Science spoken for the common man, it’s your country butt doctor host, Dr. Ken Brown and your co-host, Mr. Sleep himself, Eric Rieger talk the dangers of too much of a good thing CAN be bad. Join the Gut Check Project for a little pre-Christmas research. Don’t forget that even water, when consumed in massive amounts, can be harmful. RIP mice.
All right. Welcome to the gut check project. I’m here with your host, Dr. Kenneth Brown. I’m Eric Rieger. This is gut check project, Episode Number 26. We’re going to wind up 2019 with some awesome info. What’s up, Ken?
What’s going on Eric? How are you doing, man? Episode 26.
I apologize if I’m a little too sexy today because I’m just coming off of a small cold.
I think the hottest people are those that are sick.
Well, I’m not sick. I’m post sick. Remember, the viral prodrome. The reason why we always like pass so many viruses is that you tend to pass the virus before you even know that you’re sick by the time you’re actually sick. You’re probably okay
Yeah. At that point you can go back and say I heard you might be sick. I was too back then.
Good to see you?
Well, today’s episode is going to be pretty awesome. We’re going to tackle number one, we’ve received tons of email in your clinic because you also sell the KBMD CBD at your clinic, you get these questions. These have been coming in Fast and Furious over the last little over 14 days. And it’s questions about the safety of CBD oil and its application. So we’re going to tackle that I do need to tell everyone. Thank you. We’re on episode 26 because the first 25 shows were so well supported by all of you who’ve been keeping up with a gut check project. We grow every single day. Paul, the guy who’s helping us put together the production now and helping us spread the word. We just hung up the phone with him. We’ve gotten more and more downloads each week. So thank thank you every single one of you for liking, sharing, emailing, telling your friends about it. We sincerely appreciate it.
We learned so much about it like today we have a new a different guests we do Instead of gutsy our little mascot or green frog, but since we do film on a green screen, he gets blocked out did not know that didn’t even realize that. So now we’re going to go with a dung beetle, right here?
Yeah, yeah, we did. So that’s Dilbert, the dung beetle,
Dilbert, the dung beetle. So one of my favorite things is whenever we’re bringing any patients back and somebody sees you, and they’re like, hey, you’re Eric, I watch your show that just warms my heart. So if you happen to be a patient and show up and you watch the show, if you say that it just makes us both feel really, really well…needed wanted, appreciated.
Yeah. At least outside of me putting you to sleep. Take five or six good deep breaths.
Today’s episode is sponsored by Atrantil. Your bloating relief, it’s what we do. So go to Atrantil.com or lovemytummy.com/KBMD. Today it’s also sponsored by KBMD CBD oil. You can find your own KBMD CBD oil at kbmdhealth.com which of course, the initials KB, Kenneth Brown, it’s endorsed by the guy who’s sitting across the table from me. So Ken, why is…
What does MD stand for?
Well, I’m not really sure.
I thought it was your buddy Mike Doyle, but I don’t know.
Yeah, it’s probably. So tell us a little bit about KBMD CBD.
Alright, so KBMD CBD oil. I got involved with the science of CBD because I saw the beneficial effect with my patients when we developed Atrantil I then learned that the science of Atrantil the polyphenols in it actually augment CBD. So I’m seeing this combination do incredible things for people. So this particular CBD is one that we have researched, I’ve seen it work clinically. And we know that it comes with a certificate of analysis. It is organically grown, it is naturally extracted with co2, so it meets all the criteria that you want in your CBD because this is important. The rest of this podcast is going to be all about the dangers of CBD.
Definitely and It’s really interesting since we do have so many people who have begun to purchase CBD find benefit. It’s really kind of weird what’s occurred over the last two weeks. And what I would say is a little bit of misinformation. But it’s more or less probably just misunderstood information and or or misapplied information. But regardless, the benefits of CBD used correctly, have been undeniable with the people who’ve come back through the clinic with people that we’ve scoped, and how well that they are doing. And so, hopefully today, we’re going to provide some context on why more or less the dangers that you may or may not have read about in the news recently are really a little concerned. But we’ll, we’ll see. We’ll see how far along we get in at the last. The last thing. Our last sponsor is the KBMD health box. You can find KBMD health box by going to kbmdbox.com. Now last week we did a full unboxing which is something I think we’re going to try to do at least once a month. But essentially, if you want almost $300 of physician vetted supplements that can help you benefit your life and get them for only $147 which you would spend, not you would spend more than $147 worth of time driving somewhere to pick them out for yourself and having someone handpick them for you. Go to KBMDbox.com. What was one of the things that we had a patient come through just earlier this week, who showed us his lab results that he took to his primary care physician?
So we’re starting to make a difference in the landscape of health here in the DFW Metroplex and different places. I’ve been getting emails and calls from people around the country that will actually hear the podcast and then they’ll want to sign up for the box. And what we’re seeing is that these vetted supplements actually are making a difference with both subjective how they feel and objective the labs. So the reason why I chose these things is they all have third party analysis. And they all have some scientific background that actually explains how they’re going to help you. So much so that I’m thinking of ordering my household, another box. So although it is the KBMD Health box, I actually I love the fact that I can get these things that I’m going to purchase anyways, they come into my house, so my whole family’s on it. Now we’re running out of stuff. So I’m gonna end up having to double up on everything. So it’s one of those things that I feel really good that we can look at different aspects. And when somebody says, Oh, I tried X, Y, and Z, I didn’t notice anything. I’m like, oh, did you try one that had a third party analysis? No. And then they do and they’re like, Oh my gosh, big difference. Same thing with CBD. I mean, a lot of CBD out there doesn’t really have what’s on the label. And we’re going to get into that because we’re going to talk about what the FDA thinks about it. We’re going to talk about the different media and what they’re doing, and hopefully get into all that but that’s the whole point of that box is I want to deliver these vetted things to your house monthly so that you can continue to improve your health.
Hundred percent. So without further adieu, be sure to like and share the gut check project. We certainly appreciate all of the support to date. We’re going to hop right into it. So what we’ve received here recently is a lot of speculation and concern from people who have said, Hey, I’m interested in CBD. I know that you and Dr. Brown have heavily studied, been entrenched with CBD and its application over the last few years. I just learned that the FDA is associated or made public a study that says that it may be hepatic toxic or bad for my liver. It’s, unfortunately, it’s a weird jump off point. So I’m going to kick it to you. Because immediately I had lots of different thoughts and instead of getting emotional, what did we do? We went and tried to find the sources of where this information came from. We want to backtrack on how they got to that conclusion. And I think that we can put a lot of questions at ease and even help people learn how to be a little bit more critical with the data that they receive when they receive it. Because let’s face it, lots of stuff that we see on the internet, or that we hear on the news or reading the paper, it’s basically clickbait. It’s basically things to keep you engaged, whether or not the actual substance is worth the headlines that are written so…
So what you’re referring to is recently the FDA put out a statement, a consensus statement in the news and it’s making all kinds of traction in the news that they’re saying that CBD is not as safe as people think not only that it can be harmful. Now this has bled onto TV and my patients have been asking me about this FDA statement. Then there’s been other news articles like the one that Forbes published, read said that CBD causes liver failure.
That was the title liver failure caused by CBD. I want to get into all that I wanted to take a really deep dive into the science of all of this as a gastroenterologist, I’m board certified gastroenterologist, which means not only am I a simple country, butt doctor from Texas, but we actually have to learn liver disease, hepatology, I’m not a hepatologist like some of my other friends where I send like really complex things, but we at least have to understand the liver, how it works and what it does. So a lot of these articles discuss this but they don’t clarify so many little things. Because and they shouldn’t it’s a it’s a journalist writing an article they want they want it to be shared. And anytime you mentioned CBD, anytime that that is thrown out there, you’re going to get some clicks, you’re going to get a whole lot more clicks. If you say you’re going to die from taking CBD. It reminds me of the I remember Jerry Seinfeld was on Saturday Night Live one time and they were making fun of the nightly news where they always do the promo at like three o’clock. Like five household items that are guaranteed to kill you, tonight at six.
You’re like what?
If it was so important, they probably wouldn’t make you wait.
No, I’m gonna die before you put this on the air. So what I’d like to do is talk about the briefly the science of the endocannabinoid system and CBD, then do a little bit deeper dive into the liver. So everyone’s going to get a primer on the liver 101 here, because these studies don’t make sense unless you know, some of this knowledge. It’s just sensationalism. For some of it, some of it is a little bit unfair. I think some of it is for what the FDA got, and it’s there. But I just want this podcast today to be something that can be useful for industry people that can be useful for patients or people that are thinking about taking CBD and it can be useful for a subset a small subset of people that may be should not consider taking it.
So all of this is kind of, you know, for the future of this podcast, It’s almost going to be a bit of a rebuttal. Not necessarily a defense of hemp derived CBD. But let’s just buckle up and kick some science. This might be a little bit I don’t know how long we’re going to go where we’re going to go with this. We’re just going to feel it out and see what happens. But I at least want to be able to explain why I still believe that a lot of people should be taking CBD even though Forbes is like you’re gonna die from this.
It’s not arsenic people.
No it isn’t and I think another cool application here is there are people out there who have been on the fence on whether or not I should try CBD or is this something that’s good for a family member for me? And unfortunately, there you hit this intersection, where a news headline is written that CBD causes liver failure. Well, if they’ve been on the fence, that’s a pretty big No, no, right? So now you’ve taken away maybe an avenue that they were considering to help them out. What I hope that we can do with this particular episode is basically let’s temper and let’s see things in context. I think context is a word that as you get into sensationalism is something that is kind of the rescue item. If I could put something into context, then at least I’m giving someone a fair chance to understand the information that’s before them. I don’t feel like sensationalized headlines do things like that. Then again, I also don’t feel like someone who shakes, hand picked or cherry pick studies is doing that either. So what I think today that we can do is fairly evaluate and talk about the process of how the liver works, and why some of these studies are or are not applicable to the nature they were presented.
Absolutely. So the first one we got to discuss is what what what the heck did the FDA say?
So the FDA came out and they mentioned that they’ve got several issues with the safety of CBD. The two main ones that they’re really concerned about are potential for liver injury, and interactions with other drugs. What they actually said is that they’re concerned that people may mistakenly believe that trying CBD can’t hurt the agency wants to be clear that they have seen only limited data about CBD safety. And these data point to two real risks that need to be considered as part of the drug review and approval process for the prescription drug containing CBD.
Now, what I say this is because the FDA is referring to the data that was presented to them by GW Pharmaceuticals, who has a epid… eipdi..x you know?
Yes, which is the first FDA approved prescription CBD isolate,
for seizure disorders.
It’s important to point out that is not full spectrum.
That is not full spectrum. And there’s some that’s important because here later in the podcast, and think we’re going to draw some comparisons and just if you’re listening, just remember, epidiolex is a CBD Only isolate it is not a full spectrum product.
So let’s talk about what the FBA what the FDA actually does. So the FDA has a really daunting task. The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy and security of products. So it is super daunting because there’s a lot of products hitting the market, and the FDA has tried keep up with this to try and protect people. And let’s be honest, let’s look at the elephant in the room. The elephant in the room is that there are a lot of bad CBD products out there.
In fact, in a jam article 2017 showed that 70% of the CBD products that they looked at did not have what was on the label and what was there could be higher levels of CBD could be lower levels of CBD. So it’s a gamesmanship that’s going on right now. So it is totally true that you need to make sure that you’ve done your homework on what type of CBD that you’re actually taking. There currently is little to no regulation in the CBD industry. There is the President and CEO of Natural Products Association NPA. His name is Daniel Fabricant. He’s a PhD. I love this quote. He’s quoted as saying it is well past time to bring science into the equation, as federal rules require safety and Consumer Protection must come first.
And we all agree with that.
And I think that all companies that have reputable CBD companies, they all want that. Problem is when you have these different stories leaking out, which gain much more traction, it just starts creating a little bit of confusion misconception, and then people don’t really know where to turn. So the feeling is, is that possibly statements by the FDA saying that it creates this narrative that questions the safety of CBD overall, strictly to address a few number of companies which are producing quite frankly, some crap products.
What was the number that we learned the last time that we were in Utah at meeting I believe it was one out of every 23 to 24, I could be off it was definitely in the 20s. But every to every 23 or 24,25, CBD labels available for retail purchase. One is seen as a reputable well marketed or correctly labeled product, which means that even if it happens to be off a little bit, you’ve got 23 or 24 other labels which are just not truthful or probably not correct, don’t have a certificate of analysis or are blatantly, just not even what’s in the bottle.
100%. There’s a lot of people out there trying to take advantage of this wave that’s coming. So I do not. I believe that the FDA is doing their job by looking at the data that was actually presented to them
So let’s take some time and break all this down for the consumers, health care providers, industry personnel. Starting with the question, does CBD cause liver damage? Unfortunately, or fortunately, because I like science we really need to talk about what the endocannabinoid system is. Because if somebody’s listening to this, they’re like, Well, I was thinking about taking this but I’m worried becasue it can cause liver failure. I don’t know why I’m taking it. Why in the world should I be taking it? So let’s do a quick one minute discussion of the endocannabinoid system.
Let’s do it!
All right, the endocannabinoid system. The endocannabinoid system is a system which was discovered in the 90s that we now realize it’s probably everywhere in the body. There’s primarily two different types of receptors, but essentially, the way that I try to explain it to my patients, it’s concentrated more so in the neural areas, nerves, brain and the immune areas. Although we now know it’s in every single organ, that’s where all the original research was. We now realize that its job, the endocannabinoid system is to produce these products called endocannabinoids. Which work as traffic cops. They just kind of get your body to get back to an area of balance. If you’ve got too much activity, they go Whoa, slow down a little bit. If it’s not enough, they go, come on. Let’s go ahead and get some more going here. So you have this fantastic system in your body that really just tries to keep balanced. Think of it that way. And you’re going to hear a little bit later why I think most of America is out of balance. I think most of America needs some replenishment of their own endocannabinoid system. So that’s the important thing is is that there’s a dire need to try and get us all back to a certain balance, because the reality is we’re getting sicker as a nation. And one of the causes could be that we took hemp derived foods out of our diet and out of our livestock diet. And there’s a theory on that, that possibly that’s one of the reasons why we’re having more autoimmune diseases, why we’re having more of the other problems that we’re seeing,
Well at least contributing factor.
Certainly at least a contributing factor. So keep this in mind. So the the primer on the endocannabinoid system is if you’re, if you have ears and you’re hearing this, you also have an endocannabinoid system, and you have a higher than likely chance that you are out of balance with that. And if you are out of balance with that, then you probably could benefit from some of this.
So right now you’re going well, I’m out of balance, I’m going to probably benefit but I’m going to go into liver failure if I do this. So let’s talk about what liver failure means. You have a genius living within you. You probably have multiple geniuses living within you.
Thank you. That feels great.
Sometimes the voices in your head don’t say to do bad things.
The evil genius. Yeah.
Well, one of the geniuses living within you as this beautiful origin called your liver. So you have this and it’s amazing. So to understand where they’re going with this, let’s talk about what the liver actually does. So we all have livers. And they work differently in every single person, and they can continue to adapt, evolve and change. One of the only organs that you can transplant a partial portion of it and it will grow into a full liver. So the nephrologist think that the kidneys, the smartest organ, the neurologists will think that the brain is the smartest organ
The cardiologist says if you don’t have blood, you can’t think so It must be the heart.
Yeah, yeah, exactly. I’m gonna say, well, for health span, smartest organ in the body is the endocannabinoid system. So eventually, we’re going to have Endocannabinoidologists. Because what ends up turning out is that the endocannabinoid system is in all these different organs.
They’re not completely separated. So let’s talk about the liver. The liver is responsible if you ever wonder what the liver does. So do you have any idea what the liver does?
I’ve got a little bit of an idea…
Little bit of an idea. So the liver is responsible for selective uptake, concentration, metabolism, and excretion of the majority of drugs and toxins, also known as xenobiotics. So let me just say that again. Basically, the liver takes the crap that you bring into the world. And it says, I’m going to convert it to something useful, or I’m gonna get rid of it for you. Yeah, it can detoxify it, or it can say, Oh, you need to be this and then you’re useful. That’s why I say it’s a genius in your body. And it the liver figures this out, it figures out what you need, and it determines if it’s a drug, or if it’s a toxin, and it can turn into a better form. Now, one of the problems I have with these different articles that I’ve been reading, is that they discuss that then enzymatic process called the P 450 system, and they just write it like that they’re like, CBD has been shown to affect the P 450 system.
What doesn’t affect the P450?
So that’s the issue. So let me break that down, I bring up the P 450 because in the lay literature without even describing what it is, it is a complex. It’s called a phase one metabolism of the liver. Under p 450. It’s an umbrella term that has over 60 different genes, that code for hundreds of enzymes to break down anything that comes your way. So the P 450 enzyme is like saying, Oh, I don’t even know an analogy, but it’s top of the funnel down. It’s like you just so generic, that you can’t just say that. So but they write it in the lay literature almost as a sounds sciency so I’m sure that it’s, I’m sure that it’s right. That’s kind of my feeling on I’m like, why would and all these people it’s almost like these news articles parrot each other. And nobody’s stopping going, wait a minute, because as it turns out, the P450 system, not the P450 enzyme, the system breaks down almost everything that we put in our bodies.
Yeah, no joke. So a lot of going back to the pharmaceutical days, I remember that was one of the biggest challenges with with any of the drugs that we detailed a physician on was, how is it affecting the P 450. And that would be something that they would be all salespeople be coached on that before they would go on calling a physician. But the truth is, it doesn’t have to be a compound. It doesn’t have to be a medical pharmaceutical compound for that to be somewhat important. Something as simple as grapefruit juice. Also, detectibily inhibits the metabolic ability of the P 450. So there’s all there’s a handful of different drugs that people who are elderly, maybe caution, don’t drink grapefruit juice, because it will inhibit your ability for your body to clear this particular drug. And I say that to say this. It’s not nothing is inherently just special because it does or does not directly affect the P450, almost everything you take into your body is either cleared quickly or slowly by that same system.
Yeah, so they kind of imply like CBD is the only thing that gets…
Not even close.
…that gets processed in the in the P450 system. In fact, we know that there are multiple medications that can be altered by certain foods. Grapefruit is the most common one, and that really affects like immunosuppressants tremendously and that’s where it really came up. When they realized, oh my gosh, you have these different drugs, let’s say blood thinners and immunosuppressants, which have a very narrow therapeutic window, you have to have these things like right dialed in. Yeah. And then people talk about grapefruit but you know, other things that have actually been shown to do this cranberry juice, black tea, pepper, even chocolate
has been shown to affect drug absorption and they have been shown to affect certain pharmaceuticals. We don’t even know the tip of the iceberg on this because you have to do the study on it. You have to do the pharmaco kinetics, the PK is what it’s called to actually determine that which is so funny because they say oh CBD is metabolized by the P450 system.
That means nothing.
And so if you take CBD and or chocolate and or drink tea, be careful. I mean…
I think a good analogy a seriously a good analogy is it the P450 being metabolized by the P450. It may be good for base knowledge, but the truth is, is does it overwhelm that, as you put it system, if it is overwhelming that system, chocolate, for instance, for most intents and purposes would be like a single car driving down a six lane highway by itself. It’s not really if the highway was a P450 and the car was the chocolate. It doesn’t take anything to funnel that that car through.
The problem is is whenever you happen to overwhelm that system. And that is important to know. But I would say in terms of context, kind of the way that we started this discussion in context. It’s not my belief through what I’ve read and seen that CBD inherently overwhelms or becomes more than a single car down that six lane highway.
So not only is it just one single car going down the highway, remember that not only foods but drugs, nobody’s talking about drug drug interaction.
So there’s a reason. So I see a lot of patients that one drug may be very effective one thing may be very effective, but there’s so many variables like for instance, drugs, the sex of the person plays a role, you may have different levels, the age of the person and any diseases can all affect this whole system called the P 450 which produces enzymes. So not only that, but then genetics play a huge factor,
Alcohol intake, all of that. I mean, genetically, this may be why some drugs work on certain people and why they don’t work and others fact there’s a whole field of science right now where people are trying to determine the genetics ato go, Oh, you’re going to need a higher level of whatever Plavix which is one that they’ve actually looked at. Or you can, you’re going to take less. So we this is a whole field of this beautiful science where we can go Okay, genetically, you’re going to be predisposed to need more medications. So when these enzymes get used up, basically if you’ve got this one chocolate, which is a car, one on six lane highway, and then you add fluconazole, which is an antifungal, that’s an but that’s not a car, that’s a semi now and then you add alcohol, which is a minivan
could be ccould be a couple minivans
and then you do whatever something else, but you can see that the liver has to try and process this right. So what happens is it becomes this once it becomes a traffic jam. Then people start getting angry, they start honking their horn that is a rise in your what we call lfts liver function panels liver function test Yeah, so AST and ATL are the two ones that we always talk about, that’s exactly what the FDA was referencing. So I want everybody hear this. When you overwhelm the liver with multiple cars using your analogy, then honking starts and the honking the warning sign is this rise in AST and ALT. So, for instance, your body can adapt to it. We’ve seen this all the time. If you drink alcohol on a regular basis.
you build more lanes,
you build more lanes, you get really good at metabolizing alcohol.
I’ll use myself as an example.
Not with alcohol.
I always have to laugh. Whenever I go to the my own doctor. They say how much coffee do you take? I just write obscene amount because I’ve down regulated by receptors or I’ve had the ability to ramp up my my livers ability to convert that coffee into an inert thing and there it is. So you see it as an anesthesiologist or as a crna. I mean, describe what your experiences whenever you try and put somebody to sleep using propofols, different medications.
Yeah, well, I mean, definitely, if someone says that they happen to be a large consumer of or a consumer of large amounts of alcohol, it generally takes anywhere between 20 and 30% more of an agent to put them to, to sleep safely, say, But back to your point of body habitus, for whatever reason, even just something as simple as someone being a redhead fair skinned, those people generally take more agent to make them go to sleep.
Yeah, let’s go ahead and clarify this. This is a well known thing in anesthesia. You’re not being prejudiced?
No, not at all. No, they literally just for whatever reason, the metabolism rate of someone who’s fair skinned with red hair is typically higher than the average calculation and you can go through any types of weight based medications that we use to bring sedation to someone and generally fair skin redhead folks just take more.
Is that interesting?
Yeah, it is.
So that is more than just anecdotal like they’ve actually done some studies on this and they’ve actually shown probably because whatever lineage, they come from Scotland, Ireland, they have a higher P450 to metabolize that particular or a higher subset of the P450 systems. So just keep that in mind. So when you take certain foods or drugs, everything’s competing for your liver, to do to just say, hey, fix me, you know, figure out what’s going on. Fortunately, it is a badass organ and the liver is tough and it can handle a lot, the largest solid organ that we have in the body. So usually it can handle everything. Now the most common example like we’ve talked about, if you take grapefruit juice with certain immunosuppressants and things then that particular combo because those drugs need exact or how they were manufactured need exact metabolism numbers. Not only that, did you know that like nutrition plays a big role. So, high protein diet will actually affect your P 450 and malnutrition will affect it.
of course it will.
So those are all of our paleo friends over at paleo FX and such those guys have revved up p 450s. Eating a lot of protein working out a whole lot, they’re able to do this. Unfortunately, malnourished people probably can’t tolerate as much
No and they aren’t they aren’t they honestly they don’t have the supply to rebuild the enzymes that are that are used within the P 450 I mean it’s just malnutrition is going to deplete all different types of systems, not just the liver.
So in the intro, I kind of mentioned that we’re getting sicker. And so let’s use nutrition as an example. federal policies tightened by the controlled substance act of 1970 essentially banned the production of industrial hemp during the war on drugs effectively we made hemp CBD illegal and put it under the umbrella of cannabis cultivation. Now what were we were talking with Will Clyden of O-hi energetics right, who actually discussed this and he said some cool stuff on this. He back before this when they were they were using hemp and hemp has been used for ever like since we landed in America, hemp has been using hemp has been used in China for thousands of years and all this other stuff that we were feeding because it’s a fantastic crop. It’s it detoxifies the soil. And it actually works. It grows quick. It’s a great crop industrial. What were we thinking making it a banned substance, I don’t know, separate discussion. But they’ve got data to show that when they were feeding chickens, so for everybody out there I had a patient today who said I said Oh, she was suffering from some things and I think CBD would help with and I mentioned Hey, have you ever considered CBD Oh, I would never ever, ever, ever do anything like that. I am not like that. I said, Okay, that’s cool. said hey, let me tell you something. Do you know that before 1970 we were actually feeding animals like chickens and cattle. One of the primary things that we would feed them would be hemp, and it’s been shown that you can take a chicken egg and it had over 250 milligrams of CBD, right so right now if you’re somebody that just spent $200 on your CBD that has 300 milligrams in 1968 you could’ve just had an egg.
A three cent egg.
I know 3 cent egg. And I looked at the literature and I and I could not find anything that said death by egg otoxicity. It didn’t so everybody that’s sitting there thinking oh my gosh, no. I’m not going to do CBD. We were having CBD in our diet. A great Great example, to learn a lot more about this and do a deep dive. Our friend Chris kresser had Will Clyden and the CEO of O-hi, O-hi energetics on and he went into this tremendously. It was so cool. It was just like I just it’s crazy that we stopped like, and I as a physician have seen that we are getting sicker as a country. So in 1970, we’ve got since 1970. We’ve got more chronic disease, we’ve got more dementia, we’ve got more autoimmune disease. coincidence, like we said in the intro, maybe it’s at least a contributing factor. And now we have the FDA saying that CBD can be harmful yet it was in our food supply up until 1970.
That’s nuts, dude.
It is nuts. And it doesn’t make sense and if you look at mean hemp seed, birds eat seeds, birds consume seeds, they do all kinds of things where they can they take in product, What’s the matter?
No, I’m just looking at I’m trying to make sure we get through everything.
Okay good, but I mean they eat everything and people have been consuming eggs from not just chickens they’ve been consuming eggs from all different birds on the planet for that long. The fact that we’ve restricted hemp growth etc has only taken away one of the natural things that birds were eating.
If you’re if you’re really interested in this like I said go to Chris Cressors podcast where he’s got Will Clyden on there is really cool wills smart dude Chris is super smart dude. So those guys those guys kick some crazy knowledge.
So that is it’s weird that we’re talking on this episode about CBD causing hepatotoxicity. And we’ve already shown that the liver’s pretty badass, right? It can do a whole lot and we’ve already shown that the endocannabinoid system is necessary and since 1970, or up until 1970. We are taking in significant amounts of CBD in our diet
It is weird, but it’s not so weird when we get down to why everyone’s alarmed. So you want to get into a…
Now let’s go ahead and look at the studies. So that is sort of the phase one of this podcast because now we’re going to start geeking out a lot. So I hope I didn’t hope I didn’t lose everybody with a but you kind of need that background to understand what we’re going to talk about next.
Sure, you definitely that background.
Alright. So what they’re talking about is the FDA published this revised consumer update. So this is the consumer update that they put out there for everybody detailing the safety concerns about CBD products. Now, this was based on the studies provided by GW Pharmaceuticals, GW Pharmaceuticals has done multiple different studies looking at different things to get their FDA approval. And I’m going to say right now, that kudos to GW for being the first company to step up and really try and make something for a group of people with intractable seizures have an alternative. Kudos to the FDA for doing their job and looking at the data that was presented to them. What I’m going to do is go next level and say, Well, you didn’t look at everything. That’s the bottom line here. So I’m not bashing anybody. Let’s make let’s make certain of this. Sure. So there have been several randomized, controlled and open label trials that studied the effects of epidolex, I’m going to call it epidolex from now on it’s just easier, which is a 99% pure oral CBD extract on patients with refractory epilepsy. So this in turn led to the FDA approval for two diseases, dravet syndrome and Lennox-Gestaut syndrome. So if you recognize those names, bless you, because you’re dealing with some serious stuff,
It’s a serious seizure issue.
If you don’t know those. Count your blessings. It’s one of those times to go well, no matter where you’re at in life. It’s like well, thank goodness that I don’t have to Deal with a child that has this because that’s, that’s a really big deal. These are intractable seizures. So they looked at the data on that. And in these studies, the kicker here is I’m going to say it again, getting back to the lane highway, the patients maintained on their stable drug regimen with a median of three anticonvulsant drugs.
It’s super important. Three anticonvulsant drugs. So when we use the analogy of the car on the road, imagine a six lane road. And three of those roads. Three of those lanes are double semis.
Yeah, that are closed construction…
Or closed, Yeah, that’s more likely or closed.
So let’s talk about that. So when we’re talking about three different agents used to control seizures, some of those agents would be and I’m assuming here, but probably Depakote, probably Dilantin, also known as phenytoin, or fosphenytoin, which is seravex. There’s a handful of anti seizure medications and through my knowledge, all of them, all of them have been recorded as raising the enzyme levels used by the liver which of course would lead to ALT and AST elevation, showing that the liver is essentially working overtime to long term process these drugs right or wrong?
Correct. Correct, which is exactly what the FDA is supposed to do. They’re supposed to look at this data and go Okay, so let’s just look at the study that they’re talking about. So the FDA accumulated this data, and they looked at what GW presented GW presented in isolette of CBD, not a full spectrum. And the dose they ramped up to 20 mg’s per kick 20 mg’s per kick. What that means is a guy like me would take 1954 milligrams a day.
That’s a lot more…
of CBD isolate. Now I see the effects, beneficial effects of taking KBMD health CBD 15 milligrams twice a day,
that’s 30 milligrams,
that’s 30 milligrams.
The exact dose of what makes people feel better is very argued because all the data coming out of Israel shows that a lot higher doses, but I’m seeing effects at these doses
So let’s be real quick let’s stop for context. So right now at this intersection what we’re what you’re saying is with a full spectrum and we said this at the beginning of the podcast that what GW Pharmaceuticals has with epidiolex is a CBD isolate and what they’ve done…
You’re saying epidiolex now that’s funny.
Yeah, whatever it is,
Well, because I started with that. Then you told me no, that’s not how you say it.
I think we should switch it up the whole time. EPA max the way it was edimax. What they did is they were able to establish that almost 2000 milligrams for you would be the ideal dosage however, you…isn’t that correct?
That’s the dosage that they went for or the dosage that they felt was safe,
Safe. Okay, I’m sorry. So but but on the upper end of…
That was what they were aiming for on everybody.
In essence, though, from where you have had beneficial effects, you’re talking 60 times that amount, two months worth, is what they are saying the safe level would be in one day where you’re finding the beneficial spectrum. So just just in terms of context, full spectrum, CBD, one 60th of the dose that they’re saying it’s a it’s a safe level is really all that you need from our experience.
Yeah. Now in GW’s defense, let’s look at the data. So in dravet syndrome, seizures dropped 39% and in Lennox-Gestaut 42%. So…
So they probably did their homework and said, well, we need to get up that high to actually help that so I don’t know anything about that. I’m not a neurologist. That’s where it’s at. But I’m just saying that when we look at that dose, no average consumer is going to be able to consume that Much CBD in a single day, unless it comes through this
2 full grams a day is more than most take Yes,
yeah. Now here’s the problem 94% of the people had side effects.
94% at the highest dose compared to 75% placebo, kind of weird. So there’s just a huge placebo side effect profile that doesn’t get discussed at all.
Did they say what it just had a curiosity do they state with the placebo was for the control,
They did not stay with the placebo was oh, I take that back. I don’t know what they use, but basically they left people on the same medications. So, essentially, let’s just look at this and say okay, but the good news is, most of it was not a big deal. Most of it was what the FDA also discussed beyond the liver tests and beyond the drug metabolism. They also said Oh, CBD can cause nausea. It can cause drowsiness. It can cause all these other kind of nuisance things. That’s what they’re referring to right here.
It’s interesting though, that have a side effect profile assigned to a placebo that’s that exceeds around the 30% range, because that’s generally the throwaway number.
So we’ve gone twice away from the throwaway number. And they’ve had they’ve had reported side effects, which I’m not trying to over draw conclusions here, but it could at least indicate that side effect profiles assigned to CBD in this study probably weren’t solely to CBD,
Well, you’re dealing with one of the highest risk populations you can get your hands on, when I did clinical research and when we would do a moderate to severe Chron’s study. The placebo arm would have tons of side effects because the disease is bad. That’s what’s going on here also. So most was not a big deal, upper respiratory tract infection, somnolence, decreased appetite, diarrhea, blah, blah, blah, blah, blah. But the one that they focused on is the increase in amino transferase concentrations. This once again was a revised consumer update, they put this out to the public and their statement is increase in liver amino transferase concentrations when I just got done explaining what the liver does. Did I ever say amino transferase concentrations?
I said liver enzymes.
frickin talk to the public if you’re going to release a consumer paper.
liver enzymes. AST ALT.
This is hiding behind scientific garbaly goop.
It’s like you’re doing half science half anyway. But but whatever. So a patient show up and they’re like, I need you to check my amino transferase concentrations. I’m like, Whoa, why? They Hand me this, this, this news article.
This is what we’re trying to address right here. So what they found is that in the higher dose, 20 mgs per kg, there was a rise in some patients in three times the level which is significant, so if your normal is 20. You can be 60 if your normal is 40 it can be 120. When patients come into me and it’s three times the level it sounds alarming. Do you know what happens when somebody gets hepatitis A acute infection?
It’s way more than that
thousands of times the level when somebody goes into foaming at failure there AST and ALT will go from 40 to 10,000.
AST and ALT have risen for almost everyone who’s listened here, way more than three times throughout their lifetime multiple times in acute or in very isolated settings. It happens with illness.
So getting back to your highway analogy, which I think is really cool analogy. I’m glad you came up with that.
Thank you .
Getting back to the highway analogy. 80% of them were taking a drug called valproic
Yeah, that matters. That matters a lot.
It’s when you take these medications, which is why at the beginning of the show, I said you’re more likely don’t have to worry about it. But if you’re on certain medications, keep it in mind. Now that being said at the lower dose didn’t see this stuff. So there is a dose dependent usage of the P450 enzyme you can if I give you one drink, or if I give you a bottle of tequila 512 which in my opinion is really one of the tastiest, most fantastic tequilas you can ever get your hands on.
It is delicious.
It’s delicious. I’m gonna I’m gonna digress right here. Oh my God, Tequila 512…
Also sponsored by Tequila 512
Tt was really good seriously, ummm in every single person with liver test rose.
They went back to normal if they decreased the anticonvulsant or decreased the CBD. So either one it went back to normal.
So it wasn’t number one, it wasn’t permanent liver damage. More than likely correct they were able to return back to normal. And number two, it was simply A case of an overwhelmed P450 pathway more more than likely.
So you want to get really confusing?
Not really but we might as well try.
I don’t want to but here’s what’s really interesting, then they kind of get a little geeky. So GW presented their their stuff and then they showed that the P450 in this enzymes and they went into will, the CYP to, 2c19 CYP three a four can inhibit the CYP blah, blah, blah.
Those are all just cytochromes people.
Those are all just cytochromes It’s under the umbrella of P 450. That’s how complex this is.
It is nuts how complex. The highest plasma concentration to CBD occurs within two to three hours after exposure to the Epidolex. With medication, so timing of these medications going to play a role, which actually got me down a weird rabbit hole where i started thinking. We haven’t done this much analysis on what happens if you take your Ace inhibiter and you take your cholesterol medicine, timing wise PK analysis on different people and everything. Because when they do these pharmacokinetics, they do it to get the FDA approval, they do it on people that are healthy, that they can understand it.
Let’s put this into context again, if you’re listening to this you’ve ever taken tagamet. Have you ever thought about when you take your tagamet, you probably only take it whenever you’re afraid that you’re going to have acid problems, right?
Yeah, guess what? It’s also known as a high level p 450 inhibitor if it’s over consumed. So I guess what I’m saying here is, there’s probably way more alarms being driven over something that yes, is handled by the P 450 system, but is far less invasive or it’s much it’s a much smaller vehicle on this highway than some of the other things that the alarms are not sounding over.
And then surprise surprise after I just got done talking about the liver and the genetic variability and all these other things. When they looked at the pharmacokinetics there was tremendous variation.
Yeah. Odd, right? So and anybody that’s listening to this that is a, a pharmacist or is a scientist or like Well, yeah, duh. Like I know, duh. But why put out such an alarming statement?
Yeah, yeah, you’re right. So it for Okay, so it’s a little bit of clickbait stuff, right. And so maybe even the journalist who wrote it doesn’t understand specifically, the implication, they may have only seen P450, written somewhere turned to a health care provider and said, What is this? Well, that’s indicating that things are rising up, they freak out. They write a headline that says CBD causes liver failure. I just learned that from this health care provider. So I’m going to write this piece.
Well, that we’re going to get into that. The liver failure. This is still just the FDA.
To the consumer. So I hope that the FDA looks at this and says, You know what? That’s right. All that stuff that was just being said it’s right. But we didn’t have the time to do it. We couldn’t sit there put that on paper, we’d lose everybody. I get it.
It’s quite true.
We all we all but we all have a responsibility, much like any doctor to try and explain. You and I have this ability to have this forum to reach hundreds of trillions of people.
Yeah. It eflects in our subscriptions on YouTube. They so many trillions of people subscribed, they started his back over to about 200.
Yeah, so every time we got trillions, they start back over.
So So anyways, so what what you’re realizing here is exactly what we’re talking about. When you put stress on the liver. The liver honks its horn and does a little rise and the lfts goes, Well, hey, guys, maybe not so much. Can we just back off the traffic a little bit and see what’s happening here. So additional studies have shown that levels of the anticonvulsant drugs actually caused the daily effects. So now we start wondering that the that the CBD may actually rise some of the anticonvulsants and then you have more side effects from that comes down to the same thing we’re talking about how many things do you want to tax your liver, that’s the bottom line. To summarize high dose of a pure CBD isolate, not full spectrum, while using a mean of three other anticonvulsants can cause temporary rise in liver tests and affect the metabolism slightly of the anticonvulsant. Of note, it did not happen at lower doses. So one more time, if you are on an anticonvulsant discuss with your doctor and make sure that you stay well below the 2000 milligrams a day.
So this whole thing of Oh We’re going to block the P 450 the P450 is So frickin complex, it is nuts. So anything you want to add to that, because I’m going to move on to the thing that I really want to, like kind of make fun of
No, not really, I just want to say that I think that the FDA, unfortunately, is a very important and serious organization within our government. And I think that for all of the flack that they take their, unfortunately, with any other entity, there are limitations on what it is that they can do. And I do believe that they try their best to fairly ascertain and address situations as they are presented to them. Regardless of how frustrated that one of this may get is we don’t get a result from them. A lot of it is just simply because there’s not enough manpower.
Oh, absolutely. They get thrown everything think about, think if you’re in an organization where you know that 70% of the crap that’s out there needs to be pulled off the shelves and you’re limited. It’s a government organization. These people making these statements are MD’s. I’m really limited fortunately, I have well, we have the show where I kind of enjoy looking up some of this stuff. Fortunately, we have some friends of ours that are that work in the nutrition industry that are fantastic at researching articles. And some of that gets gets brought to me I want to make sure that we all get better this is the whole purpose of this.
I want to help the FDA and help GW I want to help the CBD industry. I want to help all of it. But let’s just talk about this because something super weird happened. And this is the one that got the most press A Forbes article came out that promoted a mouse study and made the sensational claim that CBD causes liver failure.
Yeah, that’s kind of what I was referencing earlier. I may steal the thunder but yeah, you’re right.
Yeah, so this is you’re exactly right. In the intro, you said it was clickbait. I really after looking at this study after pulling the study, because how many people read that article are actually going to pull the study.
Well is the is the person who wrote this study that well versed in reading studies like that. I mean, that’s that’s an important thing. I mean, they I think that probably even the author of the article feels like that they are doing a service to the reader, but probably doesn’t understand. And if they do, then shame on them, but if they don’t, I think that would be a better explanation doesn’t fully understand how to read the study and the quality and the qualifications of that study to make a statement like that.
Yeah. And you know, this, this could be an arguable point, I’m sure that the person that that wrote this feels very strongly that what they said was right, the bottom line is the goal of this study was to investigate CBD cannabidiol hepatic toxicity, meaning liver issues in an eight week old male mouse. So they they took a group of eight week old male mice, and then they gave them a CBD that they produced. The CBD that they produced and Will Clyden will just jump up and down when he hears this because he decided Is this on Chris Cresser’s podcast. The CBD that they produced was used to extract using hexane, which is a molecule that is known to be hepatotoxic.
Yeah, you’re not supposed to have heaxane.
Don’t do that! Will Clyden talked about the fact that if you find a CBD with an outrageously high amount of of CB, if you find a full spectrum CBD with an outrageously high amount of CBD more so and the price ranges, okay? Because what they did is they extracted that with hexane in a cheap way and threw it in their bottle and said, there you go. Now you can check that’s got 10,000 milligrams of CBD or whatever. And it’s really interesting because there’s so much going on in the industry like this. So this particular study out of the University of Arkansas, took the CBD, or they made their own CBD using hexane which is a hepatotoxic in itself and in their certificate of analysis. It was there and then they gave it to these mice. Second thing neat
I don’t even know there has to be a second but we can hear it. Because I mean seriously, that’s, that’s like saying, I know your stomach hurts. You should take this Pepto bismol. And then I don’t tell you that I’ve broken up some glass shards and have you drink it and you’re like i’m bleeding now! What’s going on? I’m like, I don’t know.
Yeah, but you only paid half the price.
I made it myself.
Which, by the way, that last batch of propophol that you did in your bathtub is working phenomenally.
I’m sure it is.
Now we do not make propophol in our bathtubs.
Alright, so the second issue. If we have any mice that are subscribers to our show, or listening, I would like you to have your children removed from the room at this moment. Because they took these poor mice, and they gavaged to them. Would you mind defining what gavaged is?
I think it’s when you kind of force feed somebody I don’t think it’s willing. That’s your I think gavaged something you kind of threw one at me there I think to gavaged someone you basically introduce a funnel to the esophagus and well you kind of get after it, don’t you?
Yes, I’m currently gavaging my mic right now trying to figure it out. I just undid everything.
You’re gavaging our ears with your, your microphone adjustments?
All right, so gavage is they forcibly give these mice?
The CBD extract?
Yeah, I don’t think it’s comfortable nor pleasant.
No typically through a tube feeding or down the throat to the stomach is how they generally gavage things. A quick side note, now because I’m now all of a sudden I feel like I’m living in a glass house when I was an undergraduate student. I actually did my first surgery on a rat and we took out their adrenal glands. And I’m just saying that so I don’t want to sit there and pretend like I’m not done mean things to an animal. But that was when I knew immediately I could not be a bench researcher. I did not like that. At all, now I was like, I need to,
I want to heal.
I want to heal. I don’t want to hurt these animals, but it’s it’s a whole separate discussion. So anyways, so they gavage these animals with different doses, and it’s really interesting. Now in what they call their defense, they call it allometric dosing, which means they’re trying to get the body weight to human weight ratio appropriate. I’ve read some rebuttals of this article where it is a joke, you just can’t do that. And when I read vitamin weed
Michelle Ross, when I read vitamin weed she dis… she specifically discusses why research on CBD versus mice is very difficult to do because the weight basing the endocannabinoid system is different, all these other things. So allometric dosing being said, assuming that they’re saying it’s right, so the dose would be the equivalent of what they gave and What a human would give So I’m doing the allometric dosing, which I think is actually higher than what it actually is separate thing. They took mice and they gavaged them with zero milligrams of hexane derived CBD 246 milligrams per kilogram 738 milligrams per kilogram or 2460 milligrams per kilogram of dirty CBD.
It doesn’t make sense
dirty CBD isolate. So for instance, in a horrible alternate universe where humans are now the test subjects and we have large mice which are running tests on us, and they decided to gavage me with the same thing. That would be the equivalent at the highest dose of 241,080 milligrams of hexane derived CBD isolate. I’m not even sure what the hexane would do it 240,000 milligrams 242,000 milligrams.
No I mean that being the more or less than now at this point, it’s just an additive. It’s just I mean it’s it’s not an excipient It’s a straight up additive. That would not make sense at all.
Oh, it’s crazy.
This article came out in Forbes and said CBD causes hepatotoxicity.
Also hexane causes hepatotoxicity.
It is nuts. Alright, spoiler alert. The mice suffered hepatic toxicity and death at the highest dose.
Shocking… You know what? I also hear it’s bad to have breakfast cereal with not milk but drain-o. Just something that I’m gonna go out on a whim. Don’t think you’re supposed to do that. It just doesn’t make sense. It’s It’s It’s not. That is not an apples to apples comparison if you’re talking Okay, so we talked about it earlier. reputable CBD source there is no reputable CBD producer that’s going to have and Will special shout out to you it’s going to have hexane as a byproduct or an excipient in their full spectrum COA approved
which is also why KBMD Health with powered by olyxenol
is does not have that. I mean they do co2 extraction, which is the important thing
which is a reason why we partnered with them to make that product. So we are the one out of the 23 or 24 that is the safe and trusted COA back no hexane etc etc. Doing this study is not an apples to apples comparison on what would happen because who knows? Who Okay,
I don’t get it because GW we already did that study. They determined that 20 Meg’s per kg which is still a shit ton.
It’s a lot.
It’s a lot.
is the safe maximum dose. These guys went times it by 100.
Yeah, they did.
And see what happens? Yeah, it’s it’s a bad it’s a bad comparison. I mean, yeah, honestly, if you wanted to find out if CBD plus hexane causes liver toxicity at a ridiculous amount, top to bottom, then that’s a great study outside of that, since nobody does it, I would say it’s a bad study. Speaking of road, that’s a road to nowhere.
Yeah. And so study like this, uh, like you had mentioned is essentially it’s not science. It’s clickbait.
And right now that that author, that journalist is just kind of laughing. He’s like, I know, and now you’re bringing it up, and I’m going to get another whatever, because that’s what people are trying to do. They’re trying to get attention at this point.
So at that point, good for you, you got to click but I would be truly interested if possibly that particular journalists would say, you know what, I didn’t fully understand it. I mean, that’s okay. Let’s look reading studies, right? There’s there’s a study to reading studies. I mean, we heard that we heard the breakdown that kresser did on Joe Rogan is he Twice had to address his approach to completely different topic about the the plant based diet and then how he had to re approach that with the rebuttal. All that just simply to say, there is a science to reading studies and being really good at understanding what is and is not applicable and then how to find studies that you can compare to each other for good meta analyses.
So what we’re doing right now is I’m telling you that maybe sometimes there aren’t studies, but my anecdotal evidence, I have a busy practice, you hear the patients, we hear them talk I listen to them, when they say that doesn’t work. I go, Okay, I’m not publishing it. I don’t have time to do that. I wish I did. If I published everything that we’re gathering data on, if we’re looking at, you know, just so many different things, CBD is just one of them. We’ve got I love I’m a huge fan of brain.FM for the ability to use sound to change your mood. I Would love to they’re unpublished, a lot of studies on stuff like that. There’s, there’s tons of stuff. So when people go, oh, the studies aren’t out there, there is something to be said about the Socratic method, or I’m sorry, the paternalistic method, the way that medicine used to be where the guy in front of you that saw thousands of patients, this is the method that he has. You see me scope, I mean, there’s a difference in scope techniques.
So they, although some may even still say it qualifies as anecdotal, I will say that there’s objective data in both in a scope, somebody can’t just come, anybody can come to you say I feel better. Anybody can even if they don’t mean it. But they can’t make the disease disappear from the imaging that we see in their colonoscopy, or the the mucosal samples that you take. And that’s something that’s completely objective data. That we see. So those are the everyday results that we see from these types of applications where you just, look it’s not made up whenever we okay full pleasure when we first started looking at CBD, I thought was bullshit.
Who you looking at?
Just anybody who’s out there. But when we first started talking about it, I didn’t believe it. I was like, man, let’s see, because we’ve been down this road before but we tried new, new without throwing a bunch of things under the bus. We tried new or innovative different things and high hopes. And unfortunately, low expectations and the expectations get met and the hopes are never never realized. The opposite for me personally occurred with CBD over the last three and a half years. And that is it actually stinking works.
Dude, I knew that we were onto something with Atrantil, because after we did the initial studies, everybody came back and said, I want more. I knew that I was onto something or I was not on something. I knew that CBD had a viable place in my practice, because I bought and the story goes all the way back which is why we work with which is why it’s powered by elyxenol right now, when we went to paleo FX, and I ordered a couple cases and I just gave them away to patients. That was not cheap. Not because I was sitting there trying to be altruistic, not because I was doing charity. I’m like, I don’t know. I didn’t. And I told everybody, I don’t have a clue. I haven’t even looked at this yet. All I know is try this. Tell me what happens. And when about 80% of them came back said I want more. And I went, Okay, we’re onto something. And that’s when I took my clothes off the deep dive into the science and went, holy cow.
this is crazy
Up until that point, I just didn’t know there was a whole lot to it. I mean, it really didn’t. And then the fact is, oh, and to clarify, it’s not like Brown just handed out CBD to just anybody who came to the clinic. You literally just like we did with Atrantil you found very diseased patients to say and who had gone through a gamut of different pharmaceuticals and weren’t finding relief, and suddenly they’re like, this is working for me. Tell me more about it. And I was, I was blown away.
So let’s talk a little bit. So we’re I’m over here going well studies I haven’t published and everything. Let’s talk about a few studies. So I’ve got a Mendeley account, I know how to look at PubMed. I know how to get a Google Scholar, I just want to talk about a couple studies have come out recently. And let’s kind of compare it and see if it still makes people concerned that they’re going to die of liver failure.
Alright. So in the Journal of Clinical Pharmacology published in 2019, the this was actually a study, also sponsored by GW Pharmaceuticals, as part of the process of getting the FDA approval that the FDA did not reference the best I can tell they did not reference this. This is way more complex and it gets super cool, because what they’re looking at is the pharmacokinetics or how CBD is actually metabolized by that beautiful genius called a liver. In high doses in people with liver disease. Yeah, they went through the trouble to take high doses of CBD and give it to people People that did not have liver disease had mild liver disease moderate and severe. This was ballsy to say the least, because using a product like this in somebody with liver disease is is risky. This thing could backfire and it could shut down the whole process. Here’s what’s nuts, the pharmacologic and safety of a single oral dose of 200 milligrams of epidolex, which is the CBD isolate. They were assessed in subjects they had eight people with moderate or with mild disease, six people with moderate and eight people with severe and then they had this collection of normal people. Blood samples were collected to check for the pharmacokinetics This is how drugs are looked at. They give you a drug and then they check your levels. Basically, the blood concentration was higher in the hepatic impairment and they describe it in nanograms. So the nanogram comparison is that it’s a little bit higher in those with severe hepatic impairment. But this is what’s nuts there was no increase in adverse reactions. There was no change in blood levels. So basically, the only adverse reaction that they found was a little bit of diarrhea. And it all happened in the mild hepatic impairment. So the FDA had mentioned Oh, studies have shown that it causes diarrhea. What was really funny about this particular study, it was that all three people were in the mild hepatic impairment, which I don’t get it at all And in the severe and moderate, they were all on other drugs also.
So it should have done the thing that it did with the anticonvulsants.
But anyways, keep that in mind. So basically, no change in liver function in people with liver disease. As long as you take a moderate dose 200 mgs.
People who are already compromised didn’t weren’t made worse by using CBD.
The FDA didn’t mention that one. That’s weird.
Kind of odd. Oh, and then another one. They looked at the safety and tolerability of CBD single dose epidolex 1500 milligrams, 3000 milligrams, 4500 milligrams or 6000 milligrams. CBD was well tolerated in multiple doses. They even use 1500 milligrams twice daily for six days for six days, and a single dose on day seven, there was no clinically significant findings for laboratory parameters, meaning no change in lfts physical examination vital signs or body weight or anything else. So the FDA has this beef with a mild liver enzyme elevation in the file for epidolex. But even GW has these studies that shows that high levels didn’t affect it as long as you weren’t taking other anticonvulsants as long as you weren’t blocking up the highway. You can handle this stuff your livers good at it. So that’s really interesting to me. So even GW has these two other studies that actually show that even in hepatic impairment it did well,
You hate to say it, but I mean, come on, it looks as if it appears as if it’s sometimes that to create an advantage, it’s a it’s certain intersections, people and or companies may hide a test result or a study so that a certain story is or is not said, and then put another one forward. And any one of those could be used in any of these scenarios. I could be wrong. They could have all been available, but it just doesn’t.
In defense of that. I did a there If somebody took time they can find articles in 1970, that can rebute this who knows.
So I mean, this can go on and on. This is exactly what we were talking about when we were saying that
It’s the quality of the study and is it applied correctly, because I think that this is far more applicable to show that somebody who’s already been compromised with liver issues didn’t suffer from the use of CBD which is way more important than giving somebody a tainted CBD substance with hexane and then eliciting liver failure
Yeah, in fortunately for them, they did not gavage any of them. All right, so this is this is where it gets really kind of fun. So here’s some other articles that I that I pulled up. This is on my Mendeley accounts. My Mendeley is a repository where where our good friend, Rn, and nutrition that deposits all these articles and I can look at these kind of things. And when I get time to do this, and this was really fun to prepare for this because here’s an article that is titled cannabinoids and the microbiota gut brain access now you know that I’m a huge gut brain guy.
you know that the KBMD box is there to protect the gut brain access. The title of the article is emerging effects of cannabidiol and potential applications to alcohol use disorder. Now, we had mentioned that alcohol could be a minivan or bigger than that. It’s another vehicle tying up the lane tying up the P450 enzyme. CBD may influence alcohol use disorder symptoms through its actions across the digestive, immune and central nervous system, collectively known as the gut brain access. Notably, emerging work suggests that alcohol and cannabinoids exert opposing effects on this and other words, it doesn’t compete with the experience of being a little tipsy. It competes with protecting your liver when you drink.
So you can still experience liver but in this particular study, they showed that CBD actually hepato protective
hepato protective nuts and small study. I bring the next one up because as a gastroenterologist, I know how important your microbiome is we always talk about microbiome. This study is called the gut microbiome modulates the changes and liver metabolism and inflammatory processes in the brain of chronic, mildly stressed rats. So, fancy title, but basically what it says is that when your microbiome is disrupted, you can actually develop depression and further causes of liver metabolic disorders. So, in other words, a microbiome with dysbiosis CBOE, in other words, can actually affect your liver depression and anxiety. Hmm, kind of odd. So, looking at that, then they looked at a single dose of pharmacokinetic and preliminary safety assessment and the use of CBD rich hemp in healthy dogs and cats. So, I mentioned that the industry cannabinoid system is a cross, I guess I didn’t mention in the beginning, it’s across all mammals and vertebrates, but they actually showed it to be very healthy in animals. So CBD can be given to animals. So this all leads up to this thing. So now I’ve just kind of brought up a case where we looked at CBD in the setting of the microbiome, the microbiome in the setting of the brain inflammatory process. Now we look at cannabadial protecting against hepatic and reperfusion injury. So, this is nuts. CBD significantly reduce the extent of liver inflammation oxidative night in nitrate stress and cell death in bacterial endotoxin activation of TNF alpha production. So in other words, if you go into sepsis,
and you go into what we call shock liver,
the study looked at cannabidiol protecting your liver during that.
Interesting all on also not nearly as bad as the hexane study before right?
And another article you’re seeing the pattern here, like no these were brought up in the study Canada dial predicts liver from binge alcohol induced theotosis. Cannabadial has been shown in this particular study to help attenuate weather cannabadial can work as an antioxidant protect the liver from alcohol generated oxidative stress. Steotosis is fat in the liver, right? So breaking it down when you drink a whole lot or when you put on weight or when you have diabetes, you have fat in the liver that fat in the liver can then lead to something called NASH which is non alcoholic steatohepatitis. If you drink alcohol, it’s alcoholic steatohepatitis. This study looked at the fact that it actually helped decrease markers and it gets real sciency. But all these studies that I’m talking about, are generally around 5 Mg’s per kg. So every other study that we brought up that said it hurt you was obscene amounts!
So it’s too much.
Can you give me an example of something that is actually good for you? That can
Oh yeah, I could do that. You mean would you agree that water is something that we all need?
I would agree that water is good for me.
Would you say that good clean water is safe trusted good clean, certified water is something that you would drink. Is that something you would drink?
Yes certified. COA water.
Can you imagine putting that through a gas chromatograph? Hey, I know you’re paying for this but it’s it’s says
We detect hydrogen and oxygen.
So what I’m saying here is that that water is it’s okay to drink we all drink water however, did you know that you can actually consume too much water? I mean, so if you have too much water there’s there’s tons of stories. There’s even a handful over the last five or six years that people being hazed by drinking water and hang on a second. This isn’t that long ago. I know that in PubMed, there is a specific Hang on. Here it is. It’s been back in 2002 2002 in May great year by the way, study here death by water intoxication study in PubMed. So, with recent emphasis on increased water intake during exercise for the prevention of dehydration and exertional heat illness, there’s been an increasing cases of hypernatremia which is basically the delusion of existing of sodium from excessive water intake. So essentially, these people were observed by taking too much water to combat their loss of fluids. But they didn’t do it with the correct ratios of electrolytes. And they ended up with hydro encephalopathy and they died.
You’re blowing my mind. Are you trying to tell me that too much of something that’s good for you can actually be bad?
Too much of something that’s good can be bad. I know like my kids. I like hugging on my kids but sometimes they’re like Dad, I want to hang out my friends. You’re gonna have to get out of the car. Yeah, but I mean, it’s the same thing. It’s Yes.
Why don’t the FDA do a whole study on the…
Why didn’t Forbes write an article saying that, that you can die from drinking water?
Oh my gosh.
That’s the problem, though is we’re talking we’re not comparing apples to apples here. When we say that. CBD causes liver failure. Whenever we’re not we’re not disclosing that it’s it’s somebody who’s getting way too much. These these poor mice were being gavaged also with hexane an additive. So same thing. So if you if we were to talk about Flint, Michigan water, that would be like a hexane situation, right? So we wouldn’t necessarily consume Flint, Michigan water and say, you know what water isn’t so good. Let’s stop it. We don’t use hexane derived CBD. In fact, for that matter, we don’t use CBD isolate. That’s not really something that we endorse on this particular show. So the quality matters, amount matters, intention matters and most importantly, context matters when we’re talking about these subjects. Yes. I also think that if I were to consume 200,000 milligrams of CBD every day, then my body may say, I that’s okay, that’s enough.
We saw I was watching a, you know, we’re I was watching a podcast on Rhonda Patrick, where she was talking about With a PhD on sulforaphane. Oh yeah. And sulforaphane is an incredible molecule that does amazing things. And he said it right there. He was like, Yeah, but of course you don’t want to take too much because too much of this causes XYZ. Polyphenols, same thing. You can overdo the polyphenols
Salt, anything you name you pick up anything the fact that you just proved that water is toxic.
Yeah, it is.
But now wait a minute. The fact that we said water is toxic. I do not want this to turn into idiocracy.
Don’t drink, don’t drink water. The Rondo president Camacho
Oh know you’re going they’re gonna play it’s great. Electrolytes.
Well, the crops aren’t grown because you’re not using water. What’s water? The stuff that we have in the toilets?
You mean from the toilet?
So, yeah, we’re not in idiocracy right now. It’s okay. CBD is generally safe. Don’t consume 200,000 milligrams of it per day, and don’t use it with hexane and don’t have someone put a funnel down your esophagus to consume it. We don’t sell KBMD CBD does not come with a funnel.
Eric, remember that music festival went to.. Hey man, what’s going on over there? That’s CBD bongs you just get underneath it.
That’s our next ad. Our CBD does not come with the funnel. It doesn’t. It’s unnecessary.
The final one that I want to throw out there because clearly this research is already published. Some researchers looked at cannabidiol protecting liver against high fat high cholesterol diet steato hepatitis looking at different markers. There was that one and then the final one which is really cool. They looked at it was a mouse one cannabidiol attenuates palmitic acid induced injury they gave an actual hepato toxin, and then they had this arm and then they gave the other one seed PD and the ones that got CBD did better. So I just named like five or six articles that looked in detail at how CBD can actually attenuate some of the liver damage in common liver diseases that we experience
And in context with appropriate dosing. Right. I mean, we’re not talking about crazy ass…
none of them seem very high. It was always now. Okay, now, don’t want to go off on a rabbit hole. But let’s talk real briefly about full spectrum. Yeah. So one of the things about this is, is that there’s bunch of articles I mean, we could talk for a long time on this, but it appears that the flavonoids, the terpenes, and the polyphenols and a full spectrum, all work to actually protect the liver as well.
And so different. I came across an article. Remember altran tales made of polyphenols I came across an article where it looked at how polyphenols were able to attenuate the P 450 system to offset different things. So under the P 450. We’ve got 50 different genes, we’ve got hundreds of different enzymes. If you take in polyphenols, it was shown in a couple studies to go, Okay, we’re running low here. Let’s come up high here. So, Mother Nature once again, in my opinion does it best, we can’t just isolate something. And I’ll say it again. GW Pharmaceuticals do an amazing job to help a group of people with really tough disease. And they spent a lot of money to get that FDA approval. That’s cool. But let’s keep everything in context. We there is data out there. So when I talk to doctors, and they go oh, or I’ll talk to a patient and be like, Hey, have you ever considered taking CBD for your sleep issues ever considered taking CBD for your neuropathy for your whatever just because that there are and much like we discussed in our episode with with Khiran, about how there are studies to show like the ones I just talked to about you don’t have to sit there make a claim. Don’t say Oh, CBD, you know, prevents liver failure in this study in an animal model with palmitic acid causing liver failure CBD attenuated that in this study a decrease TNF alpha in this study. That’s where it comes back to the science of this. So when we look at this, we can sit there and say that possibly a full spectrum still is the best vehicle to deliver protection for your body. And the whole concept getting back full circle, that CBD causes hepato toxicity. I don’t know, have I had I changed your mind?
Well, you didn’t change my mind personally. But I do. I do trust the process. I mean it. I believe, again, that that that author saw something that was glaring and seemed like something that they should put in front of people, but the truth is, is that that story was a microcosm and without digging in and understanding what you’re reading That’s really not it’s not what we’re it’s not what we talked about when we talk about utilizing CBD. It’s not even remotely what we’re, I mean, when I tell my my kiddos I’m going to teach them to drive a car, you know, they’re getting their license. My youngest gets his license here and only two months, right? So when I tell him I’m going to teach him how to drive a car and a vehicle and to be safe. It isn’t a NASCAR. Okay.
We’re gonna learn how to drive.
That’s not what we’re getting into.
Dad! There’s a cougar in the car.
Yeah, I know Mack doesn’t walk up to the vehicle I’m training him in and says, Why are we undoing a net? If we don’t, we don’t put on helmets before we get in there. It none of that stuff and I’m not walking to him after I’m strapping in and handing him the steering wheel to attach. Like it’s all of those things. That’s not what we’re talking about. We’re talking about certified CBD. And if the appropriate dosages I’m not teaching my son how to drive over 200 miles an hour on a left turn on the track. No, that’s not what we’re doing.
Your analogies always crack me up.
Yeah, they’re bad. But they’re visual.
And what I’ve noticed is you’re really stuck with the whole driving analogy.
Oh, I’m this is we’re on a road to somewhere we’re not on the road to nowhere. I mean, it’s it’s rather ridiculous whenever you break it down in terms that this is what I mean because we have people who wrote into the show we’ve had our patients who have come through, even if we think it’s ridiculous The truth is it got out in front of people and it made people think and in a more serious approach. I do want people to feel better whether or not they ever buy a bottle of KBMD CBD to me is completely irrelevant. I want people to be better. And if they can be better than they should be able to do so with the right information and if they choose not to do it with CBD, I do want them to at least have the approach and the availability to have real truthful information. And unfortunately, my opinion that headline is not truthful whenever you take everything and weigh it and put it into context.
I mean, this gets back to and I don’t blame anybody because how do you get somebody to look twice at something? You know, you log on there there’s clickbait everywhere. Just happens to be this particular clickbait was was done by Forbes and I just think that there should be a responsibility to look into a little bit deeper. I’m a little bit confused as to the author to the authors of the study itself, where they sat there and said, how much how much should we give these mice? Like, give them 10 times the amount, and somebody says, Give it 20 times don’t screw that we’re doing 1000 times we’re going gavage these mice and we’re going to see what will happen.
I mean, you know, what could have been a mistake? What if a little time trader ran out of control?
Well, it looks like we had a whole arm of…
Well we don’t want to waste the study…it’s kind of ridiculous.
Just like…boss what to do with this, like, well, they all died. So
we gotta write something they are they are going to pay for the mice if we don’t write something. But I mean, it’s…
Jimmy, I’m up for tenure this year. This is this has to be published.
You do begin to wonder, but we could sit there and pick apart motives all day. And then that also is just an in the rabbit hole that leads to nowhere the truth is. How can you learn how to read a study and then if you don’t want to waste that time, I feel like that what we are trying to do is be honest in our approach, and give a real dissection and lay people’s terms that know CBD is not hepato toxic.
One of the things that really happens in these these articles kind of surmise that it’s that to do a true in depth randomized placebo controlled trial on a human, where you have variables to try and take out is it’s so labor intensive. It’s so expensive. And it’s one of the reasons why these drug companies have to invest so much money to get the FDA to say, okay, yes, you’ve done all the appropriate work. I went through that for, you know, 10 years ago and I was doing pharmaceutical research. You realize how much goes into it? You’re like, are they ever gonna get their money back? Some of these companies folded mid study, they ran out of money. And you know it, they were trying to go that route. The other flip side is, and this gets back to what I really want my company D-hat to do I really want to do functional research, we call it functional or natural or whatever, we can put people on different things. I want to know if the KBMD health box over a three month period changes stuff and collect the data on that. What if?
I mean, I’m seeing it, I’m seeing it anecdotally. It’d be awesome. If we could sit there and do stuff like that.
And I want everyone to realize please share this. If you know anybody who’s ever taken CBD, if you are in the industry, share this because I kind of feel like we did a neutral job of I mean, once again, I’m not really trying to bash anybody here. I’m just saying that the data can be delved nn a little bit deeper
Let us hear from you go to KBMdhealth.com and head to the show shoot us an email if you have a comment about it I would love to hear about it and if you feel like that there is another study that we we need to break down
Let’s let’s do it.
I want to hear I want to hear if you have any compliments please direct them towards me if you have any arguments or complaints go to Eric
Yea do that. I’m really good about returning the email right away.
I’m just a really sensitive person.
Yeah, I’m not. So I’ve heard.
But uh, you know, and in fairness to to GW you did talk about the investment of what it takes to to push something through. Whether I do or I don’t agree completely with their stance on on how they market epidiolex is is irrelevant. I do recognize that it did take quite a bit of money to fund studies and then to do so especially if you’ve got people invested in your company or publicly traded you have to make the money back. And so to protect yourself, you need to find something that’s an active ingredient that belongs, quote, unquote, to you. And I know that that’s more or less what they fought really, really hard to do. In my opinion, the isolate is inferior to the full spectrum. I can give some other examples of pharmaceutical companies that did that one I even worked for that we all thought that it’s isolated melatonin was going to outperform naturally occurring melatonin and it flopped. It didn’t do that at all. In fact, it was even shown in small studies to be 14 times the efficacy of melatonin it binding to the MT1 and MT2 receptor, but the truth is, it didn’t make people sleepier it didn’t work. It was just an expensive pharmaceutical prescription that didn’t outperform its natural melatonin counterpart. So it happens. They’re not alone. So I’m glad that they did the research and I’m glad that they fought hard to bring awareness to hemp products to solve these issues. But I still, I still believe that the natural full spectrum approach is still going to be where the better solution is.
So what that same thing that I tell all my patients because of what the FDA said, I still stand by some of what they have recommended. So if you want a seizure medication that has a narrow therapeutic window. Be cautious before you take CBD. I’m going to tell you if you’re like, Oh, I want to buy your, your KBMD health CBD. If you’re on a seizure medication, I really want you to talk to your neurologist first. If you’re on a immunosuppressant, I want you to do that, just as I would sit there and say be very careful in taking grapefruit juice. Yeah, or eating grapefruits? Yeah, because it can do that. Now that if you listen to the first part of the show, you’ll understand that the P 450 enzyme pathway is very complex and it can be affected by a lot of different things. In fact, we should probably have a more in depth conversations with these narrow therapeutic windows. Meaning that if you take a little too much Coumadin a blood thinner, you can bleed out and die. Yeah. If you don’t take enough of your anticonvulsant clot and die, yeah, or Yeah, so the Coumadin, if you don’t think enough, you’ll get a clot and die. If you don’t take enough or if you’re, suddenly you change your diet. I mean, I just said right there, like I’ve learned a ton with this
That is spot on. So with Coumadin, suddenly, if you if you take Coumadin, warfarin, you’re more than aware of this. Suddenly, now you have to pay attention to how much of the leafy greens that you eat every single day, especially with spinach. Yeah. And
Why is that?
Oh, because the vitamin K.
Vitamin K levels.
And by doing so, it, it inhibits the way that you can consume those foods and if you’re going to change it, it’s fine. You have to let your doctor know so they can check your INR and that way they can match everything back up. It’s just illustrative that it does matter not CBD is so far from being the only item that might affect anything else. I mean, candy canes around Christmas time, we’re going to affect the diabetic so they have to take more insulin. I mean, there’s so many independent things that that aren’t written about in Forbes, I guess is what I’m trying to say.
Exactly. I mean, even if you change your diet to a high protein diet, we realized that that will actually rev up your P450 and it may take more meds, it gets really complex. But the bottom line is, keep an open mind. Sometimes its clickbait it did exactly what it was supposed to do. And you don’t want to know what thank you for doing that Forbes because it drove people to my office, I got a chance to look it up, dive deep into this little thing. And then hopefully this wasn’t too much scientific information. We didn’t geek out a little too much. But if you if you heard this, if you’ve got other questions about other things, this is kind of stuff that we love to do. This is what the show is about the gut check project. We’re going to look at stuff. Check your ego at the door. Take an objective Look, if I’m wrong, I’m wrong. I get it. And I’m sure I’m wrong on a few of these points, if somebody was an expert and delve deeper, but this is what we have to go with.
Come join us!
And come join us and it just sparks the conversation. Yeah, this is this is just interesting. But all this other data is out there that nobody’s talking about. These people that are doing these other studies aren’t being discussed. Why not?
No I don’t know. If you’re ever really bored of the hobby and this no joke. Learn how to read a study. Learn how to learn how to break down a study you you may end up learning. Oh, my gosh, I thought all of this stuff before, but learning how to read the methods of a study will open your eyes to how unfortunately how quickly somebody can take some really superficial data and make an argument that probably isn’t nearly as truthful as it looks.
When I was a medical student at University of Nebraska and golly his name escapes me. But for one rotation, I had a professor who initially was an epidemiologist and then became an MD. So he was obsessed with the whole stats. So he came up with a method to analyze a study, where you had to check these boxes he had a little card, you had to check these boxes. Was it randomized? Was the placebo controlled? Was there an intention to treat analysis? Was there? And then you went through and then what you could do is before you even read the study, you can go BS or not BS. Before you even started. It was really interesting because there’s I can, you can do a lot with stats and an intention to treat analysis alone as a thing a lot of people hide behind. What do you do with the people that drop out of the study? So in these severely sick people, do you call them a win or do you call them a loss? So an intention to treat analysis is you’re supposed to, I intended to treat you and you quit the study, you did something you never showed up. You just got the money. You just took the money and ran. And they don’t include those. Like, yeah, well, so I’ve done studies before where the drug company will take an ad out. And they’ll put it in the observer. They’ll put it in the Dallas Morning News or do different things and Brandy and I were just getting random people showing up with ulcerative proctitus and they just had rectal bleeding, and we’d scope them it was like, you don’t have that. And they’d never be seen again. Yeah. So it just completely skewed the data if they did an intention to treat analysis, because they’re trying to recruit more people. And in the process, they’re also losing more people. And when you do that, if you’re a very honest researcher, it really messes with that because it’s like getting, it’s the same thing when you talk to your kids. If you get 100 on your test, or you get a zero, which one actually drives your grade up or down more and that’s zero, just blahhhh.
Yeah, yeah, definitely. Well, man, that was an awesome an awesome breakdown. I really hope that People like and share. This doesn’t have to be the last conversation on how CBD works. Is it safe? Really, it doesn’t have to stop at CBD. I think that we can continue to to examine these types of reports, whether they be sensationalized or not. And see where the studies come from the power behind because this this was fun and the types of conversations that we have with the patients who came through the clinic here recently were were about this and this is good.
Yeah, absolutely. So I hope it wasn’t too much but it was something I really think it’s important. Hopefully this can help some people in the industry hoping this will help the FDA hope it will help GW everybody involved in this whole process. We are all here to help each other. Keep that in mind. Everybody we’ve talked to is here for the benefit of human health
Hundred percent. Go to gut check project on YouTube or iTunes like and share, like and share. Check us out on KBMDhealth.com and pick your yourself up a bottle of Atrantil at either kbmdhealth.com or go check out lovemytummycom/KBMD and you got anything to add today?
No we’re good. That’s all good. That’s a lot
That’s Episode 26 I hope you all have a merry Christmas what do you what do you think?
I think it was great everyone have a very Merry Christmas Happy Holidays, Happy Hanukkah and whatever else that everybody celebrates.
All that stuff.
All that stuff so Oh really, really quick family doing good
Family’s doing great.
We’re gonna kick it at home for Christmas. It’ll be fun and basketball, basketball, basketball,
Tennis Tennis Tennis
Y’all have a great, great Christmas, great New Year. Great holiday and we’ll see y’all in 2020