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Colo. parents, nonprofit leaders react to FDA approval of CBD-based drug

Author: Ellie Mulder - June 25, 2018 - Updated: June 25, 2018

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Before trying the cannabidiol-based drug Charlotte’s Web, Kim Shaw Clark said she was waiting for the seizure that would claim her son’s life.

Caden, now 14, tried more than a dozen medications – from antipsychotics to benzodiazepines – and underwent brain surgery during their years-long attempt to relieve the symptoms of his Lennox-Gastaut syndrome, a severe form of epilepsy.

“Some of them he would have mild success, and the other ones he would just kind have none and just get all the yucky side effects,” Clark said.

> RELATED: FDA approves prescription-grade CBD oil for rare epilepsy disorders

As a last resort, she moved with her two sons to Colorado Springs in 2014 to try Charlotte’s Web – leaving her husband in Atlanta, where he works as a longtime police officer overseeing the department’s confiscated narcotics.

“We did not believe it would work,” Clark said. “We thought all of the people that lived in Colorado were a bunch of crazy pot-heads, giving their kids drugs.”

In this Feb. 7, 2014 file photo, a special strain of medical marijuana known as Charlotte’s Web grows inside a greenhouse, in a remote spot in the mountains west of Colorado Springs. (AP Photo/Brennan Linsley, File)

But for the first time in her son’s life, he began to have seizure-free days. Before taking the CBD extract, he would have up to 150 seizures a day. Now, on his worst days, he might have 25.

“Our best days before are sort of our worst days now,” Clark said.

The Food and Drug Administration on Monday approved the first prescription drug made from marijuana, Epidiolex, to treat Dravet and Lennox-Gastaut syndromes, two rare forms of epilepsy that begin in childhood.

The strawberry-flavored syrup is a purified form of a chemical ingredient found in the cannabis plant – but not the one that gets users high.

British drugmaker GW Pharmaceuticals studied the drug in more than 500 children and adults with hard-to-treat seizures, overcoming numerous legal hurdles that have long stymied research into cannabis.

FDA officials said the drug reduced seizures when combined with older epilepsy drugs.

The FDA has previously approved synthetic versions of another cannabis ingredient for medical use, including severe weight loss in patients with HIV.

Epidiolex is essentially a pharmaceutical-grade version CBD oil, which some parents already use to treat children with epilepsy.

“We’re excited about this development with the FDA, because we were told, you know, ‘It’s a Schedule I substance, it doesn’t have any medicinal value,'” Clark said. “We’re excited that more children are going to get access and that the government is finally validating what we saw all along – that it can help some of these children.”

But Paige Figi, the executive director of the Colorado Springs-based nonprofit Coalition For Access Now, said she was “outraged” by Monday’s FDA approval because it’s a step in the wrong direction for advocates of CBD.

She sees it as “this small little move to help a tiny percentage of kids that could potentially really throw this whole thing in reverse.”

Figi said she worries that the approval will lead the FDA to crack down on the CBD market and said “this is just one entity looking for a financial way to profit in this market.”

“A lot of people are saying this news, this FDA news, sort of legitimizes the use of (CBD) because it’s a drug now, a doctor can prescribe it, but I think we’re way past that,” she said. “This does more harm than good. I’m glad we’re pursuing multiple lanes – I think this should be available as a drug, as a supplement, I think this should be in your vitamins – (but) … I don’t think any of those lanes and companies should be shutting it down for anybody else.”

The solution, Figi said, is instead to decriminalize CBD-based products. Her organization supports legislation that would “exclude cannabidiol (CBD) and cannabidiol-rich plants from the definition of marijuana, therefore exempting CBD from the legal restrictions,” its website says.

“I am not encouraged or happy,” Figi said. “It’s going to be prohibitively expensive, and it’s going to shut down all the advocacy. People are going to think that a lot was done here because of all the positive news. They’re going to stop advocating for reform … and we’re absolutely not even close to being done here.”

While she’s cautiously optimistic about the development, Clark said worries the approval of Epidiolex could create hurdles for her son, who continues to use Charlotte’s Web.

“We hope we’re not going to be forced out of using a product that works for us while other children are getting broader access,” she said.

Treating the seizures can be a delicate process, said Clark, who returned to Atlanta after the medicinal use of CBD was legalized there.

“As our neurologist taught us early on with Caden, with these children, it’s like orchestrating a symphony within – if you get sort of a right formula in these catastrophic epilepsies, you don’t move it. You don’t change it,” she said.

CBD oil is sold online and in specialty shops across the U.S., though its legal status remains murky.

For some, using FDA approved products such as Marinol – a synthetic form of THC prescribed as an appetite stimulant – causes unneeded headaches.

“For families like mine, where pharmaceutical was a ball and chain for a decade of our lives, I don’t want to subscribe to that model,” Heather Jackson, the CEO of Colorado Springs-based nonprofit Realm of Caring.

The nonprofit is affiliated with Colorado-based CW Hemp, one of nation’s largest CBD companies, which produces Charlotte’s Web.

“These are families who have fought for their kids’ lives, and if what they are using is working right now, I can’t imagine they will look to something else,” she said.

The Associated Press contributed to this report.

Ellie Mulder, The Gazette

Ellie Mulder, The Gazette