Elixir sulfanilamide scandal
The Elixir sulfanilamide scandal, which unfolded in the late 1930s, represents a significant event in the history of pharmaceutical regulation in the United States. After the introduction of sulfanilamide, a widely praised antibiotic, the S. E. Massengill Company created a liquid version to meet consumer demand. However, the company used diethylene glycol, a toxic substance, as a solvent without proper safety testing. This resulted in the deaths of over one hundred people, including many children, due to severe kidney damage caused by the poison. The subsequent public outrage highlighted the vulnerabilities in existing drug regulations, as the Food and Drug Administration (FDA) lacked the authority to prevent the distribution of the dangerous elixir. In response to the crisis, the U.S. Congress enacted the 1938 Federal Food, Drug, and Cosmetic Act, instituting safety testing requirements for pharmaceuticals. This scandal not only shook public trust in medical products but also underscored the need for stricter regulations to protect consumers against untested and harmful drugs.
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Elixir sulfanilamide scandal
The Event Mass-poisoning tragedy
Date 1937
Approximately one hundred American citizens, many of whom were children, died after consuming a liquid preparation of a popular antibiotic. The company that manufactured this elixir used a toxic, industrial solvent to dissolve the antibiotic but never tested its safety before distributing it. This enormous tragedy ignited a public outrage that spurred the writing and passage of the 1938 Federal Food, Drug, and Cosmetic Act.
In November, 1936, President Franklin D. Roosevelt’s son, Franklin, Jr., was cured of a serious sinus and throat infection with the sulfur-containing antibiotic sulfanilamide. This initiated an enthusiastic demand for this “miracle” drug in the United States. In 1937, an exhaustive animal and clinical study published in the Journal of the American Medical Society endorsed sulfanilamide as a treatment for streptococcal infections. Soon thereafter competing brands of sulfanilamide flooded the American drug market.
In June, 1937, a salesman for the S. E. Massengill Company of Bristol, Tennessee, reported a demand for a liquid preparation of this popular antibiotic, because the solid form of the drug was distasteful. Sulfanilamide does not dissolve easily, but Massengill’s head chemist, Harold Cole Watkins, found that the clear, odorless, but highly toxic liquid diethylene glycol could dissolve it. Unbeknownst to Watkins, the Food and Drug Administration (FDA) had advised against the use of glycols in foods, and published reports from other labs that showed that diethylene glycol was toxic to laboratory animals. Watkins used raspberry extract and saccharine to sweeten the elixir and increase its palatability. Because the law did not require Massengill to test the safety or efficacy of the preparation before distributing it, the company tested only the color, taste, and smell of the solution before shipping it.
Beginning on September 4, 1937, Massengill shipped 633 commercial lots of elixir sulfanilamide and delivered some 671 samples to physicians nationwide. The product labels on the elixir containers failed to list any of the ingredients other than sulfanilamide.
The first reported elixir-related deaths were in Tulsa, Oklahoma, in early October. By mid-October, 1937, additional deaths were reported in the Deep South and Illinois. After consuming the elixir, patients initially experienced nausea and vomiting, followed by a progressive cessation of urine output, accompanied by severe back and abdominal pain, culminating in death two to seven days later. Autopsies revealed extensive kidney damage, and poisoning was suspected. The American Medical Association determined on October 12, 1937, that Massengill’s elixir contained substantial amounts of diethylene glycol. Animal experiments conducted at the University of Chicago firmly established that diethylene glycol was the poisoning agent in the elixir.
On October 15, 1937, Massengill sent approximately 1,100 telegrams to elixir consignees that directed them to return all unused stocks at the company’s expense, but failed to mention the toxicity of the product. That same day, FDA field inspectors began the herculean task of recalling and confiscating the distributed elixir bottles, even while reports of elixir-induced deaths continued to mount nationally. By the end of October, exacting searches helped recover 228 of the 240 gallons of elixir produced. The last elixir victim died on October 31. Overall elixir poisoning killed more than one hundred people, 30 percent of whom were children and infants.
Massengill paid more than one-half million dollars in claims, and the owner, Samuel E. Massengill, pled guilty to 174 counts of adulterating and misbranding elixir sulfanilamide. Nevertheless, the company refused to admit liability. On January 17, 1939, Watkins, the chemist who designed the elixir, committed suicide.
Impact
The elixir sulfanilamide scandal eroded the foundational trust between patients and physicians. Massengill had used the public as guinea pigs for untested drug concoctions and was completely unwilling to admit that they had done anything wrong. The public was outraged.
This scandal also revealed the weaknesses in the 1906 Pure Food and Drug Act. The FDA had little authority to act and was only able to stop the distribution of the elixir bottles on a mislabeling charge, because elixirs normally contain alcohol and the Massengill elixir contained no alcohol. Otherwise, the FDA would have been powerless to confiscate the poisonous elixir. Congress responded by passing the 1938 Federal Food, Drug, and Cosmetic Act, which required companies to perform safety tests on their products and submit their results to the FDA before they were allowed to market them.
Bibliography
Braithwaite, John. Corporate Crime in the Pharmaceutical Industry. London: Routledge & Kegan Paul, 1984.
Ghosh, Tapash, and Bhaskana R. Jasti. Theory and Practice of Contemporary Pharmaceutics. Boca Raton, Fla.: CRC Press, 2004.
Wax, Paul. “Elixirs, Diluents and the Passage of the 1938 Federal Food, Drug, and Cosmetic Act.” Annals of Internal Medicine 122 (1995): 456-461.