What if the DEA reschedules THC and CBD but not cannabis?
Last week we asked the question, “Why is the U.S. rescheduling cannabis important to you?” As often happens in life, one thing leads to another and this week we have another question: What if the U.S. Drug Enforcement Administration (DEA) reschedules THC (delta-9-tetrahydrocannabinol) and CBD (cannabidiol) but doesn’t reschedule cannabis? Our thanks to reader K.S. for sharing background information.
Cannabis has been a Schedule 1 drug in the United States since the establishment of the Controlled Substances Act (CSA) in 1970 but it was illegal prior to this date. The CSA identifies the DEA and the FDA (Food and Drug Administration) as the two bodies that determine where drugs fit in the Schedules 1 – 5.
There is a lesson to be learned from the case of opium that is a Schedule 1 drug. Long ago, scientists extracted the active ingredients of opium that are included in pharmaceutical products such as morphine, codeine, hydrocodone and oxycodone. In other words, there is a precedent for the DEA approving the chemicals derived from a drug but not the source of the derivatives that remains Schedule 1 and federally illegal. This means oxycodone is federally legal in the U.S. but, of course, opium is not.
Synthesized THC has already been approved by the DEA and the Food and Drug Administration (FDA) and is being sold in drugs. Marinol is an FDA approved drug used to relieve nausea and vomiting associated with chemotherapy and to treat loss of appetite in AIDS patients. Marinol is a Schedule 3 drug and synthetic THC is the active ingredient. Similarly, Cesamet is an FDA approved, Schedule 2 medicine available through prescription. The active ingredient is Nabilone, a synthetic cannabinoid with a chemical structure similar to THC used in the same applications as Marinol.
There is another characteristic that marijuana and opium share. There are no FDA approved medicines that are smoked and for justifiable reasons. Ssmoking is a poor way to deliver a medicine. It is difficult to administer an accurately measurable dosage when a drug is smoked. Second, smoking itself is dangerous. Smoked marijuana contains over 400 different chemicals and carcinogens including most of the hazardous chemicals found in tobacco smoke. This is important because since the passage of the 1906 Pure Food and Drug Act, any drug that is marketed in the United States must undergo an approval process to ensure claims of safety and therapeutic value are supported by clinical evidence. This also keeps unsafe, ineffective, and dangerous drugs off the market.
The FDA approval process is long and arduous. GW Pharma (NASDAQ: GWPH) announced it was commencing Phase 1 Clinical Trial of a potential treatment for epilepsy on September 18, 2013. By that time, GWPH had been conducting extensive pre-clinical cannabinoid research for five years. We first reported on GWHP and their work on January 16, 2015 because this product, Sativex, had reached a late stage clinical trial point and failed. Epidiolex which was also in a late clinical trial stage was a fall-back application “…still a year away from possible approval.” That approval stretched out another two and one-half years.
The potential good news from GWPH’s recently FDA approved drug Epidiolex is a fundamental difference from Marinol and Cesamet. It is the first drug approved by the FDA that is derived totally from the cannabis plant. The chemical contents are not created synthetically. This might complicate the DEA’s case for separating rescheduling of THC and CBD from the cannabis plant but they have around 90 days to figure it out.
Can CBD and THC be approved while cannabis is not? Unfortunately, it does appear possible. A 1999 report by the Institute of Medicine, a highly regarded organization chartered by the National Academy of Sciences summarized the results from the most comprehensive, scientifically rigorous review of smoked marijuana. It did not recommend using smoked marijuana but concluded the active ingredients in marijuana could be isolated and developed into a variety of pharmaceuticals. When you combine this with the precedent of opium, it seems like a most likely path the DEA might try to take.
What’s the solution? As we said last week, the only real answer is for U.S. lawmakers to reschedule or de-schedule cannabis at the federal level. The U.S. federal law must change cannabis so it is not a Schedule 1 drug. Unless this happens, the progression of legalization will mean more people are at risk in relationships with the U.S. and that could include government employees after October 17, 2018.