Ergot and the First Roots of the FDA

Editor’s Note: Today’s post comes from Naomi Rendina. Rendina is a PhD candidate at Case Western Reserve University. She is expected to defend her dissertation, Pushing Too Hard: Pharmaceuticals and the Nature of Childbirth, in early March 2020. Here she explores the role a controversy of ergot played in creating the Food and Drug Administration (FDA), which was first formed in 1906. 

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Naomi Rendina

Pharmacists and historians celebrated the 200th anniversary of the United States Pharmacopeia (USP) at the 44th International Congress for the History of Pharmacy, on September 5- 8, 2019, in Washington, DC. Founded in 1819, the USP remains the non-profit organization responsible for creating the standards for medicines, food ingredients, and supplements. These standards ensure that each compound is appropriately identified, and is of consistent strength, quality, and purity. For three days, historians and pharmacists presented their research on drugs, as well as histories of the profession and institutions that shape pharmacy. 

What most stood out to me was a comment that  FDA historian Dr. John Swann made during his portion of the Opening Ceremony comments. He said that the period between 1906 and 1938 were formative years of what became the Food and Drug Administration. This statement underlined one of my frustrations in researching the history of ergot (a group of fungi that have been used to treat a variety of medical issues, including inducing contractions and controlling bleeding after childbirth). The incident fascinated me, but I stumbled through reasons why anyone else would find this as amazing as I did. Dr. Swann argued that these years were foundational to the institutionalization of science and of the regulation of food and medicine in the United States, but are all too often only given a cursory glance. 

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Ergot extract at the USP

While researching labor-inducing pharmaceuticals, I stumbled upon a 1930 Senate hearing that investigated accusations of impure ergot being allowed into the country. There is evidence that importers knew that the ergot was bad, and that they manipulated the preparation to appear to fit the standard. Impure and adulterated medicines and compounds explicitly defied the regulations set forth in the 1906 Food and Drug Act. 

Howard Ambruster, a New York City-based importer of Spanish ergot, charged the Department of Agriculture, pharmaceutical companies, and even the American Medical Association of willfully admitting and using substandard ergot from Russia. Ambruster was convinced that this low-quality preparation contributed to the poor maternal mortality rate across the United States. Earlier, in 1912,  at the annual meeting of the New York Branch of the American Pharmaceutical Association, Drs. H. H. Rusby, C.E. Vanderkleed and Cornelius De Jonge participated in a symposium questioning “what shall we do about ergot?” noting that the “conditions of growth, preparation, transportation, etc., all act to prevent our obtaining reliable preparations of ergot.”

This gathering concluded a few things about ergot. First, the preparations for transportation were incorrect because the ergot was not given enough time to dry. Moisture and mold were in about seventy-five percent of the defective ergot. Another factor was the “adulteration of ergot with 20 per cent or more of water,” and Rusby suggested that the bags of ergot were dipped in water because of the amount of absorbed fluids. Vanderkleet also noted that the storage of the fluid extract of ergot is important to its stability because, if left unsecured, the integrity of the preparation declines with time. 

After Ambruster entered the ergot trade in 1927, prominent drug companies, including Park, Davis, & Company and Abbott Laboratories, allegedly promptly conspired to not buy any of Ambruster’s Spanish ergot. Ambruster took these companies to court “to recover damages for a conspiracy to destroy [his] business.” Squibb pharmaceuticals was known for being the “first producer of ergot preparations of exceptional quality and absolutely reliability.” A Squibb representative admitted in court that they did not use Spanish ergot despite the company advertising since 1919 that their “fluid extract of ergot was made from Spanish ergot and nothing else, which was a falsehood by its officer’s own admission since about 1921.” 

It was not until 1928 that the American public really got wind of the role and potentially hazardous effects of ergot in childbirth. In the New York State Journal of Medicine, “obstetricians complain[ed] that the present fluid extract of ergot is not reliable and is not dependable in producing contractions of the muscles of the uterus and stopping hemorrhage following childbirth.”Ambruster turned to the medical profession to discuss his concerns, but was met with resistance when the editor of the Journal of the American Medical Association refused to allow him to publish advertisements seeking profession-wide attention. Morris Fishbein, another ergot importer, accused Ambruster of trying to corner the ergot market for his own financial gain. Correspondence between Fishbein and Ambruster continued for about ten years. It was constant petty bickering, each suggesting that the other was being dismissive, a liar, and selfish. 

The United States Senate Committee on Agriculture and Forestry heard arguments, testimony, and evidence presentations over five months in 1930. The only thing to come from this hearing was an exceptionally long transcript record of the proceedings. However, as early as 1968, scholars like C.O. Jackson recognized that the ergot controversy was important to the creation of the modern FDA. This controversy is an example of the importance of scientific standards for drugs, and the beginnings of institutionalized science.