Several organizations have filed amicus briefs in support of Dr. Sue Sisley, who is petitioning the Ninth Circuit to rule that the DEA’s five-part test to assess if a drug has medical use and can be rescheduled is arbitrary and capricious.
Rice University’s Baker Institute, the Iraq and Afghanistan Veterans of America (IAVA) and several doctors filed the amicus briefs Oct. 6 in support of Sisley’s petition, which ultimately seeks to facilitate medical cannabis research for veterans suffering from post-traumatic stress disorder (PTSD).
The briefs urge the court to grant Sisley’s Petition for Review, which would allow researchers to study the effects of cannabis as a treatment for PTSD.
Cannabis has long been classified as a Schedule I substance under the Controlled Substances Act, which severely limits researchers’ ability to access cannabis for clinical trials.
“The Veterans Administration can’t do anything with medical marijuana because it’s a Schedule I substance, [and] Sue Sisley and her company couldn’t go and get marijuana for her clinical trial from anyone other than a government-authorized supplier because it is a Schedule I drug,” Susman Godfrey attorney Erica Harris, who represented IAVA in its amicus brief in support of Sisley’s petition, told Cannabis Business Times and Cannabis Dispensary.
Sisley and other researchers have been critical of the quality of the medical cannabis produced by the University of Mississippi, the only organization licensed to grow cannabis for medical research in the U.S.
Sisley and her team sued the Drug Enforcement Administration (DEA) and the Justice Department last year after they applied for a license in 2016 to grow their own cannabis for the ongoing study on medical cannabis as a treatment for veterans suffering from PTSD.
The DEA announced in August 2016 that it would begin accepting new cultivation license applications and received 25 applications in the year following the announcement, but the agency has not approved or denied a single one.
Following Sisley’s lawsuit, a federal court ordered the DEA to explain why it has not responded to the applications, and the agency announced in August 2019 that it would take steps to approve additional cultivation licenses from the pool of applications that have been pending since 2016.
In October 2019, a federal court dismissed Sisley’s lawsuit after a judge ruled that the DEA’s announcement made the case moot.
Sisley’s new petition comes after the DEA denied a veteran’s request to reschedule cannabis in an effort to advance research on medical cannabis and PTSD. While this most recent unsuccessful request to reschedule cannabis is certainly not the first, Harris said Sisley’s petition likely stems from recent changes to the Chevron Deference Standard for Administrative Rulings.
“Basically, they’ve ordered the DEA to re-assess it because it makes no sense what they’re doing,” Harris said. “There are 33 states and all these territories that are using medical marijuana. There’s all this evidence in literature saying medical marijuana can have all these different medical uses, and it doesn’t make sense to keep it on a Schedule I status because that prevents all sorts of studies and good things from happening to better understand this drug.”
The IAVA represents more than 400,000 veterans from the Iraq and Afghanistan wars, and its main priority is to reduce the veteran suicide rate, Harris said.
“They’ve worked very hard and they’ve obtained legislation in prior years to prioritize reducing veteran suicide and to get them more resources, but nothing is helping in the sense that the veteran suicide rate keeps going up,” she said.
There are only two drugs authorized by the FDA to treat PTSD, Harris said, and neither gives relief to a sizeable percentage of the veteran population suffering from PTSD. The IAVA, therefore, wants medical cannabis to be studied as a potential treatment, and for it to be covered by veterans’ benefits.
“IAVA is not taking a position on whether medical marijuana should be allowed as treatment for PTSD or not,” Harris said. “IAVA’s position is, we need clinical studies of what’s on the market to know whether that’s safe and effective for the long-term for the treatment of our veterans because if it’s not, they should be able to know that and not use it, and doctors should stop prescribing it. And if it is, that’s a life-saving treatment because you can control the symptoms of PTSD and decrease the suicide rate.”
The Ninth Circuit must decide whether they will hear oral arguments in the case, and if not, Harris said they will issue an opinion.
If the court orders the DEA to re-assess cannabis’s classification as a Schedule I drug, she said it could have a tremendous impact on the industry, as well as veterans suffering from PTSD.
“If marijuana is removed from Schedule I and moved to a different schedule, it will open up the ability of the Veterans Administration and other groups of scientists, like Sisley’s organization and others, to perform clinical studies on the type of marijuana that is prescribed legally by doctors in states where it’s legally prescribed and the type of marijuana people buy at their local dispensary in the states and territories where it’s legal,” Harris said. “If that evidence shows that medical marijuana is an effective treatment for the symptoms of PTSD, that would be life-changing for these veterans, a certain percentage of whom come back from our wars with this syndrome.”
The federal government has indicated that preventing veteran suicide is one of the nation’s highest priorities, she added, and while Congress has passed legislation saying it is important to conduct clinical studies on potential treatments for PTSD, the DEA has consistently said it will not move cannabis from Schedule I.
“It’s so inconsistent with what they’re saying we need to prioritize as a nation, and it’s so detrimental to a population to which the country owes a debt,” Harris said. “I’m very hopeful that the petition is granted and marijuana is rescheduled, and over the course of the next 10 years, we see the science come out.”