TMC PULSE

T M C » P U L S E | J U LY 2 0 1 8 27 a legal gray area. The problem with that, doctors say, is it's difficult to determine the precise potency of the drug the patient is receiving. "It's kind of risky, but these parents and families are desperate for their kids," said Gretchen Von Allmen, M.D., chief of pediatric epilepsy with McGovern Medical School at UTHealth and a pedi- atric neurologist at Memorial Hermann-TMC. Under the state's compassionate use law, patients' medicine must contain at least 10 percent CBD oil and no more than 0.5 percent THC. For context, recreational marijuana might measure 20 percent THC. Those restrictions ensure Texas CBD oil makers maximize the compounds that provide symptom relief while minimizing those that can cause side effects or a high (Trysten Pearson, for his part, said he experiences no side effects from CBD oil). Still, Texas's CBD law is consid- ered "pretty restrictive" compared to those involving cannabis in other states, said Katharine Neill Harris, Ph.D., a drug policy fellow at Rice University's Baker Institute for Public Policy. Texas patients must get two doctors to approve their use of CBD oil. And they are only eligible for a prescription if they have what's called "intractable" epilepsy—mean- ing at least two other medications have failed to help them. Harris said she wouldn't even call Texas' policy a "medical marijuana" law. Perhaps the biggest hurdle of all is price. The Pearsons pay $350 per month for Trysten's CBD oil— a typical amount—and the cost isn't covered by insurance. That's unlikely to change, experts say, as long as the federal government views cannabis as a Schedule I drug with no accepted medical use. In May, a federal appeals court sided with the Drug Enforcement Administration, ruling that CBD oil is a Schedule I controlled substance. But in June, the U.S. Food and Drug Administration approved Epidiolex, a CBD oral solution to treat seizures associated with rare and severe forms of epilepsy. Morris Denton, CEO of Compassionate Cultivation, which provides the CBD oil used by the Pearson family, has launched a discount program with the Epilepsy Foundation Texas to help subsi- dize CBD oil costs for low-income Texans. So far, the program has served 12 of its approximate 300 customers. Meanwhile, the Texas law doesn't permit people with any diagnosis besides intractable epilepsy to use CBD oil, even though some other states allow those with multiple sclerosis, late-stage cancer, Crohn's disease and other conditions to access CBD oil or medical mari- juana. That has frustrated some patients and advocates, but skeptics say more research must be done to evaluate whether and how CBD oil can treat those illnesses. "Now that the people of Texas are seeing the real impact of this medicine, not just the potential impact, we need to figure out how to get it into other people's hands that are as deserving as people with intractable epilepsy," Denton said. "That's up to the legislature to figure out how to make that happen." EXTRACTING CANNABIDIOL OIL Chris Woods, director of process, extraction, and testing at Xabis, uses a machine to extract pure plant oil from cannabis. The machine uses a carbon dioxide (CO2) extraction process in a closed-loop system to recapture more than 90 percent of the CO2 used. After extraction, several steps including purification, distillation and chromatography will yield oil with cannabinoid purities as high as 99 percent. Now that the people of Texas are seeing the real impact of this medicine, not just the potential impact, we need to figure out how to get it into other people's hands that are as deserving as people with intractable epilepsy. That's up to the legislature to figure out how to make that happen. — MORRIS DENTON CEO of Compassionate Cultivation

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