Why Do You Need to Know About the Elixir Sulfanilamide Disaster?
Understanding this situation and its implications gives candidates valuable insight into aspects of medical responsibility and how lessons can be learnt from tragedy to improve the future of medicine. If such topics come up in your interview, you can prove your knowledge and motivation for medicine by referring to what you learnt from the Elixir Sulfanilamide poisoning! Many more hot topics like this one can be found on our page.
What Was the Elixir Sulfanilamide Disaster?
In the early 20th century, there were few legal acts in place to regulate the production of food and drugs in the United States. Although the Food and Drug Administration was established in 1906 it then mainly aimed to ensure ingredients were accurately labelled on packaging.
In 1937, the pharmaceutical company S. E. Massengill Company responded to increasing demands for medication in liquid form by developing an oral formula for the antibiotic Sulfanilamide.
Chief pharmacist Harold Cole Watkins found the medication could be dissolved using the chemical diethylene glycol (DEG) which also added an appealing sweet taste. Once raspberry flavouring was added, the liquid medication, marketed as ‘Elixir Sulfanilamide’, was ready to hit the shelves.
At the time, animal testing of medications was not required by law and there were no safety regulations in place for new products. One month after the release of the new medication, the American Medical Association (AMA) started receiving reports of deaths occurring after patients took Elixir Sulfanilamide.
Investigation
The AMA took quick action to investigate the cause behind these fatalities and soon found that the solvent DEG, a primary ingredient in antifreeze, was responsible. Interestingly, DEG had already been established as being toxic and leading to kidney failure but this was not widely known and not known by Harold Watkins, the chief pharmacist at S. E. Massengill.
The FDA was notified and initiated an unprecedented search to recover the distributed medicine and managed to recall an extensive amount. In total, Elixir Sulfanilamide caused 107 deaths, however, this could have been as high as 4000 without the recovery and customer warning efforts.
When faced with legal action, the companies’ owner Mr Watkins refused to accept any responsibility, stating that they “could not have foreseen the unlooked-for results”. Mr Watkins committed suicide while awaiting trial and the company ended up paying a fine and compensating the families of the victims a total of around $10 million in today’s money.
Following the tragedy, there was a large amount of public outcry and demand for companies to test and ensure the safety of their products. Additionally, the mother of a young girl who had fallen victim to the medication wrote a harrowing letter to US President Roosevelt, imploring him to take action to prevent this from happening again.
Subsequently, in 1938 the Food, Drug and Cosmetic Act was established which required companies to perform animal safety checks on their products and submit the data to the FDA for approval before marketing.
Medical and Ethical Implications
When thinking about ethical issues surrounding a topic, it is really good practice to take time and reflect on what you think about the various issues surrounding it, and then try to formulate an argument to back up your opinion.
Here are some examples of ethical and medical implications you may mention, although there is no definitive list.
Non-maleficence
Non-maleficence is the principle of ‘do no harm’ which all medical practitioners aim to abide by. Medicine should improve patients’ health and quality of life, not harm them like Elixir Sulfanilamide did. Proper protection of patients involves ensuring treatments do no harm and this could have been achieved by testing the product first and checking each ingredient is safe.
Whose responsibility?
There are multiple parties in this case who it could be argued had some responsibility for the tragedy. Firstly, we have the company itself that did not understand the danger of DEG, did not check it was safe for use first and did no checks before releasing their product to the market.
Secondly, the government has a duty to protect its citizens through acts and laws, which at the time failed to ensure the safety of products that companies manufactured for public use. Finally, one could argue that individual doctors and pharmacists who have a duty of care to their patients should have been checking what they are giving their patients and ensuring its safety.
Animal testing
Although animal testing became mandatory after this incident to establish products safety for humans, there are many valid arguments against animal testing including inaccurate results due to genetic differences and the inhumane manner in which animals with sentience are treated.
Subsequent protections
The actions taken by the government and the foundation of the FDA as a result of this incident has meant the incidence of situations like this have been greatly reduced. One good example to highlight this is the rejection of the use of thalidimide in the US by the FDA due to insufficient evidence.
It later turned out that thalidimide had serious effects on the babies of pregnant women who took it and this act protected many unborn children in America. It could also be argued that the FDA have made similar failings in more recent years and there is still more to learn, for example, from the opioid crisis in America and the role of the FDA and Purdue Pharma.
Interview Questions on the Elixir Sulfanilamide Disaster
Below are some example interview questions that may be used relating to this incident and some guidance on how to answer them.
What was the Elixir Sulfanilamide mass poisoning, and what were its consequences?
For a question like this, provide a brief summary of the storyline of the events that took place and focus on the outcomes, including the harm it caused, the actions taken to address the disaster and the founding of the modern FDA with its significance to protecting future patients.
How did the Elixir Sulfanilamide incident impact the field of medicine and pharmaceutical regulation?
For this question, explain how the incident led to the origins of the modern FDA and its subsequent role in performing checks for new consumer products including mandatory testing for new drugs to increase patient safety.
What ethical considerations arise from the Elixir Sulfanilamide tragedy and how can they be applied to modern healthcare practices?
In answering this question, reflect upon ethical considerations such as the ones listed above or ones you’ve thought of. Explain these implications and how they are still relevant and can be applied to medicine today.
For example, when considering whose responsibility it is to ensure the safety of patients, you could explain that doctors today still have a duty to make sure treatment does not cause harm to their patients, hospitals have systemic responsibility to protect patient welfare and perhaps any recent governmental action taken to keep patients safe.
For further guidance on answering medical interview questions, visit our page here.
Lessons for Prospective Medical Students
Understanding important historical medical events such as the Elixir Sulfanilamide poisoning demonstrates insight and motivation for aspiring medical students as well as understanding how certain events in medicine can be used to make important changes to improve patients’ quality and effectiveness of healthcare.
Additionally, applying examples like this one in interview answers can demonstrate qualities that are important in a future doctor such as decision-making, appreciation for patient safety and problem-solving.
The most important reason for learning about cases like the Elixir Sulfanilamide poisoning, not only for future medical students but for all medical professionals is to reflect on the lessons learnt, identifying what went wrong and how it could have been improved and then applying this to your future practice.
