1,000
3.001: What happened with the FDA testing?
In the original FAQ, I wrote:
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.
I got this information from (company CEO) Aaron, who says he got it from (original inventor) Jeffrey Hillman.
Commenters (and Kevin Drum) searched publicly-available archives and found a slightly different story, with three trials:
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)
A Phase 1b trial, scheduled January 2011. Nobody can find any details on this one, but Oragenics says it never took place because of “the very restrictive study enrollment criteria required by the FDA”.
Some people have tried to argue that someone must be lying, because I wrote about a 100 person trial age 18-30 with dentures, and this doesn’t match either of the two trials we know about.
I think two more likely explanations are:
This is Trial 3, the one we know nothing about
Or someone in the Dr. Hillman → Aaron → me chain mixed up details of the three trials into a mishmash with some characteristics of each.
https://www.astralcodexten.com/p/updates-on-lumina-probiotic