Genotoxicity reviews
Because most products were developed absent of genotoxic risk,
genotoxicity reviews of hundreds to thousands of medical device and drug
submissions showed mostly negligible human safety concerns. Rare
exceptions of notable human hazards included a known mutagen with direct
exposure to human germ cells, encountered early on. This was not
recognized as a hazard despite my efforts. Later on, my opinion might
have had more impact. A different agent, methylene blue, was reviewed as
a drug with multiple indications and was also a component of medical
devices. This was the most interesting agent I ever encountered,
considered non-hazardous by physicians because of its continuous use for
by Larry Loeb and others and activated by enzymes or light. It has been
cited as the world’s oldest drug and seems to be treated as GRAS
(generally recognized as safe), although that attribution is usually
limited to food-based agents. You can buy it at Walmart for your fish
tank. I made a presentation illustrating the dual non-overlapping
pathways of methylene blue as a therapeutic and as a classical mutagen.
And never the twain have met.