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of disordered law; hazards of gazing into them.Status update on Part 5 of vaccine non-regulation series, 1798 to 1972.
Series so far:
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
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)
Other reports, some behind pay walls 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
1972 Nicholas Wade series on regulatory failures at NIH Division of Biologics Standards, 1958 to 1972:
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
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.
1 FDA non-regulation of biological products and vaccines, 1973 to present, series:
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