UM Researchers, Physicians Cite Benefits of Harper Grace’s Law

Bill provides opportunity to develop FDA-approved, cannabis-derived treatment for epilepsy

Researchers, lawmakers are hopeful of new legislation passed that may allow physicians to treat seizures in children with epilepsy.

Researchers, lawmakers are hopeful of new legislation passed that may allow physicians to treat seizures in children with epilepsy.

OXFORD, Miss – A bill passed by the Mississippi Legislature could provide researchers at the University of Mississippi an opportunity to develop a cannabis-derived treatment of seizures in children with a form of epilepsy.

The proposed Harper Grace’s Law exempts a specialized cannabis preparation from the state’s Controlled Substance Law. Now that legislators have agreed to the measure, it goes to Gov. Phil Bryant for final consideration.

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 non-psychoactive constituent of the cannabis plant that may have anti-seizure activity.

Sen. Josh Harkins of Flowood was instrumental in crafting the bill. He said that if the bill is signed into law, he hopes it will pave the way for physicians in Mississippi to prescribe the preparation to children like Durval.

Harkins noted the process would 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 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. If the bill is passed, they would 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. This is going to distill down to a few hundred of these patients that are going to qualify for this. But 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 could be dispensed with a doctor’s prescription only at UMMC.

This could provide 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 could open 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.”