FDA Approves CBD Epilepsy drug; Some in VT stick with Charlotte’s Web

Ed. Note: Why would anyone trade a drug that works and costs about $200 per month for one they don’t know and costs almost $3000 per month. The logic escapes us.

The U.S. Food and Drug Administration in June approved a cannabis-derived drug to treat severe seizures related to epilepsy, but some families are giving the treatment a pass. Epidiolex, the first FDA-approved drug from “an active ingredient derived from marijuana,” is a treatment for seizures associated with two severe forms of epilepsy. The drug is a cannabidiol, commonly known as CBD. And it doesn’t get you high. But Epidiolex isn’t the first CBD treatment for seizures.

Burlington parent Shelly Waterman, with the OK of pediatric neurologists, has been successfully treating her daughter Hannah, 16, with a CBD oil known as Charlotte’s Web for about three years. “We are sticking with Charlotte’s Web,” Waterman of Burlington said. “We know it works.” Charlotte’s Web is an extract oil produced from the whole hemp plant. Hemp is a type of cannabis plant with a very low tetrahydrocannabinol or THC. That’s the chemical that makes you high.

Marijuana experiment for children

Waterman’s daughter, Hannah, was diagnosed with a rare form of epilepsy when she was 11. The family fought to be able to use the hemp-derived drug in Vermont.

CBD is legal, but watch state lines

CBD products are legal in Vermont and other states, but medicines are tricky, according to Cary Giguere, director of the Vermont Agency of Agriculture’s resource management division. Vermont’s hemp program was large enough in 2017 to be considered a pilot program, which makes it legal to produce and distribute CBD products, if they contain 0.3 percent THC. But there are limitations. Growing under the national pilot program rules is not the same as growing under FDA rules, according to Giguere.

The company that produces Charlotte’s Web can’t make any medical claims on its website, according to cease and desist letters from the FDA.

Where’s that CBD from anyway?

Neither Epidiolex nor Charlotte’s Web are produced in Vermont, or even in the United States. The strain of hemp used to produce Charlotte’s Web oil was created by a family of growers in Denver, Colorado, but the product used by Waterman’s daughter comes from Uruguay, according to reports from Al Jazeera Amercia in 2014Extractor Frank Bianco during a Charlotte's Web ethanol
Extractor Frank Bianco during a Charlotte’s Web ethanol extraction, the solution is heated in a rotary evaporator from a high-CBD strain bred by the Realm of Caring at the ROC labs LLC. August 07, 2014 Denver, CO. (Photo: Joe Amon )

Joel Stanley of Stanley Brothers Inc., which developed the hemp variety which produces Charlotte’s Web, said they were beginning production in the South American country to avoid federal laws preventing the distribution of the medicinal-strength product across state lines. Epidiolex, which is produced in the United Kingdom, by GW Pharmaceuticals is the only CBD product not considered a controlled substance by the Drug Enforcement Administration.

Epilepsy is big business

Cost is another reason the Watermans are sticking with Charlotte’s Web. Epidiolex costs $32,000 a year, though many health insurance plans will cover portions of the cost. The Waterman’s spend about $250 per bottle on Charlotte’s Web for about about a month’s worth of the oil concentrate.

Epilepsy is one of the most common conditions affecting the brain, according to the Centers for Disease Control. Approximately 3 million adults and 470,000 children were living with epilepsy nationwide, according to 2015 data from the U.S. Census Bureau. The risk of Sudden Unexpected Death in Epilepsy due to seizures increases the need for drugs to prevent the spasms. About 1 in 1,000 adults and 1 in 4,500 children with epilepsy die from SUDEP each year, according to the Epilepsy Foundation, a nonprofit advocacy group.

 Contact Nicole Higgins DeSmet ndesmet@freepressmedia.com or 802-660-1845. Follow her on Twitter @NicoleHDeSmet.

Source: FDA approve CBD Epilepsy drug; some in VT stick with Charlotte’s Web

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