or simpler medications such as hydroxychloroquine, Ivermectin, azithromycin, zinc, and vitamin D. Prospective, large-scale, nationwide study of these treatment options and combinations would have generated compelling information regarding which treatments (or treatment combinations) are effective and safe, and which are not. In order for these studies to generate optimally meaningful, scientifically sound information, the Ct values of these outpatient’s COVID PCR tests would need to be included in the data collection and analysis.

Incidentally, the Task Force would have insisted that all of the above-mentioned treatments for mild, moderate, and severe COVID illness (i.e., outpatient and inpatient treatments) be provided at no charge to patients, during this urgent national emergency. The goal would be to make certain that no patient suffered from lack of access to appropriate health care.

  1. Mitigation Measures: During the first 2-3 weeks of the pandemic, when much was unknown about the SARS-CoV-2 virus and COVID illness, the Task Force would have recommended a temporary lockdown, particularly in nursing and retirement homes, to minimize spread of the virus to the most vulnerable people while more was learned about the pandemic. After those 2-3 weeks, however, the Task Force would not have favored a prolonged lockdown of the general population. It would have recommended at least partial lockdown protections for the most vulnerable (those in nursing homes and retirement homes and those with predisposing co-morbidities), but it would have encouraged the rest of the population to simply (but assiduously) use the common-sense precautions that have been used during all past seasonal influenza epidemics. Schools, businesses, and public places would have been open, much like the policy implemented in Sweden. The adverse consequences of prolonged, indefinite lockdown of the general public would have been deemed far more harmful than no lockdown of the general public. (Please see article #17.)
  2. Vaccine development and study: In anticipation of potential need for COVID vaccines, the Task Force would have mobilized efforts to create COVID vaccines. However, before implementing a campaign of rapid mass vaccination, we would have insisted on sufficient proof of the safety, efficacy, and necessity for rapid deployment of such a campaign. The data generated via steps 1-7 would have provided solid, high quality, scientific data, regarding the extent to which rapid mass vaccination was truly necessary and truly urgent. We would have emphasized and explained to the public that: without high quality epidemiologic data (including CT information and the results of study of prompt appropriately aggressive treatment of severe COVID illness and appropriate treatment of outpatients with mild-moderate COVID), it would be difficult to know how truly necessary and truly urgent mass vaccination was; without high quality efficacy data, it would be difficult to know how truly beneficial the proposed vaccines would be; without adequate high-quality short and long-term safety data it would be difficult to know how truly safe the vaccines are; and without all three of these types of quality data, it would be impossible to accurately know whether the benefits of COVID vaccination out-weighed the risks, or vice versa. (Please see articles #6-12 for further discussion of vaccine issues.)

If it were decided that there was adequate evidence that the COVID vaccines might be safe, effective, and necessary, the Task force would have recommended that they be used only for the vulnerable, and then only very carefully, with very close post-vaccination surveillance for adverse effects of the vaccines.

The Task Force would make certain that, if COVID vaccines were introduced, it would be understood (and explained to the public) that there has not been enough time or sufficient study to assure their safety. Accordingly, the Task Force would make certain that the Vaccine Adverse Events Reporting system (VAERS) would be used in a mandatory (not passive) fashion that assures that as close as possible to 100% of vaccine-related side effects would be reported and thoroughly examined.

  1. Public Education and Informed Consent: Throughout the pandemic, a top priority of the Task Force would have been superb and comprehensive public education about all of the issues discussed in steps 1-9. And certainly, if properly collected high-quality data revealed necessity for urgent COVID vaccination, we would have insisted upon obtaining informed consent—meaning that individuals about to receive the vaccine, as well as the public at large, would need to be adequately informed of the experimental nature of the vaccines and the limited knowledge we have regarding the safety, efficacy, necessity, and wisdom of using these vaccines.

 

  1. Careful distinction between hypothesis and proven fact: Throughout the pandemic the Task Force would be careful, amongst themselves and in discussions with the public, to always carefully distinguish between hypothesis and proven fact. Hypotheses and assumptions would not be presented as “proven scientific fact.” This includes informing the public of the level of the quality of data presented to them. When the public is told, “the data show,” the public needs and deserves to know whether those data are of high scientific quality, or very low scientific quality.

 

  1. Prevention of extremism, polarization, division, intolerance, shaming, and shunning: As leaders of the country’s response to the pandemic, a top priority of the Task force would have been to discourage extremism, polarization, division, intolerance, shaming, and shunning—within the medical community, the government, the media, the general public, and even within families. Regarding the seriousness of the pandemic, we would have tried to prevent excessive fear on the one hand and excessive denial on the other. We would have encouraged appropriate moderation. Honest, comprehensive public education would have been a major means of achieving this balance and promoting healthy dialogue. (Please see articles #2, #12, #13, and #17.)
  2. Promotion of critical thinking, careful examination, and healthy dialogue: The foundation of our efforts to guide the public through the epidemic would have been a strong emphasis on critical thinking, careful examination, and healthy dialogue. We would have exemplified this within the medical community and encouraged it within government, among the media, in the general public, and within families. We would have viewed the COVID pandemic as an opportunity to bring people together, develop new collective medical and social insights, and envision new social arrangements that give practice to the best aspects of Human Nature and could optimize public health. (Please see articles #2 and #13.)

The above steps are some of the most important steps that I imagine a COVID Task Force comprised of pediatric rheumatologists would have taken. That is how we would have taken the COVID pandemic seriously. That is how we would have demonstrated the rigorous, disciplined practice of science and medicine. That is how we would have honored the public. That is what we would have done in an effort to save lives. That is how we would have demonstrated and encouraged careful examination, healthy dialogue, and common sense.

How the actual USA COVID Task Force has guided the country through the COVID pandemic:

To what extent have those 13 steps been taken by the actual COVID Task force (during both the Trump and the Biden administrations) that has been managing the COVID pandemic for the past 14 months?

  1. Quality of COVID PCR test kits: At least 150 COVID test kits have been granted Emergency Use Authorization (EUA). The vast majority of these kits have been manufactured by private for-profit lab companies. The manufacturers have provided data suggesting that their test kits have a very high and acceptable level of specificity and sensitivity and a very low level of false positivity (around 1%). However, this testing of specificity, sensitivity, and false positivity appears to have been done only in patients with compelling clinical evidence of symptomatic COVID illness. Studies of specificity, sensitivity, and false positivity do not appear to have been done in the setting of mass screening of asymptomatic individuals. These two settings are completely different. Specificity, sensitivity, and false positivity need to be studied in both settings and across the entire spectrum of Ct values. Unfortunately, 14 months after onset of the pandemic, we still do not know how accurate the test kits are, particularly in the surveillance setting (screening of asymptomatic people), particularly the false positivity rate in the surveillance setting (which might be as high as 70%, according to one peer-reviewed publication). (Please see articles #3 and #15 for further discussion and peer-reviewed references.)
  2. Disclosure of the Ct value at which a COVID PCR test is positive: Almost all of the COVID PCR test kits used in the USA have been set to perform at least 40 cycles of amplification in their search for presence of the virus. Most kits have been set to perform 45 cycles of amplification before declaring the result to be negative (if no virus is detected after 45 cycles). Throughout the first 14 months of the COVID pandemic the official recommendation by the WHO and the CDC has been to routinely set the test to perform 45 cycles. Some test kits are set to routinely perform 50 cycles—meaning that the person’s test is not declared negative unless no evidence of virus is found after 50 cycles of amplification. For years it has been known that the results of PCR testing are unreliable and uninterpretable after 30 cycles of amplification, and for years it has been recommended that no more than 30 cycles of amplification be performed when using PCR tests to identify pathogens. But this knowledge and recommendation have been ignored during the COVID pandemic.

With very rare exception, the Ct values at which COVID PCR tests have been positive have not been reported to the patient, their physician, or to health officials. The Ct values have routinely been completely ignored and not made available. Throughout the pandemic, patients and their physicians have been told only whether the COVID PCR test was positive or negative—with no information as to how strongly or weakly positive; no information as to whether the test was positive after 18 cycles of amplification or only after 45 cycles. Throughout most of the pandemic, most physicians have not even heard of Ct values. When physicians who know about Ct values have asked for the Ct value at which their patient’s positive test became positive, they have routinely been told, “We do not have that information; it is unavailable.”

This means that diagnoses of COVID cases, COVID hospitalizations, and COVID deaths have been based on a “positive” COVID PCR test, but not with any information as to how strongly or weakly positive the test was. It makes a huge difference whether a test is positive after only 18 cycles of amplification (meaning a huge viral load is present and the patient is very contagious) or only after 45 cycles (meaning the result is uninterpretable, the patient is very unlikely to be contagious, and the result most likely represents a false positive).

This failure to pay attention to Ct values means that we really have no idea what percentage of “positive” tests (during a given week of national testing) have been positive only after 40 or 45 cycles of amplification and what percentage have been positive at a Ct of 30 or less. That information has been available (it is automatically provided by the machine that does the test), but it is being ignored, and in many cases that Ct information is, reportedly, being irretrievably discarded. So, when the public is told that 100,000 people “tested positive” on a particular day of national screening, but no Ct information is provided, it is impossible to know what that information means. (Please see articles #3 and #15 for more details.)

  1. Public education regarding Ct values: Throughout the pandemic there has been no public mention of Ct values by any of the medical correspondents in the mainstream media, or by any members of the USA COVID Task Force. It is unclear whether these people simply do not know about Ct values; they know about Ct values, but have decided, or been told, that the public “would not be able to understand” such information; or they have been instructed not to educate the public about the importance of knowing the Ct value at which a COVID PCR test is positive.
  2. Establishment of strict diagnostic and classification criteria: Throughout the pandemic strict, uniform, accurate diagnostic and classification criteria have not been adequately used in the collection of data regarding cumulative and new COVID cases, COVID hospitalizations, and COVID deaths. Certainly, Ct values have not been included in the data collection, and this, by itself, has markedly decreased the quality of data. It has been unclear what criteria have been used (and how uniformly so) to define a definite COVID case, a definite COVID hospitalization, or a definite COVID death. For example, it has been quite unclear what criteria need to be fulfilled, or do not need to be fulfilled, in order for a death to be designated a “COVID death. Imagine, for example, an 85-year-old man with long-standing chronic heart disease who tested “positive” for COVID (at an unreported and, therefore, unknown Ct value) during a routine mass screening at his nursing home. He had no COVID symptoms at the time of the testing or subsequently. Then, two weeks after his COVID testing, he suddenly dies from a heart attack, at which time he still had no COVID symptoms. It is unclear whether such a person is counted by the CDC as a “COVID death.” According to some reports, any person who dies within 28 days after having a positive COVID PCR test (even if positive only after 45 amplification cycles) is automatically considered to be a COVID death (“out of an abundance of caution”) and is included in the national COVID death count. If that is true, the cumulative COVID death count would be highly misleading. (Please see articles #4 and #16 for more details.)
  3. Quality epidemiologic data: Because Ct values of COVID PCR tests have not been taken into account, and because strict uniform diagnostic and classification criteria have not been applied to data collection, the quality of the data, regarding cumulative and new COVID case, COVID hospitalizations, and COVID deaths has been unclear (at best) or of very low scientific quality (at worst, and most likely). As a result, the true number of COVID cases, COVID hospitalizations, and COVID deaths has remained very unclear throughout the pandemic. (Please see articles #4 and #16.)
  4. Prompt, appropriately aggressive treatment of patients with severe COVID illness: As explained in articles #5 and #14, patients with severe COVID illness have not often received the kind of care that pediatric rheumatologists would routinely provide. As a result, it is unclear how many of the true COVID deaths could have been prevented with more prompt and appropriately aggressive care, including use of Ct values for guidance. Likewise, it is unclear how much long-term damage could have been prevented in survivors of severe illness, had they received more effective care. Absence of this information impairs our ability to interpret current COVID death data (and disease damage data) and to gauge the true necessity and urgency for mass vaccination.
  5. Early preventive treatment of mild-moderate COVID illness: Early in the pandemic the USA COVID Task Force conveyed the notion to the public that many of the simpler treatments, such as hydroxychloroquine and ivermectin, were either ineffective or harmful. Such treatments were officially and strongly discouraged and belittled. The Task Force made no effort to set up adequate large-scale national studies of outpatient preventative treatments. In order to generate meaningful, scientifically sound data, such studies would need to include the Ct values of these outpatients’ COVID PCR tests. No such studies have been done. As a result, we have limited information about the efficacy (or inefficacy) of such treatments. Several studies that have been unfairly dismissed by the USA Task Force have suggested efficacy of hydroxychloroquine and ivermectin.
  6. Mitigation Measures: The USA Task Force chose to chronically lockdown the entire society, to varying and fluctuating extents. This has resulted in severe side effects for most of the population, particularly the poor and already struggling. Children, in particular, have suffered. It has least affected the wealthy and already privileged. (Please see article #17.)
  7. Vaccine development and study: The USA Task Force has certainly rushed to make vaccines available as soon as possible. Unfortunately, they have entrusted for-profit pharmaceutical corporations that have been convicted of major criminal activity (Pfizer and Johnson and Johnson) to produce the vaccines, and they have also entrusted these corporations to perform and report the safety and efficacy studies, which the public and medical community are then asked to trust. Unfortunately, a rapid mass vaccination campaign has been hastily deployed before efficacy and short and long-term safety could be adequately studied. Unfortunately, this haste has been justified by the low-quality data discussed earlier in this article—data that is falsely purported to “clearly show that the risks associated with contracting SARS-CoV-2 infection greatly outweigh the risks of COVID vaccination.” As a general common-sense rule, low quality data often leads to low-quality medical and public policy. (Please see articles #6-12.)

The USA Task Force has recommended that as many of the world’s 7.8 billion people as possible be vaccinated, as rapidly as possible, including children, despite the paucity of high-quality data to justify such a hasty vaccination campaign and despite lack of adequate data regarding safety and efficacy.

The extent to which the USA Task Force has made assurances that the Vaccine Adverse Events Reporting System (VAERS) is capturing and thoroughly examining as close as possible to 100% of vaccine-related side effects is unclear.

  1. Public education and informed consent: The USA Task Force and the conventional media have not provided adequate public education about COVID. The best example of this is the total absence of any discussion of the highly relevant and important Ct values. There has also been an absence of explanation of what criteria must be fulfilled before a patient is counted as a “COVID case” or a “COVID death.” There has been no discussion of the actual scientific quality of data being presented to the public. There has been no thorough discussion or explanation of the many things that could be done to improve the care and outcome of patients with severe COVID illness. Discussion of preventative treatment for early and mild COVID has been discouraged, as if such discussion is a waste of time. Finally, there has been grossly inadequate discussion of the potential short and long-term side effects of the COVID vaccines.
  2. Careful distinction between hypothesis and proven fact: A fundamental principle of science and Medicine is to very clearly and carefully distinguish between hypothesis and proven scientific fact—between what you suspect to be true and what has been proven to be true. Throughout the pandemic the Task Force and the conventional media have not been careful to distinguish between hypothesis and proven scientific fact. Assumptions have frequently been presented as if they are proven scientific fact. A good recent example of this is the statement being made that “the emergence of new more worrisome SARS-CoV-2 variants is due to too few people getting vaccinated and too many people not complying with mitigation measures.” This is a hypothesis, not a proven scientific fact. There are other equally plausible (or more plausible) hypotheses/explanations for the emergence of more worrisome strains. The fact is, we do not know which of these hypotheses is most true. Even the statement that “new more worrisome strains are emerging” is still a hypothesis and not yet a proven scientific fact. Many good scientists contest both of these just-stated hypotheses, which are being presented by the USA Task Force as proven facts. (Please see article #9.)
  3. Prevention of extremism, polarization, divisiveness, intolerance, shaming, and shunning: During both the Trump and Biden administrations, the Task Force and the conventional media have created conditions that have made extremism, polarization, division, intolerance, shaming, and shunning inevitable. In fact, the Task force and the media have fueled those fires. Instead of listening to challenges to their narrative, the Task Force and conventional media have summarily dismissed those challenges as “misinformation,” “disinformation,” “conspiracy theory,” and “anti-science.” Those citizens (including eminent scientists and physicians) who have questioned the prevailing narrative have been maligned, demeaned, and called deplorably irresponsible, selfish, even “stupid.” The Task Force and the conventional media have done all they can to create extreme levels of fear. Those who have questioned the justification for such extreme fear have been portrayed as “not taking the pandemic seriously.”
  4. Promotion of critical thinking, careful examination, and healthy dialogue: Instead of promoting critical thinking, careful examination, and healthy dialogue, the USA COVID Task Force and the conventional media have demonstrated the opposite. Within the medical community and conventional media only one narrative has been tolerated. Alternative points of view have been quickly and summarily dismissed, usually with disgust. Eminent physicians and scientists who have challenged the prevailing narrative have been intimidated into self-censorship or censored outright. The Task Force has neither exemplified critical thinking and careful examination, nor encouraged it in the rest of society. A telling and compelling example of this is the Task Force’s decision to not explain to the public the importance of knowing the Ct values at which COVID PCR tests are positive, and their decision to not report Ct values. Instead of encouraging healthy dialogue, the Task force has fueled frustration, confusion, excessive fear, anxiety, intolerance, shaming, shunning, and has made healthy dialogue almost impossible, even within families. (Please see articles #2, #13, and #17.)

The above decisions of the USA COVID Task Force (during both the Trump and Biden administrations) have led to an excessively fearful, confusing, and misleading prevailing COVID narrative (throughout the pandemic), which is based on data of low scientific quality. This narrative has been supported by an excessively compliant and unquestioning conventional media and has been protected by intolerance (often extreme) and shaming of challenges to the narrative. (Please see articles #2, #13, and #17.)

Ultimately, this has led to public policies of dubious merit and an unfortunate, agonizing vaccine predicament.

Has the USA Task Force exemplified the best way to take the COVID pandemic seriously? In its data collection has this Task force demonstrated rigorous, disciplined , exemplary practice of science and medicine? Has it exemplified how to best save lives? Has it provided exemplary patient and public education about COVID? Why has it managed the pandemic in a way that is so different from the rigorously scientific way in which an imagined Task Force comprised of pediatric rheumatologists might have managed the pandemic? Why did the USA Task Force, for example, make the decisions it has made, regarding the Ct values of COVID PCR tests? Why would competent, knowledgeable, caring people respond to the COVID situation the way the USA Task Force has responded? Has that response exemplified the way science, medicine, and democracy are meant to be practiced? (Please see articles #19, #20, and #21.)

What can be done now?

It is not too late to limit the damage done by the above decisions. (See article #13.) A new approach is possible—one that is honest, scientifically unassailable, and honors the public. Effective public education, public examination, public dialogue, and public pressure are the keys. For example:

  1. Quality of COVID PCR Tests: The public can insist that the specificity, sensitivity, and false positivity rate of the COVID PCR tests used during this pandemic be thoroughly examined by an unbiased, independent panel of laboratory scientists, virologists, and physicians—both in the setting of patients with compelling clinical evidence of COVID illness and in the screening of asymptomatic people (the surveillance setting).
  2. Disclosure of the Ct value at which a COVID PCR test is positive: The public can insist that the Ct values of all positive COVID PCR tests be disclosed and analyzed, both retrospectively (since the beginning of the pandemic) and prospectively (from now on). It is unclear, however, how much of the Ct data from COVID PCR tests done since the beginning of the pandemic has already been irretrievably discarded. The public deserves to know the extent to which those Ct data have been destroyed. Destruction of such data would constitute a major crime. The public also deserves to be told when/if a decision is made to reduce the number of amplification cycles routinely performed by COVID PCR tests from 45 cycles to 30 cycles. For it will be impossible for the public to accurately interpret a “drop in COVID cases, COVID hospitalizations, and COVID deaths,” if the public is not informed of such a reduction in cycles performed, if such a reduction were to occur.
  3. Public and Physician Education about Ct values: The public can insist that all physicians, as well as the general public, be educated about the importance of knowing the Ct value at which COVID PCR tests are positive. This includes public and physician awareness that knowledge of Ct values markedly improves the quality of epidemiologic data and the care of individual patients.
  4. Establishment of strict diagnostic and classification criteria: The public can insist that all “COVID deaths” be retrospectively examined (using new, accurate, strict diagnostic criteria, including Ct values) to determine what percentage of the reported cumulative COVID deaths have truly been definite COVID deaths and what percentage have been probable COVID deaths, possible COVID deaths, or not COVID deaths. And the public can insist that this same scientific rigor be applied to collection of COVID death data from now on. The public also deserves to be told when/if the criteria for diagnosis of definite COVID case, COVID hospitalization, or COVID death are made more strict, more difficult to fulfill. For it will be impossible for the public to accurately interpret a “drop in COVID cases, COVID hospitalizations, and COVID deaths,” if the public is not informed of such a change in criteria, if such a change in criteria were to occur.
  5. Quality epidemiologic data: In the above ways, the public can insist that current and past scientifically unsound, low-quality epidemiologic data collection be replaced with data collected according to long-established, highly disciplined scientific practices. Accurate data (past, current, and future data) are absolutely essential for optimal public health decision-making, optimal public understanding of the COVID situation, and optimal individual decision-making.
  6. Prompt, appropriately aggressive treatment of patients with severe COVID illness: The public can insist that patients with severe COVID illness benefit from the same clinical approach and quality of care that children with life-threatening autoimmune and autoinflammatory diseases have routinely received for many years prior to the appearance of COVID. (See articles #5 and #14.)
  7. Early preventive treatment of mild-moderate COVID illness: The public can also insist that treatment of mild-moderate COVID (to try to prevent its evolution into severe COVID illness) be better studied (large-scale, national studies, with excellent study design and high-quality data collection, including attention to Ct values) and better provided.
  8. Mitigation Measures: The public can insist that lockdown policies for the general public be thoroughly re-evaluated, with rigorous analysis of risks vs. benefits, based on quality scientific data.
  9. Vaccine development and study: The public can insist on full disclosure of all vaccine-related data—data generated both during clinical trials (including Ct values, for example) and since deployment of mass vaccination. The public can insist on a mandatory (not passive) vaccine adverse events reporting system (VAERS) that assures that as close as possible to 100% of adverse events (split into categories of “definitely,” “probably,” “possibly,” and “probably not” vaccine-related, as defined by uniform strict criteria) are reported, carefully studied, and made known to the public.
  10. Public education and informed consent: The public can insist on a thorough re-evaluation of the hastily implemented mass vaccination campaign. In addition to being taught about Ct values and the strict criteria that ought to be used to collect and interpret epidemiologic data, the public can insist on being taught all of the potential short and long-term side effects that need to be considered and studied with the new COVID vaccines—including what we do not yet know. The public can also insist on full disclosure of what we know and do not know about the efficacy of these vaccines. Informed consent requires this information, as well as quality data regarding the true number of definite COVID cases, COVID hospitalizations, and COVID deaths. Without this complete and accurate information, it is impossible for individuals and public policy makers to accurately understand whether the risks of COVID illness outweigh the risks of vaccination, or vice versa. The public can insist that the current hastily implemented mass vaccination campaign be immediately re-evaluated to determine if scientifically sound data and scientifically sound understandings justify such a campaign.
  11. Careful distinction between hypothesis and proven fact: The public can insist that health care professionals and the media be far more careful to distinguish between hypothesis and fact.
  12. Prevention of extremism, polarization, divisiveness, intolerance, shaming, and shunning: The public can insist that the current Task Force and the conventional media stop fueling excessive fear, extremism, polarization, division, intolerance, shaming, shunning, and censorship; and start promoting critical thinking, careful examination, and healthy dialogue (instead of exemplifying the opposite). Likewise, the public can insist that the more extreme challengers to the USA Task Force narrative do their part by cleaning up their overstatements, misstatements, and misleading presentations. (Please see articles #2 and #13.)
  13. Promotion of critical thinking, careful examination, and healthy dialogue: The public can unite to encourage all citizens, including health care professionals, governmental officials, the media, and family members to engage in critical thinking, careful examination, and healthy dialogue.

By taking the above steps, the public can insist on a thorough, objective, science-based re-appraisal of the current prevailing COVID narrative, current and past public policies, and current governmental and media behaviors—-the goal being to create a more accurate, more scientifically sound, more helpful COVID narrative and a healthier COVID response. With careful examination, clarity of thought, and common sense, the public and the COVID Task Force can collaborate to bring about a successful resolution of the COVID-19 pandemic. That is how science, medicine, and democracy are supposed to work.

It is our social responsibility to take the above concerns seriously; participate in healthy, science-based public dialogue; and support the above public actions. The world’s children need us to do so.

Welcome to the Social Clinic—where all may participate as Social Clinicians and contribute to the creation of Social Beauty.

RMR

4/28/2021

 

INTRODUCTION and SUMMARY

Careful Examination of the COVID-19 Pandemic

Robert M Rennebohm, MD

The articles listed below are intended to contribute to a deeper public examination and understanding of the COVID-19 pandemic. Most importantly, these articles offer new, positive, practical, public-honoring recommendations for successful resolution of the pandemic:

  1. INTRODUCTION and SUMMARY: Careful Examination of the COVID-19 Pandemic
  2. A Middle Narrative
  3. The Importance of Knowing the Ct Value at which a COVID PCR Test is Positive
  4. Critically Examining COVID Data
  5. Treatment of Severe COVID Illness
  6. Vaccine Concerns
  7. An Interview with the Human Immune System
  8. Spiritual Appreciation of the Human Immune System
  9. Hypotheses Regarding New COVID strains
  10. Lessons the Human Immune System Teaches
  11. Marek’s Disease—A Cautionary Tale?
  12. Che—the Rebel Chicken
  13. COVID Analysis—The Big Picture
  14. Treatment of Severe COVID-19 Illness—LONG VERSION
  15. The Importance of Knowing the Ct Value at which COVID PCR Tests are Positive—LONG VERSION
  16. Critically Examining COVID-19 Data—LONG VERSION
  17. Analysis of COVID-19: An Additional Narrative; An Alternative Response—LONG VERSION
  18. The Nature of Epidemics
  19. Analysis of COVID-19: Geo-political Aspects
  20. The Corporate Consortium
  21. Letter to Dr. Anthony Fauci

These 21 articles are posted in full on a Social Clinic website, which may be accessed by googling: notesfromthesocialclinic.org

The above articles simply represent one pediatric rheumatologist’s assessment and recommendations, regarding the COVID-19 Pandemic. I am a pediatric rheumatologist, which means I have specialized in the study and clinical care of children with autoimmune and autoinflammatory diseases—such as juvenile idiopathic arthritis (formerly called juvenile rheumatoid arthritis), childhood lupus, juvenile dermatomyositis, Kawasaki disease, Susac syndrome, and many other diseases, all of which are due to disorders of immune regulation. I do not want to speak for all pediatric rheumatologists, but I do want to explain how I imagine a COVID Task Force comprised of excellent, experienced, caring pediatric rheumatologists might have guided the public through the COVID pandemic. The purpose of doing so is to explain how and why a new approach, which is outlined at the end of the article, could bring about a successful resolution of the COVID-19 pandemic.

How an imagined COVID Task force comprised of pediatric rheumatologists might have guided the country through the COVID pandemic:

Below are the most important steps such a Task Force might have taken:

  1. Quality of COVID-19 PCR Test Kits: A first step would have been to develop a COVID PCR test of indisputably proven excellence. The test would need to be proven to be specific for detection of the SARS-CoV-2 virus—i.e., it must be positive only in the presence the SARS-CoV-2 virus and not positive because of cross-reactivity with other coronaviruses or other viruses. The test would need to be optimally sensitive. The test would also need to have a very low false positivity rate, both in the setting of clinical illness and when used to screen people who are asymptomatic. (Please see articles #3 and #15 for more information about COVID PCR tests, including published peer-reviewed references.)
  2. Disclosure of the Ct value at which a COVID PCR test is positive: Great attention would be paid to the Ct value at which a COVID PCR test is positive. A COVID PCR test would be declared “definitely positive” only if it were positive after 30 or fewer cycles of amplification (i.e., at a Ct value of 30 or less). If a test became positive only after 31-35 cycles of amplification, it would be labeled “possibly positive.” If a test became positive only after 36-40 cycles, it would be declared uninterpretable (for research and epidemiological purposes) and considered negative for clinical purposes. If a test were negative after 40 cycles, it would be declared “definitely negative.” Testing would not continue beyond 40 cycles of amplification. It would be made clear that data on people whose test was positive between 31-40 cycles were being collected primarily for research purposes, out of an abundance of caution. A strong argument could be made, however, to cease amplification after 30 cycles and declare all tests that are negative after 30 cycles to be “definitely negative.” (Please see articles #3 and #15 for more about the Ct values of COVID PCR tests, including published peer-reviewed references.)
  3. Public education regarding Ct values: From the beginning of the epidemic, the public would have been thoroughly educated about the importance of knowing the Ct value at which a COVID PCR test is positive. This would include explaining that if a person’s test is positive, for example, at a Ct value of 18 (i.e., after 18 cycles of amplification), this means the person is carrying a very high viral load and is very contagious; but if a person’s test is positive only at a Ct of 37 (only after 37 cycles of amplification), the result is uninterpretable and even if that test were accurately detecting a tiny amount of SARS-CoV-2 virus (as opposed to being a false positive), it would almost surely be detecting just a tiny quantity of remnants of dead virus, and the person would not be contagious. It would also be explained, however, that in a very rare instance a test that is positive at 31-35 is detecting a person who has very recently entered a pre-symptomatic phase of infection—in which case the person should be retested in 2-5 days (to see if the Ct value drops below 30) and monitored for COVID symptoms.

The Task Force would have felt strongly that the public is perfectly capable of understanding the practical aspects and importance of knowing Ct values. The public would have been taught that If a person’s COVID PCR test comes back “positive,” that person and their physician need to know how strongly the test was positive, and they need to ask the lab, “At what Ct value was the test positive?” The public would easily understand that asking this question makes common sense. (Please see articles #3 and #15 for further details.)

It would also be explained to the public and physicians that there are limitations to the accuracy of Ct values, and that these limitations need to be taken into account. The COVID PCR test is a qualitative test, not a quantitative test, and the Ct value at which a test is positive is only an indirect and imperfect estimate of viral load. Furthermore, the Ct value at which a given test is positive can vary modestly from one lab to another, though not to a practical, clinically significant degree. Despite these limitations, the Ct value provides a very good estimate of how strongly positive a test is. A very good estimate is far more valuable than no estimate at all. Reporting a test as “positive at a Ct of 45” (as opposed to being positive at a Ct of 18) is far more helpful than simply reporting the test as “positive,” with no information about the Ct value at which it was positive.

  1. Establishment of strict diagnostic and classification criteria: A next step would have been to establish uniform, accurate, strict criteria for diagnosis of a “definite COVID case,” a “definite COVID hospitalization,” and a “definite COVID death.” In addition to clinical features, these criteria would take into account the Ct value at which a person’s PCR test was positive. Included in this classification scheme would be specific criteria for designation as a “probable” or “possible” COVID case/hospitalization/death, and criteria for designation of “not COVID (even if a person has had a ‘positive’ PCR test).” Uniform data record forms would be accurately and fully completed for all persons reported to state health departments and the CDC. Those forms would indicate which criteria were fulfilled, the Ct values at which the person’s PCR test was positive, and what the basis was for the person’s ultimate classification/diagnosis. (Please see articles #4 and #16 for more details about quality data collection.)
  2. Quality epidemiologic data: The above steps would have resulted in epidemiologic data of high scientific quality. These epidemiologic data would be broken down into “definite,” “probable,” and “possible” categories. Public health officials and the general public would, thereby, have accurate, scientifically sound information regarding the true number of definite new and cumulative COVID cases, COVID hospitalizations, and COVID deaths—as well as numbers of probable and possible cases, hospitalizations, and deaths. Public health officials and the general public would also know what percentage of cumulative and recent (during a given week of screening) COVID PCR tests were positive at a Ct of 30 or less, and what percentage were positive at higher, far less worrisome Ct values. Steps 1-4 not only make scientific sense, but also common sense.
  1. Prompt, appropriately aggressive treatment of patients with severe COVID illness: Pediatric rheumatologists have had many years of experience with the clinical study and treatment of life-threatening hyperimmune disorders, including spontaneous and infection-triggered “cytokine storm.” An early step would have been to apply that knowledge and experience, including the results of past clinical trials, to the new COVID situation. We would have immediately developed nationwide protocols that would make it possible to offer prompt, appropriately aggressive treatment to all patients with severe COVID illness, and, simultaneously, make it possible to learn maximally from each of those patients. Those protocols would have included use of Ct values of COVID PCR tests for guidance in interpreting whether a given patient’s primary problem (at a given point in time) was out-of-control active viral infection (in need of anti-viral treatments) or an excessive out-of-control hyperimmune reaction (in need of immunosuppression). (Please see articles #5 and #14 for further discussion of treatment of patients with severe COVID illness, including a specific and detailed protocol for such treatment, as well as published peer-reviewed references.)
  1. Early preventive treatment of mild-moderate COVID illness: In an effort to prevent outpatients with early mild-moderate COVID illness from progressing towards severe illness and need for hospitalization, we would have developed, implemented, and studied large-scale nationwide protocols for treatment of such outpatients. Each and every outpatient diagnosed with definite COVID (based on proper use of the COVID PCR test and proper use of diagnostic criteria) would have been eligible to participate in one of several outpatient preventative treatment protocols that involved various combinations of drugs such as remdesivir, other anti-viral therapies, monoclonal antibodies, and/or simpler medications such as hydroxychloroquine, Ivermectin, azithromycin, zinc, and vitamin D. Prospective, large-scale, nationwide study of these treatment options and combinations would have generated compelling information regarding which treatments (or treatment combinations) are effective and safe, and which are not. In order for these studies to generate optimally meaningful, scientifically sound information, the Ct values of these outpatient’s COVID PCR tests would need to be included in the data collection and analysis.

Incidentally, the Task Force would have insisted that all of the above-mentioned treatments for mild, moderate, and severe COVID illness (i.e., outpatient and inpatient treatments) be provided at no charge to patients, during this urgent national emergency. The goal would be to make certain that no patient suffered from lack of access to appropriate health care.

  1. Mitigation Measures: During the first 2-3 weeks of the pandemic, when much was unknown about the SARS-CoV-2 virus and COVID illness, the Task Force would have recommended a temporary lockdown, particularly in nursing and retirement homes, to minimize spread of the virus to the most vulnerable people while more was learned about the pandemic. After those 2-3 weeks, however, the Task Force would not have favored a prolonged lockdown of the general population. It would have recommended at least partial lockdown protections for the most vulnerable (those in nursing homes and retirement homes and those with predisposing co-morbidities), but it would have encouraged the rest of the population to simply (but assiduously) use the common-sense precautions that have been used during all past seasonal influenza epidemics. Schools, businesses, and public places would have been open, much like the policy implemented in Sweden. The adverse consequences of prolonged, indefinite lockdown of the general public would have been deemed far more harmful than no lockdown of the general public. (Please see article #17.)
  2. Vaccine development and study: In anticipation of potential need for COVID vaccines, the Task Force would have mobilized efforts to create COVID vaccines. However, before implementing a campaign of rapid mass vaccination, we would have insisted on sufficient proof of the safety, efficacy, and necessity for rapid deployment of such a campaign. The data generated via steps 1-7 would have provided solid, high quality, scientific data, regarding the extent to which rapid mass vaccination was truly necessary and truly urgent. We would have emphasized and explained to the public that: without high quality epidemiologic data (including CT information and the results of study of prompt appropriately aggressive treatment of severe COVID illness and appropriate treatment of outpatients with mild-moderate COVID), it would be difficult to know how truly necessary and truly urgent mass vaccination was; without high quality efficacy data, it would be difficult to know how truly beneficial the proposed vaccines would be; without adequate high-quality short and long-term safety data it would be difficult to know how truly safe the vaccines are; and without all three of these types of quality data, it would be impossible to accurately know whether the benefits of COVID vaccination out-weighed the risks, or vice versa. (Please see articles #6-12 for further discussion of vaccine issues.)

If it were decided that there was adequate evidence that the COVID vaccines might be safe, effective, and necessary, the Task force would have recommended that they be used only for the vulnerable, and then only very carefully, with very close post-vaccination surveillance for adverse effects of the vaccines.

The Task Force would make certain that, if COVID vaccines were introduced, it would be understood (and explained to the public) that there has not been enough time or sufficient study to assure their safety. Accordingly, the Task Force would make certain that the Vaccine Adverse Events Reporting system (VAERS) would be used in a mandatory (not passive) fashion that assures that as close as possible to 100% of vaccine-related side effects would be reported and thoroughly examined.

  1. Public Education and Informed Consent: Throughout the pandemic, a top priority of the Task Force would have been superb and comprehensive public education about all of the issues discussed in steps 1-9. And certainly, if properly collected high-quality data revealed necessity for urgent COVID vaccination, we would have insisted upon obtaining informed consent—meaning that individuals about to receive the vaccine, as well as the public at large, would need to be adequately informed of the experimental nature of the vaccines and the limited knowledge we have regarding the safety, efficacy, necessity, and wisdom of using these vaccines.
  1. Careful distinction between hypothesis and proven fact: Throughout the pandemic the Task Force would be careful, amongst themselves and in discussions with the public, to always carefully distinguish between hypothesis and proven fact. Hypotheses and assumptions would not be presented as “proven scientific fact.” This includes informing the public of the level of the quality of data presented to them. When the public is told, “the data show,” the public needs and deserves to know whether those data are of high scientific quality, or very low scientific quality.
  1. Prevention of extremism, polarization, division, intolerance, shaming, and shunning: As leaders of the country’s response to the pandemic, a top priority of the Task force would have been to discourage extremism, polarization, division, intolerance, shaming, and shunning—within the medical community, the government, the media, the general public, and even within families. Regarding the seriousness of the pandemic, we would have tried to prevent excessive fear on the one hand and excessive denial on the other. We would have encouraged appropriate moderation. Honest, comprehensive public education would have been a major means of achieving this balance and promoting healthy dialogue. (Please see articles #2, #12, #13, and #17.)
  2. Promotion of critical thinking, careful examination, and healthy dialogue: The foundation of our efforts to guide the public through the epidemic would have been a strong emphasis on critical thinking, careful examination, and healthy dialogue. We would have exemplified this within the medical community and encouraged it within government, among the media, in the general public, and within families. We would have viewed the COVID pandemic as an opportunity to bring people together, develop new collective medical and social insights, and envision new social arrangements that give practice to the best aspects of Human Nature and could optimize public health. (Please see articles #2 and #13.)

The above steps are some of the most important steps that I imagine a COVID Task Force comprised of pediatric rheumatologists would have taken. That is how we would have taken the COVID pandemic seriously. That is how we would have demonstrated the rigorous, disciplined practice of science and medicine. That is how we would have honored the public. That is what we would have done in an effort to save lives. That is how we would have demonstrated and encouraged careful examination, healthy dialogue, and common sense.

How the actual USA COVID Task Force has guided the country through the COVID pandemic:

To what extent have those 13 steps been taken by the actual COVID Task force (during both the Trump and the Biden administrations) that has been managing the COVID pandemic for the past 14 months?

  1. Quality of COVID PCR test kits: At least 150 COVID test kits have been granted Emergency Use Authorization (EUA). The vast majority of these kits have been manufactured by private for-profit lab companies. The manufacturers have provided data suggesting that their test kits have a very high and acceptable level of specificity and sensitivity and a very low level of false positivity (around 1%). However, this testing of specificity, sensitivity, and false positivity appears to have been done only in patients with compelling clinical evidence of symptomatic COVID illness. Studies of specificity, sensitivity, and false positivity do not appear to have been done in the setting of mass screening of asymptomatic individuals. These two settings are completely different. Specificity, sensitivity, and false positivity need to be studied in both settings and across the entire spectrum of Ct values. Unfortunately, 14 months after onset of the pandemic, we still do not know how accurate the test kits are, particularly in the surveillance setting (screening of asymptomatic people), particularly the false positivity rate in the surveillance setting (which might be as high as 70%, according to one peer-reviewed publication). (Please see articles #3 and #15 for further discussion and peer-reviewed references.)
  2. Disclosure of the Ct value at which a COVID PCR test is positive: Almost all of the COVID PCR test kits used in the USA have been set to perform at least 40 cycles of amplification in their search for presence of the virus. Most kits have been set to perform 45 cycles of amplification before declaring the result to be negative (if no virus is detected after 45 cycles). Throughout the first 14 months of the COVID pandemic the official recommendation by the WHO and the CDC has been to routinely set the test to perform 45 cycles. Some test kits are set to routinely perform 50 cycles—meaning that the person’s test is not declared negative unless no evidence of virus is found after 50 cycles of amplification. For years it has been known that the results of PCR testing are unreliable and uninterpretable after 30 cycles of amplification, and for years it has been recommended that no more than 30 cycles of amplification be performed when using PCR tests to identify pathogens. But this knowledge and recommendation have been ignored during the COVID pandemic.

With very rare exception, the Ct values at which COVID PCR tests have been positive have not been reported to the patient, their physician, or to health officials. The Ct values have routinely been completely ignored and not made available. Throughout the pandemic, patients and their physicians have been told only whether the COVID PCR test was positive or negative—with no information as to how strongly or weakly positive; no information as to whether the test was positive after 18 cycles of amplification or only after 45 cycles. Throughout most of the pandemic, most physicians have not even heard of Ct values. When physicians who know about Ct values have asked for the Ct value at which their patient’s positive test became positive, they have routinely been told, “We do not have that information; it is unavailable.”

This means that diagnoses of COVID cases, COVID hospitalizations, and COVID deaths have been based on a “positive” COVID PCR test, but not with any information as to how strongly or weakly positive the test was. It makes a huge difference whether a test is positive after only 18 cycles of amplification (meaning a huge viral load is present and the patient is very contagious) or only after 45 cycles (meaning the result is uninterpretable, the patient is very unlikely to be contagious, and the result most likely represents a false positive).

This failure to pay attention to Ct values means that we really have no idea what percentage of “positive” tests (during a given week of national testing) have been positive only after 40 or 45 cycles of amplification and what percentage have been positive at a Ct of 30 or less. That information has been available (it is automatically provided by the machine that does the test), but it is being ignored, and in many cases that Ct information is, reportedly, being irretrievably discarded. So, when the public is told that 100,000 people “tested positive” on a particular day of national screening, but no Ct information is provided, it is impossible to know what that information means. (Please see articles #3 and #15 for more details.)

  1. Public education regarding Ct values: Throughout the pandemic there has been no public mention of Ct values by any of the medical correspondents in the mainstream media, or by any members of the USA COVID Task Force. It is unclear whether these people simply do not know about Ct values; they know about Ct values, but have decided, or been told, that the public “would not be able to understand” such information; or they have been instructed not to educate the public about the importance of knowing the Ct value at which a COVID PCR test is positive.
  2. Establishment of strict diagnostic and classification criteria: Throughout the pandemic strict, uniform, accurate diagnostic and classification criteria have not been adequately used in the collection of data regarding cumulative and new COVID cases, COVID hospitalizations, and COVID deaths. Certainly, Ct values have not been included in the data collection, and this, by itself, has markedly decreased the quality of data. It has been unclear what criteria have been used (and how uniformly so) to define a definite COVID case, a definite COVID hospitalization, or a definite COVID death. For example, it has been quite unclear what criteria need to be fulfilled, or do not need to be fulfilled, in order for a death to be designated a “COVID death. Imagine, for example, an 85-year-old man with long-standing chronic heart disease who tested “positive” for COVID (at an unreported and, therefore, unknown Ct value) during a routine mass screening at his nursing home. He had no COVID symptoms at the time of the testing or subsequently. Then, two weeks after his COVID testing, he suddenly dies from a heart attack, at which time he still had no COVID symptoms. It is unclear whether such a person is counted by the CDC as a “COVID death.” According to some reports, any person who dies within 28 days after having a positive COVID PCR test (even if positive only after 45 amplification cycles) is automatically considered to be a COVID death (“out of an abundance of caution”) and is included in the national COVID death count. If that is true, the cumulative COVID death count would be highly misleading. (Please see articles #4 and #16 for more details.)
  3. Quality epidemiologic data: Because Ct values of COVID PCR tests have not been taken into account, and because strict uniform diagnostic and classification criteria have not been applied to data collection, the quality of the data, regarding cumulative and new COVID case, COVID hospitalizations, and COVID deaths has been unclear (at best) or of very low scientific quality (at worst, and most likely). As a result, the true number of COVID cases, COVID hospitalizations, and COVID deaths has remained very unclear throughout the pandemic. (Please see articles #4 and #16.)
  4. Prompt, appropriately aggressive treatment of patients with severe COVID illness: As explained in articles #5 and #14, patients with severe COVID illness have not often received the kind of care that pediatric rheumatologists would routinely provide. As a result, it is unclear how many of the true COVID deaths could have been prevented with more prompt and appropriately aggressive care, including use of Ct values for guidance. Likewise, it is unclear how much long-term damage could have been prevented in survivors of severe illness, had they received more effective care. Absence of this information impairs our ability to interpret current COVID death data (and disease damage data) and to gauge the true necessity and urgency for mass vaccination.
  5. Early preventive treatment of mild-moderate COVID illness: Early in the pandemic the USA COVID Task Force conveyed the notion to the public that many of the simpler treatments, such as hydroxychloroquine and ivermectin, were either ineffective or harmful. Such treatments were officially and strongly discouraged and belittled. The Task Force made no effort to set up adequate large-scale national studies of outpatient preventative treatments. In order to generate meaningful, scientifically sound data, such studies would need to include the Ct values of these outpatients’ COVID PCR tests. No such studies have been done. As a result, we have limited information about the efficacy (or inefficacy) of such treatments. Several studies that have been unfairly dismissed by the USA Task Force have suggested efficacy of hydroxychloroquine and ivermectin.
  6. Mitigation Measures: The USA Task Force chose to chronically lockdown the entire society, to varying and fluctuating extents. This has resulted in severe side effects for most of the population, particularly the poor and already struggling. Children, in particular, have suffered. It has least affected the wealthy and already privileged. (Please see article #17.)
  7. Vaccine development and study: The USA Task Force has certainly rushed to make vaccines available as soon as possible. Unfortunately, they have entrusted for-profit pharmaceutical corporations that have been convicted of major criminal activity (Pfizer and Johnson and Johnson) to produce the vaccines, and they have also entrusted these corporations to perform and report the safety and efficacy studies, which the public and medical community are then asked to trust. Unfortunately, a rapid mass vaccination campaign has been hastily deployed before efficacy and short and long-term safety could be adequately studied. Unfortunately, this haste has been justified by the low-quality data discussed earlier in this article—data that is falsely purported to “clearly show that the risks associated with contracting SARS-CoV-2 infection greatly outweigh the risks of COVID vaccination.” As a general common-sense rule, low quality data often leads to low-quality medical and public policy. (Please see articles #6-12.)

The USA Task Force has recommended that as many of the world’s 7.8 billion people as possible be vaccinated, as rapidly as possible, including children, despite the paucity of high-quality data to justify such a hasty vaccination campaign and despite lack of adequate data regarding safety and efficacy.

The extent to which the USA Task Force has made assurances that the Vaccine Adverse Events Reporting System (VAERS) is capturing and thoroughly examining as close as possible to 100% of vaccine-related side effects is unclear.

  1. Public education and informed consent: The USA Task Force and the conventional media have not provided adequate public education about COVID. The best example of this is the total absence of any discussion of the highly relevant and important Ct values. There has also been an absence of explanation of what criteria must be fulfilled before a patient is counted as a “COVID case” or a “COVID death.” There has been no discussion of the actual scientific quality of data being presented to the public. There has been no thorough discussion or explanation of the many things that could be done to improve the care and outcome of patients with severe COVID illness. Discussion of preventative treatment for early and mild COVID has been discouraged, as if such discussion is a waste of time. Finally, there has been grossly inadequate discussion of the potential short and long-term side effects of the COVID vaccines.
  2. Careful distinction between hypothesis and proven fact: A fundamental principle of science and Medicine is to very clearly and carefully distinguish between hypothesis and proven scientific fact—between what you suspect to be true and what has been proven to be true. Throughout the pandemic the Task Force and the conventional media have not been careful to distinguish between hypothesis and proven scientific fact. Assumptions have frequently been presented as if they are proven scientific fact. A good recent example of this is the statement being made that “the emergence of new more worrisome SARS-CoV-2 variants is due to too few people getting vaccinated and too many people not complying with mitigation measures.” This is a hypothesis, not a proven scientific fact. There are other equally plausible (or more plausible) hypotheses/explanations for the emergence of more worrisome strains. The fact is, we do not know which of these hypotheses is most true. Even the statement that “new more worrisome strains are emerging” is still a hypothesis and not yet a proven scientific fact. Many good scientists contest both of these just-stated hypotheses, which are being presented by the USA Task Force as proven facts. (Please see article #9.)
  3. Prevention of extremism, polarization, divisiveness, intolerance, shaming, and shunning: During both the Trump and Biden administrations, the Task Force and the conventional media have created conditions that have made extremism, polarization, division, intolerance, shaming, and shunning inevitable. In fact, the Task force and the media have fueled those fires. Instead of listening to challenges to their narrative, the Task Force and conventional media have summarily dismissed those challenges as “misinformation,” “disinformation,” “conspiracy theory,” and “anti-science.” Those citizens (including eminent scientists and physicians) who have questioned the prevailing narrative have been maligned, demeaned, and called deplorably irresponsible, selfish, even “stupid.” The Task Force and the conventional media have done all they can to create extreme levels of fear. Those who have questioned the justification for such extreme fear have been portrayed as “not taking the pandemic seriously.”
  4. Promotion of critical thinking, careful examination, and healthy dialogue: Instead of promoting critical thinking, careful examination, and healthy dialogue, the USA COVID Task Force and the conventional media have demonstrated the opposite. Within the medical community and conventional media only one narrative has been tolerated. Alternative points of view have been quickly and summarily dismissed, usually with disgust. Eminent physicians and scientists who have challenged the prevailing narrative have been intimidated into self-censorship or censored outright. The Task Force has neither exemplified critical thinking and careful examination, nor encouraged it in the rest of society. A telling and compelling example of this is the Task Force’s decision to not explain to the public the importance of knowing the Ct values at which COVID PCR tests are positive, and their decision to not report Ct values. Instead of encouraging healthy dialogue, the Task force has fueled frustration, confusion, excessive fear, anxiety, intolerance, shaming, shunning, and has made healthy dialogue almost impossible, even within families. (Please see articles #2, #13, and #17.)

The above decisions of the USA COVID Task Force (during both the Trump and Biden administrations) have led to an excessively fearful, confusing, and misleading prevailing COVID narrative (throughout the pandemic), which is based on data of low scientific quality. This narrative has been supported by an excessively compliant and unquestioning conventional media and has been protected by intolerance (often extreme) and shaming of challenges to the narrative. (Please see articles #2, #13, and #17.)

Ultimately, this has led to public policies of dubious merit and an unfortunate, agonizing vaccine predicament.

Has the USA Task Force exemplified the best way to take the COVID pandemic seriously? In its data collection has this Task force demonstrated rigorous, disciplined , exemplary practice of science and medicine? Has it exemplified how to best save lives? Has it provided exemplary patient and public education about COVID? Why has it managed the pandemic in a way that is so different from the rigorously scientific way in which an imagined Task Force comprised of pediatric rheumatologists might have managed the pandemic? Why did the USA Task Force, for example, make the decisions it has made, regarding the Ct values of COVID PCR tests? Why would competent, knowledgeable, caring people respond to the COVID situation the way the USA Task Force has responded? Has that response exemplified the way science, medicine, and democracy are meant to be practiced? (Please see articles #19, #20, and #21.)

What can be done now?

It is not too late to limit the damage done by the above decisions. (See article #13.) A new approach is possible—one that is honest, scientifically unassailable, and honors the public. Effective public education, public examination, public dialogue, and public pressure are the keys. For example:

  1. Quality of COVID PCR Tests: The public can insist that the specificity, sensitivity, and false positivity rate of the COVID PCR tests used during this pandemic be thoroughly examined by an unbiased, independent panel of laboratory scientists, virologists, and physicians—both in the setting of patients with compelling clinical evidence of COVID illness and in the screening of asymptomatic people (the surveillance setting).
  2. Disclosure of the Ct value at which a COVID PCR test is positive: The public can insist that the Ct values of all positive COVID PCR tests be disclosed and analyzed, both retrospectively (since the beginning of the pandemic) and prospectively (from now on). It is unclear, however, how much of the Ct data from COVID PCR tests done since the beginning of the pandemic has already been irretrievably discarded. The public deserves to know the extent to which those Ct data have been destroyed. Destruction of such data would constitute a major crime. The public also deserves to be told when/if a decision is made to reduce the number of amplification cycles routinely performed by COVID PCR tests from 45 cycles to 30 cycles. For it will be impossible for the public to accurately interpret a “drop in COVID cases, COVID hospitalizations, and COVID deaths,” if the public is not informed of such a reduction in cycles performed, if such a reduction were to occur.
  3. Public and Physician Education about Ct values: The public can insist that all physicians, as well as the general public, be educated about the importance of knowing the Ct value at which COVID PCR tests are positive. This includes public and physician awareness that knowledge of Ct values markedly improves the quality of epidemiologic data and the care of individual patients.
  4. Establishment of strict diagnostic and classification criteria: The public can insist that all “COVID deaths” be retrospectively examined (using new, accurate, strict diagnostic criteria, including Ct values) to determine what percentage of the reported cumulative COVID deaths have truly been definite COVID deaths and what percentage have been probable COVID deaths, possible COVID deaths, or not COVID deaths. And the public can insist that this same scientific rigor be applied to collection of COVID death data from now on. The public also deserves to be told when/if the criteria for diagnosis of definite COVID case, COVID hospitalization, or COVID death are made more strict, more difficult to fulfill. For it will be impossible for the public to accurately interpret a “drop in COVID cases, COVID hospitalizations, and COVID deaths,” if the public is not informed of such a change in criteria, if such a change in criteria were to occur.
  5. Quality epidemiologic data: In the above ways, the public can insist that current and past scientifically unsound, low-quality epidemiologic data collection be replaced with data collected according to long-established, highly disciplined scientific practices. Accurate data (past, current, and future data) are absolutely essential for optimal public health decision-making, optimal public understanding of the COVID situation, and optimal individual decision-making.
  6. Prompt, appropriately aggressive treatment of patients with severe COVID illness: The public can insist that patients with severe COVID illness benefit from the same clinical approach and quality of care that children with life-threatening autoimmune and autoinflammatory diseases have routinely received for many years prior to the appearance of COVID. (See articles #5 and #14.)
  7. Early preventive treatment of mild-moderate COVID illness: The public can also insist that treatment of mild-moderate COVID (to try to prevent its evolution into severe COVID illness) be better studied (large-scale, national studies, with excellent study design and high-quality data collection, including attention to Ct values) and better provided.
  8. Mitigation Measures: The public can insist that lockdown policies for the general public be thoroughly re-evaluated, with rigorous analysis of risks vs. benefits, based on quality scientific data.
  9. Vaccine development and study: The public can insist on full disclosure of all vaccine-related data—data generated both during clinical trials (including Ct values, for example) and since deployment of mass vaccination. The public can insist on a mandatory (not passive) vaccine adverse events reporting system (VAERS) that assures that as close as possible to 100% of adverse events (split into categories of “definitely,” “probably,” “possibly,” and “probably not” vaccine-related, as defined by uniform strict criteria) are reported, carefully studied, and made known to the public.
  10. Public education and informed consent: The public can insist on a thorough re-evaluation of the hastily implemented mass vaccination campaign. In addition to being taught about Ct values and the strict criteria that ought to be used to collect and interpret epidemiologic data, the public can insist on being taught all of the potential short and long-term side effects that need to be considered and studied with the new COVID vaccines—including what we do not yet know. The public can also insist on full disclosure of what we know and do not know about the efficacy of these vaccines. Informed consent requires this information, as well as quality data regarding the true number of definite COVID cases, COVID hospitalizations, and COVID deaths. Without this complete and accurate information, it is impossible for individuals and public policy makers to accurately understand whether the risks of COVID illness outweigh the risks of vaccination, or vice versa. The public can insist that the current hastily implemented mass vaccination campaign be immediately re-evaluated to determine if scientifically sound data and scientifically sound understandings justify such a campaign.
  11. Careful distinction between hypothesis and proven fact: The public can insist that health care professionals and the media be far more careful to distinguish between hypothesis and fact.
  12. Prevention of extremism, polarization, divisiveness, intolerance, shaming, and shunning: The public can insist that the current Task Force and the conventional media stop fueling excessive fear, extremism, polarization, division, intolerance, shaming, shunning, and censorship; and start promoting critical thinking, careful examination, and healthy dialogue (instead of exemplifying the opposite). Likewise, the public can insist that the more extreme challengers to the USA Task Force narrative do their part by cleaning up their overstatements, misstatements, and misleading presentations. (Please see articles #2 and #13.)
  13. Promotion of critical thinking, careful examination, and healthy dialogue: The public can unite to encourage all citizens, including health care professionals, governmental officials, the media, and family members to engage in critical thinking, careful examination, and healthy dialogue.

By taking the above steps, the public can insist on a thorough, objective, science-based re-appraisal of the current prevailing COVID narrative, current and past public policies, and current governmental and media behaviors—-the goal being to create a more accurate, more scientifically sound, more helpful COVID narrative and a healthier COVID response. With careful examination, clarity of thought, and common sense, the public and the COVID Task Force can collaborate to bring about a successful resolution of the COVID-19 pandemic. That is how science, medicine, and democracy are supposed to work.

It is our social responsibility to take the above concerns seriously; participate in healthy, science-based public dialogue; and support the above public actions. The world’s children need us to do so.

Welcome to the Social Clinic—where all may participate as Social Clinicians and contribute to the creation of Social Beauty.

RMR

4/28/2021

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