Thank you for reading and sharing Bailiwick News by email and social media. To support Bailiwick with a paid subscription: 1944-1972: Law and public policy imbued with scientific misconduct to better induce irrational fear of disease and irrational trust in vaccination.Part 5 of series on US federal biological product and quarantine law, 1798 to 1972
By Lydia Hazel and Katherine Watt JMJ Outline I. Introduction II. Historical Context; Overview of Four Layers of Scientific-Legal Misconduct III. Scientific, Medical and Mathematical Misconduct IV. Infusion of Scientific and Medical Misconduct into Legal Misconduct A. 1944 Public Health Service Act B. Quarantinable communicable disease designation by executive order C. 1944 PHSA, textual analysis D. 1947 - First post-PHSA regulations published i. Original structure of biological product regulations, 1902-1944 ii. How biological product regulation changed after Congress passed the 1944 PHSA E. 1945 - 1959 - DDT pesticide campaigns; DTP combination vaccines; polio vaccination campaign F. 1955-1972 - NIH-DBS regulatory simulation acts and omissions; J. Anthony Morris G. October 1962 - Vaccination Assistance Act and Drug Amendments Act V. Discussion VI. Summary VII. Connections to US military chemical and biological warfare programs, and corroborating reports published after 1972 I. Introduction So far in our pilgrimage to understand how perverted legal instruments (statutes, regulations, executive orders, treaties, trade agreements and contracts) have made possible the legalized, ongoing, vaccine- and pesticide-driven mass poisoning of the world's people, we have presented timelines of laws enacted between 1798 and 1943¹ and between 1972 and the present.² Our goal is to give readers a scaffolding on which to attach more knowledge. The volume of available information, and the complexity and moving target character of the deception programs make it difficult to do anything more than provide a scaffold. We are confident that our basic conclusions are supported by the evidence from the wording of legal instruments themselves, and from the written record surrounding the application of the laws, including government and academic reports, published scientific and medical literature, litigation records (stipulations and judicial decisions), and historical accounts written by researchers whose work was not funded by governments, private institutions or universities. Our conclusions: Regulation or licensing of biological product and vaccine manufacturing in the United States, by the Food and Drug Administration and its precursors, establishes and applies alternative, surrogate, proxy, indirect, uncontrolled, correlative, probability-based standards to manufacturing methods and product quality assurance methods. Because the standards are correlative, and therefore not standards at all, the procedures presented to the public as regulation have instead been a simulation of regulation, a suggestion-to-the-mind of observers, without substance or materiality. Regulatory simulation of biological product manufacturing has been going on continuously since the initial construction of the legal frameworks for biological products in 1902 with Congressional passage of the Virus-Toxin law, through the present. The basic reason for the simulation is that the simulators have want the public to believe -- contrary to the truth -- that vaccines are a class of products that can be stabilized and standardized and, in stable, standardized, identifiable and identified forms, can be demonstrated to have stable properties or attributes such as purity, therapeutic effectiveness and strength. These properties are denoted using many different terms within legal instruments. Some of the other terms are sterility, safety, efficacy, specific results, potency, dosage, contaminated, adulterated, adventitious agents, bioburden, extraneous proteins Because the contents of vaccine bottles are propagated by living organisms, vaccines are processes, and not products. And because they are non-self organic matter, injected into the blood of a recipient organism, they can also be understood as injectable pesticides. They offer a much more concentrated, effective delivery mechanism than aerial and surface spraying. As living organisms or dynamic processes encased in steel or glass, vaccines cannot be fully identified, defined, characterized, stabilized or standardized, and thus cannot be demonstrated to have stable properties or attributes such as purity, effectiveness and strength. Regulation and standardization in a substantive, material form is practically and theoretically impossible. Over the past eight decades, those who use vaccines to poison babies, children and adults under the guise of therapeutic benevolence have made changes to the wording of biological product and communicable disease control law. In most cases, these wording changes have been driven by an interest in obscuring or delaying emergence of evidence from advancements in analytical techniques and equipment, which would expose the intentional harmfulness of vaccination to public view, and to compensate for growth in public scientific literacy. Why have legislators, financial officers, military officers, public health officers, scientists, vaccine manufacturers, doctors and lawyers wanted people to believe the lies that a non-standardizable process is a standardized product and that harmful products are beneficial products? We believe the evidence supports the conclusion that these government officials and professionals seek to induce false trust by suggesting feasible and rigorous quality control oversight where none occurs, and to ensure product safety and therapeutic benefit, where neither are possible, to induce compliance with vaccination campaigns. They want people to take vaccines voluntarily, repeatedly and without resistance, and to vaccinate their children, so that more people will get sick, be sicker, and die earlier, without the poisoning crimes being traceable to the killers, and within a legal system incapable of stopping, prosecuting and punishing the criminal acts. We believe the evidence supports the conclusion that biological product regulation is a web of interwoven simulations, and that the evidence demonstrates how and by whom these simulations are performed. Some of the performers -- vaccinating doctors, nurses and pharmacists who have trusted the information provided to them during training and the teachers who provided that information -- have believed they are performing good acts with true therapeutic, disease-prevention effects. They believed error to be truth, but they believed it sincerely and with good will, out of ignorance and not malice. For some of the performers who know the truth about epidemiology, pathology, virology and vaccines, the motivation is greed and the goal is money: patient visits, drug sales, campaign contributions, bribes, getting people on the public dole as disabled, and then off the public dole as dead. For others who know the truth, and who organize the work of doctors, nurses, pharmacists, manufacturers, legislators, judges and civil administrators, it's about dominance, control, and exploitation. It's war, disguised. It's about destruction of life and productive capacity. It's about orchestration of scarcity. It's about keeping people sick, weak, disordered, indebted, confused, depressed, anxious, dependent, infertile, and incapable of producing and distributing goods and services to support themselves, their families and their neighbors. Abbreviations -
II. Historical Context; Overview of Four Layers of Scientific-Legal Misconduct Part 5 is the final installment in the series, to fill in the information for the immediate post-World War II period from 1944 to 1972, which encompasses:
Layers of deception Broken down into broad categories, there are four layers to the legal deception program that made a legal hole through which injectable organic pesticides (vaccines) have been propagated at industrial scale, bottled, refrigerated, transported through interstate commerce, and used on people and animals since 1902. Layer 1 Mutual general exclusions exist between the 1938 Food Drug and Cosmetics Act (descendant of the 1906 Pure Food and Drug Act), and the 1944 Public Health Service Act (descendant of the 1902 Virus-Toxin law, as follow: 1938 FDCA, Section 902(c): "Nothing contained in this Act shall be construed as in any way affecting, modifying, repealing, or superseding the provisions of the virus, serum, and toxin Act of July 1, 1902"; and 1944 PHSA, Section 351(g): "Nothing contained in this Act shall be construed as in any way affecting, modifying, repealing, or superseding the provisions of the Federal Food, Drug and Cosmetic Act." Layer 2 Congress enacted, by statute, different lists of terms or phrases for product standards, laying out which properties or attributes of production facilities, processing methods, packaging and products were subject to enforcement under the FDCA, for non-biological products, and under the PHSA, for biological products. 1938 FDCA, Section 505(d) authorized the Secretary of Agriculture (later Federal Security Agency Administrator, later Health, Education and Welfare Secretary) to issue orders refusing to permit new non-biological drugs to enter interstate commerce on several grounds. The manufacturing-related grounds to deny permission for distribution were: "upon finding...that the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug are inadequate to preserve its identity, strength, quality and purity.” 1944 PHSA, Section 351(d) authorized the Federal Security Agency Administrator (formerly Treasury Secretary, later HEW Secretary) to issue "licenses for the maintenance of establishments" to "propagate or manufacture" any biological product designated as a "virus, therapeutic serum, toxin, antitoxin or analogous product, or arsphenamine or its derivatives (or any other trivalent organic arsenic compound)." The manufacturing-related standards for issuing licenses were:
The most important word in the FDCA section is identity, and that's the most crucial omission from the PHSA section. Biological products are not legally required to be identifiable or identified. Without an identified, identifiable, stable product, it is not practically or theoretically possible to insure qualities, properties, characteristics or attributes of propagation materials and methods, or to insure attributes that could inhere in a product itself, such as safety, purity or potency, in initial or in continued form. Layer 3 Administrative agency regulations implemented Congressional intent to maintain two separate government oversight or product endorsement pathways (permits, authorizations, approvals, licenses) for two distinct categories of products: FDCA-governed non-biological products and PHSA-governed biological products, more properly understood as bottled biological processes. Post-1944 agency regulations exempted all new biological products from regulation as "new drugs" under the 1938 FDCA. This enabled their legal introduction and delivery through interstate commerce without proof that manufacturing methods preserved "identity, strength, quality and purity." The categorical exemption of biologics (vaccines) from FDCA 505 new drug application provisions entered into the Code of Federal Regulations (CFR) renumbered from 21 CFR 2.109 in the 1947 printing of the CFR to 21 CFR 1.109 for the 1949 printing of the CFR, as follows:
By 1956, the provision was numbered 21 CFR 1.109a. (21 FR 9890). By 1963, the provision was numbered 21 CFR 130.2 (28 FR 6377). By 1974, the provision was numbered 21 CFR 310.4 (39 FR 11680), where it stands today. A related series of regulations also exempted all "drugs intended solely for investigational use" from section 505(a) of the FDCA act (which prohibited introduction or delivery into interstate commerce of new drugs that had not filed new drug applications under FDCA 505. The phrase "Caution: New Drug - Limited by Federal (or United States) law to investigational use" appeared on labels of polio vaccine used during field trials between 1952 and 1955, indicating that campaign organizers sought a double-layer of shielding from FDCA 505 new drug application standards. The "investigational use" exemption is not covered in detail in this report, but it runs from 21 CFR 2.114 (1947) through 21 CFR 1.114 (1949), 21 CFR 130.3 (1963) to 21 CFR 312.1 (1974). A version of these exemptions, authorizing interstate delivery of "investigational new drugs," now stands at 21 CFR 312.2. Layer 4 To give the appearance of substance to vaccine manufacturing regulation, Federal Security Agency administrators (later HEW secretaries) drafted and published simulations of specific "standards" and enforcement mechanisms for biological product establishments licensed under the PHSA, for processing, storage, packaging, labeling and distribution methods or procedures, and for product characteristics. These regulations for licensing of biological product establishments mimicked the substantive, material standards applied to non-biological drugs under the FDCA, enforced by the Food and Drug Administration in cooperation with the US-Pharmacopeia-National Formulary, but were not substantive, applicable, applied, enforceable, or enforced. This is the most complex layer to understand and describe, it is the subject of the rest of this report, and it has the highest concentration of terms, definitions, exclusions, waivers, exemptions, suspensions and omissions. Words and phrases are often undefined, ill-defined or only defined in relative or contingent terms. Words and phrases used at one time are replaced with different words and phrases a few years later. When reading through our broad descriptions of how the regulatory simulation system developed and has been used, please keep in mind the difference between performative simulation -- the projection of fictional but highly realistic illusions of scientific, medical, legal and publishing integrity -- and real, observable acts and omissions. III. Scientific, Medical and Mathematical Misconduct We've chosen to begin this timeline of misconduct in 1913, noting that 20th century deceptions and omissions of material facts were built atop foundations laid in the 18th and 19th centuries by Edward Jenner, Robert Koch, Paul Ehrlich, Emil von Behring, Louis Pasteur, Rudolph Virchow, Ernst Heinrich Weber and Gustav Fechner. We hope our work laying out the history of legal misconduct founded upon scientific misconduct, supports the work of authors documenting the history of scientific misconduct and suppression of dissenters' work, and also supports a new period of scientific discovery based on the observations and research materials and methods of Ignaz Semmelweis (1818-1865); Antoine Bechamp (1816 to 1908) and Gunther Enderlein (1872 to 1968). Supporting documents are linked in Footnote 3.³ 1913 - Anaphylaxis, Charles Richet In 1913, Charles Richet published a book called Anaphylaxis, describing research investigating induction of anaphylaxis -- systemic detoxification or allergic responses -- by parenteral (outside the digestive system) injection of complex non-self biological materials such as bacteria, plant and animal proteins and lipids, into living mammalian animals. Richet received a Nobel Prize for his work, also in 1913. Organisms whose cells and tissues Richet extracted, injected and observed anaphylactic responses, ranging from mild itching to convulsions and death, included Man-o'-War jellyfish, mice, guinea pigs, rabbits and dogs, which extracts also contained any bacteria or other microscopic organisms living in or on the above listed creatures. Richet demonstrated that injecting blood taken from an animal that had been rendered sensitive during a first round of injections of non-self biological material, into a healthy, untreated animal, would cause the healthy, untreated animal to also experience anaphylactic reactions. He called this process of inducing anaphylaxis in an untreated animal, through injection of the blood of a previously anaphylactized animal, passive anaphylaxis. Animals injected with materials that induced such responses were described as "anaphylactized" and the material in the blood was described as "anaphylactogen."
Richet observed that white mice and some breeds of rats did not experience anaphylaxis. Other researchers in the same field, cited by Richet included: Milton J. Rosenau and John F. Anderson of the US-PHS Hygienic Laboratory, Clemens von Pirquet, Charles Mantoux, Bela Schick, Emil von Behring and Maurice Arthus. At the individual level, the harm caused by anaphylaxis has been called serum sickness, allergy and hypersensitivity syndrome. It manifests as rashes, itching, and sneezing at the mild end of the spectrum, through chronic autoimmune disorders, organ failure and death at the severe end. 19th and early 20th century studies of anaphylaxis and serum sickness were developed further through subdisciplines of biology including pathology, virology, immunology, toxicology and immunotoxicology. Researchers studied how living organisms respond across time intervals, to exposure, invasion or overload of foreign biological organisms, including both the organic (carbon-based) particles which living organisms produce naturally, and those which humans began producing at industrial scale through synthetic chemistry techniques. The anaphylaxis studies by Rosenau, Richet and their colleagues also formed the basis for government-directed vaccination and immunization policies and programs, as components of disease diagnosis and disease classification systems (epidemiology) and communicable, transmissible or infectious disease control. 1934 - Probability units or probits, Charles Ittner Bliss Immunity unit and antitoxin unit were the earliest terms applied by scientists and physicians to give the impression that specific results or potency for viruses, serums, toxins and antitoxins could be observed, measured, defined, described and predicted for recipients of a packaged product. Milton J. Rosenau, director of the US-PHS Hygienic Laboratory from 1899 to 1909, for example, used the term immunity unit in a 1905 Hygienic Laboratory Bulletin: The immunity unit for standardizing diphtheria antitoxin. These "units” were derived by dilution and arbitrary assumptions, from the median minimum lethal dose of toxic, heterogeneous, unstable mixtures of foreign biological substances, when injected into a group of living test subjects such as guinea pigs, mice, rabbits and dogs, suggesting a prediction as to the probability of harm to members of a population or group considered in the aggregate or collective. In 1934, Charles Ittner Bliss, trained in biology but with an interest in statistics, introduced another probability-derived term to describe the functional capacity (strength, potency, effectiveness, toxicity) of a material substance to cause organ damage, organ failure and death, when dispersed or administered to living creatures within time and space using different methods of dispersal or administration. Bliss published a report — 'The method of probits' (Science, 1934) — on how to mathematically convert data such as the percentage of a pest killed by a pesticide into a "probability unit" or "probit." Probit joined biological product potency nomenclature such as immunity unit (in use by 1905); antitoxin unit (by 1909); international unit (by 1931); and international antitoxic unit (by 1946). Probability-based pseudo-measurement units are measures of probability that a substance will have a defined effect on a predictable proportion of a population of living creatures in the aggregate. They can be re-formatted to suggest the probability that an exposure or dose will have a defined effect on an individual, but there is no way to predict the specific effect of a specific dose on a specific living cell, insect, animal or person at a specific time and place, because the infinite complexity and variety of the starting condition and dynamic biological processes comprising the specific cell, insect, animal or person and their relationships to other organisms and experimental conditions cannot be known. Other probability-derived measurement terms include median lethal dose or LD50: dose of a substance that will kill 50% of the subjects receiving it, expressed as mass of substance administered per unit mass of test subject); median infective dose or ID50: dose that has a 50% probability of producing a specified response to infection, considered as symptoms or signs of disease or death; tissue culture median infective dose or TCID50: dilution of a [presumed-present, stable, isolatable] virus required to infect 50% of a given cell culture; and Ct50: measure of intensity of exposure as a function of concentration and time. Other probability units are derived from formulas based on the proportion of particles in a sample capable of causing a presumed effect and the probability that any one such particle will have that capacity or function, such as infectious unit (IFU), plaque forming unit (PFU), colony forming unit (CFU) and transduction or transducing unit (TU). Probability units are proxy measures from observing a population of living cells, insects, animals or people during and after exposing them to poisons, counting the ones that have observable symptoms of detoxification processes (also called disease or infection) as well as the dead ones, and then expressing those numbers as a proportion of the starting population. All of these units depend, for their own validity, on the validity of the method that proponents (of the measurement unit) claim or presume has established the real presence of a named toxic particle or organism (i.e., sarin nerve gas, or a specific virus such as rabiesvirus or poliovirus) and on a real causal relationship between the presence of the named particle and observed effects. To the extent the cited scientific methods do not, in truth, establish a real causal relationship between the presence of named particles and observed effects such as cell death in a dish or paralysis or death in a living animal, the units used to measure the amount of matter and the potency, or capacity of the matter to induce predictable effects, are false units of measure. 1939-1954 studies in inducing tissue damage, brain and spinal cord damage, and death in rats, white mice, monkeys and dogs through serial passage of bacteria, mouse, rat, horse, cow, dog, monkey and human tissue mixtures by injection. In July 1939, the Journal of Experimental Medicine published a paper by Rockefeller Institute investigator Leslie T. Webster titled 'A mouse test for measuring the immunizing potency of antirabies vaccines.' Webster assumed that a material substance he called "rabiesvirus" passaged through dogs was the active component, within an aliquot of brain tissue and "horse serum," that caused rabies disease symptoms. He purported to demonstrate the "immunizing potency" of antirabies vaccine by injecting serial dilutions into inbred W-Swiss white mice (not subject to anaphylaxis, per research by Richet and others), followed by observation of the proportion of dead mice in each test group and measurement of "neutralizing antibodies in the serum" as a surrogate endpoint or proxy . 1939 - Inducing brain and spinal cord damage, paralysis and death in rats and white mice through serial passage of brain and tissue culture mixtures by injection. In September and December 1939, Charles Armstrong published two papers in the US Public Health Service journal Public Health Reports. In the September 1939 paper, 'The experimental transmission of poliomyelitis to the Eastern cotton rat,' Armstrong described receiving a sample of brain and spinal cord tissue taken from an 18-year old-boy who had died with cause of death attributed to polio in August 1937. Armstrong stated: "a strain of virus was recovered from the material which has now been through 15 monkey passages and which clinically, and pathologically as reported by Surgeon R. D. Lillie, is apparently a strain of poliomyelitis." Armstrong assumed that poliovirus was a stable, transmissible particle of matter, assumed that it was present in the boy who had died, assumed it had transmitted person-to-person to infect the boy, and assumed that it had caused the boys' death. He then claimed to demonstrate that it was solely and specifically the presumed poliovirus particles within mixtures of human, monkey, and rat brain and spinal cord tissue and bacteria, which he injected into fresh cell and tissue cultures, that caused the cell death observed in the plates (cytopathic effect or cytopathogenic effect. And he claimed to demonstrate that was solely and specifically the presumed poliovirus material within the mixtures, which he injected into healthy rats and monkeys intranasally (up the nose), and, by injection, subcutaneously (under the skin), intramuscularly, and intracerebrally (into the brain), that caused tremors, paralysis and death observed in the animals. In the December 1939 paper, 'Successful transfer of the Lansing strain of poliomyelitis virus from the cotton rat to the white mouse,' Armstrong described additional passages and inoculations, resulting in organ damage, tremors, paralysis and death in healthy white Swiss mice. (See Richet's work, above, on inbred Swiss mouse lack of susceptibility to anaphylaxis). Armstrong also described "neutralization" tests involving rats injected with mixtures of "virus" strains and "poliomyelitis antisera" derived from blood drawn from monkeys that had recovered from "virus"-induced paralysis attacks. Almost all of the rats subjected to the virus-antisera injections died. Jamie Andrews summarized Armstrong's work in 2021: "No purified/isolated “virus” is ever presented in either paper nor is pathogenicity proven." In January 1949, John F. Enders, Thomas H. Weller and Frederick C. Robbins published a paper in Science, 'Cultivation of the Lansing Strain of Poliomyelitis Virus in Cultures of Various Human Embryonic Tissues.' Enders subsequently published at least two more papers on similar work on poliomyelitis virus and measles virus: 'Cultivation of Poliomyelitis Virus in Cultures of Human Foreskin and Embryonic Tissues' (August 1949), Proceedings of the Society for Experimental Biology and Medicine) and 'Propagation in Tissue Cultures of Cytopathogenic Agents from Patients with Measles (June 1954, Proceedings of the Society for Experimental Biology and Medicine). Enders and his colleagues used the same basic materials and methods as Armstrong, and the mathematical probability methods for quantification used by Rosenau and Bliss. They injecting slurries of cells and tissues of bacteria, mice, rats, monkeys, and human beings into cell and tissue cultures, and into healthy mice, rats and monkeys; observed organ failure, tremors, paralysis and death of the animals; extracted tissues from the diseased and dead animals; and repeated the cycle. The novelty they introduced, which they then reported in the scientific literature, was laboratory methods for using tissues and cells taken from the arm muscles, leg muscles, intestines, skin and brains of human embryos and the foreskins of male human children as components of the biological slurries and cell and tissue cultures. Enders received the Lasker Prize and Nobel Prize in 1954 for his work. In 2002, Merck vaccine developer Maurice Hilleman would describe Enders' January 1949 paper as marking the "beginning of the modern era of vaccines" as a "breakthrough technology for cell culture propagation of viruses." Discussion The 1939 papers by Webster and Armstrong, and the Enders papers published between 1949 and 1954, set the frame for the next 85 years of scientific, medical and legal misconduct and deception of the public to believe false premises. In cell biology, observed cell stress, fragmentation and death is known as the cytopathic effect or cytopathogenic effect. Some of the terms used in scientific literature to denote cells undergoing stress and death processes, and fragments of such cells, include viruses, antibodies, spores, toxins, antitoxins, endotoxins, exotoxins, enzymes, proteins, exosomes, endosomes, lipids, peptides, polypeptides, nucleic acids, amino acids, alkaloids, rickettsia, antigens, toxigens, pathogens, immunogens, viroids, virions, prions, cytokines, phages, phagocytes, lymphocytes, macrophages and bacteriophages. Dying and dead cells and cell fragments, detected by microscopic observation, suggest that a living organism was enduring an invasion or attack at the time the samples were drawn and observed. Virologists, immunologists and toxicologists measure the cytopathic or cytopathogenic effect using probability-based units of measure. And they attribute mechanistic meaning to the observed existence of dead cells and cell fragments: that the host organism was losing to the foreign invaders or overload of commensal organisms (infection, disease, death) or that the organism was overcoming the challenge (healing or becoming tolerant or immune). This is the basis for "antibody titres" as a surrogate marker, biomarker, proxy, or probability-based measure of current infection status, capacity to transmit or spread infection, and capacity to respond more quickly, with fewer symptoms, to future destabilizing processes. Stefan Lanka, Jamie Andrews, Sasha Latypova, the late Tracey Northern and others are demonstrating the invalidity of foundational scientific methods underlying contagion theory and genetic theory, because of the inherent time-dependent, uncontrollable changes in form for products of biological processes in living organisms. We believe that the same materials and methods (emulsified bacterial and animal cells and tissues injected into brains and blood of other animals, followed by observation of organ failure and death) are used as evidence to support many different claims in scientific disciplines other than pathology, epidemiology, virology and vaccine manufacturing, which claims themselves require conduct of separate investigations to isolate each variable and demonstrate causal relationships. The materials and methods used by Bliss, Armstrong, Enders and their colleagues and followers, are used to support the following premises, none of which are true:
In other words, the cycle of forcible extraction of biological matter, for forcible insertion into another organism for whom it is foreign, is interpreted — in the corrupted, disintegrated, perverse scientific disciplines of pathology, epidemiology, virology and biology and in the corrupted, disintegrated medical practice of vaccination — as simultaneously evidence of disease and as correlate of protection against disease. IV. Infusion of Scientific and Medical Misconduct into Legal Misconduct Supporting documents are linked in Footnote 4.⁴ A. 1944 - Public Health Service Act In July 1944, Congress enacted the Public Health Service Act of 1944. It was a companion act to the Public Health Service Act of 1943, which had set forth a new organizational structure for the US Public Health Service. The 1944 PHSA consolidated and revised federal laws governing Public Health Service administration; research programs, including selection of projects eligible for federal funding and publication of reports; federal-state cooperation programs, including funding tied to preparation of state public health plans and submission of state "vital statistics" records; operation of public hospitals; care of lepers; care of narcotics addicts; regulation of biological products; designation (by executive order) of communicable diseases and operation of communicable disease control programs (quarantine and inspection); cancer research programs; and receipt of gifts. This series is focused on just two of those subjects: regulation of biological products (PHSA 351-352) and control of communicable diseases (PHSA 361-366). B. Quarantinable communicable disease designation by executive order The 1944 PHSA section on communicable disease control carried forward and revised authorities that Congress had previously granted the President and the PHS Surgeon General under the headings "Prevention of Epidemics" and "Quarantine Service." This sequence of laws set up a system under which Presidents designate communicable diseases by executive order. Any collection of non-specific symptoms of illness exhibited by human beings can be classified as a "communicable disease" without any supporting evidence or evidentiary review process that a specific material substance caused the symptoms; can be transmitted from person to person, or that those exhibiting symptoms will not, in most cases, recover without complications after brief illness. Communicable disease control law connects to biological product laws by way of 1) false classification of diseases as organism-caused and communicable; 2) false classification of organism-caused communicable diseases as causes of morbidity and mortality entered into centralized statistical registries (epidemiological surveillance); and 3) the bottling and labeling of vaccines -- toxic, heterogenous, unstable mixtures of allegedly transmissible, allegedly disease-causing organisms -- as preventatives for what are now often described under the non-specific heading "vaccine-preventable diseases." On March 26, 1946, President Harry S. Truman issued the first presidential executive order under Section 361 of the 1944 Public Health Service Act, "specifying communicable diseases for the purpose of regulations providing for the apprehension, detention, or conditional release of individuals to prevent the introduction, transmission or spread of communicable diseases." The list of "communicable diseases" was:
Many of the "specified" diseases, were not, in fact, communicable or transmissible diseases. Three of these terms — encephalitis, meningitis and poliomyelitis — were terms developed by centralized medical and scientific data collection and publishing institutions in the early to mid-20th century to denote symptoms of inflammation and breakdown of brain and spinal cord tissue, primarily caused by poisoning carried out through spraying of chemical herbicides, insecticides and rodenticides (pesticides, biocides) and through vaccines bearing labels alleging their contents were derived from organisms that allegedly caused diseases denoted as smallpox, diphtheria, tetanus, pertussis and influenza. The symptom constellations had previously been described in medical and scientific literature under names including Heine-Medin disease, Strumpell's disease II, infantile paralysis, flaccid paralysis, polioencephalitis, encephalitis lethargica, and Theiler's encephalomyelitis. C. 1944 PHSA, textual analysis Congress enacted three apparent changes to biological product regulation through the 1944 PHSA, specifically at section 351(d):
There is a lot packed into that paragraph. Congress added what looked like a condition that biological product makers show compliance with product standards, in order to obtain licenses for specific products, not just for the general activity of propagating products. And Congress added a list of attributes apparently (but not substantively) applicable to products, compliance with which was an apparent (but not substantive) condition for product license issuance. Prior to the 1944 Congress, manufacturers were required to submit applications only for "licenses for the maintenance of establishments." There was no mention of licenses for individual products. The Treasury Secretary (later Federal Security Agency Administrator) issued each establishment a license number, and that number was the number that appeared on labels of all products the company bottled, labeled and distributed. This is still the case today: there are no license numbers issued for specific products. The license number printed on each vaccine bottle label, since 1902, has been the license number assigned to the manufacturing company when it first applied for an establishment license. The license number also stays with the company over time, as the company is bought, sold and renamed. Pfizer, for example, holds US License No. 0001, the number originally assigned to Parke, Davis & Co., which became Warner-Lambert in 1970, and was bought by Pfizer in 2000. The wording of 351(d) is what makes it possible for regulators and manufacturers to suggest to the public that a license number corresponds to a specific, identifiable product, not to the establishment in which it was bottled, but not be required to "insure" any specific attributes of any product produced by the company. "The establishment and the products" are a single legal unit. Both the establishment and all of its products receive the same (single) license, not several (plural) licenses corresponding to products in the plural. As such, the "standards" described in the paragraph also apply to the establishment and its products existing together, not to individual products distinct from their manufacturer. In practice, this boils down to the main principle of biological product regulation, which is that if inspectors find the rooms in a factory to be well-lit, with proper ventilation and plumbing, with available hot water and working equipment, with written records purporting to document the propagation history and proper storage and handling of cell and tissue cultures and other materials, and written records documenting the processing methods purportedly used to make the finished products, then the "continued safety, purity and potency" of the package contents has been "insured." There are no physical standards applicable to the products as things in themselves. By 1924, an alert reporter had already identified this as a giant problem. Norman Hapgood, testifying at a Congressional committee, described the system succinctly:
In 1944, Congress added the text of section 351(d) but did not change the way that licensing and inspection procedures serve as a legal hole through which anything — "dirt, dung, or whatever it is" — may be bottled and distributed and used with the appearance, but not the substance, of having been subjected to regulatory enforcement. Prior to 1944, the list of biological products apparently (but not substantively) regulated by the Public Health Service included "virus, therapeutic serum, toxin, antitoxin or analogous product." In the 1944 PHSA, Congress added the phrase "arsphenamine or its derivatives (or any other trivalent organic arsenic compound)." Congress did not add the term "vaccine" to the list of biological products in 1944; Congress added the term in 1970, but did not require the HEW Secretary to define the term vaccine in regulations, and as of 2025, the term is still not defined in regulations. In 1944, Congress also left untouched the very short list of required package markings (label requirements), limited to: "the proper name of the article contained therein; the name, address and license number of the manufacturer, and the date beyond which the contents cannot be expected beyond reasonable doubt to yield their specific results." D. 1947 - First post-PHSA regulations published i. Original structure of biological product regulations, 1902-1944 For the first four decades of the biological product regulatory simulation scheme (1903-1944), when most vaccines were propagated and used at the city or state level, there were five broad sections of agency regulations ostensibly implementing the licensing scheme Congress enacted through the 1902 Virus-Toxin law. These basic provisions were written to suggest to the public that quality control system equivalent to the 1906 Pure Food and Drug Act and USP-NF production recipes and quality control tests for finished products for plant-derived and synthetic chemical drugs, was in place and operational. The five broad sections addressed
From 1903 to 1944 the license sections of biological product regulations contained no product definitions with objective, observable, measurable physical or chemical characteristics, and no defined scientific methods for identifying products, and no references to any non-governmental organization (like the USP-NF) as sources for production recipes or quality control testing methods. The 1903 regulations contained no definitions for products at all. In 1909, the Treasury Secretary and Surgeon Generals' board adopted a list of about 15 products defined as biological products simply by being listed by name, including "anti-diphtheric serum or diphtheria antitoxin, antitetanic serum or tetanus antitoxin...bacterial vaccines...and vaccine virus." The 1919 regulations set forth an early version of the circular, non-material, non-measurable, indirect or intent-based definitions still in use today. As of 1919, a virus was defined as " a product containing the minute living cause of an infectious disease." A toxin was defined as "a product containing a soluble substance poisonous to laboratory animals or to man in doses of one milliliter or less of the product, and having the property, following the injection of nonfatal doses into an animal, of producing therein another soluble substance which specifically neutralizes the poisonous substance and which is demonstrable in the serum of the animal thus immunized." An analogous product was defined as "(a) prepared from a virus, including microorganisms actually or potentially virulent, or (b) prepared from some constituent of the blood, or (c) intended for specific immunization or therapy..." Those definitions have remained in basically the same relative and contingent (non-objective) form ever since; current definitions are listed under 21 CFR 600.3(h). From 1903 to 1944, licenses were issued for establishments, "to engage in the manufacture, barter and sale" of viruses, serums and toxins. There were no objective rules or licensing procedures addressing products as pre-existing or as new. From 1903 to 1944, biological product regulations set forth procedures for inspection of facilities, equipment and methods. The regulations listed things site inspectors could look at, and authorized inspectors to obtain samples of finished products to send to the Hygienic Laboratory for examination but did not require inspectors to obtain samples or the Hygienic Laboratory to test them or publish test methods or results, and did not authorize on-site inspectors to directly assess manufacturing methods or the quality of finished products. The subjects of inspection were limited to "location, construction or administration of establishments which would tend to endanger the potency or purity of the products." These limited inspector duties and authorities were set forth in 1903 and entirely eliminated in 2019. In eliminating inspector duties and authorities in 2019, FDA gave as the reason: " to remove outdated requirements, accommodate new [risk-based] approaches, and provide flexibility without diminishing public health protections." (83 FR 3631) From 1903 to 1944, biological product regulations set forth standards for facilities. These covered subjects such as construction of bleeding rooms and stables for vaccine animals "to permit thorough hosing down;" stables to be "well lighted and well ventilated;" "hot water supplies to bleeding rooms and stables; "sterilization and subsequent handling of containers;" "efficient screening" of laboratories during "fly season;" and animal care and record-keeping. From 1903 to 1944, biological product regulations set forth standards for contents of product labels. Labels were required to contain the name of the manufacturer; address of the manufacturer; license number (assigned to the establishment, not to any specific product prepared within the establishment); proper name of product; minimum potency of product if any; "No U.S. standard of potency" if no potency standard established; lot number; and date of manufacture or issue with period of potency, or expiration date. Labels were not required to contain any information about the identity of any substances, quantity, mass, volume, concentration, purity, sterility, or predicted effects. The absence of these information items on labels rendered it impossible for any product to be deemed adulterated, contaminated or misbranded through any assessment method analogous to the requirements of the FDCA for non-biological drugs and rendered it impossible for any recipient to obtain information necessary to provide informed consent to treatment. From 1903 to 1944, biological product regulations set forth procedures for examination of products by PHS NIH laboratory staff, but (as stated above), it was optional for an inspector to collect samples and forward them to the PHS laboratory. If NIH officers tested the samples at all, they tested the samples using unpublished, unvalidated test methods, comparing unstable mixtures of biological material bottled at the commercial facility to unstable mixtures of biological material bottled at NIH laboratories. From 1903 to 1944, the only product qualities addressed in the regulations were purity and potency, and these were not mentioned or defined in the 1902 Congressional act. PHS required no specific methods to be used to demonstrate purity. For some products, makers were expected to demonstrate potency similar to reference products provided by Public Health Service officers. The reference products, if they existed at all, were subject to the same intrinsic heterogeneity and instability of the commercially-prepared products, and potency standards were expressed in probability-based, non-objective "immunity units." Further, testing responsibility was assigned to the commercial manufacturer, with options for on-site inspectors representing PHS to collect samples and submit them to the PHS Hygienic Laboratory for testing, but no requirement that the PHS Hygienic Lab test the products or publicly report the results. For other products, makers were simply directed to print on the label: "No U.S. standard of potency." ii. How biological product regulation changed after Congress passed the 1944 PHSA As the Federal Security Agency Administrator and three-member Surgeon Generals' board began to implement the provisions of the 1944 Public Health Service Act into regulations published in the Federal Register, they provided more detailed descriptions of licensing, labeling and inspection rules and procedures, and general standards for establishments. They published the first post-PHSA version of the regulations in 1947. The same broad section headings were carried forward, into the post-1944 period, including:
These basic provisions were still unintelligible, inapplicable and unenforceable, while continuing to falsely present to the public a quality control system for biological products equivalent to the 1938 FDCA 505 and USP-NF system for non-biological drugs. For the first time in 1947, biological product regulations included definitions for the standards, qualities or attributes -- "continued safety, purity and potency" -- that Congress had introduced in the 1944 PHSA when requiring, for license issuance, compliance with regulations "designed to insure" those standards. The 1947 regulations also incorporated, for the first time, a suggestion of new product license forms and procedures, but without substance; provisions setting forth general standards for safety, purity and potency; and a section called "Additional Standards" setting forth additional standards for specific products, starting with Trivalent Organic Arsenicals, to be tested for stability, solubility, arsenic content, moisture and relative non-toxicity. Definitions The 1947 regulations defined dating period as "the period beyond which the product cannot be expected beyond reasonable doubt to yield its specific results." Expiration date was defined as "the date of termination of the dating period." Standards was defined as "specifications and procedures applicable to an establishment or to the production, content, testing, labeling, or release of products prepared therein." For the adjectives, however, instead of simply defining the words, they were defined with specificity-evading phrases: "the word...," "as applied," "is interpreted to apply" and "is interpreted to mean." Quoting from the definitions section of the 1947 regulations:
Given the intrinsic, insurmountable living nature of biological products, the actual meaning of these terms is very different from what the above suggests, as follows. "Continued" actually means "decaying" and "unstable." Therefore a product's assigned "dating period," "expiration date," and "the period beyond which [it] cannot be expected beyond reasonable doubt to yield its specific results" are completely arbitrary. The specific outcomes will vary immeasurably from person to person, contingent upon the original composition of biological material and non-biological additives, the degree of transformation and decay that has occurred during the bottling, refrigeration and thawing of the bottled mixture, and the biology of each recipient. "Safety" actually means "toxicity" or "specific results" such that the product causes harm by eliciting a rejection response to a purported "nonfatal dose" of foreign organic matter in the recipient organism. "Purity" means "heterogeneity," as an indicator of how many different living organisms and organic particles of matter produced by organisms may be found in any given container. It is related to identity, sterility, adulteration, contamination and labeling "Potency," means the degree, strength or intensity of toxicity or toxic specific result. When Congress, through the PHSA of 1944, directed the Public Health Service to promulgate "standards, designed to insure the continued safety, purity, and potency of such products," it directed the Public Health Service to publish simulations of standards that would insure that unstable, decaying, toxic mixtures of biological material could be legally bottled, distributed and used. Product license The 1947 biological product regulations, at 42 CFR 73.5, introduced a simulation of a product-specific licensing procedure, complying with and also masking the unitary nature of each single license number encompassing each numbered establishments and all of the products distributed from its premises, without identifying, defining, or assessing any products in themselves. Unlike the preceding provision (42 CFR 73.4), which carried forward the "Form of license" text laying out how Establishment License numbers would be issued, to whom and by whom, the "product license" provision did not provide a form for the license, an author, or a recipient. The "product license" was not required to contain any more substantive information about product identity, ingredients or therapeutic effects than the "establishment license" alone. 42 CFR 73.5 simply stated, "Each product license shall designate: (a) The manufacturer; (b) the establishment; (c) the license number of the establishment; (d) the proper name of the product, with additional specifications, if any, which may be approved or required for additional labeling purposes." We have never located any document in the historical record purporting to be a "product license." In available lists of "US-licensed vaccines," such as the list provided in Appendix D of the 2002 NIH-NIAID Jordan Report, all vaccines produced by any one drug company hold the same license number. For example, Merck vaccines bearing measles, mumps, rubella, hepatitis, and pneumococcal names are all designated by License No. 0002-001. Standards for Products: General The 1947 biological product regulations, at sections 42 CFR 73.70 to 73.79, introduced the early form of what would later become known as "lot release." These provisions suggested enforcement mechanisms to insure relative (not objective) qualities for products that mimicked the standards under the FDCA that authorized removal of drugs from interstate commerce if "the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug are inadequate to preserve its identity, strength, quality and purity.” Recall: these qualities of non-biological drugs were defined by the USP-NF compendia (now known as Critical Quality Attributes or CQAs), and USP-NF was responsible for designating quality control testing materials and methods. The lot release system set up for biological products was riddled with get-around clauses. Examples include: "[n]o lot of any licensed product shall be released by the manufacturer prior to the completion of tests for conformity with the standards applicable to such product" in a context in which there are no applicable standards; "[t]ests for potency shall be made on each lot only after completion of those processes of manufacture which may affect the potency of the final product" in a context in which none of the processes of manufacture can be defined with specificity, and potency is an unmeasurable, infinitely variable factor of the interaction of the biological organisms in the starting materials with each other and with the animal or human recipient; and "[t]he contents of a final container of each filling of each lot shall be tested for identity, if such a test is available, and for safety either after the labels have been affixed to the final container or affixed, both outside and inside, to the multiple container storage receptacle just prior to its sealing for storage purposes, except that exceptions to this procedure may be authorized by the Institute to apply when the volume of the final container is very large and when more than one lot is processed each day," in a context in which there are no available identity tests, and in a context in which general safety tests (added in 1960 at 42 CFR 73.72, eliminated in 2015, 80 FR 37971) are comprised of injecting "maximum volume tolerated" into two mice and two guinea pigs, and assessing whether or not they sicken or die in the next seven days, and "variations of this test, either in the volume injected or in the species of test animal used" are authorized. Lot release testing was to be conducted by manufacturers themselves, with an option, but no requirement, for manufacturers to send samples to NIH for testing. "Tests for safety, purity and potency applicable to the product shall be completed for each lot of any licensed product prior to its release by the manufacturer, and samples of any lot of any licensed product may at any time be required to be sent to the Institute for examination," again, in a context in which there are no valid, applicable tests for safety, purity or potency. "Standard units or samples for comparison made available by the Institute shall be applied in testing for potency all forms of diphtheria antitoxin, tetanus antitoxin... and other products for which such units are available," in a context in which reference products are not held by NIH for products, and if they are held, their potency is expressed in probability-based, non-objective "immunity units." Labeling The 1947 biological product regulations, at sections 42 CFR 73.50 to 73.55, expanded upon the earlier forms of non-identifying label contents. As reported above, container labels between 1902 and 1944 were required to provide label readers with the proper name of the product; name, address and license number of manufacturer; lot number and expiration date. As of 1947, the outside carton was required to contain:
all in a context in which there is no stable potency, strength or dose, because the biological material is unstable and mixed, and effects vary immeasurably and unpredictably over time and across recipients, in which the source of the product is an unidentifiable collection of many biological organisms. Additional Standards The 1947 biological product regulations, at sections 42 CFR 73.90 to 73.96, added the first "Additional Standards" section, purported to require that Trivalent Organic Arsenicals be tested, by manufacturers and regulators, for "stability, solubility, arsenic content, moisture and relative non-toxicity." In 1956, additional standards for poliomyelitis vaccine were added, and in 1957, additional standards for adenovirus vaccine were added. The additional standards were inapplicable and ineffective from the day they appeared in the regulations, because they were based on the fictional scientific methods laid out by Leslie Webster (1939), Charles Armstrong (1939), and Enders et al (1949-1954), by way of Jonas Salk, Joseph Smadel and William Workman (more information below). Mixtures of bacterial, animal and human cells and tissues were to be cultured in nutrient media (chicken embryos; cow, pig, horse serums; salts, sugars, amino acids), fixed with formalin or other toxic preservatives, and injected into mouse and monkey brains and muscles. Mouse and monkey blood was to be tested for non-specific antibodies, which would be reported as specific to alleged disease-causing agents. Mice and monkeys were to be killed and necropsied. Brain tissue was to be tested for cytopathic effect/lesions. The sick and dead proportions of mouse and monkey groups were to be counted. And "equivalent methods" and "alternative demonstrations" would be permitted as needed. The conduct of even these pretenses of NIH testing was suspended by internal policy by 1962 (Smadel memo) and the "Additional Standards" sections were eliminated in their entirety in 1996. (61 FR 40153) E. 1945-1959 - DDT pesticide campaigns; DTP combination vaccines; polio vaccination campaign In October 1945, the US government authorized general use of aerial and surface spraying of DDT and other organic pesticides, allegedly to eradicate mosquito and fly populations allegedly carrying diseases such as typhus and polio. DDT had been authorized for use on US Army soldiers since 1943. In 1948, the DTP combination vaccine (diphtheria, tetanus and pertussis) entered into use. Between 1945 and 1953, US production and use of DDT increased, and reported polio cases increased. In March 1955, Johannes Ipsen and Harry E. Bowen published a paper titled 'Effects of Routine Immunization of Children with Triple Vaccine (Diphtheria-Tetanus- Pertussis)' in American Journal of Public Health. Ipsen and Bowen worked with the Massachusetts Department of Public Health Biologic Laboratories and Harvard School of Public Health. In the paper, they described the application of scientific and mathematical methods (the Bliss-Webster-Armstrong-Enders methods) of vaccine development, immunity units, and potency testing through blood antibody titers, to a statewide population, using the term "serologic epidemiology." These simulations of scientific integrity had already been used for decades in mouse, rat, dog and monkey populations in government and commercial drug manufacturing laboratories, and on small human communities such as island populations (1905-1920, Philippines, smallpox products), soldiers at military bases (bacterial meningitis and other products, 1918, Fort Riley, Kansas), and schoolchildren (diphtheria products, 1921, New York City). In 1955, Ipsen and Bowen interpreted the results of serologic epidemiology studies conducted in a state-sized pool of human subjects: adult and child populations in Massachusetts injected with the products since 1949. They mentioned the "current poliomyelitis vaccine trials," referring to the nationwide vaccination of 1st through 3rd-graders by the National Foundation for Infantile Paralysis using vaccines developed by Jonas Salk and manufactured by commercial drug manufacturers.
With the 1949-1955 DTP campaign, American public health officers further developed the performative system: manipulating and reporting data to promote vaccination by bolstering the plausibility of fictional narratives about disease causality and disease agent transmissibility; the existence of "reservoirs of disease" and agents in human, animal and bacterial hosts, including asymptomatic carriers; testing and diagnostic criteria based on non-specific antibodies classified as disease-specific; antibody titer dilutions and arbitrary delineations to interpret results as indicators of infection or indicators of natural or artificial immunity; and classification of biological responses to pesticide exposure and vaccine injury as natural infection. As polio diagnoses rose, Jonas Salk and the National Foundation for Infantile Paralysis began laboratory production and animal testing of polio vaccines in 1952. In early 1953, Congress and President Dwight Eisenhower abolished the Federal Security Agency and transferred the functions of the FSA Administrator to the Secretary of the new Department of Health, Education and Welfare (HEW). Eisenhower appointed Oveta Culp Hobby as FSA Administrator in January 1953, and then appointed Hobby as the first HEW Secretary effective April 11, 1953. In December 1953, Joseph Smadel (Army Medical Services Graduate School) and William G. Workman (chief of PHS Laboratory of Biologics Control) prepared "provisional standards" for manufacture of polio vaccine, derived from Jonas Salk’s laboratory methods, which were derived from Enders' methods, derived from Armstrong's, derived from Bliss's "probability unit" quantification of toxic exposure and Webster's false mouse antibody basis for demonstrating immunizing potency. Those production protocols were distributed, with cell lines, tissue cultures and other starter materials, from government and university laboratories to six selected drug, pesticide and chemical companies including Parke Davis, Eli Lilly, Cutter, Wyeth, Pitman-Moore, and Sharp and Dohme, to make and supply product for the field trials organized by the National Foundation for Infantile Paralysis (now called March of Dimes) and Salk. The manufacturers assembled and bottled the materials, labeled the contents as "Poliomyelitis Vaccine," and shipped them to Salk and the field trial locations. On April 12, 1955, Thomas Francis Jr. of the University of Michigan announced that the Salk-NFIP field trials had been successful, starting his Ann Arbor press conference by stating: "The vaccine works. It is safe, effective, and potent.” The same day, HEW Secretary Oveta Culp Hobby licensed the six companies to manufacture millions of doses and distribute the doses through interstate commerce, while US-PHS NIH Laboratory of Biologics Control (LBC) officials provided updated production protocols to the manufacturers. The updated protocols, still based on the Bliss-Webster-Armstrong-Enders-Salk scientific and mathematical methods for demonstrating disease causality, virus isolation, virus propagation and vaccine potency, would form the basis for production method and potency reports submitted back to LBC to reinforce the illusion of manufacturing standards and quality assurance for the general public. In late April and May 1955, public health officials claimed to detect harmful lots of vaccine produced by Cutter Laboratories in California, attributing polio diagnoses among children and adults to "infectious virus" in the Cutter vaccines. The investigators had available to them the same unvalidated scientific methods for diagnosing disease and classifying cases by cause, to facilitate statistical fraud, pin vaccine harms on one manufacturer, and generate momentum for the construction of a more elaborate, more centrally-controlled false-front federal quality control and product testing system. Cutter recalled doses remaining on shelves, took a financial hit, but quickly recovered the lost income, expanded its facilities and moved on. In June 1955, the NIH National Microbiological Institute Laboratory of Biologics Control was elevated to become the Division of Biologics Standards, firmly positioning DBS as a federal quality control institution analogous to the USP-NF for non-biological drugs, to provide government endorsement of vaccine products and control of national vaccine supply chains. In August 1955, Congress passed the Polio Vaccination Act (PL 84-377) providing federal funding for state vaccination campaigns targeting children and pregnant women: "any individual who has not attained the age of twenty years and any expectant mother." In August, the US Public Health Service published an account of PHS polio epidemic surveillance and polio vaccine development programs in PHS Public Health Reports. In February 1956, Congress passed an act to extend the duration of the Polio Vaccination Act, through June 30, 1957. (PL 84-411) In September 1958, Congress relieved the Army and Navy Surgeon Generals of their duties to serve on the three-member Surgeon Generals' board assigned, through the 1902 Virus-Toxin law to draft and promulgate biological product regulations. The move left regulation drafting authority with the PHS Surgeon General alone and approval authority with the HEW Secretary. (PL 85-881) By the 1958 print edition of the Code of Federal Regulations, HEW Secretary Marion B. Folsom had added to biological product regulations "additional standards" at 21 CFR 73.100 to 105, based on the Webster-Armstrong-Enders-Salk methods, for Poliomyelitis Vaccine (21 FR 9890, Dec. 12, 1956) and Adenovirus Vaccine (22 FR 7560, Sept. 24, 1957). F. 1955-1972 NIH-DBS regulatory simulation acts and omissions; J. Anthony Morris Roderick Murray earned a medical degree from Harvard Medical School in 1941. He served for five years as an infectious disease control specialist in an Army medical laboratory in the South Pacific. Murray joined NIH in 1947 as a commissioned PHS officer in the Laboratory of Biologics Control (LBC). He then served as Director of the NIH Division of Biologics Standards (DBS) after the LBC was elevated to division status in June 1955 until the biological product regulation program transferred to the FDA and was renamed Bureau of Biologics in 1972. Harry M. Meyer earned a degree from the University of Arkansas School of Medicine and took a research position with the Army Medical Corps. He was recruited in 1959 to direct the NIH-DBS Laboratory of Virology and Rickettsiology, and served as the first director of the FDA Bureau of Biologics when the biological product regulation program transferred in 1972. When Meyer took over the FDA Bureau of Biologics in 1972, Murray was appointed as special assistant to the director of the National Institute of Allergy and Infectious Diseases and then retired in 1973. Joseph Smadel earned a medical degree from the Washington University School of Medicine in St. Louis in 1931 and in 1933 was a part of the team that claimed to recognize an outbreak of St. Louis encephalitis virus. Smadel then worked in virology at the Rockefeller Institute under Homer Swift and Thomas M. Rivers. In 1940, he joined the U.S. Naval Reserve, and in August 1942, joined the U.S. Army Medical Department Professional Service School (MDPSS), known by 1953 as the Walter Reed Army Institute of Research (WRAIR). Smadel served as Chief Virologist with the First Medical General Laboratory in the European Theater, assigned to control typhus outbreaks in the Mediterranean in May 1943, and then became director of the WRAIR Department of Virus and Rickettsial Diseases. In 1956, Smadel transferred from WRAIR to serve as NIH Associate Director. In 1962, he received the Lasker Clinical Medical Research Award, and in 1963 became Chief of the NIH-DBS Laboratory of Virology and Rickettsiology, dying later that year. In 1959, J. Anthony Morris was recruited to NIH by Smadel to conduct vaccine research and serve as the "influenza control officer" under Smadel, DBS Director Roderick Murray and HEW Secretary Abraham Ribicoff. Ribicoff served as HEW Secretary from 1961 to 1962, was later elected to the Senate and oversaw Congressional handling of Morris's 1971 employment complaints. In 1971, Morris filed an employment grievance against NIH leaders. Reporting on the grievance proceedings in 1972, Nicholas Wade wrote that Morris alleged "that he had been harassed and pressured to leave the DBS because of his doubts about the potency and efficacy of commercial influenza vaccine." Morris transferred to the FDA Bureau of Biologics when it was established in 1972, and was fired in 1976. His firing was attributed, by the officials who fired him, to insubordination. Morris's complaints led to NIH internal investigations, a GAO investigation commissioned by Senator Ribicoff, and a series of reports in Science magazine written by Nicholas Wade. Morris' duties as influenza control officer included receipt of manufacturer reports about the production and potency of vaccines, and testing of submitted product samples against NIH reference products to confirm or refute manufacturer claims as to potency as part of the lot release process. Manufacturer claims were based on the "additional standards" protocols inserted into federal biological product regulations by NIH officers, first published in the Federal Register in December 1956. The NIH-DBS protocols were based on Smadel's protocols developed between 1952 and 1955 during the Salk/NFIP polio vaccine field trials and mass vaccination campaigns. Smadel's protocols were based on the scientific and mathematical papers published by Bliss in 1934, Webster and Armstrong in 1939, and Enders in 1949 and 1954. During the 1971-1972 investigations, as reported by Wade, Morris testified that after taking over duties of influenza control in 1960, he had frequently opposed the release of subpotent vaccines but was overruled by his supervisor, Joseph Smadel. For a time, Morris refused to sign the documents to authorize lot release, and Smadel signed them instead. Morris testified that, on Sept. 18, 1962, Smadel drafted an internal memo ordering Morris to pass vaccines on the basis of the manufacturers' tests alone. The memo stated: "The manufacturer will provide full data on the potency assay of his lots which are submitted for release. Furthermore, release by the DBS will be on the basis of data submitted by the manufacturer and not on the basis of results obtained in this institution." Morris testified that, three days later, Smadel gave Morris a written order instructing Morris not to test specific vaccine lots that were going to be released, and ordering Morris to destroy the test animals (about 2,000 mice) that had been vaccinated with two lots of the influenza vaccine. Morris testified that he continued to protest the release of subpotent vaccines. Roderick Murray testified that the internal Smadel policy ordering regulators to sign lot release documents based solely on manufacturer claims about potency continued in force after Smadel's death in 1963. Wade reported: "Under the terms of Smadel's directive...Morris's job...was simply to check that the vaccine lots were potent according to test results provided by the manufacturers." G. October 1962 - Vaccination Assistance Act and Drug Amendments Act In October 1962, Congress passed two relevant acts. One was the "Vaccination Assistance Act" (PL 87-868), which provided $36 million to the Surgeon General to make grants to states, targeting all children under the age of 5 for "intensive vaccination programs" using vaccines that manufacturers and federal public health officers claimed offered protection against polio, diphtheria, whooping cough (pertussis) and tetanus. The other was the "Drug Amendments of 1962" (PL 87-781), also called the Kefauver-Harris Act, after its sponsors, Senator Estes Kefauver and Representative Oren Harris. Passage was ostensibly driven by the thalidomide scandal: thousands of miscarriages and birth defects among women who took thalidomide during pregnancy, mostly in the UK, Spain, Australia, New Zealand, Germany and Canada. The Drug Amendments act amended FDCA 505, pertaining to premarket efficacy and safety demonstrations for new drugs that manufacturers sought to deliver through interstate commerce. To repeat: its provisions were not applicable to vaccines because of the blanket exemptions between PHSA-governed biological products and FDCA-governed non-biological drug products and other exemptions for "investigational drugs" subject to the PHSA. In the original 1938 FDCA, the term new drugs was defined as "any drug the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety of drugs, as safe for use..." (1938 FDCA 201) In 1962, Congress added effectiveness terms so that new drug was defined as "any drug the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use..." The 1962 amendments also added in "effective" language in several parts of FDCA 505 addressing conditions under which a regulator could withdraw or suspend approval for a non-biological new drug. Without such suspension or withdrawal action, the application is deemed approved and the drug can be marketed. In 1962, through the Drug Amendments act, Congress added a third condition under which approval could be suspended: "on the basis of new information...that there is a lack of substantial evidence that the drug will have the effect it purports or is represented to have...in the labeling..." (FDCA 505(e)(3)) The 1962 amendments defined substantial evidence as "consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof." Prior to 1962, even if a manufacturer presented no substantial evidence of effectiveness for a new drug, the FDA could not, on that basis, prevent the new drug from entering interstate commerce. To repeat: the provisions of the 1962 Drug Amendments Act were not applicable to vaccines because of the blanket exemptions between PHSA-governed biological products and FDCA-governed non-biological drug products and other exemptions for "investigational drugs" subject to the PHSA. By the 1967 print edition of the CFR, HEW secretaries had added "additional standards" for live, oral polio vaccine and live and inactivated measles vaccines. "Additional standards" were later added for live mumps vaccine (1969); pertussis vaccine (1969); diphtheria toxin for Schick test (1969); live rubella vaccine (1970); typhoid vaccine (1970); tuberculin (1970); smallpox vaccine (1972); and combination vaccines. All of them were based on the Bliss-Webster-Armstrong-Enders-Salk-Smadel protocols: unworkable and invalid simulations of standards for production and quality control testing of bottled heterogeneous, dynamic biological processes, falsely presented as purified, stabilized, immune-stimulating preventatives for diseases that are not caused by transmissible infectious agents. All of them were removed from the regulations in 1996, replaced by non-binding Guidance for Industry documents prepared by the FDA, and manufacturer-generated reports about Chemistry, Manufacturing and Controls, potency testing, and cGMP compliance submitted with Biologics License Application packages. In November 1969, Congress and President Nixon passed the Defense Authorization Act, funding and setting up a reporting system for "research, development, test and evaluation and procurement of all lethal and nonlethal chemical and biological agents." A week later, on Nov. 25, 1969, Nixon gave a speech announcing US renunciation of first use of lethal chemical weapons, incapacitating chemicals, and lethal biological agents and weapons together with a plan to "confine its biological research to defensive measures such as immunization and safety measures. The same day Henry Kissinger, Chair, Joint Chiefs of Staff, issued National Security Decision Memorandum 35, exempting from the renunciation of chemical weapons "the use of riot control agents or herbicides," and exempting from the renunciation of bacteriological weapons, "research into those offensive aspects of bacteriological/biological agents necessary to determine what defensive measures are required." On Feb. 20, 1970, Kissinger issued NSDM 44, renouncing "the production for operational purposes, stockpiling and use in retaliation of toxins produced either by bacteriological or biological processes or by chemical synthesis," with the provision: "The United States military program for toxins will be confined to research and development for defensive purposes only." In 1970, Congress and President Nixon passed an act to establish a Commission on Population Growth (PL 91-213) and the Heart Disease, Cancer, Stroke, and Kidney Disease Amendments to the 1944 Public Health Service Act (PL 91-515) adding the word 'vaccine' to the list of regulated biological products but not defining the term. In 1971, US Army biological weapon production and testing facilities at Pine Bluff Arsenal, Arkansas, were transferred to the FDA and renamed the National Center for Toxicological Research. By Federal Register notice published Feb. 25, 1972, Assistant HEW Secretary for Health and Scientific Affairs Merlin K. DuVal, "concurrently re-delegated" the non-regulation of biological products from the NIH Division of Biologics Standards to the FDA Bureau of Biologics and published a memorandum of understanding signed by NIH Director Robert Q. Marston and FDA Commissioner Charles Edward. (38 FR 4004) The HEW Secretary at the time was Elliot Richardson, former Secretary of Defense, Attorney General, Secretary of Commerce and Undersecretary of State. By Federal Register notice published June 29, 1972, Acting Deputy Assistant Secretary for Management (HEW) Wayne M. Wilson transferred the Division of Biologics Standards from the National Institutes of Health to the Food and Drug Administration and renamed it the Bureau of Biologics. (38 FR 12865) V. DISCUSSION Public confidence in, and use of, vaccines and biological products is promoted through a shell game in which there is no actual pea (regulatory functions or enforceable product standards) under any of the shells, and the names of the fake-regulatory divisions are changed as the divisions move across government departments along with their fake-regulatory or regulatory-simulation functions. In Section IV we described in more detail how imaginary or fictional peas are presented as real peas, and how the shells are moved around to maintain the illusion that fictional peas are real. As readers begin to absorb the information presented so far, and interpret the history of vaccination campaigns and federal vaccine regulation acts and omissions, in light of the fundamental infirmity of biological product regulation, there are two mechanisms we want to highlight. Labeling acts and omissions are important because they occur at the point at which manufacturer claims about a product, regulator endorsement of those claims, and consumer knowledge meet. Lot release acts and omissions, under "Additional Standards" provisions, are important because they occur at the point at which product manufacturer claims and regulator assessments and endorsements meet. The basic principle of product manufacturing regulation is that if starting materials and equipment, human workers, processing methods and quality control testing of finished products are sound, then finished products will also be sound, and those who buy and use the finished products can trust that the products will work properly. The drug manufacturing quality control system set up for non-biological drugs, in 1906, under the Pure Food and Drug Act, is now operated under systems referred to as current Good Manufacturing Practice rules (cGMP) drafted by national and international regulatory bodies; Chemistry, Manufacturing and Controls (CMC) reports submitted by drug makers to regulators; and Critical Quality Attributes (CQAs) established by the US Pharmacopeia-National Formulary and similar organizations in other countries. Again, the basic premise is that if a product maker starts with high quality raw materials and uses a sound method for refining and shaping the materials into finished products, then the finished products will also be of good quality, and that if the makers and regulators have developed valid tests to check whether the finished product contains what it's supposed to contain, doesn't have flaws or impurities, and does what it was designed to do, and those tests are properly conducted, then the finished products will be of good quality and fit for human use. This system works well for making good quality inanimate objects such as doorknobs, automobiles and planes. This system also works well for synthetic chemical drugs and drugs extracted from plants, especially drugs consumed through the digestive tract and lungs. The identity and purity of the starting materials of for synthetic chemical drugs and plant extracts are known and stable. The process steps are knowable, controllable, and predictably reproducible. It is possible to make tests to check the identity and purity of the finished product, and it's possible to measure the metabolism of the drug as it passes through a living creature, by measuring distinct, stable chemical metabolites isolated from samples of saliva, exhaled breath, urine, feces and blood. But for biologic propagated by higher biological organisms — bacteria, mammals and human beings which only exist in living, communal, relational, dynamic and teleological forms — the identity and purity of starting materials (living cells, tissues and organisms) is not known and is not stable. Process steps for biological product production include propagation of living organisms in nutrient media, followed by steps purported to "inactivate" or "kill" the organisms while retaining active biological function, followed by refrigeration to slow the biological processes still underway, followed by thawing to speed up the biological processes, followed by injection of the material into a living body to interact with ongoing biological processes inside the animal or human. The precise character of these steps is not known, controllable or reproducible. There exist no valid tests to assess or ensure the quality of finished products, or measure effects through identifiable metabolites, for the same reason there exist no pure, stable starting materials and no sound processing methods: higher biological organisms don't exist in isolation but in community, and they don't exist in stable and determinate form but in living, indeterminate, dynamic and teleological form. The men and women who wanted people to trust biological products and vaccines, as if vaccines had been made and regulated like doorknobs, bicycles and non-biological drugs, needed to set up what looked like a standardized manufacturing and a quality control system, without actually being substantive. They needed something that looked like the USP-NF drug recipes and quality control system. The "as-if" system they developed works through a handful of ways. Regulations include the word "standards." But because starting materials don't have stable identity or purity and the methods don't yield the products manufacturers and regulators claim they do, biological products have no predictable, measurable effects. And because there exist no physical measurement methods but only probability-based pretend "units" there can be no standards. They're imaginary standards, or fictions. Regulations then include words and phrases to render the fake standards inapplicable to products, and other words or phrases to waive the applicability of the fake standards. For example, by the 1958 printing of the Code of Federal Regulations, NIH Division of Biologics Standards had added a section called "Additional Standards: Poliomyelitis Vaccine." Subsections addressed methods of production, cultivation of virus, filtration, virus titer methods, inactivation methods, tests for safety, potency tests involving inoculation and subsequent blood tests of monkeys, interpretation of the titer test results, extraneous protein tests, as well as dosing, labeling, dating, and samples and reports to be sent to DBS. The last section, "equivalent methods," stated that "modification of any particular manufacturing method or process or the conditions under which it is conducted as set forth in the additional standards...shall be permitted whenever the manufacturer presents evidence to demonstrate that such modification will provide equal or greater assurances of the safety, purity and potency of the vaccine as the assurances provided by such standards, and the Surgeon General so finds and makes such finding a matter of official record." The "equivalent methods" were to be permitted in a context in which the baseline methods for assurance of "safety, purity and potency" were, themselves, insubstantial and false. The regulations authorized the substitution of new methods of performing the illusion of precise product manufacturing and testing, for the original methods of performing the illusion of precise manufacturing and testing. Between 1947 and 1996, biological product regulations included "Additional Standards" sections for trivalent organic arsenicals, and for vaccines purported to prevent polio, diphtheria, tetanus, pertussis, measles, mumps, rubella, typhoid, smallpox and several other named, allegedly communicable and allegedly vaccine-preventable diseases. Then in 1996, FDA removed the "Additional Standards" sections from the biological product regulations entirely, for both bacterial products (21 CFR 620 at the time) and for viral vaccines (21 CFR 630 at the time). In their place, the FDA substituted dozens of its own Guidance for Industry documents for drug manufacturers containing explicitly "non-binding recommendations," and the Chemistry, Manufacturing and Controls (CMC) sections of Biologics License Application forms submitted by manufacturers to FDA, thus authorizing manufacturers to set their own product standards and set forth the quality control tests they (the drug companies) claimed they (the drug companies) would use to assess final products for compliance with the product standards they'd set for themselves. What reasons did FDA give for the removal of "additional standards?"
As of 2025, regulations authorizing drug makers to make post-approval changes to manufacturing and quality control methods are located at 21 CFR 601.12. VI. SUMMARY The research disciplines of virology and communicable disease epidemiology and the medical practice of vaccination are fictions. Viruses, presented as unique, stable, transmissible organisms, are fictional. Potency expressed as probability of inducing observable symptoms in exposed, living organisms is fictional. Reference standard products, presented as suspensions containing unique, stable, transmissible organisms, in whole or in part, as viable, inactivated or killed, are fictional. Antibody titres as measures of infection status and immunity status are fictional. For the first four decades of the biological product regulation scheme (1902-1944), most vaccines were prepared and used at the city or state level. By the end of World War II, cell and tissue culture methods; electrification and refrigerated storage and transportation systems; synthetic chemical manufacturing methods; aerial and surface chemical dispersion methods; mass-market magazine, film and television media; and data centralization had been developed, mostly by American and German military and public health officers, far enough to make possible national and international communicable-disease outbreak simulations and vaccination campaigns. Starting in 1947, fictional American product quality and quality control standards for biological product manufacturing were published in the Code of Federal Regulations and reflected in license applications submitted by manufacturers to federal regulators and in letters of approval and lot-release documents issued by federal regulators to manufacturers. Public Health Service and NIH officials in the early years, and FDA officials since 1972, have played the role of performance directors: leading the cast and crew; supervising costumes, props, advertising and promotional events; rewriting scripts and stage directions (changing terms and definitions, adding, revising and deleting provisions), and shielding backstage areas from public view. VII. Connections to US military chemical and biological warfare programs, and corroborating reports published after 1972 Although not addressed in this series, records of American chemical and biological weapons research and development programs, especially since the putative end of World War II, are also relevant. Diseases classified as communicable by executive declaration have, historically and at present, been characterized as national security, public health and biological threats, whereby vaccine development, manufacturing and deployment become "biodefense" programs conducted by and within federal public health agencies, and by and within federal military institutions. Individuals have moved between, and sometimes served simultaneously in military and public health offices. Biodefense programs have been directed and conducted by individuals such as George W. Merck, Henry L. Stimson, Ira Baldwin, Sidney Gottlieb, Paul Vories McNutt, Allen Dulles, Abram S. Benenson, Robert McNamara, Abraham Ribicoff, Elliot Richardson, William D. Tiggert, Frank Olson and Joseph Smadel. Institutions involved include the Walter Reed Army Institute of Research, Department of Biologics Research (now called Pilot Bioproduction Facility); National Defense Research Committee; Office of Scientific Research and Development; War Bureau of Consultants; War Research Service (embedded in the Federal Security Agency); Chemical Warfare Service; U.S. Army Biological Warfare Laboratories at Camp (later Fort) Detrick (Maryland), including Special Operations Division (SOD), founded in 1949 to conduct research on covert ways to use chemical weapons; US Army Chemical Corps; Army Medical Department; Army Medical Unit; US Army Medical Research Institute of Infectious Diseases (US-AMRIID); US Army Medical Research and Development Command Unit (US-AMRDU); Pine Bluff (Arkansas) Arsenal; National Center for Toxicological Research at Pine Bluff Arsenal; Vigo, (Indiana) Ordnance Plant; Dugway (Utah) Proving Ground; Plum Island (New York) Animal Disease Center; National Bio and Agro-Defense Facility (Manhattan, Kansas). Some corroborating reports published after 1972 include:
1 US federal non-regulation of biological products, 1798 to 1972 (series by Hazel and Watt)
2 1972 to present: FDA non-regulation of biological products and vaccines (Watt series)
3 Section III - Scientific, Mathematical, Medical Misconduct
4 Section IV - Legal Misconduct
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