Jim the Horse Tetanus Scandal
“Jim” was the name of a former milk wagon horse, who was used to produce serum containing diphtheria antitoxin (antibodies against diphtheria toxin).
Jim produced over 30 quarts (7.5 US gallons) of diphtheria antitoxin in his career. However, on October 2, 1901, Jim showed signs that he had contracted tetanus and was euthanized. After the death of a girl in St. Louis was traced back to Jim’s contaminated serum, it was discovered that serum dated September 30th contained tetanus. This contamination may have been discovered if the health of the animal immunized with diphtheria toxin had been rigorously evaluated on an ongoing basis. Furthermore, samples from September 30th had also been used to fill bottles mis-labelled “August 24th” while actual samples from August 24th were shown to be free of contamination.
These failures in oversight led to the distribution of antitoxin that caused the death of 12 more children. This incident, and a similar one involving contaminated smallpox vaccine, led to the passage of the Biologics Control Act of 1902, which established the Center for Biologics Evaluation and Research (today known as CBER) . This law was also known as the Virus-Toxin Law.
The law gave the government it’s first control over the processes used to produce biological products and required inspections of manufacturing facilities. Licenses could be suspended or revoked when necessary. The law also required annual licensure for the manufacture and sale of vaccines, serum, and antitoxins. The Biologics Control Act was later replaced by the 1938 Federal Food, Drug and Cosmetics Act which regulated biologics as well as drugs, cosmetics and devices.
