EFCO Report to the Community

February 2016 Report to the Community is our most recent report.  

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 (www.floweringhope.co).
  • 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 2016. 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.

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.

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.

Previous EFCO Report to the Community:

March 2014