MEDICAL HISTORY
Allan Gaw recounts the sulfanilamide tragedy of 1937 and the role of one young research scientist in our modern approach to the approval of new drugs
Drugs that will take little lives O
UR approach to the investigation and approval of new drugs is said to be “born in scandal”. Te scandals
in question that gave birth to new drug legislation may be well-known but less oſten appreciated is the role played by one individual – a rather modest and oſten unassuming woman called Frances Oldham Kelsey, who died this year aged 101. Kelsey is best known as the FDA
regulator who kept thalidomide out of the US in the 1960s but her first brush with the kind of scandal that would shape the law came in the second year of her doctoral studies in Chicago in 1937.
An antibacterial elixir Te story began when a small drug company in the state of Tennessee, called Massengill, decided to market the new drug sulfanilamide as an oral liquid preparation. Tis antibacterial in pill form had been highly effective in combatting bacterial infections in the pre-antibiotic era and Massengill saw a market for it in children with streptococcal throat infections – hence their desire to offer it in liquid form. Te problem they faced was that the drug was insoluble in water and quite unpalatable. Te company’s chief pharmacist, Harold
Watkins, experimented and was pleased to report that he had managed to dissolve the sulfanilamide in an ethanol-like solvent that even tasted sweet. As such, the drug could be sold as an ‘elixir’, or alcohol solution. However, the solvent was not alcohol but diethylene glycol, the chief constituent of anti-freeze and highly toxic. Pre-marketing safety testing was neither
required by law nor contemplated by the company and the ‘elixir’ was merely
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assessed for flavour, appearance and fragrance. Aſter adding some colouring and raspberry flavouring, the company was satisfied on these counts and the preparation was mass-produced, bottled and shipped across the US in September 1937.
Slow and painful deaths Reports of the first six suspicious deaths arrived in the American Medical Association’s offices as early as October 11 from Oklahoma. Te Food and Drug Administration (FDA) was alerted and set about the retrieval of all shipped bottles. Of the 240 gallons that had been distributed, 234 gallons and one pint were recovered. However, the balance had been consumed and had caused the deaths of 107 people, mostly children. Tose deaths had been slow and painful; victims would typically be ill for 7-21 days and show features of renal failure, including nausea, vomiting, convulsions and severe pain. One distraught mother, Maisie Nidiffer,
wrote to President Roosevelt himself to describe the death of her six-year old daughter, Joan.
“All that is leſt to us is the caring for her
little grave. Even the memory of her is mixed with sorrow for we can see her little body tossing to and fro and hear that little voice screaming with pain and it seems as though it would drive me insane. ... It is my plea that you will take steps to prevent such sales of drugs that will take little lives and leave such suffering behind...” With her letter, she enclosed a
photograph of her now deceased child. Joan Nidiffer’s smiling face made its way into numerous newspaper reports about the incident. A face — that of a beautiful little girl — had been given to the tragedy.
Investigations Eugene Geiling of the FDA was asked to lead the pharmacological investigations into the sulfanilamide affair. As Geiling’s graduate student, Frances Kelsey helped conduct the animal studies to find out which was the toxic agent — the
SUMMONS
PHOTOGRAPHS: FDA; SCIENCE PHOTO LIBRARY
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