The approval of Epidiolex, the CBD-based drug approved by the FDA last week, is exciting news for both the Lennox-Gastaut Syndrome (LGS) and Dravet communities. Patients with either of these rare and severe seizure disorders will soon be able to try Epidiolex, which is the first FDA-approved drug that contains a purified drug substance derived from marijuana. But, along with this announcement comes some questions and concerns.
My son, Julian, is 10 and was diagnosed with LGS at 4-years-old. He was born not breathing, suffered brain damage at birth, and diagnosed with cerebral palsy at 6 months old, bringing along with that developmental delays and numerous therapies. He had a tonic-clonic (grand mal) seizure lasting an hour and 45 minutes when he was a year old, but no more until he turned 4, when daily seizures became our reality. We tried medication after medication, having tried and failed 15 anti-epileptic drugs by the time Julian was 5. One medication even gave him a severe side effect, and it was at that point that I thought there must be a better way.
It was early 2013 at the time, before the CBD craze would hit the epilepsy community, and before any clinical trials on Epidiolex had begun. But I had heard medical marijuana could help seizures, so I did some research and we embarked on trying to find a better treatment for our son. But, again, this was before artisanal CBD-based products were readily available, so we had to get creative.
I am lucky enough to live in California, where medical marijuana has been approved for use since 1996. This means that while other families were moving from their homes to states where marijuana was legalized, my family could stay put and try it without fear of prosecution. We also live in a very supportive community, and were soon put in touch with growers who had access to CBD-rich marijuana strains. CBD, or cannabidiol, is just one of the 113 cannabinoids found in cannabis. It has been shown to have medical benefits without the psychoactive effect of THC, so I was not worried that my 5-year-old would get "high".
We began to make CBD tinctures in our home, using a series of different methods and recipes. Our kitchen looked like a science experiment with
Bunsen burners, distillers, and other equipment. After the tincture was made, we would have it tested at a lab to know exactly how many milligrams CBD were in the concoction so we knew how to dose our son. Making the tincture is a long and laborious process, but with worthwhile results. Julian went from having 20 to 30 seizures a down to one to two a day. He even went seizure-free early on.
But taking this on did not go without some missteps along the way. Because marijuana is still federally illegal, many doctors cannot and will not give advice when it comes to using medical marijuana, so we essentially went through a trial and error process. We tried various strains of varying CBD to THC ratio. Too low of a dose and his seizures returned. Too high, and his appetite went away. There are also possible drug interactions with seizure medications, so that had to be considered as well.
I also learned that every child is different. Even children with the exact same diagnosis and seizure types. What may work for one child may not work for the next. That is true with any seizure treatment, and CBD is no different. Marijuana strains have varying ratios of CBD to THC, and each child responds differently to those ratios. Julian just so happens to respond well to a very high CBD to THC ratio. With our kitchen-made CBD tincture, we have gotten anywhere from a 20:1 to a 35:1 ratio, which is a huge difference.
And this brings me to Epidiolex. While there are numerous factors affecting the outcome ratio of a CBD tincture (growing conditions, how the medicine is made, what oils are used, etc.), having a product that is made in a controlled environment has its benefits. My biggest frustration with artisanal CBD products, including the ones I make for my son, is consistency. It is impossible to get the same product every time. So knowing that there is a drug out there that can guarantee consistency in every bottle makes me breathe a sigh of relief.
In addition to consistency, I would opt to try Epidiolex due to the cost of artisanals, or making it yourself. In the last five years, we have spent thousands upon thousands of dollars making and buying CBD. I like the idea of insurance covering the cost of a CBD-based medication. At least, it is our expectation that insurance will cover Epidiolex.
However, I also know Epidiolex may not be right for every child with LGS or Dravet. There is anecdotal evidence to show that whole plant is more beneficial to some children. Epidiolex is 98% CBD, and some kids just need more THC. There are also other cannabinoids being studied (like CBG and CBN) that have shown to have medicinal benefits. There is just so much more to be studied with this plant, but at least we are headed in the right direction.
After four years of clinical trials, Epidiolex has shown efficacy in LGS and Dravet patients. And the FDA has finally approved the drug. Now, the DEA must reschedule CBD (or marijuana as a whole plant) so the drug can be marketed. Then there is the question of cost. As I mentioned, it is my expectation that insurance will cover it, but we don't know if we will need to fight to get approval once it's available.
It will still be a few months before we have these questions answered, or until all LGS and Dravet patients will have Epidiolex as an option. But, at least we will have the option. And that is a boon for our community. Because after all our kids go through, we should at least be able to try to something that may help them. I have been lucky to be able to try CBD for my own son, and am elated that others will have this option as well.
Have more questions about Epidiolex? LGS Foundation’s Director of Research and Strategy, Tracy Dixon-Salazar, Ph.D, will answer questions about the approval of Epidiolex and what you can expect on a Facebook Live event Thursday, July 12, at 8 p.m. Eastern time/5 p.m. Pacific Time. To see the Facebook Live event, go to www.facebook.com/lgsfoundation.