In 1937, the S.E. Massengill Company of Bristol,
Tennessee, began selling bottles of Elixir Sulfanilamide, a liquid version of a
popular antibiotic of the day. But more than 100 people died after taking the
drug, and investigators from the US Food and Drug Administration (FDA)
identified the drug’s solvent, diethylene glycol, as the killer.
Seventy-one adults and 34 children
died in 15 states in the fall (September
and October) of 1937 after taking a
drug called Elixir Sulfanilamide to treat a variety of ailments, from gonorrhea
to sore throat. At that time, the FDA, which had been launched in 1906 as the
Bureau of Chemistry, served simply to police claims made about food and drug
ingredients. No formal government approval was required to market new
drugs.
Sulfanilamide, a drug used to treat streptococcal infections, had
been shown to have dramatic curative effects and had been used safely for some
time in tablet and powder form. In June 1937, however, a salesman for the S.E.
Massengill Co., in Bristol, Tenn., reported a demand in the southern states for
the drug in liquid form. The company's chief chemist and pharmacist, Harold
Cole Watkins, experimented and found that sulfanilamide would dissolve in
diethylene glycol. The company control lab tested the mixture for flavor,
appearance, and fragrance and found it satisfactory. Immediately, the company
compounded a quantity of the elixir and sent shipments--633 of them--all over
the country.
Because no pharmacological studies had been done on the new
sulfanilamide preparation, Watkins failed to note one characteristic of the
solution. Diethylene glycol, a chemical normally used as an antifreeze, is a
deadly poison.
The new formulation had not been tested for toxicity. At the time
the food and drugs law did not require that safety studies be done on new
drugs. Selling toxic drugs was, undoubtedly, bad for business and could damage
a firm's reputation, but it was not illegal.
FDA employees tracked down the firm's 200 salesmen and questioned
them about the dispersion of shipments and physician samples. Finding the
salesmen was the first problem. In one typical case, a salesman was reported to
be in a hotel in Washington, D.C. He was not there but forwarding addresses had
been left for him in Jackson, Mich., and in Baltimore. These turned out to be
for another man with the same name. Four days of searching finally found the
man in University Park, MD. Once the salesmen were found, there was still the
problem of getting the distribution information. One man in Texas, for
instance, revealed the necessary information only after being jailed by state
authorities.
Through the dogged persistence of federal, state, and local health
agencies and the effects of the AMA and the news media, most of the elixir was
recovered. Of 240 gallons manufactured and distributed, 234 gallons and 1 pint
was retrieved; the remainder was consumed and caused the deaths of the victims.
Twenty-five seizures were made under federal law. The charge was
misbranding. "Elixir," FDA said, implied the product was an alcoholic
solution whereas it was, in fact, a diethylene glycol solution and contained no
alcohol. If the product had been called a "solution" instead of an
"elixir," no charge of violating the law could have been made. FDA
would have had no legal authority to ensure the recovery of the drug and many
more people probably would have died.
The drug and the deaths led to the passage of the 1938 Food, Drug, and Cosmetic Act, which increased FDA's authority to regulate drugs.
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