FDA Green Lights Cannabis Study for Treatment of Epilepsy
On April 21 the Food and Drug Administration (FDA) gave the green light to GW Pharmaceuticals (GW), a UK-based company, to move forward in its research on the use of its cannabidiol-derived drug, Epidiolex, to treat epilepsy. This news comes on the heels of GW’s March 14 announcement that its Phase III epilepsy trials showed that patients taking Epidiolex achieved a statistically significant reduction in monthly convulsive seizures when compared to patients taking a placebo. That announcement sent GW’s stock price soaring more than 120 percent in one day of trading.
Clearly, this has been a momentous 2016 spring for GW and its shareholders. But what’s the impact for people in the United States, and more specifically, Missouri, trying to cope with this debilitating disorder?
According to the Epilepsy Foundation of America, approximately 3 million people in the United States have epilepsy. A total of 24 states, the District of Columbia and Guam now allow for comprehensive medical marijuana and cannabis programs. An additional 17 states (18 as of April 28, 2016 – Alabama), including Missouri, have enacted less progressive laws that allow for the use of CBD only in limited situations – mainly to treat intractable epilepsy.
Missouri’s law, enacted in 2014, provided for the issuance of licenses to two non-profit entities to grow, cultivate, process, and possess hemp and hemp extract, and distribute hemp extract to its CBD oil care centers. One of those entities is The BeLeaf Company (BeLeaf) located in Earth City which provides its CBD oil to patients across the state of Missouri.
Recently, I had the opportunity to correspond via email with Mitch Meyers, CEO and patient advocate of BeLeaf, regarding Epidiolex and the status of CBD oil in the United States and Missouri.
I assumed the good news for GW would mean bad news for BeLeaf. Meyers sees it another way, stating, “GW Pharma entering the epilepsy market using cannabis-based medicine proves the medical value of cannabis.” However, Meyers was quick to point out that not all CBD oils are created equal.
According to BeLeaf’s website, the company produces “whole-plant oil” with domestically produced hemp grown without the use of harsh chemicals. Whereas foreign produced hemp is often made using only the seeds and stalk of the hemp plant as well as with the use of harsh pesticides and toxins which may be dangerous for consumers.
According to Meyers, however, the bottom line is that “BeLeaf believes that anyone having seizures should be permitted access to CBD oil.” She added, “Waiting until an individual, especially children, have to go through three drug protocols that fail, is cruel and un-American.”
As such, Meyers would rather focus on the future of this industry and what needs to be done in order to allow sufficient access to CBD oil. There is no doubt educating the public regarding the efficacy of CBD oil in treating intractable epilepsy is critical.
However, the more effective approach to combat misconceptions and fears regarding CDB oil, and cannabis-based medicine in general, is to raise awareness regarding the vast array of additional medical conditions that can be treated using this drug. According to Meyers, BeLeaf’s CBD oil would be “very effective for Autism and other medical conditions.” In fact, “[BeLeaf is] working towards a research study with a very well-known research hospital to launch these studies.”
Of course, a shift in the public’s perception can only be perceived as a moral victory. Real change requires action from our government. To that end, Meyers indicated she recently spent three days in Jefferson City, MO, speaking with legislators about the benefits of CBD oil. “A few know and ‘get it,’” Meyers said, “but not nearly enough to influence legislation.”
Let’s hope that more of our legislators are willing to at least consider and, perhaps, even embrace modern scientific research regarding cannabis-based medicine. The news regarding Epidiolex is encouraging, however, we clearly have a long way to go.
Beleaf's Website: www.beleafco.com
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