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Editor's Message

Highly Potent Products

Not Just a 21st Century Issue

Last fall, I had the great experience of hearing popular historian Eleanor Herman discuss her book, The Royal Art of Poison, in person at the Smithsonian Institution in Washington, D.C. The premise of her book is that many royal deaths attributed to poison in the later Middle Ages and Renaissance periods were actually due to poor hygiene or toxins in medicines/cosmetics prepared by apothecaries oblivious to the dangers of, say, mercury or arsenic (1).

(Tip of the day: Drinking a portion of liquid gold a day will not stave off aging!)

One of the interesting points she brought up concerned the death of the English King Charles II in 1685. For years, it had long been thought that the “merry monarch’s” hard-partying ways had caught up with him, felling him via a sudden stroke. But in 1967, scientists at the University of Glasgow studied a lock of his hair and found high levels of mercury (1). In the year before his death, the king began spending time in an alchemy lab in the basement of his palace where he had been conducting experiments to turn base metal into gold (1). These experiments often exposed the alchemists to extensive mercury vapors and safety precautions/gear did not exist. In fact, days before his death, there had been an explosion in the lab, exposing Charles II to lethal amounts of the toxin (1). Herman, along with Dr. Frederick Holmes, Professor Emeritus at the University of Kansas Medical Center, posit that the king died due to lack of safety gear in the lab (1,2).

The concluding talks at the 2019 PDA Practical Application of Sterile Manufacturing Workshop reminded me of Herman’s talk. Richard Denk and Amir Zandnia presented how new, highly potent drugs require not only protecting the product (and by extension the patient) but also operators as these new products contain elements that could affect the health of those working with them. I will not go into much detail as the cover story covers both talks. Denk, by the way, was one of the authors behind a separate article on the topic, “Isolator Surfaces and Contamination Risks to Personnel,” in the November/December2017 issue of the Letter—an article that proved highly popular with readers. During this year’s Annual Meeting, the PDA Letter also filmed Denk for an “On the Issue” video.

Protecting product and operator presents unique challenges compared to product alone, requiring the industry to take another look at how we clean and decontaminate even. And the market for highly potent products continues to grow. You can expect to see this topic explored in future PDA Letter articles and PDA conferences. And I suspect our operators have a bit more protection than a royal 17th century wannabe alchemist!

References

  1. Herman, E. The Royal Art of Poison: Filthy Palaces, Fatal Cosmetics, Deadly Medicine, and Murder Most Foul. New York: St. Martin’s Press, 2018.
  2. Holmes, F. The Sickly Stuarts: The Medical Downfall of a Dynasty. Stroud, UK: Sutton Publishing, 2003.