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Cannabinoid Use in Pediatrics, Part 2: The Epilepsy Case Study
In Part 2 of our 3 part series on Cannabinoid Use in Pediatrics, Dr. Jennifer Griffith, a Washington University Pediatric neurologist at St. Louis Children’s Hospital discusses the case study that started the national conversation over the use of cannabinoids to treat pediatric epilepsy patients, and the clinical trials that were conducted as a result.
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Learn more about Jennifer Griffith, MD, PhD
Jennifer Griffith, MD, PhD
Jennifer Griffith, MD, PhD is a Washington University pediatric neurologist at St. Louis Children's Hospital.Learn more about Jennifer Griffith, MD, PhD
Transcription:
Melanie Cole (Host): Welcome back to part two of our three part series on cannabinoid use in pediatrics. My guest is Dr. Jennifer Griffith. She’s a Washington University Pediatric Neurologist at St. Louis Children’s Hospital. Dr. Griffith, thank you so much for joining us again. In our last segment, we provided listeners with basic information on CBD, what it is, how it works, does it work? And now we’re discussing the case study that started the national conversation over the use of cannabinoids to treat epileptic patients and the clinical trials that were conducted as a result. Please for us discuss the key takeaways from CNN’s 2013 Weed documentary and its impact on clinical research.
Dr. Jennifer Griffith (Guest): This documentary I remember very clearly when it came out, not because I watched it at the time, but because all of a sudden all of my patients were coming to ask me about CBD and what I thought about it. So I had to get caught up to speed pretty quickly. So the documentary Weed came out in 2013 and it was produced by Dr. Sanjay Gupta and he told this really fascinating story about a little girl in Colorado named Charlotte Figi and she was a 5-year-old girl who had a very severe kind of epilepsy syndrome called Dravet syndrome, and in children with Dravet syndrome, it’s a genetic condition and they have often hundreds of seizures every single day and often their seizures are very refractory to the medications that we use to control seizures and it has real implications for their development, particularly language development. In the documentary, Charlotte has – we told the story of Charlotte who had obtained CBD extract and it was produced by a company that was in Colorado at the time where certain forms of medical marijuana were legal and Charlotte had an amazing result from taking CBD. She went from having hundreds of seizures every week to just a handful per week and her language and other development skyrocketed and it was really just an incredible story and very emotional as I understand for Dr. Gupta. I think this documentary made such a big impact because one, it started the conversation on a national level so the public was now aware of what CBD was and what it could potentially do, and I think the other way it was influential was that it really pushed people in leadership positions both in medicine and in government to take CBD seriously as a potential drug that could be helpful in medicine and epilepsy in particular, and so as a consequence as that documentary and other efforts that came out of it, we come to where we are today in 2019 where we can prescribe CBD to our patients with epilepsy.
Host: Doctor, from a national perspective, how many states have approved the use of CBD for medicinal purposes as of now?
Dr. Griffith: Yeah so the answer to that is constantly changing and I should say that I am not a lawyer and so this is all based on my best understanding of the laws, but currently as I understand it, every state – in every state it is now legal to prescribe Epidiolex and that is again the FDA approved form of cannabidiol. As to other forms of CBD that is a very complicated issue and varies highly from state to state. I think as of now there are all but three states that have approved some form of medical marijuana or CBD for medical – for medical use, although those laws are highly variable from state to state as far as what conditions are approved and what forms of cannabis derived products are allowed, and of note that does include 10 states that have also approved various forms of marijuana for recreational use as well. So it highly depends on which state you find yourself.
Host: Well we find ourselves in Missouri and Illinois, what’s the legal status of those – of CBD?
Dr. Griffith: That’s right, so again Epidiolex is a FDA approved medication that I can prescribe in Missouri and Illinois. In Missouri, the current program that is in effect came into effect in 2016, it was the Missouri Hemp Card – excuse me in 2014, it’s the Missouri Hemp Card. So it allows two state dispensaries to distribute hemp oil, which is less than 0.3% THC by federal and state law and a licensed neurologist in particular has to sign off and say that they are treating a patient for epilepsy, that they think that their patient would benefit form hemp and then the patient or their caregiver goes to the Department of Health and Senior Services and applies for a card and then takes that card and goes to one of the two dispensaries and obtains the oil. Again, that is not through any insurance or prescription process, it’s just administered through the state. However, as many of you remember from the last election, there was a Missouri Amendment 2 that was passed last year, and as of today’s date, there are now applications online through the Department of Health and Senior Services for other forms of medical marijuana and so what that means coming up over the next few months I think is a topic we’re all learning more about every day as we have discussion about it. In Illinois, I am not an Illinois licensed physician, but in Illinois there is state bill 10 that was approved in 2016 and that allows providers, any physician, to say that they are treating the patient and there are a number of qualifying conditions. There are a long list of them, not just neurologic and the prescriber signs a card, and the patient then goes to again a dispensary licensed by the state of Illinois and obtains the medical marijuana product. Of note, for our population of children, the only condition that will be approved for patients under the age of 18 is seizures or epilepsy.
Host: Tell us a little bit about the experience of St. Louis Children Hospital’s pediatric epilepsy group in the use of CBD.
Dr. Griffith: So November 4th of last year was the first date that the product Epidiolex became available to be prescribed, and since then I think all of the epileptologists here have proscribed it from some of their patients. We’ve been very fortunate that St. Louis Children’s Hospital has supported us to be in line with the current available research and has allowed us to prescribe CBD products in line with the state and federal laws so that we can provide the best cutting edge care for our patient. So St. Louis Children’s Hospital does allow Epidiolex, again it is a medication that is approved by the FDA and we have it on formulary here, although we do not start it in the hospital. If our patients are already on it, they may continue to take it while they’re in the hospital with us. Other forms of CBD are much more complicated. If you have a Missouri Hemp Card and it’s active and you have a product that’s been obtained through the Missouri dispensary, then because St. Louis Children’s Hospital is located in Missouri, that is a product that’s allowed by state and federal law and therefore we have a process by which we can give that medication to our patients that are already taking it, similar that we would for other supplements that aren’t on our formulary but that we believe are of benefit to our patients. If someone is taking a form of CBD that is not legal in Missouri and that includes any form of medical marijuana that’s obtained legally in Illinois for instance, for patients who come across the river to our hospital, the process is more complicated. In that case, we call in a large group of different people, everyone from pharmacists to risk management to the epilepsy attending who’s on call and we have a discussion about for that particular patient, is it in their interest – is the benefits of continuing it, outweighed by the risks of discontinuing it and then we come to a decision about how we’re going to allow the patient to take their product within the confines of our hospital.
Host: I’m glad you described that process and meeting with other team members. Speak about the hospital policy for patients as far as the criteria and dosing recommendations.
Dr. Griffith: So for Epidiolex there’s very clear guidance, whether I prescribe it as an outpatient or the patient is in the hospital, there is – it’s a product and we know how many milligrams of cannabidiol are in a certain volume of medication and so we can prescribe it similar that we would to any other antiseizure medication. So there is clear guidance. When it comes to other products, it’s a lot more difficult to know what to allow the patient to take, and I think more importantly to know how it might interact with other medications that we start. So interestingly the Epidiolex prescribing guidelines have us giving something on the order of anywhere from 10-20 mg/kg per day of CBD to our patients and when you look online at various sources, whether it’s the state level dispensaries or the local shops selling CBD products there’s a highly variable amount of CBD that they recommend, and again those dosing recommendations are not coming from physicians, they’re coming from the manufacturers or from other people selling the products, and even assuming that what is stated is in the product is actually what’s in it, there’s a wide range of amount of milligrams that is recommended. Usually it is less CBD that is recommended than what we prescribe for our patients with epilepsy and we prescribe our dosing guidelines based on the available clinical trials.
Host: Dr. Griffith in our last question here, state and federal legislation of cannabinoid use is constantly changing the risks associated with usage haven’t really been completely vetted by the FDA, what now? What’s the future of CBD use in pediatric healthcare? Tell providers what you’d like them to know as an expert in this about CBD?
Dr. Griffith: So I think the most important thing to know is that CBD, even Epidiolex, where we know what’s in it and we know that it’s just CBD, is it’s not a miracle cure. Like many of our other new antiseizure medications that come to market, it works really well for some patients, so the best clinical trials show that about 30% of patients have a really significant reduction in seizures, another 30% get some reduction in seizures, but for patients that have hundreds of seizures a day that may not be as much as we’ve hoped for, and the rest of the patients may have either adverse effects or not see any benefit in seizure reduction at all, and I think we’ll continue to learn more and more now that – I mean Epidiolex has only been available to prescribe for the last six months so aside from a handful of my own patients, we don’t have a ton of experience personally or even at a national research level and we’re continuing to learn more and more about these drugs, both its efficacy, it’s long term effects, and it’s safety as we go on.
Host: Thank you so much again Dr. Griffith, what interesting information. To consult with a specialist or to learn more about services offered at St. Louis Children’s Hospital, please call the Children’s Direct Physician Access Line at 1-800-678-HELP. This wraps up episode two of our three part series on cannabinoid use in pediatrics right here on Radio Rounds with St. Louis Children’s Hospital. Please head on over to our website at stlouischildrens.org for more information and to get connected with one of our providers. If you found this podcast informative, please share with other providers, share on your social media, and be sure to check out all the other interesting podcasts in our library. I’m Melanie Cole.
Melanie Cole (Host): Welcome back to part two of our three part series on cannabinoid use in pediatrics. My guest is Dr. Jennifer Griffith. She’s a Washington University Pediatric Neurologist at St. Louis Children’s Hospital. Dr. Griffith, thank you so much for joining us again. In our last segment, we provided listeners with basic information on CBD, what it is, how it works, does it work? And now we’re discussing the case study that started the national conversation over the use of cannabinoids to treat epileptic patients and the clinical trials that were conducted as a result. Please for us discuss the key takeaways from CNN’s 2013 Weed documentary and its impact on clinical research.
Dr. Jennifer Griffith (Guest): This documentary I remember very clearly when it came out, not because I watched it at the time, but because all of a sudden all of my patients were coming to ask me about CBD and what I thought about it. So I had to get caught up to speed pretty quickly. So the documentary Weed came out in 2013 and it was produced by Dr. Sanjay Gupta and he told this really fascinating story about a little girl in Colorado named Charlotte Figi and she was a 5-year-old girl who had a very severe kind of epilepsy syndrome called Dravet syndrome, and in children with Dravet syndrome, it’s a genetic condition and they have often hundreds of seizures every single day and often their seizures are very refractory to the medications that we use to control seizures and it has real implications for their development, particularly language development. In the documentary, Charlotte has – we told the story of Charlotte who had obtained CBD extract and it was produced by a company that was in Colorado at the time where certain forms of medical marijuana were legal and Charlotte had an amazing result from taking CBD. She went from having hundreds of seizures every week to just a handful per week and her language and other development skyrocketed and it was really just an incredible story and very emotional as I understand for Dr. Gupta. I think this documentary made such a big impact because one, it started the conversation on a national level so the public was now aware of what CBD was and what it could potentially do, and I think the other way it was influential was that it really pushed people in leadership positions both in medicine and in government to take CBD seriously as a potential drug that could be helpful in medicine and epilepsy in particular, and so as a consequence as that documentary and other efforts that came out of it, we come to where we are today in 2019 where we can prescribe CBD to our patients with epilepsy.
Host: Doctor, from a national perspective, how many states have approved the use of CBD for medicinal purposes as of now?
Dr. Griffith: Yeah so the answer to that is constantly changing and I should say that I am not a lawyer and so this is all based on my best understanding of the laws, but currently as I understand it, every state – in every state it is now legal to prescribe Epidiolex and that is again the FDA approved form of cannabidiol. As to other forms of CBD that is a very complicated issue and varies highly from state to state. I think as of now there are all but three states that have approved some form of medical marijuana or CBD for medical – for medical use, although those laws are highly variable from state to state as far as what conditions are approved and what forms of cannabis derived products are allowed, and of note that does include 10 states that have also approved various forms of marijuana for recreational use as well. So it highly depends on which state you find yourself.
Host: Well we find ourselves in Missouri and Illinois, what’s the legal status of those – of CBD?
Dr. Griffith: That’s right, so again Epidiolex is a FDA approved medication that I can prescribe in Missouri and Illinois. In Missouri, the current program that is in effect came into effect in 2016, it was the Missouri Hemp Card – excuse me in 2014, it’s the Missouri Hemp Card. So it allows two state dispensaries to distribute hemp oil, which is less than 0.3% THC by federal and state law and a licensed neurologist in particular has to sign off and say that they are treating a patient for epilepsy, that they think that their patient would benefit form hemp and then the patient or their caregiver goes to the Department of Health and Senior Services and applies for a card and then takes that card and goes to one of the two dispensaries and obtains the oil. Again, that is not through any insurance or prescription process, it’s just administered through the state. However, as many of you remember from the last election, there was a Missouri Amendment 2 that was passed last year, and as of today’s date, there are now applications online through the Department of Health and Senior Services for other forms of medical marijuana and so what that means coming up over the next few months I think is a topic we’re all learning more about every day as we have discussion about it. In Illinois, I am not an Illinois licensed physician, but in Illinois there is state bill 10 that was approved in 2016 and that allows providers, any physician, to say that they are treating the patient and there are a number of qualifying conditions. There are a long list of them, not just neurologic and the prescriber signs a card, and the patient then goes to again a dispensary licensed by the state of Illinois and obtains the medical marijuana product. Of note, for our population of children, the only condition that will be approved for patients under the age of 18 is seizures or epilepsy.
Host: Tell us a little bit about the experience of St. Louis Children Hospital’s pediatric epilepsy group in the use of CBD.
Dr. Griffith: So November 4th of last year was the first date that the product Epidiolex became available to be prescribed, and since then I think all of the epileptologists here have proscribed it from some of their patients. We’ve been very fortunate that St. Louis Children’s Hospital has supported us to be in line with the current available research and has allowed us to prescribe CBD products in line with the state and federal laws so that we can provide the best cutting edge care for our patient. So St. Louis Children’s Hospital does allow Epidiolex, again it is a medication that is approved by the FDA and we have it on formulary here, although we do not start it in the hospital. If our patients are already on it, they may continue to take it while they’re in the hospital with us. Other forms of CBD are much more complicated. If you have a Missouri Hemp Card and it’s active and you have a product that’s been obtained through the Missouri dispensary, then because St. Louis Children’s Hospital is located in Missouri, that is a product that’s allowed by state and federal law and therefore we have a process by which we can give that medication to our patients that are already taking it, similar that we would for other supplements that aren’t on our formulary but that we believe are of benefit to our patients. If someone is taking a form of CBD that is not legal in Missouri and that includes any form of medical marijuana that’s obtained legally in Illinois for instance, for patients who come across the river to our hospital, the process is more complicated. In that case, we call in a large group of different people, everyone from pharmacists to risk management to the epilepsy attending who’s on call and we have a discussion about for that particular patient, is it in their interest – is the benefits of continuing it, outweighed by the risks of discontinuing it and then we come to a decision about how we’re going to allow the patient to take their product within the confines of our hospital.
Host: I’m glad you described that process and meeting with other team members. Speak about the hospital policy for patients as far as the criteria and dosing recommendations.
Dr. Griffith: So for Epidiolex there’s very clear guidance, whether I prescribe it as an outpatient or the patient is in the hospital, there is – it’s a product and we know how many milligrams of cannabidiol are in a certain volume of medication and so we can prescribe it similar that we would to any other antiseizure medication. So there is clear guidance. When it comes to other products, it’s a lot more difficult to know what to allow the patient to take, and I think more importantly to know how it might interact with other medications that we start. So interestingly the Epidiolex prescribing guidelines have us giving something on the order of anywhere from 10-20 mg/kg per day of CBD to our patients and when you look online at various sources, whether it’s the state level dispensaries or the local shops selling CBD products there’s a highly variable amount of CBD that they recommend, and again those dosing recommendations are not coming from physicians, they’re coming from the manufacturers or from other people selling the products, and even assuming that what is stated is in the product is actually what’s in it, there’s a wide range of amount of milligrams that is recommended. Usually it is less CBD that is recommended than what we prescribe for our patients with epilepsy and we prescribe our dosing guidelines based on the available clinical trials.
Host: Dr. Griffith in our last question here, state and federal legislation of cannabinoid use is constantly changing the risks associated with usage haven’t really been completely vetted by the FDA, what now? What’s the future of CBD use in pediatric healthcare? Tell providers what you’d like them to know as an expert in this about CBD?
Dr. Griffith: So I think the most important thing to know is that CBD, even Epidiolex, where we know what’s in it and we know that it’s just CBD, is it’s not a miracle cure. Like many of our other new antiseizure medications that come to market, it works really well for some patients, so the best clinical trials show that about 30% of patients have a really significant reduction in seizures, another 30% get some reduction in seizures, but for patients that have hundreds of seizures a day that may not be as much as we’ve hoped for, and the rest of the patients may have either adverse effects or not see any benefit in seizure reduction at all, and I think we’ll continue to learn more and more now that – I mean Epidiolex has only been available to prescribe for the last six months so aside from a handful of my own patients, we don’t have a ton of experience personally or even at a national research level and we’re continuing to learn more and more about these drugs, both its efficacy, it’s long term effects, and it’s safety as we go on.
Host: Thank you so much again Dr. Griffith, what interesting information. To consult with a specialist or to learn more about services offered at St. Louis Children’s Hospital, please call the Children’s Direct Physician Access Line at 1-800-678-HELP. This wraps up episode two of our three part series on cannabinoid use in pediatrics right here on Radio Rounds with St. Louis Children’s Hospital. Please head on over to our website at stlouischildrens.org for more information and to get connected with one of our providers. If you found this podcast informative, please share with other providers, share on your social media, and be sure to check out all the other interesting podcasts in our library. I’m Melanie Cole.