Canada and the World
Current Events with a Canadian Perspective
Last update
19 November 2010
Drug Disaster Leads to Regulation
In 1937, S. E. Massengill Co., a small
pharmaceutical manufacturer,
began to sell a product it called Elixir Sulfanilamide
Samuel Evans Massengill enrolled in medical school at the University of Nashville, Tennessee, but before he graduated he could see that making medicines for doctors would be more profitable than being a doctor.
In 1898, he started up the S. E. Massengill Company with the goal of producing pharmaceuticals. He prospered.
A Cure for Sore Throats
In the fall of 1937, the company put a new product on 
the market. Elixir Sulfanilamide
(left) was going to cure sore throats like never before. It was also promoted for
use on a variety of other ailments.
The product contained sulfanilamide, diethylene glycol, a dash of red colouring, and a smidgen of raspberry flavour to help it go down.
Unfortunately, Harold Cole Watkins, who created the medicine, didn’t know that diethylene
glycol is poisonous; it’s otherwise known as anti-
Massengill shipped the magic potion all over the U.S. Writing in the June 1981 issue of the FDA Consumer magazine, Carol Ballentine reported that “The new formulation had not been tested for toxicity. At the time the food and drugs law did not require that safety studies be done on new drugs. Selling toxic drugs was, undoubtedly, bad for business and could damage a firm's reputation, but it was not illegal.”
Deaths Reported soon after Shipping
Almost at once patients were suffering an “extremely painful, excruciating death.”
On October 11, 1937 Dr. Homer A. Ruprecht of the Springer Clinic in Tulsa, Oklahoma wrote a letter to the American Medical Association. In it he described what was happening to his patients.
“We have a list of ten patients who have received an elixir of sulfanilamide…Of these, ten patients, four are living, two of whom have definitely recovered, and the other two will probably die. Eight of these patients were children and the drug was given because of an upper respiratory infection. The other two patients were young men and the drug was used for a gonorrheal infection.
“The onset is usually with nausea, vomiting, malaise, sometimes diarrhea, and then complete anuria (inability to pass urine).”
By the time all the bottles were retrieved 107 people had succumbed.
Company Claims no Wrongdoing
S. E. Massengill Co. said it had done nothing wrong. The company chemist, Harold Watkins, thought otherwise; he took his own life, although some same his gun went off accidentally while he was cleaning it.
On October 17, 1938 Time Magazine reported that “Kin of the victims promptly started civil suits, to date have collected more than $150,000 damages (about $2.25 million in 2009 terms) from S. E. Massengill Co.”
The government only pursued minor charges involving mislabelling the product and paid a fine of $16,800 (roughly $250,000 today).
The catastrophic event led to the passage in 1938 of the Federal Food, Drug, and Cosmetic Act. The public outcry caused by the Elixir Sulfanilamide issue not only reshaped the drug provisions of the new law to prevent such an event from happening again, it propelled the bill itself through Congress.
Image credit
U.S. Food and Drug Administration
Sources
“Taste of Raspberries, Taste of Death: The 1937 Elixir Sulfanilamide Incident.” Carol Ballentine, FDA Consumer Magazine, June 1981.
“U.S. Deaths from Elixir Sulfanilamide.” B. Martin, Pathophilia, January 19, 2009.
© Canada and the World, September 2010
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PHARMACEUTICAL ACCIDENTS
Despite the existence of drug approval agencies in all advanced democracies accidents still happen.
In 1955, 164 children were paralysed and ten killed in the U.S. by a tainted batch of polio vaccine.
In 1961, the drug thalidomide was taken off the market after between 10,000 and 20,000 babies around the world whose mothers had taken it were born with physical deformities.
Cisapride, a drug used to treat stomach problems, was withdrawn from the market in 2000 after it was associated with heart disease that killed more than 100 people in the U.S.
“Since 1997, more than a dozen prescription drugs have been taken off the market
due to serious side effects -
PBS Frontline, November 2003