Rescheduling Cannabis: How it Works
June 5, 2017
Just last week, DEA Chief Chuck Rosenberg made headlines when he declared “marijuana is not medicine” during a speech at a Cleveland Clinic in Ohio. He went on to say, “”if it turns out that there is something in smoked marijuana that helps people, that’s awesome… But let’s run it through the Food and Drug Administration process, and let’s stick to the science on it.” Yet, we’ve all seen dozens of headlines stating that cannabis has been proven as an effective treatment for various forms of epilepsy, PTSD, chronic pain, and much more. So if scientists, credible labs, and in some cases, even the FDA, are coming out and saying cannabis has medical value, why is the DEA still unwilling to reschedule the drug?
To understand why cannabis remains a Schedule 1 drug we have to go back to the 1970’s. Signed on October 27th, 1970, the Controlled Substances Act declared a war on drugs that we’re still experiencing the consequences of nearly 5 decades later; one which was recently given new life by AG Jeff Sessions. In order to evaluate, regulate, and enforce drug policy, then-President Nixon established the Food and Drug Administration (FDA) and the Drug Enforcement Agency (DEA). The FDA is charged with evaluating drug efficacy, regulating testing procedures, and if appropriate, recommending schedule changes based on findings that prove a drug to provide medical value. The DEA then takes the recommendation of the FDA under consideration before deciding if any action is needed.
So why hasn’t the FDA been able to convince the DEA that cannabis contains medical properties and value? They have – several times actually. By granting FDA approval to synthetic cannabis drugs like Marinol in 1999 and Syndros just this year, the FDA seems pretty convinced that there’s at least something medically valuable in cannabis. So, why then, hasn’t the DEA rescheduled cannabis?
The DEA wants more evidence. However, in order to collect that evidence, institutions wishing to study cannabis must navigate miles of red tape with minimal guidance. Assuming they can reach the point of actually needing cannabis to study, researchers hit another hurdle when they find out that there is only one provider of cannabis for federal testing purposes, which leaves them with little diversity in the study and not to mention that the cannabis they cultivate is of relatively poor quality. It’s the classic catch-22: proving the plant’s efficacy requires more research, but the DEA is in charge of granting research permits; something they have been hesitant to do.
Despite the bureaucracy, there are studies under way. One study, led by Dr. Sue Sisley, is measuring the effects of cannabis treatment for Veterans suffering from PTSD. She is working with around 60 volunteers (out of over 5,000 applicants) to find out if cannabis is a viable treatment for PTSD in hopes of presenting those findings to the DEA; it wasn’t easy though. After gaining FDA approval in 2010 the study was hit by delays until finally receiving DEA approval in 2016. “I walk in here every day and feel so honored,” Sisley said. “I can’t even tell you … just finally seeing the study implemented and the gratitude of these veterans.”
Now that evidence is being gathered, it’s only a matter of time until cannabis is legalized across the country, right? Not so fast. Even if the FDA and DEA agree on rescheduling, the Attorney General can still put a halt on the whole thing by referencing the point in the CSA about a drug’s potential for abuse. That’s right; that loosely defined characteristic essentially grants decision-making power for AG Jeff Sessions to continue prohibition, whether science says it’s medically valuable or not.
Even though cannabis advocacy and acceptance are at an all-time high, the ability to impact change remains a lopsided game. As business operators, consumers, and patients, it is imperative to understand the process behind the change and adjust our approach to legalization by enlisting our local leaders and making sure industry voices are heard in Washington DC.
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