Children in Georgia with difficult to treat seizures could get access to a marijuana-derived oil through clinical trials at Georgia Regents University, Gov. Nathan Deal announced Thursday. But even if the state gets selected, it could be three to six months to work out the details, said a lead researcher at GRU who would likely lead the clinical trials.
After the Georgia Legislature failed to pass a bill in March that would legalize cannabidiol oil for treatment of children with seizure disorders, Deal announced he would try to find a way to do it administratively. He said he talked with the Food and Drug Administration and was told of two avenues for getting the oil to the state. One is “pairing” GRU and a company that makes a cannabidiol oil that is being tested in clinical trials elsewhere.
The news release doesn’t name the company but GW Pharmaceuticals is testing a drug called Epidiolex that is a purified cannabidiol oil. GRU has already submitted information about its patient population and its center to the company and is waiting to hear back from them, said Dr. Yong Park, who heads the pediatric epilepsy program.
“Hopefully they will select our center to participate in this study,” he said. “That’s the first step.”
The first study would be limited to children with Dravet syndrome who suffer from difficult to control seizures. Even if GRU gets the nod, it could take a while, Park said.
“Hopefully they go fast track but you have to have a contract with the pharmaceutical company” and the university, he said. “Contract issues, usually in my experience, take about three to four months, sometimes six months to get the contract.”
The other route Deal mentioned would be to get the oil from the National Institute on Drug Abuse’s marijuana farm at the University of Mississippi, which would probably take longer because it would mean going through that agency and the FDA for approval, Deal said in a news release.
It could actually do both trials at GRU in partnership with other institutions across the state, he said.
“We do not see these options as mutually exclusive, and we’re looking to move forward on both options at this time,” Deal said.
The sponsor of Georgia’s cannabidiol oil bill, Rep. Allen Peake, R-Macon, said he was told the NIDA will soon announce it is creating a strain high in cannabidiol, which is not the chemical in marijuana that creates a high.
“We want to be on the very cutting edge in an initiative seeking to obtain that from them so we can do research at our research facility at GRU,” he said.
It is impressive that the announcement included not only the governor but Chancellor Hank Huckaby of the University System of Georgia, Peake said.
“I think it is a great idea,” he said. “It still doesn’t help families immediately but it sure gives them some hope that down the road, and possibly with all of that political muscle in a shorter term, that they’ll have access to some cannabidiol oil.”
While there is little solid clinical research yet showing the oil helps children with seizures, there are numerous anecdotal stories showing remarkable progress.
The announcement was “pretty awesome,” said Valerie Weaver, whose 6-year-old son Preston has Lennox-Gastaut syndrome and suffers seizures daily despite taking a half-dozen medications.
“So hopefully maybe we can get this thing going.”
The company might cover Preston’s syndrome, which affects more patients, in a future study soon, Park said.
Having access to the oil through the federal government would be “a great thing,” he said, “then we need to find the mechanism for how we can use those rather than depend on GW Pharmaceuticals.” But that brings up one big problem, Park said.
“Who is going to sponsor it?” he said. “I don’t know whether the state has a sponsor to study it. I doubt it. We’ll see how it goes.”
After the measure ran into a snag on the last day and failed to pass despite overwhelming support, Peake said he planned to be ready to go when the next legislature convenes to help families, some of whom moved to Colorado so they could legally obtain the oil.
“I fully anticipate we’ll push forward very early in the session a protection from prosecution for possession of cannabidiol oil, similar to what we were trying to do the last day,” he said. “Maybe within a couple of weeks after next year’s session starts we’ll have a law passed so those families can come home.”