Arizona-based researcher Dr. Sue Sisley is spearheading an extraordinary lawsuit against the U.S. Drug Enforcement Administration (DEA), demanding that the agency stop dragging its feet on a years-old promise to end the federal government’s monopoly on growing cannabis for clinical research.
The DEA has two weeks to explain why it's stalled these applications from expert growers.
Sisley is a medical doctor who recently made history with her federally-approved studies regarding the effects of cannabis on military veterans with PTSD. The results of those PTSD studies are expected to be released later this year.
Her next scheduled study will look at how late-stage cancer patients can perhaps use cannabis for pain relief.
With the help of two Texas attorneys who are working pro bono, Sisley’s Scottsdale Research Institute (SRI) is calling on the U.S. Court of Appeals for the District of Columbia Circuit to order the federal government to follow through on the DEA’s 2016 announcement in the Federal Register.
In that announcement, DEA officials said they would permit other facilities to grow and manufacture cannabis for clinical trials and research.
Applications put on ice
For more than 50 years now the federal government has relied on a farm at the University of Mississippi, via a contract with the National Institute on Drug Abuse (NIDA), to produce all the cannabis used in research projects across the nation.
But that government-grown cannabis has come under criticism in recent years, including from Sisley and her colleagues, for its poor quality and low potency. There are also concerns by Sisley and others that the phenotypes and cultivars produced by the University of Mississippi’s crop are deliberately unrepresentative of the cannabis consumed by adults and patients in legal states.
According to the petition to the court, SRI repeatedly contacted the DEA about growing its own cannabis, to “improve drug quality and give it tighter control over dosages.” DEA officials have yet to respond. “With new trials around the corner, SRI can wait no longer.”
“We simply want them to make good on this pledge to the public,” Sisley told Leafly. “They promised the U.S. citizenry that they would finally end this monopoly and license other growers for research. And they’ve not followed through on this pledge.”
Demanding an explanation
DEA officials have declined to comment on the litigation. “We are still working through the process and those applications remain under review,” an agency spokesperson told the Associated Press last month.
The DEA 'isn't saying yes, and it isn't saying no. Until they respond, there's nothing to go to court with, nothing to appeal.'
Sisley wonders if this three-year-long delay might be due to something outside of the DEA’s control, and perhaps involve other federal agencies.
Matt Zorn, one of the attorneys at the Houston-based Yetter Coleman law firm working on the SRI lawsuit, declined to comment on that speculation. Instead, he’s focusing on the damage done by the government’s inaction.
“They’re not saying yes, they’re not saying no,” Zorn told Leafly. “Until the agency says something, there’s nothing to go to a court with, nothing to appeal. It’s stuck in purgatory. So what we’re trying to do is get the agency to explain why they’re not processing these applications. It’s gotten to the point where we think a court needs to step in and do something about it.”
Unleashing the writ of mandamus
Zorn and his colleague Shane Pennington are using an unusual procedure to get the legal wheels rolling in this case: a petition for a writ of mandamus.
“We’re asking one judicial branch of government to order a different branch of government to do something, and they don’t like doing that,” noted Zorn. “What we’re essentially arguing is that there’s agency action that by law was required to have been done. Not only hasn’t it been done, but it hasn’t been done and then some.”
Zorn added that there aren’t many times when a writ of mandamus gets granted by a court.
“It’s a very extraordinary remedy reserved for extraordinary circumstances,” he said, “but we carefully investigated the facts and thought there was substantial merit to this case.”
Unshackling science
The DEA’s response to this lawsuit is due before the end of August.
For their part, Sisley and Zorn are optimistic their legal strategy will have results which, if SRI prevails, could set a legal precedent.
“It’s really about unshackling science,” Sisley said. “It’s been shackled by politics in the U.S. now for over 50 years, ever since this monopoly was granted to the University of Mississippi.”
“We’ve been trying to ignite a national conversation about this,” she continued, “and trying to persuade people to pressure the government to license other growers for (cannabis) research. I don’t want to be a farmer, but I want to do research. I know what it takes to have good compliance. We’re trying to open the door for all researchers.”
Dr. Sisley, said Zorn, did everything required of her by law, “and it’s still not working.”
In cases like these, in order for change to take place, he added, “you need to show someone followed the rules and did everything right, and it didn’t work out. And that’s what we got here. We got a person who tried to work within the system and encountered system failure, at least at this juncture.”
