Transcription
Peptides are crazy, and the FDA has made their stance on peptides clear. They do not recommend them. Yet, they're hosting a meeting starting July 23rd this week for a pharmacy advisory committee to review whether several popular peptides should be moved onto the list, allowing compounding pharmacies to legally make them when prescribed by a physician. An RFK has made it seem like this proposal was intended to destabilize the gray market of peptides to make it easier to get peptides prescribed versus buying them from random websites on the internet.
And if you're buying peptides online today, you're probably worried about two things. First, you don't want to lose your easy access to peptides. And second, you don't want the price to suddenly triple if you have to go through a doctor or a pharmacy to get them. And those are legitimate concerns.
But as a physician, I also understand the other side. There are real safety concerns when people are injecting biologically active compounds into their bodies that may not be sterile, may not be accurately labeled, or may not even contain the peptide listed on the label, let alone doing this without any medical oversight.
In a previous video, I covered BPC157, TB500, Matsi, and KPV. Those are the four peptides that the committee is going to evaluate on the first day of these meetings. Today we're looking at day two of the meeting, which involves DIP, CAX, and epithelalin or epitalin. And I also want to touch more on this issue of safety and lack of medical supervision because these three peptides are a little less popular than the four being evaluated before them on day one. Most people in the world have heard of or tried BPC-157, TB500, MOSI, and KPV. And there are not as many people trying DIP, epithelen, and CAX. And so we have less anecdotal data on them in particular.
So today, I'm going to present the research that we do have and some of the anecdotal data, meaning this is what people say they experience when they take these peptides. But honestly, I think this week's meetings are about something much bigger than seven peptides. Because what happens when people find something that genuinely helps them, but the medical systems we have cannot verify that the products they're using are safe, pure, correctly labeled, or even the compound that they're thinking they're using. See, this is where medicine becomes really uncomfortable.
I just happen to be one of the many doctors rooting for people who just want better for their health. And I'm trying to view this from your side of things and my side of things. I don't think people are irrational for resisting tighter access. See, they may have found relief by taking BPC-157 after years of chronic pain or gut problems, or relief from their insomnia due to a peptide, or any problem that the medical system has failed to address for them. And so, you've been getting these things online without any problem. And then an agency steps in and says, "We don't have enough evidence or safety data to let you do this, and so we really don't want you to." And so to the person who finally feels better from using these things, that doesn't feel like safety, does it? It feels like somebody taking away the thing that gave them back their life.
But the safety concern is also real. Somebody can end up in the ER, and people are ending up in the ER after taking peptides. And we don't know if it's the peptide itself, the dose, contamination, a mislabeled vial, improper storage, or mixing multiple compounds together. And that makes things really difficult. You cannot judge the safety of M C when a person may not have actually taken M C or taken the right dose of it.
But I think that's where doctors have a responsibility not to blindly defend every peptide, not to blindly dismiss every peptide, but to separate what we know from what we don't know, and to be honest about both. And that's why I love making videos on this stuff and peeling back the layers on the science versus the safety versus the realities and the unknowns and having a conversation with you about it. So, I think a good question is, is this meeting actually making peptide use safer, or is it simply making legitimate access harder?
Anyway, let's take a detour and look at the science that they're voting on on July 24th, and you can tell me what you think in the comments. So here's the rundown on what's being discussed on July 24th.
So let's start with DIP, Delta Sleep Inducing Peptide. So the FDA is wanting to know if this peptide could be useful for opioid withdrawal, chronic insomnia, and narcolepsy. And the science on it is that DIP is a naturally occurring peptide. We make it in our bodies. It plays a highly complex role in balancing the brain's stress response with the brain's vitality and reproductive axis. In the 80s and 90s, there were some human studies showing the physical symptoms of withdrawal dampened using intravenous DIP. And we currently use a lot of benzodiazepines to do this now, like Xanax and Adavan. But those drugs can be addictive and sedating, whereas DIP is not. But the problem with these studies is that they're not double-blinded, placebo-controlled. So we don't really know how much of a placebo effect was present in the outcomes. And so on, in real life, people try to use DIP for getting better sleep. The outcomes and user reports are very inconsistent. However, some people think it works, and some people just get crazy dreams on it. But I personally think there's a lot of misinformation on it and how to use it. And so I think better protocols would need to be made with this one if it gets approved.
Moving on to another peptide, CAX. So CX has a massive cult following in the cognitive enhancement space. CAX has been studied on humans too, and it's approved for use in Russia and parts of Eastern Europe. The FDA wants to evaluate it for cerebral ischemia or stroke recovery. It wants to evaluate it for migraines and trigeminal neuralgia or pain because of the nerves in the face or the trigeminal nerve that innervates the face. Its primary developmental purpose was to serve as a high-potency countermeasure for acute brain trauma, strokes, and severe cognitive disorders, specifically for the military and space programs in the Soviet Union. And so in the United States and the peptide underground, most peptide enthusiasts are using CAX for things like brain fog and focus. And here's why those reasons make sense based on how CAX is thought to work, according to the research. So CAX is a synthetic fragment of ACTH. It works by spiking brain-derived neurotrophic factor, or BDNF, by way of selective ACTH receptors that exist in the brain. So, think of BDNF as kind of like miracle-gro for your brain cells. It can physically help protect the brain and help rewire or improve or grow new neural connections. Sounds amazing. But because most of the human data we know about on CAX comes out of Eastern Europe, the United States completely dismisses it as lacking Western clinical standardization.
Now, you need to understand the concern here before just bashing the FDA. CAX allows upregulation of BDNF in the brain, but too much BDNF isn't a good thing for all people. In fact, increased or unhinged levels of BDNF can lead to too much glutamate in the brain, which is an excitatory neurotransmitter. It excites neurons, which can lead to a heightened pain response or, worse, seizures. But we also have some great research that shows that since the half-life of CAX is short, like one to two hours, and because we have natural negative feedback loops that protect our brain from flooding itself with BDNF, CAX is unlikely to get things unhinged up there.
Let's move on to the third peptide, epithelen. The peptide you don't know if you need, but we try it anyway. The ultimate longevity wild card. The FDA is evaluating it for insomnia, just like with DIP. So epithelin is a peptide modeled after something called epialamin, which is naturally secreted by your pineal gland in your brain. In cellular research, epithelin has been shown to upregulate telomerase activity. Telomeres are the protective caps at the end of your DNA strands, and when they get too short, the cell dies. And telomerase helps extend those telomeres. So epithelin is thought to help cells live longer, basically, and it also has this ability to restore pineal gland function. So some people try to use it to reset their circadian rhythms. We actually have a very interesting observational study showing humans given epialamin having increased telomerase activity. Again, this is the enzyme that lengthens telomeres. These humans actually extended their lifespans over a 12-year period. But the argument is that epialin is not epialamin. It's a concentrated synthetic version of it that's meant to hit the same receptors. The FDA is pointing out that there are already dozens of highly standardized FDA-approved medications for sleep. And so they don't see the point in approving epalen for sleep. And because the peptide community uses it as a longevity tool, the FDA is flagging this as a safety concern. So they note that while telomere lengthening has anti-aging properties in animal models, longer telomeres are also intimately associated with an increased risk of cancer and tumor growth. So because the available clinical studies are short and narrow in scope, the FDA argues that we have absolutely no idea what epithelin's true carcinogenic potential is in humans.
To me, and this is just my personal opinion, we don't have enough things that help people sleep or get back to sleep more naturally. And adding one more tool to the bag is not a bad thing in my opinion when a lot of the approved medications we have for sleep aren't tolerated very well or flat out don't work. I'm talking things like trazodone, Ambien, Lunesta, hydroxyzine, even Unisom as a supplement.
So what happens when this meeting wraps up? Well, according to the official briefing documents posted ahead of the meeting, the FDA reviewers concluded that all seven peptides BPC57, TB500, KPV, MOS C, DIP, CAX, and epithelen should be rejected. They also argue that there's a lack of FDA-approved standards because none of these are active components in existing FDA-approved drugs, and there's insufficient high-quality human data. The FDA is explicitly dismissing the existing clinical trials, such as the ones from Russia or the 1980s trials on DIP, as lacking the randomized, double-blind, placebo-controlled design required by modern Western pharmaceutical standards.
So, if the committee votes no on these seven peptides, they will remain on the category 2 or "do not compound" list. And that means clean, regulated, third-party tested compounding pharmacies cannot make them for you, and doctors cannot prescribe them without taking a big risk of operating outside of their licenses.
And I understand why regulators are concerned, but I also understand why people feel betrayed when access to things is restricted. Medicine shouldn't be an all-or-nothing war between two camps. We need safety standards, but we also need to recognize when people are successfully using things to heal things where conventional medicine has left them stranded. America has come to the point where people are just angry and feel the need to take their health into their own hands because the system we've set up just isn't working for them. And I don't blame you. And I'm just one of many doctors who has a hard time not putting myself into your shoes. And so I like to sit down with people and meet them halfway. If there's something you want to do or try, let's think about it strategically. And as long as it's reasonable and safe, and you understand the risks involved, we can move forward. I don't think the future of medicine is blind acceptance. And I don't think it's blind rejection either. I think it's better evidence, good manufacturing standards that have nothing to do with political gain, and doctors willing to have honest conversations about uncertainty.
What do you guys think? And if you're a doctor or practitioner who wants to actually understand the mechanisms of these compounds and peptides should they become prescribable, I have a complete peptide course linked in the description below. I'm Dr. Ashley Frzy. If you like this video, please hit like for me, subscribe to my channel, and I hope you have the best.