Fungal Games: Evidence Maldigestion

The first dietary supplement brand I worked for—Nutri-Dyn, later subsumed by Metagenics in the early '80s—had a platform based on glandular extracts that were processed with solvents. A paucity of evidence supported their safety and efficacy in humans, with a lone exception: pancreatic enzyme concentrates (from pig pancreas). Back then, working with clinicians, mostly chiropractors, the most abundant positive clinical responses I encountered hailed from the use of these pancreatic enzyme (PE) concentrates.

The PE concentrate was produced by Viobin, the same company that remains a leading producer of wheat germ oil concentrate. A U.S. patent (2,503,313) was issued related to the temperature-controlled solvent process used to extract and concentrate the enzymes from pancreatic tissue. The product was called Viokase, which was launched in the late 1940s. Porcine pancreas was chosen because the digestive system of the pig (single stomach) mimics that of humans, compared to the cow, for example, with its multiple stomachs and a high reliance on bacterial fermentation.

In the ensuing decades, a number of PE products entered the medical marketplace, being used primarily for persons with cystic fibrosis or pancreatic conditions (e.g., chronic pancreatitis, or pancreatic enzyme insufficiency). A number of clinical trials were performed on PE products in these and a few other patient populations. The advent of enteric coating technologies ushered in new PE preparations that appeared to demonstrate greater efficacy—presumably due to a greater payload of enzymes being delivered into critical areas of the intestine.

In the late 80’s to early 90s I noticed the introduction of fungal enzymes, almost universally given the misnomer “plant enzymes." If a fungus like Aspergillus is a plant then why aren’t probiotics called “live plant cells that promote digestive health”? While directing R&D for KAL (which marketed a PE product for years), I was pitched fungal enzymes by a few companies. I always asked for clinical trial data and was always told, “We’re working on that," and shown a tome of in vitro digestion tests (that bear unknown relevance to clinical efficacy).

Over the past two years, the U.S. Food and Drug Administration has approved a few PE products as prescription drugs, including one at the beginning of March, while excluding several that lacked appropriate clinical evidence of safety and efficacy. Maybe we will see this happen with over the counter digestive aids, almost all lacking any appropriate controlled clinical trials evidence of safety and efficacy. As I watch the fungal enzyme market continue to grow and ferment I wonder why no controlled clinical trials, performed by experts in gastroenterology within North America have been conducted and published. Having been a co-investigator on dozens of clinical trials, and a sponsor of over three-dozen, I know that cash is not the reason. Such a clinical trial would cost less than $80,000, and the value that could emerge from such a study—presuming the data were significantly positive—would be robust and game changing. 

Data, where are thou? A rolling market gathers much fungus…