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Pharmaceutically derived Cannabis Extracts Now FDA Approved – Good News or Bad News for Medical Marijuana Patients?

Cannabis (Medical Marijuana) has been used for medicinal purposes for millennia. (Please read our previous blog: Introduction to Cannabis and its history of use in medicine.)

However, legal use of marijuana ended in 1937 with the passage of the Marijuana Tax Act of 1937. Subsequently, marijuana was classified as a class I drug with no medical benefits. This amazing herb was given the same regulatory classification as cocaine, LSD and heroin. Since 1937 possession and use of marijuana has been against federal law in the United States of America.

The legal status of cannabis has evolved over the last 20 or so years. California was the first state to allow the use of medical marijuana with the passage of Proposition 215 in 1996. Currently 29 states (plus Washington DC) allow the use of medical marijuana and 9 states permit the use of recreational marijuana. Finally, in 2018, eight decades after being misclassified as a dangerous, useless drug, the FDA has approved the first marijuana plant derived drug, Epidiolex. 

Epidiolex is approved for use in patients aged two years and older diagnosed with Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS), which are rare forms of child onset epilepsy. These life destroying, seizure disorders are very resistant to traditional pharmaceutical treatments. Epidiolex is purified cannabidiol (CBD) and contains less than 0.1% of the other well-known cannabinoid, tetrahydrocannabinol (THC) and is being marketed by GW Pharmaceuticals.  If you would like to understand more about your endocannabinoid system (ECS) and the effects of cannabinoids on your body, you can read about it here.

At first glance, one would assume the advancement of medical marijuana in the medical community; especially with the backing of the United States, government should be praised. After all, marijuana is still classified as a Schedule 1 substance (considered the most deadly and deemed to have no medical benefits) by the Drug Enforcement Administration (DEA). However, since the FDA has approved this cannabis-based drug, reclassification of cannabis is imminent. I wonder how this reclassification of cannabis will affect other forms of CBD that are currently on the market.

CBD has gained popularity as a helpful therapeutic agent for DS and LGS. One particular strain of cannabis known as “Charlotte’s Web” exploded onto the scene on August 7, 2013 after CNN ran a story titled “Marijuana stops child’s severe seizures”. The story was about a girl named Charlotte Figi, who was suffering from Dravet Syndrome (DS), experiencing hundreds of seizures each week that could not be controlled with conventional treatments. Charlotte’s parents desperately searched for a way to help their daughter and eventually learned about the benefits of marijuana in DS patients. Charlotte started using the marijuana (CBD) extract and her seizures miraculously improved.

Since the story of Charlotte’s Web broke, many parents have brought their children to medical marijuana states in the hope that CBD extracts could also help them. The benefits of CBD extracts for Dravet Syndrome have been extra-ordinary, with unmatched abatement of seizures and essentially no side effects. CBD extracts have been safely and effectively used for DS, and there is little remaining debate about CBD’s safety and efficacy,

Is Epidiolex some sort of amazing scientific breakthrough? Hardly. Epidiolex is essentially a pharmaceutical-grade version of cannabidiol, or CBD oil, marketed by GW Pharmaceutical. The only difference between Epidiolex and products available at your local dispensary (or health food store) are the legal distinctions, stringent testing of the product for quality control and the price. The estimated price for a year’s supply of Epidiolex is between $25,000 and $50,000. Conversely, medical marijuana derived CBD oil (or hemp derived CBD oil) costs between $2,000 to $12,000 for a year’s supply. GW Pharmaceutical executive Steve Schultz had this to say about his company’s new product. “We’re not looking to impact the availability of other products on the market,” “Our goal is to provide an additional option for patients and physicians who desire a purified version of CBD for treatment of seizures.”

FDA Commissioner Scott Gottlieb, M.D. made the following statement about the approval or Epidiolex

“This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies. And, the FDA is committed to this kind of careful scientific research and drug development,” “Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients. Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes. We’ll continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and work with product developers who are interested in bringing patients safe and effective, high quality products. But, at the same time, we are prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims. Marketing unapproved products, with uncertain dosages and formulations can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.”

What happens next?

The FDA will definitely reclassify CBD as a drug with medical benefits, perhaps as a schedule IV or schedule V drug. Schedule 4 (IV) Drugs have a low potential for abuse relative to the drugs in Schedule 3. Schedule V drugs are considered to have the lowest risk for abuse potential. The F.D.A. has been sending warning letters to some companies, many of them selling hemp oil containing CBD, saying that they are illegally marketing their products as drugs and that cannabidiol cannot be sold as a dietary supplement because it is being studied for use as a drug.

Will the reclassification of cannabis-based products improve patient care by providing standardized testing of cannabis-based products? Or will this reclassification result in the loss of access to medical marijuana and much higher costs to the consumers? Only time will tell.

Have You Read The Medical Marijuana Series by Dr. Michael Rothman?

In the corresponding blogs of this series, we discuss the role of cannabis, cannabinoids, and the endocannabinoid system in the treatment of chronic pain, anxiety disorders, cancer, multiple sclerosis, and Crohn’s Disease.

  • Introduction of Cannabis and its History of Use in Medicine
  • The Role of Cannabis, Cannabinoids and the Endocannabinoid System in the Treatment of Chronic Pain
  • The Role of Cannabis, Cannabinoids and the Endocannabinoid System in Disorders of your Immune System – such as Cancer and Autoimmune Diseases
  • The Role of Cannabis, Cannabinoids and the Endocannabinoid System in Anxiety Disorders
  • Pharmaceutically derived Cannabis Extracts Now FDA Approved – Good News or Bad News for Medical Marijuana Patients?
  • Pharmaceutical Agents that Affect the Endocannabinoid System, Better than Natural Cannabis?

A full list of references can be found here.

If you’d like to learn more about the benefits of medical marijuana or if you’d like to enroll in the New Jersey Medical Marijuana Program, schedule a consultation by calling (732) 268-7663 or request an appointment online. 

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To learn more about Michael Rothman MD contact us today by giving us a call at (732) 268-7663, emailing us at [email protected] or by requesting an appointment online.

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