Charlotte's Web

The children presented typical signs of intoxication by Δ9-THC (inappropriate laughter, ataxia, reduced attention, and eye redness) after using a CBD-enriched extract. The extract was replaced by the same dose of purified CBD with no Δ9-THC in both cases, which led to improvement in intoxication signs and seizure remission. 

 “It is important to know that legalizing marijuana would not mean greater access to potentially effective treatment for children and adults with a medical illness such as epilepsy. Cannabidiol, or CBD, is not at all marijuana.”

CBD is not medical marijuana. CBD does not get anyone high nor does it increase appetite. It may be beneficial in treating children with rare forms of epilepsy, often difficult to control with medication or other available treatments, but it does not work for everyone with seizures.

“The stories of kids having fewer seizures described in the media are heartwarming and can possibly be of some benefit – just like many other medications available to treat seizures,” Dr. Patel adds.

What are the possible side effects?
CBD can cause nausea, diarrhea, or worse, affect the liver.

Dr. Patel states, “There is nothing natural about marijuana and its components. It is broken down in a person’s liver, similar to many other medications. It has interactions with other medications and is still not fully understood. If further studies show that CBD is safe and effective, it will be sent to the FDA for official approval. If the FDA approves this medication, it will be available in the form of a prescription and no laws will need to be changed.”

“Legalization would make our jobs as medical providers more difficult as we will not know what changing, non-tested preparations a child may be getting. I understand that parents are desperate and want to help their children, however, it is dangerous to give a child or patient a product unless it has been studied properly and is the same consistent product each time.” If the ongoing trials show that Epidiolex is safe and effective, then all people can have access to it through a prescription and know that it has been properly tested and is consistent each month. Medical providers will know how to dose it and it will be regulated by the FDA.

Safety concerns coupled with a lack of evidence of efficacy in controlled studies result in a risk/benefit ratio that does not support use of marijuana for treatment of seizures at this time. Healthcare professionals, patients, and caregivers are reminded that use of marijuana for epilepsy may not be advisable due to this lack of information on safety and efficacy. 

A study by a team from Children's Hospital Colorado that was presented during the AES Annual Meeting in December 2014 and has recently been accepted for publication in the journal Epilepsy & Behavior, found that artisanal "high CBD" oils resulted in no significant reduction in seizures in the majority of patients and in those for whom the parents reported improvements, these improvements were not associated with improvement in electroencephalograms (EEGs), the gold standard monitoring test for people with epilepsy.

Additionally, in 20% of cases reviewed seizures worsened with use of cannabis and in some patients there were significant adverse events. These are not the stories that you have likely 

heard in your public hearings, but they are the reality of practitioners at Children's Hospital Colorado who have cared for the largest number of cases of children with epilepsy treated with cannabis in the U.S.

But these results should be taken with a grain of salt, Hussain said. "This is generally a pretty desperate group of patients and parents, and I think they are highly invested in the belief and the hope that these cannabis extracts are truly effective," he said.

Marijuana for Epilepsy: Weighing the Evidence, Epilepsy Notes, Andrew N. Wilner, MD, March 25, 2014

In 2011 (more than 2.5 years ago) in "Marijuana: A Viable Epilepsy Therapy?" I reviewed the possibility of marijuana (Cannabis sativa) for the treatment of epilepsy. That article concluded, "More research is needed before patients should consider marijuana for seizure relief, particularly because this represents criminal activity under US federal law and may be accompanied by adverse medical (and legal) events."

What Hasn't Changed Since 2011?

What hasn't changed is the desperation of people with uncontrolled seizures and their families. Heather Jackson, the mother of Zaki, one of the children who responded to Charlotte's web, stated in a Huffington Post video interview, "If you wanted to take my money, I would give it to you. I wanted to save my boy."^[13] Such vulnerable families need to be protected from scams, false promises, and dangerous drugs.

Conclusions

Despite the recent journalistic hype, my 2011 conclusions about "medical marijuana" have not changed. Marijuana is still a schedule I drug. It is not FDA-approved for the treatment of epilepsy or any other neurologic condition. Its medical (and recreational) use is still illegal under federal law. There are no controlled trials demonstrating that marijuana is "safe" or "effective" for the treatment of epilepsy. On the other hand, there is evidence that marijuana may be harmful, particularly in the developing brain after regular use. Synthetic cannabinoids appear even more toxic.

However, for many people with epilepsy, seizures cannot be controlled with FDA-approved medications. Other treatment options, such as the vagus nerve stimulator, responsive neurostimulation, or the ketogenic diet, may not work or may not be appropriate choices. For patients who have exhausted conventional therapies, medical marijuana, for which there is anecdotal evidence of seizure control, could be considered as an unproven, "compassionate use" alternative. Any such use of marijuana should be carefully monitored by a physician. A better alternative for children with intractable epilepsy would be enrollment in the new Epidiolex clinical trial.