SCHEDULE I?, NOT ALWAYS

The DEA’s recent decision to continue to classify Cannabis as a Schedule I drug was not expected by many. The hope and belief that Cannabis has proven itself to possess attributes that would justify a Schedule II or III classification were not realized.

A change in Schedule would federally validate Cannabis as having medicinal value and would allow legal possession with proper documentation. Under federal guidelines, Schedule I drugs, including Heroin, Cannabis and LSD may not be possessed legally.

As this is taking place, GW Pharmaceutical is anticipating the release of Epidiolex, their cannabinoid based anti-seizure drug. Epidiolex is a Cannabis medicine that is virtually pure CBD. It begins as whole plant Cannabis, is extracted from the plant material and then every molecule other than CBD is removed using very high tech processes. It is anticipated if Epidiolex is approved by the FDA it will be a Schedule III drug. Since 1985, the drug Marinol, which is a laboratory synthesizedTHC, has been treated as a Schedule III drug.

So the FDA in conjunction with the DEA can determine that based upon whether a medicine is “whole plant cannabis” or a single molecule of CBD or THC will determine it’s schedule; I.e. safety and efficacy are no longer important.

If you accept that logic, then you must ask, what is the difference between:
1. A “single molecule” extract, such as Epidiolex, which is extracted from the cannabis plant and then purified,
2. A “synthetic cannabinoid” medicine, such as Marinol, made in a laboratory to duplicate the properties of the cannabis plant, and
3. A “cannabinoid” medicine that is extracted from the cannabis plant along with hundreds of other molecules.

Some of the differences are:
1. The dosage required of whole plant cannabinoid medicine for a specific condition is significantly less than what is required of molecular cannabinoid or synthetic based medicines for the same condition,
2. Whole plant cannabis medicines are able to be prepared with varying combinations of the various cannabinoids to provide multiple alternative medications, which may be more effective, to the patient versus a “one size fits all” medicine,
3. Whole plant Cannabinoid medicines contain all of the major and minor cannabinoids that work in conjunction with the body’s endocannabinoid system for the greatest natural effect.

So what does all of this mean?

In conclusion, there are differences between the various Cannabis medicines. “Single molecule based” and “molecular cannabinoid” medicines are made to duplicate the best properties of Cannabinoid medicines. Pharmaceutical companies spend billions of dollars in research and development in their efforts to create effective medicines. For the most part, they create phenomenal products. But, some patients just do not respond to their medications or experience side effects that are not tolerable. For those patients we must have medications that offer an alternative to pharmaceuticals.

In my practice, I find Cannabinoid medicines to be that alternative.  Over the past 10 years while treating more than 6,000 patients, Cannabinoid medicines have proven effective for multiple serious medical conditions.

Author
Allan Frankel, MD

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