The heavily secured farm is surrounded by fencing, guards in towers and lock vaults. The sprawling 12-acre, outdoor marijuana farm and growing room is the only federally sanctioned marijuana grow in the country.
“The National Institute on Drug Abuse is the only agency that is allowed under the federal law … to actually be in charge of the manufacturing and distribution of cannabis for any purpose,” ElSohly said. “We at the University of Mississippi, we're acting as the agent for the government to carry out that function.”
Before researchers can obtain marijuana and start their studies, they need three things: an approved investigational new drug (IND) application from the FDA, a letter of approval from NIDA and a Schedule 1 clearance from the DEA. The IND requires researchers to contact NIDA about the particular marijuana that’s available because details, from strain to dosage, are required on the application.
DEA approval is needed for possessing and transporting the marijuana and researchers must prove they have a secure facility to store and keep track of the marijuana. Once they have both FDA and DEA approval, researchers can contact NIDA to obtain their marijuana.
Outside of the University of Mississippi’s contract with NIDA, ElSohly said he and the other researchers at Ole Miss are also conducting marijuana research of their own. Even though federally approved marijuana is right outside their door, they still have to go through the process of applying for it.
With a new $68.8 million contract, however, NIDA plans to help marijuana researchers by producing and growing products at the Mississippi farm that more closely mimic what dispensaries are selling to medical marijuana users.
“The products were quite limited, as far as what we could get from them (before),” Wallace said. “Now, the NIH is coming out with a lot of different products for research, as far as oils, extracts and different strains that have different levels of THC (the psychoactive cannabinoid in marijuana) versus CBD.”
NIDA’s marijuana grow at Mississippi is producing more varieties of marijuana that should be more similar to medical marijuana in the states that have approved it, ElSohly said. It’s also growing 30 times more marijuana than it did under its last contract with NIDA, two signs that researchers and NIH branches are requesting much more marijuana for medical studies.
Current research
Limited grant availability to fund those requests means that researchers need the backing and funding of a major university — as Vanderah has with Arizona or Wallace has with UCSD — or business investors. Britain-based GW Pharmaceuticals has turned investor funding into marijuana research advances in the United States. Its British base allows GW to work with marijuana grown in its own greenhouse in the U.K.
“We’ve got a full pipeline of products that are in the clinics, that have gotten through the preclinical steps,” said Steve Schultz, GW’s vice president of investor relations. “We’re looking at cannabinoids in a very large number of different therapeutic areas.”
Among those products are Sativex, a full-plant marijuana extract with both THC and CBD, and Epidiolex, a purely CBD extract. While Sativex is approved for multiple sclerosis patients in 27 countries, it’s still not approved in the United States. Epidiolex is still being tested in clinical studies.
GW extracts the marijuana’s cannabinoids in the company’s greenhouses in Britain, so only the finished Sativex or Epidiolex products enter the United States. It still needs DEA licensing to bring marijuana-based products into the country, but it has total control over the quality of marijuana.
“I think having a significant amount of variability in these medical marijuana products is a problem for research,” Schultz said. “It doesn’t result in research that has the required level of integrity because the product itself that you’re testing tends to be different every time you test it.”
Any differences from one cultivation to another have the biggest impact on whole-plant marijuana, Schultz said, which is why the company only works with extracts. Very little information about the quality and properties of federally-provided marijuana was given to U.S. researchers in the past.
While marijuana-based medicine is still in its early stages, Vanderah emphasized that it’s no different than the development process for other medications.
“I think that we are today where we were with narcotics 30 or 50 years ago,” Vanderah said. “I hope that we can advance the cannabinoid field much quicker with all that research we've done for the last 100 years on narcotics.”
