TULSA, Okla. - A vibrant little girl is no longer developing the way she once was.
Her family said she suffers dozens of seizures every day inside their Tulsa home. In an exclusive interview with FOX23, the family talked about a form of medical marijuana that it's hoping will help give the child a chance at a better life.
Jaqie Angel Warrior was born a healthy baby girl.
At the age of 5 months, she started having seizures that have become more frequent and more intense. Now, her family told FOX23 her life is getting tougher by the day.
“She has clusters of seizures,” said Jaqie’s mother, Brittany Hardy.
“They're taking her eyesight. They're taking over her brain; they're taking over everything, [in] her development,” said Hardy.
They've seen countless specialists and tried various medications. "Mama's sorry for even having to give this stuff to you,” Hardy said to Jaqie.
“That’s only a portion of what we've had to try," Jaqie’s father, Kirk Warrior, said of the quantity of medicines in their home. “It's not fair for little Jaqie. She's trying her hardest in life,” Kirk said.
Desperate, they've asked their Tulsa neurologist to test a new form of medical marijuana on Jaqie.
GW Pharmaceuticals in the UK makes a medication called Epidiolex, which is made from what's essentially an oil extract from marijuana, known as CBD.
The company's website explains that Epidiolex does not contain THC, which is the ingredient that gets marijuana users high. It's an investigational drug.
When FOX23 contacted the FDA, it said so far it has only provided an orphan drug designated to treat rare diseases.
Since medical marijuana is illegal in Oklahoma, Jaqie's doctor has to get special permission to prescribe the drug. That process is still in the works.
Jaqie Angel Warrior tries hard to be just like any other toddler.
But according to Hardy, “She hyper extends. Seeing her not develop like other kids has been such a challenge for me."
On GW Pharmaceuticals' site results from a study of 19 children given CBD show that more than half reported an 80 percent decrease in seizures.
Little Jaqie's family is hoping it helps her. “I'm hoping for her seizures to stop,” said Hardy.
“She's awesome. My God is too, but she's awesome,” said Kirk. "Yeah, she's like, ‘You guys are talking about the seizures,’ and she's yelling about them too."
Sandy Walsh from the FDA’s Office of Media Affairs provided a response to FOX23’s inquiry on the orphan drug designation for Epidiolex:
“We are prohibited by law from discussing pending applications and investigational drugs, that is confidential so we’re not able to comment on the specific company or specific product.
The FDA reviews drug products to determine whether they are safe and effective for intended indications. The Federal Food, Drug, and Cosmetic (FD&C) Act requires that new drugs be shown to be safe and effective for their intended use before being marketed in this country. FDA's drug approval process requires well-controlled clinical trials that provide the necessary scientific data upon which FDA makes its approval and labeling decisions. If a drug product is to be marketed, well-controlled clinical trials are needed to ensure that drug is safe and effective when used as indicated. Efforts that seek to bypass the FDA drug approval process would not serve the interests of public health because they might expose patients to unsafe and ineffective drug products.
I can confirm that the FDA provided an orphan drug designation (for drugs intended to treat rare diseases) for Epidiolex to treat Dravet syndrome. But beyond that we don’t have any additional information to share.” -- Sandy Walsh, FDA Media Affairs
(We've attached the two links provided by the FDA to this story.)