Unhysterical COVID-19 Assessment in Rhode Island Requires More Transparency–And Honesty

OPINION

BY ANDREW BOSTOM, M.D.

An April 30, 2020, Providence Journal editorial by my colleague, veteran journalist, and historian Ed Achorn, exposed the hysterical—and factitious—Brown University “modeling” of projected COVID-19 hospitalizations in Rhode Island. These overwrought, cataclysmic projections, mercifully and predictably, never transpired.

Nearly six months later, despite the absence of clear, justifying data, Governor Raimondo amplified the rhetoric of COVID-19 fear once again at her presser on October 14, regurgitating a warning Dr. Birx gave during a recent Rhode Island visit.

“Where we’re seeing the spread occur now, is in private spaces, where we feel comfortable, where we take off our mask, and we invite in our neighbors and friends.” 

A week later, during her October 21 presser, Governor Raimondo advocated for mass asymptomatic COVID-19 testing in Rhode Island and admonished Rhode Islanders to “Consider staying home for Thanksgiving. It’s in the state’s best interest.”

The Governor’s Reopening RI task force simultaneously proclaimed (see Tips for a safer holiday season), “new COVID-19 cases and deaths are steeply rising in Rhode Island,” while issuing a holiday season “home floor plan,” illustrated in all its bizarre intrusiveness below.

Is such alarmism warranted by honest representations of the data on Rhode Island COVID-19 mortality, hospitalization, or test positivity–so-called “infection/case” rates? Simply put, no. The current favorable reality is being cynically obscured by fearmongering manipulation of data in the public domain (i.e., “Rhode Island COVID-19 Response Data”) and lack of transparency regarding other potentially-reassuring data that are not being made available to the public. Data already in the public domain, for example, puts the lie to the  Reopening RI task force’s recent contention: “new COVID-19 cases and deaths are steeply rising in Rhode Island.”

COVID-19 mortality per day in Rhode Island crested between 4/4/20 and 5/2/20 at 24 deaths on each of those days. The interval from 5/20/20 to 6/4/20 was marked by a precipitous decline in daily deaths from 22 on 5/20 to 12 on 6/4, and there have been only seven days between 6/4 and 10/21 where daily deaths exceeded 5. [Full Excel file: https://www.andrewbostom.org/wp-content/uploads/2020/10/ri-c19-deaths-by-dod.xlsx]

The daily census for Rhode Island COVID-19 overall, and specifically intensive care unit (ICU) hospitalizations, peaked at 377 on 4/28/20 and 91, on 5/2/20, respectively. Total COVID-19 hospitalizations have remained below 150 since 6/8/20, with ICU hospitalizations holding below 50 after 5/25/20.

Moreover, while COVID-19 ICU hospitalizations (27) comprised 17.2% of total hospitalizations (157) on 6/8/20, ICU hospitalizations were only 9.7% of total COVID-19 hospitalizations on 10/14/20, the maximum daily census after 6/8, i.e., 14 ICU/145 total hospitalizations. [Full Excel file: https://www.andrewbostom.org/wp-content/uploads/2020/10/RI-Current-Hosps-and-ICU-Hosps-3.19_10.20.20.xlsx]

The percentage of positive COVID-19 tests in Rhode Island dropped steeply from 11.4% on 5/2/20 to 2.1% on 6/20/20. COVID-19 positivity was 2.0% on both 6/27/20 and 10/20/20, while there were six consecutive weeks during which the percent positive was above 2.0% from 7/18/20 to 8/22/20, reaching a maximum of 2.9% the week ending 8/1/20, before returning to ≤ 2.0% between 8/29/20 and 10/10/20. [Full Excel file: https://www.andrewbostom.org/wp-content/uploads/2020/10/RI-testing-data-5.2_10.10.10.xlsx]

Despite the dramatic, sustained fall in Rhode Island’s COVID-19 deaths since the peak in April/May, the demography of these deaths has remained constant throughout. As of April 23-24, 2020, 76% of the state’s then ~190 deaths occurred in nursing homes or assisted living facilities. Mortality data from October 21, 2020—6-months later—indicated that percentage was 78% (i.e., 913/1169) of total deaths. A more granular mortality breakdown by age reveals the overwhelming preponderance of COVID-19 deaths in the elderly and the relative paucity of deaths among Rhode Island’s younger demographic: 59% of deaths are in those ≥ 80 years old—just above the state’s mean life expectancy of 79.9 years—including 27% among persons ≥ 90 years old, and zero deaths in anyone < 30 years old.

I constructed the graphical trend content displayed in the above charts from raw data available at the R.I. Department of Health COVID-19 data hub, specifically here. It is fiendishly disingenuous that R.I. public health officials—under Governor Raimondo’s aegis— omitted such encouraging graphics, in lieu of ginning up unwarranted COVID-19 fears to cajole Rhode Islanders into severely (and freakishly) limiting cherished, private family gatherings during the holiday season. While the data in the above charts are at least available if one seeks them, other equally significant data the state collects at taxpayer expense, germane to COVID-19 testing, hospitalizations, and deaths, remain entirely concealed from requisite public scrutiny. This compounding lack of transparency must be rectified immediately.

The state of Rhode Island does not presently provide the following critical data pertaining to COVID-19 testing, hospitalizations, and deaths, respectively:

—The cycle threshold (“Ct”; explained below) at which each COVID-19 test becomes “positive,” hence defining whether a positive test defines a “case” even in the absence of any symptoms, as determined by the gold standard COVID-19 testing method, “reverse transcriptase polymerase chain reaction (rtPCR)”

—The number of patients “hospitalized for COVID-19” who also have any combination of pneumonia, acute bronchitis, lower respiratory infection, or acute respiratory distress syndrome, relative to all “COVID-19 hospitalizations”

—A de-identified analysis (as conducted by Florida; see below) of all COVID-19 death certificates in R.I.

What is the cycle threshold (Ct), and why is it essential that this COVID-19 testing data, whenever available, be made accessible to all Rhode Islanders? The rtPCR test method amplifies genetic sequences (i.e., nucleic acids from the virus’ core RNA [ribonucleic acid]) obtained in samples, typically, from nasopharyngeal swabs or saliva. This amplification of viral nucleic acid sequences is measured by the cycle threshold, or number of doubling cycles required to get enough viral material to detect, a proxy for the total amount of live virus present, or “viral load.” An rtPCR COVID-19 assay system developed at the Harvard University/ Massachusetts Institute of Technology Broad Institute, the entity that currently determines COVID-19 “positivity” at 108 northeastern universities (including R.I.’s major colleges) described this exponential relationship:

“…the Ct values correlated strongly with the logarithm of (covid-19) RNA concentration (R-squared > 0.99; indicating a very strong correlation), with the observed range from Ct =12 cycles to Ct = 38 cycles corresponding to viral loads ranging from ~1.9 billion copies/mL to (a mere!) 8 copies/mL, respectively (i.e., an ~250 million-fold difference!).”

Ct values from upper respiratory samples (nasopharyngeal and saliva specimens), symptom onset in relation to test date (STT), and the ability to culture live virus, are strongly correlated. Lower Cts indicate that less  amplification is required, and shorter STTs indicate that a patient’s infectious potential is greater. Additional validating clinical data suggest lower Cts—and hence larger viral loads—are associated with higher COVID-19 mortality when patients are hospitalized for symptomatic COVID-19 pneumonia and/or other manifestations of being heavily infected by the virusConversely, there is no tenable evidence that asymptomatic persons with “positive” COVID-19 rtPCR tests at Cts >30—particularly, K-12, or college age students—are at risk for serious COVID-19 infections themselves, nor that they pose a serious risk of infectious spread to others.

Why is it also imperative that R.I. provide granular data to the public on COVID-19 hospitalizations for acute clinical lung illnesses, not merely total COVID-19 illnesses? A longitudinal assessment of COVID-19 admissions in the U.K. revealed “a clear change in the admission profile,” punctuated by declining numbers of those admitted with “true acute COVID-19 disease.” The investigators further observed“admission figures appeared to be sustained by patients miscoded as acute COVID-19. These included patients with a historic diagnosis of COVID-19 readmitted with an unrelated condition… or asymptomatic patients with an incidental finding of SARS-CoV-2 (COVID-19) on naso-pharyngeal screening.” They concluded“the number of incidental new diagnoses persisted beyond the drop in acute admissions. This is likely due to an increase in screening of asymptomatic patients.”

Lastly, why must R.I. conduct an audit of the state’s COVID-19 death certificates and publicize the findings? A COVID-19 death certificate investigation by the Florida House of Representatives found that “nearly 60% [8,058/13.920] of the records classified by Florida’s Department of Health,” had “errors” or were “recorded in a manner inconsistent with state and national guidance.” The Florida House investigators also provided evidence that ~10% [1,256] of these alleged COVID-19 deaths were completely misclassified. My own analysis concluded that this latter ~10% estimate was far too conservative, and furthermore, the classification reflected compliance with the Centers For Disease Control and Prevention’s April, 2020 COVID-19 death certificate coding guidelines, which destroyed the logical firewall between Part 1 “specific cause” of, and Part 2 “contribution(s)” to, individual deaths. Thus, to these 1,256 records where COVID-19 is not even listed as the final cause of death, one could add the 175 listing non-CoVID-19 immediate and underlying causes, 1,345 occurring in hospice care, and the [3,697-246=] 3451 that somehow classified COVID-19, alone, as both the immediate and underlying cause of death despite acknowledging contributing co-morbidities or “conditions.” This aggregate mortality total indicates, plausibly, that up to 45% (6,227/13,920) of Florida’s death-certificate-recorded “COVID-19 deaths” may not merit that classification.

Accordingly, the following three simple bar charts of frequencies/percentages (called “histograms”) must be added to the existing charts at the state’s Dept of Health COVID-19 website, for public display:

—A 5-column bar chart for the frequencies/percentages of the cycle thresholds (Cts) at which COVID-19 PCR test “positives” occurred for as many of the positive tests as these Ct data are available, using the following cut points for the Ct frequencies/percentages:  <=20; 21-25; 26-30; 31-35; >35

—The same Ct display, separately, for the PCR positive tests in K-12 schools (listed as 249 “positives,” per 10/17 update) and R.I.’s major universities and colleges (for example, 433 “positives” at the University of R.I.’s dashboard as of 10/25/20)

—A 2-column bar chart for the frequencies/percentages of all COVID-19 hospital admissions between September 20 and October 20, 2020 (and going forward by week, etc.) under specific acute respiratory illness [ICD] codes, pooling together pneumonia [J12.9], acute bronchitis [J20.8], lower respiratory infection [J22], and acute respiratory distress syndrome [U07.1], VERSUS total COVID-19 admissions [any U07.1], during that period

In addition, consistent with the death certificate investigation and public report issued by the Florida House of Representatives, R.I.’s House must conduct an equivalent analysis of death certificates for all COVID-19 deaths in the state and make the findings public.

A peer-reviewed global assessment of COVID-19 mortality, published 10/14/20 by the World Health Organization, concluded that the COVID-19 infection/fatality ratio—(COVID-19 deaths)/(all COVID-19 infections, including asymptomatic infections)—for those under 70 years old was 0.05%, 5 deaths per 10,000 infected, comparable to seasonal influenza in that vast age bracket. Bearing those data in mind, Harvard University infectious diseases epidemiologist Dr. Martin Kuldorff and his colleague, Stanford University infectious diseases epidemiologist, Jay Bhattacharya, lamented on 10/23/20 that “…current lockdown policy—asks children and young adults—who face more medical and psychological risk from the lockdowns than from Covid infection—to accept this harm in the false hope that this sacrifice will protect the vulnerable people.”

Now is not the time to add another chamber to the Rhode Island rabbit hole we are hunkered down within, rather witlessly, and further delay complete re-opening. Such behavior sacrifices our basic freedoms and spiritual, physical, and economic health—while doing nothing to alter the ultimate trajectory of the COVID-19 outbreak. We are going to have to continue living with covid-19 in our midst. To do so rationally, without ghoulishly stoking panic, requires complete transparency—and honesty—from Rhode Island governmental and public health officials.

Updated COVID-19 testing results through 10/24/20:

Excel data file and graphic

RI C19 pos update thru 10.24

Andrew Bostom is an associate professor of family medicine at Brown University and a trained clinician, epidemiologist, and clinical trialist.