COVID-19: A Legal & Historical Retrospective

COVID-19: A Legal & Historical Retrospective
Published on September 25, 2021
Written by John O'Sullivan



The following is a summary of an excellent paper which may become a template for litigants suing corrupt government agencies, vaccine companies and shill politicians. It appears in the October 2021 edition of IPAK PHPI. [1]

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?
Introduction 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]
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 COVID19 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-COVprimate 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 highlevel 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 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 SARSCOV-2 virus had spread much wider than initially realized and most people infected developed natural, adaptive immunity. This study ques-tions the necessity of continued use of IHME Predictive Contagion Models. [23]
  
• April 14, 2020 – In potential violation of the PRA & IQA, the CDC adopts the CSTE COVID-19 Position Paper, significantly altering standard established medical criteria for diagnosis, exclusively for COVID-19 . In doing so, the CDC bypasses federal oversight by the OIRA once again.[16][18] • April 24, 2020 – National Institutes of Health (NIH) cancels funding on previously supported gain-of-function research for bat coronaviruses. [10]
  
• June 13, 2020 – CDC initiates PCR testbased 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
  
• 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] 
  
• 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 In doing so, the CDC bypasses federal oversight by the OIRA.[15][18] 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 o r 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 SARSCOV-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]
  

Did the CDC Violate Federal Law?

3.1 Basis for Allegations That the CDC Violated the Law The CDC’s rules for data collection, published data, and statistical analyses are legally required to comply with the laws established by the Information Quality Act (IQA), enacted by Congress in December 2000 as Section 515 of Public Law 106- 554, which required the Office of Management and Budget (OMB) to “provide policy and procedural guidance to Federal agencies for ensuring and maximizing the quality, objectivity, utility, and integrity of information (including statistical information) disseminates by Federal agencies,” and the Paperwork Reduction Act (PRA) which is codified at 44 USC 3501 et seq.[33][34]
The Office of Information and Regulatory Affairs (OIRA) within the Office of Management and Budget (OMB) is responsible for ensuring each federal agency is in compliance with the IQA & PRA. [35][36][37[38] The process by which any federal agency can propose changes in data collection, data publishing, and data analysis to ensure compliance is governed by 44 USC 3506 (c)(2)(A) which states, ”except as provided under subparagraph (B) or section 3507(j), provide 60-day notice in the Federal Register, and otherwise consult with members of the public and affected agencies concerning each proposed collection of information, to solicit comment to—” and 44 USC 3506 (d)(3), ” provide adequate notice when initiating, substantially modifying, or terminating significant information dissemination products. . . ;”
Neither of the exceptions is applicable in this case. We are concerned that the CDC has violated federal IQA & PRA law and, in doing so, bypassed essential oversight by the OMB/OIRA, who are legally empowered by Congress with ensuring information compliance for all federal agencies. Following review of the Federal Register for proof of the 60-day notice for ‘Proposed Data Collection Submitted For Public Comment and Recommendations’, zero evidence was found demonstrating that the CDC abided by the laws established by the IQA & PRA.[39]
All federal agencies are required to submit notification for data collection, publication, or analysis to the Federal Register BEFORE gaining approval from the OMB/OIRA to ensure they are in compliance with the IQA & PRA and therefore, approved to implement the proposed changes. Based upon the complete absence of Federal Register records for ‘Proposed Data Collection Submitted For Public Comment,’ at no point, did the CDC inform the OMB/OIRA or allow for 60 days of public comment in the following unilateral decisions that attempted to bypass Federal oversight.
We allege that the complete absence of the appropriate Federal Register records is evidence that the CDC knowingly and willingly violated the IQA & PRA.
As a direct consequence of implementing the two documents below without OMB approval, there was significant inflation of COVID-19 case and fatality data. 1. On March 24th, the National Vital Statistics System (NVSS), under the direction of the CDC, issued ‘COVID-19 Alert No. 2 ’ to all physicians, medical examiners and coroners as guidelines for making significant changes as to how cause of death was to be reported on death certificates exclusively for COVID-19.[15]
This decision was made despite pre-existing rules, approved by the OMB, issued by the CDC, and in use nationwide for at least 17 years without incident. These rules are published as, 2003 CDC’s Medical Examiners’ & Coroners’ Handbook on Death Registration and Fetal Death Reporting and the CDC’s Physicians’ Handbook on Medical Certification of Death.
Considering these handbooks have been approved by the OMB and in use without incident for 17 years, there was no justifiable reason for the CDC to implement these changes, bypass the oversight of the OMB, and fail to provide 60-days for public comment, as they are legally obligated to do.
By failing to act in accordance with Congress’ clear intent as to how an agency may propose changes to data collection as codified in 44 USC 3506 (c)(2)(A), there is no record of information the CDC relied upon to make its decision to change how deaths are reported.
Previous reports detailed the substantial changes on how causes of death were forcibly modified by the CDC through the NVSS, and how together, both federal agencies inflated the a actual number of COVID-19 fatalities by approximately 90.2% through July 12th, 2020.[18]
We believe this deliberate decision by the CDC and NVSS to deemphasize pre-existing comorbidities, in favor of emphasizing COVID-19 as a cause of death, is in violation of 44 U.S. Code 3504 (e)(1)(b), which states the activities of the Federal statistical system shall ensure “the integrity, objectivity, impartiality, utility, and confidentiality of information collected for statistical purposes.”
In doing so, the CDC and NVSS have compromised the quality, objectivity, utility, and integrity of data, and concomitantly usurped the oversight of the “Authority and Functions of the Director of the OMB/OIRA”.[40]
This document was sanctioned by Dr. Robert R. Redfield, Director of the CDC.[16] Not only does this appear to be a potential conflict of interest, it also bypasses the OMB oversight for the IQA & PRA, as directed by Congress and is rife with ex parte communications. Ex parte communications in general violate ethical standards.
By employing a non-governmental organization (CSTE), free from the oversight of the OMB and the laws detailed by Congress via the IQA & PRA, the CDC bypassed the oversight of the OMB Director’s Information Resources Management policies, plans, rules, regulations, procedures, and guidelines for public comment.
We allege this is a violation of 44 U.S. Code 3517(a), which requires an agency to provide interested persons an “early and meaningful opportunity to comment.”[41]
This violation has inevitably resulted in COVID-19 data for cases, hospitalizations, and fatalities being artificially elevated, and definitively compromises prudent decision making at federal and state executive levels. This includes policy enforcement for a public health crisis that may not have existed had the CDC abided by the laws that ensure the accuracy of data collection.

Implications for Public Health Policy

As a result of state policies based on potentially compromised data published and promoted by the CDC, Americans have lost jobs and businesses in historically unprecedented numbers. At the peak of the crisis, an estimated 20.5 to 42 million Americans had lost their jobs without 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 SARSCOV-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.
Conclusions 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.
[PSI Editor’s note: the above comprises selected extracts from the original paper. Please access the original document to see the entire presentation].

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[1] COVID-19 Data Collection, Comorbidity & Federal Law: A Historical Retrospective, Henry Ealy et al., Public Health Policy, and The Law Volume 2:4-22, October 12, 2020, https://www.ratical.org/PandemicParallaxView/C19dataCollection-C+FL-HistPerspec.pdf

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