1937

Elixir Sulfanilamide

Walter Campbell (1877–1963), Harold Cole Watkins (c. 1880–1939), Frances Oldham Kelsey (1914–2015), James Stevenson (d. 1955)

Here is a grim chapter in the story of a drug that was considered one of science’s greatest benefits to humankind. Sulfanilamide was the wonder antibiotic of the 1930s, but it was difficult to dispense to children. Like many antibiotics, it had to be given in fairly large quantities, which meant painful injections or pills that children had trouble swallowing. Sulfanilamide is not soluble in water or alcohol, which ruled them out as vehicles for delivery as well. And like many drugs, it had a bitter taste that would have to be masked in a sweet syrup to be palatable.

Formulation work—turning an active compound into a useful mixture—is essential to drug development. In modern labs, all sorts of solutions, additives, coatings, and solid forms are investigated, but the process was primitive at best in the 1930s. Harold Cole Watkins, chief chemist of a small Tennessee firm, found that diethylene glycol (DEG) would dissolve sulfanilamide in useful amounts. In 1937, the company added color and flavor and began selling this as “elixir sulfanilamide,” a name that implied that alcohol was the solvent. Within two weeks, reports began to come in of patients (many of them children) dying from kidney failure. James Stevenson, a physician in Tulsa, Oklahoma, was among the first to make the connection, alerting the American Medical Association, which tested the product and immediately warned the public. An FDA study led by American chemist Frances Oldham Kelsey showed that the DEG was the toxic agent, and the agency’s Walter Campbell pressed the company to recall all supplies. Watkins attempted to show that diethylene glycol was not toxic by ingesting some himself—but he did not have the body of a child. Eventually, he committed suicide, apparently unable to live with what his product had done.

Six gallons of the syrup were given to patients across the country before the recall, causing over a hundred deaths. The FDA was greatly strengthened by a law passed the next year, mandating that all new drugs and formulations be tested for safety and reviewed by the agency before any products entered the market.

An actual bottle of the preparation that poisoned its customers, mostly children, in 1937.