Head of the Multidisciplinary Association for Psychedelic Studies (MAPS) Rick Doblin has been working on getting marijuana approved as a medicine for years, and recently announced the Drug Enforcement Administration (DEA) is starting to open up to the idea of licensing more than one producer of cannabis product for research.
The only organization with exclusive control over the legal supply of marijuana is the National Institute on Drug Abuse (NIDA) which gets its supply from a single contractor at the University of Mississippi. NIDA has had a monopoly on research-grade marijuana for over 48 years now. MAPS was in a legal battle for over 10 years just to break the NIDA monopoly, which was instrumental in entering the industry and receiving approval from the Food and Drug Administration (FDA).
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The problem with NIDA was not just the fact that the quality and variety available from them was limited, but also that there was little to no enthusiasm for studies that could demonstrate the positive qualities of cannabis. It only showed the negative ones. Additionally, NIDA’s marijuana is only available for research, and not for sale to patients following FDA approval.
“The FDA requires that the Phase III studies be conducted with the exact same drug that the sponsor of the research is trying to market,” Doblin explained in a recent interview on the Pacifica drug policy show Century Lies. “So as long as the NIDA policy was in existence, FDA would never accept its marijuana for use in Phase III.”
MAPS is about to start a Phase II study of the use of marijuana as treatment for post-traumatic stress disorder. However, because they have to use the marijuana provided by NIDA, their studies are limited.
Since federally approved researchers are prohibited from purchasing their supply from state-licensed providers in Colorado or Washington, NIDA is the only legal source for procuring the needed materials.
This has become extremely problematic for the research company, as MAPS could not get all the different strains it needed for the study because they were unavailable from NIDA. MAPS required one strain with 12 percent THC and 12 percent cannabidiol, but were unable to obtain it as NIDA does not produce it.
Thanks to the DEA’s new decision to authorize other legal growers with more variety and initiative, companies and institutions like MAPS can apply for contracts with these suppliers in order to be able to ensure the marijuana they use in their studies and experimentation is the same they would plan to make available for the development of marijuana medication.
Doblin has expressed his frustration toward the federal government on several occasions. He complained that on the one hand, the government has said there is not enough evidence to support claims that marijuana is not as harmful as most people believe, but on the other hand, the government has not given researchers the opportunity to prove otherwise.
“And so,” said Doblin, “now the DEA says they’ll end the NIDA monopoly, that evidence can be gathered…It’s going to take four to six years, it could be $15 to $25 million to gather it. But at least it’s possible now, whereas before it was not possible.”