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Compliance In Focus
Posted by Natalie Jarmusik on Mon, Sep 8, 2014

1937 – Elixir Sulfanilamide

You may be familiar with IMARC Research’s History of Clinical Research (HCR). We recentlyElixir Sulfanilamide Disaster released an eBook about it that briefly describes all of the images that currently make up the timeline. If you have visited our office, you may have also been given a guided tour of one of our most renowned resources. Due to the overwhelmingly positive feedback we have received, we will be highlighting each time point with a series of blogs that we plan to release over the course of the 2014 calendar year.

In September and October of 1937, Dr. A.S. Calhoun innocently and unknowingly prescribed to more than 100 patients what is now known in history as the “lethal liquid:” Elixir Sulfanilamide, produced by a pharmaceutical manufacturer known as the S.E. Massengill Company, resulted in the deaths of these 100 people in various regions spreading from California to Virginia. Elixir Sulfanilamide prepared sulfanilamide medicine by using diethylene glycol, or DEG, as a solvent. Not known at the time to be poisonous to humans and animals, Harold Watkins, chief pharmacist of S.E. Massengill, approved the use of DEG without animal testing as no regulations on pre-market drug testing existed in 1937. To enhance and improve taste, raspberry flavoring was added to the concoction.

Though sweet in taste, the results of consuming Elixir Sulfanilamide were disastrous and deadly. Outrage and distress from family members of the affected patients were made public and even Dr. Calhoun himself released a statement to express his grief and distress over the mass poisoning:

“But to realize that six human beings, all of them my patients, one of them my best friend, are dead because they took medicine that I prescribed for them innocently, and to realize that medicine which I had used for years in such cases suddenly had become a deadly poison in its newest and most modern form, as recommended by a great and reputable pharmaceutical firm in Tennessee: well, that realization has given me such days and nights of mental and spiritual agony as I did not believe a human being could undergo and survive. I have known hours when death for me would be a welcome relief from this agony." (Letter by Dr. A.S. Calhoun, October 22, 1937)

Once reporting of deaths due to intake of the ‘medicine’ made way to the FDA, an investigation through research confirmed that DEG was in fact responsible for the poisonings. Watkins, who at first protested the effects were unforeseen and therefore S.E. Massengill could not be held responsible, eventually ended up committing suicide while awaiting trial. Congress responded to the public outcry by passing the 1938 Food, Drug, and Cosmetic Act, which required companies to perform animal testing on all new drug applications and submit the data to the FDA prior to marketing. As for S.E. Massengill, the company paid a minimum fine under the 1906 Pure Food and Drugs Act for improperly labeling the preparation as an “elixir” when it contained no alcohol.

The Elixir Sulfanilamide disaster thus proves as another example in history where drastic and unfortunate outcomes of one terrible event resulted in the formation of an agency found necessary to increase the protection of human subjects in the clinical realm. For more historical examples like this one, be sure to check out IMARC Research’s History of Clinical Research. Can you think of any other events, whether current or historical, that have fostered the improvement of human subject protection? Leave your thoughts below!

Image Credit: Nicolette Capuano

The History of Clinical Research

 

 

Topics: History of Clinical Research, Elixir Sulfanilamide, FDA

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