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Crusading Chemist Harvey Wiley Paved Way for Pharmaceutical Testing

15 JUN 2012
Career Path : Pharmaceutical Quality Control

Before America had its Food and Drug Administration, there was the United States Department of Agriculture’s Bureau of Chemistry, which is still famous today for Dr. Wiley’s Poison Squad, a dedicated group of staff members who, at the turn of the last century, bravely volunteered to ingest potentially toxic preservatives to firmly establish the risk they posed to public health, drawing international attention to the need for better food and pharmaceutical testing.


The concern these brave pioneers of food and pharmaceutical testing showed their fellow citizens was rewarded with a song, the lyrics of which survive today:


“O we’re the merries heard of hulks

that ever the world has seen;

We don’t shy off from your rough

on rats or even from Paris green:

We’re on the hund for a toxic dope

That’s certain to kill, sans fail.”


Although his experimental approach to food and pharmaceutical quality assurance control may seem unorthodox by today’s standard, Dr. Wiley’s legacy is undeniable. How did the Indiana-born son of a farmer come to play such a revolutionary role in the history of pharmaceutical testing?


Pharmaceutical testing pioneer Dr. Wiley’s early years


Dr. Wiley was born Harvey Washington Wiley in October 1844. He fought for the Union Army in the American Civil War. After the war, this Renaissance man took degrees in the humanities, medicine and science (at Harvard, no less). How did this lead him to a career as a trailblazer in pharmaceutical quality assurance control?


His interest in what would now be termed quality assurance and quality control may have begun when Indiana asked him to return home to analyze syrups and other sugars for signs of tampering or misrepresentation. There were many food scandals in the end of the 19th century. It was reportedly quite common for a bottle labeled as pure maple syrup to actually contain a substance more akin to corn syrup, for example.


It wasn’t very long before the federal government lured him to Washington with a position as Chief Chemist in the Department of Agriculture’s Bureau of Chemistry, where he would fully embrace his role as a crusader for food and pharmaceutical testing, forming the so-called “poison squad”: willing human guinea pigs who tested the effects of certain preservatives on humans. The goal? To establish “whether preservatives should ever be used or not, and if so, what preservatives and in what quantities.”


His tests on the preservatives in foods are credited with leading to the drafting of one of the first pieces of food and pharmaceutical quality assurance legislation, the Pure Food and Drug Act, which was enacted in 1906. The field hasn’t stopped evolving since!


Today’s food and pharmaceutical testing practices owe an enormous debt to Dr. Wiley and his Poison Squad. The doctor and his volunteers drew America’s attention to the need for quality assurance and quality control for ingestible substances.




Visit AAPS for more information on quality assurance and quality control.