Last week, a young child somewhere in Texas became the first person in the state to fill the state's most unusual prescription – a small container of cannabis oil.
Only a handful of Texas patients or physicians will ever deal with this exotic script, and yet the introduction of cannabis oil has been met with a great deal more hoopla than most medications.
"People in the general public think that this is exceptionally effective and totally safe, so the patient expectation is very high," said Karen C. Keough, MD, an Austin neurologist and one of only 18 Texas physicians registered to prescribe cannabis oil legally. "That's compounded by the political controversy about whether marijuana in general and [cannabis oil] in particular should be out there or not."
The Texas Legislature paved the way for dispensing cannabis oil in 2015 by passing the Compassionate Use Act. It legalized only the sale of cannabidiol, or CBD, which is non-euphoric and has low levels of tetrahydrocannabinol (or THC), the psychoactive element in marijuana. The Texas Medical Association at the time testified in favor of further study on the use of marijuana products as medicine.
CBD has been touted as helping with a variety of medical problems, including epileptic seizures, post-traumatic stress disorder, and multiple sclerosis. The Compassionate Use Act allowed the use of CBD for one narrow medical condition – refractory epilepsy.
Of the 17 states that permit CBD use for medical reasons, Texas has the shortest list of potential patients, Dr. Keough said. In fact, only three dispensaries are licensed in Texas: Compassionate Cultivation, located in Manchaca near Austin; Cansortium Texas (or Knox Medical) in Schulenburg; and Surterra Texas, whose website says it is located the Austin area.
M. Scott Perry, MD, the medical director of neurology at Cook Children's Medical Center in Fort Worth, said the law passed amid a lot of hype about the effectiveness about CBD. People broadcast success stories on social media about ending their seizures, and those victories were amplified in the news. Scientific studies done since then – and experience among patients in other states – shows that CBD probably will help a small subset of patients with chronic seizures.
"It's definitely another tool in the toolbox," Dr. Perry said. "But if you base it on what people saw in the beginning, which was that everybody on Facebook was seizure-free – it's not that good."
One of the problems with CBD is that the quality is so erratic that many brands – which can be ordered off the Internet – have no medicinal content at all.
The three Texas dispensaries are more likely to have consistency due to strict state regulations, but they do not have the same production standards or abilities as pharmaceutical companies. That means the quality in some cases may vary not just from brand to brand but from bottle to bottle, Dr. Perry said.
"While all CBD oils are high in CBD, they're also different," he said. "One might have 99 percent of CBD and the other might have 97 percent of CBD and 3 percent of something else, and that 3 percent of something else is important."
Dr. Keough said she has tried to address this concern that by working directly with one of the dispensaries, Compassionate Cultivation. She was personally involved in the operational planning for extraction and medicine production to make sure the oil would be consistently produced. She said it is essential for prescribers and patients to have confidence that the medicine contain the ingredients at the concentration on the label, every time.
"There will be none of this, 'I don't know what's in the bottle and is it going to be the same the next time I get a bottle?'" she said.
Dr. Keough serves as Compassionate Cultivation's chief medical officer, and she says she has a small financial stake in the company. She says her role is comparable to physicians who advise traditional pharmaceutical companies about best practices.
Another problem is the price: Physicians in other states have also found that dosages that actually treat seizures are often expensive: up to $1,500 to $2,000 a month, Dr. Perry said. CBD is not covered by insurance in Texas.
But the excitement over the availability of cannabis oil may be rendered moot soon. Dr. Perry said drug maker Greenwich Biosciences is expected to get FDA approval for a pharmaceutical-grade version of CBD called Epidiolex this summer. Assuming that happens, the oils produced by the dispensaries still might have value for experimental purposes, but physicians and patients are more likely to turn to an FDA-approved drug that is covered by insurance.
Nevertheless, patients are eager to try out CBD. Dr. Perry said one of his first conversations about CBD took place last week with a patient who has tried everything to stop his seizures and only been met with disappointment.
"He's a kid who is at such high risk for death every day that I certainly can't hurt him any more by letting him try CBD," Dr. Perry said. "It's worth a shot."
But he said in most cases, other drugs and other options make more sense.
"I found that when I get done having the conversation with the families about the science and which drugs work and whatever, most of them are not as gung-ho about it at the end," he said. "They're like, 'You're right – why don't I try something else in the meantime.'"