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Child Abuse: Responsibilities and Protection of the Reporter

 Hello and welcome to Over the Counter, a podcast from 

. In this episode made in partnership with Ananda Professional, we're joined by Dr. Alex Capano, who is Chief Science Officer at Ananda Professional to discuss what CBD is used for in mental health, where research should go next, and how to ensure that patients are getting effective CBD products. What is the role of CBD in mental health?

 The most common reason people use CBD across the board and particularly in mental health is for anxiety, but that's not the only role it has. It's certainly an option for treatment, or an adjunct for treatment, for folks with PTSD. We see that it specifically reduces nightmares associated with PTSD. It can even be used for folks who have social phobia disorders. So not your generalized anxiety disorders, but actually just social phobia. Then we're actually seeing some really interesting work and data come up on things like ADHD, Alzheimer's, and other psychiatric conditions.

 What are some conditions that CBD is commonly used with?

 Most commonly is definitely anxiety. For a number of reasons, it works and also anxiety is quite common, unfortunately. We do have a good amount of data, evaluating CBD’s safety and efficacy in anxiety. So that's the most common reason.

 Are there some conditions where CBD isn't a good fit for use?

 Interestingly, I don't think that CBD is great for major depressive disorder, where anxiety is not a component of it. If there's a depressive issue and anxiety is a component, which often happens, CBD can certainly help with anxiety. But the Depression itself, I'm really not compelled by the data. I actually think that there are other plant-based medicines or options, and even psychedelics, that are much more promising in treating depression versus CBD. It's not that it's dangerous. I just don't see the efficacy as compelling as other options. It's really not going to replace an SSRI for many people, unless they're using that only for anxiety, which is atypical.

CBD is not a problem in this case, I want to be clear about that, but some CBD products do have low levels of THC in them. I think it's important to mention that THC should not be used, without really good reason and weighing the pros and cons, in anyone whose frontal lobe is not fully developed, because it can slow the maturation of the frontal lobe, so really between 21 and 25. Then you're not going to do anything to your frontal lobe because it is what it is. So, I caution THC use in younger patients. Also if anyone has a predisposition, a family history, or even a personal history of psychosis, schizophrenia, or bipolar disorder, THC can actually aggravate that and increase the likelihood of that recurring or sort of turning that switch on with the predisposition. So again, CBD is not a concern for that. It does not work in the brain in the same way, but if you are in that camp, you certainly want to get a CBD product that does not have THC on it.

So as you mentioned, a lot of people use CBD for anxiety. What's known about why it's so efficacious in helping alleviate anxiety?

 Well, if we look at studies, there's a handful, and more coming out, of studies that look primarily at anxiety and overall they see an improvement in anxiety, both in the acute phase, in social phobia, for example, but also long term, after a month or a couple months of use, or even just a couple of weeks. We also see a lot of studies where anxiety may not be the primary outcome they're measuring, maybe that's pain or sleep or something else, but they're measuring anxiety as well. And then we see that secondary outcome where anxiety has a statistically significant improvement. There's really dozens of studies that measure anxiety as a secondary outcome. If you're asking how it works, the truth is, I don't think we fully understand all of the mechanisms of CBD yet. I know we don't. And I don't know if we really ever will in my lifetime. 

Two ways it helps with anxiety that we do know are it activates and increases the activity of the 5-HT1A serotonin receptor, which is associated with anxiety, also with nausea. So that's one of the ways and then another way it improves anxiety is by increasing one of our endogenous cannabinoids, so ones that we make in our brain on our own. It's a neurotransmitter known as anandamide. And the anandamide is actually named after the word ‘ananda’ in Sanskrit and many languages, which means bliss, because this neurotransmitter makes us feel really good. It's associated with improved mood and a decrease in anxiety responses. We don't make a whole lot of it and then our body sorts of eats it up really quickly, and it goes away. So CBD, that enzyme that eats up anandamide, it basically inhibits it. So by inhibiting the enzyme that eats up anandamide, it prolongs its half-life, and just gives you more of your bliss neurotransmitter, in your body circulating, giving you that blissful feeling. Those are the mechanisms that I feel very confident about. I'm sure we will discover more over time.

 How can pharmacists ensure that customers are safely using CBD products?

Well, picking a transparent, quality-assured CBD products. So you know they are using what you want them to use, that it's CBD, and that's the right dose of CBD. That there's not any contaminants or really high doses of THC in there that should not be in hemp products, because it wouldn't be legal, and it could actually exacerbate a lot of different psychiatric conditions. Once you've done due diligence to put a good product in your store, and recommend it, really guiding patients on dosing. Start low, go slow. I feel like I say that all the time and it is industry standard, but it's really best practice. You want to see how you respond to this. I recommend that folks try it at night, at home, a couple hours before bed the first time just to see: are they really sensitive? do they get drowsy from it? Because if that's the case, then they don't want to take it in the morning on their drive to work. So timing of dosing, slowly titrating up to really find that sweet spot because this is a bell-shaped dose response curve. More is not always better. This is truly personalized medicine. Although the therapeutic range is not that large. So it doesn't really take a long time to titrate to that optimal dose. 

And then consider other medications that people are on. CBD is metabolized through CYP450 enzymes. So are over 50% of medications that are prescription and nonprescription. People often worry about drug interactions. I understand that. The reality is drug interactions with CBD don't occur, so far that anything that we've seen in the data, until very, very high doses. Super therapeutic doses that don't really reflect real-world use, outside of controlling severe pediatric seizures and even then they're pretty benign. Evaluate the other medications, talk to the patients about possible signs of an interaction, but have confidence that the doses almost everyone is taking for an over-the-counter product are 10 to 100 times below what we see as a dose that actually causes any meaningful interaction with other medications that are metabolized through CYP450.

The one medication that's always a problem is blood thinners. If you have someone on blood thinners and they're using CBD, again, it's fine. You still have that really nice wiggle room, It does seem that it's the one class that there's a lower threshold for the interaction, but that threshold is seen at 10 milligrams per kilogram of body weight, for that patient. I don't know anyone who's taking 10 milligrams per kilogram of CBD, that's really, really high. Again have that reassurance, but tell them ‘this isn't the week or the 2 weeks, to not check your INR, your PT, however, you're measuring the efficacy of your blood thinner.’ If you see a change, come back and dose adjust. It doesn't mean it's a contraindication. You just want to watch it and adjust as necessary. You may need to decrease blood thinners over time.

 What questions about using CBD in mental health care do you think should be a research priority?

 I had 2 really fascinating things come to mind for me. One is I think that we should start looking at, and we are starting to starting to, CBD as prevention. Not just treatment, but actually preventative medicine for neurodegenerative diseases like Alzheimer's and other dementia forms. There's some pretty convincing evidence out there in animals and many researchers are looking at it in humans right now. Can this actually, not just treat the symptoms associated with Alzheimer's dementia, but can it actually prevent or slow the process in the first place? I think that is really important. Alzheimer's is on the rise globally. We want to live well and live well longer. It's not just about lifespan, because we're living longer than ever. It's really about healthspan. Someone said that to me recently and I thought that was a great way to put it. I think preventative medicine to keep our brains as healthy as our bodies. 

Then also, similar to neurodegenerative disorders is postconcussion syndrome or chronic traumatic encephalopathy (CTE). This is really common. Even high school athletes playing football, playing soccer, they get these repeated concussions, even if they're minor concussions. One study showed that 99 out of 100 football players, not even all professional, had signs in their brain of CTE or postconcussion syndrome. There's also data that having CBD onboard, reduces the negative impacts of those injuries, both acutely and chronically. I think that this is something that's really scary. We're seeing and hearing more and more about it. I think, looking at prevention, if somebody is an athlete or is at risk of repeated head injury or impact, that they are using something to preserve the health of their brain long term.

 And what has research uncovered about CBD in the mental health care space that you found surprising?

 I think the research in pediatric psych has surprised me. I hope it continues to be a priority for the folks who have started looking at this. There are research groups and institutions evaluating CBD as an option for people, primarily children, with ADHD and seeing that it's much better tolerated and actually effective, or at least as effective as many of the stimulants that are commonly used. They're finding the same outcomes in autism spectrum disorder. ADHD, autism spectrum disorder, you could argue, it's sort of the same spectrum. I've been surprised, and pleasantly surprised, at the promising outcomes in the data, using CBD in the pediatric population for those very common disorders. I'm pleasantly surprised. I hope to see even more of it, but I think in pediatrics, we need better options that are going to keep our kids feeling like themselves and able to thrive. I think we're going to see that CBD is a viable therapeutic alternative here.

: And as always, thank you for listening, and we hope to see you next time, at the counter.

Drug Topics® is joined by Dr. Alex Capano, Chief Science Officer at Ananda Professional to discuss what CBD is used for mental health, where research should go next, and how to ensure that patients are getting effective CBD products. 

Mental Health and CBD: What's the Latest Info

®: Hello and welcome to Over the Counter, a podcast from 

®. In this episode, made in partnership with Ananda Professional, we're joined by Dr. Alex Capano, who is Chief Science Officer at Ananda Professional to discuss what CBD is used for in dermatology; interesting research findings about CBD and dermatology; and how to ensure that patients are getting effective counseling and CBD products, even when they don't visit the pharmacist’s counter. 

What are some conditions that CBD is commonly used for in dermatology?

: It's commonly used for moisturizing skin, antiaging, anti-acne. and reducing inflammation, that's what I see day to day. And it makes sense to me, there was a study done in 2019, evaluating what benefits consumers saw in CBD products and it reflected pretty much what I just said. Number one was moisturizing, then there was a little bit about pain relief too, which does make sense, but it's just not something we typically think of when we talk about dermatology. Then it was about reducing inflammation, antiaging, and improving acne from there.

®: What are the signs that a product has an efficacious level of CBD?

: Well, this is really about working with a company that has transparency and quality assurance, again. You want to make sure that they're actually putting the concentration of CBD on the label and that concentration in the industry is typically for what's in the entire product. In an ideal world and an ideal product, they also have what the level per serving or application is, so it's really, really clear. ‘Okay, this is a bottle with 1000 milligrams and for every mL, I'm going to have 20 milligrams of CBD.’ So people understand what they're using, what they're taking, and exactly what's in it. Because you can have this really, really high-volume product and it may have a lot of cannabinoids in it, but how much do you actually have to use to get something that's meaningful. So really look at the concentration of the product, and that should be transparent, very easy to understand.

For example, I was asked a couple of years ago to comment on an article that a beauty reviewer was writing for a CBD shampoo and look, CBD is not going to harm you in a shampoo, it's just not going to do anything. I said ‘ well, how much is in there?’ and she said ‘I don't know’. I said ‘well, you have to ask the company how many milligrams of CBD is in this?’ And she said ‘1%’ and I said ‘1% of what?’ She said they refuse to answer. That's a red flag and you products like that do exist. She did like the shampoo, by the way. She said it smelled really good. So wasn't going to hurt her, but they didn't even know how much CBD was in there. So you're certainly not going to have an efficacious level if that's who's manufacturing the product.

®: What forms of CBD are going to be most useful for treating dermatologic conditions?

: Well, it depends on what your condition is. But we're talking topical CBD for dermatology, topical CBD at this point in history is not going to get into the bloodstream. This is topical. This is not transdermal. The rate limiting factor is the aqueous layer of the dermis, but it does actually interact with a lot of our different cells on our skin. So again, depending on the condition that you're trying to treat, you want to topical but you know what else is in that topical. If it's acne, you're trying to treat, you want something that's noncomedogenic. If you're treating something like psoriasis or eczema that's on a larger area of the body, you probably want something that's a bit easier to apply to a larger area and also has an emollient in it as well. If you're trying to treat dry skin on the face, you want to look at the other ingredients and delivery of that topical to see ‘do these also make sense?’ because it's not that you're applying only CBD to your skin, right? It's about the total formulation and what's in it to make sure that you're going to get the desired outcome and not negate it with the other ingredients in there.

®: What is known about how CBD helps dermatologic concerns?

s] bacteria, for example. I sent our extract to a third-party lab in Silicon Valley a few years ago and had them test a lot of different pathogens, one of them being 

 by log five, so 99.999% elimination. Then I asked them to do a serial passage study, which looks at the opportunity for the bacteria to mutate and then resist whatever's killing it and they found that there was no resistance. So this is a really nice thing to actually kill that bug and not worry about causing resistance, which we see with things like doxycycline and clindamycin.

In addition to that, we know that CBD increases the proliferation of skin cells. It helps with that turnover, which reduces the development of things like fine lines and it promotes apoptosis of unhealthy, damaged, or infected cells and we want that too. It reduces excess sebum production from sebaceous glands. This is something that not only can help with that desired antiaging effect and it's not going to dry the skin out like a benzoyl peroxide, but if there's an excess production of oil, or if there's 

 bacteria that can cause blemishes, it's going to reduce that production.

It's an excellent anti-inflammatory agent and antioxidant as well. A recent study out of Basel, Switzerland was published in 

 this year, found that CBD actually protects against UVA- and UVB-induced inflammation, and improves photo-aging, far better than vitamin C. That was really surprising to me, because vitamin C is sort of a champion skincare product right now, but CBD is superior to it in this study. It is shown to actually inhibit the free radical formation intracellularly and it was 1800-fold more potent than ascorbic acid or vitamin C. This is an antioxidant, anti-inflammatory, it's going to reduce those free radicals and really helped balance the skin.

Lastly, there's so much we know actually about CBD on the skin. I talked about 

 [Streptococcus] that colonizes on our skin and don't really cause an issue unless they get into a wound, rhat's a big problem and it's already resisting a lot of our typical treatments. I think we're going to see CBD as an option for wound healing over time, because it actually does improve healing and kill some of those bugs that can really cause infections in wounds, as well.

®: What questions about CBD and dermatologic care should be a research priority?

: Wound healing! I do see a lot of evidence. I don't see a lot of application yet. I think we need more research on CBD and wound healing, specifically to decrease the development of resistant superbugs. There's also an opportunity for more research in skin malignancies. What exists right now in skin cancer eruptions or eruptions of malignancies that are not necessarily dermatological but have a dermatological component, most of the evidence is promising, but there's some evidence that shows a negative impact. So, I think we really need to know: is it helpful; is it benign or does it hurt; and how do we define those buckets to understand where it's a therapeutic opportunity; If it's a therapeutic opportunity; or if it's something that's really a contraindication. I think we need more research there.

®: What research uncovered about CBD and dermatologic care that you consider to be surprising?

: Oh, hair growth! Several years ago, I gave a lecture and a pharmacist came up to me afterwards and he said ‘I really like your products, and I've been using them and my alopecia, male pattern baldness improved, my hair grew back.’ And I said ‘oh, I'm so happy for you. I don't think it was the CBD. I think it's unrelated, but you know, congratulations.’ Then I started to really look into it and more data came out and then we actually did our own study. It does, in fact, improve hair growth and fullness. It's really tricky, because it's dose dependent. If you use too much, topically on the scalp, it can potentially reduce hair growth. You have to make sure that you're working with people who understand how to dose it and exactly tell you how to use it. But it can, in fact, improve hair growth and thickness and fullness. So, I owe an apology to that fellow who gave me that idea and I said ‘it's not the CBD’ because it probably actually was.

®: How can pharmacies ensure that patients have the chance to get counseling for CBD dermatology products, especially when many can often be found in sections of pharmacies that are far away from the pharmacy counter?

: Well, I say this of all CBD products, certainly for dermatology, you have to make it a priority to make sure your whole team, not just the pharmacists, that the whole team understands what they're selling, what's on their shelves. Educating everyone, whether they're working as the cashier or they're in the pharmacy. Everyone in your store, I think really needs to be educated on what this is, so they can answer questions, they can make recommendations. Beyond that be thoughtful about merchandising, and really creating an experience for the shopper. Even having things like pamphlets or handouts that are right there that describe: what this is, why you use it, and gets people interested at the shelf, I think is really helpful. Then hopefully they can have that conversation, even if it's not at the pharmacy, but someone working in the pharmacy, that's why everyone should be educated on what these are and why people use them. 

It sounds like a lot, a lot of work, right? And everyone's really busy. It goes back to finding a brand that is going to help you achieve that and make it easy and not time consuming and not pull from your resources, and really just add to them. For example, I know, Ananda Professional, they have a whole suite of digital papers, live education opportunities that people can do on their own time. They can do them in little bite sized pieces. They can go and get a little refresher and be that champion in the store. Hopefully, everyone can do that. It's not time consuming. It's made for different levels of expertise or scientific rigor. So again, someone does not have to be a pharmacist to understand this. Companies like Ananda Professional will make those merchandising suggestions for you. They'll help you to execute it and give you those point-of-sale tools that you can have, where the patient can pick it up and it piques their interest without you having to have that interaction. There's a lot of different ways to do it. I think the investment pays off. And if you find a company who's really going to work with you to do that, then it just it takes the job away from you, so you can focus on everything else in the pharmacy.

®: And as always, thank you for listening and we hope to see you next time at the counter.

Drug Topics® is joined by Dr. Alex Capano, Chief Science Officer at Ananda Professional to discuss what CBD is used for in dermatology.

What CBD Brings to the Table for Dermatologic Concerns

Hello! I’m Gab Ientile, and this is Over the Counter, the podcast from Drug Topics®.

Welcome to the first episode of our latest Cannabis Series, focusing on the burgeoning medical marijuana landscape and featuring experts devoted to fostering research on the diverse benefits of cannabis as medicine. 

Definitive data on cannabis, the compounds found in cannabis, and their effects on the endocannabinoid system, is currently a bit of a lunar landscape. Recently though, the FDA has expressed its commitment to supporting medical cannabis and cannabis-compound research.

Cannabis, the plant, contains more than 80 biologically active chemical compounds, called cannabinoids. Two of the most popular cannabinoids are CBD and THC.

While there is a multitude of products currently on the market touting CBD as an ingredient and the benefits it can bring, these products - including oil drops, capsules, syrups, food products such as chocolate bars and tea, cosmetics, topical lotions and creams, have not been evaluated by the FDA for safety and efficacy. There’s only 1 prescription drug containing CBD that has been approved. It treats 2 rare and severe pediatric epilepsy disorders.

In 2018, Congress passed the Farm Bill, which differentiated hemp from other cannabis plants, all of which had been illegal under the Controlled Substances Act. With the passing of the Farm Bill, hemp could be cultivated, with the necessary licenses, if it contained no more than .3% of THC.

 My name is Jeff Lombardo. I'm a research assistant professor at the University of Buffalo center for integrated global biomedical sciences here in Buffalo, New York. One of the things that we have done at the university is developed a cannabinoid research program, looking at preclinical and clinical models and cannabinoids for various indications.

Dr. Lombardo is encouraged by the FDA’s pledge to facilitate clinical research on cannabis.

On July 21, 2020, the FDA released a draft guidance for cannabis-related clinical research in response to considerable interest by stakeholders in developing drugs containing cannabis and cannabis compounds. The guidance document provides industry stakeholders with practical recommendations regarding cannabis sources for research, quality consideration, and calculating THC levels in prospective drug products.

 There's promise for these agents for certain indications: for pain, for multiple sclerosis, cachexia, there are therapeutic benefits, which I think are real. I'm an oncology pharmacist by training. We have natural products that we use. I remember back in the 90s when Paclitaxel was first being investigated, and that came from a natural product like alkaloids. So for me it's not much of a far-fetch that natural products, botanicals, plant-based medications, can be therapeutically beneficial, they just need to go through the same process.

So I think what this document is and it's focused more on, I would say, the application process, standards, policy procedure, manufacturing, what you need to validate your compound and follow the guidelines.

I think the second part, which really isn’t reflected in this document, is the clinical portion. That to me, I think is the easy part. Because if there is a reschedule, or if there is an academic institution that traditionally have run the clinical trials, and if it doesn't jeopardize maybe some other NIH funding or federal grants, they really have the expertise to run the clinical aspect of the trials.

And I think this is really directed to sponsors and manufacturers if they have a vertical seed to sale type of product and production – it gives them a guidance. You know, I think over the past couple years, many, many, many companies have moved into the CBD space. There's a wide variation of standards, quality controls and ultimately finished products that are marketed. And I think documents like this and a roadmap and really a guidance document will separate those in the marketplace that are legitimate and can hold up to eventually go into the next step if they choose to do so.

Dr. Lombardo is one of the principal investigators on a study that began on July 27, 2020, which was designed with significant input from the FDA. Several leading CBD brands - Boulder Botanical & Bioscience labs, CBDistillery, CBD American Shaman, Charlotte’s Web, Columbia Care, HempFusion, and Kannaway – are participating in an industry-wide study measuring the effects that full spectrum hemp derived CBD and CBD isolates have on the liver.

This study is looking at liver toxicity with hemp-based products that are in the marketplace. I guess the genesis of this research activity came off of a really an advisory letter that came out from Dr. Abernathy from the FDA. Looking at potential liver toxicities with some CBD containing products.

A company called Valid Care, which is acting as a data aggregator and a CRO, solicited manufacturers and sponsors in the marketplace that have full spectrum hemp extracts.

One of the concerns with using some of these products and has been seen in the data with the Epidiolex FDA submission and prescription medication is at high doses, there could be a chance of liver toxicity. They were concerned from a safety aspect, the FDA, that these products, whether they're sold as nutraceuticals or as dietary supplements, that are in the marketplace and what are the effects in consumers?

We are launching the study today, so the timing is very good. We have 10 companies that have stepped up and are going to use their products for testing. The kind of the design of the study is, part of the inclusion criteria and for enrollment, is for patients to be on a hemp-based product for at least 30 days. They will be enrolled in this study and continue on the product for another 30 days. At the end of a minimum of 60 days of taking products, we will do a CMP metabolic panel and we'll look at liver function tests to see if there is an elevation in liver enzymes. We'll be looking at other biomarkers in that study, and that is being done.

The PIs are Dr. Keith Aqua, a physician, and myself running that study. And then we have our statistician and Dr. Robert Kaufman, who is our medical director, overseeing the protocol and also part of this study.

The interesting thing is that the 10 companies will be helping with enrollment, and during the 30 day period, when they're on, we'll be getting complete medical records, we'll be getting a complete medication profile, we'll be getting a utilization of products. So some of these patients, I would say that they're going to be on it for maybe 6 months, maybe even longer. And I think what we're going to get out of this is real-world evidence of what may be occurring in individuals that are taking the product for a short period of time 30 to 60 days, and individuals that may be taking the products for years. It'll be very interesting to see, and we should have some data and results that we can look at and eventually publish I would say by the end of the year.

Dr. Lombardo also explained that there’s a lot of variety in the availability of medical cannabis products state-by-state.

 I can speak specifically for the cannabis products in New York State. We have a medical marijuana program for various indications in New York state that allows a patient to go to dispensary and pick up a product.

The companies, there are 10 New York State, it's a seed to sale program where they grow, process and sell all within the organization. There's an independent third-party lab in Albany that any product that is sold in the marketplace needs to go there for testing to get a certificate of analysis. They look at pesticides, they look at fungal growth and really quality control standards. And what's actually in the bottle is on the label.

They sell the products, which they call a 1-to-1 THC to CBD ratio, so equal amounts of THC and CBD. They may have a high to low ratio or a low to high meaning you have high THC, low CBD or high CBD, low THC.

Patients come in with a recommendation from the physician and the physician could give an open recommendation as far as what dosage form a patient can be given or leave it up to the pharmacist to choose. The single dose that a patient can receive in New York State at 1 time as a maximum of 10 milligrams of THC and then the frequency whether you take it 2 or 3 or four 4 a day is usually predicated on the pharmacokinetics or the product.

In NY state there are vapors, vaporizers, you have tinctures or oils, or you have capsules or some tablets. Other states are different as far as what they can offer. Some states have combination of edibles, dry flour along with some of the products I just explained or said that we have in New York State.

There's a lot of variation a lot of fluctuation, and other states might not have a pharmacist at the dispensary looking at what are the medications are you on and recommendations and how to follow up with patients. So it's a little bit of the Wild West. But I can tell you, once again, I work with oncology patients that patients do get relief.

And I think what's really important is that dispensary pharmacy, number 1, provide education to the patient. And number 2 is provide some type of feedback mechanism to the prescriber that connects the dispensary to the patient to the physician. Once again, there's a lot of emphasis about choosing a product, you know, making that initial sale, but that's really only the first part of the equation. The second part is you need a plan in place, how to reach out to the patient when they start therapy in a week, 2 weeks, 2 months, whatever that may be, to see number 1, that it's safe, there's no adverse offense. Number 2, if they're going to be taking the medication, what's the optimal dose, because a lot of times they're taking this in conjunction with conventional pharmaceuticals for various indications.

Here are the main takeaways from this episode:

There are a lot of CBD and hemp products on the market, but they are not FDA approved, due to the fact that there’s still a lot to learn about the safety and efficacy of cannabis and cannabis-derived compounds.

The FDA is encouraging cannabis and cannabis compound clinical research, most recently with their release on draft guidelines made to offer recommendations on sources for research, quality consideration, and calculating THC levels in prospective drug products.

The FDA provided significant input in the design of the observational study that Dr. Lombardo is currently working on, which aims to provide the agency with research that will help develop the appropriate regulatory pathways for hemp derived CBD products.

If you enjoyed this episode, make sure to subscribe where you listen to podcasts. And check out DrugTopics.com for more content on CBD and medical cannabis, as well as the latest news on the most pressing pharmacy issues.

Thanks for listening, and we hope to see you next time at the counter.

Our first episode of our latest Cannabis Series is focused on the burgeoning medical marijuana landscape, featuring FDA's guidelines and research on the diverse benefits of cannabis as medicine.  

Episode 7: Cannabis Series: FDA Support, Research in the Works

The companies are marketing products that may violate Federal Trade Commission prohibition of “unfair and deceptive acts in the marketplace.”

FDA, FTC Issue Warnings to Companies Selling Copycat Food Products Containing Delta-8 THC

Researchers addressed the use of cannabis to treat cancer symptoms in rural and urban areas, as well as patients’ comfortability discussing it with their providers.

Cannabis to Treat Cancer: Younger Populations Reluctant to Disclose as Overall Use Becomes More Accepted

The ABCs of CBD: Cannabinoids in Dermatology and Skin Care

Inaccurate Labeling of Melatonin Gummies Cause for Concern for Pediatric Consumption

It's important to know the difference between CBD and THC. 

John J. Miller, MD, shares why it is important to differentiate between CBD and THC when discussing cannabis at the 2022 Annual Psychiatric Times™ World CME Conference.

 I'd like to spend a little bit of time talking about a topic that we hear all around the country, and that is cannabis. It's an area that [although] technically legally, it's still a Schedule 1 drug, which means it's illegal [on the federal level] throughout the United States. But throughout the 50 states, there's a wide range of state laws that have either legalized it for medical purposes or legalized it recreationally—or both—and in some states it’s still totally illegal.

When you look at the medical and psychiatric literature, there is a large amount of data about cannabis; there are studies looking at the psychiatric perspective, the neurocognitive perspective, medical issues, pain, sleep, et cetera. In my opinion, one of the biggest flaws with all of this literature is [researchers] continue to use the term “cannabis” as if that's a single item or a single molecule. And in fact, we know that the original cannabis that was being used in the 1960s—from plants, where it all began—only had about 2% THC [tetrahydrocannabinol] in it, as well as 2% of CBD [cannabidiol]. CBD is used commonly; you can purchase it [and] it is not illegal anymore, it’s an unscheduled drug. Whereas THC is still a Schedule 1 drug, and although in many states it's legal, federally it’s not.

When you look at the cannabis leaf, there are about 100 different molecules that are called cannabinoids. The 2 most common are THC and CBD. What's interesting is that the physiological effects of THC and CBD are kind of oppositional, but they’re used interchangeably. We know that CBD is actually FDA approved to treat 2 rare forms of seizure disorders, and so it has that medical utility. For CBD, there is [a growing body of] literature that CBD treats psychotic symptoms [and] it helps lower anxiety. Whereas we know that THC has totally opposite types of properties, especially in younger individuals, [such as] people up to age 25. When your brain is developing, THC can actually impact the way the brain wires itself and cause cognitive impairment that potentially is irreversible; it may translate to a decreased overall lifetime IQ, 5 to 10 points lower than it would have been otherwise. And especially for people with increased risk for psychotic disorders, THC can cause a 500% increased risk of having their first psychotic episode. So, these 2 molecules, important components of cannabis, are very different. When it comes to the conversations about what cannabis, is we really need to separate that conversation into, are we talking about THC or are we talking about CBD?

is Medical Director, Brain Health, Exeter, New Hampshire; Editor in Chief,

; Staff Psychiatrist, Seacoast Mental Health Center, Exeter; Consulting Psychiatrist, Exeter Hospital, Exeter; Consulting Psychiatrist, Insight Meditation Society, Barre, Massachusetts.

This article originally appeared on Psychiatric Times.

Learn more about the difference between CBD and THC—and why it matters. 

Cannabidiol (CBD)

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