Signed by Gov. Greg Abbott in June 2019, HB 3703 allows patients with epilepsy and seizure disorders, multiple sclerosis, autism, terminal cancer, and neurodegenerative conditions to pursue physician-guided and monitored treatment with low-THC medical cannabis oil that’s rich in the compound cannabidiol (CBD).
The Texas low-THC medical cannabis program, with a proven track record of success for patients with intractable epilepsy, was just expanded significantly. The growing list of qualifying medical conditions means the Texas medical community needs to prepare for increased patient awareness and interest in this treatment option.
“As far as I know, there is no other state where the physician is required to issue a specific prescription and guide therapy the way that we do in Texas,” says Karen Keough, MD, child neurologist and epileptologist at Child Neurology Consultants of Austin and Chief Medical Officer of Compassionate Cultivation, a licensed medical cannabis provider. “I feel very strongly that is a vital difference that sets us apart, and that it is a very appropriate way to run a program like this.”
The new law, which went into effect immediately after it was signed by the Governor on June 14, allows physicians approved by the American Board of Medical Specialties or the Bureau of Osteopathic Specialists to establish treatment plans for qualifying patients and prescribe state-regulated, non-smokable medical cannabis extract products that have a maximum of 0.5% THC by weight.
In addition to the program expanding beyond intractable epilepsy to include all forms of epilepsy, other qualifying medical conditions include:
- Amyotrophic lateral sclerosis (ALS) and other incurable neurodegenerative diseases
- Multiple sclerosis (MS)
- Seizure disorders
- Terminal cancer
“These conditions have had issues with the prior medical management with FDA-approved therapies,” says Edward J. Fox, MD, PhD, Director, MS Clinic of Central Texas, Central Texas Neurology Consultants PA, and Clinical Associate Professor, University of Texas Dell Medical School. “We welcomed the addition of another option.”
An MS specialist, Dr. Fox notes the potential benefits include improvement in symptoms such as bladder spasms, pain and spasticity. He also underscores the therapy’s ability to reduce pain and anxiety related to respiratory difficulty in neurodegenerative diseases, as well as its effectiveness minimizing pain and nausea associated with cancer treatments.
“As with any new therapeutic agent, education about its use regarding appropriate patients and doses will be necessary,” Dr. Fox says.
Dr. Fox does note that some of his colleagues may be skeptical about the benefits of the therapy. He also is aware that the effect marijuana has on cognition and motivation may present an issue for some individuals. However, Dr. Fox underscores the fact that the small amount of THC and the higher amount of CBD in the prescription product will offer more therapeutic benefit without causing memory issues or additional fatigue.
Learning More About CBD
Karen Keough, MD, child neurologist and epileptologist at Child Neurology Consultants of Austin and Chief Medical Officer of Compassionate Cultivation, says that in her experience, for many of her patients with refractory epilepsy the most notable benefits of cannabis oil are reduction in seizures and low reported side effects compared with many conventional medications. Reported side effects were somnolence, sleepiness, diarrhea and GI upset.
She urges her fellow physicians to educate themselves and one another about medical cannabis as a valid treatment option.
“It is our responsibility to learn as much as we can about how to help patients explore this very valuable treatment,” Dr. Keough says. “We know that it is very safe in the setting of treating refractory epilepsy, and we need to be prepared to help educate our patients.”
Texas CBD and Intractable Epilepsy
Dr. Keough says that while some of her peers may have initial concerns, the treatment of patients suffering from epilepsy in Texas has been eye-opening.
“There’s definitely a lot of skepticism still out there today. In the past year and a half, there has been progress in how people view it in my professional sector because they’re learning more about it,” she says. “There’s already a good deal of data on using [low-THC cannabis oil] as medication for epilepsy. We know how well it works.”
According to Dr. Keough, 12% of her patients receiving cannabis oil for the management of intractable epilepsy experienced a greater than 90% reduction in seizure activity. And of 113 patients on the treatment between two and 10 months, 56% reported improvement.
“We started to see an impact on a significant number of Texans’ lives,” says Morris Denton, CEO of Compassionate Cultivation. “That got a handful of legislators interested in taking a long, hard look at the existing program and try to figure out ways to improve it.”
First Steps and Law Changes
Intractable epilepsy patients first started receiving low-THC medical cannabis oil through the state program in early 2018. It marked the full implementation of Senate Bill 339, known as the Texas Compassionate Use Act, which was signed into law by Governor Abbott in 2015.
The legislation required the Texas Department of Public Safety (DPS) to create a registry of board-certified specialized physicians who treat patients with intractable epilepsy. Once a physician was registered in the Compassionate Use Registry of Texas (CURT), he or she could develop a treatment plan for the patient, involving the dosage, administration and monitoring of a patient receiving low-THC medical cannabis.
Among the other mandates in the original bill: All medical cannabis products must contain a maximum of 0.5% THC and a minimum of 10% CBD by weight; and physicians needed to obtain a concurring opinion from a second physician qualified to prescribe low-THC cannabis before initiating the treatment plan.
It’s notable that in the new legislation, lawmakers eliminated the requirement for secondary physician approval, and while keeping the 0.5% THC limit in place, have eliminated the CBD minimum, which will allow dispensing organizations to create a wider range of product formulations to address patient needs.
Added Benefit with Autism
Joshua Rotenberg, MD, pediatric neurologist and epilepsy specialist with Houston Specialty Clinic, was on board with the expansion of the Compassionate Use Program (CUP), as he has seen a positive effect on children with refractory epilepsy who also have autism and aggression.
“When you look at the improvement in aggression in those kids, only a third had no improvement in aggressive symptoms,” Dr. Rotenberg says. “Previously, the only choice was to give them antipsychotics. To have an alternative that has such a positive effect is a game changer for a lot of families.”
Epilepsy and autism often go hand in hand, and the majority of children impacted by autism have significant sleep problems. According to Dr. Rotenberg, 50% of children with both epilepsy and autism taking cannabis oil to manage their epilepsy also experienced an improvement in the quality of their sleep. Dr. Keough has also observed similar benefits.
“Most people will find that they sleep better or their behavior is better,” Dr. Keough says. “And they’re less aggressive or their irritability has improved or their anxiety has improved. That makes it a win-win, especially in patients who have tried a lot of other medicines that have had a lot of problems with side effects that limit therapy.”
“This is a life-changing medicine, and it’s not just for those diagnosed with intractable epilepsy. An ever-growing body of research indicates CBD medicine may be beneficial for a whole host of conditions.”
— Morris Denton, Chief Executive Officer of Compassionate Cultivation
Inside Look at Texas Medical Cannabis
Compassionate Cultivation, headquartered in the Austin area, is one of the organizations that dispenses low-THC cannabis oil products, including a tincture and an oral spray. The company manufactures the oils with plants that are grown at its facility without the use of pesticides.
“We wanted to create the best, most consistent medicine that delivers on its promise and helps change people’s lives,” Denton says. “We’re providing something to the state that they can be proud of.”
Jason Hamilton, PhD, Director of Quality Assurance/Quality Control at Compassionate Cultivation, explains how the company manufactures its medical-grade cannabis extract:
“We do a CO2 extraction that’s safe and clean for both humans and the environment. Then, the additional processing methods that we go through — the only solvent that we end up using in our entire process — is a food-grade ethanol,” Hamilton says. “So we are not adding any hydrocarbons or any of the other dangerous chemicals that may end up leaving behind residual solvents.”
Once the cannabis oil has been extracted, lab technicians conduct a series of purification methods, yielding a product that is about 90% to 98% pure cannabinoids.
“We are able to fine-tune that final formulation to bring it back within our variance,” Hamilton says. “Every time a patient comes in to get their medicine, they are getting the same dose, within a 5% variance. So there is consistency and quality in the product that we put out.”
Additionally, Hamilton’s team conducts a residual solvent test, residual pesticide screen, heavy metals analysis and microbial screening on each batch.
Forecast for the Future
As physicians and patients more frequently utilize low-THC cannabis therapy, companies such as Compassionate Cultivation will continue to fine-tune their product to best meet the needs of all parties involved.
“We want to see this industry improve and we want to see our products improve. We want to know how this is working for many of our patients,” Denton says. “The goal is to help provide a better service to our prescribers as well as a better product to our patients.”
This article was previously published in MD News San Antonio.