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FDA Approves Cannabis-Based Epilepsy Drug for Children


Jun. 27 2018, Published 5:27 p.m. ET

The U.S. Food and Drug Administration (FDA) has approved a new medication to treat epilepsy that is derived from cannabis.

The drug in question is called Epidiolex. It is a liquid for oral consumption that is made from cannabidiol (CBD). CBD is the non-psychoactive portion of marijuana. The high experienced from smoking the plant comes from tetrahydrocannabinol (THC). The two components behave differently and impact different parts of the nervous system.

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Epidiolex is intended to treat two forms of epilepsy that predominantly affect children. The conditions are Dravet Syndrome and Lennox-Gastaut. Side effects of the drug include liver toxicity, as well as other non-life-threatening ailments such as fatigue, nausea, diarrhea, and vomiting.

The approval follows a review of four clinical studies on the use of Epidiolex for treating the two conditions in both adults and children. Currently, the drug can only be used to treat Dravet Syndrome and Lennox-Gastaut.

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At first glance this may appear to be a win in the fight to end the war on drugs. However this latest move from the FDA seems to confirm the suspicion of many that cannabis legalization and decriminalization will only truly come into affect in a way that benefits big business, like Big Pharma.

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Cannabis has long been classified as a schedule one drug. This classification means that it is treated as having no medical benefit and is in the same class as heroin and LSD. The classification also means dire consequences for people who use the substance. As recently as May of this year The New York Times reported on a couple who lost custody of their son, after allowing him to smoke cannabis in a desperate attempt to stop his seizures. It worked. The teen went 71 days seizure-free. The couple also faced possible fines and charges of reckless conduct.

In addition to the fact that the experiment worked, it is also notable that the couple did not go into it blindly. The use of cannabis to treat seizures has been known to be effective both by medical professionals and parents of children suffering with them. Dr. Anup Patel is a pediatric neurologist at Nationwide Children’s Hospital in Ohio. When discussing the studies that lead to the approval of Epidiolex he said to ABC, “We knew about the potential for CBD in seizure treatment for years, so we expected a response. Yet we were surprised at how robust the response was in this study.”

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The medical industry has known for years that cannabis and CBD, in particular, are not dangerous in the way that other schedule one drugs are. However, federal court rulings have kept CBD as schedule one. Now that the pharmaceutical industry is involved this could be set to change. ABC reported the steps that Epidolex needs to go though before it is released to the public. First and foremost, the DEA will move towards de-listing CBD as schedule one. This process and the process of negotiating prices is expected to take just 90 days.

It seems that the legality of cannabis varies on the person or organization involved. When it comes to the pharmaceutical industry the laws can be changed to suit them. When it comes to a select number of small cannabis-based businesses, the law just about works for them. But predictably, when it comes to everyday citizens, particularity those who are Black, the law continues to work against them.

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