In God We Trust: All Others Need Data - A Look at COVID-19

SUMMARY:

• On a historical basis, the current corona virus pandemic is much smaller than the Spanish Flu pandemic (1918) and comparable to the Asian Flu pandemic (1957-1958).
• The current corona virus has been politicized in a way the previous two pandemics were not. 
• Initial 'worst case' scenarios published by the Washington Post and New York Times predicted at least 1-million virus related deaths.
• Imperial College's 'Covid Response Team' predicted over 2-million US fatalities (without control measures)
• In the United States, the median age of covid victims is ~78, and covid victims have an underlying medical condition approximately 75% of the time.
• A person aged 75 and above, is 220-times more likely to die from covid than a person aged 18-29.  (See Table 2)
• Children under 17 have little risk to covid, and this calls into question the need for so many school closures.  (See Table 2)
• Based on the experience of several European countries, draconian lockdowns have not produced demonstrably better results than those achieved in the US, at least when 'excess deaths' is the metric.  (See Figures 2 and 3)
• The case against European style lockdowns is further buttressed by the fact that one-third of the 'excess deaths' in the US are not covid related, and are likely due to the lockdown itself. 
• Given the concentration of the covid deaths among the elderly, along with the health consequences of the society-wide lockdowns, a much better approach than lockdowns would appear to be returning society to something resembling normalcy while protecting those particularly at risk from the virus.  (The Florida approach versus the New York approach.)
• Now, the media seems to be focusing on 'cases' as the new metric to assess progress against the virus. 
• However, the clinical definition of a covid 'case' does not include symptoms.  Instead, it completely relies on a positive lab test for covid. This is completely different than how SARS was assessed and managed. 
• The problem with relying on a positive lab test is the test itself.  The test - the RT-PCR test - is being used with a cycle threshold of 40.  This cycle threshold makes it impossible to distinguish between a virus capable of replication and 'dead nucleotides.'
• The CDC guidance for what constitutes a positive test for covid is in complete contradiction with a statement made by Dr. Fauci in July 2020.  
• The case data that government officials and the media are regularly trumpeting is enormously flawed and medical professionals realize this.

GENERAL OBSERVATIONS and PERSPECTIVE:
Before looking at where the corona crisis is now, some longer term perspective is useful.  Particularly interesting are some of the 'worst-case' predictions published in the New York Times and Washington Post in March of this year. 

• The Spanish Flu (1918) claimed approximately 675,000-lives when the population of the United States was roughly 103-million.  A similar toll today would produce well over 2-million deaths. 
• The Asian Flu pandemic (1957-1958) claimed roughly 116,000-lives in the US (per the Center for Disease Control).  At the time the population of the United States was 175-million.  A similar toll today would produce 215,000-deaths.  
• Neither of the two previous pandemics were politicized like this one.  Indeed, President Eisenhower left office in 1960 enormously popular.
• In March 2020, the Washington Post forecast a 'worst-case' scenario of 1.1-million Corona virus deaths in the US.  The article read in part; "In the worst case scenario, America is on a trajectory of 1.1-million deaths.  That model envisions sick pouring into hospitals, overwhelming even makeshift beds in parking lot tents.  Doctors would have to make agonizing decisions about who gets scarce resources.  Shortage of front-line clinicians would worsen as they get infected, dying alongside their patients.  Trust in government, already tenuous, would erode further." (1)
• In March 2020, the New York Times forecast a 'worst-case' scenario of 1.7-million Corona virus deaths in the US.  (2)
• In March 2020, the Imperial College (UK) Response Team predicted, 'in the absence of control measures,' the United States could expect 2.2-million deaths.  (3)  (Note the lead author of this report, Dr. Neil Ferguson, resigned from his government advisory position after it was revealed he ignored social distancing protocols to carry on an affair with a married woman.  In Moscow, senior communist officials had access to 'ZiL' lanes and never had to wait in traffic unlike the average citizen who suffered under their misrule.  London during the Corona crisis appears little different).

MORTALITY DATA & POPULATION STATISTICS:
Figure 1 below is a plot of 'excess deaths' and compares the statistics for 2020 with those for the years 2015 - 2019 and the average for these five years. (4)  As the figures make clear, 2020 has seen an increase morbidity, particularly for March and April.  Figure 1 plots 'excess deaths' and does not distinguish between 'excess deaths' and deaths attributable to covid.  According to an article published in the Journal of the American Medical Association, covid only accounts for two-thirds of excess deaths.  (5)  This will be discussed as part of the review of the efficacy of 'lockdowns' in the next section. 

The Asian Flu of 1957-58 mentioned previously exacted a fairly high toll on younger people.  This is in sharp contrast to what has been observed with the corona virus.  In July, the Centers for Disease Control (CDC) issued a report based on 'cased based surveillance' and 'supplemental surveillance' data.  (6)  For the 'cased based' results, data from the case files of 52,166 covid victims was reviewed.  As part of this review the following statistics were obtained;

• 79.6% of the victims were age 65 or older
• median age was 78

Of these 52,166 cases reviewed as part of the 'case based' review, 10,647 of these cases included considerable additional information in the case record.  This 'supplemental surveillance' made possible by the additional information  produced the following data on these 10,647 cases;

• 74.8% of the victims were age 65 or older
• There was a considerable variation in the median age depending on race of the victim. 
• Median age for Hispanics was 71; median age for non-Hispanic, non-white was 72; median age for whites was 81
• 76.4% of the victims had at least one underlying condition at the time of death
• The most common underlying conditions were cardio-vascular disease (60.9%), diabetes (39.5%), chronic kidney disease (20.8%) and chronic lung disease (19.2%)

Three months later, in October, the CDC published an updated report on covid fatalities. (7)  This report reviewed data from 114,111 covid related deaths, and reported the data included in Table 1.  Note that 56.4% of covid deaths were in people aged 75 and above, while fully 78.1% of victims were aged 65 and above.

TABLE 1

As data continued to be gathered, the initial assessment of the increased vulnerability faced by elderly people, especially those with an underlying health issue, continued to remain valid.  The CDC summarized the specific risk various age groups faced by covid, (8), and this data has been provided in Table 2

TABLE 2

REVIEW of SOCIAL DISTANCING & LOCKDOWNS
The Washington Post article referenced earlier, (1), claimed it would take America embracing "drastic restrictions" to prevent the worst case scenario from developing.   According to the Washington Post, the worst case scenario included more than 1-million deaths and healthcare professionals dying on top of their dead patients.  While this was the Washington Post's opinion on the importance of 'drastic restrictions' in suppressing the pandemic, it is an opinion that has not been borne out by the facts, at least this far into the pandemic.

Figures 2 and 3 compare excess deaths in the US with those in Italy and Spain (Figure 2) and England/Wales and France (Figure 3).  (9)  Immediately obvious from the Figures is that all the European countries suffered a much more pronounced initial spike in excess deaths than the US did.  However, the US suffered from a 'broader,' longer running period of excess deaths.  This difference is best explained by the fact that the US is a much larger country than the four European countries reviewed  here.  The reduced population density in the US makes it more difficult for a virus to spread as quickly as it could among a more concentrated population.  What Figures 2 and 3 appear to indicate is, after nine-months of the pandemic, the European countries - in spite of much more draconian 'lockdown' regulations - are in no better position relative to the US; at least when 'excess deaths' is the metric.   

As mentioned previously, the experience in the United States is that only two-thirds of excess deaths are attributed to the corona virus, (again see 5).  The most obvious source of the non-covid excess deaths is the lockdowns that have been imposed by government officials to combat the spread of the virus.  The lockdowns have imposed enormous economic havoc on entire industries.  The physical anxiety and mental anguish produced by these economic factors is real, and would appear to be manifested in the non-covid excess death figures.  In addition to the acute problems that have already manifested themselves in the non-covid excess death figures, there will be long-term chronic problems that ultimately emerge from the lockdowns. 

CASES: SARS versus COVID (NIGHT versus DAY)
Whenever a virus breaks out, among the first things that has to be done is to 'define' the clinical criteria that must be satisfied for someone to be considered a victim of the virus.  Among the clinical criteria that might have to be satisfied are subjective complaints, ('I'm tired'), objective findings, (body temperature), and even recent travel to a particular area.  A good example of all these is the case definition that was developed by the CDC for SARS (10);
"Respiratory illness of unknown etiology with onset since February 1, 2003, and the following criteria;

• Documented temperature >100.4 F
• One or more symptoms with respiratory illness (e.g. cough, shortness of breath, difficulty breathing, or radiographic findings of pneumonia or acute respiratory distress syndrome)
• Close contact within 10-days of onset of symptoms with a person under investigation for or suspected of having SARS or travel within 10 days of onset of symptoms to an area with a documented transmissions of SARS as defined by the World Health Organization (WHO)"

Note in particular, how the definition of a SARS case included symptoms and one objective measurement (body temperature).  However, in the case of covid, the WHO does not include any symptoms or objective measurements in its definition of a covid case.  Instead, the WHO defines a covid 'case' as, "A person with laboratory confirmation of COVID-19 infections, irrespective of clinical signs and symptoms."  (11)

RT-PCR TESTING, CYCLE THRESHOLD and DEAD NUCLEOTIDES
The fact that the clinical definition of a corona virus case does not include any symptoms and instead relies exclusively on the laboratory test for corona virus must mean the lab test is extremely accurate, and not subject to misinterpretation.  While that is a reasonable inference to draw from the WHO's covid case definition, nothing could be further from the truth.  In fact, criteria published by the CDC to provide 'laboratory confirmation' of a covid case 'is in complete conflict with the opinion of Dr. Anthony Fauci, the Director of the National Institute of Allergy and Infectious Diseases (NIAID).  Before discussing this conflict, a brief description of the lab test used to determine whether a person has the corona virus is required. 

The test most often used to look for the corona virus is the RT-PCR test.  There are two aspects of this test, 'RT' and 'PCR.'  'RT' is short for 'reverse transcription.'  A somewhat unique aspect of the corona virus is it only contains RNA, not DNA.  Viruses of this type don't replicate by recreating their own DNA.  Instead, these viruses use their RNA to force their hosts to replicate the virus for them.  As part of the 'RT' process, the virus' RNA is converted into DNA.  This must be done because only DNA can be 'cycled' or concentrated, and cycling DNA material is the foundation upon which the PCR test is built.  In the PCR, polymerase chain reaction, portion of the test, the sample is repeatedly cycled by heating and cooling.  This cycling is designed to allow any viral DNA in the now 'reverse transcribed'  sample to grow and replicate.  Growth, if it occurs, will then occur in a geometric manner, with each 'cycle' doubling the amount of viral DNA.  The CDC has recommended forty 'cycles' of concentration as part of its covid testing protocol.  (12)  After 40 cycles of concentration, the original viral DNA will have been concentrated one-trillion times, (2⁴⁰). 

As can be imagined, the description of the RT-PCR test is incredibly basic.  However, this description includes the most important aspect of judging the accuracy of the RT-PCR test as it is currently being administered by the CDC; the 'cycle threshold' of the test.  The cycle threshold refers to the number of times the viral sample is subjected to a concentration cycle.  As mentioned above, the CDC is using a cycle threshold of forty to test for the corona virus.  How does a cycle threshold of forty measure up?  Not very well!  If you don't believe me, take it from Dr. Anthony Fauci himself!  On a 'This Week in Virology' podcast, Dr. Fauci said, (13),
"What is now sort of evolving into a bit a standard, that if you get a cycle threshold of thirty-five or more, that the chances of it being more replication competent are miniscule.  So, that if somebody, and we do, we have patients - and its very frustrating for the patients as well as the for the physicians - somebody comes in and they repeat their PCR and it is like thirty-seven threshold.  But you never, you almost never can culture virus from a thirty-seven threshold cycle.  So, I think, if someone does come in with thirty-seven, thirty-eight, even thirty-six, you gotta say, its just dead nucleotides period."

Dr. Fauci is unequivocal on this point.  Anything above a cycle threshold of 36 shouldn't be considered a positive case for the virus.  Any genetic material that can only be identified at this cycle threshold or beyond is incapable of replicating itself.  Because it can't replicate itself, it is no risk to the person who has this genetic material in their body and even less of a risk to anyone who might be around this person.  Other experts in the field have claimed cycle thresholds much lower than 40 should be used. (14)

• Any test with a cycle threshold above 35 is too sensitive.  "I'm shocked that people would think that 40 could represent a positive."  (Juliette Morrison, virologist University of California at Riverside)
• Dr. Michael Mina, of Harvard's T.H. Chan School of Public Health, would use a cycle threshold of 30 or less.

Recall the exponential or geometric nature of the PCR portion of the test.  The difference between cycle thresholds of 40 and 35 isn't five, its two raised to the fifth power or thirty-two!  The difference between cycle thresholds of 40 and 30 isn't ten, its two raised to the tenth power (1024).  A positive PCR test at a cycle threshold of 40 requires approximately 1000-times less genetic material than one at 30!  Figure 4 demonstrates the problem with using such a high cycle threshold for a positive corona test. (15)  Look at the number of cases soaring but excess deaths do not react to the huge increase in cases.  Indeed, since a slight increase in the beginning of August, excess deaths have fallen well below where they were at the beginning of the pandemic when the case counts were much lower.  

Peter Schmidt
November 29, 2020
Sugar Land, TX

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ENDNOTES
1.  William Wan, Joel Achenback, Carolyn Johnson and Ben Guarino, "Coronavirus Will Radically Alter US," Washington Post, March 19, 2020
https://www.washingtonpost.com/health/2020/03/19/coronavirus-projections-us/

2.  Sheri Fink, "Worst Case Estimates for US Corona Deaths," New York Times, March 13, 2020
https://www.nytimes.com/2020/03/13/us/coronavirus-deaths-estimate.html

3.  Imperial College COVID-19 Response Team, Report 9: Impact of Non-Pharmaceutical Interventions (NPI) to Reduce COVID-19 Mortality and Healthcare Demand, Dr. Neil M. Ferguson, Lead Author.  (See pages 6-7 of the pdf)
https://www.imperial.ac.uk/media/imperial-college/medicine/sph/ide/gida-fellowships/Imperial-College-COVID19-NPI-modelling-16-03-2020.pdf

4.  Charlie Giattino, Hannah Ritchie, Max Roser, Esteban Ortiz-Ospina and Hoe Hasell, "Excess Mortality During the Corona Virus Pandemic (COVIC-19)," Our World in Data, University of Oxford
https://ourworldindata.org/excess-mortality-covid

5.  Steven H. Woolf, MD, Derek A. Chapman, PhD, Roy T. Sabo, PhD; et al, "Excess Deaths From COVID-19 and Other Causes," March-July 2020, October 12, 2020, Journal of the American Medical Association

6.  Morbidity and Mortality Weekly Report, July 17, 2020, Centers for Disease Control, "Characteristics of Persons Who Died with Covid-19 - United States, February 12 - May 18, 2020." 
https://www.cdc.gov/mmwr/volumes/69/wr/mm6928e1.htm

7.  Morbidity and Mortality Weekly Report, October 23, 2020, Centers for Disease Control, "Race, Ethnicity and Age Trends in Persons who Died from COVID-19 - United States, May - August 2020.
https://www.cdc.gov/mmwr/volumes/69/wr/mm6942e1.htm?s_cid=mm6942e1_w

8.  Covid-19 Hospitalization and Death by Age, Centers for Disease Control, Case Data and Surveillance, August 18, 2020;
ttps://www.cdc.gov/coronavirus/2019-ncov/covid-data/investigations-discovery/hospitalization-death-by-age.html

9.  See (4) above for the source data.  There is a considerable 'lag' with the reporting of excess deaths.  It can take some time, months in fact, for deaths to be recorded.  In the interest of ensuring that data is complete, the reporting of excess deaths is held until enough time has passed to ensure completeness. 

10.  Principles of Epidemiology in Public Health Practice, 3rd edition, May 2012, Center for Disease Control
https://www.cdc.gov/csels/dsepd/ss1978/lesson1/section5.html

11.  https://www.who.int/publications/i/item/WHO-2019-nCoV-Surveillance_Case_Definition-2020.1

12.  CDC 2019-Novel Coronavirus (2019-nCoV) Real Time TR-PCR Diagnostic Panel, Effective July 13, 2020 (see page 36 of the linked pdf)
https://www.fda.gov/media/134922/download

13.  This Week in Virology - Covid-19 with Dr. Anthony Fauci (go to the 4:20 mark)
https://www.youtube.com/watch?v=a_Vy6fgaBPE

14.  Aproova Mandavilli, "Your Corona Virus Test is Positive. Maybe It Shouldn't Be," New York Times, August 29, 2020
https://cnas.ucr.edu/media/2020/08/29/your-coronavirus-test-positive-maybe-it-shouldnt-be

15.  Excess data comes from (4), while the seven-day moving data on new cases from, CDC Covid Data Tracker, Trends in Number of Covid Cases and Deaths in the US, Reported to CDC by State, Territory
https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases