Texas Children's Is Studying a Seizure Drug Derived From Marijuana
Houston now has an unlikely new pot dealer. Well, sort of.
This month, Texas Children's Hospital will break new ground in medical marijuana research, starting an FDA-approved clinical trial of Epidiolex, an experimental marijuana-based pharmaceutical used to treat seizure disorders.
The clinic trial is the first of its kind, and during the study, the drug will be tested for safety and efficacy on a group of 30 children and adolescents who have been diagnosed with Dravet, a devastating disorder that can cause dozens of debilitating seizures each day.
The medication is unique because it utilizes CBD, an anti-seizure compound found in cannabis, as its active ingredient. That doesn't mean the kids in the study will be getting high on their pharmaceutical supply, though. That would be nearly impossible in this case.
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While Epidiolex is made from a derivative of pot, the medication contains no trace of THC, the psychoactive property in marijuana.
But glazed eyes or not, the fact that this will be study of a drug made from marijuana is nothing short of astounding, especially in Texas. After all, it can be nearly impossible to get approval for a clinical study of a treatment made from a Schedule 1 drug like marijuana.
There are federal loopholes that make clinical trials possible, but they're pretty complicated.
Because the Controlled Substances Act of 1970 deemed marijuana a drug with no medicinal value and high potential for abuse, to conduct (legal) clinical research on marijuana, you need a DEA license. Good luck with that.
Oh, and you can't just use any ol' bag of shake, either. You see, the United States has a tight grip on research-grade weed, and you have to use that super-sparkly government research-weed for your pharma-pot business. You can also only use those isolated compounds like CBD, and the drug must be approved as scientifically valid by a Health and Human Services scientific review panel before it can go into clinical trials.
Given the parameters for studying pot-based pharma, it's fairly obvious why the Epidiolex clinical trials are receiving all of this hype. But in reality, this is hardly the first time CBD has been used to treat a seizure disorder. It's just the first time the FDA has given it the go-ahead.
The cannabinoid was already plenty popular on the anti-seizure front, thanks to a cannabis oil known as Charlotte's Web.
First marketed by the medical cannabis nonprofit group Realm of Caring, the oil has become a medical marijuana dream machine. With the plant, made by splicing a CBD-rich strain of marijuana with industrial hemp, the folks behind Charlotte's Web have figured out a way to eliminate the use of THC while increasing one of the plant's anti-seizure properties.
Removing the THC has also made Charlotte's Web less offensive to anti-drug activists, which, in turn, makes for an easier sell to parents and lawmakers alike. The popularity has even led to a chain of CBD-only bills being introduced across the nation, including a federal bill aptly named "Charlotte's Web Hemp Act of 2014."
The bill, propelled by the brothers running Realm of Caring, aims to reclassify CBD and "therapeutic hemp," while removing it from any association with marijuana. Should it pass, it will essentially legalize CBD across the nation.
On the surface, a federal CBD bill would seem a victory for medical marijuana. But by reclassifying CBD, it won't do a damn thing for the rest of the marijuana plant -- or anyone with a diagnosis that falls outside of the Dravet community.
That legislation will legalize only one cannabinoid -- CBD -- and will leave the actual marijuana plant and 85 other cannabinoids illegal for people in prohibition states.
That may not be a big deal to Realm of Caring, who stand to become the primary suppliers of Charlotte's Web should the CBD legislation they're pushing for pass.
That may also not be a big deal for the pharmaceutical company behind Epidiolex, whose medication -- the first of its kind -- is derived from CBD.
But it is a big deal for the patients who have illnesses that don't respond to just CBD. You see, they need clinical trials on other cannabinoids, and keeping the plant illegal keeps other clinical trials mostly out of reach.
Hopefully this Epidiolex clinical trial is just the first of many to come. Otherwise, there will be some very ill patients in desperate need of THC, or some other derivative of marijuana, who are left behind in the CBD dust.