"Jim" was the name of a former milk wagon horse, who was used to produce serum containing diphtheria

antitoxin An antitoxin is an antibody with the ability to neutralize a specific toxin. Antitoxins are produced by certain animals, plants, and bacteria in response to toxin exposure. Although they are most effective in neutralizing toxins, they can also ...

( antibodies against

diphtheria toxin Diphtheria toxin is an exotoxin secreted by '' Corynebacterium diphtheriae'', the pathogenic bacterium that causes diphtheria. The toxin gene is encoded by a prophageA prophage is a virus that has inserted itself into the genome of the host ...

). Jim produced over of diphtheria antitoxin in his career.

History

On October 2, 1901, Jim showed signs that he had contracted

tetanus Tetanus, also known as lockjaw, is a bacterial infection caused by ''Clostridium tetani'', and is characterized by muscle spasms. In the most common type, the spasms begin in the jaw and then progress to the rest of the body. Each spasm usually ...

and was

euthanized Animal euthanasia ( euthanasia from el, εὐθανασία; "good death") is the act of killing an animal or allowing it to die by withholding extreme medical measures. Reasons for euthanasia include incurable (and especially painful) conditi ...

. After the death of a girl in St. Louis was traced back to Jim's contaminated serum, it was discovered that serum dated September 30 contained tetanus in its incubation phase. This contamination could have easily been discovered if the serum had been tested prior to its use. Furthermore, samples from September 30 had also been used to fill bottles labeled "August 24," while actual samples from the 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 Smallpox was an infectious disease caused by variola virus (often called smallpox virus) which belongs to the genus Orthopoxvirus. The last naturally occurring case was diagnosed in October 1977, and the World Health Organization (WHO) c ...

vaccine A vaccine is a biological Dosage form, preparation that provides active acquired immunity to a particular infectious disease, infectious or cancer, malignant disease. The safety and effectiveness of vaccines has been widely studied and verifie ...

, led to the passage of the

Biologics Control Act The Biologics Control Act of 1902, also known as the Virus-Toxin Law, was the first law that implemented federal regulations of biological products such as vaccines in the United States. It was enacted in response to two incidents involving the ...

of 1902, which established the

Center for Biologics Evaluation and Research The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the U.S. Food and Drug Administration (FDA), which is a part of the U.S. Department of Health and Human Services. The current Director of CBER is Peter Marks, ...

. Jim's misfortune, and the ensuing tragedy and reaction, thus established a precedent for the regulation of biologics, leading to the 1906 formation of the US

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...

(FDA).

References

{{Reflist 1901 animal deaths Individual male horses Vaccination in the United States Drug safety Medical scandals in the United States Diphtheria Tetanus

History

See also

References