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STATEMENT ON COVID-19 EPIDEMIOLOGY

BY DR SUCHARIT BHAKDI  

Emeritus of the Johannes-Gutenberg-University in Mainz and long time
director of the Institute for Medical Microbiology

MARCH 2020

APRIL 2021 UPDATE: NEW RESEARCH PAPER SENT IN BY DR CRIS LINGLE: LINK

CITATION: Academic Editor: Paul B. Tchounwou. Int. J. Environ. Res. Public Health 2021, 18(8), 4344; https://doi.org/10.3390/ijerph18084344  Received: 20 March 2021 / Revised: 15 April 2021 / Accepted: 16 April 2021 / Published: 20 April 2021  (This article belongs to the Section Environmental Health)  

ABSTRACT: Many countries introduced the requirement to wear masks in public spaces for containing SARS-CoV-2 making it commonplace in 2020. Up until now, there has been no comprehensive investigation as to the adverse health effects masks can cause. The aim was to find, test, evaluate and compile scientifically proven related side effects of wearing masks. For a quantitative evaluation, 44 mostly experimental studies were referenced, and for a substantive evaluation, 65 publications were found. The literature revealed relevant adverse effects of masks in numerous disciplines. In this paper, we refer to the psychological and physical deterioration as well as multiple symptoms described because of their consistent, recurrent and uniform presentation from different disciplines as a Mask-Induced Exhaustion Syndrome (MIES). We objectified evaluation evidenced changes in respiratory physiology of mask wearers with significant correlation of O₂ drop and fatigue (p < 0.05), a clustered co-occurrence of respiratory impairment and O₂ drop (67%), N95 mask and CO₂ rise (82%), N95 mask and O₂ drop (72%), N95 mask and headache (60%), respiratory impairment and temperature rise (88%), but also temperature rise and moisture (100%) under the masks. Extended mask-wearing by the general population could lead to relevant effects and consequences in many medical fields. 

FINDINGS: A total of 65 scientific papers on masks qualified for a purely content-based evaluation. These included 14 reviews and two meta-analyses. Of the mathematically evaluable, groundbreaking 44 papers with significant negative mask effects (p < 0.05 or n ≥ 50%), 22 were published in 2020 (50%), and 22 were published before the COVID-19 pandemic. Of these 44 publications, 31 (70%) were of experimental nature, and the remainder were observational studies (30%). Most of the publications in question were English (98%). Thirty papers referred to surgical masks (68%), 30 publications related to N95 masks (68%), and only 10 studies pertained to fabric masks (23%). Despite the differences between the primary studies, we were able to demonstrate a statistically significant correlation in the quantitative analysis between the negative side effects of blood-oxygen depletion and fatigue in mask wearers with p = 0.0454. In addition, we found a mathematically grouped common appearance of statistically significant confirmed effects of masks in the primary studies (p < 0.05 and n ≥ 50%) as shown in Figure 2. In nine of the 11 scientific papers (82%), we found a combined onset of N95 respiratory protection and carbon dioxide rise when wearing a mask. We found a similar result for the decrease in oxygen saturation and respiratory impairment with synchronous evidence in six of the nine relevant studies (67%). N95 masks were associated with headaches in six of the 10 studies (60%). For oxygen deprivation under N95 respiratory protectors, we found a common occurrence in eight of 11 primary studies (72%). Skin temperature rise under masks was associated with fatigue in 50% (three out of six primary studies). The dual occurrence of the physical parameter temperature rise and respiratory impairment was found in seven of the eight studies (88%). A combined occurrence of the physical parameters temperature rise and humidity/moisture under the mask was found in 100% within six of six studies, with significant readings of these parameters. The literature review confirms that relevant, undesired medical, organ and organ system-related phenomena accompanied by wearing masks occur in the fields of internal medicine (at least 11 publications. The list covers neurology (seven publications, psychology (more than 10 publications, psychiatry (three publications, gynecology (three publications, dermatology (at least 10 publications, ENT medicine (four publications, dentistry (one publication, sports medicine (four publications, sociology (more than five publications, occupational medicine (more than 14 publications, microbiology (at least four publications, epidemiology (more than 16 publications, and pediatrics (four publications, as well as environmental medicine (four publications. We will present the general physiological effects as a basis for all disciplines. This will be followed by a description of the results from the different medical fields of expertise and closing off with pediatrics the final paragraph.

Physiological Effects of wearing Covid masks: As early as 2005, an experimental dissertation (randomized crossover study) demonstrated that wearing surgical masks in healthy medical personnel (15 subjects, 18–40 years old) leads to measurable physical effects with elevated transcutaneous carbon dioxide values after 30 min [13]. The role of dead space volume and CO₂ retention as a cause of the significant change (p < 0.05) in blood gases on the way to hypercapnia, which was still within the limits, was discussed in this article. Masks expand the natural dead space (nose, throat, trachea, bronchi) outwards and beyond the mouth and nose. An experimental increase in the dead space volume during breathing increases carbon dioxide retention at rest and under exertion and correspondingly the carbon dioxide partial pressure in the blood. As well as addressing the increased rebreathing of carbon dioxide due to the dead space, scientists also debate the influence of the increased breathing resistance when using masks. According to the scientific data, mask wearers as a whole show a striking frequency of typical, measurable, physiological changes associated with masks. In a recent intervention study conducted on eight subjects, measurements of the gas content for oxygen (measured in O₂ Vol%) and carbon dioxide (measured in CO₂ ppm) in the air under a mask showed a lower oxygen availability even at rest than without a mask. A Multi-Rae gas analyzer was used for the measurements. At the time of the study, the device was the most advanced portable multivariant real-time gas analyzer. It is also used in rescue medicine and operational emergencies. The absolute concentration of oxygen in the air under the masks was significantly lower. Simultaneously, a health-critical value of carbon dioxide concentration increased by a factor of 30 compared to normal room air was measured (ppm with mask versus 464 ppm without mask.

THE BOTTOM LINE: These phenomena are responsible for a statistically significant increase in carbon dioxide blood content in mask wearers. Another consequence of masks is a statistically significant drop in blood oxygen saturation. A drop in blood oxygen partial pressure with the effect of an accompanying increase in heart rate as well as an increase in respiratory rate have been proven. A statistically significant measurable increase in pulse rate and decrease in oxygen saturation after the first and second hour under a disposable mask were reported by researchers in a mask intervention study they conducted on 53 employed neurosurgeons. In another experimental study surgical masks caused a significant increase in heart rate as well as a corresponding feeling of exhaustion along with a sensation of heat and itching due to moisture penetration of the masks after only 90 min of physical activity  in heart rate (p < 0.001) and respiratory rate accompanied by a significant measurable increase in transcutaneous carbon dioxide. They also complained of breathing difficulties during the exercise. The increased rebreathing of carbon dioxide from the enlarged dead space volume in mask wearers can reflectively trigger increased respiratory activity with increased muscular work as well as the resulting additional oxygen demand and oxygen consumption. This is a reaction to pathological changes in the sense of an adaptation effect. 

NOW BACK TO SUCHARIT BHAKDI

SOURCE DOCUMENT: [LINK]  THE VIDEO IN GERMAN:  [LINK]  

AN EDITED AND ABBREVIATED VERSION OF THE BHAKDI ANALYSIS

My concern is that unforeseeable socioeconomic consequences of the drastic containment measures which are currently being applied. We need to look at both the advantages and disadvantages of restricting public life in terms of its long term effects. To this end, I am confronted with FIVE UNANSWERED QUESTIONS.

ITEM #1: STATISTICS: In infectology, a distinction must be made made between infection and disease and so therefore, only patients with symptoms such as fever or cough should be included in the statistics as new cases. It is not sufficient to test positive for COVID-19 to be counted in the disease statistics.

ITEM #2: DANGER: A number of different coronaviruses have been with us for some time largely unnoticed by the media. If it should turn out that the COVID-19 virus should not be ascribed a significantly higher risk potential than the coronaviruses already circulating, all countermeasures now employed would obviously become unnecessary. The very credible International Journal of Antimicrobial Agents will soon publish a paper that addresses this issue. Preliminary results of the study lead to the conclusion that the new virus is NOT different from the corona viruses of the past in terms of danger. The title of the paper is “SARS-CoV-2: Fear versus Data“.

ITEM #3: DISSEMINATION: According to a report in the Süddeutsche Zeitung, not even the Robert Koch Institute knows exactly how many have tested positive for COVID-19. But there is no doubt that there has been a rapid increase in the number of cases in Germany as the volume of tests increases. It is possible therefore that the virus has already spread unnoticed into the whole of the population. If so, it means that the official death rate of 206 deaths from 37,300 infections by 26 March 2020, at a rate of 0.55%, is too high. This would also mean that it isn’t really possible to prevent the spread of this virus.

ITEM #4: MORTALITY: The fear of a rise in the death rate in Germany (currently 0.55 percent) currently carries an intense media interest. Many people are worried that it could go up to 7% or 10% as it had in Spain and Italy. This fear likely derives from the practice of attributing deaths to the virus only on the basis that patient had tested positive for Covid at the time of his death. This practice is flawed. To attribute death to an agent it must first be determined that the agent played a significant role in the death. The Association of the Scientific Medical Societies of Germany includes this principle in its guidelines saying that to declare a cause of death, the causal chain is more important than the underlying disease. A more critical analysis of medical records should be undertaken to determine how many deaths can be attributed to this virus.

ITEM #5. COMPARABILITY

The use of Italy as a reference scenario for evaluating the risk posed to our population by this virus is flawed because the role of the virus in the Italian fatality statistics is unclear. There are external factors at play unique to Italy that made Italy particularly vulnerable. It has not been determined that these factors also apply to Germany. A factor unique to Italy is a high level of air pollution in Northern Italy that would account for more than 8,000 fatalities even without the virus. Air pollution increases the risk of viral lung
diseases in very young and in the very old. A household feature of Italy is the cohabitation of the very young and the very old (27.4% of the population) such that the very young can pass the virus to the very old who are at a high risk of death from the virus. This social feature is also found in Spain at the higher percentage of 33.5%. But it is not found in Germany. Therefore these countries do not serve as a model for understanding the spread and fatality rate of the virus in Germany. Yet another factor that makes it difficult to compare Germany with Italy and Spain is the relatively better equipment in Germany’s health care facility.

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MORE ARGUMENTS AGAINST LOCKDOWNS IN MEDICAL RESEARCH  

López, Leonardo, and Xavier Rodó. “The end of social confinement and COVID-19 re-emergence risk.” Nature Human Behaviour 4.7 (2020): 746-755.  The lack of effective pharmaceutical interventions for SARS-CoV-2 raises the possibility of COVID-19 recurrence. We explore different post-confinement scenarios by using a stochastic modified SEIR (susceptible–exposed–infectious–recovered) model that accounts for the spread of infection during the latent period and also incorporates time-decaying effects due to potential loss of acquired immunity, people’s increasing awareness of social distancing and the use of non-pharmaceutical interventions. Our results suggest that lockdowns should remain in place for at least 60 days to prevent epidemic growth, as well as a potentially larger second wave of SARS-CoV-2 cases occurring within months. The best-case scenario should also gradually incorporate workers in a daily proportion at most 50% higher than during the confinement period. We show that decaying immunity and particularly awareness and behaviour have 99% significant effects on both the current wave of infection and on preventing COVID-19 re-emergence. Social distancing and individual non-pharmaceutical interventions could potentially remove the need for lockdowns.

Peto, Julian, et al. “Universal weekly testing as the UK COVID-19 lockdown exit strategy.” The Lancet 395.10234 (2020): 1420-1421. 

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5/12/2020: ECONOMIST DR CHRISTOPHER LINGLE ON LOCKDOWNS AND CAUSE OF DEATH DETERMINATIONS. 

The ongoing experience with the SARS-CoV-2 virus and its companion disease, COVID-19, is a matter of balancing health and medical aspects of the associated pandemic against economic costs and consequences of policy responses. Alarmed by estimates from models predicting high morbidity rates (e.g., Imperial College London model), politicians and health bureaucrats imposed lockdowns, mandated social distancing or required citizens to shelter-in-place. As it turned out, worst-case scenarios of healthcare systems and hospitals being overwhelmed were exaggerated with hotspots like Wuhan, Lombardy and NYC bearing the brunt of the wave of illnesses and treatments. The policy responses to this pandemic provide several important lessons.

First, policy makers must understand that estimates derived from models can never be treated as reflecting objective reality of Besides the subjective nature of the assumptions within these models, it is as misguided as it is misleading to treat data sets as if they are devoid of subjectivity. What this means is that claims that public policy is guided by “science and evidence” rings hollow. Science is about testing and questioning what we see around us, not about establishing a consensus.

Second, policy makers should understand and undertake cost-benefit analysis of their decisions before jumping in over their heads. In large measure, the material harm and human costs of the economic collapse are the outcome of what now seems to have been rash judgements based upon faulty modelling.

Third, the goals of policies must be tempered by reality rather than rhetoric or political impulses. For example, Illinois Governor J.B. Pritzker announced economic reopening plan would wait “until we’re able to eradicate” the novel coronavirus.

But to imagine a world that is 100% free of corona or any other virus is an unrealistic goal. As it turns out, moving the number of cases closer to zero will cause the economic and human costs of the collateral damage to rise asymptotically. The way that epidemics or pandemics end is when a large enough proportion of the population acquires immunity either from the antibodies in reaction to infections or the development of a vaccine or treatment.

Vaccines must not be thought of as a magic bullet. On the one hand, vaccines for influenza that have been developed and used for decades are effective in the range of 35% to 45%. On the other hand, the RNA nature of coronaviruses makes them harder to pin down due to more rapid mutations. As it is, there are no vaccines for HIV, Zika, or Ebola despite so much having been invested over such a long period. Indeed, there are no “cures” for these deadly pathogens, only treatments.

Insisting that restrictions should only be lifted only after a vaccine is discovered is also misguided. Discovery of the vaccine is only one part of the puzzle. Even with a miraculous discovery of a vaccine within a few months, it will take considerable time to develop the capacity to produce medically acceptable scales that guarantee purity and safety. Then there is the matter of distributing and inoculating a large enough population. All of this will extend the time horizon into the distant future.

In all events, a question arises concerning the appropriate target ratio is that we should be tracking all the way to zero. Is it the case fatality rate, the infection fatality rate, or the crude mortality rate? None of these ratios are objective ratios determined purely from the data because their interpretation in immunology and virology have a subjective component; but once published these numbers are treated as objective data.

Yet, even the published number for the total number of deaths from COVID-19 is subject to interpretation because the death of persons known to have been infected by the virus creates a strong bias to record the cause of death as COVID-19. In the US, hospitals were guided by a incentive whereby they receive higher financial assistance for such patients that is likely to contribute to an upward bias on reported cases. Similarly, regardless of co-morbidity, instructions were given that all deaths of individuals infected with COV-19 were to be counted as COV-19 fatalities, even if they died with it rather than from it.

Details on the human transmissibility and age-specific impacts of the Coronavirus were reported during an earlier SARS pandemic in 2002-03. Details can be found in this 2009 paper [LINK] by Chris Ka-fai Li and Xiaoning Xu where we learn that “The reemergence of the Coronavirus in humans remains high due to the large animal reservoirs of coronavirus and the genome instability of coronaviruses RNA.”

It is extremely difficult to make accurate estimates of the true risks arising from human encounters with SARS-CoV-2 or any other disease during the initial stages of an epidemic, making it difficult to formulate appropriate policy responses. In all events, pandemics and epidemics first require medical rather than political responses.

In assessing the risk of death from the virus, there are several indicators, i.e., the “case fatality rate”, the “crude mortality rate”, and the “infection fatality rate”.

The Case Fatality Rate (CFR) is the ratio between confirmed deaths and confirmed cases, but it is a poor measure of the overall mortality risk of the disease. As it is, CFR relies on a clear assessment of the number of confirmed cases, something that is very fluid. This is worsened by the fact that the total number of deaths from COVID-19 is subject to interpretation. Anyone testing positive for SARS-CoV-2 will be known to clinical staff, so if they should die, it will be recorded on the death certificate as Covid-19 even if it was not the cause of death.

As such, it is very likely that deaths from COVID-19 are being recorded will tend to give the appearance that Covid-19 is causing an excess number of deaths. Data from the CDC & WHO indicate the CFR for the USA rate is about 5.9%, France 15%, UK 14.4%, Italy 14%, Netherlands 12.75%, Sweden 12.2%, Spain 10%, Mexico 10%, Canada 7.1%, Brazil 6.8%, Ireland 6.3%, & Switzerland 6.1%.

While the negative impact of lockdowns and similar restrictions on movements on economic activity is very clear, it is difficult to know the health impacts. Even so, it is likely that they may also make matters worse for several reasons. First, by simply delaying an inevitable spread of a highly contagious disease from the wide community. Second, keeping people indoors, away from sunshine, fresh(er) air, confined in close quarters with other people, especially if third, they are confined with other people suffering from other communicable diseases like TB that will not be diagnosed so it could have been treated or for infected to be isolated (NB: the “poor” are likely to be hit the hardest, especially in Third World countries). Fourth, extending the timeline of moving towards “herd immunity” might actually lead to a higher overall long-term death rate.

Numbers 1 and 2 will almost surely contribute to a “2nd wave” while number 3 leads to avoidable deaths from otherwise treatable diseases. So, it is not the lifting of a lockdown so much as instituting it in the first place that leads to another round of infections.

In light of the slow progress towards & low probability of discovering, producing and administering an effective vaccine on a large scale, the immediate path towards “herd immunity” is the natural development of antibodies against the SARS-CoV-2 virus. As it is, the evidence from an earlier iteration of the SARS virus suggests that the antibodies formed in that case were effective for up to 12 months & in some cases perhaps as much as 48 months.

For its part, this novel virus does not care about the choice of timing; either accept an initial short, sharp shock or suffer through a series of lockdowns in response to successive waves. Public Choice theory as a subset of economics predicts that politicians and bureaucrats tend to avoid political costs of immediate events inducing them to follow what is in their own best interest, which they believe is to engage in more interventions rather than less. So it is better for them to claim they are being guided by “science and evidence” to issue policy declaration that really reflect their own personal incentives as political agents. In all events, they have no “skin-in-the-game” of the lockdowns since neither they nor most public sector employees will face job losses as have occurred in the private sector.

“Successful” lockdowns will almost certainly be followed by a nasty 2nd wave. In turn, this will almost surely lead to more economic damage while undermining institutional and Constitutional restraints on the democratic process that would impose greater limits on human liberty. Another concern about lockdowns, social distancing mandates, and shelter-in-place orders is if they involve heavy-handed enforcement, there are likely to be heavy impacts on racial minorities, the poor, and those less able to defend themselves.