The little victories of motherhood are more rare for Kate Hintz than they are for other moms.
Kate’s daughter, Morgan Jones, was born with a rare form of epilepsy called Dravet syndrome.
At age 3, Morgan cannot speak, sit up or stand. She is impeded by as many as 30 seizures a day, and by the numerous medications that she takes to try and control them.
"We don’t call them milestones, we call them 'inchstones,' because they’re so tiny, but to us they mean just so much," said Hintz.
But a new drug trial taking place now at NYU has the potential to dramatically change Morgan’s life.
The drug, Epidiolex, is made from CBD, a component found in marijuana that does not alter a person’s mental state, but may help with some medical ailments. It’s the first trial of such a drug – but some parents of children with Dravet syndrome have used an oil made from CBD in Colorado, where marijuana is legal, and report that the effects are dramatic.
"It would potentially be a dramatic breakthrough for those patients," said Dr. Orrin Devinsky, who is heading the trial.
Devinsky, director of NYU’s Comprehensive Epilepsy Center, says while parents are giving CBD oil to their children in Colorado, there has been no real research confirming the oil’s benefits. And Devinsky says it has been a nightmare getting through the red tape associated with testing marijuana.
“Doctors are being shackled by thoughts and misperceptions of the 1920s and 1930s,” said Devinsky. “And yet you've got progressive states legalizing marijuana products and giving it to children who are 2 years old without any data on the safety."
The FDA said in a statement that it is prohibited by law from discussing pending applications so it cannot comment on a specific trial, company or product. But FDA officials say they support the desire to study marijuana in scientifically valid investigations, in line with the FDA’s drug approval process.
“FDA has approved two drugs, Marinol and Cesamet, for therapeutic uses in the U.S., which contain active ingredients that are present in botanical marijuana,” said FDA spokesperson Sandy Walsh.
While Gov. Andrew Cuomo is moving toward allowing a limited number of hospitals to dispense marijuana for certain ailments, experts say it will take years before the drug reaches Morgan and other children in need, if it ever does. Morgan was not accepted in Devinsky's current trial, and that too is likely to take years to get to patients.
“This is extremely frustrating,” said Hintz. “Parents and doctors, we have one common goal and that’s to stop seizures safely.”
Hintz dreams of packing up her family and moving to Colorado, where she might be able to get access to the oil that could help her daughter. But leaving the place you have lived your whole life in search of a medicine that you don't know for sure will help your daughter is a lot to consider.
“Frankly, it infuriates me,” said Hintz. “Why would this be my only option?”
Devinsky says the first trial will include about 25 children but these results will not be considered conclusive until he can run another trial with placebos, to truly test the impact of these drugs.