On the heels of the reports that the Trump administration has convened an commission with an anti-marijuana objective, and news that the Justice Department is blocking Drug Enforcement Administration requests to allow research grows to produce high quality cannabis for studies, the Drug Enforcement Administration (DEA) has somehow arranged for a Canadian company to send high quality cannabis extracts to California based researchers.
The University of California San Diego’s Center for Medicinal Cannabis Research announced September 18, 2018 that the DEA has approved their proposal to import capsules of extracted cannabis compounds CBD (cannabidiol) and THC (tetrahydrocannabinol) for use in research. The British Columbia, Canada, based Tilray Inc. will supply the capsules so the UCSD researchers can study the two cannabis compounds effectiveness in treating essential tremors, which afflict millions of people and especially those over 65.
The UC Center for Medicinal Cannabis Research posted the news on their website:
“Scheduled for early 2019, the phase I/II trial will assess efficacy and tolerability of an oral cannabis formulation comprised of cannabidiol (CBD) and low-dose tetrahydrocannabinol (THC). Researchers say it will be the first time this combination has been studied for treatment of ET.
“This study will provide key insights,” said Fatta Nahab, MD, neurologist at UC San Diego Health and associate professor of neurosciences at UC San Diego School of Medicine. “If found to be safe and effective, cannabis would not only serve as an exciting new addition to the limited treatment options currently available for patients with ET, but it might also provide scientists with new insights on essential tremor.”
“It’s very telling that you have researchers in the U.S. willing to exert the patience and go through the regulatory hurdles to make this happen at the same time the United States has its own domestic supply source,” Paul Armentano, Deputy Director of NORML said.
The U.S. supply of cannabis comes from a single source grown under the DEA’s supervision at the University of Mississippi. The cannabis grown there is notoriously poor quality and very low in cannabinoid levels. They do not create extracts at the facility, either, which is necessary to do proper clinical studies with controlled dosages.
“It’s a really big milestone for Tilray and also just for the whole industry,” said Catherine Jacobson, Tilray’s director of clinical research. “Researchers in the U.S. have really been limited to doing research using dried flower. We have been able to prove to the FDA that we can manufacture investigational study drugs containing cannabinoids that meet their standards.”
This is good news for researchers overall, but it’s not an especially effective way to provide access to the needed drugs that will be needed. Having to receive your study medications from a foreign source is not a solution to the U.S. marijuana research supply problems. Hopefully the DEA will get authorization for regional medical cannabis cultivation in any one of the more than 30 legal cannabis states here.
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