Is Cannabidiol an answer to improve seizure control?

Scientists and researchers are now looking at the plausible use of cannabidiol for seizure control with Dravet syndrome — a very severe form of epilepsy.

Most known seizures can be controlled by anticonvulsant medications such as clobazam, stiripentol, topiramate, and valproate or by surgery. In many cases, it is noted that some people require lifelong treatment to control seizures. Uncontrolled seizures can have a drastic negative impact on daily life and result in high medical risks — and costs.

“Commonly misdiagnosed,” according to Epilepsy Foundation, “Dravet syndrome is a rare genetic epileptic encephalopathy (dysfunction of the brain).” It can begin in the first year of life in healthy infant and can be lifelong.

Cannabidiol as a treatment for Dravet syndrome brought increased attention in 2013 with “Charlotte’s Web” case — where a mother provided her child with cannabidiol (CBD) and tetrahydrocannabinol (THC) known as Charlotte’s Web — named after an American girl, Charlotte Figi, who developed Dravet Syndrome as an infant. At age three, she had 300 seizures a week despite being on seven different medications. She was then put on a regular regime of cannabidiol that calmed her brain and helped to limit her seizures reduce to two or three a month.

In a conversation with The Denver Post, Charlotte’s mother Paige said, “I know what we’re doing is not the FDA path, but it just got me two more years with Charlotte.”

Her story has been featured in various documentaries that led to her being described as “the girl who is changing medical marijuana laws across America,” according to National Journal. Since that time some states have passed laws to allow for the use of cannabidiol for treatment of certain medical conditions, including epilepsy.

Cannabidiol (CBD) is a medical marijuana derivative known to reduce seizure frequency in patients with epilepsy and is a major non-psychotic component of marijuana.

Cannabidiol (CBD) is a medical marijuana derivative known to reduce seizure frequency in patients with epilepsy and is a major non-psychotic component of marijuana.

Cannabidiol (CBD) is a medical marijuana derivative known to reduce seizure frequency in patients with epilepsy and is a major non-psychotic component of marijuana

 

According to Dr. Orrin Devinsky, MD, director of New York University’s Langone Health Comprehensive Epilepsy Center, “there is an enormous unmet need for better treatments for children and adults with epilepsy.”

According to Drug Enforcement Administration, “cannabidiol is considered as a Schedule 1 drug under Controlled Substances Act. Schedule 1 status is given to drugs with no currently accepted medical use and has high abuse potential.”

Times reported Dr. Devinsky’s “disbelief” in FDA; he said, “federal government still lists marijuana as a Schedule I drug, which classifies it as highly addictive and having no redeeming medical value. And that makes getting approval to study its benefits both necessary and difficult. Those advocating to reform marijuana laws believe that the drug should be classified at a lower level, if not declassified completely.”

Of interest is the fact that Dr. Sanjay Gupta researched marijuana in 1944 with the NY Academy of Science, commissioned by New York Mayor Fiorello. They found marijuana did not lead to significant addiction.

British company GW Pharmaceutical conducted a clinical trial that relied on their leading liquid formulation product of Cannabidiol called Epidiolex. The cannabidiol-based prescription drug, Epidiolex, has not yet been approved by the U.S. Food and Drug Administration.

As of today, GW Pharmaceuticals expects to file for FDA approval of the drug.

A survey that appeared in New England Journal of Medicine on May 30, 2013, showed that 76 percent of doctors would approve the use of medical marijuana. Another study of 1561 physicians conducted by Quinnipiac University found that 89% of those people surveyed support “allowing adults to legally use marijuana for medical purposes if their doctor prescribes it.”

The New England Journal of Medicine concluded that for patients with the Dravet syndrome, the use of cannabidiol resulted in a “significant reduction in convulsive-seizure frequency.”

“Cannabidiol can be a potent weapon against the disorder,” wrote Dr. Devinsky in a recent NYU Winter 2018 newsletter. Dr. Devinsky tested the chemical in 120 children and young adults and reported reductions in seizure frequency. Another research published in the New England Journal of Medicine saw a significant drop in the number of seizures from 12.4 to 5.9 per month in fifty-two children with the Dravet syndrome who took the medication over a fourteen-week test period.

Devinsky noted, “conducting studies can be difficult as researchers have limited access to marijuana due to federal regulations and even more limited access to cannabidiol; there are also increased financial and time constraints.”

Dr. Devinsky has written some research findings on cannabidiol as a treatment for Dravet Syndrome. He was part of a team of few doctors who took part in the first study of cannabis’ effects on epilepsy that had been approved by the Food and Drug Administration.

“We now have solid, rigorous scientific evidence that in this specific syndrome, cannabidiol is effective at reducing seizures,” Dr. Devinsky, the study’s lead investigator, Dr. Devinsky said in an interview with the Rolling Stones.

After reaching out to Dr. Devinsky over an email, he replied, “I am sorry — on vacation now and have had more than 400 academic and patient-related emails and issues to respond to when I return. Almost everything I know has been published and is on PubMed or an NY Times editorial I coauthored.” On further requesting him, he directed me to the links to all his published studies on PubMed.

In another finding presented at the American Epilepsy Society Annual Meeting in December 2017, the use of cannabidiol was found to be well tolerated and generally safe for children and adults presenting with Dravet syndrome with 39 percent reduction in seizure frequency.

These findings are regarded by experts in the field of epilepsy to be especially important because there are so few other new drugs or treatments on the market.

“The development of new drugs for epilepsy is paramount,” said Maria Roberta Cilio, director of research in pediatric epilepsy at the UCSF Benioff Children’s Hospital in San Francisco in a talk with International Business Times, “There is a critical need for new therapies, especially for childhood-onset treatment-resistant epilepsies that impair quality of life and contribute to learning and behavioral disorders,” she added.

According to Epilepsy foundation, Dr. Devinsky said, “as a doctor, I would gladly prescribe marijuana products for many of my patients who failed existing therapies if it were legal in my state. Until we have the scientific data, we should make medical marijuana available to physicians who care for people with treatment-resistant epilepsy and their patients.”

According to Washington Post and Food and Drug Administration reports, “a new class of epilepsy medications based on an ingredient derived from marijuana could be available as soon as the second half of 2018 in the United States, pending Food and Drug Administration approval.”

In September 2014, US Senators — Kirsten Gillibrand and Charles Schumer wrote a letter to US Department of Justice Attorney General Holder requesting him “to provide the State of New York with a waiver that would prohibit federal prosecution from the importation of Cannabidiol in the rare cases where medical marijuana is imported between two states with legalized medical marijuana, and the amount is small, finite, and prescription-based. The measure is a healthcare imperative for those who suffer from epileptic and seizure disorder and will greatly improve the lives of these children.”

As Devinsky said in a CNN interview, “natural substances are not necessarily safe and effective. They need to be evaluated rigorously.”

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