Two years ago, the Georgia Legislature tried but failed to legalize artisanal cannabidiol (CBD) oils for children suffering from epilepsy. Artisanal CBD oils are products marijuana growers are making in states that have legalized marijuana for medical use. No grower in these states has submitted its CBD product to FDA for approval as a safe or effective medicine.
In contrast, two pharmaceutical companies, GW Pharmaceuticals of Great Britain and Insys Therapeutics of the US, are developing pharmaceutical-grade CBD oils. GW’s version, Epidiolex, is in FDA Phase III clinical trials and Insys Therapeutics is about to undergo FDA testing. The Insys drug is 100% synthesized CBD, meaning it is an exact chemical duplicate of cannabidiol found in the marijuana plant but is made of pure chemicals to eliminate impurities and contaminants. Epidiolex is an extract of marijuana that has been purified to remove impurities and contaminants and is 98% CBD with trace amounts of THC and other cannabinoids. Both drugs must be tested in animals to ensure safety before companies can apply to FDA for permission to test their drugs in humans.
Artisanal CBD oils offer no such protections to patients. Random tests have shown that many contain THC, which can cause seizures, contaminants, and in some cases little to no CBD.
When the Georgia bill failed last year, Governor Nathan Deal formed a partnership with GW to conduct clinical trials of Epidiolex in Georgia as well as a statewide FDA expanded access program for children not able to enroll in the clinical trials. Both programs are up and running.
Despite this, the legislature came back with a bill this year to legalize artisanal CBD oils not only for childhood epilepsy but also for seven other diseases. Moreover, this bill permits possession of up to 20 ounces of CBD oil containing up to 5% THC. The bill passed and the governor signed it in April. It provides immunity from prosecution to those who possess CBD and calls for a special commission to recommend how best to grow marijuana, process it into CBD oils, and distribute it to patients.
Like the researchers whose work is published in JAMA today, specialists who treat epilepsy also are beginning to speak out. The NBC-TV affiliate in Atlanta interviewed several this week. Dr. Yong Park, who is helping run the clinical trials in Georgia, says doctors don’t know what the drug interactions are or what the side effects might be because they don’t have the evidence yet. Nor do they know how many pesticides artisanal CBD oils may contain nor what the long-term effects of daily exposure on the brain might be.
Under the new state law, when doctors sign a letter approving patients for the state registry that allows them to possess CBD oils, says Atlanta pediatrician Cynthia Wetmore, M.D., Ph.D., “they are required to keep track of the patients. But how do we know what dose to recommend? The oil patients have access to is not standardized. Each batch can be different. There’s a lot of variability in each batch. What side effects is it causing, if any? We have to report to the state on each patient, quarterly. It will be hard to know if it’s helping or hurting.”
Perhaps the most haunting concerns come from Dr. Amy Brooks-Kayal, a Colorado pediatric neurologist and president of the American Epilepsy Society. The Atlanta NBC-TV affiliate published her letter to a Pennsylvania representative who held hearings a few months ago on a similar bill in his state. In part, she writes:
The families and children coming to Colorado are receiving unregulated, highly variable artisanal preparations of cannabis oil prescribed, in most cases, by physicians with no training in pediatrics, neurology, or epilepsy. As a result, the epilepsy specialists in Colorado have been at the bedside of children having severe dystonic reactions and other movement disorders, developmental regression, intractable vomiting, and worsening seizures that can be so severe they have to put the child into a coma to get the seizures to stop. Because these products are unregulated, it is impossible to know if these dangerous adverse reactions are due to the CBD or because of contaminants found in these artisanal preparations. The Colorado team has also seen families who have gone into significant debt, paying hundreds of dollars a month for oils that do not appear to work for the vast majority. For all these reasons not a single pediatric neurologist in Colorado recommends the use of artisanal cannabis preparations. Possibly of most concern is that some families are now opting out of proven treatments, such as surgery or the ketogenic diet, or newer antiseizure medications because they have put all their hope in CBD oils.
All three epilepsy specialists want parents to know that giving artisanal CBD oils to children exposes them to risks that cannot be defined. They urge parents instead to enroll their children in clinical trials or expanded access programs that are testing pharmaceutical-grade CBD where doctors can monitor the children closely.
Read Atlanta story and full text of Dr. Brooks-Kayal’s letter here