Abstract

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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?

This historical retrospective will provide a timeline summary of events to help the reader orient themselves to many aspects of the crisis 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 existing COVID-19 fatality data, which has been so influential upon public policy, may be substantially compromised regarding accuracy and integrity, and illegal under existing 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

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All federal agencies, including the Centers for Disease 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 Management and Budget (OMB).[2][3][4][5][6]

The key to initiating legal regulatory oversight of all proposed changes to data collection, publication, and analysis is the Federal Register. Each Federal 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 capricious alteration to data collection has compromised the accuracy, quality, objectivity, utility, and integrity of their published data, leading to a significant 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

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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 projections produced by any entity outside of federal regulatory law, must go through strict federal procedures 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 projection 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 Reduction 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 Office of Management and Budget (OMB). PRA authorizes OIRA to establish information collection policies for all federal agencies, including 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, including the CDC. PRA amendment also affirms 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 Congressional Consolidated Appropriations Act, 2001 Public Law 106-554). All federal agencies, 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 oversight for all data collected, analyzed, and published by federal agencies.[5][6]
• 2003 – CDC publishes Medical Examiners’ and Coroners’ Handbook on Death Registration and Fetal Death Reporting and Physicians’ Handbook on Medical Certification of Death. These handbooks would immediately become the nationwide standard illustrating 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 hydroxychloroquine, “has strong antiviral effects on SARS-COV 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 Institute for Allergy and Infectious Disease (NIAID) and National Institutes of Health (NIH) “for work on gain-of-function research on bat coronaviruses.”[10]
• 2019 – Dr. Anthony Fauci authorizes an additional $3.7 million of scientific funding to the EcoHealth Alliance via the NIAID and NIH for “a second phase of the project” that included gain-of-function research on bat coronaviruses.[10]
• October 18, 2019 – Johns Hopkins Center for Health Security hosts Event 201, a high-level pandemic exercise in New York, NY.[11]
• 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 Collection 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 Submitted For Public Comment and Recommendations’ that would become known as the March 24th COVID-19 Alert No. 2.[13][15]
• January 29, 2020 – Whitehouse Coronavirus Task Force is established and included Dr. Anthony Fauci (NIAID), Dr. Robert Redfield (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 Register 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 Territorial Epidemiologists (CSTE) COVID-19 Position Paper. The CSTE is an independent, privately funded, non-governmental organization 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 citizens over the age of 60 and with comorbidities (pre-existing conditions) that they are likely at a higher risk for fatality if SARSCOV-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-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 Americans will die due to SARS-COV-2 virus in 2020 if no mitigation strategies are employed. Dr. Neil Ferguson is on record confirming 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 projections 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 seroprevalence research confirming SARS-COV-2 virus had spread much wider than initially realized and most people infected developed natural, adaptive immunity. This study questions 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 patient 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 consecutive 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 published separately by the CDC to explicitly prevent the same hospitalized patient from being inaccurately counted as a new case and hospitalization 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 Americans 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 definitive case of asymptomatic transmission, one case of definitive reinfection, or a person being 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 or suspected exposure from 14 days to 10 days. Patients can now be released from the hospital once symptoms abate. The CDC officially moves from a PCR test-based strategy to a more traditional symptom-based strategy of differential diagnosis 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 components 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, ‘Although replication-competent virus was not isolated 3 weeks after symptom onset, recovered patients can continue to have SARS-COV-2 RNA detected in their upper respiratory 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 hospitalizations 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 miscategorized 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. Infection rate, fatality rate, and recovery rate improved significantly during both time periods.[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 example of how the data they are publishing is compromised.[30][81]

3. Did the CDC Violate Federal Law?

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4. The CDC Actions Violated Data Quality, Objectivity, Utility, and Integrity Requirements

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The Information Quality Act became law through the U.S. Congress, in Section 515 of the Consolidation Appropriations Act of 2001, which empowered the OMB to ensure all federal agencies are in compliance with the IQA & PRA. [34]

Section 515 of this act reads:

(a) In General. – The Director of the Office of Management and Budget shall, by not later than September 30, 2001, and with public and Federal agency involvement, issue guidelines under sections 3504(d)(1) and 3516 of title 44, United States Code, that provide policy and procedural guidance to Federal agencies for ensuring and maximizing the quality, objectivity, utility, and integrity of information (including statistical information) disseminated by Federal agencies in fulfillment of the purposes and provisions of chapter 35 of title 44, United States Code, commonly referred 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 information (including statistical information) disseminated by the agency, by not later than 1 year after the date of issuance of the guidelines under subsection (a). . .

The IQA & PRA are intended to function as a ‘checks and balances’ system for federal agencies, 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 October1, 2001[36]

I. Procedures for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Prior to Dissemination In Governmentwide Guidelines, “quality” is defined as an encompassing term comprising utility, objectivity, and integrity.

A. Objectivity and Quality of Information

1. As defined in Section IV, below, “objectivity” is a measure of whether disseminated information is accurate, reliable, and unbiased and whether that information is presented in an accurate, clear, complete, and unbiased manner.
   
   “Utility” refers to the usefulness of the information for the intended audience’s anticipated purposes. OMB is committed to disseminating reliable and useful information. Before disseminating information, OMB staff and officials should
   subject such draft information to an extensive review process including open public comment. It is the primary 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 information.

Based upon our investigation of Federal RegisterRecords for 2020, there was no formal, transparent, 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 exclusively 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 Register 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 dramatically altered what defines a new case exclusively for COVID-19. In this regard, we allege that the CDC changes to cause of death reporting exclusively for COVID-19 violated the IQA & PRA by compromising data quality, objectivity, and utility.

By implementing new rules exclusively for COVID-19, while denying the public an opportunity 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 Enforcement – 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 transparency of information is relevant for assessing the information’s usefulness from the public’s perspective, the Lead Division should ensure that transparency is appropriately addressed.

5. When the Lead Division determines that the information it will disseminate is influential scientific, financial, or statistical information, extra care should be taken to include a high degree of transparency about data and methods to meet the Government-wide Guidelines’ requirement for the reproducibility of such information. In determining the appropriate level of transparency, the Lead Division should consider the types of data that can practicably be subjected to a reproducibility requirement given ethical, feasibility, and confidentiality constraints. In making this determination, the Lead Division 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 “objectivity” and “utility” of the information to be disseminated:
a. Preparing a draft of the document after consulting the necessary parties, including government and nongovernment 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 clearance points;
e. Determining where the final decision shall be made;
f. Determining whether peer review would be appropriate and, if necessary, coordinating such review;
g. Obtaining clearances, and
h. Overcoming delays and, if necessary, presenting the matter to higher authority.

9. The quality control procedures followed by OMB should be determined by the nature of the information and the manner of its distribution. Any information collected by OMB and subject to the Paperwork Reduction Act should be collected, maintained, and used in a manner consistent with Paperwork Reduction Act and the OMB information quality standards. The OMB clearance package should demonstrate that the proposed collection of information will result in information that will be collected, maintained, and used in a way consistent with the Government-wide Guidelines 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 Guidelines as required by Congress and, in doing so, violated 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 unauthorized unanticipated, or unintentional modification -to prevent information from being compromised through corruption or falsification.

The CDC compromised data integrity by altering 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 paper and created categories for ‘probable’ cases that eliminated the medical standards of proof of infection 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 untrained 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.

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 willfully compromised the integrity of data they collected, published, and analyzed. We allege the CDC intentionally violated federal law with respect to integrity of information.

5. How Aware Was the CDC of
Their Responsibility to Be In Full
Compliance With IQA & PRA?

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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 Submitted 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 federal filings, zero reference the March 24th, 2020 NVSS COVID-19 Alert No. 2 or the April 14th, 2020 CDC adoption of the CSTE position paper.

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 Meetings’. 3,904 of the federal filings were for ‘Proposed Data Collection Submitted For Public Comment and Recommendations’. Of the 3,904 filings, 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 position paper.

CSTE – 1 document resulted from the Federal Register unrelated to the CSTE position paper adopted by the CDC on April 14, 2020. (Most Recent Dated 2/10/2020) The document was filed by the CDC in acknowledgement of their organization being in review by the Office of Management and Budget for compliance with the Paperwork 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 justify 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 obligations 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 Register 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 adoption of the CSTE Position Paper.

Additionally, according to an April 24, 2019 memorandum issued by acting director of the Office 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 depends on reliable, high-quality information. Congress has long recognized that federal agencies should make decisions using the best data reasonably available, and Congress has entrusted OMB with the statutory role of ensuring that federal agencies collect, use, and disseminate information that is fit for its intended purpose. Within OMB, the Office of Information and Regulatory Affairs (OIRA) works with agencies to maintain information quality standards.

Implementing statutory requirements in the IQA, the Guidelines provide 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 Consolidated 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 agencies 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 memorandum 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 agencies conduct pre-dissemination review of their information products. During this review, each agency should consider the appropriate 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 ”information quality comes at a cost,” and ”that some government information may need to meet higher or more specific quality 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 regulations 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 information – The guidelines include a ”reproducibility standard” for influential information. The purpose of the reproducibility standard is to increase the credibility of federal decisions. The standard requires that influential 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 sensitivity of agency analyses. This is a higher standard than simply documenting the characteristics of the underlying data, which is required for all information.

We allege the CDC violated the IQA, PRA, OMB compliance guidelines, and Executive Order 12866. In doing so, the CDC has fatally compromised all COVID-19 data and adversely impacted federal, state, and local public health policies 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

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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

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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 emphasized COVID-19 as a cause of death, while simultaneously deemphasizing comorbidity (pre-existing conditions) in cause of death records, we encourage readers to review our previously published reference [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 conditions, 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 comorbidity have been counted as COVID-19 fatalities 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 necessary 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. However, the rules for coding and selection of the underlying cause of death are expected to result in COVID-19 underlying cause more often than not.
• Should COVID-19 be reported on the death certificate only with a confirmed test? COVID-19 should be reported on the death certificate for all decedents where the disease caused or is assumed to have caused or contributed to death. Certifiers should include 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 Guidance for Certifying COVID-19 Deaths)

Recall from the historical timeline presented earlier that the CDC understood the high-risk demographic would be over 60 years of age with comorbidities.[18] Emphasizing that COVID-19 be specifically placed in part 1 of the death certificate while any comorbidities be listed in part 2 is genuinely concerning.

Changing reporting rules exclusively for COVID-19 cause of death reporting without notifying 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 sequential order from the official cause 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 coroners and medical examiners can list recent infections as underlying, initiating factors.

Prior to the CDC’s March 24th decision, any comorbidities 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 registration of deaths strive not only for complete registration, but also for accuracy 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 immediate cause of death (the final disease, injury, or complication directly causing death) online

(a) and the underlying cause of death (the disease or injury that initiated the chain of events [SARS-COV-2 in this case] that led directly and inevitably to death) on the lowest used line. Part II is for reporting all other significant 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 factor 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 recording 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 collection 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.

8. Implications for Public Health Policy

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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 having 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 violence, and alcoholism have all reportedly risen significantly due to the economic hardships brought on by how state governors decided to exercise their authority 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 medications like hydroxychloroquine or nutrient therapies 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 investigated and critically questioned if the goal of living in a healthy society is to be realized.

9. Conclusion

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Arguing over what the most accurate COVID fatality count may be is an exercise in futility without intimate knowledge of case history and accompanying certificates of death, and it is the exact reason we entrust these determinations to the skill of our licensed professionals. With the inclusion of probable 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, fellow agencies, and policy makers they are advising, 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 exponentially 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 reexamined.

10. Author Statements

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All authors have contributed and are in full agreement with the facts and positions presented in this publication. None have declared any conflicts of interest.

References

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11. State & Territory Health Departments

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[48] Alaska Department of Health & Social Services Coronavirus Response: Alaska Coronavirus Response (arcgis.com)

[49] Alabama COVID-19 Data and Surveillance Dashboard: Alabama COVID-19 Data and Surveillance Dashboard (arcgis.com)

[50] Arkansas COVID-19 Data and Surveillance Dashboard: COVID-19 Arkansas Department of Health

[51] Arizona Department of Health: ADHS – Surveillance data dashboard (azdhs.gov)

[52] California COVID-19 Dashboard: Workbook: (Retired) COVID-19 Public Dashboard (tableau.com)

[53] Colorado Department of Public Health &Environment, Case Data: COVID19 | Department of Public Health & Environment (colorado.gov)

[54] Connecticut COVID-19 Response: COVID-19 2023 Update – Ending of the Public Health Emergency (ct.gov)

[55] Government of the District of Columbia, Coronavirus Data: COVID-19 Surveillance | coronavirus (dc.gov)

[56] State of Delaware COVID-19 Data Dashboard: My Healthy Community (delaware.gov)

[57] Florida COVID-19 Response: COVID-19 | Florida Department of Health (floridahealth.gov)

[58] Georgia Department of Public Health: Page not found | Georgia Department of Public Health

[59] State of Hawaii Department of Health, Disease Outbreak Division: Disease Outbreak Control Division | COVID-19 | State of Hawai’i – Department of Health (hawaii.gov)

[60] Iowa Department of Public Health: Health and Human Services | Health & Human Services (iowa.gov)

[61] Idaho Department of Public Health Dashboard: Profile – idaho.division.of.public.health | Tableau Public

[62] Illinois Department of Public Health COVID-19 Statistics: 404 (illinois.gov)

[63] Indiana COVID-19 Dashboard: Coronavirus: Home (in.gov)

[64] Kansas Department of Health & Environment, COVID-19 Cases: COVID-19 Cases in Kansas | KDHE COVID-19 (kdheks.gov)

[65] Kentucky Cabinet for Health & Family Services: Respiratory Viruses – Cabinet for Health and Family Services (ky.gov)

[66] Louisiana Department of Health: Respiratory Home | La Dept. of Health

[67] Massachusetts Department of Public Health COVID-19 Dashboard -Dashboard of Public Health Indicators: COVID-19 Reporting | Mass.gov

[68] Maryland Department of Health: Pages – Home (maryland.gov)

[69] Maine Center for Disease Control & Prevention: Coronavirus Disease 2019 (COVID-19) | Airborne Disease Surveillance Epidemiology Program | MeCDC | Maine DHHS

[70] Michigan Coronavirus Data: Michigan Data

[71] Minnesota Department of Health: Situation Update for COVID-19 – MN Dept. of Health (state.mn.us)

[72] Missouri COVID-19 Dashboard: Missouri COVID-19 Dashboard: The Spread of COVID-19 in Missouri (arcgis.com)

[73] Mississippi State Department of Health: COVID-19 – Mississippi State Department of Health (ms.gov)

[74] Montana Response: COVID-19 – Coronavirus – Global, National, and State Information Resources: MONTANA RESPONSE: COVID-19 – Coronavirus – Global, National, and State Information Resources (arcgis.com)

[75] North Carolina NCDHHS COVID-19 Response: North Carolina COVID-19 Information | NC COVID-19 (ncdhhs.gov)

[ ] North Dakota: Coronavirus Cases | Health and Human Services North Dakota

[76] Coronavirus COVID-19 Nebraska Cases: ArcGIS Dashboards

[77] New Hampshire Department of Health & Human Services: Welcome | NH COVID-19 Response

[78] New Jersey COVID-19 information Hub: New Jersey COVID-19 Information Hub (nj.gov)

[79] New Mexico Department of Health: NMDOH – Coronavirus Updates | Coronavirus Updates in New Mexico (nmhealth.org)

[80] State of Nevada Department of Health & Human Services, Office of Analytics: Microsoft Power BI (powerbigov.us)

[81] New York Department of Health, NYSDOH COVID-19 Tracker: https://covid19tracker.health.ny.gov/views/NYS-COVID19-Tracker/NYSDOHCOVID-19Tracker-Map

[82] New York City Coronavirus Data: GitHub – nychealth/coronavirus-data: This repository contains data on Coronavirus Disease 2019 (COVID-19) in New York City (NYC), from the NYC Department of Health and Mental Hygiene.

[83] New York City Department of Health: COVID-19: Latest Data – NYC Health

[84] Ohio Department of Health: Coronavirus Disease 2019 – (COVID-19) in Ohio | Ohio Department of Health

[85] Oklahoma State Department of Health: COVID-19 (oklahoma.gov)

[86] Oregon Health Authority: https://govstatus.egov.com/OR-OHA-COVID-19

[87] COVID-19 Data for Pennsylvania: COVID-19 Data for Pennsylvania (pa.gov)

[88] Puerto Rico Health Statistics: COVID-19 | Estadísticas.PR (estadisticas.pr)

[89] Rhode Island COVID-19 Response Data: RI Department of Health COVID-19 Response Data Hub (arcgis.com)

[90] South Carolina Testing Data &Projections (COVID-19): 404 – Page Not Found | SCDHEC

[91] South Dakota Department ofHealth: doh.sd.gov

[92] Tennessee Department of Health: Novel Coronavirus (tn.gov)

[93] Texas Health & Human Services: ArcGIS Dashboards

[94] Utah Department of Health: COVID-19Surveillance: coronavirus-dashboard.utah.gov

[95] Virginia Department of Health: Tableau

[96] U.S Virgin Islands Department of Health: Home – VI Department of Health

[97] Vermont Current Activity Dashboard: COVID-19 Data | Vermont Department of Health (healthvermont.gov)

[98] Washington State Department of Health: COVID-19 | Washington State Department of Health

[99] Wisconsin Department of Health Services: COVID-19: Wisconsin Data | Wisconsin Department of Health Services

[100] West Virginia Health & Human Resources: Coronavirus Disease 2019 (COVID-19) (wv.gov)

[101] Wyoming Department of Health: Page not found – Wyoming Department of Health