The five-hour “Stakeholder Engagement Meeting” held February 21 to publicize the NAS Report on “The Health Effects of Cannabis and Cannabinoids” has just been posted here. (The day after the meeting we ran a quick take on it.)

The authors of the NAS report evaluated what they called the “strength of the evidence” regarding the health benefits and risks of cannabis as medicine. By far the strongest evidence, from their perspective, are randomized, placebo-controlled clinical trials (RCTs). Clinical evidence —the findings and observations of physicians who monitor cannabis use by patients— was ignored completely in the NAS Report. It wasn’t even dissed as “low quality!”

The NAS Report is already out of date with respect to epilepsy, thanks to the publication in Epilepsy & Behavior of a paper by Drs. Dustin Sulak, Russell Saneto, and Bonni Goldstein entitled “The current status of artisanal cannabis for the treatment of epilepsy in the United States.”  

Goldstein  reported on 225 patients with intractable seizures seen at her practice in the Los Angeles area. Saneto reported on 47 patients seen at Seattle Children’s Hospital. Sulak, who is based in Maine, contributed four detailed case studies. They aggregated their results:

“Of 272 combined patients from Washington State and California, 37 (14%) found cannabis ineffective at reducing seizures, 29 (15%) experienced a 1–25% reduction in seizures, 60 (18%) experienced a 26–50% reduction in seizures, 45 (17%) experienced a 51–75% reduction in seizures, 75 (28%) experienced a 76–99% reduction in seizures, and 26 (10%) experienced a complete clinical response. Overall, adverse effects were mild and infrequent, and beneficial side effects such as increased alertness were reported. The majority of patients used cannabidiol (CBD)-enriched artisanal formulas, some with the addition of delta-9-tetrahydrocannabinol (THC) and tetrahydrocannabinolic acid (THCA).”

Most newsworthy —historic, actually— is the fact that a peer-reviewed publication has acknowledged the validity of data compiled by cannabis clinicians. Goldstein and Sulak are each identified as running “a private cannabinoid medicine practice.” Kudos to the editors at Epilepsy & Behavior who recognized their findings as worthy of inclusion in their journal! Henceforth the paper by Sulak et al will have to be acknowledged as evidence when the efficacy of cannabis in the treatment of epilepsy is assessed. A wall has been breached —kind of like when the Baseball Hall of Fame enshrined the star players from the Negro Leagues  at Cooperstown.  Sulak, Saneto and Goldstein are our Satchell Paige, Buck Shaw and Josh Gibson.

In January the National Academies of Science, Engineering and Medicine (NAS) released a 400-page report evaluating  the “strength of the evidence” regarding the health benefits and risks of cannabis as medicine. By far the strongest evidence, from the NAS experts’ perspective, were randomized, placebo-controlled clinical trials (RCTs). The findings and observations of physicians who monitor cannabis use by patients —clinical evidence— was ignored completely, as we noted here. It wasn’t even dissed as “low quality!”  

But from now on, when medical-establishment experts review the evidence on cannabis as a treatment for epilepsy, the paper by Sulak et al cannot be overlooked. It’s part of “the literature.” It has been “published.” (The jargon is inherently elitist.)

Because Sulak, Goldstein, and Saneto are cannabinoid-medicine specialists who care for  patients in ways that go beyond documenting seizure reduction, their paper provides extremely pertinent information not typically found in medical journal articles. Consider the following dense, poignant paragraph listing the “non-medical risks” that physicians must bear in mind when recommending a trial of cannabis to the parents of epileptic children: 

 “Availability of a consistent supply of the medication is frequently interrupted due to horticultural, manufacturing, and economic factors. Current market prices for artisanal cannabis preparations observed in Maine, California, and online range from 5 to 50 cents per milligram. Higher dosing ranges are financially unfeasible for many patients unless they grow and produce their own medicine, a complex process that presents many potential interruptions in treatment. Sudden loss of access to cannabinoids may result in rebound seizures. Hospital admissions present challenges, and patients or their guardians often must choose between interrupting cannabis treatment and violating hospital policies that forbid self-administration of medications, especially those with Schedule I status. In one of the sites (RPS), the hospital has families sign a waiver and allows them to administer home dosing of product, but does not provide storage. The potential for disruption of medical treatment or family structure related to child protective services and other legal agencies, even when the patient and medical provider operate within state laws, must also be carefully considered on a case-by-case basis.”

Sulak et al’s bottom line:

“Overall, the safety profile of quality-controlled herbal cannabis preparations is likely equal or superior to most Anti-Epileptic Drugs… Herbal cannabis has remarkably low toxicity, even at high doses, and no lethal dose of cannabis has been described. Conversely, the morbidity of AEDs are the most common impediment to achieving full effective dosing due to multiple types of toxicity ranging from tiredness to memory problems and even death.”