terra health essentials liposomal glutathione Bundle Excessive Shedding BPC-157 - 5mg Size:250 Grams

terra health essentials liposomal glutathione Bundle Excessive Shedding BPC-157 - 5mg Size:250 Grams

BPC-157 - 5mg

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Excessive Shedding

Size:250 Grams

and others It’s a relatively small issue, but Peter has taken a lot of arrows for that To be clear, we don’t have compelling human data for its effect on aging, but even so, it’s in a completely different echelon to injectable peptides when you consider the volume of scientific data we have Rapamycin was FDA approved as an immunosuppressant in the 90s, and it’s commonly used in transplant and oncology patients Which means we have decades of use in some of the sickest and most vulnerable humans We also know the pharmacokinetics We know the mechanism of action We know the appropriate dosing ranges And we have plenty of long-term safety profile data in all sorts of human cohorts Including general healthy populations when you look at some of the immune modulating studies We know how it interacts with other drugs We know there are certain dietary factors that can influence bioavailability The studies on aging and lifespan have been mostly limited to animals outside of the immune modulating stuff, but the results have been very consistent across multiple species and multiple research groups So reproducible that rapamycin is basically used as the benchmark for testing other alleged longevity molecules And again, Peter is not saying any of this to try to convince anybody that they should be taking rapamycin (that’s a very controversial topic) Peter is just illustrating a point: if we want to consider rapamycin somewhat risky and controversial, gray market peptides are in another room We’re talking about something that is so far off the deep end in terms of data quality Peter would even say something like NAD ‒ at least we have much more clear data for their use than we do for these peptides And he’s been very critical of the NAD precursors, having found effectively no value in them from an efficacy standpoint ⇒ NAD was recently discussed with Eric Verdin in episode #359 Understanding peptide regulation: FDA approval, supplement oversight, and the risks of gray-market compounds [1:23:00] Talk more about another topic mentioned earlier—the fact that most of these are not FDA-approved, and that can create safety concerns Basically, we have 3 levels of regulatory oversight for this type of wellness market peptide 1 – We talk about peptides that are FDA-approved but they’re used off-label 2 – Peptides that are regulated as supplements 3 – Peptides that have almost no FDA oversight at all We’ll go through this quickly at this point because it’s a bit redundant 1 – Peptides that are FDA approved for some indication, but that are being commonly used off-label These require clinical testing to demonstrate safety and efficacy The results of these tests are reviewed by the FDA before the drug goes to market And then they’re also subject to ongoing post-market surveillance This is true of any FDA-approved drug ⇒ But they require specific indications for which they’re approved, which means there’s no guarantee of efficacy for the off-label condition And now you might say, “ Well, hey, at least we know they’re safe .” And in many cases, that’s true, but safety data exists on a spectrum depending on the approved indications So if an FDA-approved drug is approved for someone that’s got a very high risk condition like legitimate mitochondrial dysfunction, they might be willing to tolerate far more in terms of side effects than if you’re just a healthy person otherwise You have to weigh in mind the cost-benefit analysis that the FDA is doing might not be the one you’re doing You mentioned other types of FDA oversight