And I'm curious, what specific risks or

side effects have been documented in this space? So first of all, there's not a lot of tracking systems in place.

There are no robust tracking systems in place.

I've talked to some other physicians about this whole compounding thing, which we can talk about later, and how there's no infrastructure to actually track things if that happens.

No one's measuring blood levels of peptides to correlate a dose with a response.

Nobody is tracking anything.

People who are using these don't have a control comparator.

Do you see this getting better or getting worse? And please don't sugarcoat it for my own fear, but is there a world in which these will properly be researched and we will be able to really identify the safety concerns, remove those that should not be in anywhere near human use for safety concerns, remove the ones that just aren't effective and maybe find the one or two in the gold mine that that might actually have benefit? Do you see a world in which that happens or no? It's complicated.

... clinical trials, that involves humans, and then there are lots of different phases of that as well.

Yep, exactly.

And not only safety.

In the, in the preclinical space, there are specific safety studies that you have to do depending on the drug modality.

So for small molecules, one of the things you'll hear about is something called safety toxicology and safety pharmacology.

Um, so for, for one of those, for the pharmacology study, you give kind of chronic dosing at an a do- at a dose in an animal that you could extrapolate to like a human dose, right? So like a low level, whatever.

And you look for specific types of adverse events over a long term.

Is there anything that we didn't discuss that you feel we'd be remiss if we didn't cover in this episode?

First thing he says, is this a good idea? Where should I buy these from? And what things do I have to look out for if I'm taking these things?

Yeah, it's a lot to unpack.

So the majority of those have very little human data, except for the ipamirelin.

There are some that have a specific indication in HIV that they've been approved for.

But nonetheless, the sort of broad claims made in the wellness community for these, none of those claims are proven in randomized human clinical trials.

For many of those, we don't even know the molecular target or have preclinical data packages.

There are red flags associated with many of the biological mechanisms inducing growth hormone.

And so, you know, what's the future? So where is this peptide trend heading, do you think?

Mm-hmm.

So we go through this process to develop a molecule.

We do all this testing.

Then we move into animal studies where we wanna make sure that this molecule does what we are hoping it will do based on our cellular data.

But we also do really important animal studies to de-risk, and these de-risking studies are based on the target and the kind of biology we're affecting.

And there are specific types of studies that you're required to do to show that you don't pose risk, and all of that has to be done before you submit what's called an investigational new drug, or IND package, which allows you to have approval for human trials.

So that IND package will show you that with animal studies we can show that this is gonna work.

Mm-hmm.

We talk about it all the time, and it I'm not sure people know what's involved and why do we do them and who does them?

Yeah.

So randomized controlled clinical trials are really the basis of all of our human clinical studies that allow us to establish whether something is both safe and efficacious.

And by efficacious, I mean, does it work for the condition we're developing it for? The reason that we used randomized human clinical trials is because people are different and Everyone has a different lifestyle, different demographics, different diets.

So what you need to do is collect a huge group of people where you've recorded all of these details about those people.

And then you sort of arbitrarily divide them into the groups.

And one of those groups is going to be treated with either a control, that could be a placebo, it could be nothing, it could be something different, or the thing that you're interested in developing.

Go ahead.

Like it doesn't mean that we're OK, we're good as humans.

It's going to be safe.

It's not even I mean, if you're referring to the like regulatory changes for the peptides, which we're talking about, it's not even fast tracking, it's exemption.

Exemption.

OK, so skip it.

Exactly.

Just like we're just going to say it doesn't have to do it.

Where did these come from?

Mm-hmm.

And they have ideas for new medicines.

But because these are academic researchers, they do not have the background or the tools to understand how to translate that into a therapeutic.

So we have a team of people who some have come from the pharmaceutical industry, the biotech industry, and academics, and together we synergize and we bring the tools and the knowledge that are needed to move something from, "This is really interesting research," to, "We can harness this therapeutically to actually benefit people." And I work specifically in the preclinical phase.

So we only move up to, like, animal studies.

We're not doing any clinical research or human research, but I need to understand the whole span of the drug development process because to do the preclinical work well, you also need to know what comes next and understand how to position things well.

Yeah.

So yeah, asking for the, the data, where the data's coming from.

... clinical trials, that involves humans, and then there are lots of different phases of that as well.

Yep, exactly.

And not only safety.

In the, in the preclinical space, there are specific safety studies that you have to do depending on the drug modality.

So for small molecules, one of the things you'll hear about is something called safety toxicology and safety pharmacology.

Um, so for, for one of those, for the pharmacology study, you give kind of chronic dosing at an a do- at a dose in an animal that you could extrapolate to like a human dose, right? So like a low level, whatever.

And you look for specific types of adverse events over a long term.

Is there anything that we didn't discuss that you feel we'd be remiss if we didn't cover in this episode?

How does that make you feel as someone who understands this entire process and is considering efficacy and safety?

Frustrated.

Worried for people.

I don't think-- You know, we have such an issue with trust right now, trust in science, trust in medicine, for a large variety of reasons.

But things like that, which I think are somewhat disingenuous, not saying what data does or doesn't support a claim that you're making, I don't think that helps the situation.

You're, you're trying to sell something.

You have a financial incentive to sell that product, so of course you wanna make it sound appealing.

And they hear this conversation and they think, "Yeah, this is easy for you to say, but those studies are not coming down the pipeline." And they've heard that pharma, big pharma-Is not going to research these peptides, these natural compounds because they can't be patented, they can't be protected, and as a result, there's no money in it, so it never gets studied.