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D.C. Policy Summit – Researchers Working on First-Ever Federally-Approved Medical Marijuana Study Fighting to Overcome Significant DEA, NIDA Obstacles

The 10th Annual DuPont Summit on Science, Technology and Environment Policy held in Washington, D.C. on December 1 is usually reserved for issues like equitable access to broadband technology or building sustainability in policy or cybersecurity risk management.

This year, the summit also included a session on cannabis, “Medical Marijuana-Miracle or Madness?” – a title that suggested how polarizing the issue of medical marijuana has become in circles of academia, science and policymakers.

On hand to discuss the issue was Michael Correia, director of government relations and a lobbyist for the National Cannabis Industry Association; Gail Rand, CFO of ForwardGro, a grow facility in Maryland certified for cultivation under the Americans for Safe Access (ASA) Patient Focused Certification (PFC) program; David Mangone, legislative analyst for Americans for Safe Access; and Dr. Sue Sisley, researcher and president of Scottsdale Research Institute.

Every speaker told their story: Correia’s was about what the industry needs and his work as a lobbyist (“Although I care about federal legalization, it is years away. My focus now is on Congress to respect the states and allow states to go forward and operate in a safe spot.”); Rand’s story of being an “accidental advocate” in medical marijuana due to her child Logan’s serious epilepsy (“I wanted to give Logan when he was four years old a chance at this medicine.”); and Mangone’s story about difficulties with government agencies and how that affects policy.

All of the presentations were compelling, but the story of Dr. Sisley’s work in her study of medical marijuana demonstrated how difficult it is to work with the federal government on a the first-ever study of medical marijuana using federally approved marijuana grown at the only place in the U.S. where it’s allowed – the University of Mississippi in Oxford, Mississippi.

This monopoly between National Institute on Drug Abuse (NIDA) and the university has existed since 1968, and costs taxpayers $68 million every five years, most recently in 2015.

Sisley first began her work on PTSD and cannabis at the University of Arizona, where the lab trials for marijuana ran afoul of the stigma of cannabis and the fear that any university-related study would create trouble when that university wanted to get federal grants on other research that it wanted to do.

They fired her in July, 2014, and terminated the study, which resulted in a windfall of press that actually helped Sisley’s cause. “It was actually a huge gift to the study because we got two years of free coverage,” she said. “It drew a big spotlight on the barriers for marijuana research and the cannabis research in general.”

She ultimately ended up getting access to a $2.2 million research grant from the state of Colorado, reportedly funded by state license fees from the state’s legal cannabis industry, sponsored through the Multidisciplinary Association for Psychedelic Studies (MAPS).

The project was funded over the next three years to study the efficacy of cannabis for PTSD and other conditions on an FDA-controlled trial with 76 military veterans using four different strains of cannabis.

“This is the first and only study in the world about cannabis for Post Traumatic Stress Disorder (PTSD) and that is why we couldn’t stop pushing to do it no matter how many barriers we ran into,” she said. “We had to just keep pushing on.”

Sisley and her research group got a Drug Enforcement Administration (DEA) schedule 1 license, allowing them to purchase cannabis from the University of Mississippi. “We got eight kilos ordered from the university through National Institute on Drug Abuse (NIDA), and I assumed that marijuana would come in an armored truck, but instead it showed up at the lab by FedEx delivery.”

What they got was sub-par cannabis. “We opened up the cooler and see that the marijuana is basically frozen after sitting in a freezer and locker at the DEA and NIDA for over 2 years,” she said. “This is what we are forced to use for any controlled trial, this kinda green talcum power, a very strange consistency, basically with a lot of stems and sticks that look like lawnmower clippings. This is the challenge because this sabotages efficacy from the beginning.”

They did three rounds of testing and discovered excessively high levels of mold in the cannabis, confirming its sub-standard nature. “We asked NIDA about mold testing and they said they never tested for mold,” she said. “Every medical cannabis state now has a threshold for mold in cannabis, and they never tested since 1968, with their grow monopoly. The FDA and NIDA said that we should radiate the cannabis to get rid of mold.”

So she went public in March with the mold news, and their partners at Johns Hopkins dropped out of the study because they didn’t want to be aligned with a group that critized the government. “But we were just trying to be transparent to the public,” Sisley said. She is now continuing her study at the Scottsdale Research Institute. They have 30 vets now that have completed the protocol.

Even though skittish academics have been problematic in helping her continue her lab work, it’s really the NIDA/DEA monopoly that is the major barrier to research, she said. “Ending the monopoly would not violate international treaty despite what the DEA says,” she said. “That claim is bogus.”

Cannabis, unlike other schedule 1 drugs, has to go through two additional agencies for review – the U.S. Public Health Service (PHS) and NIDA. “And those two agencies don’t have a timetable. So they can take ten years to review your study. And that is how they have impeded this research. They took three years to review our protocol that had already been approved by the FDA. During that time period of waiting, 24,000 veterans killed themselves.” They did get the Obama administration to drop the PHS review.

She said that, in two years, her study group will be ready to go to phase three trials. But the problem is that the federally approved cannabis from the Mississippi farm cannot be used for drug development research, just academic research. “We won’t have any drug supply for phase three,” she said. “That is why we want to license other growers. If we don’t, we will get to phase 3 and not be able to do anything. Physicians won’t get on board if a drug does not do phase 3 trials.”

Sisley now has a more personal relevance to her lab studies about medical marijuana. For 46 years, Sisley had never tried cannabis. But she was diagnosed with breast cancer this year, and is using high THC oil to try to prevent recurrence.

David Hodes

David Hodes

David Hodes is based in the greater Washington DC metropolitan area. He is the former editor of seven different business magazines, and has contributed feature articles to several business/lifestyle publications and national cannabis magazines. Hodes is also a former field producer for CBS News, NBC, NFL Network, ESPN and other media outlets; worked as a news promotions producer for two network affiliates; and was the morning news editor for a third network affiliate.

He is member of the National Press Club, and deputy booking agent for the National Press Club Headliners Committee.

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