The FDA recently gave the go-ahead to Yale University researchers and a Connecticut pharma company to study the use of cannabis- based tablets in the treatment of chronic pain and stress. This double-blind, randomized, placebo-controlled clinical trial with human subjects will be the first of its type ever in the United States.
Why is this such a big deal?
Well, with all the talk and hype about medical marijuana laws many people assume that cannabis has been well-researched for its effectiveness. But, those people would be wrong because even though cannabis has a long history of being prescribed for a range of medical concerns, the United States government has strict limitations on conducting cannabis research (for more information see our resource page: History of Cannabis).
What many people don’t know is that about 50 years ago, the US government awarded a contract to the University of Mississippi to grow cannabis solely for research purposes. Sounds good, so what’s the problem, right? Well, there are lots of problems when you consider other government actions and rulings.
First, if you want to do plant-based cannabis research in the US, you need to have a Schedule 1 drug license AND you’re required to use the cannabis crop grown at the National Institute on Drug Abuse (NIDA)-approved facility at Ole Miss.
Still not seeing the problem? Well consider this. You’re part of a research team who wants to develop a plant-based drug using cannabis and study its effect on particular medical problem, let’s say nausea and vomiting in people who are undergoing chemotherapy. Your team gets through the Phase 1 and Phase 2 trials of testing the cannabis-based drug for safety, reliability and efficacy.
Hooray!! Now onto Phase 3!! You’re ready to test the drug formulation you developed with patients who are undergoing chemotherapy and have nausea and vomiting. But hold on – you can’t do that because according to the Federal Government cannabis is dangerous, has no medicinal use and is a Schedule 1 drug, making it illegal. (for more information see Controlled Substances Act on our resource page: Cannabis Terms)
Now you’re stuck, because you can’t test the cannabis-based medication you developed with patients because it’s illegal. And even if you did and it worked, you wouldn’t be able to bring it to market as long as cannabis is classified as Schedule 1 drug.
So, is it any surprise that for the past 50 years in the United States, no commercially available plant-based medications have come to market using the cannabis crops grown at Ole Miss?
Right now, the first and only plant-based FDA approved medication available in the US is sourced from plants grown in the United Kingdom. It’s called Epidiolex® and is a prescription cannabindiol (CBD) that’s used to treat severe seizure disorders.
The only other cannabis plant-based medication available in the US is Nabiximols (Sativex®), which is currently in a Phase 3 trial for pain relief associated with cancer. Nabiximols® is an oral spray of 1:1 THC:CBD and guess what? The cannabis source is also grown in the UK not in the US.
That’s why the FDA’s recent approval of a human study using cannabis plants from a Connecticut grower is a big deal. A federal agency is actually supporting cannabis research, AND with growers other than Old Miss. This is a promising leap forward from the last 50 years when the only plants allowed for research were tightly controlled by the government. Crops in Connecticut are grown in different soil, under different conditions, and come from different plant varietals. All of these factors are meaningful in botanical research and support the opportunity for different outcomes.
And maybe even more importantly, the Federal government is partnering with a State-run cannabis program expanding the opportunities for research.
With FDA’s interest is the effects of cannabis for medical purposes and the expansion of research options, maybe we’ll see the removal of cannabis from the Schedule 1 list of drugs in the near future.