By ANISH KOKA
Frances Oldham Kelsey by all accounts was not mean to have a consequential life. She was born in Canada in 1914, at a time women were meant to be seen and not heard. Nonetheless, an affinity for science eventually lead to a masters in pharmacology from the prestigious McGill University. Her first real break came after she was accepted for PhD level work in the pharmacology lab of a professor at the University of Chicago. An esteemed professor was starting a pharmacology lab and needed assistants, and the man from Canada seemed to have a perfect resume to fit. That’s right, I said man. Frances was thought to be a man’s name, and the acceptance letter accepted Mr. Frances Oldham. Given the times, her Canadian mentor advised the young Frances she not write to inform the Chicago professor of the mistake but to simply sign the acceptance letter as Miss Oldham. The rest, as they say, is history. Ms. Frances Oldham arrived in Chicago in 1936, and just two years later was asked to work on figuring out what caused one of the worst poisonings in American history by the nascent US Food and Drug Administration (FDA).
The FDA at the time was a small organization within the federal government that had come into being a few decades earlier after the passage of one of many progressive laws passed to protect consumers from rapacious pharmaceutical companies of the day. At the time there was no standard for claims that could be made to an unsuspecting public and no requirement that drug companies specify what ingredients were being consumed by the public. The companies of the day would take alcohol, water and coloring mixed together – give the formulation a name, get a US patent, and make millions by heavily marketing testimonials of cures to all that ails directly to the consumer. At one point, it was estimated that there was more alcohol being sold via ‘patent medicines’ than at liquor stores.
Sadly, it was not medical professionals that put a stop to this, but muckraking journalists like Samuel Hopkins Adams who exposed the seamy underside in a series of articles for Collier’s Weekly entitled The Great American Fraud. Popular outrage followed publication of this series in 1905 and in response, the first draft of the FDA came into being by order of Congress in 1906.
The initial purpose of the FDA was a small, but important one – ensure the correct labeling of drugs being sold to the public. The 1906 act – fought tooth and nail by industry – mandated that ingredients such as alcohol, cocaine, heroin, morphine and cannabis be accurately labeled with contents and dosage. To understand the scope of the problem at the turn of the century, understand that Coca-Cola (Coke) was sold initially as a ‘patent medicine’ that was marketed as a cure for headaches, impotence, morphine addiction as well as a number of other ills. The main ingredients? Cocaine and Caffeine. Current drinkers of Coke will be happy to know that cocaine was eliminated from the formula in 1903.
The FDA as we know it now is a result of the passage of the Federal, Food, Drug and Cosmetic Act (FFDCA) of 1938 that came as a reaction to national tragedy in 1937 that once again drove home the point that the public needed protection from private corporations. The matter was a simple one that involved an ingredient that actually worked – sulfanilamide. Sulfanilamide was an antibiotic that killed bacteria by preventing the synthesis of Folic Acid. Humans are relatively primitive and don’t make Folic acid – so it isn’t toxic to humans. That is, unless you’re the chief chemist of S. E. Massengill Company, and you create a preparation of sulfinilamide that is dissolved in di-ethylene glycol (DEG). DEG is toxic to humans – the first case reports of toxicity had been reported six years earlier. Unfortunately the chemist, Harold Watkins, who worked for the company was unaware as this was not widely known at the time. Watkins simply added some raspberry flavor to the sulfa dissolved in DEG, and the company founded by a Tennessee medical student who saw more opportunity in selling drugs to doctors than practicing medicine started distributing the drug widely. No animal studies or any type of premarket testing was required at the time, and so the drug went straight from the lab to the consumer. More than a hundred people died.
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