Even today, being stricken with pneumonia, meningitis or strep throat is serious, but in the early 20th century these bacterial infections were killers. Then in 1937 a powerful new cure arrived: sulfanilamide, a derivative of a red dye that German microbiologist Gerhard Domagk had discovered was stunningly effective against bacterial infections. Better still, sulfanilamide was an old chemical long out of patent, so anyone could manufacture it cheaply.
Drug companies leapt on the bandwagon, quickly making “sulfa” a household name as the first modern wonder drug. But just as Americans were gratefully downing their first doses, troubling news was emerging from Tulsa, Oklahoma. Children treated with sulfa were dying in agony, and nobody knew why. What the Food and Drug Administration was to discover scandalised a nation, and forever changed the way drugs were sold in the US.
SULFANILAMIDE was the drug everyone had been waiting for, a “magic bullet” that would vanquish the bacteria responsible for all manner of infections, from sore throats to pneumonia. But in October 1937, patients in Oklahoma who had taken sulfa began to die, and they died horribly – racked by excruciating abdominal pain for days or even weeks, thrashing about and vomiting, then going blind before slipping into a fatal coma. Many of the victims were children. One mother in Tulsa, after watching her 6-year-old daughter die in agony, wrote an anguished letter to President Franklin D. Roosevelt describing how she had witnessed “her little body tossing to & fro…& that little voice screaming with pain and it seems as tho it drive me insane”. Autopsies revealed catastrophic kidney and liver failure in the victims, with the kidneys bloated and purple and filled with urine they were no longer able to excrete. Soon scores of cases were appearing from Tennessee to California.
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Suspicion fell on the one medication that all the victims appeared to have consumed. Elixir Sulfanilamide was a sweetened, easy-to-swallow sulfa solution supplied to pharmacists across the country by the S. E. Massengill Company of Bristol, Tennessee. When investigators from the Food and Drug Administration (FDA) visited the Massengill plant, they were met by the company’s chemist, Harold Watkins. That Watkins lacked any formal qualifications and had had a previous run-in with the law over a weight-loss drug was alarming, but not surprising: the American pharmaceutical industry was notoriously unregulated in those days. But Watkins was unapologetic about his company’s product. There was nothing wrong with it, nothing at all, he insisted. And to prove his point, Watkins downed a slug of it himself.
One day later, the American Medical Association (AMA) received an urgent telegram from the Massengill office. Watkins had fallen deathly ill. “Please wire collect by Western Union suggestion for antidote,” it begged.
Watkins, it emerged, had engaged in a rather cavalier bit of experimentation in creating Massengill’s new product. There was great demand for a form of sulfa that was easy to swallow, but no one had yet found a solution that was saleable. Watkins hit upon the expedient of dissolving the compound in a solution of 25 per cent water and 75 per cent of the pleasantly sweet chemical diethylene glycol. DEG and its cousin ethylene glycol are well known today as key ingredients of antifreeze. But Watkins had not bothered testing DEG for safety in humans. Drug companies were not required to in those days.
At first, it was not even entirely clear whether it was DEG or its combination with sulfa that was the problem. The FDA and the AMA quickly arranged tests at the University of Chicago by pharmacologist Eugene Geiling and his graduate assistant Frances Kelsey. Their suspicions were confirmed. “In next to no time, you could tell it was the diethylene glycol,” Kelsey later recalled. “The rats that took it got sick and shrivelled and the urine got red and they would shortly after die.” It was this deadly poison, barely diluted, that had been shipped untested to pharmacies across the country.
On 19 October the FDA swung into action, racing against time before more people swallowed what newspapers were now calling “the Fatal Elixir”. US Marshals raided Massengill’s office in New York while every one of the FDA’s 239 inspectors frantically sped to pharmacies and doctors’ surgeries in a desperate attempt to track down every bottle that had been sold. At one business alone, agents had to sort through 20,000 sales slips. At another, a pharmacist fell to his knees in horror when he realised what he had prescribed to his patients. Some doctors refused to cooperate, and examination of prescriptions revealed that they had been handing out the antibacterial wonder drug for everything and anything, bacterial or not.
Damning evidence quickly piled up. One doctor in South Carolina insisted that he had not prescribed Elixir to a now-dead patient, but the FDA’s inspectors learned that the victim’s family had followed a local custom of leaving a few personal effects atop the new grave. When they arrived at the graveyard they found a bottle of Elixir, almost empty, lying on the grave.
By November, the FDA had recovered 234 gallons of the 240 that had been manufactured. The remainder, consumed by the victims, resulted in 107 deaths and left 260 people with debilitating illnesses. The death toll might easily have run into thousands if the shipment had not been recalled. An even bigger scandal awaited. Samuel Massengill, founder of the company, was sorry for the deaths, he wrote in a letter to the AMA, but “I have violated no law”.
Incredibly, Massengill was largely correct. There was no provision in the 1906 Pure Food and Drug Act to forbid the sale of useless or even lethal medicine; it only prohibited mislabelling of the contents. The best the FDA could do was prosecute Massengill for falsely selling an “elixir”, a term which incorrectly implied that the medicine contained alcohol. The company was fined the maximum amount possible, a paltry $26,000. The agonising deaths went unpunished.
The response to this outrage was swift, and would change the course of medical history in the US. Legislation to improve drug safety, which had been languishing in Congress, suddenly gained support from a handful of southern senators whose states had been hit hard by the Elixir deaths.
Despite intense lobbying by manufacturers of drugs and patent medicines, the tide had turned. On 15 June 1938, nine months after the Elixir claimed its first victims, President Roosevelt signed into law the Federal Food, Drug, and Cosmetic Act. It was a landmark in drug safety: drug companies now had to prove their product was safe before they could market it. It was this key provision that enabled Kelsey – the one-time graduate assistant who saw the effects of DEG on rats – to delay and finally block the sale of thalidomide in the US in 1961.
Still, the sweet and lethal temptation of DEG keeps returning. Most infamously, small amounts used to cheaply “age” Austrian wine nearly destroyed the country’s wine industry in 1985. In the 1990s, a children’s medicine adulterated with DEG claimed hundreds of victims in India, Nigeria and Bangladesh. In 1995 and 1996, DEG-adulterated acetaminophen poisoned 109 children in Haiti, and at least 88 died as a result.
Even the one man who notably avoided death from diethylene glycol found he couldn’t escape entirely. Harold Watkins, the Massengill chemist, miraculously survived his own dose of Elixir, but he could not bear the aftermath. Not long after the scandal broke, he turned a gun on himself. With a pull of the trigger, the fatal Elixir claimed its final victim.