Sulfanilamide elixir

The interface between chemistry and society refuses to be drawn in such neat lines as good and bad, however. The search for chemical warfare agents popularized the method of project research that would be used so fruitfully in peacetime investigations. The ravages of Elixir Sulfanilamide provoked the present stricter food and drug legislation. These case studies suggest some of the complexity, as well as the diversity, of chemistry s influence on modern civilization. 

In a promotional brochure sent to physicians in October 1937, the S. E. Massengill Company of Bristol, Tennessee, announced "A New Sulfanilamide" (1 ). "Our research department has just released an Elixir Sulfanilamide," the report read, "40 grs to the fluidounce. It is ideal for your patients who can take liquids—but little else. Also, it is not unpleasant to take, so is suitable for children. The color is brilliant red.. .."... 

Thus began the marketing of a therapeutic solution that mixed two chemical compounds, one the first drug to combat effectively bacterial infections, the other a powerful poison. The prescribing of Elixir Sulfanilamide caused over a hundred deaths, many of them of children provoked national panic and spurred a desperate effort, led by the Food and Drug Administration, to track down the lethal "elixir" and to remove it from drugstores and homes. In the longer run, the Elixir... 

On October 11, American Medical Association officials in Chicago received two telegrams, one from the president of the Tulsa County Medical Society in Oklahoma, the other from the Springer Clinic of Tulsa (23, 29, 30). Six deaths had occurred following the administration of Elixir Sulfanilamide-Massengill. What, the telegrams inquired, was the composition of this drug ... 

The inspectors had been invited to attend a postmortem examination of the adult man. His kidneys were "excessively enlarged," about fifty percent larger than normal. "Clotted, purplish congestion" appeared "on [the] periphery of [the] kidneys." Samples of Elixir Sulfanilamide collected by the inspectors were sent to Central District headquarters in Chicago (33). 

The first reports from Tulsa led the FDA to dispatch the agency s chief medical officer, Theodore G. Klumpp, accompanied by an inspector, William T. Ford, from Cincinnati, to the plant in Bristol at which Elixir Sulfanilamide had been conceived and first prepared (21, 22) ... 

Other tales had less happy endings. In South Carolina an inspector found on the grave of a black man a partly used bottle of Elixir Sulfanilamide, bearing the name of the physician who had denied having prescribed it (4 ). In accordance with Gullah custom, the medicine—as well as dishes, spoon, and a bottle of catsup—which he had been using when he died accompanied him to his final resting place. 

Besides seizing Elixir Sulfanilamide wherever it could be traced, the Food and Drug Administration saw to the filing of criminal charges against Dr. Massengill and his firm, both in Knoxville and in Kansas City (54 ). Because he had conceded two earlier prosecution charges, he was a second offender and thus subject to more severe sanctions under the 1906 law. 

Campbell and his staff anticipated that the battle in court would be hard fought. They knew that company agents had been active gathering affidavits from patients who had used Elixir Sulfanilamide and who would testify that they had not been harmed ( 55). Some would say that the medicine had helped them. Perhaps as many as 680 such documents, the FDA believed, had been collected (60). It was also anticipated that the company intended to assert that sulfanilamide afflicted the same proportion of patients who took it alone as had been afflicted while taking it mixed with diethylene glycol, about fifteen percent in both circumstances. 

A Division of Pharmacology had been formally set up in the Food and Drug Administration in 1935, composed mostly—as one of its members, Edwin P. Laug, remembered—of "biochemists who then changed sails and became pharmacologists" (7] ). To study the toxicity of lead and arsenic pesticide residues formed the division s initial purpose, but the Elixir Sulfanilamide crisis brought an almost total shift of effort to diethylene glycol. 

The results presented in these papers, and the methodology underlying the results, came at a crucial time, the initial stage of the chemotherapeutic revolution, during which hundreds of new drugs would enter the medical marketplace. Elixir Sulfanilamide had waved the warning flag of toxicity, and in response FDA... 

The report that the Secretary of Agriculture made to the Congress on the Elixir Sulfanilamide affair reiterated this argument (23). The report cited a letter written to President Roosevelt by the mother of one of the "elixir s" first victims in Tulsa, a little girl of six. The mother told how her child had died in agony, and begged the President to get a law so that other... 

Nonetheless, more than eight months elapsed between the first reports of deaths from Elixir Sulfanilamide and the enactment of the law (53. Two more major obstacles had to be overcome—who should control food and drug advertising, the FDA or the Federal Trade Commission, and what process of court appeal should govern FDA regulation-making—before enough consensus came to get the law passed. 

Wallace, Henry A. "Report of the Secretary of Agriculture on Deaths Due to Elixir-Sulfanilamide-Massengill." 75 Cong. 2 sess., Senate Document 124, Serial 10247. 

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