Would you smoke this stuff in the name of science?
The only cannabis currently legal for use in FDA-approved clinical trials is so bad that it’s harming marijuana clinical research trials, according to a new federal appeals court filing by a pioneering researcher seeking to grow her own.
Dr. Sue Sisley, who for years has battled the government to get her clinical trials up and running, filed the action late last month in U.S. District Court, naming Attorney General Willam Barr and the federal Drug Enforcement Agency for extreme delays in granting cultivation permits for her Arizona-based Scottsdale Research Institute.
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The filing alleges that federally-supplied marijuana – grown on a single 12-acre farm run by the University of Mississippi – is so woeful that it’s sabotaging research, including her landmark studies of PTSD and pain. The document also notes the irony of a bud bottleneck created by the same federal agencies that insist more clinical study is necessary to shape policy.
“It arrived in powdered form, tainted with extraneous material like sticks and seeds, and many samples were moldy,” according to the action. “Whatever reasons the government may have for sanctioning this cannabis and no other, considerations of quality are not among them. It is not suited for any clinical trials … simply put, this cannabis is sub-par.”
[Read the entire filing below]
Sisley is asking the U.S. Court of Appeals for the D.C. Circuit for a writ of mandamus, a court order compelling a government official to fulfill his or her duties. In this case, Sisley wants Barr and the DEA to process the cultivation license she applied for nearly three years ago.
Sisley started that process shortly after the DEA announced a new policy to increase the number of cultivators for research, and Congress amended the Controlled Substances Act to require the Attorney General to publish notices of application after 90 days.
But, after more than two years, the government has yet to respond to her application. “Thus, agency action has been unlawfully withheld,” the filing reads.
And Sisley kept the receipts, submitting to the court several pages of exhibits (below) to demonstrate due diligence.
If successful, the legal action would force the government to take the first step toward processing Sisley’s application, which could lead to breaking a 50-plus-year monopoly the University of Mississippi has held on cultivating legal research cannabis.
And maybe not a moment too soon.
“The quality of the cannabis from this farm — and its delivery logistics — are poor,” according to the filing. “Some has languished on the shelves for years. It looks more like green talcum powder than medical grade cannabis.”