Oil derived from marijuana represents one thing for Valerie Weaver: hope that she might regain the son she lost to seizures.
Even though the Georgia Legislature failed to pass a very narrow medical marijuana bill that would have allowed research on the oil in specific cases, Gov. Nathan Deal is trying to find a way to allow it. And even without the Georgia law, a research trial at Georgia Regents Medical Center or elsewhere in the state might be possible, officials said.
Legislation that would have allowed for clinical trials in Georgia at academic medical centers like GRMC was “held hostage” the last night of the legislature and was not allowed to be put up for a vote, said Rep. Allen Peake, R-Macon, its main proponent.
“It was a crushing defeat for a lot of the families,” he said. But since then, Deal announced he would try to seek a solution through another avenue to allow that access.
“It’s going to require some study because of the complexities of complying with federal laws,” spokesman Brian Robinson said. “But he wants to help these families get the help they need.”
Peake said he is encouraged by that.
“He’s got a lot of smart lawyers around him, a lot of smart advisors around him,” he said. “I’m hopeful and optimistic that the governor is going to be able to come up with something that is going to help these families immediately, to do what we failed to do in the legislature.”
Peake and others advocating for the bill are also pursuing other potential solutions, such as lobbying Congress to change marijuana from a Schedule 1 drug to a lower schedule that would allow for cannabidiol oil to be transported across state lines, Peake said. That is also the aim of a petition the Epilepsy Foundation started on the White House’s Web site to change marijuana from a Schedule 1 controlled substance, which is considered to have no medical value, to a lower schedule, said Angela Ostrom, vice president of public policy and advocacy for the Epilepsy Foundation.
Because it is Schedule 1, that requires clinical trials to get additional approvals from federal drug agencies, restricts drug sources, and requires a much higher level of security, she said.
“There is a lot of increased protocols and securities that are extremely costly and we think a deterrent to that kind of research,” Ostrom said.
Even with restrictions, clinical trials are moving forward with one pharmaceutical company, GW Pharmaceuticals, on its cannabidiol drug called Epidiolex.
Dr. Yong Park, who heads up the pediatric epilepsy program at GRMC, said the program is awaiting word from the company on when more clinical trials will begin and whether the company’s approvals or pending approvals from the Food and Drug Administration could allow for it to be done in states that have not passed medical marijuana legislation.
It could be “in your state it has to be legalized first,” he said. “Or even though it is not legalized … as long as you belong to this study you are okay. We don’t know yet.”
In fact, Peake said, “from our standpoint, from everything we looked at, there wasn’t a need for legislation for that particular clinical trial” to take place in Georgia. He spoke to a pediatric neurologist in Atlanta who is getting set up to participate in that clinical trial, but it will only be for 25 patients.
The federal-state complexity is adding to the confusion and it could be that state legislation is necessary, Ostrom said. The bottom line is getting families access to the cannabidiol oil to see if it will help, she said.
“Right now what we’ve been advocating for is compassionate access to say that while we don’t know what the best route for marijuana is, we are seeing for people with catastrophic epilepsies that these anecdotal stories are providing a venue for hope,” Ostrom said.
That is certainly the case for Weaver and her 6-year-old son, Preston. He has Lennox-Gastaut Syndrome, a very severe form of childhood epilepsy that often is accompanied by developmental delay.
He was born seven weeks premature and was struggling to meet developmental milestones like holding his head up, sitting up and rolling over. Still, he had managed to learn to drink from a bottle and eat baby food, was sitting up with help and could hold himself up for a short time.
Around five months old, however, he would suddenly look away and smile, Weaver said. They didn’t know it at the time, but it was later diagnosed as infantile spasm. Tests confirmed severe brain damage, seizures seemed to bombard the little boy and he began to regress.
“All of that got wiped away,” Weaver said. “Everything he learned.”
Now at 6 years old, “he’s basically like a two- or three-month-old baby,” she said. “He can’t sit up, he can’t hold his head up.” They had to put in a tube to feed him because he lost the ability to eat. They have tried 12 or 15 medications without finding a combination that truly works and he still suffers seizures every day. And he is not alone.
“There’s an entire community of these children that could benefit from this,” Weaver said. “Everybody needs to be pushing for this to help these kids.”
Peake said he spoke to GW Pharmaceuticals and an official told him it could be 2017 before the drug is approved and widely available.
“For these families, that’s too long to wait,” he said. “Some of these children may not live that long.”
What makes it all the more urgent are those families that have moved to Colorado, where the cannabidiol oil is legal, and “are seeing amazing results, really life-changing, life-altering changes in their behavior and reductions in seizures.” Peake said.
Part of his effort is trying to raise financial help for those families that need to move to Colorado. Weaver said she would consider it “in a heartbeat” but it is not something her family could afford.
While the anecdotes are great, and the cannabidiol has anti-seizure effects in animal models, good human clinical trial data is lacking and still needed, Park said.
But those stories are where Weaver is pinning her hopes for the future for her son, who is blind and noncommunicative. With the cannabidiol, could he learn to eat again and have his tube removed, she wonders. Without a constant barrage of procedures, what would emerge from her son?
“I don’t know that he even understands what I am saying to him right now,” Weaver said. “He doesn’t respond to me any way at all. Could he learn to say, push this button for yes or push this button for no? To me the possibilities are endless. We don’t have any way of knowing. I am so eager, very, very eager to find out.”