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When the Medicine Man Comes Knocking: The Push for Modernization of Pharmaceutical Safety

Updated: Jul 24, 2023

Editor’s Note: Camille King returns with Part Two of ‘When the Medicine Man Comes Knocking’. She picks up where Part One left off, with an understanding of how some patent medicines were marketed misleadingly based on their alleged ability to cure a range of physiological symptoms. In this post she considers how greater awareness was created regarding the content of patent medicines and their implications for public health.


Introduction


The marketing and administration of patent medicines in the 19th-20th centuries in the United States left the public with more health issues, while making many entrepreneurs wealthy at consumer expense. Part One of this essay discussed the methods used in marketing these patent medicines and portrayed the dangers to the public that occurred when these medicines were ingested. This post (Part Two) will address how the public became aware of the dangers of patent medicines and how the United States government developed protocols to ensure safety in pharmaceutical development.


Journalism Brought Awareness to the Public


Increased awareness of some of the dangerous ingredients in patent medicines were reported to the public by progressive journalists of the time, also known as muckrakers. Muckrakers are what we call investigative journalists today. Muckrakers had a large following and provided evidence of fraud and corruption. This new type of reporting brought about a change in attitudes of U.S. doctors and drug companies. Physicians viewed over-the-counter patent medicines with distaste.1 Greed and profit took a back seat to scientific evidence.


Figure 1. Samuel Hopkins Adams (Source: Wikimedia Commons)

One popular muckraker, Samuel Hopkins Adams (Figure 1), wrote a book in 1905 called The Great American Fraud.  He reported that millions of dollars were spent by the American public on the purchase of large quantities of alcohol, huge amounts of opiates and narcotics, and dangerous heart depressants and liver stimulants, which were typical ingredients in patent medicines.


He wrote advertisements that caused public concern about what they were ingesting into their bodies. Poster displays would show the name of a disease in heavy black type e.g., MENINGITIS, and claim that witch hazel is about as effective a cure as molasses. This caused people to be alarmed. Hopkins Adams divulged that cocaine and opium stop pain, but these narcotics aren’t the safest medications to put in the hands of the public, especially when disguised in cough syrups and catarrhal powders.


Hopkins Adams also wrote about the high content of alcohol in patent medicines – fed daily to women and children – which subsequently caused drunkenness. Other health-destroying compounds were addressed in The Great American Fraud, such as Paine’s Celery Compound and Duffy’s Pure Malt Whiskey (advertised as an exclusively medical preparation); “the catarrh powders – which breed cocaine addicts, and the opium-containing soothing syrups – which stunt or kill helpless infants”.


Revised Legislature and Government Control the Industry


Testimonials, increased writings of misleading patent medicine marketing and the dangerous ingredients in the products, as well as the unsanitary conditions of the manufacturing plants, brought about a public outcry. On June 23, 1906, the Pure Food and Drug Act was enacted by U.S. Congress for consumer protection (Figure 2). The FDA laws are intended to assure the consumer that foods/medications are pure and wholesome, safe to ingest, and produced under sanitary conditions.3 Active ingredients were to be placed on packaging labels and drugs could not fall below purity levels established by the U.S. National Drug Formulary. Any dangerous or addictive drugs must be displayed on the product label.



The Push for Safety Changed an Era of Patent Medicines


In 1938, the Federal Food, Drug, and Cosmetic Act (FFDCA) was enacted by Congress.4 This act continues today to be the basis for federal regulation of foods, drugs, biological products, cosmetics, medical devices, tobacco, and radiation-emitting devices used in the United States.


Muckrakers continued to target patent medicines and their dangerous high contents of alcohol, opium derivatives, and other narcotics such as morphine, cocaine, heroin, and cannabis. Loopholes existed with the new laws. The 1906 law did not require information be submitted to the Food and Drug Administration before marketing. The law only required that drugs had specific strength and purity standards. After 1906, specifically on the Lash’s Bitters product, the inscription ‘Purity Guaranteed’ was removed from medicine bottle labels and replaced with the percentage of alcohol content (21%).5 To remove a drug from the market, the government had to show that the label was misleading or false. Congress enacted the Sherley Amendment in 1912 prohibiting labeled medicines with false or misleading claims intended to dupe the customer.6 Trade cards that claimed disease cures of all kinds were no longer able to market fraudulently by 1912. 


Conclusion


The history of United States patent medicine era of the 1800s-1900s was one filled with hidden agendas. Entrepreneurs who wanted to make money, learned early on that good advertising would draw in buyers for their product. There was an open market without any regulations or oversight and just about any ingredient could go into a bottle to be sold, with little promise of a cure or any consequences for failures. Innocent people looking for relief from their symptoms became victims of poisonings, and addictions. Journalism brought the evidence of fraud to light and educated the public. The U.S. government subsequently attempted to control and regulate the industry, provided protocols for medication development, educated the public on appropriate labeling of medication ingredients and indications, and promoted safety with the ingestion of pharmaceuticals.

 

References

Feature Image: (L to R) Coltsfoot expectorant, Dr. Parker’s Cough Cure, Licoricine For coughs/colds “Acts like Magic,”, Dr. Hooker’s Cough and Croup Syrup, Tonsiline (Source: Author’s personal collection).

1 Joseph M. Gabriel, “Pharmaceutical Patenting and the Transformation of American Medical Ethics,” British Journal for the History of Science 49, no 4 (2016): 577-600. Doi: https://doi.org/10.1017/S0007087416001138

2 Samuel Adams Hopkins, The Great American Fraud, Colliers National Weekly October 7, 1905: www.gutenberg.org/files/44325/44325-h/44325-h.htm

3 FDA. (2021). United States Food and Drug Administration. https://www.fda.gov

5 Michael T. Torbenson, Robert H. Kelly, Jonathan Erlen, Lorna Cropcho, Michael Moraca, Bonnie Beiler, B., K. Rao & Mohammed Virji, “Lash’s: A Bitter Medicine: Biochemical Analysis of an Historical Proprietary Medicine,” Historical Archaeology 34 (2000): 56-64

6 FDA. (2021). Milestones of drug regulation in the United States. U.S. Food & Drug Administration. https://www.fda.gov/media/109482

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