Gary Brecka

So if I were looking down the lane of the FDA for the next three years and areas where it's going to widen, areas where it's going to narrow, I mean, obviously we need to widen the lanes for functional medicine-like treatments and modalities.

lifestyle medicine, which is things like dietary exercise, those kinds of things.

Peptides, for example, which have been used at scale and have been proven to be safe in the mass population.

Where do you fall on some of these areas that I would consider them gray areas right now where they're kind of being done and people are benefiting from it, but the FDA hasn't really taken a strong position like peptides, for example, which we used in our practice and with astounding results, things like BBC 157 for tissue and wound repair.

for healing and sealing the gut for people that had gut dysbiosis, Crohn's disease, diverticulitis, ulcerative colitis, these inflammatory bowel conditions that were not responsive to anything other than high doses of corticosteroids, which just bought you another problem down the road.

Where do you see some of the lanes potentially widening, if you can talk about it, potentially widening for some of these therapies?

So I would say in the lane of cutting edge new areas, we've got to talk about the microbiome and we cannot use our old model of approving drugs for the microbiome.

If somebody has a probiotic that has a reasonable safety profile

We've got to have a different amount of regulatory flexibility for something like that because the microbiome is a lining of a billion different bacteria that is in an equilibrium naturally in the body.

And so things alter that microbiome and things can help repair that microbiome.

And so if we wanna run a randomized trial for each molecule or component of some probiotic therapy, we're gonna be spinning our wheels for a long time.

And so the agency, and this is common of regulatory agencies, tend to fall behind and not be able to keep up with the times.

The microbiome is the biggest frontier of medicine that we are not talking about, that we need to talk about.

We know things mess up the microbiome and directly result in diseases.

One of the biggest studies in modern medicine that has been ignored, and I think one of the most important studies, has been a recent study out of the Mayo Clinic that looked at kids who got antibiotics in the first two years of life and then tracked them as to what diseases they developed later.

Now, why would antibiotics potentially cause disease?

Well, the theory is that we know antibiotics alter the microbiome.

It's almost like carpet bombing parts of the microbiome.

And you get bacterial overgrowth.

We don't know what to do with it.