My about-face on Lumina

I’m putting the post about Lumina Probiotics back up, now edited to avoid any possible threats of libel. To explain, here’s a timeline of my last 72 hours.

1. I get an email Friday night from Aaron Silverbook, founder of Lumina, that says only “Hey Trevor; want to do a call?”. He follows up on Saturday afternoon.

2. I get an email Sunday afternoon (yesterday) with explanations of Lumina’s manufacturing, along with a legal threat. Email is reprinted verbatim below¹.

3. I agree to temporarily take the post down, post an update to my readers, and ask for a meeting to ask scientific questions. Aaron refuses my request to record the meeting, so I take notes instead and email them to him afterwards. As my last post indicates, Aaron mostly deferred scientific questions to his advisor, Justin Merritt, and his employee, Rob Williams. I send emails to both of them.

4. In the few hours after publishing my updates on Lumina, I get 4 comments on my post, one supportive, three negative. The supportive one is from Will Manidis, who’s been reading my blog for a while. One critical comment is from Aaron, and contains multiple factual inaccuracies, which I address below². Note that I was unable to refute them directly because he directly references the post that he requested I take down.

The other two critical comments are from people who I’ve never heard from before. On further research, one of them is from someone who subscribed to my Substack directly before commenting. They follow Lumina on Twitter. The other is from someone who doesn’t subscribe to my Substack, which is suspicious, because I didn’t share this post anywhere except to my subscribers.

5. Rob Williams writes me a long response to my email in which he dodges my main questions. I ask follow-up questions to get clarifications. He asks me “how I’d like to be served” and threatens me with “spending years in and out of a California courtroom” (full email printed below)³.

6. I get some advice from fellow bloggers and write this post.

Let’s hope Lumina’s threats are toothless. But yeah, I mostly just wanted this as the header image.

Why I’m now putting the post back up

I had my suspicions that Aaron did not want to engage in legitimate scientific debate, given that he did not respond to my email. I was willing to give him the benefit of the doubt, though, even when he threatened legal action, refused to be recorded or in writing giving any responses, and deferred all scientific questions to his advisors.

However, given that he’s now said deliberately inaccurate things on my blog, I believe engaged his supporters to brigade my blog, and connected me with an employee who also threatened to sue me, I will no longer give him or Lumina the benefit of the doubt. I think Aaron and Lumina would rather their product claims be not submitted to scrutiny by anyone, and are willing to intimidate and lie in order to do so.

What I believe about Lumina Probiotics

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.

1. Aaron’s email follows below.

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? 

2. Aaron’s comment in italics, with my responses below.

Hey Trevor, Aaron here. I appreciate you making the update.

However, I feel you're still downplaying the extent to which, for questions you didn't have the answer to, you assumed the worst. For example:

• You assumed we'd never gene sequenced the bacteria, even though I posted the sequence publicly.

I assumed you did not regularly sequence the bacteria because you did not say that you did and you did not report anything about following manufacturing regulations. I’m glad that you did and do. Sequencing the bacteria regularly is critical to make sure what people are putting in their mouths is what they think is putting in their mouths. And by “post the sequence publicly”, you mean on Manifold, rather than on your company’s website, for whatever reason. Sorry I didn’t check all of Manifold.

• You assumed ProBiora didn't work because you misread the title of a paper

No, I assumed that was their one-and-only human trial, which they failed. That’s still correct.

• You assumed chlorhexidine wouldn't kill off the bacteria because you misread a (different) paper

I did not assume that. In my initial email to you, I asked about this, because I had not done the research yet. In my blog post, I did not write this.

• You assumed there was no ComE deletion in BCS3-L1, for reasons unclear to me.

No, I had asked about this in my initial email. In my blog post, which apparently you misunderstood (or didn’t read), I did not state this. I stated that comE deletion probably did not have the effect that you think it does. I stand by that, because you told me that you are not scientifically competent to judge this.

• You assumed we weren't abiding by good manufacturing practices because, when I offered to call you and answer your questions, I...didn't answer your next email within 48 hours??

No, because I sent you an email saying that I wanted to get your responses in writing, in part so we wouldn’t be doing this “he said, she said” nonsense in which you misrepresent what I told you (although apparently it doesn’t matter, because you do it anyways). 

I also wrote in the email that I would delay the publication of the post if you needed time to answer the questions. You did not, and instead chose not to reply. Then, this past weekend, you sent me one email asking to arrange a call, another email asking to follow up, and then a third email with the subject line “Defamation”. Apparently, you can email within 48 hours when you want to.

I had some skepticism, but after talking with our mutual friend Elizabeth, I do believe you're acting out of a desire to help people. That's my motivation too, although it seems likely that we disagree about some FDA issues. I do empathize with your position here, at least, and I think we could have good arguments about this topic, even!

I doubt we can have good arguments when you refuse to answer scientific questions and misrepresent what I said.

Anyway, I appreciate your impulse to help. But with regards to Lumina, in the future, please limit your criticisms to things that are true.

Done.

3. Rob William’s email follows below.

Subject line: Re: Questions about Lumina

From: rob[at]lanternbioworks.com

To: trevor@highwaypharm.com

Trevor, 

GMP compliance is a continuous process. There is no point where you say we are GMP and are done getting compliant. Maybe you should take my course in GMP compliance. 

I have tried multiple times to be kind and have given you the benefit of the doubt. However, you are continuing to make false claims. 

I have everything that you wrote in your blog that breaks defamation laws printed out and documented evidence of financial harm. I don't think you understand the severity of the situation.

You are also making it difficult for people who have real claims about contaminated products from coming forward because you stated facts that were untrue. Without evidence. 

Do you want to want to spend the next couple of years in and out of a California court room? I'll tell you nobody wins, regardless of how much money we will be awarded for a text book case of liable. 

I don't owe you anything. I opened up to you multiple times and was kind. It would have been a good gesture for you to do the same.  

How would you like to be served? I find it awkward and unnecessarily mean to surprise somebody. We can arrange a location of your choosing.  I hope we can be cordial during this process. 

Rob