In addition, GRU and the state of Georgia will pursue their own clinical trial of cannabidiol oil, although that will take longer to set up, he said. But some parents at his press conference said they think Deal should do something to shield them from prosecution so they can get cannabidiol oil themselves and administer it to their children right away.
Deal met Tuesday with officials from GW Pharmaceuticals and GRU as well as other Georgia providers such as Children’s Healthcare of Atlanta to talk about the logistics of expanding clinical trials of Epidiolex, a cannabidiol oil being tested on children with certain difficult to treat seizure disorders.
Deal said Georgia’s arm of the trial would actually be expanded to cover more than just certain diagnoses.
“We all have to be sensitive to the children that have these seizures,” he said. “That’s the focal point for all of the discussion. It was the genesis of why legislation was attempted this last session. And that should always be our focus.”
Deal said he has heard estimates of 300 to 400 such children in Georgia.
As he spoke, one of them, six-year-old Preston Weaver, sat nearby with his mother, Valerie. He has Lennox-Gastaut syndrome and suffers up to 70 seizures a day despite multiple medications. Preston is on the list to join the GRU trial once it begins, but his mother wanted to see Deal do something to shield parents from prosecution should they go out and get the oil on their own.
“I think the families here should have immunity,” Weaver said. “If we can find a way to get it ourselves, I think we should be able to do that. I think that should be an option.”
Dawn Beals said the oil is also being tried for children with other problems besides seizure disorders. She would like her six-year-old daughter, Hope, to have access to see if it can help her condition. She has Ehlers-Danlos Syndrome Type IV, where her body does not produce enough collagen and she has fragile blood vessels, intestines and joint problems.
The oil could be better than the current pain medication Hope is on, for instance, but because it would only be given in clinical trials she would not be a candidate.
“Why should they have to wait (when the company) is picking and choosing who can have this?” Beals asked.
But Deal said he did not want “to cross that line right now” in trying to grant some kind of immunity from prosecution. For one, federal statutes govern transportation and possession, which a clinical trial would avoid.
“I think it is dangerous for us to start trying to figure out whether we can do things through the legislative process that is not taking into account all of the scientific evidence and the scientific processes that we would normally go through in order to put something on the marketplace,” he said.
Dr. Geoffrey W. Guy, the founder and chair of GW Pharmaceuticals, said Deal and the state approached the company about doing the clinical trial, and it became the second state after New York to become a partner with the company.
“We thought it was a very good idea, an excellent idea, an excellent initiative,” he said.
It is now a matter of drawing up proper scientific protocols that have to be approved by the Food and Drug Administration, said Dr. Michael Diamond, the vice president of clinical and translational services at GRU.
“We are hoping that we will be able to initiate the trial, at least some component of the trial, before the end of the year,” he said. The GRU-initiated clinical trial, which might use cannabidiol oil from a crop grown on a federally controlled farm at the University of Mississippi, will obviously take longer, Deal said. But the FDA has been very supportive of the idea, he said.
“They were very interested in a state doing it the right way,” Deal said.
GW also works with individual physicians in about 14 states, including Georgia, who petition the company to treat their patients with Epidiolex and through a certain process the company provides them the drug for free, Guy said.
There are about 50 childhood seizure syndromes and the drug has been tried in about half and Georgia’s extended program will likely see a similar spread, he said.
“It is really down to the clinicians to identify those patients that meet the criteria for entry into the study,” he said. Diamond said that extended use could begin with a Georgia physician within a month.
The company’s drugs are “not medical marijuana,” Guy said.
The plants were carefully bred and grown in its controlled indoor facility and it is refined under very precise controls that create a highly standardized oil, he said. It avoids some of the problems associated with other types of marijuana-derived products, such as variable potency or contaminants such as pesticides, microbes and heavy metals, Guy said.
“You’re dealing with a neurological condition and the last thing you want to be doing is giving a four-year-old something that contains pesticides” and other impurities, he said.
The drug is given in the trial in addition to other anti-epilepsy drugs and it is imperative that parents not go out and decide to stop their child’s current medications and start administering the oil on their own, Diamond said.
“It is very important that the care of each child be individualized by that child’s physician in order to try to optimize the outcome for that child,” he said.