USDA recommends Cannabis-Derived Drug Approval For First Time Ever
By Roger Malespin photo/istock.com/Visivasnc
The US Food and Drug Administration has recommended the approval of Epidiolex, a drug used to treat severe forms of epilepsy called Dravet syndrome and Lennox-Gastaut syndrome. This is the first time in history that the USDA has recommended the approval of a cannabis-derived drug, marking an important step in the growing de-stigmatization of cannabis in America.
Epidiolex’s active ingredient, cannabidiol, also called CBD, is one of the chemical compounds found in the cannabis plant, but is totally non-psychoactive. Dr. Igor Grant, director of the Center for Medicinal Cannabis Research at the University of California San Diego, praised the decision.
“This is a very good development, and it basically underscores that there are medicinal properties to some of the cannabinoids,” he said. “I think there could well be other cannabinoids that are of therapeutic use, but there is just not enough research on them to say.”
What Dr. Grant is referring to is the fact that despite many states legalizing cannabis for medical and/or recreational use, it remains a schedule 1 drug at the federal level - the same as heroin, LSD and cocaine - meaning it is considered to have “no currently accepted medical use and a high potential for abuse.” Because of this status, no federal funding can be allotted to research into the medical benefits of cannabis.
The restriction made co-author of the study, Dr. Daniel Friedman, go through a more complex set of rules in order to conduct his study on Epidiolex, including having a special license from the DEA and special equipment, and “all that infrastructure makes it prohibitive to do studies in other conditions by people who may want to do so, but don’t have the resources,” he said.
Lennox-Gastaut syndrome and Dravet syndrome are regarded as among the most severe forms of epilepsy, with almost all patients continuing to suffer seizures with current treatment methods. The F.D.A. wrote that GW Pharma had submitted positive results of efficacy from three randomized, double-blind, placebo-controlled trials conducted with Epidiolex in patients with both diseases. While the FDA is not bound to follow the committee recommendations, they often do. Epidiolex would be the first in a new class of cannabis-derived drugs to treat epilepsy.
This is one of many instances of the federal government’s classification of cannabis as a schedule 1 drug shamefully working against the interests on medical progress and patient comfort. With their hands all but tied, Friedman’s team managed to conduct the proper research and experiments to get the FDA to recognize the benefit of cannabinoids for the first time ever. If they had the funding and easy access to testing as government approved research, there’s no telling what benefits researchers could find.
Declassification of cannabis at the federal level is an essential part of the legalization movement. Though the tide seems to be turning in our favor, advocates are urged to stay politically active, even something as simple as writing to your congressman. Health issues affect everyone in society, young or old, and the government has a moral duty to allow scientists to follow any promising leads that will help those who suffer from epilepsy and other illnesses..