How the DEG molecule (tragically) changed the history
The Deadly Cost of No Pharmaceutical Regulations in the Early 20th Century
When Medicine Became Poison
In 1937, the pharmaceutical industry in the United States was largely unregulated. Companies could manufacture and sell medications without proving they were safe for human consumption. This lack of oversight led to one of the deadliest drug-related disasters in history: the sulfanilamide tragedy.
A Tennessee-based company, S.E. Massengill Co., produced a liquid form of sulfanilamide, a popular antibiotic at the time. To dissolve the drug into a syrup, the company used diethylene glycol (DEG), an industrial chemical found in antifreeze. No one tested its safety before mass distribution. The result? Over 100 people died, many of them children, due to acute kidney failure caused by the toxic ingredient.
Why Did This Happen?
The answer is simple: there were no laws requiring drug safety testing. At the time, the Pure Food and Drug Act of 1906 only required that drugs be properly labeled—it said nothing about testing for safety before they were sold. As a result, companies could use any ingredient they wanted without proving its effects on human health.
The Aftermath: How Tragedy Changed the Law
Public outrage over the sulfanilamide disaster led directly to the passing of the Food, Drug, and Cosmetic Act of 1938. This landmark legislation forced pharmaceutical companies to:
- Test new drugs for safety before selling them
- Submit their findings to the U.S. Food and Drug Administration (FDA) for approval
- Properly label products with warnings and directions for safe use
This law laid the foundation for modern drug regulation, ensuring that new medications undergo rigorous testing before they reach the public.
What If Regulations Had Existed?
If stricter laws had been in place in 1937, the sulfanilamide disaster could have been prevented. Testing would have shown that DEG was highly toxic, and the deaths of over 100 innocent people—many of them children—would have been avoided.
Unfortunately, similar tragedies have occurred in countries with weaker pharmaceutical regulations. The absence of strong oversight continues to put lives at risk worldwide.
The Lesson: Regulation Saves Lives
Some argue that government regulations slow down innovation in the pharmaceutical industry. But history tells a different story. The absence of oversight doesn’t lead to progress—it leads to disaster. Strong regulations ensure that life-saving drugs don’t turn into deadly poisons.
As new medicines continue to be developed, the lesson from 1937 remains clear: without regulations, there is no safety.
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