Before the 2019 Texas Legislature passed House Bill 3703, the medical use of cannabidiol (CBD) products in Texas was confusing for physicians and authorized only a narrow group of patients: people with intractable epilepsy.
Thanks in part to the new state law, it’s still confusing and includes a somewhat larger group of patients – all patients with epilepsy as well as those with seizure disorders, multiple sclerosis, spasticity, amyotrophic lateral sclerosis (ALS), autism, terminal cancer, and incurable neurodegenerative diseases.
Confusion has been fueled by another 2019 measure: House Bill 1325 legalized the production and sale of hemp and some products derived from hemp that have high levels of CBD, which is non-euphoric and has low levels of tetrahydrocannabinol (or THC), the psychoactive element in marijuana.
Previously, hemp-based oils were not legal in Texas. The state had permitted only three state-regulated dispensaries to create medical-grade CBD oil, though non-medical grade oil could be widely – if illegally – purchased over the internet. HB 1325 changed all that. It made the sale of non-medicinal-grade CBD oil legal. Now, that kind of oil can be found in grocery stores and farmer’s markets across Texas.
As access increases, perhaps the biggest problem physicians will face concerning CBD oil is educating themselves about it in a fast-changing medical, regulatory, and economic landscape, says M. Scott Perry, MD, the medical director of neurology at Cook Children’s Medical Center in Fort Worth. More research would definitely help physicians make better decisions about when and when not to use CBD oil.
“Physicians as a whole are still not nearly as educated as they need to be or probably as comfortable as they need to be with CBD,” he said. “Some of that is just because the information’s just not there. How exactly does it work? We’re not really sure. …What’s the dose supposed to be? A lot of that’s going to be up to trial and error to figure it out.”
The heightened availability of non-medical-grade CBD oil, combined with abundant misinformation on the internet, also has helped create health problems, says Sami Aboumatar, MD, an Austin neurologist who specializes in seizure disorders. Many patients don’t know there’s a difference between medical and non-medical grade CBD oil. About 15% to 20% of the epilepsy patients who see Dr. Aboumatar add CBD oil to their anti-seizure medication regimen. Another 5% use CBD oil to replace their medications completely.
“They get from their reading that if they consume marijuana products that should be enough for their seizures, so they don’t take their seizure medication,” he said. “And as a result many injuries and accidents … frequent back-to-back seizures happen because they thought those products should be enough, or that the chemicals [in them] are more natural and have less potential for risk for their bodies.”
While the market for non-medical-grade CBD oil has grown, the effort to revamp the bureaucratic framework for medical-grade CBD oil under HB 3703 is expected to grind on until at least December, says Karen C. Keough, MD, an Austin neurologist registered to prescribe cannabis oil legally. For instance, the Texas Department of Public Safety has yet to determine the list of physician specialties that now can prescribe CBD, and the Texas Health and Human Services Commission has yet to create the list of neurodegenerative diseases that can be treated with CBD oil.
“There’s still work to be done to make this happen,” she said.
Meanwhile, HB 1325, the law that legalized hemp production, may inadvertently push marijuana use in unexpected directions. The law redefined marijuana in a way that makes it difficult for law enforcement lab tests to tell the difference between marijuana and hemp. As a result, several big cities in Texas have thrown out or postponed low-level marijuana-related criminal cases.
This is mostly a criminal justice issue, and it’s too early to tell if this will encourage wider illegal use of marijuana, says Dr. Keough, who also is medical director for Compassionate Cultivation, one of the three state-sanctioned dispensaries. But it certainly feeds into critics’ argument that using CBD oil or similar products normalizes the use of marijuana as a recreational drug.
“That’s an additional problem, for sure,” she said. “It’s important to emphasize that medical use of CBD is not the same as smoking or ingesting marijuana.”
Great expectations
Texas moved toward greater CBD use in 2015, when lawmakers approved the Compassionate Use Act. It allowed CBD oil to be used for the first time legally in the state, but only to treat intractable epilepsy. The law also allowed for the creation of three CBD oil dispensaries. The Texas Medical Association at the time testified in favor of further study on the use of marijuana products as medicine. (See “Texas Medical Association Policy on Cannabis Products,” below.)
Anecdotally, CBD is touted as a treatment for all kinds of illnesses, including those spelled out in HB 3703, like spasticity and autism. But even when the bureaucratic problems with CBD regulation are ironed out later this year, it’s unlikely physicians will rush to prescribe it for anything other than epilepsy because the scientific evidence that CBD helps with other illnesses is still being developed, Dr. Keough says.
“We expect to see only gradual involvement from doctors in the non-neurology world because it’s too hazy,” she said. “There’s not enough evidence-based guidance for people to feel really confident that, ‘Well, I’m going to sign my name to that prescription.’ But there is more and more data all the time about what CBD can do for these various conditions.”
Meanwhile, the CBD oil sold in stores remains subject to little or no regulation, she says. That means the chemical composition can vary greatly not just from maker to maker but from bottle to bottle. (See “CBD 101,” below.)
“There isn’t any way [for patients to tell what’s in most CBD oil] short of doing some sort of chemical analysis of every bottle they get,” Dr. Keough said.
When CBD oil first became available, one of physicians’ biggest challenges was tamping down expectations about what it could treat. (See “Oversold: Has Cannabis Oil Been Overhyped in Texas?” May 2018 Texas Medicine, pages 32-34, www.texmed.org/CannabisOil.) Some of that hype has dissipated, but many patients still turn to CBD with hope, says Dr. Perry.
“There’s no shortage of patients asking about it,” he said. “I get asked about it multiple times a day.”
However, neither patients nor the dispensaries are happy with the current economics of CBD oil. Because it’s not a drug approved by the Food and Drug Administration (FDA), CBD oil is not covered by insurance. One month’s dosage can cost up to $3,000, Dr. Aboumatar says.
HB 3703 may improve both demand and supply by expanding the list of illnesses that can be treated and giving the dispensaries a larger patient base, says Dr. Keough. The law also makes prescribing easier. Previously, patients had to get approval from two concurring neurologists to get a CBD oil prescription. Now, only one physician has to sign the prescription.
Some epilepsy patients can now turn to Epidiolex, the first FDA-approved drug that uses CBD. Approved in 2018, it can only be used for two diagnoses: Lennox-Gastaut syndrome or Dravet syndrome. Nevertheless, physicians favor it over CBD oil when they can use it because Epidiolex is scientifically proven to be effective in some patients and there are no questions about its purity or dosage, says Dr. Perry. For at least some patients, Epidiolex also is covered by insurance – a big advantage over CBD oil.
But another reason the hype over CBD oil has died down is because it’s available everywhere and people are learning themselves what it can and can’t do, Dr. Aboumatar says. He hears about patients taking CBD oil for all kinds of ailments tied to pain, anxiety, and sleep. Since it’s essentially an over-the-counter drug, there’s no way for physicians to stop this. But they can try to monitor it, he says.
“We’re seeing a movement to self-medicate in a way,” Dr. Aboumatar said. “I just try to encourage [patients] to tell us what they’re taking, so that way it doesn’t interfere with other medications” and blood test results, he said.
Even when treating intractable epilepsy, neither CBD oil nor Epidiolex would be the first medications most physicians reach for, Dr. Perry says. As for treating other conditions with CBD, he says “there’s limited evidence so it’s probably reasonable to try in the right situations.”
Tex Med. 2019;115(9):42-44
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