Abysses of disordered law; hazards of gazing into them.
Abysses of disordered law; hazards of gazing into them.
Status update on Part 5 of vaccine non-regulation series, 1798 to 1972.
Series so far:
Aug. 5, 2024 - Part 1 - Federal communicable disease control, quarantine and biological product law, 1798 to 1972: orientation through founding of Marine Hospital Service. (Lydia Hazel and Katherine Watt)
Aug. 12, 2024 - Part 2 - US federal quarantine and biological product law: Marine-Hospital Service (1798); National Quarantine Act (1878); Laboratory of Hygiene (1887) (Lydia Hazel and Katherine Watt)
Sept. 10, 2024 - Part 3 - 1901-1910: Federal government licensing of virus and toxin propagation establishments; criminalization of traffic in adulterated or misbranded drugs. (Lydia Hazel and Katherine Watt)
Oct. 9, 2024 - Part 4 - 1911-1943: Continued non-existence of legal provisions directing federal agencies to establish and enforce biological product definitions and standards. (Lydia Hazel and Katherine Watt)
I’ve been working on Part 5 for several weeks, reading and thinking about things and drafting summaries of some of the key Congressional acts. I’ve been having difficulty processing and prioritizing all the information I’ve read, and so have decided to take a two-week computer and internet break to recover.
I began planning the 1798 to 1972 series in December 2023 after writing about FDA suspension of factory inspections in 2019 and then writing a series of reports about 1973 to 2024 non-regulation history1.
I thought that the earlier history (pre-1972) would be useful to Bailiwick readers because regulatory deception surrounding vaccines was in slightly simpler form when Congress set it up in 1902, as compared to the monstrous construction of non-regulation (cross-referencing, exemptions, suspensions…) that presently hides in the black hole between the Public Health Service Act and the Food Drug and Cosmetic Act.
The main methods of deceit — not defining terms clearly and coherently; not establishing measurable product standards; not requiring development of validated tests to assess product compliance with standards; and not assigning duties of enforcement and substantive penalties for non-compliance — have remained the same.
But the more I read this past month, the more I realized that the deceits and irrationality and incoherence were already very layered even at the beginning in 1902 and became even more so by mid-century, with scientific methods and scientific data fraud (in virology, pathology, epidemiology, and other fields) and public health policy (such as the nationwide polio vaccination campaign) evolving in complexity and incoherence alongside the legal and regulatory fraud.
I’m hoping to rest and then come back to the material in early December, better equipped to write the 1944-1972 story, to convey useful information without getting overwhelmed by the details myself, and without overwhelming readers too.
In the meantime, for readers who are interested in digging deeper, I’m linking to some of the documents I’ve found most useful, while working on Part 5, for understanding how some of the regulatory, scientific and medical deceptions have been legalized and carried out.
12 key Congressional acts, 1944 to 1972
1944.07.01 PL 78-410 Public Health Service Act - Consolidated and revised Public Health Service statute, incorporating 1902 Virus-Toxin law.
1948.06.16 PL 80-655 National Heart Act - Established National Heart Institute (to join National Cancer Institute) to study heart disease.
1951.10.26 PL 82-215 Durham Humphrey Act to Amend FDCA 303 and 503 - Established two categories of drugs: over-the-counter and prescription, with prescriptions required for products characterized by “toxicity or other potentiality for harmful effect” and authorized Federal Security Agency Administrator to “by regulation remove drugs…from the [prescription] requirements…when such requirements are not necessary for the protection of the public health.”
1955.08.12 PL 84-377 Polio Vaccination Assistance Act - Funding from federal government to states to inject polio vaccines into children and expectant mothers.
1956.02.15 PL 84-411 Act to extend Polio Vaccination Assistance Act
1958.09.02 PL 85-881 Act to relieve the Surgeons General Army Navy of certain responsibilities under PHSA - Eliminated three-member Surgeon Generals’ board responsibility for drafting and publishing biological product regulations.
1958.09.06 PL 85-929 FDCA Food Additives Amendment Delaney. - Established category of food additives “generally recognized as safe” (GRAS) under food adulteration laws, and provided that the Health, Education and Welfare “Secretary shall by regulation provide for exempting from the requirements of this section any food additive…intended solely for investigational use…”
1962.10.10 PL 87-781 Drug Amendments Act Kefauver Harris - Established authority for FDA to require evidence of effectiveness in review of New Drug Applications, and provided for conditional exemptions, “within the discretion of the [HEW] Secretary…among other conditions relating to the protection of the public health,” and exemptions from requirements to “obtain the consent of such human beings or their representatives…where [investigational drug manufacturers or sponsors] deem it not feasible or, in their professional judgment, contrary to the best interests of such human beings...”
1962.10.23 PL 87-868 Vaccination Assistance Act - Funding from federal government to states for polio, diphtheria, whooping cough (pertussis) and tetanus vaccines and vaccination programs.
1964.09.19 PL 88-605 Virus Leukemia Program (at p. 14/23). Later known as Special Virus Cancer Program.
1970.10.30 PL 91-515 Heart Disease, Cancer, Stroke, and Kidney Disease Amendments to PHSA - Added vaccine to list of biological products for the first time, did not define the product or direct federal agencies to establish definition by regulation.
Biologics regulations promulgated by agencies, 1903 to 1972
(Treasury, 1903 to 1939; Federal Security Agency, 1939 to 1953; Health Education and Welfare, 1953 to 1979; Health and Human Services, 1979-present)
1903.02.21 PHS Treasury Regulations for the Sale of Viruses, Serums, Toxins and Analogous Products
1909.05.11 PHS Treasury Regulations for the Sale of Viruses, Serums, Toxins and Analogous Products
1919.02.12 PHS Treasury Regulations for the Sale of Virues, Serums, Toxins and Analogous Products
1923.08.01 PHS Treasury Regulations for the Sale of Viruses, Serums, Toxins and Analogous Products
1934.03.13 PHS Treasury Regulations for the Sale of Viruses, Serums, Toxins and Analogous Products
1935.02.25 PHS Treasury Regulations for the Sale of Viruses, Serums, Toxins and Analogous Products (last version published before Federal Register Act)
1940 version 42 CFR 22 Viruses Serums Toxins and Analogous Products (first version published after Federal Register Act)
1947 version 42 CFR 73 Biologic Products 11 p (first version published after 1944 Public Health Service Act)
1958 version 42 CFR 73 Biologic Products 19 p (after 1954-1955 polio vaccination campaign and Cutter incident)
1972 version 42 CFR 73 Biological Products 89 p (last version before transfer from NIH to FDA 21 CFR 273 and then 21 CFR 600)
Other reports, some behind pay walls2
1910 papers by Milton J. Rosenau, Director of Hygienic Laboratory, published in JAMA
1924 Rathbone hearings on Regulation Viruses Serums Toxins - 236 pages. Discussions in the first 50 or so pages give a good overview of the different arguments mounted by PHS officers, drug manufacturers and AMA physicians against Congressional reform. Related Bailiwick reporting.
1958 - Federal Regulation of Biologicals Applicable to the Diseases of Man (Parke M. Banta, HEW General Counsel, Food, Drug, Cosmetic Law Journal)
“…[A]s far as I can determine, there has not been since the enactment of the statute in 1902 any litigation directly involving its application or interpretation; no one has been penalized for its violation nor, so far as I know, charged under its penalty provisions with any violation of any of its provisions. Moreover, I am informed that no license has been suspended or revoked over the protest of the licensee…”
1972 Nicholas Wade series on regulatory failures at NIH Division of Biologics Standards, 1958 to 1972, published in journal Science:
Feb. 25, 1972 - Division of Biologics Standards: In the Matter of J. Anthony Morris
March 3, 1972 - Division of Biologics Standards: Scientific Management Questioned
March 10, 1972 - DBS: Officials Confused over Powers
March 17, 1972 - Division of Biologics Standards: The Boat That Never Rocked
April 7, 1972 - DBS: Agency Contravenes Its Own Regulations
June 30, 1972 - DBS Scientist to Head New [FDA] Vaccine Bureau
1972 - GAO report: Problems Involving the Effectiveness of Vaccines
1980 - GAO report: Answers to Questions on Selected FDA Bureau of Biologics Regulation Activities
2016 - Early Developments in the Regulation of Biologics (Terry S. Coleman, Food and Drug Law Journal)
Note:
It’s important to read between the lines of these documents, understanding that the authors used a variety of methods to deflect readers away from concluding that the US Public Health Service, drug manufacturers and physicians have been engaged in a joint criminal enterprise to
intentionally sicken people and shorten life expectancy using poisons labeled as vaccines to cause cancers, heart disease, autoimmune, neurological and gastrointestinal disorders and other chronic disease, and
hide the truth about what they’re doing behind pharmaceutical (poison) manufacturing regulatory programs, public health and communicable disease control (quarantine and vaccination) programs and chronic disease research (vaccine-injury cover-up) programs.
Otherwise seemingly inexplicable statutory and regulatory (Congressional and federal agency) acts and omissions have been attributed to lack of delegated regulatory authority; lack of need for regulatory authority; lack of knowledge or use of regulatory authority; and lack of regulatory competency, funding and personnel.
Otherwise seemingly inexplicable acts and omissions have also been attributed to cooperative, communicative, mutually-trusting, non-confrontational relationships between regulators, drug manufacturers and physicians, such that vaccines have been construed as so properly-developed, properly-manufactured, self-tested, self-monitored and self-reported by manufacturers that there has never been any need for observable, recorded regulatory enforcement action or criminal prosecution.
FDA non-regulation of biological products and vaccines, 1973 to present, series:
March 8, 2024 - Part 1: Mutual Recognition Agreements. First in series on legal links connecting domestic and international non-regulation of non-medicines
March 12, 2024 - Part 2: Statutory and regulatory definitions for drugs, biological products, and biosimilars
March 15, 2024 - Part 3: Deregulation of biological product manufacturing, mid-1990s to present
March 20, 2024 - Part 4: Vaccines have always been heterogeneous mixtures of toxins used to intentionally sicken people and animals
March 21, 2024 - Part 5: Vaccine and related biological product manufacturing as US government-licensed poison manufacturing Evidence from November 1986 'mandate for safer childhood vaccines' codified at 42 USC 300aa-27, and July 2018 stipulation by HHS.
April 3, 2024 - Part 6: On why FDA revised written non-rules for non-regulation of biological products to make them more unintelligible, inapplicable and unenforceable since the 1990s.
April 25, 2024 - Part 7: Terms, phrases and organizations involved in worldwide regulatory and manufacturing deception surrounding vaccines and other biological products.
May 21, 2024 - Part 8: There is no legal limit to the amount of so-called contamination that can legally be included in vaccines or any other biological products.
May 25, 2024 - Part 9: On FDA buildings as virtual mailboxes to project the public illusion of biological product manufacturing regulation.
June 4, 2024 - Part 10: Sen. Rand Paul, FDA Modernization Act 2.0, and animal testing of new drugs.
June 17, 2024 - Part 11: Pretense of biological product manufacturing de-regulation layered on pretense of biological product manufacturing regulation.
July 5, 2024 - Part 12: 120+ years of legalized, US-government-led pharmaceutical fraud.
I’ve obtained the pay-walled papers and have them in my files, but have not uploaded them for public access, to avoid violating the terms-of-use for the journals.