Professional Documents
Culture Documents
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?
∗
Energetic Health Institute
†
Contact COVIDResearchTeam@protonmail.com Medicine, Royal Australian College of General Practition-
‡
Metabolic Healing Institute ers. Lotus Institute of Holistic Health
∗∗
§
TrueReport Nutrigenomics Research Institute Climate Change Truth
††
¶
University of Maryland Beacon of Hope
‡‡
k
Australian College of Nutritional & Environmental Anderson Medical Group
1
Sci, Pub Health Pol, & Law COVID19 Comorbidity & Federal Law - October 12, 2020
Contents 1. Introduction
All federal agencies, including the Centers for Dis-
1 Introduction 2
ease Control and Prevention (CDC), are lawfully
2 COVID-19 Data Historical Timeline 2 required to comply with the Paperwork Reduction
3 Did the CDC Violate Federal Law? 6 Act (PRA) and the Information Quality Act (IQA).
3.1 Basis for Allegations That the CDC Violated Data being collected, analyzed, and published by
the Law . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 any federal agency is required to meet the highest
standards for accuracy, quality, objectivity, utility,
4 The CDC Actions Violated Data Quality, Ob-
and integrity as defined by the PRA, IQA, as well as
jectivity, Utility, and Integrity Requirements
additional guidelines issued by the Office of Man-
10
agement and Budget (OMB).[2][3][4][5][6]
5 How Aware Was the CDC of Their Respon- The key to initiating legal regulatory oversight
sibility to Be In Full Compliance With IQA & of all proposed changes to data collection, publica-
PRA? 15
tion, and analysis is the Federal Register. Each Fed-
6 The Impact of Potential PRA & IQA Viola- eral agency is required to submit a formal change
tions Upon the Current COVID-19 Data 17 proposal to the Federal Register before enacting
7 COVID-19 Fatality Data Using 2003 CDC Pub- their proposed changes. By submitting a change
lished Guidelines 17 proposal to the Federal Register, federal agencies
8 Implications for Public Health Policy 19 open the minimum 60-day public comment and
peer-review process. Additionally, it is the “change
9 Conclusions 19
proposal submission” to the Federal Register that
10 Author Statements 21 alerts the OMB that legal oversight of the process
References 21 has been initiated. Federal agencies that make
11 State & Territory Health Departments 23
changes to how they collect, publish, and analyze
data without alerting the Federal Register and OMB
Abstract ( Continued from page 1 ) as a result, are in violation of federal law.
The CDC published guidelines on March 24,
This historical retrospective will provide a 2020 that substantially altered how cause of death is
timeline summary of events to help the reader recorded exclusively for COVID-19. This change
orient themselves to many aspects of the cri- was enacted apparently without public opportunity
sis previously unknown and will discuss the for comment or peer-review. As a result, a capri-
significance of the March 24, 2020 COVID- cious alteration to data collection has compromised
19 Alert No. 2 that had a dramatic impact the accuracy, quality, objectivity, utility, and in-
upon cause of death reporting numbers. tegrity of their published data, leading to a signifi-
Supportive data comparisons suggest the ex- cant increase in COVID-19 fatalities. This decision
isting COVID-19 fatality data, which has by the CDC may have subverted the legal oversight
been so influential upon public policy, may of the OMB as Congressionally authorized by the
be substantially compromised regarding ac- PRA & IQA as well.[7][8]
curacy and integrity, and illegal under exist-
ing federal laws. If the fatality data being 2. COVID-19 Data Historical
presented by the CDC is illegally inflated, Timeline
then all public health policies based upon
A historical timeline of events is presented relative
them would be immediately null and void.
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 of Death. These handbooks would imme-
regulatory law, must go through strict federal proce- diately become the nationwide standard illus-
dures for OMB oversight before being used by any trating exactly how cause of death should be
federal agency for any purpose. These regulatory recorded in cases of comorbidity for all death
laws apply to the use of data being published at certificates. These handbooks have been used
the university level, such as the COVID-19 projec- successfully for 17 years without need of
tion models developed by the Institute for Health update. They remain in use today for all
Metrics Evaluation (IHME) at the University of causes of death except where involvement of
Washington. All federal agencies must abide by COVID-19 is suspected or confirmed. When
the laws in place before they can use external data involvement of COVID-19 is suspected or
from any source to inform the public or develop confirmed, the March 24th, 2020 COVID-
legislation or policy. 19 Alert No. 2 guidelines are used instead.
[7][8]
• December 11, 1980 – Paperwork Reduc-
tion Act (PRA) becomes law (44 U.S.C. §§ • August 22, 2005 – The Virology Journal
3501–3521, Public Law 96-511, 94 Stat. 2812). publishes research demonstrating that hydrox-
PRA establishes the Office of Information ychloroquine,“has strong antiviral effects on
and Regulatory Affairs (OIRA) under the Of- SARS-COV-2 primate cells. These inhibitory
fice of Management and Budget (OMB). PRA effects are observed when the cells are treated
authorizes OIRA to establish information col- with the drug either before or after exposure
lection policies for all federal agencies, in- to the virus, suggesting both prophylactic
cluding the CDC.[2] and therapeutic advantage.” The research is
• May 22, 1995 – PRA is amended (44 U.S.C. acknowledged and lauded by Dr. Anthony
§§ 3501–3521, Public Law 104-13, 109 Stat. Fauci.[9]
182). PRA amendment confirms that the • 2014 – Dr. Anthony Fauci authorizes $3.7
OIRA has authority over all data collected million of scientific funding to the Wuhan
by and shared between federal agencies, in- Institute of Virology via the National Insti-
cluding the CDC. PRA amendment also af- tute for Allergy and Infectious Disease (NI-
firms that OIRA has authority over all data AID) and National Institutes of Health (NIH)
provided to the public.[3][4] “for work on gain-of-function research on bat
• October 1, 2002 – Information Quality Act coronaviruses.”[10]
(IQA) takes effect (Section 515 of the Con-
• 2019 – Dr. Anthony Fauci authorizes an addi-
gressional Consolidated Appropriations Act,
tional $3.7 million of scientific funding to the
2001 Public Law 106-554). All federal agen-
EcoHealth Alliance via the NIAID and NIH
cies, including the CDC, are required to be in
for “a second phase of the project” that in-
full compliance with guidelines issued by the
cluded gain-of-function research on bat coro-
Office of Management and Budget (OMB),
naviruses.[10]
which has been authorized by Congress to
have its OIRA branch enact executive over- • October 18, 2019 – Johns Hopkins Center
sight for all data collected, analyzed, and pub- for Health Security hosts Event 201, a high-
lished by federal agencies.[5][6] level pandemic exercise in New York, NY.
[11]
• 2003 – CDC publishes Medical Examiners’
and Coroners’ Handbook on Death Registra-
tion and Fetal Death Reporting and Physi-
cians’ Handbook on Medical Certification
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 brief the President is sourced from the IHME
known case of COVID-19.[12] in potential violation of the PRA & IQA.[16]
• November 30, 2019 – Deadline passes for • February 14, 2020 – Deadline passes for
any federal agency to submit 60-day notice CDC to submit 60-day notice to Federal Reg-
to Federal Register for ‘Proposed Data Col- ister for ‘Proposed Data Collection Submitted
lection Submitted For Public Comment and For Public Comment and Recommendations’
Recommendations’ that would enable the use that would become known as their April 14th
of IHME projection data to inform the public adoption of the Council of State and Terri-
and enact federal policy.[13] torial Epidemiologists (CSTE) COVID-19
Position Paper. The CSTE is an independent,
• January 21, 2020 – CDC confirms 1st privately funded, non-governmental organi-
known case of COVID-19 in US.[14] zation and has no legal approval to provide
data for policy development without adhering
• January 24, 2020 – Deadline passes for to strict regulatory laws governing the use of
CDC and/or National Vital Statistics System non-governmental data.[13][16]
(NVSS) to submit 60-day notice to Federal
Register for ‘Proposed Data Collection Sub- • March 9, 2020 – CDC alerts American citi-
mitted For Public Comment and Recommen- zens over the age of 60 and with comorbidi-
dations’ that would become known as the ties (pre-existing conditions) that they are
March 24th COVID-19 Alert No. 2.[13][15] likely at a higher risk for fatality if SARS-
COV-2 virus is contracted.[17]
• January 29, 2020 – Whitehouse Coron-
avirus Task Force is established and included • March 24, 2020 – In potential violation of
Dr. Anthony Fauci (NIAID), Dr. Robert the PRA & IQA, the CDC issues
Redfield (CDC), and Derek Kan (OMB). COVID-19 Alert No. 2, significantly
Primary data being used to forecast the altering cause of death reporting
situation and exclusively for COVID-
4
Sci, Pub Health Pol, & Law COVID19 Comorbidity & Federal Law - October 12, 2020
19. In doing so, the CDC bypasses federal altering standard established medical criteria
oversight by the OIRA.[15][18] for diagnosis, exclusively for COVID-19 . In
doing so, the CDC bypasses federal oversight by
• March 26, 2020 (March 7, 2020 Initial
the OIRA once again.[16][18]
Pre-Publish Date) – Imperial College of
London research team, led by Dr. Neil
Ferguson, publishes COVID-19 predictive • April 24, 2020 – National Institutes of
model incorrectly asserting 2.2 million Amer- Health (NIH) cancels funding on previously
icans will die due to SARS-COV-2 virus supported gain-of-function research for bat
in 2020 if no mitigation strategies are em- coronaviruses. [10]
ployed. Dr. Neil Ferguson is on record con- • June 13, 2020 – CDC initiates PCR test-
firming that his research team had shared their based strategy requiring all patients that need
wildly inaccurate projections with the White hospitalization for any reason be tested at
House COVID-19 Task Force approximately time of entry regardless of symptoms. A pa-
1 week prior to publication. The data projec- tient testing positive is categorized as a new
tions shared were neither peer-reviewed, nor COVID-19 case and hospitalization. Patients
submitted to the Federal Register to initiate testing positive are required to be PCR tested
a 60-day public comment period as required every 24 hours until they have 2 consecu-
by law. As a result, the OMB was not able to tive negative PCR tests at least 24 hours apart.
approve the use of these projections, which There are no data collection guidelines within
makes their use by any federal agency, for the CSTE Position Paper adopted by the CDC
any reason, illegal. Dr. Neil Ferguson had on April 14, 2020 to prevent the same patient
previously and severely overestimated fatality being counted multiple times. Additionally,
data in earlier predictive models for Bird Flu, there are no data collection guidelines pub-
Mad Cow Disease, and Swine Flu.[19][20] lished separately by the CDC to explicitly pre-
[21] vent the same hospitalized patient from being
• April 13, 2020 – US Surgeon General inaccurately counted as a new case and hos-
Jerome Adams confirms that the Whitehouse pitalization each time they are tested while
COVID-19 Task Force has terminated the hospitalized.[24]
use of IHME Predictive Contagion Models in • June 13 thru July 16, 2020 – Over this 34-
favor of actual data collected from each US day time period using the CDC test-based
State Health Department. [22] strategy nationwide, current hospitalizations
• April 14, 2020 – Dr. John Ioannidis of more than doubled while 678,720 Ameri-
Stanford publishes COVID-19 antibody sero- cans recovered, and 21,323 Americans passed
prevalence research confirming SARS- away. [State & Territory Health Departments]
COV-2 virus had spread much wider than • July 15, 2020 – Health and Human Services
initially realized and most people infected (HHS) assumes control of COVID-19 data
developed natural, adaptive immunity. This collection from the CDC. [25]
study ques-tions the necessity of continued
use of IHME Predictive Contagion Models. • July 17, 2020 – After being unable to
[23] clinically prove the existence of one defini-
tive case of asymptomatic transmission, one
• April 14, 2020 – In potential violation of
the PRA & IQA, the CDC adopts the CSTE
COVID-19 Position Paper, significantly
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- 34-day time period using the CDC symptom-
ing contagious with the SARS-COV-2 virus based strategy nationwide, current hospi-
for longer than 10 days following initial talizations declined by 15,717 Americans.
symptom presentation, the CDC no longer While more Americans passed away during
recommends daily testing for hospitalized this time period than during the previous 34-
patients. The CDC has also reduced the day time period, many of these fatalities can
amount of quarantine time recommended be attributed to Americans being hospitalized
for definitive o r s uspected e xposure from from June 13th to July 16th and miscatego-
14 days to 10 days. Patients can now be rized as a COVID-19 case without having
released from the hospital once symptoms COVID-19 symptoms. Between July 17 and
abate. The CDC officially m oves f rom a August 20, 3,656,822 Americans recovered,
PCR test-based strategy to a more traditional and 34,616 Americans passed away. Infec-
symptom-based strategy of differential diag- tion rate, fatality rate, and recovery rate im-
nosis that incorporates corroborative PCR proved significantly during both time peri-
testing when appropriate.[24][26][27] ods.[State & Territory Health Departments]
• July 17, 2020 – Dr. Sin Hang Lee publishes • August 23, 2020 – The CDC reports 32,582
Testing for SARS-COV-2 in cellular compo- total fatalities for New York state. The
nents by routine nested RT-PCR followed by New York State Department of Health reports
DNA sequencing confirming concerns that 25,282 for the same day. This is an inflated
demonstrate SARS-COV-2 PCR testing is discrepancy by the CDC of 7,300 fatalities
50% reliable at best. CDC confirms that, ‘Al- that they cannot justify, and another exam-
though replication-competent virus was not ple of how the data they are publishing is
isolated 3 weeks after symptom onset, re- compromised.[30][81]
covered patients can continue to have SARS-
COV-2 RNA detected in their upper respira-
tory specimens for up to 12 weeks.’[26][28] 3. Did the CDC Violate Federal
Law?
• July 17 thru August 20, 2020 – Over this
6
Sci, Pub Health Pol, & Law COVID19 Comorbidity & Federal Law - October 12, 2020
3.1 Basis for Allegations That the CDC Vi- lection Submitted For Public Comment and Recom-
olated the Law mendations’, zero evidence was found demonstrat-
The CDC’s rules for data collection, published data, ing that the CDC abided by the laws established by
and statistical analyses are legally required to com- the IQA & PRA.[39]
ply with the laws established by the Information All federal agencies are required to submit noti-
Quality Act (IQA), enacted by Congress in De- fication for data collection, publication, or analysis
cember 2000 as Section 515 of Public Law 106- to the Federal Register BEFORE gaining approval
554, which required the Office of Management and from the OMB/OIRA to ensure they are in compli-
Budget (OMB) to “provide policy and procedu- ance with the IQA & PRA and therefore, approved
ral guidance to Federal agencies for ensuring to implement the proposed changes.
and maximizing the quality, objectivity, utility, Based upon the complete absence of Federal
and integrity of information (including statisti- Register records for ‘Proposed Data Collection Sub-
cal information) disseminates by Federal agen- mitted For Public Comment,’ at no point, did the
cies,” and the Paperwork Reduction Act (PRA) CDC inform the OMB/OIRA or allow for 60 days
which is codified at 44 USC 3501 et seq.[33][34] of public comment in the following unilateral deci-
The Office of Information and Regulatory Af- sions that attempted to bypass Federal oversight.
fairs (OIRA) within the Office of Management and We allege that the complete absence of the ap-
Budget (OMB) is responsible for ensuring each fed- propriate Federal Register records is evidence that
eral agency is in compliance with the IQA & PRA. the CDC knowingly and willingly violated the IQA
[35][36][37[38] & PRA. As a direct consequence of implementing
The process by which any federal agency can the two documents below without OMB approval,
propose changes in data collection, data publishing, there was significant inflation of COVID-19 case
and data analysis to ensure compliance is governed and fatality data.
by 44 USC 3506 (c)(2)(A) which states,
1. On March 24th, the National Vital Statis-
”except as provided under subpara- tics System (NVSS), under the direction of
graph (B) or section 3507(j), provide the CDC, issued ‘COVID-19 Alert No. 2
60-day notice in the Federal Register, ’ to all physicians, medical examiners and
and otherwise consult with members of coroners as guidelines for making significant
the public and affected agencies con- changes as to how cause of death was to be
cerning each proposed collection of reported on death certificates exclusively for
information, to solicit comment to—” COVID-19.[15]
and 44 USC 3506 (d)(3),
This decision was made despite pre-existing
” provide adequate notice when
rules, approved by the OMB, issued by the CDC,
initiating, substantially modifying,
and in use nationwide for at least 17 years with-
or terminating significant informa-
out incident. These rules are published as, 2003
tion dissemination products. . . ;”
CDC’s Medical Examiners’ & Coroners’ Handbook
Neither of the exceptions is applicable in this on Death Registration and Fetal Death Reporting
case. and the CDC’s Physicians’ Handbook on Medical
We are concerned that the CDC has violated Certification of Death.
federal IQA & PRA law and, in doing so, bypassed Considering these handbooks have been ap-
essential oversight by the OMB/OIRA, who are proved by the OMB and in use without incident
legally empowered by Congress with ensuring in- for 17 years, there was no justifiable reason for the
formation compliance for all federal agencies. CDC to implement these changes, bypass the over-
Following review of the Federal Register for sight of the OMB, and fail to provide 60-days for
proof of the 60-day notice for ‘Proposed Data Col- 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’ tion, with the assistance of 4 CDC-employed
clear intent as to how an agency may propose subject matter experts (Dr. Susan Gerber,
changes to data collection as codified in 44 USC Dr. Aron J. Hall, Sandra Roush, & Dr. Tom
3506 (c)(2)(A), there is no record of information Shimabukuro). This document was sanc-
the CDC relied upon to make its decision to change tioned by Dr. Robert R. Redfield, Director of
how deaths are reported. the CDC.[16]
Previous reports detailed the substantial changes
on how causes of death were forcibly modified by Not only does this appear to be a potential con-
the CDC through the NVSS, and how together, flict of interest, it also bypasses the OMB oversight
both federal agencies inflated t he a ctual number for the IQA & PRA, as directed by Congress and is
of COVID-19 fatalities by approximately 90.2% rife with ex parte communications. Ex parte com-
through July 12th, 2020.[18] munications in general violate ethical standards.
We believe this deliberate decision by the CDC By employing a non-governmental organization
and NVSS to deemphasize pre-existing comorbidi- (CSTE), free from the oversight of the OMB and the
ties, in favor of emphasizing COVID-19 as a cause laws detailed by Congress via the IQA & PRA, the
of death, is in violation of 44 U.S. Code 3504 CDC bypassed the oversight of the OMB Director’s
(e)(1)(b), which states the activities of the Federal Information Resources Management policies, plans,
statistical system shall ensure “the integrity, objec- rules, regulations, procedures, and guidelines for
tivity, impartiality, utility, and confidentiality of public comment. We allege this is a violation of 44
information collected for statistical purposes.” U.S. Code 3517(a), which requires an agency to pro-
In doing so, the CDC and NVSS have compro- vide interested persons an “early and meaningful
mised the quality, objectivity, utility, and integrity opportunity to comment.”[41]
of data, and concomitantly usurped the oversight of This violation has inevitably resulted in
the “Authority and Functions of the Director of the COVID-19 data for cases, hospitalizations, and fa-
OMB/OIRA”.[40] talities being artificially elevated, and definitively
compromises prudent decision making at federal
2. On April 14th, the CDC adopted a po- and state executive levels. This includes policy en-
sition paper authored by the Council forcement for a public health crisis that may not
of State and Territorial Epidemiologists have existed had the CDC abided by the laws that
(CSTE), a 501c (6) non-profit organiza- 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]
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 4. The CDC Actions Violated Data
violated the clear intent of Congress with respect to Quality, Objectivity, Utility, and
rule making and data collection, failed to create a
record of their decision making, engaged in ex parte Integrity Requirements
communications with CSTE personnel, and disen- The Information Quality Act became law through
franchised the public from meaningful participation the U.S. Congress, in Section 515 of the Consolida-
in the decision making process. This compromised tion Appropriations Act of 2001, which empowered
the accuracy and integrity of the data collected. 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 CDC has yet to publish its own unique the Office of Management and Bud-
Information Quality Statement as mandated get shall, by not later than September
by the IQA and OMB Guidelines. The refer- 30, 2001, and with public and Fed-
enced CDC webpage for Information Quality eral agency involvement, issue guide-
is also filled with ”404 – Page Error” links, lines under sections 3504(d)(1) and
which places them further out of compliance 3516 of title 44, United States Code,
with the OMB/OIRA.[42] 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
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 for assessing the information’s use-
COVID-19, while denying the public an oppor- fulness from the public’s perspec-
tunity for meaningful participation in the decision tive, the Lead Division should en-
making process and failing to create a record in sure that transparency is appropri-
which the agency clearly set forth the reasons for ately addressed.
its action, we allege the CDC violated the express
5.When the Lead Division de-
intent of Congress and acted in an arbitrary and
termines that the information it
capricious manner.
will disseminate is influential scien-
As a result of these changes, we allege the
tific, financial, or statistical infor-
CDC compromised the quality, objectivity and
mation, extra care should be taken
integrity of all COVID-19 data collected to date.
to include a high degree of trans-
(OMB Guidelines for IQA & PRA Enforce-
parency about data and methods to
ment – Continued)[36]
meet the Government-wide Guide-
Sections 6 & 8 are purposefully omitted.
lines’ requirement for the repro-
4. The Lead Division should ducibility of such information. In de-
consider the uses of the information termining the appropriate level of trans-
both the perspective of and the public. parency, the Lead Division should con-
When it is determined that the trans- sider the types of data that can practi-
parency of information is relevant cably be subjected to a reproducibility
12
Sci, Pub Health Pol, & Law COVID19 Comorbidity & Federal Law - October 12, 2020
13
Sci, Pub Health Pol, & Law COVID19 Comorbidity & Federal Law - October 12, 2020
14
Sci, Pub Health Pol, & Law COVID19 Comorbidity & Federal Law - October 12, 2020
While the rationale for doing so is speculative ings, 120 were made this year. Of the 120 that
at this point, the reality is that COVID-19 became were made this year, zero reference the March
emphasized as a cause of death as frequently as 24, 2020 NVSS COVID-19 Alert No. 2 or the
possible, while comorbidity was simultaneously April 14, 2020 CDC adoption of the CSTE posi-
deemphasized as causes of death. We reported this tion paper.
in a previous research article.[18] CSTE – 1 document resulted from the Fed-
By adopting both the March 24, 2020 NVSS eral Register unrelated to the CSTE position paper
COVID-19 Alert No. 2 and the April 14, 2020 adopted by the CDC on April 14, 2020. (Most Re-
CSTE position paper, the CDC knowingly and will- cent Dated 2/10/2020) The document was filed by
fully compromised the integrity of data they col- the CDC in acknowledgement of their organi-
lected, published, and analyzed. We allege the CDC zation being in review by the Office of Manage-
intentionally violated federal law with respect to in- ment and Budget for compliance with the Paper-
tegrity of information. work Reduction Act.[42]
IHME – Zero documents resulted from the
Federal Register. This demonstrates that the
5. How Aware Was the CDC of wildly inaccurate Institute for Health Metrics
and Evaluation (IHME) projection data, used
Their Responsibility to Be In Full by the COVID Task Force to influence and jus-
Compliance With IQA & PRA? tify executive responses to this crisis, was done
As of August 16, 2020, the Federal Register returns so in violation of the IQA & PRA.
the following results from their database of federal As evidenced by the 120 filings in 2020 alone,
documents dating back to 1994, for the following our investigation of the Federal Register confirms
search terms: that the CDC was well aware of their legal obliga-
NVSS – Eighteen documents resulted from the tions to file all intended changes for data collection,
Federal Register. (Most Recent Dated 2.18.2020) publishing, and analysis with the Federal Register
The Federal Register shows zero federal filings for oversight by the OMB.
from the NVSS for ‘Proposed Data Collection Sub- Further, our investigation of the Federal Regis-
mitted For Public Comment and Recommendations’ ter confirms that, while the CDC has routinely filed
in 2020. to be in compliance with the IQA & PRA for the
COVID – A total of 2,006 documents resulted vast majority of their activities, they violated the
from the Federal Register. The Federal Register law in failing to do so for the March 24th NVSS
shows 31 federal filings from the CDC for COVID COVID-19 Alert No. 2 and the April 14th adop-
and 8 filings from the CDC for ‘Proposed Data tion of the CSTE Position Paper.
Collection Submitted For Public Comment and Additionally, according to an April 24, 2019
Recommendations’ in 2020. Of these 8 fed- memorandum issued by acting director of the Of-
eral filings, zero reference the March 24th, 2020 fice of Management and Budget, Russell T. Vought,
NVSS COVID-19 Alert No. 2 or the April 14th, the agency reminded all federal agencies that the
2020 CDC adoption of the CSTE position pa- OMB bears the responsibility for the enforcement
per. of the IQA & PRA which ensure the accuracy of
CDC – A total of 13,124 documents resulted data by protecting the quality, objectivity, utility,
from the Federal Register. (Most Recent Dated and integrity of all data collected, published and
8.21.2020) The Federal Register shows that 1,429 analyzed by all federal agencies.[44]
of these filings were for ‘Notices of Closed Meet-
ings’. 3,904 of the federal filings were for ‘Pro- Prudent decision making de-
posed Data Collection Submitted For Public Com- pends on reliable, high-quality infor-
ment and Recommendations’. Of the 3,904 fil- mation. Congress has long recognized
15
Sci, Pub Health Pol, & Law COVID19 Comorbidity & Federal Law - October 12, 2020
that federal agencies should make de- According to the April 24, 2019 memoran-
cisions using the best data reasonably dum issued by the OMB Director these may
available, and Congress has entrusted include:[44][45]
OMB with the statutory role of ensur-
ing that federal agencies collect, use, • Incompetent pre-dissemination review of
and disseminate information that is fit information: Fitness for Purpose and Pre-
for its intended purpose. Within OMB, Dissemination Review the IQA requires agen-
the Office of Information and Regula- cies conduct pre-dissemination review of
tory Affairs (OIRA) works with agen- their information products. During this re-
cies to maintain information quality view, each agency should consider the appro-
standards. priate level of quality for each of the products
Implementing statutory require- that it disseminates based on the likely use of
ments in the IQA, the Guidelines pro- that information.
vide a framework for oversight of the
• Incompetent attention to standards of
quality of information disseminated
by the federal government throughout quality: OMB guidelines recognize that ”in-
formation quality comes at a cost,” and
its lifecycle, which includes creation,
”that some government information may
collection, pre-dissemination review,
need to meet higher or more specific qual-
transparent and reproducible use, and
ity standards than those that would apply
ultimately correction and disposition.
to other types of government information,
depending on the information’s expected
All federal agencies, including the CDC, are
use.”
required to comply with the IQA & PRA and are
required by law (IQA: Section 515 2(a) of the Con- • Under Executive Order 12866, federal
solidated Appropriations Act of 2001) to issue their agencies that peer review complex models
own unique guidelines in order to transparently underlying economically significant regu-
demonstrate how their agency is in compliance with lations are required to obtain inter alia
the IQA and the OMB published guidelines for IQA peer review. The March 24th NVSS
enforcement. In order to facilitate this, the OMB COVID-19 Alert No. 2 and the April 14th
Guidelines require each agency to have at least one adoption of the CSTE Position Paper that
webpage dedicated to their own unique Information shaped all data collection for COVID-19
Quality Statement (IQS).[36] were not independently peer reviewed as
Despite the April 24, 2019 OMB Memorandum required by this Executive Order. [46]
issued by Director Vought that gave all federal agen-
cies 90 days to get into full compliance, the CDC • Lack of reproducibility of influential infor-
has failed to publish its IQS.[41] The CDC webpage mation - The guidelines include a ”repro-
for this is filled with ”404 – Page Error” links and ducibility standard” for influential informa-
redirects to the Health & Human Services (HHS) tion. The purpose of the reproducibility stan-
Information Quality Guidelines rather than their dard is to increase the credibility of federal
own unique guidelines, further placing them out of decisions. The standard requires that influ-
compliance with the express intent of Congress and ential analyses must be disseminated with
the OMB/OIRA.[42] sufficient descriptions of data and methods
Moreover, our research team has found that the to allow them to be reproduced by qualified
CDC may be in violation of several additional IQA third parties who may want to test the sen-
& PRA laws and the OMB guidelines established sitivity of agency analyses. This is a higher
to ensure compliance. 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 Despite the CDC’s March 9, 2020 admission
required for all information. that the highest risk group of Americans would be
over 60 years of age and have pre-existing condi-
We allege the CDC violated the IQA, PRA,
tions, only 7 state health departments are reporting
OMB compliance guidelines, and Executive Or-
comorbidity in a manner that can be statistically
der 12866. In doing so, the CDC has fatally com-
analyzed (New York Pennsylvania, Massachusetts,
promised all COVID-19 data and adversely im-
Georgia, Utah, Oklahoma, Iowa).[17]
pacted federal, state, and local public health poli-
Would the 94% of fatalities with at least 1 co-
cies regarding COVID-19. As a result of these
morbidity have been counted as COVID-19 fa-
far-reaching and adverse impacts, the CDC as
talities if the CDC had used the guidelines for
a federal agency MUST be held to the highest
reporting that the nation has been using for 17
of standards for the assurance of flawless data
years instead of the COVID-19 guidelines issued
quality.
on March 24, 2020?
To properly answer this question, it is neces-
6. The Impact of Potential PRA & sary to compare the unproven March 24 COVID-
IQA Violations Upon the Current 19 Alert No. 2 cause of death reporting guidelines
COVID-19 Data against the 2003 CDC Medical Examiner’s and
Coroner’s Handbook on Death Registration that
Data provided for all figures is collected directly
has been the proven national standard for 17 years
from each US Health Department through August
without incident.
23, 2020. The data collected is based upon the
March 24th, 2020 – NVSS COVID-19 Alert
CDC’s March 24, 2020 COVID-19 Alert No. 2
No. 2 [15]
guidelines and the CDC’s adoption of the
CSTE’s Position Paper on April 14, 2020.
Will COVID-19 be the underlying
cause? The underlying cause depends
7. COVID-19 Fatality Data Using upon what and where conditions are
2003 CDC Published Guidelines reported on the death certificate. How-
Of all the data collected at state health department ever, the rules for coding and selection
levels, comorbidity data are the most statistically of the underlying cause of death are
significant in light of the March 24, 2020 expected to result in COVID-19 under-
COVID-19 Alert No. 2 guidelines published by lying cause more often than not.
the CDC and the revelation presented at the
beginning of this historical retrospective, “For 6% Should COVID-19 be reported on
of the deaths, COVID-19 was the only cause the death certificate only with a con-
mentioned. For deaths with conditions or firmed test? COVID-19 should be re-
causes in addition to COVID-19, on average, ported on the death certificate for all
there were 2.6 additional conditions or causes per decedents where the disease caused
death.”[1][15] or is assumed to have caused or con-
To understand the significant implications of tributed to death. Certifiers should in-
these guidelines and how they substantially empha- clude as much detail as possible based
sized COVID-19 as a cause of death, while simul- on their knowledge of the case, medical
taneously deemphasizing comorbidity (pre-existing records, laboratory testing, etc. If the
conditions) in cause of death records, we encourage decedent had other chronic conditions
readers to review our previously published refer- such as COPD or asthma that may have
ence [18]; If COVID Fatalities Were 90.2% Lower, also contributed, these conditions can
How Would You Feel About Schools Reopening?. 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 that all persons concerned with the reg-
Deaths) istration of deaths strive not only for
complete registration, but also for accu-
Recall from the historical timeline presented racy and promptness in reporting these
earlier that the CDC understood the high-risk de- events.”
mographic would be over 60 years of age with
comorbidities.[18] Emphasizing that COVID-19
The principal responsibility of the
be specifically placed in part 1 of the death certifi-
medical examiner or coroner in death
cate while any comorbidities be listed in part 2 is
registration is to complete the medical
genuinely concerning.
part of the death certificate. The cause-
Changing reporting rules exclusively for
of-death section consists of two parts.
COVID-19 cause of death reporting without no-
Part I is for reporting a chain of events
tifying the Federal Register, OMB, OIRA, or the
leading directly to death, with the im-
public, and therefore potentially breaching the PRA
mediate cause of death (the final dis-
& IQA, is even more concerning.
ease, injury, or complication directly
It’s worth noting that Part I of a death certificate
causing death) online
is the immediate cause of death listed in sequen-
(a) and the underlying cause of
tial order from the official cause on line item (a)
death (the disease or injury that initi-
to the underlying causes that contributed to death
ated the chain of events [SARS-COV-
in descending order of importance on line item (d),
2 in this case] that led directly and in-
while Part II is/are the significant conditions NOT
evitably to death) on the lowest used
relating to the underlying cause(s) in Part I.
line. Part II is for reporting all other sig-
Comorbid conditions have been listed on Part I
nificant diseases, conditions, or injuries
of death certificates as causes of death per the CDC
that contributed to death, but which did
Handbook since 2003 to ensure accurate reporting
not result in the underlying cause of
can be developed. Comorbidities are seldom placed
death given in Part I.
in Part II. Part II is typically the section where coro-
ners and medical examiners can list recent infec-
tions as underlying, initiating factors. Under these 2003 guidelines, the highest
Prior to the CDC’s March 24th decision, any co- COVID-19 could be listed in the presence of an
morbidities would have been listed in Part I rather established comorbidity would be on the lowest
than Part II and initiating factors such as infections used line at the bottom of Part I as an initiating fac-
including the SARS-COV-2 virus, would have been tor or, more correctly, in Part II as an infection that
listed on the last line in Part I or more commonly contributed to death.
in Part II. However, on March 24, 2020 the CDC elected
The 2003 CDC Medical Examiner’s and to forgo this trusted method of cause of death record-
Coroner’s Handbook on Death Registration ing in favor of recording comorbidities in Part 2, so
[7][8]: COVID-19 could be listed exclusively in Part 1.
This has had a significant impact on data collec-
Because statistical data derived tion accuracy and integrity. It has resulted in the
from death certificates can be no more potential false inflation of COVID-19 fatality data
accurate than the information provided and is a potential breach of federal laws governing
on the certificate, it is very important 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 passed away alone, without the comfort of their
Policy family members, and the collateral damage of
our one-size fits all policies becomes even more
As a result of state policies based on potentially unpalatable.[47]
compromised data published and promoted by the All non-COVID related healthcare priorities
CDC, Americans have lost jobs and businesses in have also suffered including elective surgeries,
historically unprecedented numbers. proper monitoring of medications, and checkups
At the peak of the crisis, an estimated 20.5 to 42 for the elderly and our children. De-prioritizing all
million Americans had lost their jobs without hav- non-COVID cases created collateral damage that
ing any voice in the decision-making process due far outweighs the infective damage of the SARS-
to shelter in place mandates issued by every state COV-2 virus. Public health policies that create
with the exceptions of Arkansas, Iowa, Nebraska, more collateral damage while attempting to avoid
South Dakota, Utah & Wyoming.[30][31] an infection with a 99.05% rate of recovery in the
Anxiety, depression, suicide rates, domestic vi- vast majority of citizens must be objectively investi-
olence, and alcoholism have all reportedly risen sig- gated and critically questioned if the goal of living
nificantly due to the economic hardships brought on in a healthy society is to be realized.
by how state governors decided to exercise their au-
thority in response to the potentially compromised
data published by the CDC.[32] 9. Conclusions
Tens of thousands of Americans have died Arguing over what the most accurate COVID fatal-
without access to potentially life-saving medica- ity count may be is an exercise in futility without
tions like hydroxychloroquine or nutrient ther- intimate knowledge of case history and accompany-
apies like intravenous Vitamin C. Couple this ing certificates of death, and it is the exact reason
with the tragic reality that so many Americans 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- ulations, Public Law 96-511 . United States
ble fatalities and significant changes made to how Code, Deceber 1980. U. S. Congress.
certificates of death are recorded exclusively for
[3] United States Congress. United States Code,
COVID-19 , scientific objectivity demands that we
Title 44, Public Printing and Documents,
acknowledge the data presented is inaccurate.
Chapter 35 Coordination of Federal Infor-
Federal agencies have a legal obligation to mation Policy, Section 3516 Rules and Reg-
provide the most accurate data to the public, fel-
ulations, Public Law 104-13 . United States
low agencies, and policy makers they are advis-
Code, May 1995. U. S. Congress.
ing, and they have a responsibility to abide by
every federal law. This responsibility to collect, [4] United States Congress S.244. Paperwork
analyze, and publish data accurately, transparently, Reduction Act of 1995 . May 1995.
and with unquestionable integrity increases expo- U. S. Congress.
nentially during a national crisis.
[5] United States Congress. Public Law 106-554
It is concerning that the CDC may have willfully
Consolidated Appropriations Act, Section
failed to collect, analyze, and publish accurate data
515 . December 2000. FWS.GOV.
used by elected officials to develop public health
policy for a nation in crisis. [6] Marshall A Sands S. Federal Agencies Sub-
Further federal investigation is justified by the ject to Data Quality Act . Findlaw, March
magnitude of the crisis and the collateral damage 2008. Findlaw.
generated by policies based upon projection data [7] CDC. Medical Examiners’ and Coroners’
that was unproven and never peer reviewed. If the Handbook on Death Registration and Fe-
data being reported was indeed compromised by tal Death Reporting, 2003 Revision . CDC,
the CDC’s perplexing decision to abandon proven 2003. CDC.
data collection and reporting practices in favor of [8] CDC. Physicians’ Handbook on Medical
untested methods, then all public health policies Certification of Death, 2003 Revision . CDC,
based upon these inaccurate data must be reexam- 2003. CDC.
ined.
[9] Vincent M, Bergeron E, Benjannet S, Erickson
B, Rollin P, Ksiazek T, Seidah N, and Nichol.
10. Author Statements Chloroquine is a potent inhibitor of SARS
coronavirus infection and spread . Virology
All authors have contributed and are in full agree- Journal, August 2005. PubMed.
ment with the facts and positions presented in this
[10] Guterl F. Dr. Fauci Backed Controversial
publication. None have declared any conflicts of
interest. Wuhan Lab with U.S. Dollars for Risky
Coronavirus Research . Newsweek, April
2020. Newsweek.
References [11] Center for Health Security. Event 201 A
[1] CDC. Weekly Updates by Select Demo- Global Pandemic Exercise . Johns Hopkins
graphic and Geographic Characteristics, Center For Health Security, October 2019.
Comorbidities . National Center for Health Johns Hopkins .
Statistics, page Table 3, Aug 2020. CDC. [12] Ma J. Coronavirus: China’s first confirmed
[2] United States Congress. United States Code, Covid-19 case traced back to November 17 .
Title 44, Public Printing and Documents, South China Morning Post, March 2020. SCM
Chapter 35 Coordination of Federal Infor- [13] National Archives. Federal Register . 2020.
mation Policy, Section 3516 Rules and Reg- Federal Register .
21
Sci, Pub Health Pol, & Law COVID19 Comorbidity & Federal Law - October 12, 2020
[22] Spiering C. Surgeon General: We’re Work- [33] United States Code. Title 44, Public Printing
ing with Real Coronavirus Data Now, Not and Documents, Chapter 35 Coordination
Models . Breitbart, April 2020. Breitbart. of Federal Information Policy, Section 3516
Rules and Regulations. Office of the Law
[23] Ioannidis J and Bhattacharya J.COVID-19 Revision Counsel, August 2020. USC.
Antibody Seroprevalence in Santa Clara
County, California . medrxiv preprint server, [34] Congress United States. Public Law106-554
April 2020. MEDRXIV.ORG . Consolidated Appropriations Act, Section
515. December 2000.U.S. Congress.
22
Sci, Pub Health Pol, & Law COVID19 Comorbidity & Federal Law - October 12, 2020
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Sci, Pub Health Pol, & Law COVID19 Comorbidity & Federal Law - October 12, 2020
[61] Idaho Department of Public Health [79] New Mexico Department of Health:
Dash-board: HERE HERE
[62] Illinois Department of Public Health [80] State of Nevada Department of Health &
COVID-19 Statistics: HERE Human Services, Office of Analytics: HERE
[63] Indiana COVID-19 Dashboard: HERE [81] New York Department of Health,
NYSDOH COVID-19 Tracker: HERE
[64] Kansas Department of Health &
Environment, COVID-19 Cases: HERE [82] New York City Coronavirus Data: HERE
[65] Kentucky Cabinet for Health & Family [83] New York City Department of Health:
Services: HERE HERE
[68] Maryland Department of Health: HERE [87] COVID-19 Data for Pennsylvania: HERE
[69] Maine Center for Disease Control & Preven- [88] Puerto Rico Health Statistics: HERE
tion: HERE
[89] Rhode Island COVID-19 Response Data:
[70] Michigan Coronavirus Data: HERE HERE
[71] Minnesota Department of Health: HERE [90] South Carolina Testing Data &
Projections (COVID-19): HERE
[72] Missouri COVID-19 Dashboard: HERE
[91] South Dakota Department of
[73] Mississippi State Department of Health: Health: HERE
HERE
[92] Tennessee Department of Health: HERE
[74] Montana Response: COVID-19 -
[93] Texas Health & Human Services: HERE
Coronavirus - Global, National, and State
Infor-mation Resources: HERE [94] Utah Department of Health: COVID-19
Surveillance: HERE
[75] North Carolina NCDHHS COVID-19
Re-sponse: HERE [95] Virginia Department of Health: HERE
[76] Coronavirus COVID-19 Nebraska Cases [96] U.S Virgin Islands Department of Health:
HERE HERE
[77] New Hampshire Department of Health & [97] Vermont Current Activity Dashboard:
Human Services: HERE HERE
[78] New Jersey COVID-19 information [98] Washington State Department of Health:
Hub: HERE HERE
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Sci, Pub Health Pol, & Law COVID19 Comorbidity & Federal Law - October 12, 2020
25