| Perspectives on Texas

Patients with intractable epilepsy have now had access to regulated, locally made cannabidiol (CBD) products for nearly five months, and state-licensed provider Compassionate Cultivation — where I serve as chief medical officer — has been able to get medicine into the hands of roughly 85 patients after welcoming patients into the state’s first dispensary on Feb. 8.

Because not many physicians have registered yet in the Compassionate Use Registry of Texas (42 as of June 28), doctors who plan to enroll soon will need to be prepared for an onslaught of inquiries. I have had to create additional appointments to accommodate dozens of patients seeking CBD prescriptions. Many are my own established patients who have been anxiously awaiting the start of the program, but we’ve had a lot of press exposure, so there are many new ones as well.

At the clinic I share with 10 fellow neurologists, including two other epileptologists, we have set up a screening system to make sure anyone attempting to make an appointment would qualify for CBD medicine. Most people understand the requirements, but it’s important to filter out those asking if they can get medical cannabis for purposes that aren’t legal in Texas.

But even with patients who have done their research, I find that I often need to temper expectations during the first office visit.

None of the patients I am working with have reported that their seizures have stopped completely, but about 20 percent of patients now taking our Lonestar CBD oil tincture have shown marked improvements in terms of dramatic decreases in the number of seizures they are experiencing and/or the intensity of those seizures. Ten patients have reported a greater than 90 percent reduction in seizures, and six reported a 50 percent or greater reduction. Another 20 percent have reported a decrease in seizures at a less dramatic, but meaningful level.

On the other end of the spectrum, I’ve instructed three patients to stop using the product because their seizures increased. This doesn’t necessarily indicate that CBD caused the increase, and it doesn’t mean it was a bad idea to try, but for now ceasing new medicine is the right thing to do for each patient.

This is an expected outcome — sometimes a form of medicine helps, and sometimes it doesn’t. But what I’m finding is that patient expectations are higher for prescribed CBD products than for conventional medications. A parent may say, “I want to try this because I’m anxious to get my son off his other medication.” That’s an unrealistic initial expectation; I’m hopeful it will happen for some patients, but I want us to take a wait-and-see approach.

I’m giving patients a treatment plan to increase dosages slowly, week-by-week, at home. I ask patients or their caregivers to keep a daily seizure log, so that we can look at any changes in seizure frequency and intensity.  And I’ve purposefully started patients with small doses and am only gradually increasing them. That said, the titration I’m using with patients is faster than ones they may have seen shared by organizations like Colorado-based Realm of Caring, which recommends an increase of dosage approximately every two months.

One of the other challenges has been working with patients who had been using a CBD product from out of state and now want to switch over to what is legal in Texas. What is concerning is the shaky legal status of CBD products shipped to Texas that contain any THC; according to the Department of Texas Safety, any such product is illegal. The only scenario where possession of CBD is legal in Texas is through the Compassionate Use Program.

Compassionate Cultivation has a strict, lab-tested formulation for the ratio of THC to CBD in their products. The Compassionate Use Program regulations require a minimum of 10 percent CBD weight / volume to a maximum of 0.5 percent THC. Making the conversion from other products can be complicated. Haleigh’s Hope, for example, has one product with a 20:1 ratio, which is essentially the same. But they also have products with 30:1, 15:1 and 10:1 ratios. Charlotte’s Web has several different formulations, including 6.5 percent to 0.2 percent, which works out to 32.5:1, a much higher CBD:THC ratio.

When we start to move individual patients over to our product or any other made by a licensed Texas medical cannabis provider, we can’t be sure what effect the different ratio will have. I work to match the dose of CBD that patients are currently taking, even if the THC converts to a different amount than they’re used to. Studies of Epidiolex have shown improvement in seizures with even lower amounts of THC.

One issue that must still be worked out in these early months of legal medical cannabis is what to do with patients if they are hospitalized. Hospitals need to establish policy that incorporates CUP-sanctioned cannabidiol, as this medicine is not FDA-approved. Leaving it up to parents or caregivers to administer CBD products to a hospitalized patient places undue burden on them. Hospital staff must be able to treat CBD as prescribed medicine to be dispensed like any other.

My hope for the Texas medical cannabis program is that the state is able to collect data around how patients and their physicians are utilizing this program. Objective evidence will show that having this treatment option benefits qualifying patients and strengthens the relationship between patients and physicians, and that the regulated program is a worthy endeavor.