Harper Grace’s Law paves way to develop epilepsy treatment

Oil for the study will come from cannabis grown at UM.

bill signed by Gov. Phil Bryant will provide researchers at the University of Mississippi an opportunity to develop a cannabis-derived treatment of seizures in children with a form of epilepsy.

Harper Grace’s Law exempts a specialized cannabis preparation from the state’s Controlled Substances Law. The bill is named for Harper Grace Durval, a 2-year-old Mississippi girl who suffers from a rare form of epilepsy called Dravet Syndrome.

Unlike “medical marijuana” that is legal in some states, the oil that is the subject of Harper Grace’s Law is extracted from cannabis and is orally administered, not smoked. In addition, the specially processed oil contains a very low amount of tetrahydrocannabinol, or THC, the principal psychoactive constituent of the cannabis plant, and a high amount of cannabidiol, or CBD, a nonpsychoactive constituent of the plant that may have anti-seizure activity.

Sen. Josh Harkins of Flowood was instrumental in crafting the bill. He said he hopes it will pave the way for physicians in Mississippi to prescribe the preparation to children such as Durval.

Harkins noted the process will involve federal-agency approvals to allow the UM National Center for Natural Products Research to grow the required variety of cannabis and provide the specially processed oil for approved research use in patients. Physicians at the University of Mississippi Medical Center would conduct the clinical trials.

“This is a big step toward eventually providing relief for Mississippi children suffering from epilepsy,” Harkins said. “I appreciate the cooperation of UM experts on this complex issue. They will have to seek federal approvals to move ahead, but we want to lose no time at the state level once the drug is available.”

While creating the language in the bill, Harkins enlisted the input of UM researchers, particularly Mahmoud ElSohly, NCNPR research professor and director of the university’s Marijuana Project.

ElSohly has been working closely with the National Institute on Drug Abuse for final approvals to grow a special low-THC, high-CBD variety of cannabis this season. For more than 30 years, UM has been the only federally sanctioned grower of marijuana for research purposes.

“Provided necessary approvals are granted by NIDA and the Drug Enforcement Administration, we would move as quickly as possible to prepare the extract and work with NIDA and the Food and Drug Administration to provide it for investigation under approved protocols in Mississippi,” ElSohly said.

Dr. Brad Ingram, pediatric neurologist at UMMC in Jackson, treats many children suffering from epilepsy, including some who might benefit from CBD oil.

“For Mississippi, I would say we take care of 3,000 to 6,000 patients a year with epilepsy,” Ingram said. “This is going to distill down to a few hundred of these patients that are going to qualify for this. But [for] those few hundred – we don't have a lot else to use. We are scratching the bottom of the barrel and not necessarily doing anything to make them better.”

Under the provisions of the bill, the oil will be dispensed with a doctor’s prescription only at UMMC.

This provides another great opportunity for university research efforts to directly improve the lives of patients, said Larry Walker, NCNPR director.

“For more than 20 years, Ole Miss has pursued a number of avenues to develop FDA-approved drug products from marijuana,” Walker said. “We have to move beyond the idea of delivering critical medicines through a crudely rolled joint or a weed pipe.

“This opens the door for Mississippi researchers and clinicians to evaluate the benefits of this specialized oil from cannabis for children’s seizures, while avoiding the unwanted abuse potential and the inhalation of possible carcinogens from smoking marijuana. We really appreciate Sen. Harkins’ vision and drive to do the right thing on this.”