COVID-19 Data Collection, Comorbidity & Federal Law: A Historical Retrospective

Abstract

According to the Centers for Disease Control and Prevention (CDC) on August 23, 2020,
“For 6% of the deaths, COVID-19 was the only cause mentioned. For deaths with conditions
or causes in addition to COVID-19 , on average, there were 2.6 additional conditions or
causes per death.”[1] For a nation tormented by restrictive public health policies mandated for
healthy individuals and small businesses, this is the most important statistical revelation of
this crisis. This revelation significantly impacts the published fatalities count due to COVID-19.
More importantly, it exposes major problems with the process by which the CDC was able
to generate inaccurate data during a crisis. The CDC has advocated for social isolation,
social distancing, and personal protective equipment use as primary mitigation strategies in
response to the COVID-19 crisis, while simultaneously refusing to acknowledge the promise
of inexpensive pharmaceutical and natural treatments. These mitigation strategies were
promoted largely in response to projection model fatality forecasts that have proven to be
substantially inaccurate. Further investigation into the legality of the methods used to create
these strategies raised additional concerns and questions. Why would the CDC decide
against using a system of data collection & reporting they authored, and which has been
in use nationwide for 17 years without incident, in favor of an untested & unproven system
exclusively for COVID-19 without discussion and peer-review? Did the CDC’s decision to
abandon a known and proven effective system also breach several federal laws that ensure
data accuracy and integrity? Did the CDC knowingly alter rules for reporting cause of death in
the presence of comorbidity exclusively for COVID-19? If so, why?

Full text

Science, Public Health Policy,
and The Law
Volume 2:4-22
October 12, 2020
An Institute for Pure
and Applied Knowledge (IPAK)
Public Health Policy
Initiative (PHPI)
COVID-19 Data Collection, Comorbidity & Federal
Law: A Historical Retrospective
Henry Ealy
∗
,
†
, Michael McEvoy
‡§
, Daniel Chong , John Nowicki , Monica Sava
¶
, Sandeep Gupta
k
, David White ∗∗
, James Jordan , Daniel Simon ††
, Paul Anderson ‡‡
Abstract
According to the Centers for Disease Control and Prevention (CDC) on August 23, 2020,
“For 6% of the deaths,
COVID-19
was the only cause mentioned. For deaths with conditions
or causes in addition to
COVID-19
, on average, there were 2.6 additional conditions or
causes per death.”[
1
] For a nation tormented by restrictive public health policies mandated for
healthy individuals and small businesses, this is the most important statistical revelation of
this crisis. This revelation significantly impacts the published fatalities count due to
COVID-19
.
More importantly, it exposes major problems with the process by which the CDC was able
to generate inaccurate data during a crisis. The CDC has advocated for social isolation,
social distancing, and personal protective equipment use as primary mitigation strategies in
response to the
COVID-19
crisis, while simultaneously refusing to acknowledge the promise
of inexpensive pharmaceutical and natural treatments. These mitigation strategies were
promoted largely in response to projection model fatality forecasts that have proven to be
substantially inaccurate. Further investigation into the legality of the methods used to create
these strategies raised additional concerns and questions. Why would the CDC decide
against using a system of data collection & reporting they authored, and which has been
in use nationwide for 17 years without incident, in favor of an untested & unproven system
exclusively for
COVID-19
without discussion and peer-review? Did the CDC’s decision to
abandon a known and proven effective system also breach several federal laws that ensure
data accuracy and integrity? Did the CDC knowingly alter rules for reporting cause of death in
the presence of comorbidity exclusively for COVID-19? If so, why?
continued on next page
Keywords
COVID-19 , SARS-COV-2 , comorbidity, fatality, impact, regulation
∗Energetic Health Institute
†Contact COVIDResearchTeam@protonmail.com
‡Metabolic Healing Institute
§TrueReport Nutrigenomics Research Institute
¶University of Maryland
k
Australian College of Nutritional & Environmental
Medicine, Royal Australian College of General Practition-
ers. Lotus Institute of Holistic Health
∗∗Climate Change Truth
††Beacon of Hope
‡‡Anderson Medical Group
1

Sci, Pub Health Pol, & Law COVID19 Comorbidity & Federal Law - October 12, 2020
Contents
1Introduction 2
2COVID-19 Data Historical Timeline 2
3Did the CDC Violate Federal Law? 6
3.1
Basis for Allegations That the CDC Violated
the Law . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
4The CDC Actions Violated Data Quality, Ob-
jectivity, Utility, and Integrity Requirements
10
5How Aware Was the CDC of Their Respon-
sibility to Be In Full Compliance With IQA &
PRA? 15
6The Impact of Potential PRA & IQA Viola-
tions Upon the Current COVID-19 Data 17
7COVID-19 Fatality Data Using 2003 CDC Pub-
lished Guidelines 17
8Implications for Public Health Policy 19
9Conclusions 19
10 Author Statements 21
References 21
11 State & Territory Health Departments 23
Abstract ( Continued from page 1 )
This historical retrospective will provide a
timeline summary of events to help the reader
orient themselves to many aspects of the cri-
sis previously unknown and will discuss the
significance of the March 24, 2020
COVID-
19 Alert No. 2
that had a dramatic impact
upon cause of death reporting numbers.
Supportive data comparisons suggest the ex-
isting
COVID-19
fatality data, which has
been so influential upon public policy, may
be substantially compromised regarding ac-
curacy and integrity, and illegal under exist-
ing federal laws. If the fatality data being
presented by the CDC is illegally inflated,
then all public health policies based upon
them would be immediately null and void.
1. Introduction
All federal agencies, including the Centers for Dis-
ease Control and Prevention (CDC), are lawfully
required to comply with the Paperwork Reduction
Act (PRA) and the Information Quality Act (IQA).
Data being collected, analyzed, and published by
any federal agency is required to meet the highest
standards for accuracy, quality, objectivity, utility,
and integrity as defined by the PRA, IQA, as well as
additional guidelines issued by the Office of Man-
agement and Budget (OMB).[2][3][4][5][6]
The key to initiating legal regulatory oversight
of all proposed changes to data collection, publica-
tion, and analysis is the Federal Register. Each Fed-
eral agency is required to submit a formal change
proposal to the Federal Register before enacting
their proposed changes. By submitting a change
proposal to the Federal Register, federal agencies
open the minimum 60-day public comment and
peer-review process. Additionally, it is the “change
proposal submission” to the Federal Register that
alerts the OMB that legal oversight of the process
has been initiated. Federal agencies that make
changes to how they collect, publish, and analyze
data without alerting the Federal Register and OMB
as a result, are in violation of federal law.
The CDC published guidelines on March 24,
2020 that substantially altered how cause of death is
recorded exclusively for COVID-19. This change
was enacted apparently without public opportunity
for comment or peer-review. As a result, a capri-
cious alteration to data collection has compromised
the accuracy, quality, objectivity, utility, and in-
tegrity of their published data, leading to a signifi-
cant increase in
COVID-19
fatalities. This decision
by the CDC may have subverted the legal oversight
of the OMB as Congressionally authorized by the
PRA & IQA as well.[7][8]
2. COVID-19 Data Historical
Timeline
A historical timeline of events is presented relative
to the PRA, IQA, cause of death reporting, and
how the
COVID-19
crisis has unfolded as a result.
Please note that all data, including statistical pro-
2

Sci, Pub Health Pol, & Law COVID19 Comorbidity & Federal Law - October 12, 2020
jections produced by any entity outside of federal
regulatory law, must go through strict federal proce-
dures for OMB oversight before being used by any
federal agency for any purpose. These regulatory
laws apply to the use of data being published at
the university level, such as the
COVID-19
projec-
tion models developed by the Institute for Health
Metrics Evaluation (IHME) at the University of
Washington. All federal agencies must abide by
the laws in place before they can use external data
from any source to inform the public or develop
legislation or policy.
•December 11, 1980
– Paperwork Reduc-
tion Act (PRA) becomes law (44 U.S.C.
§§
3501–3521, Public Law 96-511, 94 Stat. 2812).
PRA establishes the Office of Information
and Regulatory Affairs (OIRA) under the Of-
fice of Management and Budget (OMB). PRA
authorizes OIRA to establish information col-
lection policies for all federal agencies, in-
cluding the CDC.[2]
•May 22, 1995
– PRA is amended (44 U.S.C.
§§
3501–3521, Public Law 104-13, 109 Stat.
182). PRA amendment confirms that the
OIRA has authority over all data collected
by and shared between federal agencies, in-
cluding the CDC. PRA amendment also af-
firms that OIRA has authority over all data
provided to the public.[3][4]
•October 1, 2002
– Information Quality Act
(IQA) takes effect (Section 515 of the Con-
gressional Consolidated Appropriations Act,
2001 Public Law 106-554). All federal agen-
cies, including the CDC, are required to be in
full compliance with guidelines issued by the
Office of Management and Budget (OMB),
which has been authorized by Congress to
have its OIRA branch enact executive over-
sight for all data collected, analyzed, and pub-
lished by federal agencies.[5][6]
•2003
– CDC publishes Medical Examiners’
and Coroners’ Handbook on Death Registra-
tion and Fetal Death Reporting and Physi-
cians’ Handbook on Medical Certification
of Death. These handbooks would imme-
diately become the nationwide standard illus-
trating exactly how cause of death should be
recorded in cases of comorbidity for all death
certificates. These handbooks have been used
successfully for 17 years without need of
update. They remain in use today for all
causes of death except where involvement of
COVID-19
is suspected or confirmed. When
involvement of
COVID-19
is suspected or
confirmed, the March 24th, 2020
COVID-
19 Alert No. 2
guidelines are used instead.
[7][8]
•August 22, 2005
– The Virology Journal
publishes research demonstrating that hydrox-
ychloroquine,“has strong antiviral effects on
SARS-COV-2
primate cells. These inhibitory
effects are observed when the cells are treated
with the drug either before or after exposure
to the virus, suggesting both prophylactic
and therapeutic advantage.” The research is
acknowledged and lauded by Dr. Anthony
Fauci.[9]
•2014
– Dr. Anthony Fauci authorizes $3.7
million of scientific funding to the Wuhan
Institute of Virology via the National Insti-
tute for Allergy and Infectious Disease (NI-
AID) and National Institutes of Health (NIH)
“for work on gain-of-function research on bat
coronaviruses.”[10]
•2019
– Dr. Anthony Fauci authorizes an addi-
tional $3.7 million of scientific funding to the
EcoHealth Alliance via the NIAID and NIH
for “a second phase of the project” that in-
cluded gain-of-function research on bat coro-
naviruses.[10]
•October 18, 2019
– Johns Hopkins Center
for Health Security hosts Event 201, a high-
level pandemic exercise in New York, NY.
[11]
3

Sci, Pub Health Pol, & Law COVID19 Comorbidity & Federal Law - October 12, 2020
Figure 1. Test Based Strategy vs. Symptom Based Strategy. The impact of using a previously
untested and unproven test-based strategy (Jun 13 to Jul 17) vs the more traditional globally-accepted
symptom-based strategy (Jul 17 – Aug 20). For statistical comparison, 34-day periods of time are used
to
equivocate the analysis. Using a symptom-based strategy, hospitalization counts dropped. As of July 17,
2020, symptoms are required along with a positive test to confirm the COVID-19 diagnosis for
hospitalization, but probable COVID-19 cases can still be added. Using a symptom-based strategy
confirmed safe by the CDC provides a more accurate count of total recoveries for Americans who did not
require medical care. If accuracy in data collection and reporting was a goal, a symptom-based strategy
would be best.[26][27][State & Territory Health Departments]
•November 17, 2019
– China records 1st
known case of COVID-19.[12]
•November 30, 2019
– Deadline passes for
any federal agency to submit 60-day notice
to Federal Register for ‘Proposed Data Col-
lection Submitted For Public Comment and
Recommendations’ that would enable the use
of IHME projection data to inform the public
and enact federal policy.[13]
•January 21, 2020
– CDC confirms 1st
known case of COVID-19 in US.[14]
•January 24, 2020
– Deadline passes for
CDC and/or National Vital Statistics System
(NVSS) to submit 60-day notice to Federal
Register for ‘Proposed Data Collection Sub-
mitted For Public Comment and Recommen-
dations’ that would become known as the
March 24th
COVID-19 Alert No. 2.[13][15]
•January 29, 2020
– Whitehouse Coron-
avirus Task Force is established and included
Dr. Anthony Fauci (NIAID), Dr. Robert
Red
field (CDC), and Derek Kan (OMB).
Primary
data being used to forecast the
situation and
brief the President is sourced from the IHME
in potential violation of the PRA & IQA.[
16
]
•February 14, 2020
– Deadline passes for
CDC to submit 60-day notice to Federal Reg-
ister for ‘Proposed Data Collection Submitted
For Public Comment and Recommendations’
that would become known as their April 14th
adoption of the Council of State and Terri-
torial Epidemiologists (CSTE)
COVID-19
Position Paper. The CSTE is an independent,
privately funded, non-governmental organi-
zation and has no legal approval to provide
data for policy development without adhering
to strict regulatory laws governing the use of
non-governmental data.[13][16]
•March 9, 2020
– CDC alerts American citi-
zens over the age of 60 and with comorbidi-
ties (pre-existing conditions) that they are
likely at a higher risk for fatality if
SARS-
COV-2 virus is contracted.[17]
•March 24, 2020
– In potential violation of
the PRA & IQA, the CDC issues
COVID-19 Alert No. 2
, significantly
altering cause of death reporting
exclusively for
COVID-
4

Sci, Pub Health Pol, & Law COVID19 Comorbidity & Federal Law - October 12, 2020
19
.In doing so, the CDC bypasses federal
oversight by the OIRA.[15][18]
•March 26, 2020 (March 7, 2020 Initial
Pre-Publish Date)
– Imperial College of
London research team, led by Dr. Neil
Ferguson, publishes
COVID-19
predictive
model incorrectly asserting 2.2 million Amer-
icans will die due to
SARS-COV-2
virus
in 2020 if no mitigation strategies are em-
ployed. Dr. Neil Ferguson is on record con-
firming that his research team had shared their
wildly inaccurate projections with the White
House
COVID-19
Task Force approximately
1 week prior to publication. The data projec-
tions shared were neither peer-reviewed, nor
submitted to the Federal Register to initiate
a 60-day public comment period as required
by law. As a result, the OMB was not able to
approve the use of these projections, which
makes their use by any federal agency, for
any reason, illegal. Dr. Neil Ferguson had
previously and severely overestimated fatality
data in earlier predictive models for Bird Flu,
Mad Cow Disease, and Swine Flu.[19][20]
[21]
•April 13, 2020
– US Surgeon General
Jerome Adams confirms that the Whitehouse
COVID-19
Task Force has terminated the
use of IHME Predictive Contagion Models in
favor of actual data collected from each US
State Health Department. [22]
•April 14, 2020
– Dr. John Ioannidis of
Stanford publishes
COVID-19
antibody sero-
prevalence research confirming
SARS-
COV-2
virus had spread much wider than
initially
realized and most people infected
developed
natural, adaptive immunity. This
study ques-
tions the necessity of continued
use of IHME
Predictive Contagion Models.
[23]
•April 14, 2020 – In potential violation of
the PRA & IQA, the CDC adopts the CSTE
COVID-19 Position Paper, significantly
altering standard established medical criteria
for diagnosis, exclusively for
COVID-19
. In
doing so, the CDC bypasses federal oversight
by
the OIRA once again.[16][18]
•April 24, 2020
– National Institutes of
Health (NIH) cancels funding on previously
supported gain-of-function research for bat
coronaviruses. [10]
•June 13, 2020
– CDC initiates PCR test-
based strategy requiring all patients that need
hospitalization for any reason be tested at
time of entry regardless of symptoms. A pa-
tient testing positive is categorized as a new
COVID-19
case and hospitalization. Patients
testing positive are required to be PCR tested
every 24 hours until they have 2 consecu-
tive negative PCR tests at least 24 hours apart.
There are no data collection guidelines within
the CSTE Position Paper adopted by the CDC
on April 14, 2020 to prevent the same patient
being counted multiple times. Additionally,
there are no data collection guidelines pub-
lished separately by the CDC to explicitly pre-
vent the same hospitalized patient from being
inaccurately counted as a new case and hos-
pitalization each time they are tested while
hospitalized.[24]
•June 13 thru July 16, 2020
– Over this 34-
day time period using the CDC test-based
strategy nationwide, current hospitalizations
more than doubled while 678,720 Ameri-
cans recovered, and 21,323 Americans passed
away. [State & Territory Health Departments
]
•July 15, 2020 – Health and Human Services
(HHS) assumes control of COVID-19 data
collection from the CDC. [25]
•July 17, 2020
– After being unable to
clinically prove the existence of one defini-
tive case of asymptomatic transmission, one
5

Sci, Pub Health Pol, & Law COVID19 Comorbidity & Federal Law - October 12, 2020
Figure 2. Confirmed Recoveries vs. Confirmed Fatalities. Based upon data collected from each US
state health department, confirmed recoveries = 5,071,975 while confirmed fatalities = 156,010.
Americans are now 32.5 times more likely to recover from COVID-19 (as of 8.23.2020). [30][State &
Territory Health Departments]
case of definitive reinfection, or a person be-
ing contagious with the
SARS-COV-2
virus
for longer than 10 days following initial
symptom presentation, the CDC no longer
recommends daily testing for hospitalized
patients. The CDC has also reduced the
amount of quarantine time recommended
for definitive o r s uspected e xposure from
14 days to 10 days. Patients can now be
released from the hospital once symptoms
abate. The CDC officially m oves f rom a
PCR test-based strategy to a more traditional
symptom-based strategy of differential diag-
nosis that incorporates corroborative PCR
testing when appropriate.[24][26][27]
•July 17, 2020
– Dr. Sin Hang Lee publishes
Testing
for
SARS-COV-2
in
cellular
compo-
nents
by
routine
nested
RT-PCR
followed
by
DNA
sequencing
confirming concerns that
demonstrate
SARS-COV-2
PCR testing is
50% reliable at best. CDC confirms that, ‘Al-
though replication-competent virus was not
isolated 3 weeks after symptom onset, re-
covered patients can continue to have
SARS-
COV-2
RNA detected in their upper respira-
tory specimens for up to 12 weeks.’[26][28]
•July 17 thru August 20, 2020
– Over this
34-day time period using the CDC symptom-
based strategy nationwide, current hospi-
talizations declined by 15,717 Americans.
While more Americans passed away during
this time period than during the previous 34-
day time period, many of these fatalities can
be attributed to Americans being hospitalized
from June 13th to July 16th and miscatego-
rized as a
COVID-19
case without having
COVID-19
symptoms. Between July 17 and
August 20, 3,656,822 Americans recovered,
and 34,616 Americans passed away. Infec-
tion rate, fatality rate, and recovery rate im-
proved significantly during both time peri-
ods.[State & Territory Health Departments]
•August 23, 2020
– The CDC reports 32,582
total fatalities for New York state. The
New York State Department of Health reports
25,282 for the same day. This is an inflated
discrepancy by the CDC of 7,300 fatalities
that they cannot justify, and another exam-
ple of how the data they are publishing is
compromised.[30][81]
3. Did the CDC Violate Federal
Law?
6

Sci, Pub Health Pol, & Law COVID19 Comorbidity & Federal Law - October 12, 2020
3.1 Basis for Allegations That the CDC Vi-
olated the Law
The CDC’s rules for data collection, published data,
and statistical analyses are legally required to com-
ply with the laws established by the Information
Quality Act (IQA), enacted by Congress in De-
cember 2000 as Section 515 of Public Law 106-
554, which required the Office of Management and
Budget (OMB) to “
provide policy and procedu-
ral guidance to Federal agencies for ensuring
and maximizing the quality, objectivity, utility,
and integrity of information (including statisti-
cal information) disseminates by Federal agen-
cies,
” and the Paperwork Reduction Act (PRA)
which is codified at 44 USC 3501 et seq.[33][34]
The Office of Information and Regulatory Af-
fairs (OIRA) within the Office of Management and
Budget (OMB) is responsible for ensuring each fed-
eral agency is in compliance with the IQA & PRA.
[35][36][37[38]
The process by which any federal agency can
propose changes in data collection, data publishing,
and data analysis to ensure compliance is governed
by 44 USC 3506 (c)(2)(A) which states,
”except as provided under subpara-
graph (B) or section 3507(j), provide
60-day notice in the Federal Register,
and otherwise consult with members of
the public and affected agencies con-
cerning each proposed collection of
information, to solicit comment to—”
and 44 USC 3506 (d)(3),
” provide adequate notice when
initiating, substantially modifying,
or terminating significant informa-
tion dissemination products. . . ;”
Neither of the exceptions is applicable in this
case.
We are concerned that the CDC has violated
federal IQA & PRA law and, in doing so, bypassed
essential oversight by the OMB/OIRA, who are
legally empowered by Congress with ensuring in-
formation compliance for all federal agencies.
Following review of the Federal Register for
proof of the 60-day notice for ‘Proposed Data Col-
lection Submitted For Public Comment and Recom-
mendations’, zero evidence was found demonstrat-
ing that the CDC abided by the laws established by
the IQA & PRA.[39]
All federal agencies are required to submit noti-
fication for data collection, publication, or analysis
to the Federal Register BEFORE gaining approval
from the OMB/OIRA to ensure they are in compli-
ance with the IQA & PRA and therefore, approved
to implement the proposed changes.
Based upon the complete absence of Federal
Register records for ‘Proposed Data Collection Sub-
mitted For Public Comment,’ at no point, did the
CDC inform the OMB/OIRA or allow for 60 days
of public comment in the following unilateral deci-
sions that attempted to bypass Federal oversight.
We allege that the complete absence of the ap-
propriate Federal Register records is evidence that
the CDC knowingly and willingly violated the IQA
& PRA. As a direct consequence of implementing
the two documents below without OMB approval,
there was significant inflation of
COVID-19
case
and fatality data.
1. On March 24th, the National Vital Statis-
tics System (NVSS)
, under the direction of
the CDC, issued ‘
COVID-19 Alert No. 2
’ to all physicians, medical examiners and
coroners as guidelines for making significant
changes as to how cause of death was to be
reported on death certificates exclusively for
COVID-19.[15]
This decision was made despite pre-existing
rules, approved by the OMB, issued by the CDC,
and in use nationwide for at least 17 years with-
out incident. These rules are published as, 2003
CDC’s Medical Examiners’ & Coroners’ Handbook
on Death Registration and Fetal Death Reporting
and the CDC’s Physicians’ Handbook on Medical
Certification of Death.
Considering these handbooks have been ap-
proved by the OMB and in use without incident
for 17 years, there was no justifiable reason for the
CDC to implement these changes, bypass the over-
sight of the OMB, and fail to provide 60-days for
public comment, as they are legally obligated to do.
7

Sci, Pub Health Pol, & Law COVID19 Comorbidity & Federal Law - October 12, 2020
Figure 3. Recovery Rates By Age Compared To Preceding Weeks. Recovery rates and fatality rates
are reciprocal ways of looking at the data available. If a fatality rate is 0.018%, as is the case for the age 0
to 19 demographic on Aug 23, then the reciprocal recovery rate is 99.982%. Based upon this information,
Americans in the age 0 to 19, 20 to 49, and 50 to 69 demographics are at extremely low risk of fatality due
to COVID-19 . Recovery rates rise even higher if the methods for recording cause of death reporting
based upon the March 24, 2020 COVID-19 Alert No. 2 guidelines are proven to have violated the PRA
& IQA.[33][34][State & Territory Health Departments]
By failing to act in accordance with Congress’
clear intent as to how an agency may propose
changes to data collection as codified in 44 USC
3506 (c)(2)(A), there is no record of information
the CDC relied upon to make its decision to change
how deaths are reported.
Previous reports detailed the substantial changes
on how causes of death were forcibly modified by
the CDC through the NVSS, and how together,
both federal agencies inflated t he a ctual number
of
COVID-19
fatalities by approximately 90.2%
through July 12th, 2020.[18]
We believe this deliberate decision by the CDC
and NVSS to deemphasize pre-existing comorbidi-
ties, in favor of emphasizing
COVID-19
as a cause
of death, is in violation of 44 U.S. Code 3504
(e)(1)(b), which states the activities of the Federal
statistical system shall ensure
“the integrity, objec-
tivity, impartiality, utility, and confidentiality of
information collected for statistical purposes.
”
In doing so, the CDC and NVSS have compro-
mised the quality, objectivity, utility, and integrity
of data, and concomitantly usurped the oversight of
the “Authority and Functions of the Director of the
OMB/OIRA”.[40]
2. On April 14th, the CDC adopted a po-
sition paper authored by the Council
of State and Territorial Epidemiologists
(CSTE), a 501c (6) non-profit organiza-
tion
, with the assistance of 4 CDC-employed
subject matter experts (Dr. Susan Gerber,
Dr. Aron J. Hall, Sandra Roush, & Dr. Tom
Shimabukuro). This document was sanc-
tioned by Dr. Robert R. Redfield, Director of
the CDC.[16]
Not only does this appear to be a potential con-
flict of interest, it also bypasses the OMB oversight
for the IQA & PRA, as directed by Congress and is
rife with ex parte communications. Ex parte com-
munications in general violate ethical standards.
By employing a non-governmental organization
(CSTE), free from the oversight of the OMB and the
laws detailed by Congress via the IQA & PRA, the
CDC bypassed the oversight of the OMB Director’s
Information Resources Management policies, plans,
rules, regulations, procedures, and guidelines for
public comment. We allege this is a violation of 44
U.S. Code 3517(a), which requires an agency to pro-
vide interested persons an “
early and meaningful
opportunity to comment.”[41]
This violation has inevitably resulted in
COVID-19
data for cases, hospitalizations, and fa-
talities being artificially elevated, and definitively
compromises prudent decision making at federal
and state executive levels. This includes policy en-
forcement for a public health crisis that may not
have existed had the CDC abided by the laws that
ensure the accuracy of data collection.
8

Sci, Pub Health Pol, & Law COVID19 Comorbidity & Federal Law - October 12, 2020
Figure 4. US Cases By Age Note: Although the age 70+ demographic makes up a small percentage of
cases (12.7%), the age 70+ demographic makes up a disproportionate percentage of hospitalizations and
fatalities. Additionally, roughly 92.5% of the more than 74 million Americans tested have tested
negative for the SARS-COV-2
virus, and at least 89,009 reported cases are unconfirmed because of
inaccuracies of contact
tracing.[30][State & Territory Health Departments]
For example:
•
The CSTE position paper in Section VII es-
tablished rules for
COVID-19
data classifi-
cation and collection that allowed for proba-
ble diagnoses unconfirmed by lab testing, a
test-based strategy for lab testing, and set the
stage for people with no medical licensure to
contact trace and illegally diagnose American
citizens they have never seen.
The latter is a clear violation of nationally recog-
nized state laws prohibiting the practice of medicine
without a license.
•
In Section VII.B, the CSTE position paper
specifically declined to define a method for
ensuring that rules for data collection pre-
vented the same person from being counted
multiple times as new COVID-19 cases.
As a result, people hospitalized with a positive
PCR test could be tested every 24 hours and each
time counted as new
COVID-19
to the complete
absence of basic rules to ensure that this could not
happen.
Upon Investigation:
•
The CDC did not submit a proposal to the
Federal Register for public consideration and
comment regarding their desire to adopt these
unnecessary changes.
•
The CDC did not submit a proposal to the
Federal Register for public consideration and
comment regarding their desire to forgo exist-
ing rules for infectious disease data collection
that has been in use, without incident, for at
least 17 years.
9

Sci, Pub Health Pol, & Law COVID19 Comorbidity & Federal Law - October 12, 2020
Figure 5. US Hospitalizations By Age. Note: The age 70+ demographic makes up the largest
percentage of hospitalizations (43.3%) yet makes up a small percentage of cases (12.7%).[
30
][State &
Territory Health Departments]
In adopting the CSTE position paper, the CDC
violated the clear intent of Congress with respect to
rule making and data collection, failed to create a
record of their decision making, engaged in ex parte
communications with CSTE personnel, and disen-
franchised the public from meaningful participation
in the decision making process. This compromised
the accuracy and integrity of the data collected.
•
The CDC has yet to publish its own unique
Information Quality Statement as mandated
by the IQA and OMB Guidelines. The refer-
enced CDC webpage for Information Quality
is also filled with ”404 – Page Error” links,
which places them further out of compliance
with the OMB/OIRA.[42]
4. The CDC Actions Violated Data
Quality, Objectivity, Utility, and
Integrity Requirements
The Information Quality Act became law through
the U.S. Congress, in Section 515 of the Consolida-
tion Appropriations Act of 2001, which empowered
the OMB to ensure all federal agencies are in com-
pliance with the IQA & PRA. [34]
Section 515 of this act reads:
(a) In General. – The Director of
the Office of Management and Bud-
get shall, by not later than September
30, 2001, and with public and Fed-
eral agency involvement,
issue guide-
lines under sections 3504(d)(1) and
3516 of title 44, United States Code,
that provide policy and procedural
guidance to Federal agencies for en-
suring and maximizing the quality,
objectivity, utility, and integrity of
10

Sci, Pub Health Pol, & Law COVID19 Comorbidity & Federal Law - October 12, 2020
information
(including statistical in-
formation) disseminated by Federal
agencies in fulfillment of the purposes
and provisions of chapter 35 of title
44, United States Code, commonly re-
ferred to as the Paperwork Reduction
Act.
(b) Content of Guidelines. –
The
guidelines under subsection (a) shall
– (1) apply to the sharing by Federal
agencies of, and access to, information
disseminated by Federal agencies; and
(2)
require that each Federal
agency
to which the guidelines apply
–
(A)
issue guidelines ensuring and
maximizing the quality, objectivity,
utility, and integrity of informa-
tion (including statistical informa-
tion) disseminated by the agency
, by
not later than 1 year after the date of
issuance of the guidelines under sub-
section (a). . .
The IQA & PRA are intended to function as
a ‘checks and balances’ system for federal agen-
cies, including the CDC, that disseminate data and
statistics. The enforcement of the IQA & PRA falls
directly under the administrative regulation of the
Executive Branch of Government, specifically the
Office of Management and Budget (OMB), and its
sub-agency Office of Information and Regulatory
Affairs (OIRA).[33][34][35[36][37[38]
From the OMB Guidelines Published Octo-
ber 1, 2001[36]
I. Procedures for Ensuring and
Maximizing the Quality, Objectivity,
Utility, and Integrity of Information
Prior to Dissemination In Government-
wide Guidelines, “quality” is defined
as an encompassing term comprising
utility, objectivity, and integrity.
A. Objectivity and Quality of Infor-
mation
1. As defined in Section IV, be-
low,
“objectivity” is a measure of
whether disseminated information
is accurate, reliable, and unbiased
and whether that information is pre-
sented in an accurate, clear, com-
plete, and unbiased manner.
“Utility” refers to the useful-
ness of the information for the in-
tended audience’s anticipated pur-
poses.
OMB is committed to dissem-
inating reliable and useful informa-
tion.
Before disseminating informa-
tion, OMB staff and officials should
subject such draft information to an
extensive review process including
open public comment.
It is the pri-
mary responsibility of the Division or
Office (hereafter collectively referred
to as “Division”) drafting information
intended for dissemination to pursue
the most knowledgeable and reliable
sources reasonably available to confirm
the objectivity and utility such informa-
tion.
Based upon our investigation of Federal Regis-
ter Records for 2020, there was no formal, transpar-
ent, public review process initiated by the NVSS
or CDC prior to or following the issuance of the
March 24th NVSS
COVID-19 Alert No. 2
that
dramatically altered cause of death reporting exclu-
sively for
COVID-19
. In this regard, we allege
that the CDC and NVSS’s alterations to cause of
death reporting guidelines exclusively for
COVID-19
, violated the IQA & PRA by
compromising data
quality, objectivity, and utility.
Additionally, our investigation into Federal Reg-
ister Records for 2020 revealed that there was no
formal, transparent, public review process initiated
by the CDC prior to or following the adoption of
the April 14th CSTE position paper that dramati-
cally altered what defines a new case exclusively
for
COVID-19
. In this regard, we allege that the
CDC changes to cause of death reporting exclu-
sively for
COVID-19
violated the IQA & PRA by
compromising data quality, objectivity, and utility.
11

Sci, Pub Health Pol, & Law COVID19 Comorbidity & Federal Law - October 12, 2020
Figure 6. US Fatalities By Age. Note: The age 70+ demographic makes up the largest percentage of
fatalities (72.9%). This is alarmingly disproportionate to their relatively small percentage of cases
(12.7%), and thus defines them as a high-risk population. The opposite is true for the age 0 to 19
demographic which makes up a small percentage of fatalities (0.0554%).[30][State & Territory Health
Departments]
By implementing new rules exclusively for
COVID-19
, while denying the public an oppor-
tunity for meaningful participation in the decision
making process and failing to create a record in
which the agency clearly set forth the reasons for
its action, we allege the CDC violated the express
intent of Congress and acted in an arbitrary and
capricious manner.
As a result of these changes, we allege the
CDC compromised the quality, objectivity and
integrity of all COVID-19 data collected to date.
(OMB Guidelines for IQA & PRA Enforce-
ment – Continued)[36]
Sections 6 & 8 are purposefully omitted.
4. The Lead Division should
consider the uses of the information
both the perspective of and the public.
When it is determined that the trans-
parency of information is relevant
for assessing the information’s use-
fulness from the public’s perspec-
tive, the Lead Division should en-
sure that transparency is appropri-
ately addressed.
5.
When the Lead Division de-
termines that the information it
will disseminate is influential scien-
tific, financial, or statistical infor-
mation, extra care should be taken
to include a high degree of trans-
parency about data and methods to
meet the Government-wide Guide-
lines’ requirement for the repro-
ducibility of such information.
In de-
termining the appropriate level of trans-
parency, the Lead Division should con-
sider the types of data that can practi-
cably be subjected to a reproducibility
12

Sci, Pub Health Pol, & Law COVID19 Comorbidity & Federal Law - October 12, 2020
requirement given ethical, feasibility,
and confidentiality constraints. In mak-
ing this determination, the Lead Divi-
sion should hold analytical results to a
higher standard than original data.
7.
The Division responsible for
the dissemination of information
should generally take the following
basic steps to assure the “objectiv-
ity” and “utility”
of the information
to be disseminated:
a. Preparing a draft of the doc-
ument after consulting the necessary
parties, including government and non-
government sources, as appropriate;
b. Determining/assuring accuracy
and completeness of source data;
c. Determining the expected uses
by the government and public;
d. Determining necessary clear-
ance points;
e. Determining where the final de-
cision shall be made;
f. Determining whether peer re-
view would be appropriate and, if nec-
essary, coordinating such review;
g. Obtaining clearances, and
h. Overcoming delays and, if nec-
essary, presenting the matter to higher
authority.
9. The quality control procedures
followed by OMB should be deter-
mined by the nature of the informa-
tion and the manner of its distribu-
tion.
Any information collected by
OMB and subject to the Paperwork
Reduction Act should be collected,
maintained, and used in a man-
ner consistent with Paperwork Re-
duction Act and the OMB informa-
tion quality standards. The OMB
clearance package should demon-
strate that the proposed collection
of information will result in infor-
mation that will be collected, main-
tained, and used in a way consistent
with the Government-wide Guide-
lines and OMB guidelines.
COVID-19
was declared a pandemic on March
11, 2020 by the World Health Organization. As
such, any data gathering related to this illness must
be done with the utmost transparency to ensure the
public and public officials have sound data upon
which to make vitally important decisions.
Yet, the CDC failed to follow the OMB Guide-
lines as required by Congress and, in doing so, vio-
lated the law and also violated the public trust.
(OMB Guidelines for IQA &
PRA Enforcement – Continued)[36]
B. Integrity of Information
1.
”Integrity” refers to the
security of information -protection
of the information from unautho-
rized unanticipated, or uninten-
tional modification -to prevent in-
formation from being compromised
through corruption or falsification.
The CDC compromised data integrity by alter-
ing how cause of death records are reported, and
did so exclusively for
COVID-19
, in the March 24,
2020 NVSS COVID-19 Alert No. 2.
On April 14, 2020, the CDC again compromised
data integrity when it adopted the CSTE position pa-
per and created categories for ‘probable’ cases that
eliminated the medical standards of proof of infec-
tion through positive lab testing. From April 14th to
July 16th, the CDC actively promoted a test-based
strategy for diagnosis, meaning everyone should
be tested regardless of the presence or absence of
symptoms. Additionally, the CSTE position paper
paved the way for unlicensed and medically un-
trained contact tracers to illegally diagnose patients
without any medical examination or confirmatory
lab testing. In fact, they could do so without even
seeing or talking to the patient in question.
13

Sci, Pub Health Pol, & Law COVID19 Comorbidity & Federal Law - October 12, 2020
Figure 7. CDC Conditions Contributing to Deaths involving Coronavirus Disease (COVID-19 )
Data from the CDC shows that only 6% of 161,392 COVID fatalities had no mention of any comorbidity.
This calculates to approximately 9,684 total fatalities in the US directly due to COVID-19 .[1]
14

Sci, Pub Health Pol, & Law COVID19 Comorbidity & Federal Law - October 12, 2020
While the rationale for doing so is speculative
at this point, the reality is that
COVID-19
became
emphasized as a cause of death as frequently as
possible, while comorbidity was simultaneously
deemphasized as causes of death. We reported this
in a previous research article.[18]
By adopting both the March 24, 2020 NVSS
COVID-19 Alert No. 2
and the April 14, 2020
CSTE position paper, the CDC knowingly and will-
fully compromised the integrity of data they col-
lected, published, and analyzed. We allege the CDC
intentionally violated federal law with respect to in-
tegrity of information.
5. How Aware Was the CDC of
Their Responsibility to Be In Full
Compliance With IQA & PRA?
As of August 16, 2020, the Federal Register returns
the following results from their database of federal
documents dating back to 1994, for the following
search terms:
NVSS
– Eighteen documents resulted from the
Federal Register. (Most Recent Dated 2.18.2020)
The Federal Register shows zero federal filings
from the NVSS for ‘Proposed Data Collection Sub-
mitted For Public Comment and Recommendations’
in 2020.
COVID
– A total of 2,006 documents resulted
from the Federal Register. The Federal Register
shows 31 federal filings from the CDC for COVID
and
8 filings from the CDC for ‘Proposed Data
Collection Submitted For Public Comment and
Recommendations’ in 2020. Of these 8 fed-
eral filings, zero reference the March 24th, 2020
NVSS COVID-19 Alert No. 2 or the April 14th,
2020 CDC adoption of the CSTE position pa-
per.
CDC
– A total of 13,124 documents resulted
from the Federal Register. (Most Recent Dated
8.21.2020) The Federal Register shows that 1,429
of these filings were for ‘Notices of Closed Meet-
ings’. 3,904 of the federal filings were for ‘Pro-
posed Data Collection Submitted For Public Com-
ment and Recommendations’.
Of the 3,904 fil-
ings, 120 were made this year. Of the 120 that
were made this year, zero reference the March
24, 2020 NVSS COVID-19 Alert No. 2 or the
April 14, 2020 CDC adoption of the CSTE posi-
tion paper.
CSTE
– 1 document resulted from the Fed-
eral Register unrelated to the CSTE position paper
adopted by the CDC on April 14, 2020. (Most Re-
cent Dated 2/10/2020)
The document was filed by
the CDC in acknowledgement of their organi-
zation being in review by the Office of Manage-
ment and Budget for compliance with the Paper-
work Reduction Act.[42]
IHME
– Zero documents resulted from the
Federal Register.
This demonstrates that the
wildly inaccurate Institute for Health Metrics
and Evaluation (IHME) projection data, used
by the COVID Task Force to influence and jus-
tify executive responses to this crisis, was done
so in violation of the IQA & PRA.
As evidenced by the 120 filings in 2020 alone,
our investigation of the Federal Register confirms
that the CDC was well aware of their legal obliga-
tions to file all intended changes for data collection,
publishing, and analysis with the Federal Register
for oversight by the OMB.
Further, our investigation of the Federal Regis-
ter confirms that, while the CDC has routinely filed
to be in compliance with the IQA & PRA for the
vast majority of their activities, they violated the
law in failing to do so for the March 24th NVSS
COVID-19 Alert No. 2
and the April 14th adop-
tion of the CSTE Position Paper.
Additionally, according to an April 24, 2019
memorandum issued by acting director of the Of-
fice of Management and Budget, Russell T. Vought,
the agency reminded all federal agencies that the
OMB bears the responsibility for the enforcement
of the IQA & PRA which ensure the accuracy of
data by protecting the quality, objectivity, utility,
and integrity of all data collected, published and
analyzed by all federal agencies.[44]
Prudent decision making de-
pends on reliable, high-quality infor-
mation.
Congress has long recognized
15

Sci, Pub Health Pol, & Law COVID19 Comorbidity & Federal Law - October 12, 2020
that federal agencies should make de-
cisions using the best data reasonably
available, and Congress has entrusted
OMB with the statutory role of ensur-
ing that federal agencies collect, use,
and disseminate information that is fit
for its intended purpose. Within OMB,
the Office of Information and Regula-
tory Affairs (OIRA) works with agen-
cies to maintain information quality
standards.
Implementing statutory require-
ments in the IQA, the Guidelines pro-
vide a framework for oversight of the
quality of information disseminated
by the federal government throughout
its lifecycle, which includes creation,
collection, pre-dissemination review,
transparent and reproducible use, and
ultimately correction and disposition.
All federal agencies, including the CDC, are
required to comply with the IQA & PRA and are
required by law (IQA: Section 515 2(a) of the Con-
solidated Appropriations Act of 2001) to issue their
own unique guidelines in order to transparently
demonstrate how their agency is in compliance with
the IQA and the OMB published guidelines for IQA
enforcement. In order to facilitate this, the OMB
Guidelines require each agency to have at least one
webpage dedicated to their own unique Information
Quality Statement (IQS).[36]
Despite the April 24, 2019 OMB Memorandum
issued by Director Vought that gave all federal agen-
cies 90 days to get into full compliance, the CDC
has failed to publish its IQS.[
41
] The CDC webpage
for this is filled with ”404 – Page Error” links and
redirects to the Health & Human Services (HHS)
Information Quality Guidelines rather than their
own unique guidelines, further placing them out of
compliance with the express intent of Congress and
the OMB/OIRA.[42]
Moreover, our research team has found that the
CDC may be in violation of several additional IQA
& PRA laws and the OMB guidelines established
to ensure compliance.
According to the April 24, 2019 memoran-
dum issued by the OMB Director these may
include:[44][45]
•Incompetent pre-dissemination review of
information:
Fitness for Purpose and Pre-
Dissemination Review the IQA requires agen-
cies conduct pre-dissemination review of
their information products. During this re-
view, each agency should consider the appro-
priate level of quality for each of the products
that it disseminates based on the likely use of
that information.
•Incompetent attention to standards of
quality:
OMB guidelines recognize that
”in-
formation quality comes at a cost,” and
”that some government information may
need to meet higher or more specific qual-
ity standards than those that would apply
to other types of government information,
depending on the information’s expected
use.”
•Under Executive Order 12866, federal
agencies that peer review complex models
underlying economically significant regu-
lations are required to obtain inter alia
peer review.
The March 24th NVSS
COVID-19 Alert No. 2
and the April 14th
adoption of the CSTE Position Paper that
shaped all data collection for
COVID-19
were
not independently peer reviewed as
required by this Executive Order. [46]
•Lack of reproducibility of influential infor-
mation
- The guidelines include a ”repro-
ducibility standard” for influential informa-
tion. The purpose of the reproducibility stan-
dard is to increase the credibility of federal
decisions. The standard requires that influ-
ential analyses must be disseminated with
sufficient descriptions of data and methods
to allow them to be reproduced by qualified
third parties who may want to test the sen-
sitivity of agency analyses. This is a higher
standard than simply documenting the char-
16

Sci, Pub Health Pol, & Law COVID19 Comorbidity & Federal Law - October 12, 2020
acteristics of the underlying data, which is
required for all information.
We allege the CDC violated the IQA, PRA,
OMB compliance guidelines, and Executive Or-
der 12866. In doing so, the CDC has fatally com-
promised all
COVID-19
data and adversely im-
pacted federal, state, and local public health poli-
cies regarding
COVID-19
.
As a result of these
far-reaching and adverse impacts, the CDC as
a federal agency MUST be held to the highest
of standards for the assurance of flawless data
quality.
6. The Impact of Potential PRA &
IQA Violations Upon the Current
COVID-19 Data
Data provided for all figures is collected directly
from each US Health Department through August
23, 2020. The data collected is based upon the
CDC’s March 24, 2020
COVID-19 Alert No. 2
guidelines and the CDC’s adoption of the
CSTE’s
Position Paper on April 14, 2020.
7. COVID-19 Fatality Data Using
2003 CDC Published Guidelines
Of all the data collected at state health department
levels, comorbidity data are the most statistically
significant in light of the March 24, 2020
COVID-19 Alert No. 2
guidelines published by
the CDC and the revelation presented at the
beginning of
this historical retrospective, “For 6%
of the deaths,
COVID-19
was the only cause
mentioned. For deaths with conditions or
causes in addition to
COVID-19
, on average,
there were 2.6 additional
conditions or causes per
death.”[1][15]
To understand the significant implications of
these guidelines and how they substantially empha-
sized
COVID-19
as a cause of death, while simul-
taneously deemphasizing comorbidity (pre-existing
conditions) in cause of death records, we encourage
readers to review our previously published refer-
ence [
18
]; If COVID Fatalities Were 90.2% Lower,
How Would You Feel About Schools Reopening?.
Despite the CDC’s March 9, 2020 admission
that the highest risk group of Americans would be
over 60 years of age and have pre-existing condi-
tions, only 7 state health departments are reporting
comorbidity in a manner that can be statistically
analyzed (New York Pennsylvania, Massachusetts,
Georgia, Utah, Oklahoma, Iowa).[17]
Would the 94% of fatalities with at least 1 co-
morbidity have been counted as COVID-19 fa-
talities if the CDC had used the guidelines for
reporting that the nation has been using for 17
years instead of the COVID-19 guidelines issued
on March 24, 2020?
To properly answer this question, it is neces-
sary to compare the unproven March 24
COVID-
19 Alert No. 2
cause of death reporting guidelines
against the 2003 CDC Medical Examiner’s and
Coroner’s Handbook on Death Registration that
has been the proven national standard for 17 years
without incident.
March 24th, 2020 – NVSS COVID-19 Alert
No. 2 [15]
Will
COVID-19
be the underlying
cause? The underlying cause depends
upon what and where conditions are
reported on the death certificate. How-
ever, the rules for coding and selection
of the underlying cause of death are
expected to result in
COVID-19
under-
lying cause more often than not.
Should
COVID-19
be reported on
the death certificate only with a con-
firmed test?
COVID-19
should be re-
ported on the death certificate for all
decedents where the disease caused
or is assumed to have caused or con-
tributed to death. Certifiers should in-
clude as much detail as possible based
on their knowledge of the case, medical
records, laboratory testing, etc. If the
decedent had other chronic conditions
such as COPD or asthma that may have
also contributed, these conditions can
be reported in Part II. (See attached
17

Sci, Pub Health Pol, & Law COVID19 Comorbidity & Federal Law - October 12, 2020
Guidance for Certifying
COVID-19
Deaths)
Recall from the historical timeline presented
earlier that the CDC understood the high-risk de-
mographic would be over 60 years of age with
comorbidities.[
18
] Emphasizing that
COVID-19
be specifically placed in part 1 of the death certifi-
cate while any comorbidities be listed in part 2 is
genuinely concerning.
Changing reporting rules exclusively for
COVID-19
cause of death reporting without no-
tifying the Federal Register, OMB, OIRA, or the
public, and therefore potentially breaching the PRA
& IQA, is even more concerning.
It’s worth noting that Part I of a death certificate
is the immediate cause of death listed in sequen-
tial order from the official c ause on line item (a)
to the underlying causes that contributed to death
in descending order of importance on line item (d),
while Part II is/are the significant conditions NOT
relating to the underlying cause(s) in Part I.
Comorbid conditions have been listed on Part I
of death certificates as causes of death per the CDC
Handbook since 2003 to ensure accurate reporting
can be developed. Comorbidities are seldom placed
in Part II. Part II is typically the section where coro-
ners and medical examiners can list recent infec-
tions as underlying, initiating factors.
Prior to the CDC’s March 24th decision, any co-
morbidities would have been listed in Part I rather
than Part II and initiating factors such as infections
including the
SARS-COV-2
virus, would have been
listed on the last line in Part I or more commonly
in Part II.
The 2003 CDC Medical Examiner’s and
Coroner’s Handbook on Death Registration
[7][8]:
Because statistical data derived
from death certificates can be no more
accurate than the information provided
on the certificate, it is very important
that all persons concerned with the reg-
istration of deaths strive not only for
complete registration, but also for accu-
racy and promptness in reporting these
events.”
The principal responsibility of the
medical examiner or coroner in death
registration is to complete the medical
part of the death certificate. The cause-
of-death section consists of two parts.
Part I is for reporting a chain of events
leading directly to death, with the im-
mediate cause of death (the final dis-
ease, injury, or complication directly
causing death) online
(a) and the underlying cause of
death (the disease or injury that initi-
ated the chain of events [
SARS-COV-
2
in this case] that led directly and in-
evitably to death) on the lowest used
line. Part II is for reporting all other sig-
nificant diseases, conditions, or injuries
that contributed to death, but which did
not result in the underlying cause of
death given in Part I.
Under these 2003 guidelines, the highest
COVID-19
could be listed in the presence of an
established comorbidity would be on the lowest
used line at the bottom of Part I as an initiating fac-
tor or, more correctly, in Part II as an infection that
contributed to death.
However, on March 24, 2020 the CDC elected
to forgo this trusted method of cause of death record-
ing in favor of recording comorbidities in Part 2, so
COVID-19 could be listed exclusively in Part 1.
This has had a significant impact on data collec-
tion accuracy and integrity. It has resulted in the
potential false inflation of
COVID-19
fatality data
and is a potential breach of federal laws governing
information quality.
18

Sci, Pub Health Pol, & Law COVID19 Comorbidity & Federal Law - October 12, 2020
Figure 8. US Fatalities With At Least 1 Comorbidity. Note: 88.6% of fatalities had at least 1
comorbidity, which is below the more official 94% reported by the CDC on Aug 22, 2020.[30][State &
Territory Health Departments]
8. Implications for Public Health
Policy
As a result of state policies based on potentially
compromised data published and promoted by the
CDC, Americans have lost jobs and businesses in
historically unprecedented numbers.
At the peak of the crisis, an estimated 20.5 to 42
million Americans had lost their jobs without hav-
ing any voice in the decision-making process due
to shelter in place mandates issued by every state
with the exceptions of Arkansas, Iowa, Nebraska,
South Dakota, Utah & Wyoming.[30][31]
Anxiety, depression, suicide rates, domestic vi-
olence, and alcoholism have all reportedly risen sig-
nificantly due to the economic hardships brought on
by how state governors decided to exercise their au-
thority in response to the potentially compromised
data published by the CDC.[32]
Tens of thousands of Americans have died
without access to potentially life-saving medica-
tions like hydroxychloroquine or nutrient ther-
apies like intravenous Vitamin C. Couple this
with the tragic reality that so many Americans
passed away alone, without the comfort of their
family members, and the collateral damage of
our one-size fits all policies becomes even more
unpalatable.[47]
All non-COVID related healthcare priorities
have also suffered including elective surgeries,
proper monitoring of medications, and checkups
for the elderly and our children. De-prioritizing all
non-COVID cases created collateral damage that
far outweighs the infective damage of the
SARS-
COV-2
virus. Public health policies that create
more collateral damage while attempting to avoid
an infection with a 99.05% rate of recovery in the
vast majority of citizens must be objectively investi-
gated and critically questioned if the goal of living
in a healthy society is to be realized.
9. Conclusions
Arguing over what the most accurate COVID fatal-
ity count may be is an exercise in futility without
intimate knowledge of case history and accompany-
ing certificates of death, and it is the exact reason
we entrust these determinations to the skill of our
19

Sci, Pub Health Pol, & Law COVID19 Comorbidity & Federal Law - October 12, 2020
Figure 9. COVID-19 Using the March 24 Exclusive Guidelines vs Using the 2003 Guidelines. Had
the CDC used the 2003 guidelines, the total COVID-19 be approximately 16.7 times lower than is
currently being reported. [1][30][State & Territory Health Departments]
20

Sci, Pub Health Pol, & Law COVID19 Comorbidity & Federal Law - October 12, 2020
licensed professionals. With the inclusion of proba-
ble fatalities and significant changes made to how
certificates of death are recorded exclusively for
COVID-19
, scientific objectivity demands that we
acknowledge the data presented is inaccurate.
Federal agencies have a legal obligation to
provide the most accurate data to the public, fel-
low agencies, and policy makers they are advis-
ing, and they have a responsibility to abide by
every federal law.
This responsibility to collect,
analyze, and publish data accurately, transparently,
and with unquestionable integrity increases expo-
nentially during a national crisis.
It is concerning that the CDC may have willfully
failed to collect, analyze, and publish accurate data
used by elected officials to develop public health
policy for a nation in crisis.
Further federal investigation is justified by the
magnitude of the crisis and the collateral damage
generated by policies based upon projection data
that was unproven and never peer reviewed. If the
data being reported was indeed compromised by
the CDC’s perplexing decision to abandon proven
data collection and reporting practices in favor of
untested methods, then all public health policies
based upon these inaccurate data must be reexam-
ined.
10. Author Statements
All authors have contributed and are in full agree-
ment with the facts and positions presented in this
publication. None have declared any conflicts of
interest.
References
[1]
CDC.
Weekly Updates by Select Demo-
graphic and Geographic Characteristics,
Comorbidities
. National Center for Health
Statistics, page Table 3, Aug 2020. CDC.
[2]
United States Congress.
United States Code,
Title 44, Public Printing and Documents,
Chapter 35 Coordination of Federal Infor-
mation Policy, Section 3516 Rules and Reg-
ulations, Public Law 96-511
. United States
Code, Deceber 1980. U. S. Congress.
[3]
United States Congress.
United States Code,
Title 44, Public Printing and Documents,
Chapter 35 Coordination of Federal Infor-
mation Policy, Section 3516 Rules and Reg-
ulations, Public Law 104-13
. United States
Code, May 1995. U. S. Congress.
[4]
United States Congress S.244.
Paperwork
Reduction Act of 1995
. May 1995.
U. S. Congress.
[5]
United States Congress.
Public Law 106-554
Consolidated Appropriations Act, Section
515 . December 2000. FWS.GOV.
[6]
Marshall A Sands S.
Federal Agencies Sub-
ject to Data Quality Act
. Findlaw, March
2008. Findlaw.
[7]
CDC.
Medical Examiners’ and Coroners’
Handbook on Death Registration and Fe-
tal Death Reporting, 2003 Revision
. CDC,
2003. CDC.
[8]
CDC.
Physicians’ Handbook on Medical
Certification of Death, 2003 Revision
. CDC,
2003. CDC.
[9]
Vincent M, Bergeron E, Benjannet S, Erickson
B, Rollin P, Ksiazek T, Seidah N, and Nichol.
Chloroquine is a potent inhibitor of SARS
coronavirus infection and spread
. Virology
Journal, August 2005. PubMed.
[10]
Guterl F.
Dr. Fauci Backed Controversial
Wuhan Lab with U.S. Dollars for Risky
Coronavirus Research
. Newsweek, April
2020. Newsweek.
[11]
Center for Health Security.
Event 201 A
Global Pandemic Exercise
. Johns Hopkins
Center For Health Security, October 2019.
Johns Hopkins .
[12]
Ma J.
Coronavirus: China’s first confirmed
Covid-19 case traced back to November 17
.
South China Morning Post, March 2020. SCM
[13]
National Archives.
Federal Register
. 2020.
Federal Register .
21

Sci, Pub Health Pol, & Law COVID19 Comorbidity & Federal Law - October 12, 2020
[14]
Schumaker E.
1st confirmed c ase of
new coronavirus reported in US: CDC ABC
News, January 2020.
. ABC News, January
2020. ABC News.
[24]
CDC.
Overview of Testing for SARS-CoV-
2 (COVID-19)
.CDC, updted August 2020.
CDC .
[25]
Rodriquez A and Weise E.
Trump adminis-
tration cuts CDC out of data collection on
hospitalized COVID-19 patients The move
has immediate effect
.USAToday, July 2020.
USA Today .
[32]
[33]
22
[15]
Centers for Disease Control & Prevention.
COVID-19 Alert No. 2.
. National Vital Statis-
tics System, March 2020. CDC.
[16]
Turner K, Davidson S, Collins J, Park S, and
Pedati C.
Position Paper - Standardized
surveillance case definition and national no-
tification for 2019 novel coronavirus disease
(COVID-19); Interim-20-ID-01.
. Council
of State & Territorial Epidemiologists,, April
2020. CSTE.ORG.
[17]
Kopecki D, Higgins-Dunn N, and Miller H.
CDC tells people over 60 or who have
chronic illnesses like diabetes to stock up on
goods and buckle down for a lengthy stay at
home . CNBC, March 2020. CNBC.
[18]
Ealy H, McEvoy M, Sava M, Gupta S, Chong
D, White D, Nowicki J, and Anderson P.
If COVID Fatalities Were 90.2Schools Re-
opening?
. Children’s Health Defense, July
2020. Childrens Health Defense.
[19]
Ferguson N and Ghani A.
The Global Impact
of COVID-19 and Strategies for Mitigation
and Suppression
. Imperial College of London,
March 2020. Imperial College.
[20]
Onge P The Flawed COVID-19 Model
That
Locked Down Canada. Montreal Economic
Institute, June 2020.
MEI.
[21]
Fink Sheri.
White House Takes New Line Af-
ter Dire Report on Death
. New York Times,
March 2020. New York Times.
[22]
Spiering C.
Surgeon General: We’re Work-
ing with Real Coronavirus Data Now, Not
Models . Breitbart, April 2020. Breitbart.
[23]
Ioannidis J and Bhattacharya J.
COVID-19
Antibody Seroprevalence in Santa Clara
County, California
. medrxiv preprint server,
April 2020. MEDRXIV.ORG .
[31]
Kochhas R. Unemployment rose higher in
three months of COVID-19 than it did in
two years of the Great Recession. Pew
Research Center, June 2020. Pew Research
Wilson T. UW Health research study
results show significant and alarming
mental health impacts on school closures
and sport cancellations. Wisconsin Sports
Network, August 2020. WS Network
United States Code. Title 44, Public Printing
and Documents, Chapter 35 Coordination
of Federal Information Policy, Section 3516
Rules and Regulations. Office of the Law
Revision Counsel, August 2020. USC.
[26]
[27]
[28]
[29]
[30]
CDC. Duration of Isolation & Precautions
for Adults with COVID-19. CDC, July
2020, Updated August 2020. CDC.
CDC. Discontinuation of Isolation for Per-
sons with COVID-19 Not in Healthcare
Settings. July 2020. CDC.
Lee S.
Testing for SARS-CoV-2 in cellu-
lar components by routine nested RT -PCR
followed by DNA sequencing
. International
Journal of Geriatrics and Rehabilitation, July
2020. Geriatrics.
Ortiz J and Hauck G.
Coronavirus in the
US: How all 50 states are responding – and
why eight still refuse to issue stay-at-home
orders. USAToday, 2020. USAToday.
CDC. Centers for Disease Control & Pre-
vention : Cases in the U.S. 2020. CDC.
[34] Congress United States. Public Law106-554
Consolidated Appropriations Act, Section
515. December 2000. U.S. Congress.

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Sci, Pub Health Pol, & Law COVID19 Comorbidity & Federal Law - October 12, 2020
[35] Office of Management and Budget,
Paperwork Reduction Act Compliance.
OMB.
[36] Office of Management and Budget, Office of
Management and Budget Information
Quality Guidelines, October 2002.
OMB.
[37] Office of Management and Budget, Code of
Federal Regulations Regarding Information,
Title 5, Volume 3, Part 1320, Controlling
Paperwork Burdens on the Public, January
2010. OMB.
[38] Office of Management and Budget,
Paperwork Reduction Act Guide, Version
2.0, April 2011. OMB.
[39] National Archives. Federal Register. 2020.
Federal Register.
[40] United States Code. Title 44, Public Printing
and Documents, Chapter 35 Coordination of
Federal Information Policy, Section 3504,
Authority and Functions of Director.
Office of the Law Revision Counsel,
August 2020.
USC.
[41] United States Code. Title 44, Public Printing
and Documents, Chapter 35 Coordination of
Federal Information Policy, Section 3517,
Consultations with Other Agencies and the
Public. Office of the Law Revision, August
2020. law.cornell.edu.
[42]
Centers for Disease Control and
Prevention, Information Quality Support,
October 2017. CDC.
[43]
Jeffrey M. Zirger. Federal Register, vol. 85,
no. 27, 10, Agency Forms Undergoing Pa-
perwork Reduction Act Review, page 7557,
February 2020. Federal Register.
[44] Office of Management and Budget,
Memorandum For The Heads Of Executive
Departments And Agencies, Improving
Implementation of the Information Quality
[45] Office of Management and Budget.
Statistical Programs & Standards, 2020.