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Why do patients refuse statins backed by decades of data in millions of people yet eagerly inject peptides tested in fewer than 20? Emergency medicine physician and longevity practitioner Vikas Patel confronts this paradox head-on. In this episode, based on his KevinMD article “Why the FDA regulations on peptide therapy matter,” he breaks down what compounds like BPC-157 actually promise, what the evidence really shows, and why the gap between anecdotal hype and clinical proof should concern both physicians and patients. You will learn how the erosion of trust in medicine through the COVID years fueled demand for unregulated therapies promoted on podcasts and social media, why physicians who take an absolutist stance risk pushing patients further from reliable guidance, and how reframing long-term statin data dramatically changes the risk conversation. Patel also shares his practical approach to meeting patients where they are without compromising scientific integrity, and why he believes at least a handful of popular peptides will eventually prove their worth if anyone bothers to study them. If you want to have smarter conversations with patients about peptide therapy and rebuilding trust, press play.

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Transcript

Kevin Pho: Hi. Welcome to the show. Subscribe at KevinMD.com/podcast. Today we welcome Vikas Patel. He’s an emergency medicine physician. Today’s KevinMD article is “Why the FDA regulations on peptide therapy matter.” Vikas, welcome to the show.

Vikas Patel: Thank you for having me.

Kevin Pho: All right, let’s start by briefly telling us a little bit about yourself and then why you decided to write this article on KevinMD.

Vikas Patel: Sure. So as you mentioned, I’m an emergency room physician trained. I also run a longevity practice. My training and career have taken a bunch of paths. I was trained in emergency medicine, but I also was in the Navy and did primary care as a flight surgeon in the Navy a few years back.

Got interested in longevity space and have been doing that part-time along with the ER track. Part of the evolution of this article that I wrote for your site was really that I get quite a bit of resistance from patients on standard therapy and statins and cholesterol. I think it hits a nerve with a lot of people because of a lot of bad press that cholesterol management has gotten and this general distrust of pharmaceutical companies, what their biases may be.

And then really, I think, through the COVID years, as a general mistrust of physicians and what our motivations are. And you flip that with this intense interest in this peptide industry right now. And I don’t know how many calls I get a week, either from prospective patients or from my existing patients asking me my opinion on certain peptides.

So obviously I want to be educated on these topics, and in doing this research it becomes kind of glaring what the pitfalls are here, what the evidence really says, and how to translate that to patients is quite challenging.

Kevin Pho: So peptide therapy definitely has been in the news. I see it all the time in social media. There are political figures that promote peptides. Tell us where a lot of your patients are calling you about them. Where are they hearing about peptides from, and what do they want peptides to do for them?

Vikas Patel: Oh man. Loaded question. So I think most of where they’re getting their information from is podcasts. I hear so many people listening to Joe Rogan saying Rogan promotes these, he’s on these things. Even RFK Junior has admitted to using them. And as you said, there’s this push right now even to deregulate peptide therapy, which is one of the main reasons why there’s been this bigger interest in just popular news right now. But most of my patients are really hearing this off of social media, whether it’s podcasts, Instagram, TikTok. I think that’s where the majority of the information is coming from.

Kevin Pho: And for those who haven’t heard about peptides, just give us a little primer about what they are, how they’re administered, what they claim to do.

Vikas Patel: So peptides are essentially short chains of amino acids. They’re basically chains of partial proteins in our body that for the most part exist within our system. And these are signaling molecules that tell our genome to do something. So for instance, the most popular of these peptides are actually FDA regulated, and those are the GLP-1 drugs right now. And these are compounds that our body makes. Obviously the drug form that are marketed now, we’re getting monster doses of them, more than what our body generally makes. And we’ve made it such that you can do like a once a week dosing of this so that it stays in the system much longer than it would naturally in our body.

Most peptides have to be injected into the body. There’s just cutting edge now that there’s some pill formats of the GLP-1s. But the reason why pill formats have not traditionally worked is that our stomach acid breaks down peptides very quickly, so they cannot typically be absorbed by the oral route. And there’s been some clever pharmaceutical engineering to bypass some of that with the newer pill formats.

Everything else that gets talked about on TikTok or Instagram, almost everything else has to be injection format because none of these compounding pharmacies that are typically selling these drugs to whoever’s going to actually market them, they don’t have the R and D that Eli Lilly does to go through a good scientific process on how do we actually get gut absorption of these. And so everything else is for the most part subcutaneous injection.

Kevin Pho: So a common one of course is BPC-157. Now, what are some of the health claims that that compound makes?

Vikas Patel: So this compound was discovered in, I think, 1992. And the initial studies on it were in a rodent model, and it showed that it was helping to repair damaged tendons. So there were some good outcomes in that rodent model. The compound actually got purchased by a big biotech firm and essentially got buried, because we have no public knowledge of what happened. But most big companies, if they were going to, if they found something positive on their own internal trials, typically it would then move into phase one, phase two, phase three through the FDA regulation process. And it never has over 30 years.

That has not stopped people from talking about it. And really this compound got its moment a few years ago, I think, on the Huberman podcast, and there was a researcher who had talked about how there’s anecdotal evidence that it’s working to repair tissue.

So there’s two possible benefits. One is within the gut itself, to help restore some type of GI function. People talk about things like leaky gut syndrome and inability of the GI tract to absorb nutrients well. So that’s one potential benefit. And the second is just repair of injury. So you get a rotator cuff injury or tendonitis or a muscle strain that’s nagging you for months, and you do a round of BPC-157 for six to eight weeks, and all of a sudden everything goes back to normal when physical therapy perhaps was not working.

Kevin Pho: So to your knowledge, what is the evidence behind BPC-157? Are there any prospective randomized trials? What is the current evidence?

Vikas Patel: Yeah. So basically what I said, right? There’s not much to date. There were 42 patients that were enrolled in a trial in 2016 that was supposed to be a prospective trial. That trial closed without ever reporting any results. And so we have no idea what happened to those 42 patients. After that, there were two observational trials, one with 12 patients, and one with two patients.

The two patient trial, all it reported was nothing about whether the compound worked for what they were giving the patient for the reason they were giving it to the patient. All they reported was that there were no side effects to the two patients that received it. And the other trial with 12 patients, again, they commented nothing about whether there were any positive results for the patient.

So in actual documented studies, we have 14 patients that have gotten this compound. Yet I guarantee there are thousands and thousands of people in this country that have actually taken it and have, who knows what their outcomes are, because we don’t have any data on it.

Kevin Pho: And at the beginning of our conversation, you mentioned statins, which has been studied in literally millions of patients. And then you have something like BPC-157, which is fewer than 20. Now, yet patients still distrust statins and they’re asking for BPC-157. So what do you think about that? Why do you think that is? Why do you think that despite the evidence mismatch, patients are still wanting compounds like BPC?

Vikas Patel: I think part of the issue is us as physicians, that we didn’t understand the data when it first came out correctly. I don’t think we made a good case for it once people started questioning the data. And then there’s this change in psychology that’s occurred, especially over the last decade, and especially through the COVID years, that we’ve really failed to figure out how to communicate to patients and regain this trust.

Talking about the physician piece of this, a lot of the trial data that came out initially was five year data, and cardiovascular disease is a lifelong disease. So if you start somebody on a lipid lowering strategy today, and we see that the number needed to treat to prevent one adverse major cardiac event is between 16 and 33 patients to prevent one event, that’s over a five year span. And someone may look at that and be like, well, you’re going to treat 30 patients to prevent one heart attack, and that seems like it’s not that great of a deal. But then you look at the same set of data comparisons for hypertension treatment, and it’s about the same.

The thing that people are realizing is that we’re not treating this disease for five years. We’re treating this disease process for 40 years. If you’re 40 years old and you get diagnosed with hypertension or high cholesterol, we care what your outcome is between now and the time that you die, which hopefully we’re going to extend by using this treatment. So the number needed to treat, I’ve done mathematical models on this, and obviously I can’t project out what 40 years of data looks like, but even being conservative, the number needed to treat drops to something like one in four, one in five when you’re looking at 40 years.

And so that’s the component of this that physicians have really not paid attention to. In looking at these trials, they’re looking at this five-year data. Even up until very recently, we were looking at 10 year chance of MACE, major adverse cardiac event, because that’s what the AHA guidelines were talking about. It’s only just in the last couple months that the American Heart Association has updated this to say, OK, 10 years was what we had. That was the data that we had when we really came out with these guidelines. But now we know, looking at 30, almost 40 years of statin data, that we should be doing this risk calculation in a very different way. We should be talking to patients in their early thirties about their cholesterol management because it will make a difference for them by the time they’re 70.

Kevin Pho: So tell us about the path forward. And you gave the context that we currently live in. I think that there is a political devaluation of expertise, and during COVID-19, I think that we, in the health care profession, we’ve lost a lot of that public trust. So now when a patient asks you and they want to be started on a peptide, and if it’s not BPC-157, it’s going to be something else in the future that’s being talked on a podcast, how should we as physicians address that request?

Vikas Patel: I think this is where if we’re absolutist about anything, especially when we don’t know the answer, we’re going to lose trust. And so my approach to this is I just present the data and I tell patients, look, this is what we have information on, this is what we do not have any information on, this is what we have some anecdotal evidence for. You have to make the decision that you’re comfortable with. My job is to give you as much information as I can and tell you whether I would do this myself, whether I’d recommend this for my own child or my wife.

The reality is, most likely with so many of these peptides, if they’re being used in a well thought out manner, there’s probably not a ton of harm. And what I mean by that is, I think there’s a difference between using something and staying on it for 30 years versus using something for six weeks. If you have a goal and you know what the goal is, and you’re going to use this substance to try and reach that goal over a short term and then go off of it, mostly because we have no long-term data on any of this.

Things like BPC, the concern is that there’s some angiogenesis that occurs. That’s one of the mechanisms that it repairs by. It increases blood flow to areas that may not be getting good blood flow, which is the issue of tendons and ligaments. And so if it’s increasing blood flow in one location, it can also be increasing blood flow to potential cancer cells, and that’s the long-term concern. Are you expediting the growth of something like a cancer?

So if we have these conversations with patients in that manner and say, here’s the potential risk you’re taking because this is the mechanism of this compound, you make up your mind. I’m going to support you either way, but you have to know, eyes wide open, what you’re getting into.

Kevin Pho: So typically how much does it cost? If you were to prescribe BPC-157 or advise patients to get it, what’s a typical treatment cost like?

Vikas Patel: I think it varies widely by source, because there’s zero regulation for this right now. So you can order some stuff from China and it shows up, and you may not spend that much money. But I’d say a course of BPC, probably for a four week supply where you’re injecting three days a week, it’s probably around 300 dollars for a month’s supply. It could range from 150 to 450, 500, depending on how good of a source you’re getting it from.

Kevin Pho: And as far as you know, are there any studies that’s on the horizon looking at it or that will be looking at it?

Vikas Patel: There are no studies that I know of that are kind of what we’re used to seeing. I think there are some practitioners out there that are doing observational studies, but there are no randomized control trials that are out there, and none that I know of right now. But I have heard at least anecdotally of several physicians who run private clinics that are doing observational studies.

Kevin Pho: What do we have to look forward to? Like I said, if it’s not this compound, it’s going to be something else. You run a longevity clinic. What are some other requests that you get when it comes to stuff people are hearing on podcasts?

Vikas Patel: It runs the gamut. So exchange transfusions have become popular. Red light therapy is very popular. Everyone wants to know about sauna. I’d say those are some of the things that I get asked about the most frequently. The data there, there’s actually good data on sauna, I would say. There’s very limited data on the other things, such as exchange transfusions, but I have patients that have done this before, and when you spend 5,000 dollars on a treatment, I think there’s a mental incentive to report back that, yeah, I think I feel better objectively.

What are they measuring to know that they’ve had a good outcome? Nothing. These patients aren’t actually measuring anything, which is the only way that we would know that there’s a good outcome, is that we have some biomarker that we can look at and say, oh, this biomarker that was at this level, and now it’s at this new level, and we can see the difference. And that’s really the way that I think of most of the treatments that we do, is that if there isn’t a biomarker to track it, then how do we know what we’re actually getting as an outcome.

I think there’s something to the peptides, because there are too many people that report that, yes, I’ve had an improvement. And some of that stuff makes sense. If you’re taking testosterone or some testosterone analog and you’re noticing that your exercise tolerance is better or your sexual desire has gone up, we know and we have mechanisms that support that. The same thing for the growth hormone analogs. We already know, because there are people of growth hormone deficiency that take growth hormone analogs, and we know the mechanism. We know that these drugs do something. What we don’t know is, well, what happens if somebody’s taking growth hormone when they don’t actually need it, and they take it for 10 years, because it makes them feel a little bit better and it gives them more energy and more exercise tolerance? Well, what’s the downside to that? That’s what we don’t know. And those are the questions that are really difficult to answer.

Kevin Pho: You talked about your approach, which I agree sounds very reasonable, in terms of treatments that are unlikely to harm. You present the data and ultimately you have the patient make the decision on whether to pursue it or not. Do you have a message to physicians who are absolutists? Because I know, as you know, a lot of physicians who simply won’t engage with patients on treatments and therapies that aren’t evidence-based. Is there a message for them? Because aren’t patients going to keep looking for clinicians who would engage them, or at least talk to them or have a discussion with what they’re hearing on podcasts? Do you have a message to physicians who perhaps take a more absolutist approach?

Vikas Patel: I think my message is, I’m not prescribing things that I wouldn’t take myself. But I’m willing to have the conversation with patients, and I’m willing to educate myself on these things, because patients want to know. I’d much rather have them get the information from me than look it up on TikTok, because that’s purely the Wild West.

And if we’re not willing to have an open mind, the reality is, I am sure that of the 20 or so very popular peptides that are out there, I am sure at least three, four, or five of them are probably good, and at some point, if somebody were to bother studying them, they would be able to get a decent protocol that makes sense for a subset of patients. That means that the patients aren’t completely wrong. They’re not wrong to look for something that they’re not getting from regular, traditional medicine. It just means that we have to be able to meet them where they’re at, and if we can’t meet them where they’re at, we’re never going to close that gap in trust that has developed.

I don’t think any doctor, I wouldn’t tell any doctor to go against their own morals. But I don’t think it’s going against our morals to have a legitimate conversation and empower the patient to make a well-informed decision, understanding what the risks are of what they want to do.

Kevin Pho: We’re talking to Vikas Patel, emergency medicine physician. Today’s KevinMD article is “Why the FDA regulations on peptide therapy matter.” Vikas, we’ll end with take-home messages you want to leave with the KevinMD audience.

Vikas Patel: Honestly, I think for physicians, it’s really what we just talked about, which is, I think it’s very important for us to have a working knowledge of things that our patients are looking up. If you’re a cardiologist and you are not able to speak to really the latest trials that say that the muscle side effects of statins are truly reported in about a half percent to possibly 2 percent of patients, yet it’s probably the most common thing that patients say. Just in my population of patients alone, easily 10 percent of them will say that I have to stop because of muscle side effects. How could that possibly be true? It’s not true. I know it’s not true, but that’s what they believe, because they’ve been told that this is something they need to watch out for.

So I think we have to be very educated on the things that our patients are reading online and the information that they’re getting from their friends and neighbors. And we have to arm ourselves with good information and still take them seriously.

I think for the patients that are out there, I really think that they should be seeking out their physician’s opinions on things that are not considered standard therapy. They should ask people who, if they don’t know, like I have plenty of patients who ask me things that I don’t know the answer to, and I tell them, I don’t know the answer to this. I’m going to do some research for you and I’ll get back to you. And I think that’s a perfectly valid approach. And I want patients to ask me rather than just go online and find some information, and we have no idea whether that’s accurate or not.

Kevin Pho: Vikas, thank you so much for sharing your perspective and insight. Thanks again for coming on the show.

Vikas Patel: Thank you for having me.