BIRMINGHAM, Ala. (WIAT) — Neurologists at UAB and Children’s of Alabama are in the beginning stages of setting the groundwork for trials to treat debilitating seizures with an oil extract from marijuana.
The extract is called Cannabidiol, or CBD oil, and for the first time doctors in Alabama have state approval to study the controlled substance.
Legislators cleared the way by passing Carly’s Law last week. Governor Robert Bentley signed the bill just days ago.
On Wednesday, CBS42 spoke with the chair of UAB’s Department of Neurology about the steps that still must be taken before the drug can get into the hands of those who need it most.
Doctor David Standaert says that’s just a small step in a much longer process. Researchers also need to get clearance through federal agencies like the DEA, the FDA, and the IRB.
At best guess that could take at least six months.
“As soon as we get those regulatory approvals in place we can move ahead very quickly,” Standaert said. “Of course, the other element is supplying the medication. And there are companies that will manufacture this and make it available, but they’ve made it very clear to us that we need the regulatory approval before they will allow shipment into our pharmacies.”
The hospital will also have to define the study and set the rules of treatment, which includes understanding the side effects that come with treatment.
“Almost all drugs do have some side effects. What’s published about Cannabidiol doesn’t suggest they are very severe, but there are some side effects of this,” said Standaert. “Like any other medical treatment you have to ask the question of is the benefit of the treatment outweighed by any potential risks or side effects.”
The next step is to establish a panel who will select those who will be allowed to participate.
The panel will be made up of neurologists, pharmacists and attorneys.
With 40,000 people in our state suffering from seizures, interest is expected to be very high.
Doctors stress the study will not be exclusive to children.
As for the price? That will not be determined until all legal hurdles are cleared.
To apply for the study call the UAB Cannabidiol program at 205-975-8883 or email email@example.com
2014 WIAT-TV CBS42