Updates on Lumina Probiotic - by Scott Alexander
Lumina, the genetically modified anti-tooth-decay bacterium that I wrote about in December, is back in the news after lowering its price from $20,000 to $250 and getting endorsements from Yishan Wong, Cremieux, and Richard Hanania (as well as anti-endorsements from Saloni and Stuart Ritchie). A few points that have come up:
Professor Hillman started a company “Oragenics” and applied for FDA approval. The FDA demanded a study of 100 subjects, all of whom had to be “age 18-30, with removable dentures, living alone and far from school zones”. Hillman wasn’t sure there even were 100 young people with dentures, but the FDA wouldn’t budge from requiring this impossible trial. Hillman gave up and switched to other projects.
A Phase 1 trial, scheduled April 2005, on 26 people, age <55, with dentures. The company couldn’t find enough people who met enrollment criteria, so they renegotiated with the FDA and switched to (2).
A second attempt at Phase 1 trial, scheduled October 2007, on 10 people, age 18-30, no dentures necessary, done in a hospital setting. This trial succeeded, escalating the process to (3)
