The FDA Voted for 6 Peptides. Its Own Scientists Said No

Jordan Feigenbaum (0:01)

Just over a week ago, an FDA advisory committee voted 8-6 to open a legal supply line for BPC-157. The thing they voted on it was for treating ulcerative colitis. Almost nobody buying PPC-157 is buying it for ulcerative colitis, though. The whole human evidence base the FDA could find for that use is just a single trial, and it was reported as a conference abstract and not a peer-reviewed journal. In it, the drug was given as an enema, nobody takes it like that, at 80 mg once a day for two weeks. But tendonitis is closer to why most of you have probably heard of this stuff, and tendonitis was on the nomination list too. But the FDA didn't evaluate it for tendonitis, and the reason sits in one line in a footnote. The nomination didn't include enough evidence to assess it, and the agency couldn't find a single clinical study of BPC-157 in those patients. So the committee opened a door using evidence for a condition people don't want it for, and the condition they do want it for never got looked at.

I'm Dr. Jordan Feigenbaum, and this is the Barbell Medicine Podcast.

I've posted about peptides a few times this year, and each time the posts blow up, particularly the comment section. Now people make real arguments, and a few of them have come up over and over again, so I'm going to try to work through those and see if we can find some common ground. But before we do any of that, two things about what I'm claiming, because I think both tend to get misread, and I want to nail down my position. The first one, I am not telling you that BPC 157 does nothing. I don't know that, and neither does anybody selling it to you. Nobody's done the study that would answer the question anyway. The FDA's own reviewers put it carefully, and I'm using their words, not mine. There is a lack of evidence to make a conclusion on effectiveness. Not it failed, they're just saying that we can't conclude. There's no evidence. Those are different senses and different claims, and I'll keep saying the second one. We just don't have the evidence.

Also, a note on how that first sentence tends to land. When I say a thing hasn't been tested, a lot of people hear me saying that they were stupid to try it, but that's not what I'm saying at all. There's no evidence is a statement about what's going on in the research world. It's not a statement about your judgment. You didn't decide not to run the trial. Somebody else decided that, and there's money talking behind that. The second thing that I'm saying, I am not telling you what to put in your body. Several folks said, look, it's not my business. And on the personal question, that's fine. But that's not what happened last week. What happened is that a federal advisory committee voted to build a legal supply chain for compounds that have never been tested for the things people are trying to use them for. That's a public decision made by named people, and I think that's fair game.

Let's start with the objection that isn't about peptides at all, because I think it's underneath all of the other claims. Somebody commented that after what we watched the medical professionals say during COVID, that they have zero trust in the entire system. Look, I'm not going to pretend that those years went well. Guidance changed, sometimes quickly, and plenty of it got delivered with more confidence than the evidence behind it could carry. That part's on us.

Updating an answer when the data changes is the thing that's supposed to happen with science, but from the outside, it looks identical to having been wrong the whole time. Almost nobody stopped to explain the difference while it was going on. Where I get off the train is the conclusion. Guidance changing is not evidence that somebody was hiding something. But if what you took away from all of that is that you should always ask who has money in a particular answer, follow the money, well, look, I think that's the right instinct. And this vote is a great place to apply it. In September of 2023, the FDA moved close to 20 peptides into what's called Category 2, which means they have significant safety risk or there's a concern for it. That shut down compounding of them essentially overnight. Peptide medications like BPC-157 and TB-500 disappeared from licensed supply chains within weeks, and demand went straight to the gray market. Then in February of this year, the Secretary of Health and Human Services went on a podcast and called the 2023 restrictions illegal. His argument, in his words, was that the agency isn't supposed to restrict these without a safety signal, and he says that there isn't one. And that the FDA isn't allowed to look at efficacy and use that to move something into Category 2 He also said, and I'll quote this part because it's honest, We created the gray market. Now, to be clear, what the FDA ways here isn't just safety. Category 2 isn't a separate program with its own rulebook. It's a holding spot. Somebody nominates a substance for the compounding list, and while the FDA works through it, they sort it. Enough information and no safety concern, it goes to Category 1, and pharmacies can keep using it. Enough information, but there's a safety problem? It goes to Category 2 They can't. Not enough information to evaluate it at all? It goes to Category 3