Doing large studies of marijuana's potential as medicine means getting it removed from an official federal list of substances with no official medical use—which requires more proof of its potential as medicine.
Medical marijuana is now available in 28 states. But a big obstacle to research on marijuana as medicine is that it’s listed by the federal government on what’s called Schedule I. Assignment to Schedule I means that the Food and Drug Administration does not recognize a legitimate medical purpose to a substance.
At a session on medical marijuana at the annual meeting of the American Association for the Advancement of Science on February 19th, I asked researcher Ryan Vandrey, of the Johns Hopkins University School of Medicine, about getting marijuana off of the list of Schedule I substances.
RV: “Well, it can’t come off of Schedule I to a different schedule until the traditional drug development work has been done, and I don’t think the traditional drug development work really can be done while it’s Schedule I. It just makes large Phase III trials in hospital-based programs near impossible.”
SM: “So it’s a catch-22.”
RV: “It’s a catch-22. So I think the only way to really get around that is kinda two paths. One, you just unscheduled it completely. Alcohol is not scheduled, for example, so that’s the pathway that some of the states have gone, just making it available. Or treating is as like a botanical, herbal product. The other way would be to kinda wait until we get more targeted, specific products. So not whole plant cannabis, but maybe more specific formulations with specific cannabinoid profiles, would be the other way.”
SM: “Your life would be easier with it off?”
RV: “Oh, absolutely. [laughs] Without a doubt. And just to clarify, the limitations that we have in doing research is that we are limited to doing research with products that are available through the federal drug supply program. They have quite a bit, but they don’t have everything. And then the limitation is even using their product we have to go through extra levels of regulatory scrutiny and experience substantial delays in doing our research.”
[The above text is a transcript of this podcast.]