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The Biologics Control Act was a second piece of legislation enacted in
1902 that had major consequences for the Hygienic Laboratory. It charged
the laboratory with regulating the production of vaccines and antitoxins,
thus making it a regulatory agency four years before passage of the better-known
1906 Pure Food and Drugs Act. The danger posed by biological products-technologies
that had emerged from bacteriologic discoveries—resulted from their
production in animals and their administration by injection. Diphtheria
antitoxin, for example, was made by inoculating horses with increasingly
concentrated doses of diphtheria bacteria, then bleeding the animals to
obtain their blood serum, which was bottled as antitoxin. When injected
into the body of a patient suffering from diphtheria, the antibodies in
the horse serum neutralized the toxin causing the patient’s symptoms.
Possibilities for contamination lurked at every stage of the antitoxin
production process, and the amount of horse serum necessary to cure was
initially undefined. In 1901, thirteen children in St. Louis died after
receiving diphtheria antitoxin contaminated with tetanus spores. This
tragedy spurred Congress into passing the Biologics Control Act. Between
1903 and 1907 standards were established and licenses issued to pharmaceutical
firms for making smallpox and rabies vaccines, diphtheria and tetanus
antitoxins, various other antibacterial antisera, thyroidectomized goat
serum, and horse serum. The research required to set standards led investigators
into new fields, such as immunology, in order to understand the sudden
deaths that sometimes followed repeated injections of biologics prepared
in foreign-protein media such as horse serum. (Note: In 1972, responsibility
for regulation of biologics was transferred to the Food
and Drug Administration.)
In 1912 another Service reorganization act shortened the name of the
PH-MHS to Public Health Service (PHS). This brief act also authorized
the laboratory to conduct research into noncontagious diseases and into
the pollution of streams and lakes in the United States. Under this law,
PHS officer Joseph
Goldberger in 1914 conducted an epidemiological study that identified
the cause of the disease pellagra, a scourge of poor Southerners, as a
dietary deficiency and brewers’ yeast as a cheap and widely available
cure. Also, Earl B. Phelps, then director of the Division of Chemistry,
described the behavior of oxygen in water that fostered better understanding
of the effects of pollution in lakes and rivers.
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Credits
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One of the first bottles (1895) of
diphtheria antitoxin produced at the Hygienic Laboratory |
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Dr. Joseph Goldberger |
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