In recent years, lawsuits directed against the federal government’s prohibition of cannabis have tried—and repeatedly failed—to knock down marijuana’s Schedule I status.
A recently filed lawsuit, however, suggests the legal wall against cannabis legalization should not even exist, due to a mistake made more than 25 years ago.
In late May, Sue Sisley with the Scottsdale Research Institute (SRI) in Arizona, along with three military veterans, filed a legal action against the Drug Enforcement Administration (DEA) in the U.S. Court of Appeals for the Ninth Circuit.
Sisley, a medical doctor, has made headlines in recent years for her groundbreaking clinical trials that have examined the potential benefits of using marijuana to treat veterans suffering from Post Traumatic Stress Disorder (PTSD). The results of that study are expected to be published later this year. She has also publically called out the federal government over what she has described as the poor quality and low potency of the U.S.-government grown cannabis that federal law requires scientists use in their limited, federally-approved cannabis studies, as provided via the National Institute on Drug Abuse (NIDA).
The ‘Catch 22’ of Schedule I
According to a press release from SRI, the DEA has for decades now “applied the wrong legal standard in determining whether a drug has a ‘currently accepted medical use’ under the Controlled Substances Act,” the law that since 1970 has classified cannabis as a Schedule I Drug, defined as having “no currently accepted medical use and a high potential for abuse.”
Research is needed to move cannabis out of Schedule I. But that research can't be done with Schedule I drugs.
That classification, the release continues, is “directly responsible for the current ‘Catch-22’ many have noted, where marijuana is in Schedule I because of the absence of clinical trials, but no robust clinical trials can be conducted because it is in Schedule I.”
“We’re focused on getting ‘real world’ cannabis flower in the lab,” Sisley said in an email to Leafly. “The NIDA/DEA monopoly represents one of the final and most onerous barriers to cannabis efficacy research. We want to do clinical trials with whole flower. Marijuana’s current schedule is part of a system that is preventing that from happening.”
Reconsidering a 1992 test
The lawsuit seeks a review of the DEA’s interpretation of the phrase, that marijuana has “no currently accepted medical use in treatment.”
According to the court petition, the DEA uses a five-part test that originated in 1992 when the agency considers whether a drug or other substance can be considered for “accepted use in medical treatment” in the United States. That test looks at:
(1) Whether a drug’s chemistry is known and reproducible
(2) Whether there are adequate safety studies
(3) Whether there are adequate and well-controlled studies proving efficacy
(4) Whether the drug is not accepted by qualified experts
(5) Whether the scientific evidence is not widely available
The new lawsuit claims the DEA-created test has no basis and rests on “flawed and outdated case law.” It also requests the Court vacate and set aside that 1992 five-factor test—while also seeking a “review of DEA’s final determination that marijuana must be placed in either Schedule I or II” of the Controlled Substances Act.
New realities and international treaties
Matt Zorn is an associate at Yetter Coleman, the Houston law firm that is filing the lawsuit on behalf of Dr. Sisley, the three veterans and the SRI. Zorn said the DEA is not paying attention to the realities of how cannabis has been used medically over the past several decades.
The lawsuit, he told Leafly, is “about challenging the rule that DEA uses to evaluate rescheduling petitions.”
Zorn noted that DEA officials have been doing their job by applying a standard for cannabis that a court, at one point, approved. However, he continued, “we just don’t think the full body of evidence was before the court then.”
One other issue, he said, is the federal government’s reference to international treaty obligations when the DEA pushes back against cannabis legalization. He noted that Canada and other countries that have legalized cannabis have found ways around that dilemma.
Zorn said the lawsuit’s opening brief is scheduled to take place this August.
Researchers want to study real-world cannabis
“The federal government has repeatedly said it is powerless to reschedule marijuana because of the absence of clinical trials,” said Sisley. “But what we’ve shown over the past few years is that there are few randomized controlled trials (RCT) because of marijuana’s scheduling. They have set an unattainable standard by demanding RCTs but not allowing for real-world cannabis study drug to be utilized. So you’re in the classic situation of garbage in equals garbage out.”
Moving cannabis to a Schedule III classification, which encompasses drugs with moderate to low potential for physical and psychological dependence, “wouldn’t legalize marijuana or make marijuana an FDA approved drug, but it would allow researchers to start obtaining real-world cannabis to study,” she added.