The products being taken by children with epilepsy are not the equivalent of the marijuana widely used for recreational purposes.

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1 Epilepsy Foundation of Colorado The Use of Cannabis to Treat Children with Epilepsy Updated February 2016 The use of extracts from marijuana plants (cannabis) to treat children with epilepsy has been in the national spotlight since CNN s Sanjay Gupta featured in August 2013 the story of Charlotte Figi, a Colorado child with Dravet syndrome. Charlotte s seizures declined dramatically after she began taking a product called Charlotte s Web extracted from cannabis. Charlotte s Web oil differs in composition from standard marijuana in that it has a high level of cannabidiol (CBD), the component that appears to be frequently effective in controlling seizure activity, and very low levels of THC, the psychoactive component that makes marijuana users high. Colorado has been at the epicenter of this development because the Stanley brothers, the producers of Charlotte s Web, are located here. In fact, families from around the United States moved to Colorado in order to access Charlotte s Web for their children, since federal law prohibits transporting marijuana across state lines, even to other states that permit use of marijuana for medical purposes. That influx has declined since the Stanleys and others have begun mailing their product to other states, on the basis that it contains less than 0.3% THC and thus qualifies as industrial hemp, which may be legally transported across state lines. This summary provides information about CBD-related products, the status of related research, and resources for families, medical professionals, and others contemplating treatment decisions. For further information, see our FAQ page and our interview with Dr. Edward Maa, Denver epileptologist and member of the Epilepsy Foundation of Colorado board of directors. Key Points The products being taken by children with epilepsy are not the equivalent of the marijuana widely used for recreational purposes. These products are generally taken in liquid form (or more recently through gels or patches), not smoked. They are high in cannabidiol (CBD), a component in marijuana that has shown some ability to reduce the frequency of seizures, and very low in THC, the psychoactive component of marijuana (that is, the substance that makes users high ). A variety of products containing CBD have been used to treat children with severe epilepsy. Charlotte s Web, extracted from marijuana plants by the Stanley brothers and dispensed in Colorado Springs, can be used legally in Colorado (see theroc.us for more information). Other Colorado producers have also entered the market. The best-known competing product is Haleigh s Hope, associated with Jason Cranford and the Flowering Hope Foundation (

2 Epidiolex, which contains almost pure CBD and was developed by the British company GW Pharmaceuticals, has received Investigational New Drug (IND) approval by the Food and Drug Administration and is available only by physician application to the FDA, but is not currently available in Colorado. Epidiolex has no detectable THC; other products have varying amounts. Research suggests that cannabis-related products may help to reduce seizures in some children with severe forms of epilepsy. Dr. Orrin Devinsky at New York University is leading a study on Epidiolex. In December 2015, Dr. Devinsky reported summary data on an open-label study (not a randomized controlled trial, which is considered the most reliable form of medical research) of 261 children with treatment-resistant epilepsy. Within 8 to 12 weeks, 47% of patients had a reduction in seizure frequency of 50% or more, as reported by their families. The median seizure reduction was over 40% by week 8 and 50% by week 20 of treatment; 9% of patients were seizure-free at 12 weeks. Researchers at Children s Hospital Colorado performed a retrospective case review of 75 pediatric epilepsy patients who used some form of cannabis extract containing CBD. They found that 57% had some seizure reduction and 33% had a reduction of at least 50%. The response rate was twice as high in patients who had moved to Colorado for the oil. Also, 33% reported improved behavior or alertness, whereas 44% had some adverse effect. The Realm of Caring Foundation, which is associated with the Stanleys operation and assists patients using medical cannabis, reported that it was supporting 1,394 pediatric epilepsy patients as of January Dr. Margaret Gedde, who conducted an observational study of 107 children taking Charlotte s Web, reported that 60% percent achieved at least a 50 percent reduction in seizures and 10% became seizure-free. These are uncontrolled studies; the first randomized controlled trial of a medication containing CBD (Epidiolex) is just beginning. Two research studies are taking place at Children s Hospital Colorado, with funding from the Colorado Department of Public Health and Environment. Dr. Kelly Knupp intends to follow 110 pediatric patients in a three-year study, using blood tests, EEGs, and patient diaries to obtain more complete data than a retrospective study can provide. Dr. Sam Wang is conducting a study of how the body processes CBD, as how quickly it takes effect and how long it remains in the system are important considerations in determining suitable dosages. Also, Dr. Edward Maa of Denver Health is recruiting children with Dravet syndrome using Charlotte s Web for a study aimed at identifying genetic differences between those who do and do not respond to this product. Haleigh s Hope has been the subject of research in Israel and the Czech Republic, and a study beginning in Colorado will examine persistence of improvements and drug interaction issues among children taking this product.

3 The Epilepsy Foundation of Colorado believes that treatments containing CBD should be available to children with severe epilepsy, but should be viewed as a last resort to be considered if established epilepsy medication regimens are unsuccessful. In the Epidiolex study, serious adverse effects related to the treatment, such as convulsions or impact on liver enzymes, were observed in 5% of patients. Less severe side effects, each observed in at least 10% of cases, included drowsiness, diarrhea, decreased appetite, and vomiting. A report on the first 162 patients to have 12 weeks of follow-up indicated that 79% of them had some adverse effect. The retrospective patient review completed at Children s Hospital Colorado found that some adverse effect occurred in 44% of cases; among these, increased seizures (13%) and fatigue (12%) were most common. The long-term effects of CBD use by young children remain unknown. Parents and professionals contemplating the use of CBD for children with epilepsy should be cautious in arriving at informed treatment decisions and should recognize important differences between the market for these treatments and that for traditional pharmaceuticals. The FDA plays no role in ensuring the quality and consistency of medical marijuana products as it does for pharmaceuticals. No pharmaceutical-grade marijuana is available in Colorado. Beginning later in 2016, Colorado will require producers of medical marijuana to send their products to an independent laboratory for testing. Colorado licenses private laboratories for this purpose; it does not have a state-run testing lab. Samples must be tested for THC but not for CBD. The makers of Charlotte s Web and Haleigh s Hope do their own testing to maintain product consistency. Private citizens in Colorado are not permitted to take marijuana-related products to a laboratory on their own for testing. The unusual legal status of medical marijuana in the United States today presents additional complications. For example, products containing CBD cannot be administered by school nurses. Physicians cannot prescribe cannabis-related products but can monitor patients receiving these treatments. Given that marijuana dispensary staff are not experts in medicine or in interaction issues with other drugs, it is important for patients receiving these treatments to remain under an epilepsy doctor s care. There is some evidence of adverse interactions between CBD and clobazam, for example. Cannabis-related products are not currently covered by health insurance. Costs can be substantial, although the makers of Charlotte s Web and Haleigh s Hope have associated foundations that can provide financial assistance. Should the FDA approve Epidiolex for medical use following clinical trials, it could eventually be eligible for insurance coverage.

4 Government actions could improve the current situation regarding use of products containing CBD, with regard to both treatment and research. Marijuana is currently classified as a Schedule I substance, with no medicinal value, on the federal schedules of controlled substances. A change in this classification could make it easier to conduct research on cannabis-based products, or for physicians to obtain and prescribe them. We join the national Epilepsy Foundation in calling on the Drug Enforcement Administration to implement a lesser schedule for products containing CBD so that they can be more accessible for medical research. The federal government should provide assurance to healthcare organizations that their eligibility for federal funding will not be endangered if members of their organizations participate in research on medical marijuana.

5 Frequently asked questions about cannabidiol (CBD) and children with epilepsy (NOTE: The Epilepsy Foundation of Colorado provides this information as a public service, but we do not make treatment recommendations. Treatment decisions should be made by patients and family members based on appropriate consultation with physicians and careful consideration of each individual case. The Epilepsy Foundation of Colorado is not affiliated with any entities involved in producing or marketing CBD-based products.) What is the medical marijuana product known as Charlotte s Web? Charlotte s Web is a extract made from cannabis plants and administered in liquid form. Its popular name refers to Charlotte Figi, the child with Dravet syndrome whose seizures decreased after she began taking this product. It is produced in Colorado by the Stanley brothers and sold at their Colorado Springs dispensary. Does Charlotte s Web give children a high as is the typical result with other forms of medical marijuana? No, because Charlotte s Web has a low level of THC, the psychoactive component of marijuana that makes users high. In fact, its THC level is so low (0.3% or less) that the Colorado Department of Agriculture has classified Charlotte s Web as hemp rather than marijuana, making it eligible to be transported across state lines under federal law. (This change, combined with the fact that 16 states have passed laws permitting the use of low-thc cannabis products with children, has greatly reduced the flow of families relocating to Colorado to access products containing CBD.) Is medical marijuana legal for children? Yes. In Colorado, cannabis-related products may be obtained for children with the recommendation of two doctors (as opposed to one doctor for adults). Presumably it would be difficult to get two doctors approval for a young child to take a form of marijuana that is high in THC, although Dr. Kelly Knupp of Children s Hospital Colorado reports having seen children with epilepsy who have taken high-thc products. What is the evidence that CBD is having a positive effect in controlling seizures among children with intractable epilepsy? The most extensive study thus far is led by Orrin Devinsky of New York University. In this study, 261 children with severe epilepsy received Epidiolex, a medication containing CBD, for at least three months at 16 U.S. sites. According to family logs, 47% of these patients had at least a 50% seizure reduction at three months and 9% were seizure-free. On the other hand, 16% of patients stopped treatment due to lack of efficacy or an adverse effect. More information on this and other studies is available at Researchers at Children s Hospital Colorado found that 33% of 75 pediatric epilepsy patients using a CBD-related treatment experienced at least a 50% seizure reduction.

6 Dr. Margaret Gedde, who has followed hundreds of children with epilepsy using CBD-related treatments, reported in an observational study (not independently verified) that 60% achieved a seizure reduction of 50% or more. No results of a randomized controlled trial are available yet. This type of research is the standard used to determine efficacy of medications. Are there medical marijuana treatments for children with epilepsy other than Charlotte s Web? Yes. Other marijuana dispensaries in Colorado are also offering products reported to be high in CBD and low in THC. The best-known alternative is Haleigh s Hope, associated with Jason Cranford and the Boulder-based Flowering Hope Foundation. The breadth of applications has also expanded. CBD oils are now available in gels or patches as well as in oil form. Action by Congress to clarify that a product classified as industrial hemp in its own state can be transported across state lines has also impacted the market. At least six companies, located in Kentucky and South Carolina as well as Colorado, are marketing nationally hemp oils that are reportedly high in CBD and low in THC. Epidiolex, the medication being used in Dr. Devinsky s study, is made by GW Pharmaceuticals, a British company. It is high in CBD and contains no detectable THC. GW Pharmaceuticals has obtained permission from the Food and Drug Administration to make Epidiolex available as an Investigational New Drug (IND) by application from physicians wishing to prescribe it. Sixteen physicians are participating in the study, but none of them are in Colorado. A randomized trial is now occurring to determine the efficacy of this product for children with epilepsy. Are all these products basically the same? No. Epidiolex is refined to eliminate the psychoactive THC completely; other products have low levels of THC. There is considerable debate as to whether THC or other chemicals in marijuana could have an entourage effect, i.e., working in combination to provide medical benefits not obtained from taking pure CBD. Under what circumstances might this treatment be considered? Given the lack of rigorous medical evidence at this point, the use of Charlotte s Web or similar treatments by children with epilepsy is recommended only for severe, intractable cases that have not responded to other, more established medications. Any child taking cannabis-related products should be closely monitored by a physician. Parents of children with severe, intractable epilepsy may understandably be tempted to take desperate measures. But when asked what he thought parents should know, Jason Cranford said, Tell them not to wean their child off other drugs, without a doctor s oversight, based on what some other parent who doesn t know their child is telling them on Facebook. What are the known side effects of Charlotte s Web or other cannabis-related products generally in children? The most commonly reported side effects in the Epidiolex study have been drowsiness, diarrhea, and decreased appetite. Increased seizures and convulsions have occurred in a small

7 number of cases. Long-term effects are an open question. Marijuana use in children has been shown to have negative effects on the brain, but we do not know whether treatments containing little or no THC will have any long-term side effects. How do I know what is actually in the product I am buying? That can be a challenge. No pharmaceutical-grade medical marijuana is available in Colorado. No FDA testing or oversight is required; the FDA has issued warning letters to some producers (not in Colorado) after testing their products and finding that they did not contain the CBD claimed on the label. Beginning later in 2016, Colorado will require testing of medical marijuana products for THC, but not for CBD. The Stanley- and Cranford-led operations have used both inhouse and third-party testing processes in an attempt to ensure that Charlotte s Web and Haleigh s Hope have consistent chemical content. Other growers and dispensaries may also claim to offer forms of marijuana that are high in CBD and low in THC, but parents cannot arrange for their own lab testing in Colorado, because marijuana testing labs are not permitted to test samples from private citizens. Families considering the use of cannabis-related products should make sure that they are comfortable with the process by which the product s quality and consistency are achieved. Dr. Gedde encourages asking for lab reports showing the product s composition. She indicated confidence in the consistency of both Charlotte s Web and Haleigh s Hope. Does medical insurance cover CBD-based products as a treatment for children with epilepsy? Not yet. As a result, families can expect to pay for it themselves. As of 2014, the cost of Charlotte s Web ranged from $100 to $600 per month, depending on dosage level and patient weight. Many Charlotte s Web patients receive financial assistance from the Realm of Caring Foundation or ), which is related to the Stanleys organization. Haleigh s Hope is priced at 9 cents per milligram; according to Cranford, the average patient dose costs $150 per month (contact information: or ). If the efficacy of Epidiolex or other cannabis-related products could be documented through clinical trials, they might become eligible for insurance coverage in the future. Although the Drug Enforcement Administration currently classifies marijuana as a Schedule I controlled substance (which means that it has no currently accepted medical use in the United States), Marinol, a drug prescribed for side effects of chemotherapy that contains THC, is classified separately as Schedule III. GW Pharmaceuticals hopes that Epidiolex would be similarly reclassified if the FDA approves its use following clinical trials.

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