A Cannabis skeptic and marijuana legalization naysayer in his medical school days, Dr. Kevin Frey saw firsthand the effects that CBD oil was having on his patients. But, rather than just believing the hype at face value, Dr. Frey used his training to seek out research on the topic. Specializing in Internal Medicine in Canton, Ohio. Dr. Frey received his medical degree from Northeast Ohio Medical University and completed his residency at the Mayo Clinic.
Today CBD oil sits at a crossroads, debated by politicians and pundits alike as either a miracle cure or another drug to be banned, with hardly any room for a grey area in between. The truth, however, as with most things, is a bit more complicated than the headlines would have one believe. As pharmaceutical company GW Pharmaceuticals, plc (NASDAQ:GWPH) is hailed for its so-called medical breakthrough for the cannabidiol-based drug Epidiolex, the DEA fights to keep CDB as a Schedule I narcotic. Lost in the fray is a weary public looking for honest answers.
Dr. Frey, hoping to bring sensibility to the debate over CBD oil, recently joined up with The CBDistillery, a company “founded by a group of Colorado natives with a strong belief that people have a right to the highest quality, fairly priced hemp derived CBD.” We sat down with Dr. Frey recently to discuss the science behind CBD, some of the more interesting breakthroughs that have occurred with the extract, as well as his thoughts on the future of the industry.
Before we begin, I’d like to ask you about your background and how you came to be an advocate for cannabidiol or CBD. Specifically, can you discuss the attitudes you faced towards cannabis-based therapies in medical school and how your own views transformed over the years?
Well, I’d say, back in med school and residency, whenever someone would say the phrase “Medical Marijuana,” it was just kind of laughed at. They were saying that there’s no utility to it, that patients are taking it just to get high. Even if it’s CBD, their using it and abusing it somehow, for illicit purposes.
My experience changed after I opened my first practice. I was down in Columbus, Ohio, and I had a lot of patients from a lot of different backgrounds —this was around 2014, 2015. They had these chronic debilitating diseases like neuropathy from diabetes, but mostly chronic pain issues. Then, I’d see them for their monthly appointments. I’d try them on this medicine, that medicine, and would come to find that they stopped taking what I gave them and they tried something else, and it worked for them. It turns out, in this particular instance, it was either straight up marijuana or they were taking CBD extracts.
I remember the first time I heard it, I was like, “Okay, yeah. Sure, I’m sure it’s helping you,” and kind of rolled my eyes. Then, after I kept hearing it, and I’d say maybe after I had about 10-15 patients who would tell me this, I thought, “well, maybe there’s something to it.” And the more research I’ve done on it, I could see how it could have a lot of plausible mechanisms of actually doing something medicinal.
And now you work with The CBDistillery a supplier of CBD products with a hand in research and education as well. How did that come about and what exactly does your role with them entail?
When I started researching CBD I was like, “Okay, so these people are just buying it online.” I thought that was interesting because I didn’t know that the Farm Bill in 2014 allowed people to actually manufacture and ship it. So I ran across them, not just from stories of patients, but primarily because there’s a lot of good reviews out there. I think one of the trickier things is that not all companies out there on the web are necessarily equal, in terms of quality, right?
So I was seeing articles and lab report data that their product is relatively pure. Not only that, but they actually have a good price. So I thought that because they were priced well below a lot of their competitors. I was like, “This is too good to be true.” Anyways, it seems like they had their hearts in the right place. They were actually trying to give people who maybe could benefit from CBD essentially at a decent price, and I thought that was kind of good of them, so I ended up contacting them. I was like, “Hey, you know, I think that this could have a lot of benefits for people. Do you guys need any help with anything?” They said, “Well, sure,” so my current role is basically, and we’re still kind of working with the details, but it’s basically as a medical advisor or kind of a scientific analyst. I haven’t really had any specific role in anything else but education. So my main role for me, kind of rolling this out, is to be up-to-date with the scientific literature and to just kind of distill that down into something that the average person can digest and understand.
We just put an article on the website, and I think it’s pretty easy to understand compared to the more technical documents. But I think a lot of the education’s out there, and a lot of people who are taking this don’t really know how it works. So, for my medical training and background, if I recommend a medicine to somebody, I want to know how it works and what the potential side effects are going to be and that’s kind of what I do here. But, aside from that, it’s just basically trying to get the message out and hopefully get rid of the stigma.
So let’s start with the Endocannabinoid system; if you could break it down into layman’s terms for our readers I think that would be really helpful. Exactly what is it, and what does it do?
I don’t know how many years it’s been since they kind of figured out a lot of it, but there’s still a lot left to discover. It’s basically just a collection of receptors in certain neurons and other tissues that respond to a certain chemical in the body or transmitter, neurotransmitter or something, is the best way to look at it.
The Endocannabinoid system, as it turns out, tends to impact a lot of different functions in the brain. It turns out, there are two main cannabinoids that your body produces, and these are called endocannabinoids. Endo just means ‘from within your body,’ so it’s naturally produced, endocannabinoids. The big one here is anandamide and the other one is called 2-arachidonoylglycerol, which is abbreviated for simplicity, 2-AG. So, anandamide and 2-AG, and they work on some cannabinoid receptors called CB1 and CB2. These are found all over in synapses within the brain, and that’s basically where two nerves come together and transmit information, and modify signals from a lot of different parts of the brain.
It’s really complicated, and they’re still kind of working all this out as far as the basic science. But it also turns out that plants can make chemicals that mimic our body’s own cannabinoids, and that is most notably THC which acts directly on these receptors. But THC isn’t the only one, of course, CBD also impacts this system as well, although not as directly as THC would. This is where it gets interesting.
Let’s talk about the science behind CBD because there are so many claims out there about what it can do and what it can’t do -- For the benefit of our readers can you discuss exactly how CBD works and what are its main benefits? More succinctly, can you help us separate fact from fiction?
So THC, like I said before, acts directly on the cannabinoid receptors. So it’s going to cause an effect that mimics what the body’s own receptors can do, only it tends to magnify those effects more so than your body can. Well, CBD works in a more indirect method. So, it actually doesn’t act too big on the pain response in your body. So if you take CBD, its effects aren’t really mediated directly through CBD’s interaction through the cannabinoid receptors. Now how it does work is really cool. What it does is it prevents the uptake and recycling of your endogenous cannabinoids, mainly anandamide. Which, if it can’t … and the body has to take these neurotransmitters up, and keep them up at a kind of near-constant level so they’re not being overproduced or overexerting their effects at any given point. So there’s always a constant balance between production, secretion, uptake, and trying to keep a nice, balanced chemical in between these synapses.
Well, what CBD does, is it prevents anandamide from being taken up, so it just basically increases the amount of your natural anandamide levels between these two nerves, kind of augmenting those effects of your natural cannabinoids themselves. So that’s really cool.
But you’re absolutely right in saying that there is a lot of fiction out there too, and there’s a lot of hype. I’ve seen some articles saying that “Gosh, if you take CBD your cancer is going to go away,” and I think that’s irresponsible to say. Because, number one, I hate to have somebody take that and not take their other drugs that are actually proven to do something. Before we make or give any type of claims, you really have to have a nice randomized control trial to back that up. No drug out there, no compound out there is a miracle drug. I don’t think I’ve seen any compound hyped as much as CBD but, as with anything, there’s usually a little grain of truth to these claims or these rumors.
I know the FDA is very specific about what can and cannot be said about CBD products and what they can do. Are you able to discuss that a bit and give us some of your thoughts on their position?
It’s still a kind of gray area. For instance, in Ohio we’re just getting our project started, you know, 2018, September of this year is when we at Physicians Care recommend it to patients if we think that they have certain criteria of symptoms. Well, basically, by our state medical board, you can’t prescribe it, you can only recommend it, and you can recommend it under these certain conditions. They’re basically implying that there are benefits, which the FDA does not necessarily agree with. But I certainly agree with the FDA in some respects, in that they’re designed to help protect consumers from harm and make sure the medications people take will help them, at least, in some way and they’re not being bamboozled.
So I respect them in that point because there are people out there who may not make a pure product, it might be tainted with certain chemical extracts or solvents that you just don’t know about, right, or maybe there’s a product you think you’re buying. So it definitely is more in being able to test, and support and protect the public, that’s great, they do a great job as far as on the other medical criteria with other drugs for the most part. But, I think that, as far as their position that public opinion is swaying, a lot of people are trying to get some more research done. There’s something here that says, you know, “We’ve got to really pay attention to it.”
But we’re in this gray area. It’s state versus federal law, and it’s uncomfortable for patients who are using the stuff. I think the ones at the most risk are the patients because they’re the ones benefitting. I really think Congress needs to kind of clear this up because you can’t have states doing one thing and the federal government doing another for too much longer. At some point, something’s going to have to change and I just don’t think living in this gray area is good for anybody.
That’s a great point, I hear that over and over the more and more people I talk to. It just is this gray area, this house divided kind of thing is just not going to work for too much longer.
Yes, and how can I, as a physician —let’s say we get the certificate in Ohio to recommend medicinal cannabis products, whether it’s pure CBD or whatever else. How can I do that in my state, but then, knowing that this could potentially violate…if a patient has that, they can get in trouble under federal statutes. It just blows my mind, I don’t like it.
I can only imagine how uncomfortable it makes you feel. Especially knowing that the federal government could change their mind and start knocking down doors any time they feel like it.
Exactly. You just don’t know what’s going to happen. But fortunately, it’s kind of a state’s rights issue, and most states are more sensible than Congress at this point. Every couple months, you find this state is getting more liberal with their marijuana laws, and I think that’s also good. Of course, you have Canada to the north being a little more aggressive with their law changes, so I think it’s going to trickle down, it’s just slow, really slow.
I’m also interested in the recent news of Pharmaceutical company GW Pharmaceuticals and their patent awards for their drug Epidiolex -- Now that the first pharmaceutical-based versions of CBD are right around the corner what do you think this means for the CBD industry at-large? Is this a game-changer, so to speak, or will it not have as big an impact as it appears it may on paper?
That’s a good question. I think it’s great that this company has been allowed to do research as far as CBD being an investigational drug. But to my understanding, I think their extract is just pure CBD without any alterations. So obviously, their research gives credence to CBD as a whole, that it is a medication that does indeed have a role for patients. But here’s what I don’t get about it. And the same thing with Marinol, which is the synthetic THC that was passed years ago through the FDA. I don’t know how that got Schedule III status, and this is going to be Schedule III under the Controlled Substances Act, which allows it to basically be researched and used, and prescribed, etc., but the same exact compound removed from the natural resource, or utilized from the natural source is somehow illegal and has no medicinal benefit when it’s the exact same structure? I don’t get it. It just blows my mind that, if a pharmaceutical company tells the government that it’s the same thing as what patients and physicians have been advocating for years, the same drug, just manufactured and put in a different bottle. Then, all of a sudden, it’s not Schedule I?
And so, I personally see that, especially with all the different medicinal marijuana markets now in all the different states, I kind of feel this is going to be a major flop. Because there are some unanswered questions. How much is this going to cost? How much is it going to cost compared to the more cost-effective pure CBD extracts from other companies that are offered? I just don’t see that, when there are better and cheaper options for patients, why they’d probably spend thousands of dollars on this drug that this pharmaceutical company is making. It just seems odd to me, that this company has been given the green light whereas the natural source is still kind of in the dark. Hopefully, that, if it does get approved and they’ll mark it as schedule 3, if they do it, it would be cheaper and affordable, but that doesn’t seem to be the case with any new pharmaceutical on the market now.
It leaves so many questions up in the air about what’s going to happen with the CBD industry itself.
Yes. And what might end up happening is, and I wasn’t preparing for this part but this is interesting, too. Remember this cholesterol drug that’s called statin?
So, they were first derived from a natural supplement called red yeast rice. So you could go to your store, your GNC or your grocery store, and pick up red yeast rice. The active ingredient of one of the statins called lovastatin is in that supplement, okay? But, they ended up having to remove lovastatin from red yeast rice and, that’s my understanding, there might be some extract that will still have it in, but it’s not nearly as effective as it was for some patients who were taking it, so I’m not sure if that’s been deregulated or not, but what you see is that any option that’s affordable and potentially just as therapeutic is pushed aside for those more expensive and whatnot.
Recently the DEA made headlines when they included cannabidiol in their listings of Schedule I drugs, which, as you know, denotes that it has no medical value whatsoever. The Ninth Circuit in San Francisco just ruled in favor of the DEA, though purely on procedural grounds. From a medical standpoint, how does the DEA’s ruling affect patients across the country?
I just don’t understand how they can schedule that as Schedule I, when it wasn’t initially even part of the Controlled Substance Act, and just kind of make that declaration themselves. Maybe if you get into, as far as the patients themselves, it seems to me that, from what I’ve heard about as far as the DEA, and Sessions, and everybody else involved, they’re not really going after the patients which is great, but a lot of the distributors, especially, I’ve heard stories about Indiana. I think that’s affecting businesses, that’s impacting people who are trying to provide a service to these patients. I really don’t like it one bit, where, it’s just so hypocritical to me that you can have a pharmaceutical grade, being the exact same compound be considered to be a Schedule III when the exact same thing you’re providing in the hemp-based extracts that are cheaper, and they just suddenly have no medicinal value.
Yes, so you have to consider, you have some time with men and women who actually wrote the bill, the Agricultural Act, who said it was not intentional to make CBD legal during this litigation, or during this law that they were trying to pass. I think I don’t remember how many people signed it, but that’s pretty good evidence for the courts to decide what was the initial attempt of the bill, what was the purpose in that regard. So I really think that it’s going to end up going onto the favor of the CBD industry. What I think is even more important, you have the WHO saying that it’s a non-addictive compound that has efficacy. And WHO, last I checked, was a part of the UN which is a part of the United States. So if they can make these decisions and have these claims, why are there so many different layers of outdated policy that really need to be addressed and, unfortunately, there’s just kind of a media circus out there now, and you can’t get anything accomplished through Congress at all. It’s just going to be really slow before anything changes.
Maybe what ultimately is going to end up happening is that you have the pharmaceutical grade as a Schedule III drug, and if CBD becomes more legal from a DEA perspective, well then hemp-based companies might just end up having their products in this crossfire as more of a supplement. I don’t know how that’s going to go, but I think something might happen like that because I don’t think that all the differing hemp manufacturers of CBD are going to necessarily want to go through the same rigorous process of testing and producing the pharmaceutical. That takes a lot of adjustment, a lot of know-how as far as FDA regulations go. So that might ultimately be what ends up happening, is having it go as a nutraceutical route, basically. But, again, that’s just my speculation, I’m not a businessman nor a lawyer, but that’s just kind of what I’m thinking.
Finally, and this is my final question, what do you wish the public understood about cannabidiol right now that they don’t? In other words, what is something that is overlooked in all of the scientific, medical, and even political debate surrounding CBD?
I think this is the biggest thing right now is, if you mention anything cannabis related, you’re automatically put into a category of, “Gosh, you know, this person’s endorsing people getting high for being high’s sake.” Or just kind of abusing this for their own personal gain. I think CBD needs to be taken out of that category. It needs to be looked at as a viable alternative treatment for a lot of different things, and we have a lot of good data to support that it can have a role in, potentially, multiple different pathways and kind of helping relieve suffering which is the whole point of medicine and being a doctor, is to improve patients’ quality of life.
I don’t think there’s any reason to dispute that if these people benefit from it and you’re not taking it but they’re saying it is, I would just take their opinion as just that, you know, it’s their opinion, and see, it’s helping them, you should give it some weight behind it. Because there’s a lot of people out there who claim that this helps, even though they can’t say that legally through an FDA standpoint as far as claims for any particular compound, but as far as basic research goes, I can see the mechanism that supports their personal claims and anecdotal reports, but I think we should be taking it seriously, at face value and not dismissing it as something that’s not important.