COVID-19 Data Collection, Comorbidity & Federal Law

Written by Multiple authors on June 13, 2021. Posted in Current News

According to the Centers for Disease Control and Prevention (CDC) on August 23, 2020, “For 6 percent 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 cri- sis previously unknown and will discuss the significance of the March 24, 2020 COVID- 19 Alert No. 2 that had a dramatic impact upon cause of death reporting numbers.

Supportive data comparisons suggest the existing COVID-19 fatality data, which has been so influential upon public policy, may be substantially compromised regarding ac- curacy 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.

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 Fed- eral agency is required to submit a formal change proposal to the Federal Register before enacting their proposed changes. By submitting a change proposal to the Federal Register, federal agencies open the minimum 60-day public comment and peer-review process.

Additionally, it is the “change proposal submission” to the Federal Register that alerts the OMB that legal oversight of the process has been initiated. Federal agencies that make changes to how they collect, publish, and analyze data without alerting the Federal Register and OMB as a result, are in violation of federal law.

The CDC published guidelines on March 24, 2020 that substantially altered how cause of death is recorded exclusively for COVID-19. This change was enacted apparently without public opportunity for comment or peer-review. As a result, a 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]

COVID-19 Data Historical

Timeline

A historical timeline of events is presented relative to the PRA, IQA, cause of death reporting, and how the COVID-19 crisis has unfolded as a result. Please note that all data, including statistical pro-jections produced by any entity outside of federal regulatory law, must go through strict federal proce- dures for OMB oversight before being used by any federal agency for any purpose.

These regulatory laws apply to the use of data being published at the university level, such as the COVID-19 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.

3501–3521, Public Law 96-511, 94 Stat. 2812).December 11, 1980 – Paperwork Reduction Act (PRA) becomes law (44 U.S.C.

PRA establishes the Office of Information and Regulatory Affairs (OIRA) under the Office of Management and Budget (OMB). PRA authorizes OIRA to establish information col- lection policies for all federal agencies, including the CDC.[2]

3501–3521, Public Law 104-13, 109 Stat. May 22, 1995 – PRA is amended (44 U.S.C.

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]

The impact of using a previously untested and unproven test-based strategy (Jun 13 to Jul 17) vs the more traditional globally-accepted symptom-based strategy (Jul 17 – Aug 20). For statistical comparison, 34-day periods of time are used to equivocate the analysis. Using a symptom-based strategy, hospitalization counts dropped. As of July 17, 2020, symptoms are required along with a positive test to confirm the COVID-19 diagnosis for hospitalization, but probable COVID-19 cases can still be added. Using a symptom-based strategy confirmed safe by the CDC provides a more accurate count of total recoveries for Americans who did not require medical care.

If accuracy in data collection and reporting was a goal, a symptom-based strategy would be best.[26][27][State & Territory Health Departments]

November 17, 2019 – China records 1st known case of COVID-19.[12]

November 30, 2019 – Deadline passes for any federal agency to submit 60-day notice to Federal Register for ‘Proposed Data Col- lection Submitted For Public Comment and Recommendations’ that would enable the use of IHME projection data to inform the public and enact federal policy.[13]

January 21, 2020 – CDC confirms 1st known case of COVID-19 in US.[14]

January 24, 2020 – Deadline passes for CDC and/or National Vital Statistics System (NVSS) to submit 60-day notice to Federal Register for ‘Proposed Data Collection Sub- mitted For Public Comment and Recommendations’ that would become known as the March 24th COVID-19 Alert No. 2.[13][15]

Primary data being used to forecast the situation and January 29, 2020    – Whitehouse Coronavirus Task Force is established and included Dr. Anthony Fauci (NIAID), Dr. Robert Redfield (CDC), and Derek Kan (OMB) brief the President is sourced from the IHME in potential violation of the PRA & IQA.[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 SARS- COV-2 virus is contracted.[17]

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]

COVID-19 Alert No. 2, significantly altering cause of death reporting exclusively for COVID-March 24, 2020 – In potential violation of the PRA & IQA, the CDC issues

19. 19. In doing so, the CDC bypasses federal oversight by the [15][18]

[21]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 con- firming that his research team had shared their wildly inaccurate projections with the White House COVID-19 Task Force approximately 1 week prior to publication. The data 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]

April 14, 2020   – Dr.  John Ioannidis of Stanford publishes COVID-19 antibody sero- prevalence research confirming SARS- COV-2 virus had spread much wider than initially realized and most people infected developed natural, adaptive immunity. This study questions the necessity of continued use of IHME Predictive Contagion Models. [23]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] 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 14, 2020 – In potential violation of the PRA & IQA, the CDC adopts the CSTE COVID-19 Position Paper, significantly

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 pre- vent the same hospitalized patient from being inaccurately counted as a new case and hospitalization each time they are tested while hospitalized.[24]April 24, 2020 – National Institutes of Health (NIH) cancels funding on previously supported gain-of-function research for bat coronaviruses. [10]

July 15, 2020 – Health and Human Services (HHS) assumes control of COVID-19 data collection from the CDC. [25]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] 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 f rom 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 – After being unable to clinically prove the existence of one definitive case of asymptomatic transmission, one

July 17 thru August 20, 2020 – Over this 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, ‘Al- though replication-competent virus was not isolated 3 weeks after symptom onset, re- covered patients can continue to have SARS- COV-2 RNA detected in their upper respiratory specimens for up to 12 weeks.’[26][28] 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]

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