U.S. researchers turn to Canada for help

SAN DIEGO» In a rare move, the U.S. government has approved the importation of marijuana extracts from Canada for a clinical trial, highlighting a new avenue for American researchers who have long had trouble obtaining the drug for medical studies.

The University of California San Diego’s Center for Medicinal Cannabis Research announced Tuesday the Drug Enforcement Administration has OK’d its plans to import capsules containing two key cannabis compounds — CBD and THC — from British Co lumbiabased Tilray Inc. to study their effectiveness in treating tremors that afflict millions of people, especially those older than 65.

Marijuana remains illegal under federal law, making it impossible for researchers to simply obtain forms of the drug from one of the many medical marijuana programs approved by individual states — even a state with a pot culture as prevalent as California’s.

Instead, federal law dictates that researchers typically must obtain any weed for clinical trials through the National Institute on Drug Abuse, which uses cannabis grown at the University of Mississippi. Scientists have long com plained about the difficulty of obtaining that marijuana, as well as its limited quality, variety and usefulness for clinical research.

UCSD researchers said they needed marijuana extracts in capsule form because it’s easier to monitor the doses that patients receive, compared with having patients smoke or vaporize it. They also believed many older patients would be reluctant to participate in the study if they had to inhale the drug, according to Dr. Fatta Nahab, a UCSD neurologist and the tremor study’s principal investigator.

NIDA doesn’t offer capsules, so the researchers spent about two years going through regulatory hoops to obtain permission to import the drug from Canada, where medical marijuana is federally legal and where recreational sales begin nationwide next month.

Paul Armentano, deputy director of the marijuana law reform organization NORML, said that illustrates how badly American researchers need alternative sources for cannabis. The House Judiciary Committee last week passed a bill to require the Justice Department to issue at least two more licenses to U.S. facilities to grow pot for research.

“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,” Armentano said.

Marijuana compounds have been imported for clinical trials before, including by Britainbased GW Pharmaceuticals, which won approval this year to sell its purified CBD capsule, Epidiolex, to treat severe forms of epilepsy — the first cannabis drug approved by the U.S. Food and Drug Administration. While GW Pharmaceuticals developed that drug inhouse before bringing it to the U.S. for testing, Tilray said it can work with researchers to develop the cannabis formulations they hope to study.