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Pediatric Epilepsy And Epidiolex

Branna Z.
cannabis, Epidiolex, CBD, THC, CBD extract, pediatric epilepsy, seizures, FDA-approved, legalization, USA

Pediatric epilepsy is a condition that can be life threatening. We now have clinical evidence cannabis works, so when will patients get universal access?

There has been an increased interest during the past decade in using cannabis for pediatric epilepsy. This is partially due to the anecdotal evidence from parents reporting a decrease in seizures in their own children. There are signifiant roadblocks, however, for parents trying to access legal sources of cannabis medicine. The knowledge/support of the prescribing neurologist, and the legal status in their home state, are the two biggest.

Pediatric Epilepsy and Defining Medicine

There is growing evidence in the clinical support of cannabis treatment for pediatric epilepsy, but there remains a big hesitation in the opinions of the healthcare professionals as to the effectiveness and safety of cannabis for kids. And that has everything to do with our experience and expectations of clinically trialled “medicine.”

In 2014, a  study investigated the oral cannabis treatment of 58 children (average age of 7), at the Children’s Hospital in Colorado, suffering from refractory epilepsy. Of the 48.3% of children whom experienced improvement in seizures, about 31% reported greater than 50% reduction in seizures. Significantly, parents also reported improvement in alertness, behavior, and language.

Currently, there are 37 registered clinical trials using different forms of cannabis for the treatment of pediatric epilepsy, which will result in an abundance of the new data in the coming years. This volume of research indicates definite optimism. It shows that preliminary data warrants further investigation into the use of cannabis for pediatric epilepsy.

Epidolex

In June 2018, the FDA approved the pharmaceutical, Epidiolex, which is CBD derived from the plant and formulated into an oral solution for the treatment of seizures. Experts reccomend the drug for the treatment of two severe-forms of epilepsy: Lennox-Gestaut, and Dravet, syndromes, in patients two years and older.

This is the only CBD drug the FDA will approve at this time. It was a unanimous decision of the FDA agency to approve the drug, after the conclusion of 3 well-controlled trials of 516 patients with either Lennox-Gestaut or Dravet. The clinical trials generated substantial evidence of the effectiveness of CBD for stopping seizures.

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Is Epidolex Legal?

Whereas Epidiolex is legal in all 50 states, provided the child has a prescription, the cannabis plant is not. There are some legitimate limitations to the unregulated cannabis market in that individual states have different processing and extraction regulations. Even within the harvesting of the plant, there can be variances in cannabinoid concentrations. These depend on when the farmer harvests the plant. And extraction processes can also affect cannabinoid concentrations.

The concern is that growers who make the preparations of cannabis don’t have the technology to control for medicinal consistency batch to batch.  All these conditions (grow, harvest, processing) must be the same in order for treatment of pediatric epilepsy to be consistently successful. Still, all of these issues exist precisely because cannabis is illegal.

The legal barriers still exist in the US because the state and federal law are not in harmony. Cannabis comes under Schedule I, meaning doctors will have difficulty prescribing it. In fact, the law forbids the majority of physicians from prescribing cannabis, even if they think it might help. This, in the end, impedes research as well, in terms of progress, access to quality cannabis with which to trial, and time/money required to complete clinical trials.

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FDA Approval

Approving Epiodiolex is a double edged sword in many ways. On the one side, it paves the way for cannabis’ acceptance as mainstream medicine. The other, however, leaves the development of cannabis medicine in the hands of Big Pharma.

There is no doubt that cannabis helps stop the seizures associated with pediatric epilepsy. All of the anecdotal evidence is also there, from families living with the condition. Big Pharma has gone through the expense of clinical trials to prove CBD works, now we need the funding and permissions to pursue natural cannabis medicine, without dangerous additives and side effects, and with different ratios of cannabinoids that can be grown according to patient needs. This, the possibility of personalizing medicine according to individual patient needs, is perhaps the most interesting, and important, aspect of cannabis medicine. With it, cannabis will certainly triumph over Epidolex.

In the meantime, which medicine would you choose for your child?

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Branislava Zagorac
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