Update:

Trevor Klee (author of the linked post) has published an update in which he (arguably) moderates his view (or at least that which he expresses publicly). Specifically, he states: 

I believe (note the libel-friendly phrasing) that:

1. Lumina’s manufacturing process follows legally mandated GMP protocols, if not the probiotic trade association’s voluntary best practices.

2. It is weird to be secretive about your manufacturing until pressed on it, especially when you have made a point of trying to evade regulations. See Zbiotics for a great example of how to behave responsibly and communicate openly when selling genetically modified bacteria for human health issues. It’s especially weird to threaten lawsuits when people ask follow-up questions about your manufacturing.

3. Lumina’s product is a drug, not a cosmetic product.  And, regardless of whether it is a cosmetic product, it has the potential to cause great harm. This means it needs extensive human safety testing. This can be under the FDA or not.

4. There are scientific reasons to believe that Lumina’s product can be unsafe and ineffective in humans, based on the reasoning in my previous posts. This uncertainty can and should be resolved by careful, well-designed human trials, not by releasing the product into the wild.

5. It was wrong for Lumina to take money for the product, like they did in Honduras and in pre-orders, without doing proper testing.

6. Threats of lawsuits have no place in open scientific debate.

This was prompted by Lumina founder Aaron Silverbook sending the following email to Klee:

Subject line: Defamation

From: Aaron Silverbrook aaron[at]lanternbioworks.com

To: trevor[at]highwaypharm.com 

Hi Trevor;

I believe your post was made in good faith. Or rather—I didn’t, really, but after talking with Elizabeth, she vouched for your character and convinced me that it probably was, comments about my friends aside. So, I appreciate the efforts you've gone through out of a desire to keep people safe. As such, it’s probably for the best if we talk.

To speak to several of your concerns about our manufacturing processes—we are, actually, following Good Manufacturing Practices. We have, actually, sequenced the genome of the bacteria, and I posted that genome publicly on Manifold after "declaring mission success". We conduct batch testing through Eurofins. We have an experienced biomanufacturing team scaling our production, and if you want to talk to them directly to hear about our sterile process flow, we can arrange that (although you’re not their favorite person right now). 

One of our production engineers posted approximately this information in the comments already, but you may have missed it.   

I am, to be honest, feeling pretty taken aback by this sudden defamation. I had rather considered us to be adjacent companies in the synthetic biology space. Plus your false assertions that we're an unclean product have hurt my CMO’s feelings. They've been designing our GMP scale-up for months.

Fair warning, investors are recommending we sue you for libel. My team thinks I'm being a real bleeding-heart about this, that we haven't already sued. But, y'know, spirit of rational inquiry, good faith effort to protect people, all that. At a minimum, we'd like you to take the post down. 

Dude, if the product wasn't safe, I wouldn't be using it myself, giving it to my girlfriend, and giving it to my friends. 

Let's talk? 

Original post:

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.