I suspect some number of LWers have taken or are are considering using Lumina's probiotic. If you're in either of those camps, Klee's post might be worth reading. He paints a picture of an unprofessional company skirting regulations and risking customers health to sell a dubious health product. I can't speak to the veracity of those claims, but think they are worth sharing given the potential downsides if they are true. 

Fast-forward to last year, when rationalist Aaron Silverbook came across Hillman’s original work with the genetically modified bacteria. Aaron, based on his previous work as guy at a rationalist nonprofit, videogame producer, and porn producer, decided to recreate Hillman’s work4. First, he applied for funding from FTX. He got it, but then FTX collapsed. Then, he applied for funding from alternative rationalist funding source Manifund, got that, and failed to recreate Hillman’s work. However, Aaron declared mission success anyways in that he negotiated with Oragenics to acquire a sample of BCS3L-1, one of Hillman’s later strains5, in exchange for $50k and promise of royalties, although he didn’t get any intellectual property rights .

Aaron then went on an intellectual journey where he tried to figure out what exactly to do with this genetically modified bacteria. After all, he was faced with basically the same daunting FDA journey as Hillman, but without Hillman’s scientific background or financial resources. After talking to a bunch of people, including me, he eventually decided on a very rationalist, very Bay Area, very strange approach:

1. Sell the genetically modified bacteria as-is for a one time payment of $20,000 in a libertarian charter city in Honduras

2. Give a bunch of rationalist-adjacent celebrities free samples of the GMO bacteria as-is in exchange for positive press, including Scott Alexander, Aella (the porn star/escort/sex researcher who he’s the business manager for), Richard Hanania, Cremieux, and Bryan Caplan

3. Take preorders for $200 a piece from the general public

It’s worth noting that, regardless of what I think of this plan (i.e. it’s bad and maybe unethical), I’m pretty sure this plan is also illegal. While Lantern claims to be marketing this probiotic as a cosmetic, it is meant to prevent and cure tooth decay. According to the WHO, tooth decay is a disease. A product meant to cure and prevent a disease is a drug, and legally needs to go through the drug approval process. But, you know, whatever.

Some critiques from the post: 

  • Lumina has marketed their probiotic as a cosmetic product, thereby avoiding the necessary FDA safety and efficacy trials required for drugs. This could be bad because the product is meant to prevent cavities, which could require classification as a 'drug' and thereby require FDA approval. 
  • Klee speculates that Lumina is not following Good Manufacturing Practices (GMP). He's doesn't have evidence for this, only a suspicion.
    • Without strict manufacturing controls, there is a risk that consumers could be exposed to mutated or contaminated versions of BCS3L-1, which could produce harmful byproducts like lactic acid or harbour dangerous pathogens.
  • Klee speculates that Lumina are not regularly sequencing their bacteria before selling them. Again, he presents 0 evidence:

Similarly, I don’t think Lumina is regularly sequencing the bacteria that they are sending out to people. They certainly aren’t following the Best Practices Guidelines for Probiotics, which require you to state how much of each strain in CFUs is in each batch that you send out on your packaging. So, when Lumina claims that you are receiving BCS3L-1, which has the modifications above, they actually have no idea what you’re receiving. 

You could be receiving:

1) Just BCS3L-1

2) Random contaminants

3) Mutated BCS3L-1 (like one that regained the ability to produce lactic acid)

4) Dangerous bacteria or fungi that have taken over your batch

5) Some combination of 1 through 4

  • BCS3L-1 produces mutacin (an antibiotic) whilst also being resistant to it. The deletion of the comE gene might not have reduced the risk of genetic transformation sufficiently, but probably did reduce BCS3L-1's reproductive fitness. This creates the risk that other bacteria might acquire BCS3L-1's resistance to  mutacin and outcompete it. 
  • BCS3L-1 produces achohol instead of lactic acid. It also produces mutacin-1140, an antibiotic. This antibiotic can be cytotoxic ("somewhat dangerous to the body") and has caused hypersensitivity reactions in rats, making its continuous production in the mouth potentially dangerous. 
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I would appreciate a version of this post that evaluate dangers. This post uses a lot of fear mongering language that I don't feel helps me calibrate as someone considering the product.

[-]ROM10

I think this is fair. That said, a version of the post evaluating the dangers is arguably what Lumina should (and hopefully have) done. If they have, then publishing it should dispel most of what Klee critiques. 

This is a hit piece. Maybe there are legitimate criticisms in there, but it tells you right off the bat that it's egregiously untrustworthy with the first paragraph:

I like to think of the Bay Area intellectual culture as the equivalent of the Vogons’ in Hitchhiker’s Guide to the Galaxy. The Vogons, if you don’t remember, are an alien species who demolish Earth to build an interstellar highway. Similarly, Bay Area intellectuals tend to see some goal in the future that they want to get to and they make a straight line for it, tunneling through anything in their way.