After learning about the horrible thalidomide scandal, I was wondering are there any other medical scandals like this one. I did some research and found this Elixir Sulfanilamide mass poisoning case.
Around 1937, a US manufacturer of pharmaceutical company called S.E. Massengill Company claimed they have produced a type of very powerful and effective pill that can treat colds, flu symptoms and strep, then in later that year, they developed a raspberry flavored liquid form of the pill that they called the “Elixir Sulfanilamide”. Then they put this elixir into markets and it was sold in drugs store around the country. Plus!!!Anyone can purchase this medicine without t prescription!!! By October 11, 1937 the AMA(American Medical Association) got reports that saying the elixir caused several deaths. Soon enough, FDA rounded up all bottles of the Elixir. As a result, 105 people died from ingesting the toxic liquid. Furthermore, FDA promulgates the policy later that sulfanilamide and selected other dangerous drugs must be administered under the direction of a qualified expert, thus launching the requirement for prescription only (non-narcotic) drugs.
One thing about this tragedy happened was because no one really performed any experiment on this medicine. Although animal testing should have been routine in most drug company operations, Massengill performed none and there were no regulations requiring pre-market safety testing of new drugs. All the patients who had this medicine all experienced similar symptoms, characteristic of kidney failure: stoppage of urine, severe abdominal pain, nausea, vomiting, stupor, and convulsions.
Before S.E. Massengill company produced this liquid medicine, this medicine was originally in tablets. However, the taste of this medicine was not that good. In attempting to prepare a liquid form of sulfanilamide had discovered that the drug would dissolve in diethylene glycol, a compound with a somewhat sweet taste similar to raspberries. When the mixture was tested for taste, appearance, and fragrance, it was found to be acceptable. Surprisingly, the company did not bother to test for toxicity. The reasons why taking this drug is so fatal is because diethylene glycol, a chemical customarily employed as an antifreeze, was a deadly poison and known to be such by the FDA. However, Massengill made no pre-sale examination of the drug’s safety nor was it customary for the FDA to conduct such tests, although to do so was within their warrant.
Again, this tragedy gave people a lot to think about. When we are given certain types of medicine, are they really safe or should we do our research first?
References
http://www.independent.org/pdf/policy_reports/2010-02-10-fda.pdf
http://www.the-scientist.com/?articles.view/articleNo/35714/title/The-Elixir-Tragedy–1937/
http://en.wikipedia.org/wiki/Elixir_sulfanilamide
http://www.ashp.org/menu/News/PharmacyNews/NewsArticle.aspx?id=1443