Sulfa drugs held out the promise of being the wonder drugs of the 1930s: they cured bacterial infections such as pneumonia, blood poisoning, and meningitis. And so their use spread rapidly. Output of sulfa drugs in the United States in 1937—the first year of real commercial production—totaled about 350,000 pounds; by 1940, it had more than doubled. By 1942, it topped an estimated 10 million pounds.
Sulfanilamide, one of the first of the sulfa drugs, had been used safely for some time in tablet and powder form, but it was hard to swallow as a tablet and not especially palatable as an injection either. Children tended to balk at both.
In 1937, S. E. Massengill Co., a small drug formulator in Bristol, TN, sought to meet the demand for a drinkable liquid preparation. Harold Cole Watkins, Massengill’s chief chemist, 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.
The concoction was called Elixir Sulfanilamide despite the lack of ethanol, an ingredient that was required for a preparation to receive the elixir designation. Immediately, the company compounded a quantity of the elixir and sent shipments–633 of them–all over the country. The presence of diethylene glycol was not divulged on the bottle labels. Furthermore, Massengill made no tests on its elixir before shipping from its plant in September.
One of the major points of delivery of the drug was Tulsa, OK. By early October, James Stephenson, the president of the Tulsa County Medical Society, had been notified that six local patients had unexpectedly died from renal failure after ingesting Elixir Sulfanilamide. In an October 11 telegraph to the American Medical Association, Dr. Stephenson requested the composition of the elixir. The AMA responded that they were unaware of any product from the Massengill Company and had never approved a liquid sulfanilamide preparation.
The AMA telegraphed Dr. Samual Evans Massengill, the firm’s owner, requesting the composition of the elixir. Massengill released this proprietary information but urged that it be kept strictly confidential. He hypothesized that the deaths may have been caused by mixing the elixir with other drugs. Massengill and Watkins reluctantly admitted, however, that toxicity tests had not been done. To show confidence in his product, Watkins self-administered small amounts of diethylene glycol and elixir. No adverse effects were noted.
But the AMA laboratory had meantime isolated diethylene glycol as the toxic ingredient and immediately issued a warning, through newspapers and radio, that Elixir Sulfanilamide was toxic and deadly.
Walter Campbell, the chief of the Food & Drug Administration, assigned almost all of the bureau’s 239 inspectors and chemists to the case, sending field agents immediately to the Massengill’s headquarters in Bristol and to branch offices in Kansas City, New York, and San Francisco. They found that the firm had already learned of the poisonous effects of the liquid sulfanilamide and had sent telegrams to more than 1,000 salesmen, druggists, and doctors.
However, the telegrams merely requested the return of the product and failed to indicate the urgency of the situation or say that the drug was lethal. At FDA’s insistence, the firm sent out a second wave of messages, worded more strongly: “Imperative you take up immediately all elixir sulfanilamide dispensed. Product may be dangerous to life. Return all stocks, our expense.”
Dr. Massengill said: “My chemists and I deeply regret the fatal results, but there was no error in the manufacture of the product. We have been supplying a legitimate professional demand and not once could have foreseen the unlooked-for results. I do not feel that there was any responsibility on our part.” The firm’s chemist apparently did not share this feeling; Harold Watkins committed suicide after learning of the effects of his latest concoction.
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 were retrieved; the remainder was consumed and caused the deaths of more than 100 victims nationwide.
Under the U.S. food and drug law then in place, the government seized Massengill’s deadly mixture only because it was misbranded; “elixir” implied that the solvent in the bottle was ethyl alcohol. Drug dispensers were required by law to label their products accurately but not to test them for safety. The company was fined $16,800 for its false label.
The lethal mixture, however, did encourage enactment of a much-strengthened food and drug law that was then pending in Congress. The Federal Food, Drug, and Cosmetics Act of 1938, which overhauled the law of 1906, stipulated that manufacturers must test any new drug for safety and report the results to the U.S. Food and Drug Administration. Some predicted that the new act would stifle research, but FDA historian Wallace Janssen says the reverse has been true: the research required by the law has stimulated medical progress.
Strauss’s federal drug laws and examination review, by Steven Strauss, CRC Press, 2000