In 1937, the S.E. Massengill Company, a pharmaceutical manufacturer in the United States, introduced Elixir Sulfanilamide, a liquid form of the antibiotic sulfanilamide. During this period, antibiotics were scarce, and sulfanilamide had proven effective against streptococcal infections. However, the formulation of this medication led to one of the most tragic public health disasters in American history.
Instead of using glycerin to create the medication's liquid form, chemists at the S.E. Massengill Company opted for diethylene glycol (DEG), a less expensive chemical with similar solvent properties. DEG was known for its use in antifreeze but was highly toxic when ingested. Unfortunately, at that time, the toxic properties of DEG were not well-known or documented.
The Consequences
DEG is highly toxic and causes renal failure and death when ingested. Its pleasant taste masked its lethal nature, leading to widespread poisoning. Over 100 fatalities were reported across the United States, with children being the primary victims due to the syrupy sweet taste of the medication.
Public Health Response
The high casualty rate from Elixir Sulfanilamide quickly caught the attention of public health officials. On November 19, 1937, they alerted physicians nationwide about the elixir’s dangers. By December 10, almost all shipments were tracked down and seized. However, one package resurfaced in January 1938, resulting in additional fatalities.
Legislative Impact
The Elixir Sulfanilamide disaster profoundly impacted drug regulation in the United States. The tragedy led Congress to pass the Federal Food, Drug, and Cosmetic Act (FDCA) in 1938. This legislation required pharmaceutical companies to:
- Establish Safety Protocols: Companies must establish their products’ safety before being scientifically released.
- Ensure Accurate Labeling: Accurate and comprehensive product labeling became mandatory.
- Pre-Market Testing: Rigorous pre-market testing and quality control measures were enforced.
Creation of the FDA
The FDCA also led to the establishment of the modern Food and Drug Administration (FDA). The FDA was empowered to oversee drug safety, efficacy, and labeling to ensure that such a tragedy would not occur again. This marked significant improvements in pharmacological oversight and regulatory practices.
Ongoing Challenges
Despite lessons learned from the Elixir Sulfanilamide disaster, cases of DEG poisoning continue globally, particularly in less developed countries. Poor pharmacovigilance and using DEG counterfeit, legitimately marketed drugs remain significant challenges. Efforts to improve drug safety regulatory practices are ongoing to prevent similar tragedies.
Conclusion
The Elixir Sulfanilamide disaster poignantly reminds us of rigorous drug safety regulatory standards. The tragedy highlighted the lethal consequences of inadequate testing and poor quality control and spurred the development of comprehensive drug regulations. Establishing the FDA and enacting FDCA are crucial steps to ensure the safety and efficacy of pharmaceuticals, ultimately saving countless lives.
References
1 “The Elixir Sulfanilamide Disaster” FDA Consumer Magazine Retrieved from FDA History2 Carpenter D (2010) “Reputation Power Organizational Image Pharmaceutical Regulation FDA” Princeton University Press ISBN: 978-06911418073 “Diethylene Glycol Poisonings Contaminated Pharmaceuticals” World Health Organization WHO Retrieved from WHO Publications4 Wax P M (1995) “Elixirs Diluents Passage 1938 Federal Food Drug Cosmetic Act” Annals Internal Medicine 122(6) 456-461 doi:10 7326⁄0003-4819-122-6-199503150-00006