The author claims that the FDA set impossible standards for getting this approved when it was originally discovered and that those same standards prevent them from seeking FDA approval now....but further down acknowledges that probiotics like this product are actually subject to much more lenient standards.
The treatment was proposed to the FDA decades ago as a drug. The drug approval process yielded the impossible ask. Those same standards prevent them from seeking FDA approval now as a drug.
That this could be approved as a probiotic is a recent idea. The impossible standards are not the probiotic lenient standards.
For a product supposedly being pushed by a bunch of rationalists, nothing about this drug or the underlying story is actually rational if you know anything about how the FDA approval process works.
The approval process supposedly required an impossible ask. Oddly enough, I could find no record of this impossible ask anywhere except in this company's website or on other "rationalist" websites, all of whom cite this company as the sole source.
And in fact...this impossible ask doesn't actually take into account how the FDA approval process works...or has ever worked...
It's the kind of story someone make ups when they're trying to explain why their miracle invention failed.
(And note that oral probiotics have been approved by the FDA for human use for several decades, including back when this supposed miracle bacteria was discovered. And Japan and Europe have much more lenient standards, now and then, for oral treatments and yet no attempt was made to launch the product there. And China and much of South East Asia don't even bother regulating this type of product, so why wasn't this launched in Asia? Why is the only market they're launching this product in a jurisdiction in which "biohacking" products are completely exempted from regulationo)
Nothing about this product adds up, and it bares multiple hallmarks of being a scam. (See the currently top-ranked comment on this post.)
"Dr. Hillman has been working on this therapy for 25 years and first applied to the F.D.A. for permission to begin a clinical trial in 1998. The agency, the company said, has demanded change upon change to make sure the modified bacteria would not run amok, cause undesirable changes in the mouth, or revert to a cavity-producing form. To win approval, Oragenics has agreed that the 15 volunteers in the first trial will not even have teeth -- they will have dentures."
This differs from the version I heard from Aaron in that Aaron said 100 people and NYT says 15 people, but NYT says the FDA demanded "change after change", so the 100 might be either an earlier or a later version of this.
Hopefully this changes your opinion of whether or not this is a scam, and of how much you understand about the FDA approval process.
Given that this version from the NYT is very different from the one in the post, and far more reasonable in its requirements, it makes it even more apparent that the linked product is a scam.
Exaggerating details the way the linked post does is one of the major red flags of almost every scam. Especially dangerous is the way it attempts to make the regulator the enemy based on a fraudulent retelling of actual events.
I really hate to appeal to authority but Scott Alexander is the single last person on earth, and I am not exaggerating, who I would accuse of analyzing a topic in bad faith.
Scott absolutely analyses topics in bad faith, particularly when it comes to politics or movements/people he personally supports. Here's one where he essentially says 'no study is ever fully representative, therefore my friends twitter polls are exactly as good evidence as a scientific study':
Your comment is an example of analyzing in bad faith.
In the linked article there is a whole section that starts with "Selection bias is disastrous if". He definitely does not says anything remotely close to "twitter polls are exactly as good evidence as a scientific study".
It's essentially the thesis of the post. I will say the "exactly" part was a bit hyperbolic.
He starts by stating that people say his surveys and Aella's Twitter polls (which he calls surveys) have selection bias, meaning the conclusions don't count.
He then goes on to say (paraphrasing): "people say surveys have selection bias, but don't think real scientific studies have selection bias" and in the next paragraph says "but scientific studies do have selection bias and that's ok." Note that in this section, he is implictly relating scientific studies with his and aellas surveys.
In the section that starts with "selection bias is disasterous if", he gives a narrow view of why and when it's bad: "only if you're doing a poll or census that should include everyone". He neglects to say the ways in which it's bad for literally all science (it's a massive problem in drug RCTs, but he literally uses RCTs as a point for why selection bias isn't so bad later on).
In the next few paragraphs he says that selection bias is fine for correlations, and gives some examples of when scientific studies have selection bias that we accept (I'm not going into details here because the post is long, and I'm on my phone).
So he's said why selection bias is present in science, and that it's only really bad for census's and polls. He then concludes, "hey guys stop saying surveys are bad because selection bias, science is also biased".
In this post he starts by bringing up a critism of Aella's 'research', which she uses data from Twitter polls for. He then implicitly equates surveys and scientific studies, and says "look, science is biased too, so selection bias isn't bad". He then concludes, "so stop saying surveys are a bad because of selection bias".
He might not literally say "twitter polls are exactly as good evidence as a scientific study", but the point of the post was to detract from the valid criticisms against his and Aella's posts that use survey/twitter poll data by saying "science does it too".
His thesis is “you should not discount twitter polls with large sample sizes out of hand as totally meaningless, or if you’re going to, you need a better reason than this long list of issues that twitter polls share with RCTs.”
The contrapositive of his thesis is “there is some interesting signal worth paying attention to in large twitter polls, selection bias is in many unexpected places so be skeptical about sweeping conclusions even in RCTs”.
Your characterization of this as “so twitter polls are just as good as RCTs” seems wildly uncharitable to me.
I'll definitely admit to some bias here, I've been reading Scott's content for 7ish years and I've gone from loving his content to being increasingly skeptical about his writings.
Something I feel Scott (and rationalists in general) tend to do is obfuscate their points in large walls of text, that allude to their actual reasons for writing without directly stating it. Aside from the beginning and end of the post, he never mentions the context or specifics, and just talks about broad counterarguments against selection bias in general. He doesn't bring up relevant specifics like "Aella does polls about sex to an audience she cultivated by doing porn", which seems like an obvious source of bias to me. Instead he gets the best of both worlds, if someone criticizes internet surveys he can point them to the post, without including any specifics that can be easily argued against. It requires a similarly sized wall of text to respond, which most people won't bother with. I personally used to argue that's just how he writes and it's not intentional, but stuff like the email leaks made me change my mind on that [1].
I do wish I'd picked a better example though, what I'm really trying to say is that Scott is definitely capable of analyzing a topic in bad faith. He has his biases like the rest of us, and they get infused into his writing.
The author claims that the FDA set impossible standards for getting this approved when it was originally discovered and that those same standards prevent them from seeking FDA approval now....but further down acknowledges that probiotics like this product are actually subject to much more lenient standards.