Antecdotal Epidiolex

When Senator Gillebrand mentioned in The Senate Caucus on International Narcotics Control hearing about the current state of cannabis research being primarily in the hands of one pharmaceutical company, she was talking about GW Pharmaceutical. They’ve been working on marijuana based medicines in top “secret locations” at least since the mid nineties. Their highly anticipated CBD pharmaceutical medication, Epidiolex, is in the middle of phase 3 clinical trials. And considering how much parents talk about pediatric cannabis, the families in these trials have been noticeably missing from the dialogue. Naturally, with all the hype and hush-hush, I couldn’t help but be curious.

Hank’s mom Megan told me they weren’t suppose to talk to other parents - “maybe to avoid the placebo effect?” she wondered. (She can talk about it now because their portion of the trial is over.) This is impossibly hard for me to imagine, because our group of moms has been meeting monthly for over a year and a half. What would I have done without their friendship, support and wisdom? But then again, Megan had a doctor to advise her. Which, in the beginning at least, I couldn’t have imagined either.

Megan and her family live in Illinois. I’ve only spoken to 2 moms who have a child with Doose Syndrome and she’s one of them. So I felt instantly connected to her good-natured, raspy voice. She told me they were figuring out how to move to Colorado when her 7 year old son Hank was accepted into the Epidiolex clinical trial. So in July of 2014, just about 6 months after my son started an “artisanal” form of CBD (because that’s all that was available to us), her son started a pharmaceutical form of CBD (because that’s all that was available to them). You can learn more about their story here.

It didn’t take long for Megan to hook me: “Epidiolex gave us our happy little boy back.” Because isn’t that the nut right there that makes any form of CBD such a miracle for our kids. Instead of encouraging cognitive decline and decreasing quality of life, like the bulk of our current pharmaceutical options (i.e. “dope-a-max,” “depa-dope” and “kepp-rage”), CBD “anecdotally” does the opposite by increasing cognitive functioning and quality of life.

She went on to tell me that within 6 months of adding Epidiolex to his treatment Hank went seizure free and stayed that way for 6 months. And during that time, he began to develop. Hank is nonverbal and she said prior to CBD his development was so low they didn’t really know where to place him on a developmental scale - less than a year maybe? But while seizure free, he tested at a Pre-K level. (With therapy and accommodations obviously, but who cares.) Benefits she noticed include increased speech, increased sleep, increased motor skills, increased engagement with people and activities, increased focus, increased memory retention, and decreased anxiety. She only knew 2 other families in the trial. They also reported large reductions in seizure frequency, although not as significant as Hank, and huge cognitive gains.

I reached out to another mom in Utah I know with a child in an Epidiolex trial. She pointed me in the direction of a panel she spoke on where she reported a 10% reduction in her son’s seizure count, as well as huge cognitive gains. She highlighted a disappointing part of their experience that I think is significant - that the study will reduce their results to a fail.

But I hear this mother - for us any reduction in seizure count is a success. Particularly when quality of life increases. I did some math. Depakote dropped my son’s seizures 80% and made them considerably less violent. For that I’m incredibly grateful. But it also slowed him down. That was by far one of the more creepy and chilling parts of our journey - watching my sharp son suddenly struggle to find words or put sentences together, not be able to sing, watching him subtly and slowly start to disappear. We were beyond relieved and grateful to see those side effects reverse when we had to reduce the Depakote 25% after adding CBD.

What might quantitatively look like minimal improvement may qualitatively be huge. A 10% reduction plus huge cognitive gains is a lot more than a lot of families get with our current options. And how do you really weigh that 10%? Megan told me that her family hadn’t slept more than 2 hours at a time during the night for years and years and years. But sleeping through the night was one of the first improvements they saw. How life changing is that? If we have to learn to live with seizures (and tragically many of us do), can’t our kids and families have a life too? Anecdotally, Epidiolex would say yes.

But, of course, we’ll have to wait and see the research to know for sure! In the meantime, those of us in the “artisanal” camp aren’t surprised. The ground level reports of Epidiolex sound about the same as what we’ve already been learning on our own - CBD can definitely lead to a good reduction in seizure count, if not to complete seizure freedom, and huge cognitive benefits.

So does this mean Epidiolex will replace artisanal products? I doubt it. In the hearing, Dr. Tomas Minahan pointed out the number of challenges our community has to face when going the artisanal route, including weeding through products that are expensive and of questionable, inconsistent quality. Theoretically, a pharmaceutical version would resolve these issues. Yet it takes a while for insurance companies to cover a new medication and Epidiolex is rumored to be upwards of $1,000 a month. And what if your child doesn’t respond to that stabilized product? What if your child (gasp!) even needs a little THC?

There isn’t a lot we know about treating epilepsy, but one thing we DO KNOW is that individual responses to all of our options vary greatly. So if you try Epidiolex and it doesn’t work, does that mean you can check cannabis off the list? Absolutely not. There are real differences between the two products. Artisanal oils, very basically, extract the whole plant material. This includes the CBD, THC and all the other cannabinoids and terpenoids that naturally exist within the plant. GW Pharmaceutical, very basically, has just extracted the CBD. Some say that to be therapeutic, you need it all for the “entourage effect,” but GW is banking that you don’t. So which is more effective?

I’m going to take a stab at answering that ever so important question - the most effective option will be which ever one your child responds to. So its not a matter of better, its a matter of more - we need as many treatment options as possible. There is account after account of children doing horribly on one strain of cannabis and bouncing back after switching to a different one. In my simple mind, Epidiolex is just another strain.

Your unique situation and individual child will inform you which will make the most sense to try first. Rumor has it that the FDA should give the green light to Epidiolex by this fall or spring. And if you can’t wait for their approval or generic pricing and need ACCESS NOW, CW Botanicals is already shipping their high CBD product, Charlotte’s Web, into almost every state, as well as Canada. Over time, I definitely see families using both forms - individually, together, with and without pharmaceuticals. But in the meantime I’m here to reassure you, if one form of CBD doesn’t work DON’T NECESSARILY GIVE UP on cannabis.

From different kids, to different strains, to different ratios, to different extraction methods, to different carrier oils, to different cannabidiols (including THC!) - cannabis brings options. And where you find options, YOU FIND HOPE.