9 Facts about Cannabidiol (CBD) Oil and the Texas Compassionate Use Act

The Texas Compassionate Use Act (Senate Bill 339) was signed by Gov. Greg Abbott and became effective June 1, 2015. The bill required the Texas Department of Public Safety to create a secure registry of physicians who treat epilepsy for the purpose of prescribing low-THC cannabis to patients who have been diagnosed with intractable epilepsy.

The bill required DPS to license at least three dispensing organizations by Sept. 1, 2017, should they meet requirements.

On Feb. 8, 2018, the first medical dispensary in the state of Texas will open.

What does all of this mean for children with epilepsy?

1. What is it in the cannabis plant that helps treat epilepsy?

The truth is we don’t yet really know. There are over 500 chemical compounds in the cannabis plant and over 100 of them are plant-based cannabinoids (phytocannabinoids) which may interact with the endocannabinoid system of the human body and treat disease. Cannabidiol (CBD) is a non-psychoactive component (i.e. does not produce a “high” feeling) and has been most widely studied so far for epilepsy. It does not interact with either of the two known cannabinoid receptors in the brain and its mechanism is still unclear. Tetrahydrocannabidiol (THC) is the component in the plant that produces a high and does interact with the cannabinoid receptors, but for many reasons, is not likely to be a good choice as an antiepileptic compound.

2. What is CBD oil and what types of CBD oil are now legal in Texas?

A CBD oil is an oil made from a cannabis plant that is high in CBD and typically lower in THC. The oil may contain amounts of multiple other compounds found in the plant as well. The 2015 Texas Compassionate Use Act allows for “high” CBD (more than 10 percent by weight)/”low” THC ( less than 0.5 percent by weight). This is slightly higher than the amount of THC (less than 0.3 percent) allowed in a plant to be considered hemp. Hemp oils are produced from these lower THC plants and are often a poor source of CBD but have been legal and widely available.

3. People on the Internet already say CBD oil works, so why aren’t all doctors OK with using it over typical medications prescribed for seizures?

All FDA approved antiepileptic medications have gone through rigorous studies to prove they work and they are safe to use. The studies are blinded and placebo-controlled which means neither the doctor nor the patient knows whether they are getting the real drug or a placebo until the study is complete. This helps remove bias (i.e. people feeling like their seizures are better because they know they are taking the real drug). It also helps separate which side effects are due to the drug and which occur randomly in the course of life (for example fevers, rash, nausea which can occur commonly regardless). CBD has only recently been tested in this type of rigorous study – more on this later – and the other components of the plant lack this type of research so far.

4. If CBD has already been studied, why are some doctors still hesitant to recommend CBD oil?

When people are treated with typical antiepileptic drugs, they are taking a single compound, like carbamazepine or levetiracetam for example. When you get a CBD oil, you get a substance that may have a high amount of CBD, but it also can contain varied amounts of the multiple other compounds from the plant. We do not know how effective and safe those other compounds are, so we must be cautious to recommend it to treat your child. Currently, there are no testing standards to make sure the CBD oil you get from a company contains what the label says, thus the formulation may change some from month to month – something akin to getting a different generic antiepileptic medication each month. While all CBD oils contain the similar CBD compound, they may be produced from different types of plant, using different growing techniques/conditions, and manufactured with different processes – thus creating different medications with different other compounds included. Think of it as being prescribed a sodium-channel drug like carbamazepine, but potentially getting one of multiple other sodium channel drugs such as oxcarbazepine, phenytoin, rufinamide, lamotrigine, etc. So doctors aren’t necessarily averse to CBD oils, we just have to be realistic about their limitations.

5.What did the studies of CBD show?

First, understand that the Greenwich Biosciences CBD compound Epidiolex is not the same as the CBD oil you get from a dispensary. It is a nearly pure CBD substance produced under strict standards to ensure the drug is the same with every batch. In 120 patients with Dravet syndrome, 43 percent on CBD had more than 50 percent reduction of convulsive seizures versus 27 percent on placebo. This was actually not a statistically significant difference. In 171 patients with Lennox-Gastaut syndrome, 44 percent on CBD had more than 50 percent reduction of drop seizures versus 23.5 percent on placebo and this was significant. From these results we can conclude that CBD does appear to have some antiseizure effect, but it is not necessarily any better than most other available drugs. It is also not without side effect, as diarrhea (19%), sleepiness (15%), fever (13%), decreased appetite (13%), and vomiting (11%) were reported. So CBD is an option for epilepsy treatment, but is not likely to cure every patient.

6. How does the Texas Compassionate Use Act work?

Under this law, doctors can register to recommend CBD oils only to patients with intractable epilepsy. To register, a doctor must be board certified in Neurology or Child Neurology and must also be certified in Epilepsy/Neurophysiology or spend more than 50 percent of their practice treating patients with epilepsy. If a registered doctor feels CBD oil is appropriate for their patient because the patient has tried all reasonable, better-studied and available treatment alternatives, the doctor can recommend an amount of CBD to be taken. This recommendation must be approved by a second registered doctor who reviews the case and agrees with the decision. Registered patients can then go to one of three dispensaries in the state to get a CBD oil.

7 .Will the CBD oil be covered by insurance?

No. As this is not an FDA approved treatment, it is unlikely any insurance company will cover the cost. The price is typically several hundred dollars per month depending on the amount of CBD recommended.

8. Now that we have this law, it is legal right?

The cannabis plant and all the components of the plant remain a schedule 1 substance on the Drug Enforcement Agency’s list- meaning it has no medicinal value and is illegal. CBD is part of the plant and still falls under this category for federal law despite what a state law may say. While the 2013 directive from the Department of Justice indicated they had better things to do than prosecute people following the laws of their state, Jeff Sessions reversed this opinion several weeks ago – thus it is unclear how the federal government will choose to deal with CBD oils now.

9. When will a pharmaceutical grade CBD oil be available?

Greenwich Biosciences has submitted their drug, Epidiolex, to the FDA for approval December 2017. While the FDA could take years to rule, they have indicated their plan is to rule on approval by summer 2018. Once approved, this drug would be obtained from a pharmacy, prescribed by a doctor, and more likely to be covered by insurance.

Previously on this topic:

• Texas legalizes non-euphoric cannabdiol for seizures in epileptic patients
• Drug in Cook Children's epilepsy trial shows positive results in separate trial
• Success in CBD study: Cook Children's researchers play a vital role
• Cannabis oil trial ongoing at Cook Children's
• Study: Cannabis Oil Can Dramatically Decrease Epileptic Seizures