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A Letter from the Executive Director- Fight For Access Edition

My teeny tiny federal perspective…

Flying over the US, seeing no boundaries or walls of separation between states, as it should be… on my way to drop the Federal Senate Companion Bill (S.1333). I cannot help but get excited and a little nervous.

I arrive and meet with a few families for dinner the night before the big day and press conference. We revel in what our lives have become. We experience the overwhelming sensations that not only are we in over our heads, but that we actually have the power, the will, and the heart to get this done!

The Federal Senate Companion Bill opened and was authored by Senator Orrin Hatch and has 6 co-sponsors. Senator Hatch was the father of the Dietary Supplement Health and Education Act (DSHEA) so we could not have asked for a better person to put the pen to paper. The companion House Bill (H.R. 1635), Charlotte's Web Medical Access Act of 2015, dropped in March and already has 34 co-sponsors.

These efforts are meant to deschedule both CBD (cannabidiol) and hemp (cannabis with < 0.3% THC). This will correct outdated and antiquated regulations; this will open up safer access, allow for research and will designate parents as caretakers-- not criminals.

The sense of urgency is overwhelming. After being there, and seeing how quickly things are moving I am enthusiastic that this bill will pass. And not only that it will pass, but that can happen this year! Do not be misled, however… it will not happen without your help. I cannot stress how many times while in D.C. I heard,

“...But I need to hear from my constituents on this matter...”

That is you. Yes, you have the power to make history. #FightForAccess

With you in the fight,
- Heather Jackson

Join the Fight!

Whole Cannabis Extract of High Concentration Cannabidiol May Calm Seizures in Highly Refractory Pediatric Epilepsies

Authors: Margaret Gedde MD, PhD (a), Edward Maa, MD (b)
a - Gedde Whole Health LLC and Realm of Caring Foundation; b - University of Colorado School of Medicine


Rationale: Despite constant but interval advances in antiepileptic drug (AED) pipeline development, a large unmet need still exists for therapies to address medically refractory epilepsies. This is particularly challenging in some forms of devastating pediatric epilepsy syndromes (Dravet, Doose, Lennox-Gastaut). Evolving pre-clinical and early clinical research suggests that cannabidiol (CBD), a nonpsychoactive compound found in the cannabis plant, may be a potent antiepileptic agent. A botanical extract from a form of cannabis known as Charlotte’s Web™ hemp oil (CWHO), which contains CBD at a ratio of >16:1 relative to other cannabinoids, has recently become available in Colorado for medical use.

Methods: CWHO is available for medical use under supervision by a Colorado treating physician in patients with appropriate state licensure for the use and possession of medical marijuana. Parents of children with severe, medically refractory epilepsy and who had received CWHO for at least three months were invited to participate in a survey of the effects of CWHO. Thirteen patients were identified that met criteria. Data regarding epilepsy diagnosis, general epidemiological information, baseline and post treatment seizure frequency, side effects, and average dose, were collected in a deidentified manner. Simple statistics were used for data analysis.

Results: 11 of 13 patients (parents) completed interviews. 4 were diagnosed with Doose syndrome, 2 with Dravet syndrome, 1 with Lennox-Gastaut syndrome, 1 with metachromatic leukodystrophy, 1 with cortical dysplasia and 2 with idiopathic epilepsy. Patients had received an average of 10 AEDs in their lifetime.

11 of 11 patients (100%) reported reduction in weekly frequency of motor type seizures (generalized tonic-clonics plus tonic, myoclonic and atonic seizures). Of the 11, 8 reported 98-100% reduction, 1 reported 75% reduction, and 2 reported 20-45% reduction in weekly seizures relative to baseline at the end of three months. Seven of 11 children achieved this reduction within the first month of treatment. At three months, 5 of the 11 children (50%) were seizure-free. Of the 2 children who have received CWHO for more than one year, both have continued to enjoy the seizure reduction attained after 3 months of CWHO treatment.

Average therapeutic dose of CBD (as administered in CWHO) ranged from 4 to 12 mg/kg/day, in 2 or 3 divided doses. CWHO was remarkably well tolerated. Side effects included sedation and unsteadiness, similar to the profile of existing medications.

Conclusions: While the sample size is small, high concentration CBD extract (CWHO) appears to reduce seizures in a highly refractory pediatric epilepsy population. Despite its being a whole plant extract, no psychotropic effects were reported, in keeping with previous clinical studies involving CBD. We propose that the results of this survey can inform the design of a large, randomized, double blinded, placebo-controlled efficacy trial to investigate CWHO as an adjunctive therapy in highly refractory pediatric epilepsies.

In Press with the American Epilepsy Society, 67th Annual Meeting, December 6-10, 2013

Survey of Current Cannabidiol Use in Pediatric Treatment-Resistant Epilepsy

Catherine Jacobson, Ph.D. & Brenda E. Porter, M.D., Ph.D.
Department of Neurology, Stanford University

Introduction

Severe childhood epilepsies are characterized by a high seizure burden and are often associated with neurodevelopmental delays. When traditional medications fail to control a child’s seizures, families look to alternative treatments to help their children. One of these alternative treatments that has become more widespread over the past year involves the use of a compound from the Cannabis plant, Cannabidiol (CBD). CBD is a non-psychoactive compound that has been shown to have anticonvulsive properties in a number of animal models of epilepsy. In limited human adult trials, CBD has shown promise as an anticonvulsant with very few negative side effects. The purpose of this survey was to understand current use of CBD in children with treatment-resistant epilepsy.

Methods

The Stanford University institutional review board judge the study exempt from requiring full review by the board. Study data were collected and managed using REDCap electronic data capture tools hosted at the Stanford Center for Clinical Informatics. The CBD survey consisted of 24 questions that measured clinical factors, the effect of CBD on the child’s seizure frequency and side effects. The CBD survey was presented to a Facebook group composed of parents dealing with issues surrounding the use of CBD to treat seizures in children with treatment- resistant epilepsy. The survey link was posted for two weeks. Twenty parents responded to the survey. Nineteen responses met the inclusion criteria, which were a diagnosis of epilepsy and CBD use. Survey responses were descriptively analyzed.

Results

  • Sixteen of 19 parents reported a reduced seizure frequency during CBD treatment
  • Three of these parents reported complete seizure freedom during CBD treatment
  • A child had tried an average of 12 AEDs before the parent began CBD treatment
  • The most often reported side effects were better mood, increased alertness, better sleep and drowsiness
  • Common negative side effects often associated with other AEDs were notably absent from parent reports about CBD

Conclusions

  • Parents are administering CBD to their children as an alternative treatment when traditional anti-seizure medications have failed.
  • Parents report a high rate of success in reducing seizure frequency with CBD treatment
  • CBD treatment appears to be behaviorally well-tolerated, with some positive side effects not normally noted with other AEDs
  • A pharmaceutical-grade formulation of CBD would reduce the risks associated with artisanal preparations that contain THC
  • Further study is required for objective measurements of CBD’s safety, tolerability and efficacy

Acknowledgments

This work was supported by the NIH/NINDS Epilepsy Training Grant 5T32NS007280. We would like to thank the members of the Pediatric Cannabis Therapy Facebook Group for their time and effort in filling out the survey.

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