The Luckily Mislabeled Medicine That Poisoned America
Taste the raspberries, taste the death.
During September and October 1937 doctors prescribed a drug that went on to kill over 100 people. This wasn’t surprising, given the principal ingredient in the drug was anti-freeze. How did the drug get handed out to vulnerable patients and how were thousands of people spared by a simple linguistic mix-up?
What happened would shape the way that the US regulates all its drugs and pave the way for groundbreaking legislation.
What was the drug?
The drug in question was Sulfanilamide. It was developed in 1908 by Austrian chemist Paul Josef Jakob Gelmo and patented in 1909. The drug acts as an anti-bacterial and was used extensively in the first world war in powder and tablet form.
Across the 1920s the drug was well known by doctors and medical practitioners as a safe and effective cure for strep throat and similar infections. It was popular with consumers and medical professionals alike.
Demand began to rise for a liquid form of the drug, something that could be more easily administered to children and babies and those with problems with swallowing tablets. Salesmen for the S.E. Massengill Company in Tennessee was determined to exploit a niche in the market.
Harold Cole Watkins, the chief chemist worked hard to find a solution, figuratively and literally. He found that Sulfanilamide dissolved very well in diethylene glycol and this became the standard base.
Diethylene glycol is colorless, odorless and slightly sweet to the taste and a deadly poison if consumed in enough quantities. Watkins, unaware of this, added raspberry flavor on top and named the product ‘Elixir Sulfanilamide’. The company then fired shipments out all over the United States and began to sell the product.
The creation of a toxic medicine was considered bad for business, it wasn’t necessarily a criminal offence. The new drug was never tested to see if it was poisonous or not because such studies were considered irrelevant. In 1937, the only regulatory legislation was the 1906 Food and Drugs Act which was largely considered obsolete
This piece of legislation would accidentally prove to be a literal lifesaver in this particular instance.
The deaths begin
Nobody but Almighty God and I can know what I have been through these past few days. I have been familiar with death in the years since I received my M.D. from Tulane University School of Medicine with the rest of my class of 1911. Covington County has been my home. I have practiced here for years. Any doctor who has practiced more than a quarter of a century has seen his share of death.
“But to realize that six human beings, all of them my patients, one of them my best friend, are dead because they took medicine that I prescribed for them innocently, and to realize that that medicine which I had used for years in such cases suddenly had become a deadly poison in its newest and most modern form, as recommended by a great and reputable pharmaceutical firm in Tennessee: well, that realization has given me such days and nights of mental and spiritual agony as I did not believe a human being could undergo and survive. I have known hours when death for me would be a welcome relief from this agony.” (Letter by Dr. A.S. Calhoun, October 22, 1937)
By mid October, the American Medical Association (AMA) was beginning to receive worrying reports that a new Sulfanilamide compound was causing deaths. The AMA immediately tested the elixir and found diethylene glycol to be the toxic ingredient. They notified the S.E. Massengill Company who immediately began a recall.
They fired out warnings on radio and in the newspapers that the new product was deadly.
The Food & Drug Administration (FDA) joined the fray, strengthening the the S.E. Massengill Company message. Rather than politely requesting that salesmen return any of the formula they still had, it was made explicitly clear the elixir was poisonous.
“Imperative you take up immediately all elixir sulfanilamide dispensed. Product may be dangerous to life. Return all stocks, our expense.”
Almost everyone employed at the FDA was out in the field desperately hunting down salesmen, doctors and chemists. The companies shipping records were examined very thoroughly and their sales force tracked down — something easier said than done.
Once the salesmen were tracked down they weren’t always forthcoming with the information about sales. Concerned in part by protecting their leads but also by the notion they may become responsible for any deaths that transpired. The same was also true of doctors, many of whom falsely reported that there had been no deaths as a result of their prescriptions and some who had been very lax about recording who they had given prescriptions to.
Eventually, the FDA discovered a small loophole by which the medicine could be legally seized and requisitioned, bypassing any need for permission or discussion.
The word ‘Elixir’ heavily implied the drug contained alcohol. It didn’t. It had therefore been mislabeled and violated the 1906 Food and Drug Act. If they’d called the drug ‘a solution’ then no laws would’ve been broken.
It’s thought this exploited linguistic loophole may have saved around 4000 lives.
The Aftermath
Thanks to the persistence of local, state and federal agencies, the AMA and the news media the vast majority of the elixir was recalled. 240 gallons were distributed, 234 gallons and 1 pint were brought back. The remainder was consumed and led to the deaths of 104 people in 15 different states, many of them children.
One mother wrote to President Franklin D. Roosevelt (D-New York).
“The first time I ever had occasion to call in a doctor for [Joan] and she was given Elixir of Sulfanilamide. All that is left to us is the caring for her little grave. Even the memory of her is mixed with sorrow for we can see her little body tossing to and fro and hear that little voice screaming with pain and it seems as though it would drive me insane. … It is my plea that you will take steps to prevent such sales of drugs that will take little lives and leave such suffering behind and such a bleak outlook on the future as I have tonight.”
The firm that manufactured the elixir held firm to their belief that they had done no wrong. It was regrettable that people had been poisoned but it was simple supply and demand.
“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.” — Dr. Samual Evans Massengill,
In reality, there was already some studies that had demonstrated diethylene glycol to be poisonous and it was a lack of research that had led directly to the deaths.
The company view was not shared by the senior chemist who concocted the compound. Harold Cole Watkins shot himself in Janurary 1939.
A new set of standards
The FDA Commissioner was scathing in his review of the federal regulation of drugs.
“It is unfortunate that under the terms of our present inadequate Federal law, the Food and Drug Administration is obliged to proceed against this product on a technical and trivial charge of misbranding. …[The Elixir Sulfanilamide incident] emphasizes how essential it is to public welfare that the distribution of highly potent drugs should be controlled by an adequate Federal Food and Drug law. These unfortunate occurrences may be expected to continue because new and relatively untried drug preparations are being manufactured almost daily at the whim of the individual manufacturer, and the damage to public health cannot accurately be estimated. The only remedy for such a situation is the enactment by Congress of an adequate and comprehensive national Food and Drugs Act which will require that all medicines placed upon the market shall be safe to use under the directions for use. …— Walter Campbell (FDA Commissioner)
And his wish was granted. The poisoning of 100 American citizens by raspberry flavored anti-freeze created a new set of standards. The 1938 Federal Food, Drug and Cosmetics Act.
It was this piece of legislation that prevented the widespread adoption of Thalidomide. Pharmacologist Frances Oldham Kelsey insisted there wasn’t enough evidence the drug was safe despite widespread pressure from pharmaceutical companies who were determined to sell it.
She was absolutely right and duly got the President’s Award for Distinguished Federal Civilian Service from John F Kennedy. In the US, only 17 children were born with deformities caused by Thalidomide, mostly as a result of a clinical trial. This figure can be compared with around 2000 in the UK, with around 400 surviving into adulthood and being compensated by the UK Government and pharmaceutical companies who provided the drug.
So although this event caused huge amounts of suffering across many different states, it became a learning point for future generations of US Citizens.
A tragedy that was learned from and one which would echo through the years.
References
The phrase taste of raspberries; taste of death comes from a 1981 issue of the FDA Consumer Magazine .
Frances Oldham Kelsey (1914–2015) (https://cfmedicine.nlm.nih.gov/physicians/biography_182.html
