Cough Syrup, Dead Children, and the Case for Regulation

By Deborah Blum

Kathleen Hobson was eight years old when her mother unknowingly dosed her with poisonous cough syrup. She’d only taken a couple spoonfuls but when investigators came round, they still found nothing left to test. After the little girl died, her mother had set the bottle on fire and then thrown it into the trash.

Charlene Canady was just four when she died from the same medication. Her father had carefully packed the cough syrup bottle, waiting for justice to come calling. I always imagine him silent when he handed the bottle over, grief and his daughter’s name caught like a kind of suffocation in his throat.

Both little girls lived in Tulsa, Oklahoma, both came down with nasty little colds in the fall of 1937, and both died because they were dosed with a brand new medication, a popular, raspberry-flavored cough syrup. In all, the syrup would kill 11 people in Oklahoma, within a few weeks. Ten in Alabama. Ten in Georgia. Twenty-three in Mississippi. Nine in South Carolina. Seven in Texas. More in California, Ohio, Illinois, Missouri, Virginia, Louisiana, and more.

More than one hundred dead nationwide, in fact, and most of them children, Charlenes and Kathleens scattered across the United States like so much storm wreckage. “Nobody but Almighty God and I can know what I have been through these past few days,” a Louisiana doctor later wrote to the U.S. Food and Drug Administration, after six of his patients died in one week.

As FDA scientists would quickly realize, the syrup was lethal because it was sweetened by a compound known as diethylene glycol which kills by causing acute kidney damage. Both diethylene glycol and the obviously closely related compound, ethylene glycol (even more toxic) are best known today for their use as antifreeze agents and homicidal weapons on more than one occasion.

But at the time that Elixir Sulfanilamide came to be, produced by the S.E. Massengill Company of Bristol, Tennessee, that wasn’t well understood. There was actually no legal requirement that companies understand their products, much less safety test them.

The company chemist who designed the cough syrup by mixing a sulfa drug into the poisonous sweetener claimed to have no such knowledge. And as the company president, Samuel Massengill responded: “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 resulting Elixir Sulfanilamide scandal – and it was, indeed, an incendiary, nation-rocking scandal at the time - is mostly forgotten today. But it shouldn’t be. Those rippling deaths, the feeble government response, the indifference of the manufacturer and its big business allies - provoked such a passionate outcry that a year later, the long-delayed U.S. Food, Drug and Cosmetics Act was signed by President Franklin Roosevelt.

The 1938 law was first major upgrade of 1906 legislation. The earlier law established the U.S. government as a guardian of the American people’s safety, set precedents in regulating toxic chemicals in food and drugs. But that turn-of-the century law was in many ways a piece of regulatory lace, full of exceptions and exemptions. The new law filled many of those holes, gave power to protective rules.

Now, for the first time, manufacturers were required to safety test their wares and could be held responsible for consumer death and injury. In the case of Elixir Sulfanilamide, the company could not be held liable for a single death. It could only be charged with mislabeling – elixirs were supposed to contain alcohol and the cough syrup contained none.

The 1938 law also required manufacturers to list ingredients on their labels in some detail – another first. One of my favorite books of the 1930s, 100,000,000 Guinea Pigs, by Arthur Kallet and F.J. Schlink, is basically a litany of the hidden dangers that preceded that rule: the toothpaste that contained so much potassium chlorate that it was possible to commit suicide by eating a single tube; the high levels of lead in hair dye,;and the use of the toxic element thallium in depilatory creams. One of the side effects of thallium poisoning is that hair falls out. Cosmetic manufacturers of the 1930s thus found it handy in hair-removal products. They expressed surprise at the small epidemic of baldness, paralysis and occasional death that resulted. But, as they reminded irate physicians, they could not be held responsible for that.

But although advocates like Kallet and Schlink spent years marshaling such evidence in an effort to persuade the government to give the FDA actual enforcement powers, they were stymied by business opposition until the Elixir Sulfanilamide scandal galvanized the country. In an essay for the Annals of Internal Medicine, toxicologist Paul M. Wax called it “one of the most consequential mass-poisonings of the twentieth century.”

And it’s that case that always comes to mind when I hear politicians trumpeting the wonders of an unregulated marketplace, as with the current Republican party mantra that we don’t need strong environmental protections or – at the most extreme vantage point – even a U.S. Environmental Protection Agency at all. Last year, along the same lines, conservative legislators were busily trying to defund the FDA as well.

The Washington Post’s Ezra Klein points out that Americans tend to sound anti-regulation when queried. But, he adds, if you press them on which oversight they’d like to give up, the picture becomes more complicated. Klein cites a Pew Research survey done in February which found that 53 percent of respondents wanted food and food product regulation increased – only seven percent thought it should be reduced. For environmental regulation, slightly more – a full 17 percent – argued for relaxing the rules. The survey was, actually, unable to locate a majority of American citizens seeking to be less well protected.

We hear legislators suggest that hard economic times demand the loosening of regulations. But don’t forget that our country was still mired in the long-reach of the Great Depression when that 1938 law was passed. The government recognized, even then, that protection of American citizens meant more than policing our cities and defending our borders. It meant dedicated protection of public health.

Do we sometimes wish that such protection was smarter, moved faster, was more richly knowledge-based? Less influenced by politics, on occasion, by corporate lobbyists? Of course, we do. But I see that as a call to keep the process as politics free as possible (dreaming, I know), to invest more in good risk research and to use that knowledge to improve protection against everything from food poisoning to chemical contamination.

We may not remember by name the Kathleen Hobsons and Charlene Canadays of our past. And as I said, the Elixir Sulfanilamide story, is mostly forgotten as well. But we should be grateful for the way it changed our lives. And we should occasionally acknowledge those lost children; whether we recognize it or not, their ghosts still walk among us today, reminding us of what is right.