Andrew Porterfield has a master’s degree in biotechnology management from the University of Maryland and has worked as a marketing communications consultant for many biotechnology and pharmaceutical firms.
It’s very difficult to practice veganism—the avoidance of any type of animal product, including milk and eggs. Practicing vegans find it especially challenging to find drugs that are completely free of animal products. Even if active ingredients are synthetic or plant-derived, many excipients—the fillers, extenders, diluents, solvents, emulsifiers, flavors, and absorption enhancers that are part of just about every preparation—are made from animals.
A new book, “Veganissimo A to Z,” authored by two German vegans, documented 2,500 products and discovered that pharmaceuticals in particular are manufactured without strict vegetarians or vegans in mind. There’s a very practical reason for this. As illustrated by the Food and Drug Administration’s most recent (2005) guidance on excipients, regulatory agencies primarily focus on safety, in the United States and in Europe. And animal-based products often pass as generally regarded as safe (GRAS). These safe ingredients can include glycerin, gelatins, and stearates—all animal-derived.
There is, however, an animal-originated product that is of safety concern: lactose. Found in milk, different grades of lactose are used in formulations to make binders more efficient (and improve granule quality), enhance an inhaled compound’s ability to infiltrate the lungs, and make preparations more compressible. It also can cause adverse reactions in lactose-intolerant people, including young children, according to a recent World Health Organization report.
Research on vegetarian sources of excipients (and active ingredients) is rather scarce. But a group at Manchester Royal Infirmary in England reported in the Postgraduate Medical Journal that 43.2% of urological patients preferred not to ingest drugs with animal-derived ingredients, and that slightly more than half of the patients there were given products containing animal-derived gelatin despite their religious and moral views. Pirzada Sattar and his colleagues at the Omaha Veterans Administration Medical Center cited four cases in Annals of Pharmacotherapy that document patients who refused treatments that contained pork- or beef-derived gelatins and stearates on religious grounds. While the patients eschewed the treatments, their illnesses relapsed.
Replacing animal-derived excipients with synthetics or botanicals is not a matter of simple substitution. The FDA regulates botanicals just as it does any other therapeutic or diagnostic product, and notes that plant-derived products have unique and often powerful properties. Even one of the authors of Veganissimo recalled comparing heparin (derived from pig mucosa) with the synthetic fonaparinux—the synthetic, it turned out, can increase bleeding;, hardly the side effect a surgery patient would want.
Although veganism may not be a mainstream practice or philosophy, it is a part of a body of ethical and religious beliefs that have interfered with common prescribing practice, and common prescription drug preparation—which is all food for thought for manufacturers.