Federal Statutory and Ethical Violations in COVID-19 Pandemic Response
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Over the course of the COVID-19 pandemic, a growing body of documentation has raised serious questions about the conduct of key scientific and governmental actors involved in the development, funding, regulation, and commercialization of pandemic-related biomedical interventions, including the Covid-19 vaccines.
Among those who are most frequently cited are Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases (NIAID); Dr. Ralph Baric of the University of North Carolina at Chapel Hill, a leading coronavirus researcher; and Dr. Peter Daszak, President of the nonprofit EcoHealth Alliance. These individuals, along with institutions such as the Wuhan Institute of Virology in China, have been linked through a web of collaborative research, exchange of scientists, patent filings, and federal grant funding that, according to several independent investigations, skirted or violated U.S. laws related to public health ethics, intellectual property, federal disclosure requirements, and international biosecurity standards.
Particularly concerning are the allegations that federally funded research enabled gain-of-function manipulation of coronaviruses; this was despite the Obama administration’s moratorium on such experiments from 2014 to 2017.
These experiments were conducted in partnership with the Wuhan Institute of Virology, and received funds that were funneled through grants awarded by NIAID to EcoHealth Alliance. The scientific knowledge and intellectual property produced by the funding, which was commercialized by private pharmaceutical firms notably Pfizer and Moderna, culminated in the rapid deployment of mRNA-based vaccines under rushed emergency use authorizations.
According to its critics, these vaccines were developed and distributed under conditions that lacked transparency regarding their experimental status, potential risks, and the government’s long-term financial stake. The key legal, scientific and ethical concerns about these actors involved in pandemic interventions have been drawn from publicly available documents, patent records, congressional testimonies, and regulatory filings in order to assess whether their collective actions may constitute violations of U.S. statutes and/or international norms.
Violations of the Patriot Act
Dr. Anthony Fauci, the NIAID, and several collaborating entities unlawfully provided funding that could be construed as support for acts of terror. This was in violation of 18 U.S.C. §2331 §§ 802 from the Domestic Terrorism statute in the USA Patriot Act whereby through research financing the pathogenic potential of coronaviruses was enhanced. As early as 2005, Dr. Fauci publicly recognized the bioterror potential of SARS by referencing a “SARS Chip” DNA microarray for the rapid detection and development of spike-protein-based vaccine candidates. Research teams under Dr. Fauci’s direction at the Vaccine Research Center at NIAID, including Chinese researchers Zhi-yong Yang, Wing-pui Kong, and Yue Huang, were actively engaged in DNA vaccine trials in animals by 2004. These efforts were reportedly conducted in partnership with organizations such as Sanofi, Scripps Research Institute, Harvard University, MIT, and the NIH.
Under NIH grant R01AI110964, the CDC and NIAID, through collaboration with Dr. Peter Daszak’s nonprofit EcoHealth Alliance Inc. entered partnerships with the Wuhan Institute of Virology and the Chinese Academy of Sciences. This grant and its collaborations funded research to study the potential for bat coronaviruses to infect humans. It also included research focused on how to manipulate surface proteins of coronaviruses to increase their ability to infect human respiratory systems. According to patent expert Dr. David Martin, these experiments were conducted in violation of the NIH’s moratorium on gain-of-function research during the years following the 2014 moratorium. This work was also funded by NIH grant R01AI079231 to EcoHealth Alliance and the Wuhan lab to collect bat coronaviruses that would be capable of infecting humans.
In 2013, research led by Dr. Zhengli Shi at the Wuhan Institute was instrumental in isolating and enhancing coronavirus spike proteins capable of infecting human cells via ACE2 receptor binding. In 2015 quote by Dr. Daszak emphasized the need to create media hype around pandemics in order to continue funding for vaccine development, “We need to use that hype to our advantage… Investors will respond if they see profit at the end of the process.” This statement is an indication of financial and strategic intent to capitalize on public fear. It contributes to the argument that federal agencies and their partners knowingly used public funding and manipulated information to prepare for and benefit from a global health crisis.
Under the scope of the Patriot Act’s 18 U.S.C. §2331 §§ 802, Dr. Fauci’s response to the COVID-19 pandemic may be constituted as acts of domestic terrorism, which is defined as activities that are dangerous to human life, violate U.S. law, and are intended to coerce or intimidate civilian populations or influence government policy. According to Dr. Martin, Dr. Fauci amplified fear propaganda among the American public by promoting the worst-case projections voiced by Dr. Neil Ferguson of Imperial College London. Ferguson predicted there could be 2.2 million deaths alone in the U.S. due to COVID-19, despite the utter absence of viral evidence at the time.
These predictions lacked peer review and verification. They were used to justify unprecedented public health interventions such as mass quarantines, lockdowns, social distancing mandates, and face mask requirements. Moreover, these mandates were not based on sound scientific evidence. In March 2020, an article in the Journal of the American Medical Association (JAMA) stated that there was no evidence to support face masks by healthy individuals to prevent respiratory infections. Sharp criticism is also warranted against Further criticism is directed at the use of models from the Institute for Health Metrics and Evaluation (IHME), which is heavily funded by the Bill and Melinda Gates Foundation, for using models on pandemic measures that had no validation or transparency for public scrutiny.
In addition, Dr. Fauci suppressed emergency use authorizations for repurposed drugs and alternative treatments, such as hydroxychloroquine and ivermectin, that had shown promise in the scientific literature to treat and lessen coronavirus infections. This suppression steered public policy and healthcare responses toward untested and later controversial interventions such as mRNA vaccines developed by Moderna and Pfizer/BioNTech, and expensive novel drugs such as Remdesivir, thereby increasing avoidable deaths and societal harm.
Lying to Congress
Dr. Fauci and other officials at the National Institutes of Health knowingly provided false or misleading statements to Congress and other government bodies regarding intellectual property and licensing revenue. This is in violation of statute 18 U.S.C. § 1001 in the antitrust laws of the Sherman Act that criminalizes willfully making false statements and concealing material facts in legal matters under the jurisdiction of the federal government. An October 2020 report from the U.S. Government Accountability Office (GAO) states that the NIH had received up to $2 billion in royalties from 34 federally supported drugs sold between 1991 and 2019. However, a comparative review of the NIH Office of Technology Transfer found clear discrepancies with many active licenses and patents omitted from the GAO summary.
The NIH’s omissions reflect a pattern of deceptive concealment regarding the agency’s commercial interests in pharmaceutical developments, which includes the COVID-19 vaccines and novel anti-SARS2 therapeutic drugs. This lack of transparency undermines public trust and violates legal obligations concerning financial disclosures tied to federally funded research. The implication is that Dr. Fauci and NIH officials materially misled Congress about the scope and scale of revenue generated from publicly funded patents thereby obstructing government oversight.
Criminal Commercial Activity
Statute 15 U.S.C. §8 prohibits conspiracies that unreasonable monopolization of markets that engage in anti-competitive practices. The statute can be used in arguments that claim key health agencies and pharmaceutical firms may have colluded to dominate the pandemic response market and suppress alternative treatments. Multiple federal agencies, academic institutions and private corporations engaged in a criminal conspiracy to monopolize coronavirus-related research and product commercialization. The claim centers around the collaboration between NIAID, CDC, WHO, and pharmaceutical giants including Moderna, Pfizer, Gilead, Sanofi, Johnson & Johnson, and numerous biotech startups to control diagnostics, treatments, and vaccine distribution during the pandemic.
In October 2019, the Event 201 pandemic simulation was conducted by the Johns Hopkins Center for Health Security, the Bill and Melinda Gates Foundation, and the World Economic Forum. This event was a precursor to orchestrating a market monopoly. Individuals who would later be key players in the COVID-19 public health response attended this tabletop exercise. In particular, emphasis was placed on global preparedness for a respiratory virus pandemic. This response required coordination across various government and public health sectors to manage public messaging, streamline vaccine production, and develop rapid international supply chains. Event 201 also laid the groundwork for a market framework that disproportionately benefited firms and institutions already positioned to profit from these pandemic response measures. Commercial entities with preexisting government contracts or who held crucial intellectual property had the most to gain.
Key patent holdings of Dr. Ralph Baric at UNC Chapel Hill (specifically U.S. Patent 6,593,111) and the CDC (U.S. Patent 7,220,852) formed the backbone of a legal and commercial structure that required all U.S. coronavirus research to pass through a narrow corridor of licensed access. U.S. Patent 6,593,111 for Recombinant Coronavirus is owned by Dr. Ralph Baric and his colleagues, and covers methods for producing recombinant, or genetically engineered, coronaviruses. This patent forms the basis for claims that segments of the coronavirus genome were manipulated for research or therapeutic use, such as vaccines. It raises concerns over whether such research should have ever been legally patented if it was conducted with public funds.
Filed by The CDC’s 2003 U.S. Patent 7,220,852 covers the isolated SARS-CoV genome and methods for detecting the virus. This patent potentially violates federal statute 35 U.S.C. §101 that prohibits patenting natural phenomena. In addition, this patent also blocks independent SARS research by controlling access to the virus’ genome.
This control over these patents enabled these entities to dominate the development and distribution of diagnostics, treatments, and vaccines for the earlier SARS-CoV virus and the later SARS-CoV-2. These patents also blocked independent researchers’ investigations and limited public access to information that would have enabled the scientific community to explore alternative solutions; this effectively created a biomedical monopoly during a global crisis.
Conflicts of Interest
Legal statute 15 U.S.C. § 19 prohibits individuals from serving on the boards of competing corporations if such service reduces or disrupts competition. The statute is relevant in accusations that key figures held simultaneous roles in regulatory, advisory, and commercial entities that led to flagrant conflicts of interest during pandemic-related decision-making. There were numerous individuals involved in coronavirus research and policy decisions who held simultaneous roles in both regulatory bodies and commercial enterprises. These conflicts of interest violated antitrust laws.
For example, Dr. Ralph Baric served as both an academic researcher and a member of the WHO’s Coronaviridae Study Group, which determined the taxonomic classification and novelty of viruses. This was a role that had direct implications for patent filings and research funding. There were also overlapping roles held by individuals across the CDC, NIAID, WHO, Gilead Sciences, Sanofi, Pfizer, Moderna, Ridgeback Biotherapeutics, and Sherlock Biosciences. These affiliations constituted a coordinated web of influence that enabled this same group of stakeholders to shape public policy and the commercial development of countermeasures. This entire federal-private enterprise undermined competitive neutrality and had a detrimental effect on lessening the pandemic’s risks and mortality figures.
Government Disclosure Failures
Statute 35 U.S.C. §§ 200–206 relates to the Bayh-Dole Act and addresses the government’s interests in federally funded inventions. These provisions mandate that inventions arising from federally funded research must disclose government interest and ensure fair access. It also gives the government certain rights over patents. Critics such as Dr. David Martin have argued that some of the COVID-related patents failed to disclose federal support and this in turn undermined the public’s rights to equitable access, oversight and actual financial benefit.
Specific examples include patents related to the manipulation of coronavirus spike protein that was developed at UNC Chapel Hill by Dr. Baric and others directly associated with the NIAID- or NIH-funded work in collaboration with EcoHealth Alliance, the Wuhan Institute of Virology, and commercial partners like Moderna. According to Dr. Martin, this lack of disclosure not only violated statutory requirements but also concealed the extent to which public funds underwrote the commercial successes of private corporations during the pandemic.
Illegal Clinical Trials
Finally, section 21 C.F.R. § 50.24 is an FDA regulation that permits human clinical research without informed consent under very strict emergency conditions; one clear example would be life-threatening situations with no proven treatment and an inability to obtain consent. Allegations around this regulation focus on whether the Emergency Use Authorization that was approved for the COVID-19 vaccine trials met the ethical and legal requirements for informed consent as well as comprehensive disclosures of risks.
Moderna’s and Pizer’s clinical trials conducted for their COVID-19 mRNA vaccines violated ethical norms and legal standards. In particular were violations concerning informed consent and public transparency. The fact remains that these so-called vaccines were not traditional immunizations but rather experimental gene therapy platforms that introduced synthetic mRNA to stimulate spike protein production within the human body.
Dr. Martin asserts that both companies, with federal backing, presented these interventions to the public as vaccines in a manner that sidestepped the rigorous consent processes typically required for novel therapeutics. Worse, the Emergency Use Authorization (EUA) was used to expedite these experimental vaccines’ deployment while downplaying the investigational nature of the products and minimizing disclosure of known risks. In doing so, the trials contravened U.S. regulations and failed to meet the ethical requirements laid out in both domestic law and international bioethics guidelines.
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Richard Gale is the Executive Producer of the Progressive Radio Network and a former Senior Research Analyst in the biotechnology and genomic industries.
Dr. Gary Null is host of the nation’s longest running public radio program on alternative and nutritional health and a multi-award-winning documentary film director, including his recent Last Call to Tomorrow.
They are regular contributors to Global Research.
Note
[1] The following review is a summary of legal statutes, data, and patent analyses compiled by Dr. David Martin from his The Fauci/Covid-19 Dossier published online in 2021. For greater details and Dr. Martin’s analyses: https://www.davidmartin.world/wp-content/uploads/2021/01/The_Fauci_COVID-19_Dossier.pdf
Featured image is from Children’s Health Defense
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