Poisoning Children

The discovery of the first sulfonamide drugs ("sulfa" for short) in the 1930s helped pave the way for the antibiotic revolution that would soon follow.   The development of Prontosil (the first true sulfonamide antibiotic) in 1935 earned its discoverer the 1939 Nobel Prize in medicine and pharmaceutical companies quickly took an interest.  As an effective treatment for various streptococcal infections, the economic potential for sulfonamide compounds seemed limitless.   Sulfa drugs could be taken in tablet or powder form and physicians regularly prescribed it for their patients, adults and children alike.   Unfortunately, children often had difficulty taking them orally and a salesman for the S.E. Massengill company based in Bristol, Tennessee told his head office of a growing request for a liquid version.

Realizing the potential for a new product, the company head, Samuel Massengill, assigned his chief chemist and pharmacist, Harold Cole Watkins to develop a sulfonamide syrup that would appeal to children.  Since sulfonamide wasn't easily dissolved in ethanol (the standard solvent for medications), Watkins experimented with alternatives and soon discovered that sulfanilamide (one of the most commonly used sulfonamides) could be dissolved in diethylene glycol (DEG).   Primarily used as a solvent, DEG is derived from ethylene oxide and seemed like an ideal ingredient since it was odourless and colourless.   After Watkins developed the basic compound, the Massengill laboratory then tested different flavourings and dyes and settled on a final product that they named "Elixir Sulfanilamide".   There were no laws regulating drug testing at the time and no safety studies were done on the new drug but Massengill still rushed it into production.  In September 1937, more than six hundred shipments of Elixir Sulfanilamide were sent across the country and sales representatives marketed it aggressively to physicians and pharmacists.

What followed was one of the first great pharmaceutical scandals of the 20th century.   Since no pharmacological studies had ever been done on DEG, both Watkins and the Massengill Company overlooked one important factor:  diethylene glycol is a deadly poison.   By October 11, the American Medical Association began receiving reports from physicians in Tulsa, Oklahoma that an unfamiliar sulfanilamide compound was responsible for a number of local deaths.   After obtaining samples of the product from Massengill and testing it in their own laboratory,  they quickly identified DEG as the toxic ingredient.  A series of warnings were issued, through newspapers and radio, that taking Elixir Sulfanilamide was potentially fatal. 

Amazingly, the AMA didn't contact the Food and Drug Administration (FDA) directly (there was no procedure in place at the time).  It took a complaint from a New York physician who learned about the poisonings to spur the FDA into action.   An inspector from the FDA's Kansas City branch office confirmed that eight children and one adult had died from taking Massengill's new product.   FDA inspectors immediately descended on Massengill's Bristol headquarters as well as branch offices in Kansas City, New York, and San Francisco.  They learned that the company had already realized that Elixir Sulfanilamide was poisonous and had sent telegrams to all its salesmen requesting the return of their product.  At no time did they include a warning to physicians of the risk involved or that taking the medicinal syrup was fatal.    At the insistence of the FDA, the Massengill company sent off a second round of telegrams that were more strongly worded:  "Imperative you take up immediately all elixir sulfanilamide dispensed. Product may be dangerous to life. Return all stocks, our expense.".

Tracking down the remaining shipments that had already been distributed was a massive operation.  Not only were all 239 FDA inspectors and chemists involved across the United States, but state law enforcement agencies and local health officials were used as well.   By the time the warning went out,  thousands of bottles had been sold and FDA inspectors had to check each sales slip by hand (no computers in those days).  Massengill sales representatives were tracked down and questioned although not all of them were willing to cooperate (one salesman only provided his customer list after he was jailed by Texas police).    Further detective work was needed to track down customers since many drugstores sold the elixir over the counter without a prescription.  While doctors and pharmacists did everything they could to help, contact information for the customers who had bought the elixir was often incomplete and the search for potential poisoning victims became desperate.

Those victims of Elixir Sulfanilamide who could be traced all tended to display the same symptoms:  inability to urinate, severe abdominal pain, nausea, vomiting,  stupors, and convulsions.   Since there was no known treatment for DEG poisoning at that time, physicians could do nothing but stand by and watch the poisoning take its course.  Those patients who survived suffered unremitting pain for seven to twenty-one days.   In all,  there were more than 107 patients who died of DEG poisoning (mostly children).  Autopsies showed severely enlarged kidneys, up to twice normal size in most cases. 

Testimony by family members of DEG fatalities was often heartbreaking.  In a letter that one mother wrote to President Franklin D. Roosevelt, she stated that

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..

In another letter by a family doctor who had prescribed Elixir Sulfanilamide for his patients, he wrote:

"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."

Of the estimated 240 gallons of Elixir Sulfanimide that were manufactured and distributed, 234 gallons and one pint were successfully traced and destroyed.  The rest went to patients who died.  As for Samuel Massengill, the owner of the company that distributed the drug to the public without proper testing, his public response has become legendary:  "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".   Harold Watkins obviously disagreed;  he shot himself while awaiting trial over his role in the disaster (some sources suggest that this was accidental since he was cleaning his gun at the time). 

While there have been more widespread cases of mass poisoning in the United States, public outrage over the Elixir Sulfanilamide incident and the deaths of so many patients (including children) spurred the passage of the 1938 Federal Food, Drug and Cosmetic Act.  That same act would help protect the American public from the thalidomide epidemic that affected many European countries between 1957 and 1961.  As for DEG, its value as a low-cost substitute for glycerin would ensure its popularity with producers of counterfeit medications and foodstuffs around the world.  DEG poisoning been linked to subsequent epidemics of contaminated medications in numerous countries including South Africa, Spain, India, Nigeria, China and Bangladesh.   DEG has also been used as a component of some brands of toothpaste as well as certain winemakers to produce "sweet wine".

You get what you pay for.

 

           

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