Joe: On this episode of the "CBD University Podcast," the next part of our series is looking at an industry-leading study on CBD and liver health that customers from our brands, Hemp Bombs and Nature's Script are participating in. Hear from the company behind the study and how the study is capturing real-world evidence on the effects of CBD. This is the "CBD University Podcast," and it starts right now.

I'm Joe Agostinelli, host of the "CBD University Podcast." If this is the first time that you have tuned in to our podcast, I welcome you to our podcast. If you are a returning listener or viewer, welcome back to our podcast. And a reminder to everybody, you can subscribe to our podcast on your favorite audio podcast platform of choice or for full video episodes, you can catch us on the Global Widget YouTube channel and the YouTube channel of our brands.

We continue our series looking at an industry-leading study which is examining the CBD effects on liver health. Now, if you remember back a few episodes in part one, we discussed how our customers from Hemp Bombs and Nature's Script are involved in the study and how science is driving research and development of CBD products here at Global Widget. In this part, we are joined by the company behind the study, ValidCare. And to tell us more about the study, where it stands, the process, and a lot more information here in part two of our series is the CEO of ValidCare, Patrick McCarthy. Patrick, thanks for taking time out of your day to join us remotely.

Patrick: Hey, happy to be here. Thanks for inviting me.

Joe: And hopefully, maybe someday we'll have you down here in studio. Off-camera before the recording, full transparency, and everything we do, we gave Patrick a virtual tour of our in-house podcast studio with this, another one of our podcasts which you'll notice on our YouTube channel that we are using Zoom to get the full video for. So, we thank you for coming on your first podcast episode. Little bit of background information on ValidCare before we get into the study itself. Why don't you tell our listeners and viewers a little bit about the company?

Patrick: Sure. So, I'm one of the co-founders of ValidCare. We started back in 2014 and we came out of traditional healthcare. My last full-time role was running orthopedics for Cardinal Health Worldwide, and had at a 30 plus-year career from pharmaceuticals to med product, healthcare IT, and med devices. And I have two partners in the business. One who came also out of healthcare on the nutraceutical and infant pediatric products and then some implantables, and the other's a technologist. And so, with that, we were attacking issues in healthcare associated with patients that were not home...I'm sorry, that were at home, not in the office and bad stuff was happening in surgery and/or post-surgery.

And so, we were able to help doctors connect to patients and identify things that otherwise might cause adverse events or readmissions. And around 2017, we met with Mary's Medicinals here in Colorado, where we're based, and they said, "We need use of that platform." And I said, "What are you talking about?" They said, "We've got a product that's a patch that we think is helping people and we need to collect data and we need real science to submit to FDA." And so, that was our first foray over into the what I call the endocannabinoid space to start understanding exactly what the products are and how they interact with the body. But since that time, there's been a lot of interest, of course, with the Farm Bill passing and CBD being reclassified not as a scheduled drug. Still might be a drug, but it's no longer scheduled. The FDA hasn't decided what to call it yet.

And they're reticent to do anything until they have safety data. And so, we supplied them with some data that we had a year ago, and then this past fall, we actually were able to get an audience with the Cannabis Work Group that's headed by Dr. Amy Abernethy, and they laid out for us exactly what they're looking for and what their concerns are. And so, we've done our best to bring industry together against a protocol that meets the FDA's concerns. And so, we can bring that data to them so they can do their job and the industry can move forward. So, probably tied a couple of things together there on you, Joe. Never let an Irishman loose.

Joe: No, awesome. Now, let's talk about the study for those who may not have listened yet to the first part of this series, which is back in episode 35. Why was this study formed? You alluded a little bit to it I think there in the introductory, and what are the objectives of this particular study? And just to note in full transparency, we are not the only CBD brand taking part in this study.

Patrick: Right. Yeah. So, the impetus for the study is FDA is concerned that there could be liver toxicity due to CBD. There's a drug that went through the drug channel that's made...it's called Epidiolex. It's on the market today. And in the clinical trials with that, kids were dosed at very high levels. And they were really sick kids and they also had some other medications on board and they did see some signs of liver toxicity. With CBD being so new to being allowed to be studied because before it was just considered marijuana and you were not allowed to do that research, FDA didn't have any data to counterbalance Epidiolex.

And so, they said, "Hey, we're concerned. This is all we have. This is what we see. There are animal studies, but there's no other human studies out there to either confirm or deny this." And so, a year ago, so let's say in 2019, they asked by end of May or end of June for industry to come forward with any, you know, human data. And nobody had it because it's only been legal for six months. So, you couldn't really collect that data. And so, what we did was met with them toward the end of 2019 and better understood exactly what they're looking for. And they're looking to understand, do liver enzymes go up on a dosage basis or for ongoing use?

They're most concerned with ongoing use of oral products right now. Because they're out in the marketplace, they saw what they saw with Epidiolex. And they just don't have evidence to the contrary. It's not a study about, hey, I'm going to approve this product for Hemp Bombs or for some other company. This is just to see, do we have a population health, public safety issue? That's the very first thing. From there, once we collect data, we should be able to have brands come forward and say, now I want to prove things either as a drug or a supplement, all depending on which way FDA goes. But so, the rationale is to get safety data so that they can determine what the right regulatory path is for CBD.

Joe: And how does this study differ from a clinical trial?

Patrick: Great question. So, it actually is a clinical trial. When we think about clinical trials, we usually think of, hey, I'm going to go to a site or a doctor's office, and someone's going to give me something and someone else is going to get a placebo, right? So, this, while it's clinical, it's observational only. So, by design, we want people that have been using CBD for at least 30 days. So, their livers have already been exposed. This isn't naive or first-time people. We want them to use it for another 30 days. And they're using our app-based platform to give us that information of what they're taking and how much they're taking, and how they feel before and after. And then at the end of the 30 days, they go to a lab, whether it's a Quest or a LabCorp, and they give a blood sample. And from there, we then see where their liver enzymes are.

Now, if you go in a placebo-controlled study, you'd have someone taking, I don't know, an oil or water, or whatever's in the placebo, and you could compare the two. You usually do that when you're looking for efficacy. Here, we're just looking for safety. So, it's very similar, too, for those that have followed the convalescent plasma with COVID. People got convalescent plasma and they kept track of it through Mayo Clinic to look at safety. They noted what the efficacy was, but FDA's not going to say that it is efficacious until they can compare it to a placebo. So, that is not...and that study, it's not in this study. It should be the next study or the next studies. We would expect there should be tons of more research coming out of this based on the data that we collect.

Joe: As I mentioned earlier, customers from both our brands, Hemp Bombs and Nature Script's are a part of this study. Talk a little bit about the selection process, how many people are taking part, and criteria maybe for including or excluding folks who may have been interested.

Patrick: Sure. So, and we're really happy to have both of them on board. We ultimately need 681 participants in order to hit a power score or a p-score, for those of you that are big statisticians, of 80%. So, that means that the data that we collect is 80% reliable. If we can go over 681, it gets more and more reliable. And so, with that, each brand that has signed on, and sponsored, and participated like Hemp Bombs is asked to bring forward 100 participants to complete the study. We have 12 brands engaged right now. So, we have the opportunity for 1200 people, which will be the largest human research project on CBD to date. And we would take that power score and take it well north of 90%, which is great for industry and it's also great for FDA that they know that this data then would be really, really reliable, and they can count on it as they go down a regulatory path.

Joe: And has the study been tweaked at all, you know, given the current health pandemic, especially with the nationwide focus on telehealth and remote health consultation for maybe how it was going to be originally implemented?

Patrick: Very little. So, we'd started believing that this was going to be virtual research. So, we're definitely tip of the spear with that. Doing our virtual care for the past five, six years, we've been out ahead of it. With COVID coming in, had we not planned this, we'd have to do it this way. We're actually been a bit of a luxury that we've already had to think this way. Now, what we did do are two things.

One, we slowed the start date to accommodate so the world can learn, what are we really dealing with with COVID so people aren't leaving their house in danger? Two, we're sending people to a lab as opposed to a doctor's office or having them come in somewhere and we know there aren't other people with COVID in there. So, from a safety perspective, folks that are participating are either in the comfort of their home, or they're going to a lab where they're just getting a blood draw and they get back out. So, that's been really, really good. But we delayed the process by three months to accommodate, so, we knew what we were doing with COVID.

The other thing we did was added an exclusion so anyone that's had COVID would be excluded from the study because we really don't know, from a pathogenicity perspective, what COVID does to the liver or a lot of other parts of the body. For instance, there's a study that was just released that looked at athletes that had COVID and once they recover, they're seeing 15% of them actually have some sort of a coronary issue. So, not knowing what we can't know yet we said, we've got to exclude that population. So, recruitment has become a little bit more difficult. We are looking for healthy adults. And with that, you can't have liver disease, as you might imagine, and you can't be cancer patient. You can't be using marijuana either because then you got competing CBD pluc THC, maybe keep it clear. But COVID then becomes another exclusion and pregnancy and some other things that you might imagine.

Joe: And how long will the study be conducted for? And at the conclusion of the study, where does that data go?

Patrick: That's a great question. So, the study, once someone enrolls, is only 30 days long. It's very short. We started officially on August 7th, and instead of everyone starting at the exact same time by brand and by participant, we've been doing a rolling start with each of the 12 brands. And we're allowing their participants to come in overtime. We expect by the end of September to have all of the consumers in the system and journaling so that by Halloween, everyone can have their blood tests and we can lock down the data. And then from there, we would expect by year-end to be able to give the data back to each of the brands and deliver a final output to FDA.

Now, the study is planned to be peer-reviewed and entered into a journal. And each of the participants will get their own data back so they can understand what their products look like across the populations. And some will also have the opportunity to see aggregate de-identified data across all of the brands. So, and from there, we have the right to resell this data. So, if you look at really large consumer-packaged-goods companies that are standing on the sidelines, they're trying to figure out if they can come in safely. They will want to see is CBD safe? They also want to know who's using this and not who as in, hey, it's you Joe, but who has a 35-year-old male with anxiety? What are the populations that would be served?

So, before they make investments, they first want to know it's safe. They then want to understand what are the markets and the demographics that might be interested, and then see the effects. And so, we have all of that data here that can be really useful for large companies that are standing on the sideline to use in their exploration as they do their business development efforts too.

Joe: And how will reproductive health in male participants be measured in the study?

Patrick: That's a great question. So, we've not been real public about this, but FDA has three concerns. One is the leverage of safety. Two is sleep and drowsiness. And then the third, they've done some studies in adolescent rodents that has shown that reproductive organs have gotten smaller over time. So, we're measuring liver safety. Once a week, the participants are going to be asked about sleep and drowsiness using the Stanford sleep score, which is the standard in healthcare.

And then for male participants, we're asking them to also, as part of their blood sample, to draw free and total testosterone. So we can see, is there anything that we can see from a low T perspective that might be tied back to CBD? It wouldn't be anything definitive, but it might give us a hmm-mm, should we do something about that? Is there something here? Because FDA has seen it rats, so why not measure it in humans and see if anything's there to be concerned with? So, we're really getting a bit of a trifecta out of this as the data all comes clean. And, you know, thankfully, each of the brands has sponsored this so that we can get this really, really meaningful research done.

Joe: And you touched on this a little bit in a previous answer now. So, once this study is published in a peer-reviewed journal, are there any followup steps or studies that may or may not take place, or is this the final part?

Patrick: So, we architected the study on purpose as an umbrella study so we can do one-offs from this data. If folks want to continue and go for another six months, we can do that immediately. If they want to study more on sleep under the same protocol, we can quickly go back to the Institutional Review Board, or you've heard the word IRB, that's the body that governs what we do. We go back with an application and we don't have to do a full application and we can just continue. So, we've architected this study from the get-go that we can add on to it. We don't have anyone yet saying they want to do it, but we're in a position to do that. And we're very, very hopeful that of these 12 brands, folks are gonna start putting more and more resources towards science based on whatever this data shows.

Joe: Awesome. Well, we are happy to be a part of the study, and it's a pleasure being able to talk to you about this today. We would love to have you back as we go along the study and certainly, as things wrap up, but take a look back and see how everything went. So, we'll definitely keep in touch and hopefully have you back on a future episode of the "CBD University Podcast."

Patrick: Well, I look forward to it and thank you so much for your interest and your time. And hopefully, we kept it simple. I know there's some complicated stuff in here, but it's really meaningful and really appreciate the sponsorship by both of your brands. And for those of you that are participating and might be listening, thank you too for participating in this research. It's going to help the industry quite a bit.

Joe: And for more information on this study, you can visit our website at www.globalwidget.com. You can see some of the news and press releases in regards to the study. And I want to, once again, thank Patrick McCarthy, he is the CEO of ValidCare, my guest on this episode of the "CBD University Podcast." And as I mentioned in the intro, if you have not yet done so, I do invite you to subscribe to the "CBD University Podcast," the audio version on your favorite podcast platform of choice or the video version or both. The video version could be found on the Global Widget YouTube channel and the YouTube channel of our brands. Wherever you do subscribe, you'll receive notifications each week when new episodes are published. I'm Joe Agostinelli, the host of the "CBD University Podcast." Thanks for tuning in.

These statements have not been evaluated by the Food and Drug Administration. The CBD products are not intended to treat, cure, or prevent any disease or condition. Always consult your personal physician about CBD and using CBD products. CBD should never be used by anyone under the age of 18. This content is not intended to provide legal advice regarding the legal status of CBD and CBD products.